687 Amendments of Anna ROSBACH
Amendment 2 #
2013/2233(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. RecogniStresses the two comments made by the Court of Auditors which focus on the physical inventory and on the budgetary management; is at the same time also aware of the Agency's reply; points out that the carry-overs derive partly from the multi-annual nature, of IT development projects, partly from translations not delivered by year-end and the start of new biocides and PIC activities in the second half of the year; reminds however the Agency to respect the annuality principle of the budget as close as possible; asksinsists that the Agency to completes as soon as possible the asset inventory exercise and to enforce the asset inventory management with the new version for ABAC assets; recognises at the same time that some shortfalls are legacy driven and arise from the set-up stage of the Agency when laptops and computers were provided through Commission framework contracts and have been used by Commission staff seconded to the Agency at that time; would like to mention that according to the Agency the untraced laptops from the early days have an overall residual value of EUR 5000;
Amendment 5 #
2013/2233(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Is satisfied withAknowledges the operation of the Agency in implementing the Union’s chemicals' legislation within its legal role and responsibilities; is aware that the reserve amounting to EUR 230.198.367 in 2012 (EUR 280.565.807 in 2011) deriving from fee income will be used up in 2015 at the latest as envisaged by the REACH and CLP regulation; takes note that the reserve is managed through service level agreements with two different banks (EIB and Central Bank of Finland) in accordance with standards agreed by the Agency's Management Board;
Amendment 7 #
2013/2233(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Believes that the discharge decision should be based upon OECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common framework for all European institutions and bodies;
Amendment 9 #
2013/2233(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Recommends on the facts available that discharge canshould not be granted to the Executive Director of the European Chemicals Agency in respect of the implementation of the Agency's budget for the financial year 2012.
Amendment 2 #
2013/2221(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. RecogniStresses the comments made by the Court of Auditors which focus on the legality and regularity of transactions, on the internal controls and on budgetary management; is at the same time also aware of the Centre's reply; welcomes that the Centre itself has informed the Court in October 2011 regarding the exceedance of the payment ceiling of the framework contract and seeking advice and guidance in this matter with the spirit of full transparency; considers the immediate measures taken by the Centre as appropriate in terms of business continuity as well as corrective actions; takes note that no funds were lost and no parties were damaged; notes that the Centre has revised its grant verification policy in order to ensure the eligibility and accuracy of the costs claimed; is aware of the multi-annual activities of the Centre which caused carry- overs of EUR 8.3 million; asks nevertheless the Centre to respect the annuality principle of the budget;
Amendment 4 #
2013/2221(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Believes that the discharge decision should be based upon OECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common framework for all European institutions and bodies;
Amendment 6 #
2013/2221(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Recommends on the facts available that discharge canshould not be granted to the Executive Director of the European Centre for Disease Prevention and Control in respect of the implementation of its budget for the financial year 2012.
Amendment 2 #
2013/2220(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. RecogniStresses the three comments made by the Court of Auditors which focus on the reliability of accounting data, on internal controls and on budgetary management; is at the same time also aware of the Authority's reply; welcomes the Authority's comprehensive self-assessment of its internal control system in 2012, a process which is still on-going; notes further that carry-overs amounting to EUR 4.03 have been in conformity with the management plan or were related to payments suspended for reasons beyond the Authority's control; draws attention to additional carry-overs amounting to EUR 3.87 million for which a better budgetary management is required to be in conformity with the annuality principle;
Amendment 4 #
2013/2220(DEC)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Believes that the discharge decision should be based upon OECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common framework for all European institutions and bodies;
Amendment 6 #
2013/2220(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Is especially aware of the public interest in the decision-making process within the Authority, which is done within its legal role and responsibilities; welcomnotes that the Authority is dedicating 70% of its human resources to scientific activities, evaluation and data collection; heartens the Authority to further progress on this path;
Amendment 8 #
2013/2220(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Recommends on the facts available that discharge canshould not be granted to the Executive Director of the European Food Safety Authority in respect of the implementation of the Authority’s budget for the financial year 2012.
Amendment 2 #
2013/2215(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. RecogniStresses the three comments made by the Court of Auditors which focuses on the reliability of the accounts, on the legality and regularity of transactions and on the budget management; recognises the Agency's reply; considers the explanations given by the Agency on the introduction of the SAP accounting system to recognise revenue for all fee application types with more precision as well as the information on the validation of its accounting system for intangible assets as fully sufficient; has to point out that the decision taken by the European Court of Justice on the salary method for 2011 from 19 November 2013 has also consequences for payments with regard to the correction coefficient as well as for the applicable exchange rate from EUR to GBP as the salary adjustment package includes also these two issues; invitessists that the Agency, in close cooperation with the Commission, to finds a solution in the interest of the employees and in compliance with the rules; wonders why the Court has not commented on the issue of fees payable to schools in previous years, supports the argumentation of the Agency with regard to the payment of school fees in the absence of a European School; has taken note of the reduced amount carried over to 2013 in comparison with 2010 and 2011; is aware that the carry-over is partly related to the new building project; reminds the Agency however on the annuality principle fir the budget;
Amendment 6 #
2013/2215(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Believes that the discharge decision should be based upon OECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common framework for all European institutions and bodies;
Amendment 8 #
2013/2215(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Recommends, on the basis of the facts available, that discharge should not be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency’s budget for the financial year 2012.
Amendment 3 #
2013/2212(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. RecogniStresses the comment on internal controls made by the Court of Auditors; is at the same time aware of the Agency's reply; has carefully taken note that the Agency has drawn up an action plan to ensure reasonable assurance on cost statements; welcomes further the decision to increase the number of on-the-spot verifications to ensure the best management as to eligibility and accuracy of costs;
Amendment 5 #
2013/2212(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Believes that the discharge decision should be based upon OECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common framework for all European institutions and bodies;
Amendment 7 #
2013/2212(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Is pleased that the Agency has revised itNotes the Agency's policy for dealing with potential conflict of interest; has noted that respective details are part of the obligations of the Agency's officials and other servants under the staff regulation and conditions for employment, an information transparently presented on the Agency's webpage; has also noted that besides the signature of a declaration of commitment at the start of the term as scientific committee member, it is also necessary to sign an annual declaration on conflicts of interest;
Amendment 9 #
2013/2212(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Recommends on the facts available that discharge canshold not be granted to the Executive Director of the European Environment Agency in respect of the implementation of the Agency’s budget for the financial year 2012.
Amendment 1 #
2013/2195(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. ConsiderNotes wit noteworthyh serious concerns in this context, that the chapter Rural development, environment, fisheries and health appears with the highest error rate in the report of the Court for 2012 with 7, 9% against 4,8% in average; observes that the Court refers in its report only to one project related to the LIFE+ programme and to the internal control system of DG SANCO; is very much concerned, taking into account Commission's replies, as the error rate accounts for all policy areas; notices that there are different views between the Court of Auditors and the Commission with regard to the way in which errors should be calculated; understands that, unlike the Commission services, the Court quantifies a 100 per cent error rate of a project even if the error is solely administrative or only one part of the project amount is effected;
Amendment 1 #
2013/2195(DEC)
Draft opinion
Paragraph E
Paragraph E
E. Notes with concern that the Court of Auditors draws attention in its report to a high overall error rate; deeply regrets that this error rate has risen by comparison with the previous financial year but also notes the change in the Court's sampling method; deplores the fact that the information submitted by the Court of Auditors is not more specific to the policy areas concerned;
Amendment 3 #
2013/2195(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. With regard to the overall implementation of the budgetary headings for environment, climate action, public health and food safety in 2012, the Committee on the Environment, Public Health and Food Safety is not fully satisfied; recalls again that less than 0,8 per cent of the Union budget is dedicated to those policy instruments bearing in mind the clear EU added value in these fields and the support from European citizens for EU environmental and climate policies as well as for public health and food safety;
Amendment 6 #
2013/2195(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Believes that the discharge decision should be based upon OECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common framework for all European institutions and bodies;
Amendment 8 #
2013/2195(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. takes note that DG CLIMA has improvraised its implementation raising to 98,57% of EUR 42.585.882 in commitment appropriations and 73,44% of EUR 27.917.373 in payment appropriations; is aware that an higher implementation was not achievable partly due to an unsuccessful call jointly with Member States for the procurement of the EU ETS auction monitor and to a contract for the provisional EU ETS auctioning platform which was, in the end, at no cost;
Amendment 10 #
2013/2195(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Is again very satisfied withAcknowledges the 98,75% overall implementation of the LIFE+ operational budget; notes that in 2012 EUR 280.771.849 were dedicated to call for proposals for projects in member States, EUR 8.999.631 supported operational activities of NGOs that are active in protecting and enhancing the environment at European level and which are involved in the development and implementation of Community policy and legislation and EUR 47.283.151 were used for measures intended to support the Commission's role of initiating and monitoring policy and legislation development; an amount of EUR 17.589.277 were used for administrative support;
Amendment 12 #
2013/2195(DEC)
Draft opinion
Paragraph 10
Paragraph 10
10. Considers the progress in the implementation of six Pilot Projects (PPs) and five Preparatory Actions (PAs) amounting all together to EUR 15.733.692 as very satisfactory; is aware that the execution of these actions can be burdensome for the Commission due to the small amounts available in relation to the necessary procedures for execution (e.g. action plan, call for proposals); encourages the budgetary authority to focus in the future on PPs and PAs with true added value for the Union;
Amendment 15 #
2013/2195(DEC)
Draft opinion
Paragraph 13
Paragraph 13
13. Notes the observations by the Court of Auditors on the Executive Agency for Health and Consumers, an administrative entity of the Commission; is aware that the Executive Agency was responsible to implement EUR 37.8 million in commitments available to the Public health programme in 2012 and for EUR 35.5 million in payment appropriations; considers ECA's remarks as exaggerated as both comments are in relation to external participants and external meeting participants, issues beyond Commission's direct control; has of course taken careful note of the replies given by the Executive Agency and supports its intention to further improve the cooperation with external contractors and participants;
Amendment 17 #
2013/2195(DEC)
Draft opinion
Paragraph 16
Paragraph 16
16. Is of the opinion, on the basis of the data available and the implementation report, that discharge canshould not be granted to the Commission in respect of expenditure in the areas of environmental and climate policy, public health and food safety for the financial year 2012.
Amendment 43 #
2013/2135(INI)
Motion for a resolution
Recital A
Recital A
A. whereas security of supply, competitiveness and climate objectives are of the utmost importance for the EU, are inextricably linked and must be addressed and considered on an equal footing;
Amendment 175 #
2013/2135(INI)
Motion for a resolution
Recital I
Recital I
I. whereas studies indicate that upgrading the grids is the bestone way to improve the internal market, reduce energy costs and boost the competitiveness of industry;
Amendment 178 #
2013/2135(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas the reduction of GHG emissions will also have positive effects on public health by reducing air pollution especially in and around population centres;
Amendment 196 #
2013/2135(INI)
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. whereas increased research in various new and sustainable kinds of energy and the exchange of best practice offers the best bid to a long-term solution to the problem;
Amendment 210 #
2013/2135(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission Green Paper on a 2030 framework for climate and energy policies and expects the European Council to address these issues with realistic but ambitious responses that will work in both the short-term and long- term;
Amendment 326 #
2013/2135(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is of the opinion that support schemes and the Green Public Procurement Policy, if better used, could be an appropriate tool to incentivise the development of renewable energy sources (RES) and energy efficiency; sees an important role for the Commission in providing guidance in this regard;
Amendment 415 #
2013/2135(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that increased energy efficiency and energy savings will play an essential role in the decarbonisation of the energy sector and can help make the European economy more competitive in the long run;
Amendment 525 #
2013/2135(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Asks Member States for better cooperation and interaction at EU level in order to make national measures more consistent and to encourage companies to provide greener products and services by actively pursuing the implementation of the Green Public Procurement Policy;
Amendment 606 #
2013/2135(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Asks the Commission to assess the evolution of energy savings in the EU and the progress on the implementation of green procurement policies in Member states;;
Amendment 835 #
2013/2135(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Strongly underlines that any future EU policy must address the comparative strengths and weaknesses of its economy, particularly with regard to any free trade agreement the EU signs up to, especially in light of the planned free trade agreement (TTIP) with the US where energy prices have been decreasing significantly while efforts to reduce GHG emissions are not on par with the progress already achieved in the EU;
Amendment 14 #
2013/2113(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas plastic waste forms a large part of the growing issue of marine litter, polluting our waters and hurting the creatures living in and around the marine environments;
Amendment 15 #
2013/2113(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas more efforts should be made to gather, reuse and recycle the plastic waste that are currently polluting our waters;
Amendment 21 #
2013/2113(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas plastic waste should no longer be seen just as garbage but instead should be regarded as a resource;
Amendment 25 #
2013/2113(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas not all Member States are doing enough to sort and recycle plastic waste;
Amendment 35 #
2013/2113(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the EU could benefit in terms of job creation and, growth and security of supply from a robust effort to move towards a balanced, cradle- to-cradle circular economy, based on the concept of waste as a resource;
Amendment 52 #
2013/2113(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission's Green Paper and recognises the need for specific EU legislaction on plastic waste, as well as more rigorous implementation of the existing legislation concerning waste;
Amendment 61 #
2013/2113(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that in order to make the EC approach to waste streams more consistent within the framework of the ongoing legislative ‘fitness check’ and given that some 40 % of plastic waste derives from packaging while the packaging directive is the only one with a specific target for plastic waste collection, it is necessary as a matter of urgencyto better implement the existing directives as well as to revise that directive by separating the waste norms pertaining to the environmental sphere from the product rules and standards as such that fall under the umbrella of industrial or trade legislation;
Amendment 66 #
2013/2113(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses the need to enhance recovery and recycling of all plastics, and underlines that having integrated waste management planning in the Member States can ensure that waste treatment facilities are located where needed and have sufficient capacity;
Amendment 79 #
2013/2113(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that the EU legislation on plastic waste should define: specific targets for collection and, sorting and recycling plus a mandatory criteria for recyclability (clarifying the distinctions between mechanical/organic recycling and recovery/incineration; the aim should be a target of at least 75 % of recycled plastic by 2020); specific labelling of materials in order to inform consumers concerning their mechanical or organic recyclability; and, finally, criteria for the replacement of single-use and short-lived plastic products by reusable and more durable materials where this is possible, underlines however that this must not endanger the health and safety of the citizens - such as would be the case with for instance many single use medical devices;
Amendment 96 #
2013/2113(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Agrees that plastic waste should be treated as a valuable resource by following the waste hierarchy and promoting its reuse, recycling, and recovery; believes that in any case landfilling should be banned by 2020, without, however, incentivising as a result the energy recovery option over recycling; considers that, alongside the targets mentioned above for recycling, it is therefore advisable to introduce appropriate sanctions for incineration of recyclable and biodegradable plastics, in order to level the playing field for different plastic types; points out that this would also invert an unsustainable tendency that has until now privileged the use of virgin products over the more expensive recycled ones;
Amendment 103 #
2013/2113(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Believes that the most dangerous plastics, those that are the most disruptive to human health and the environment (such as micro- and oxo-biodegradable plastics) and those which contain heavy metals that can also make recycling processes more difficult, should be phased out of the market or banned outright where this is possible without endangering the health and safety of the citizens, as soon as possible before 2020; also believes that, as demanded by a majority of European citizens (and consumers), it is finally time to investigate to which degree it is possible to phase out or ban single-use, non- biodegradable and non-compostable consumer plastic products, also before 2020, but recognizes that in some sectors, such as the health sector, doing this would be detrimental to the health and safety of both patients and staff and therefore this sector might need to be exempted;
Amendment 130 #
2013/2113(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that for biodegradable, bio- based and compostable plastics, adequate measures should, where health and safety concerns allow it, be adopted to promote them, provided their production does not impact negatively on agricultural output for human or animal consumption; also believes that clearer information on their characteristics should be provided to consumers;
Amendment 131 #
2013/2113(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that for biodegradable, bio- based and compostable plastics, adequate measures should be adopted to promote them, provided their production does not impact negatively on agricultural output for human or animal consumption; also believes that clearer information on their characterisit important to keep them separate from the normal plastic waste so as not to damage the possibilitices should be provided to consumersof recycling;
Amendment 142 #
2013/2113(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls for more private sector investment in research and technologies aimed at obtaining more environmentally sustainable plastics and a better integration of various types in production processes and reprocessing activities, without affecting the quality of materials; considers that new technologies arecan also needed forhelp with regards to enhanced plastic biodegradation processes, waste sorting methods, mechanical recycling, eco-design and smart packaging; believes that to this end, Horizon 2020 could offer opportunities to respond to this important societal need and that the advantages wcould be far-reaching, for both the environment and citizens, from the creation of new economic activities to the reduction of marine litter and health- related risks;
Amendment 149 #
2013/2113(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for more public procurement tenders, including those of the European institutions, to include clear demands as regards the recycling of plastic waste as well as favouring the use of recycled plastic where possible;
Amendment 154 #
2013/2113(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Believes that bolderconcrete steps must be taken by both the Member States and the European Commission to tackle illegal exports of plastic waste, including stricter enforcement of EU shipment regulations, as well as stricter monitoring and inspections schemes at ports and all waste treatment facilities; notes that the application of the extended producer responsibility principle, as well as consumer awareness, have a role to play in preventing illegal exports; believes furthermore that the EU should promote a coherent waste management approach in all possible international forums, agreements and institutions; also considers it essential to have access to reliable, comparable data on waste streams, flows in and out of Europe, volumes and management systems;
Amendment 160 #
2013/2113(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Trusts thatEncourages European municipalities and local governments willto make all possible efforts to motivate citizens to adopt a circular economy concept with regard to plastic waste, by encouraging effective collecting and recycling schemes and establishing adequate recycling infrastructure such as collection points for plastic waste, especially in coastal areas; also believes they could make a major contribution towards harmonisimproving plastic waste management activities throughout Europe by agreeing on common standards and practices where this would be advantageous;
Amendment 165 #
2013/2113(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for the establishment of a European Day for plastic waste, on which citizens could return any volume of plastinitiatives to increase public awaste to predetermined points in return for appropriate monetary compensation, as a means of ensuring the supply of recyclable plastic and increasing public awareness of recyclingreness of recycling, including in schools; considers that this eventese initiatives could also include community beach cleaning activities, as a symbolic contribution to the containment of coastal pollution caused by plastic waste;
Amendment 1 #
2013/2079(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to the Council decision concerning the approval on behalf of the European Community, of the Amendments of Annex II and Annex III to the Convention for the protection of the marine environment of the North-East Atlantic (OSPAR Convention) in relation to the storage of carbon dioxide streams in geological formations 2009/0071(CNS)
Amendment 2 #
2013/2079(INI)
Motion for a resolution
Recital A
Recital A
A. whereas Carbon Capture and Storage (CCS) is a provenmising technology that potentially can significantly reduce CO2 emissions from industrial sources and fossil fuel power plants but requires private sector investment and industrial-scale demonstration to promote innovation and secure cost reductions;
Amendment 16 #
2013/2079(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the general public should always receive a full and clear picture of CCS advantages and possible threats before any projects are developed at commercial scale;
Amendment 17 #
2013/2079(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recognises that CCS deployment is needed forhas the potential to allow the EU to meet its 2050 low- carbon aspirations at least cost; affirms the urgent need to develop a range of full- chain low-cost CCS flagship projects; appreciates that instruments in addition to the EU ETS are needed to drive forward their development;
Amendment 25 #
2013/2079(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Believes that although CCS might offer part of the solution to reaching the goals for limiting greenhouse gas emissions, it would be even better if the Member States could reach these goals without the use of CCS;
Amendment 40 #
2013/2079(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Recognises that CCS development cannot take place without support from Member States and private sector investment; regrets that application of the technology has been encouraged by so few, but underlines that it is up to the individual Member States if they want to allow or encourage CCS;
Amendment 47 #
2013/2079(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Emphasises that Member States, in case they decide to make use of CCS technology, have the a key role in providing a transparent revenue stream, such as feed-in tariffs, to support the construction and operation of flagship projects while enabling operators to secure a return on their investment, and in introducing regulatory requirements such as environmental safety standards and guarantees that first-mover CCS power plants provide baseload electricity generation;
Amendment 59 #
2013/2079(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to propose creating an EU Industrial Innovation Fund from the sale of 600m allowances from the EU ETS to support the development of CCS flagship projects, other innovative low-carbon technologies, and measures to reduce CO2 emissions from energy- intensive industries, but underlines that it is important that the creation of such a fund does not lead to an increase in the overall EU budget;
Amendment 68 #
2013/2079(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Believes that longer-term CCS support should be derived principally from the production and import of the fossil fuels responsible for the release of CO2; calls on the Commission to propose the introduction from 2020 of a system requiring the purchase of either CCS certificates proving the storage of CO2 in proportion to that embedded within their products, or another form, excluding the purchase of emissions quotas, of compensating for the CO2 emissions;
Amendment 89 #
2013/2079(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Acknowledges that significant financial savings can be made by prioritising CCS clusters of industrial installations served by shared pipelines; suggests that plant operators cannot be expected to take into account the future requirements of other installations, so trunk pipelines that may eventually carry CO2 from numerous sources should often be developed through public-private sector partnerships; emphasises that Member States have a direct role to play in ensuring the provision of CCS transport and determining the availability of storage infrastructure, if they decide to allow or encourage the use of CCS technology;
Amendment 96 #
2013/2079(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Notes claims that a North Sea hub could provide storage for 100m tonnes of CO2 pa by 2030 and 500m tonnes pa by 2050; supports the use of EU funds to establish a common definition of a storage site's character, identify the geological potential of storage locations across Europe, develop pilot projects and prepare sites for commercial-scale storage in the Member States that decide to allow CCS on their territory;
Amendment 105 #
2013/2079(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recognises the concern of potential CCS developers that the requirements of the CCS Directive appear one-sided, may require private companies to accept excessive liability for CO2 storage despite their work being approved by a Member State's competent authority, and could pose a significant deterrent to investment, also recognises however the sovereign right of the individual Member States to decide to discontinue the use of CCS if they should wish to do so;
Amendment 113 #
2013/2079(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Fully accepts that any accidental release of CO2 from a storage site must be prevented, but believes thate Commission must look into whether the individual Member States mustshould share the liability once they have authorised a storage site and approved the conditions for its use; insists that the details of such liability should be a matter for negotiation between potential operators and the competent authorityies of the individual Member States;
Amendment 125 #
2013/2079(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Suggests that the CCS Directive requirement that in the event of CO2 leakage operators must surrender allowances does not take into account the costly remedial efforts required; fears that this obligation puts a further obstacle in the way of CCS development; calls on the Commission to propose a revisionreview if this is a real problem or not in its assessment of the CCS Directive;
Amendment 131 #
2013/2079(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Insists that it is no longer acceptable to invest in power plants or industrial installations likely to emit large quantities of CO2 without regard to how this will be reduced in the future;
Amendment 135 #
2013/2079(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to proposesuggest that it can be a condition, in the Member States that have decided to make use of CCS technology, of construction that adequate preparation for CCS implementation is made for all new fossil fuel power plants and high-emission industrial installations above an agreed size, except in the case of electricity demand peak shavers or when a Member State has complied with a legislative requirement to publish a roadmap indicating how it will meet its 2050 CO2 reduction goals without the use of CCS;
Amendment 139 #
2013/2079(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Welcomes the various initiatives to make use of CO2 in ways that reduce overall emissions into the atmosphere; calls in particular for the Commission urgently to assess the potential for the use of CO2 to enhance oil and gas recovery within the EU and underlines the need to focus on the long term security of the projects;
Amendment 16 #
2013/2061(INI)
Motion for a resolution
Recital E
Recital E
E. whereas there has been an increase in the mobility of the general public within the healthcare systems of their own countries, and it is now also possiblemore common for themsome to undergo medical treatment outside their country of residence;
Amendment 23 #
2013/2061(INI)
Motion for a resolution
Recital H
Recital H
H. whereas there is a need for ICT specialists, consumers, patients, healthcare professionals in general – and doctors in particular – and the public health authorities to work together in this field;
Amendment 26 #
2013/2061(INI)
Motion for a resolution
Recital I
Recital I
I. whereas health and safety as well as legal and data protection considerations should constitute a priority;
Amendment 34 #
2013/2061(INI)
Motion for a resolution
Recital J
Recital J
J. whereas it is necessary to standardiseensure that the system technology used in the various Member States, can interact with each other in order to guarantee its effectiveness;
Amendment 41 #
2013/2061(INI)
Motion for a resolution
Recital K
Recital K
K. whereas not only healthcare professionals but also patients, carers and, where necessary, other members of civil society or government entities dealing with patient care and/or counselling, should be provided with on-going training in the use of the ICT applied in healthcare systems;
Amendment 54 #
2013/2061(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Recommends that the necessary steps be taken to ensure that having access to and use of quality eHealth services benefits all EU citizens equally, without this becoming a source of social inequality and underlines the need to ensure that people that are not familiar with computers and other forms of ICT should not be left behind;
Amendment 65 #
2013/2061(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to bring forward legislative proposals to fill the legal gaps which currently exist and ensure effective implementation of the eHealth system across the EU;
Amendment 69 #
2013/2061(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses the need for doctors and, patients, carers, other healthcare professionals and, where necessary, other members of civil society or government entities dealing with patient care and/or counselling, to be provided with special training in eHealth:
Amendment 83 #
2013/2061(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Member States to share their experiences, knowledge and good practices and to work among themselves, with relevant stakeholders and with the Commission to increase the effectiveness of eHealth systems;
Amendment 99 #
2013/2061(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Urges the Commission and the Member States to work together with patients and other relevant stakeholders to pinpoint eHealth tools and models to support the implementation and development of Article 12 of Directive 2011/24/EU, which deals with the development of European reference frameworks;
Amendment 116 #
2013/2061(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Emphasises the need to ensure the technical standardisation and interoperability of European healthcare systems;
Amendment 9 #
2013/2022(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
- having regard to the report of the Committee on the Environment, Public Health and Food Safety on the Microbial Challenge - Rising threats from Antimicrobial Resistance (2012/2041(INI)),
Amendment 15 #
2013/2022(INI)
Motion for a resolution
Citation 6 b (new)
Citation 6 b (new)
- having regard to the Commission communication of 15 November 2011 on an action plan against the rising threats from antimicrobial resistance (COM(2011)0748),
Amendment 16 #
2013/2022(INI)
Motion for a resolution
Citation 6 c (new)
Citation 6 c (new)
- having regard to the Council conclusions of 22 June 2012 on 'The impact of antimicrobial resistance in the human health sector and in the veterinary sector – a "One Health" perspective',
Amendment 32 #
2013/2022(INI)
Motion for a resolution
Recital A
Recital A
A. whereas patient safety isand wellbeing are key to overall healthcare quality;
Amendment 57 #
2013/2022(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas it is estimated that the annual number of patients with acquiring at least one Healthcare Associated Infection during their stays in European acute care hospitals in 2011-2012, in the European Union as a whole is 3.2 million 1 . __________________ 1 according to Commission reply E- 004648/2013
Amendment 77 #
2013/2022(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas only 13 Member States have implemented national surveillance of Clostridium difficile infections1 and in only 3 of the surveillance systems are general practitioners also involved in the data collection - a situation that should be improved. E-004649/2013 __________________ 1 According to reply from the Commission E-004649/2013 these 13 countries are: Austria, Belgium, Bulgaria, Denmark, Germany, Finland, France, Hungary, Ireland, the Netherlands, Spain, Sweden and United Kingdom. http://www.europarl.europa.eu/sides/getAl lAnswers.do?reference=E-2013- 004649&language=EN
Amendment 81 #
2013/2022(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas there is a decline in the development of new antimicrobials
Amendment 83 #
2013/2022(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas the issue of antimicrobial resistance is a serious, and in some countries growing, threat to patient safety, that can complicate the recovery from and treatment of infections and that increases the national costs for health;
Amendment 103 #
2013/2022(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the measures put in place by Member States with the principal aim of improving general patient safety and reducing the incidence of HAIs, but urges that these efforts must be increased;
Amendment 106 #
2013/2022(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the steps taken by the Commission to improve general patient safety by promoting mutual learningexchange of best practice between Member States and putting forward common definitions and terminology for patient safety;
Amendment 111 #
2013/2022(INI)
Motion for a resolution
Paragraph 4 – indent 2 a (new)
Paragraph 4 – indent 2 a (new)
- have action plans in place for combating HAIs
Amendment 117 #
2013/2022(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Urges the Member States to continue their efforts to improve patient safety by taking, if they have not already done so, new measures, including setting up action plans for combating HAIs, in order to fall fully into line with the Council's recommendations;
Amendment 127 #
2013/2022(INI)
Motion for a resolution
Paragraph 10 – indent 4 a (new)
Paragraph 10 – indent 4 a (new)
- measures to prevent the occurrence as well as combat the spread of antimicrobial resistance including the development of new antimicrobials;
Amendment 227 #
2013/2022(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Encourages the ECDC in its efforts to support and standardise the monitoring of HAIs, and, in particular, calls on it to continue developing structure and process indicators and to facilitate the exchange of best practice in monitoring HAIs;
Amendment 232 #
2013/2022(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
35. Calls on the Member States to establish a joint database to be used to compile information concerning adverse events in healthcare and to encourage the use of all relevant data collection mechanisms (including those based on confidential declarations) and for this database to be shared with both the Commission and the ECDC;
Amendment 11 #
2013/2006(INI)
Draft opinion
Recital A
Recital A
A. having regard towhereas the Commission communication highlights the importance of energy costs for industry, energy security and the rising energy price differences between Europe and other industrialised countries, as highlighted in the Commission communication;
Amendment 52 #
2013/2006(INI)
Draft opinion
Paragraph 2
Paragraph 2
Amendment 68 #
2013/2006(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that the industrial strategy should emphasise access to cheap sources of energy through diversification and the use of non-conventional sourcesand reliable sources of renewable energy and energy sources with low levels of pollution through diversification;
Amendment 36 #
2013/0371(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Consumption of plastic carrier bags results in high levels of littering and an inefficient use of resources and is expected to increase if no action is taken. Littering of plastic carrier bags contributes to the problem of marine litter that threatens marine and freshwater eco-systems worldwide.
Amendment 46 #
2013/0371(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Despite being fully recyclable, current recycling rates remain low across the Union as there is no separate collection for plastic bags.
Amendment 49 #
2013/0371(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3b) One method of dealing with the problem of littering and low collection and recycling rates could be the introduction of a refund system for plastic carrier bags similar to those that already exist in several Member States for glass, plastic and metal containers.
Amendment 50 #
2013/0371(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Consumption and recycling levels of plastic carrier bags vary considerably across the Union due to differences in consumption habits, environmental awareness, waste collection and recycling strategies as well as the effectiveness of policy measures taken by Member States. Some Member States have managed to reduce consumption levels of plastic carrier bags significantly, with the average consumption level in the seven best performing Member States amounting to only 20% of the EU average consumption.
Amendment 74 #
2013/0371(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
Amendment 116 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 94/62/EC
Article 4 – paragraph 1a – subparagraph 1 a (new)
Article 4 – paragraph 1a – subparagraph 1 a (new)
Reductions should be achieved by reference to the [total number of lightweight plastic carrier bags used in the 2010 calendar year] ("the baseline") unless Member States have already taken measures.
Amendment 120 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 94/62/EC
Article 4 – paragraph 1a – subparagraph 2
Article 4 – paragraph 1a – subparagraph 2
Amendment 138 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 94/62/EC
Article 4 – point 1b (new)
Article 4 – point 1b (new)
(1a) In Article 4, a new paragraph 1b is inserted: '1b. Member States shall take measures to ensure that very lightweight plastic carrier bags used to wrap dry loose, unpackaged foods (such as fruits, vegetables and confectionery) are reduced or replaced progressively by carrier bags that are made from environmentally friendly materials that are resourced in a sustainable manner. Member States shall take such measures by ...*. ______________ * OJ: please insert the date – two years after the entry into force of this Directive.'
Amendment 139 #
2013/0371(COD)
Proposal for a directive
Article 1 –point 1 b (new)
Article 1 –point 1 b (new)
Directive 94/62/EC
Article 4 – paragraph 1 c (new)
Article 4 – paragraph 1 c (new)
(1b) In Article 4, a new paragraph 1c is inserted: '1c. Member States shall ensure that the measures to reduce the consumption of lightweight plastic carrier bags do not lead to an overall increase in the generation of packaging or waste, including food waste.'
Amendment 146 #
2013/0371(COD)
Proposal for a directive
Article 2 – paragraph 1 – subparagraph 1
Article 2 – paragraph 1 – subparagraph 1
Member States shall bring into force theadopt initiatives, awareness campaigns, laws, regulations and administrative provisions necessary to comply with this Directive by twelve months after the entry into force of this Directive. They shall forthwith communicate to the Commission the text of those provisions in order to facilitate the exchange of best practice between Member States.
Amendment 148 #
2013/0371(COD)
Proposal for a directive
Article 2 – paragraph 1 – subparagraph 2
Article 2 – paragraph 1 – subparagraph 2
When Member States adopt those legal provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Amendment 149 #
2013/0371(COD)
Proposal for a directive
Article 2 – paragraph 1 – subparagraph 2 a (new)
Article 2 – paragraph 1 – subparagraph 2 a (new)
In instances where Member States have already taken measures during or after the 2006 calendar year, the baseline shall be the total number of lightweight plastic carrier bags used in the 2005 calendar year.
Amendment 195 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By way of derogation from the barestrictions set out in Article 7(1), points (a), (b), (c), (e) and, (f) of Article 7(1and (g), Member States shall establish a permit system allowing establishments that are authorised to carry regarding activities on invasive alien species of Union concern. Activities involving farming of animal species shall also be allowed provided that they are covered by Directive 1998/58/EC and without presearch or ex-situ conservation to perform such activitiesjudice to point (b) of Article 22 of Directive 92/43/EEC and Article 11 of Directive 2009/147/EC. In exceptional cases of undeniable contribution to human health, if there is no other option than the use onf invasive alien species of Union concern, Member States can also permit their medicinal use.
Amendment 198 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
(b) the activity is to be carried out by personnel possessing the scientific andor technical qualifications prescribed by the competent authorities;
Amendment 199 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point d
Article 8 – paragraph 2 – point d
Amendment 203 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point g
Article 8 – paragraph 2 – point g
(g) The permit referred to in paragraph 1 shall be limited to the number of species and specimens that is necessary for the research or ex-situ conservation concerned and shall not exceed the capacity of the closed facility. It shall include the restrictions necessary to mitigate the risk of escape or spread of the species concerned. It shall accompany the invasive alien species to which it refers at all times when these are kept, brought into and transported within the Union.
Amendment 206 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) they are physically isolated and they cannot escape or spread or be removed from the facilities were they are kept by unauthorised persons; cleaning, waste handling and maintenance protocols shall ensure that no specimens or reproducible parts can escape, spread or be removed by unauthorised persons;
Amendment 211 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. Member States shall once a year inform the Commission of the number of granted permits.
Amendment 214 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 4 b (new)
Article 8 – paragraph 4 b (new)
4b. Member States shall ensure that inspections are carried out by the competent authority to ensure the facility’s compliance with the conditions set for the permit issued.
Amendment 216 #
2013/0307(COD)
Proposal for a regulation
Article 8 – paragraph 4 c (new)
Article 8 – paragraph 4 c (new)
4c. Member States shall submit to the Commission reports on the inspections required pursuant to paragraph 4b.
Amendment 47 #
2013/0169(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The general objective of Union legislation in those areas is to contribute to a high level of health and wellbeing for humans, animals and plants along the food chain, a high level of protection and information of consumers and a high level of protection of the environment while favouring competitiveness and creation of jobs.
Amendment 48 #
2013/0169(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The pursuit of that general objective requires appropriate financial resources. It is therefore necessary that the Union contributes to the funding of measures undertaken in the different areas pertaining to that general objective. In addition, in order to efficiently target the use of the expenditure, specific objectives should be laid down and indicators should be set to assess the achievement of those objectives. It is important that the funds for this does not lead to an increase in the overall EU budget, but that they instead come from already existing posts on the Union budget.
Amendment 53 #
2013/0169(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with regard to the establishment and amendment of the lists of animal diseases and zoonoses which qualify for Union funding, as well as the establishment of work programmes. When amending the list of animal diseases qualifying for emergency measures funof work programmes and decisions regarding, the Commission should take into account the animal diseases which must be notified in accordance with Council Directive 82/894/EEC of 21 Decimplementation of ember 1982 on the notification of animal diseases within the Community15 gency measures. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers16 . __________________ 15 OJ L 378, 31.12.1982, p. 58. 16 OJ L 55, 28.2.2011, p. 13.
Amendment 54 #
2013/0169(COD)
Proposal for a regulation
Recital 29
Recital 29
Amendment 55 #
2013/0169(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) the general objective of contributing to a high level of health and wellbeing for humans, animals and plants along the food chain and in related areas and, by preventing and eradicating diseases and pests ensuring a high level of protection for consumers and the environment while enabling the Union food and feed industry to operate in an environment favouring safe food stuffs, competitiveness and the creation of jobs;
Amendment 69 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) costs of compensation to owners for the value of their animals slaughtered or culled, within the limit of the market value of the animals immediately before they were slaughtered or culledhad they not been affected by the disease;
Amendment 72 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a a (new)
Article 9 – paragraph 1 – point a a (new)
(aa) costs of transporting, culling or slaughtering the animals;
Amendment 74 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) costs of cleaning, desinsectisation and disinfection of holdings and equipment specific to the disease;
Amendment 75 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point d
Article 9 – paragraph 1 – point d
(d) costs for theransport and destruction of the contaminated feeding stuffs and, where it cannot be disinfected, contaminated equipment;
Amendment 78 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point f
Article 9 – paragraph 1 – point f
(f) costs of transport of carcasses to processing plants where applicableand disposal of carcasses;
Amendment 82 #
2013/0169(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) costs of compensation to owners for the value of their animals slaughtered or culled in the framework of the national programme, within the limit of the market value of thesuch animals immediately before they were slaughtered or culledhad they not been affected by the disease;
Amendment 94 #
2013/0169(COD)
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. The Commission, after consulting the Member States, may adopt annual or multiannual guidelines containsuggesting the veterinary priorities and criteria to be used in evaluating the national programmes.
Amendment 104 #
2013/0169(COD)
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
5. The Commission, after consulting the Member States, may adopt annual or multiannual guidelines containsuggesting the phytosanitary priorities, including in particular pests not known to occur in the Union territory and pests considered to be most dangerous for the Union territory, and criteria to be used in evaluating the survey programmes.
Amendment 93 #
2013/0140(COD)
Proposal for a regulation
Recital 56
Recital 56
(56) The direct or indirect refund of fees collected by the competent authorities should be prohibited as it would put operators not benefitting from the refund at a disadvantage and potentially create distortions of competition. However, in order to provide support to micro- enterprises, these should be exempted from the payment of the fees collected in accordance with this Regulation.
Amendment 221 #
2013/0140(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
Amendment 232 #
2013/0140(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
Amendment 247 #
2013/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
Amendment 311 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Official controls shall be performed as much as possible in a manner that minimises the burden on the operators but without this affecting the quality of the control negatively.
Amendment 320 #
2013/0140(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) on substances, materials or objects which may influence the characteristics or health of animals and goods, at all stages of production, processing and distribution;
Amendment 342 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. To ensure the uniformmost efficient implementation of the rules provided for in paragraph 1 of this Article, the Commission shall, by means of implementing acts, lay down and update as necessary the format inminimum requirements for which the information referred to in that paragraph shall be publishmust be included. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141(2).
Amendment 371 #
2013/0140(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b – point i
Article 13 – paragraph 2 – point b – point i
(i) primary producers' installations and other businesses, including their surroundingsproduction areas (fields, meadows, orchards, forests, etc.), premises, offices, equipment, installations and machinery, transport and their animals and goods;
Amendment 374 #
2013/0140(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b – point ii
Article 13 – paragraph 2 – point b – point ii
(ii) raw materials, ingredients, processing aids, food contact materials and other products used for the preparation and production of goods or for feeding or treating animals;
Amendment 396 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point a
Article 15 – paragraph 1 – point a
(a) the verification, by or under the responsibility of an official veterinarian, of the health and welfare of the animals prior to the slaughter;
Amendment 436 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – point e
Article 15 – paragraph 2 – subparagraph 1 – point e
Amendment 810 #
2013/0140(COD)
Proposal for a regulation
Article 82 – title
Article 82 – title
Fees refunds and exemption for microenterprises
Amendment 813 #
2013/0140(COD)
Proposal for a regulation
Article 82 – paragraph 2
Article 82 – paragraph 2
Amendment 822 #
2013/0140(COD)
Proposal for a regulation
Article 82 – paragraph 3
Article 82 – paragraph 3
Amendment 1022 #
2013/0140(COD)
Proposal for a regulation
Article 135 – paragraph 2 – point e a (new)
Article 135 – paragraph 2 – point e a (new)
(ea) require business operators carrying out the killing of animals or any related operations falling within the scope of Regulation (EC) No 1099/2009 to amend their standard operating procedures and, in particular, slow down or stop production;
Amendment 1023 #
2013/0140(COD)
Proposal for a regulation
Article 135 – paragraph 2 – point f
Article 135 – paragraph 2 – point f
(f) order that certain activities of the operator concerned be subject to increased or systematic official controls including in the case of the transport of animals, requiring the presence of a veterinarian at loading of the animals;
Amendment 1024 #
2013/0140(COD)
Proposal for a regulation
Article 135 – paragraph 2 – point j
Article 135 – paragraph 2 – point j
(j) order the suspension or withdrawal of the approval of the establishment, plant, holding or means of transport concerned, or of the authorisation of a transporter or of the certificate of competence of the driver;
Amendment 192 #
2013/0136(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 13, Article 43(2), Article 114(3) and Article 168(4)(b) thereof,
Amendment 199 #
2013/0136(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In laying down those animal health rules, it is essential that considerations are given to the link between animal health and public health, the environment, food and feed safety, animal welfare, food security, economic, social and cultural aspects trying to minimize animal suffering and provide pro-active solutions to disease risks.
Amendment 241 #
2013/0136(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘operator’ means a natural or legal person, having animals and products under their responsibility, including animal keepers and, transporters and those engaged in the commercial breeding and sale of animals, but excluding pet keepers and veterinarians;
Amendment 242 #
2013/0136(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 24 – introductory part
Article 4 – paragraph 1 – point 24 – introductory part
(24) ‘establishment’ means any premises, structure, or any environmentplace, in which animals or germinal products are kept, except for:
Amendment 247 #
2013/0136(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 37
Article 4 – paragraph 1 – point 37
(37) ‘outbreak’ means the official confirmation of one or more cases in an establishment, household or other place where animals are kept or located;
Amendment 252 #
2013/0136(COD)
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 2 – point a – point -i (new)
Article 5 – paragraph 2 – subparagraph 2 – point a – point -i (new)
(-i) animal health;
Amendment 268 #
2013/0136(COD)
Proposal for a regulation
Article 13 – paragraph 1 – introductory part
Article 13 – paragraph 1 – introductory part
1. The competent authority may delegate one or more of the following activities to veterinarians, animal health professionals or other relevant stakeholders:
Amendment 269 #
2013/0136(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Member States may decide that: a) notifications provided for in paragraph 1(a) shall be directed to a veterinarian b) notifications provided for in paragraph 1(b) shall be directed to the competent authority.
Amendment 289 #
2013/0136(COD)
Proposal for a regulation
Article 61 – paragraph 1 – point b
Article 61 – paragraph 1 – point b
(b) the killing and disposal or slaughtering, using pre-stunning, of animals that may be contaminated and contribute to the spread of the listed disease;
Amendment 292 #
2013/0136(COD)
Proposal for a regulation
Article 65 – paragraph 1 – point g
Article 65 – paragraph 1 – point g
(g) the designation or where relevant, approval of a food business establishment for the purposes of the slaughtering, using pre-stunning, of animals or the treatment of products of animal origin originating from the restricted zones;
Amendment 295 #
2013/0136(COD)
Proposal for a regulation
Article 70 – paragraph 1 – point a
Article 70 – paragraph 1 – point a
(a) conduct, where relevant for that particular listed disease, surveillance in the wild animal population and if relevant in kept animals;;
Amendment 311 #
2013/0136(COD)
Proposal for a regulation
Article 82 – paragraph 1 – introductory part
Article 82 – paragraph 1 – introductory part
1. Operators of establishments keeping terrestrial animals or collecting, producing, processing or storing germinal products shall, in order to bebefore they commence such activities in order to get the establishment registered in accordance with Article 88, before they commence such activities:
Amendment 316 #
2013/0136(COD)
Proposal for a regulation
Article 94 – paragraph 2 a (new)
Article 94 – paragraph 2 a (new)
2a. The competent authority grants approval of an establishment where it appears, based on the application of the operator and the subsequent on-site visit of the establishment by the competent authority as provided for in paragraph 1 and 2 of this Article, that it meets all the requirements for approval provided for in Article 92(1) and the rules adopted pursuant to Article 92(2).
Amendment 358 #
2013/0136(COD)
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
1. Operators of slaughterhouses receiving kept ungulates and poultry from another Member State shall slaughter, using pre- stunning, those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2.
Amendment 361 #
2013/0136(COD)
Proposal for a regulation
Article 140 – paragraph 2 – introductory part
Article 140 – paragraph 2 – introductory part
2. Operators shall notmay only move kept terrestrial animals from a restricted zone due to disease control measures within a Member State or from one Member State to another Member State unless theyif the animals are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 146(1), and where the conditions referred to in the following points (a) and (b) are meet:
Amendment 362 #
2013/0136(COD)
Proposal for a regulation
Article 141 – paragraph 1 – point a – point iv a (new)
Article 141 – paragraph 1 – point a – point iv a (new)
(iv a) their origin in a Member State and transport through another Member State en route to a different part of the Member State of origin; or
Amendment 376 #
2013/0136(COD)
Proposal for a regulation
Article 178 – paragraph 1 – point f a (new)
Article 178 – paragraph 1 – point f a (new)
(fa) the water supply and discharge of the establishment
Amendment 377 #
2013/0136(COD)
Proposal for a regulation
Article 181 – paragraph 2 a (new)
Article 181 – paragraph 2 a (new)
2 a. The competent authority grants approval of an establishment where it appears, based on the application of the operator and the subsequent on-site visit of the establishment by the competent authority as provided for in paragraph 1 and 2 of this Article, that it meets all the requirements for approval provided for in Article 179(1) and the rules adopted pursuant to Article 179(2).
Amendment 382 #
2013/0136(COD)
Proposal for a regulation
Article 197 – paragraph 1
Article 197 – paragraph 1
By way of derogation from Article 196(1), Member States may authorise operators to move aquaculture animals into a zone or compartment in another Member State for which an eradication programme has been established in accordance with Article 30(1) and (2) as regards the listed diseases referred to in Article 8(1)(b) and (c), from another zone or compartment for which such a programme has also been established for the same listed diseases, provided that such movement will not jeopardise the health status of the Member State, zone or compartment of destination.
Amendment 388 #
2013/0136(COD)
Proposal for a regulation
Article 246 – paragraph 1 – introductory part
Article 246 – paragraph 1 – introductory part
1. In case of suspicion of or the event of an outbreak of a listed disease or an emerging disease, or the occurrence of a hazard which is likely to constitute a serious risk, the competent authority of the Member State where it occurred shall, depending on the gravity of the situation and the disease or hazard in question, immediately take one or more of the following emergency measures to prevent the spread of the disease or hazard:
Amendment 13 #
2013/0130(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Article 10 of Regulation (EU) No 691/2011 invites the Commission to report first on the implementation of this Regulation to the European Parliament and the Council andby 31 December 2013 and then, if appropriate, to propose the introduction of new environmental economic accounts modules, such as Environmental Protection Expenditure and Revenues (EPER)/Environmental Protection Expenditure Accounts (EPEA), Environmental Goods and Services Sector (EGSS) and Energy Accounts.
Amendment 29 #
2013/0130(COD)
Proposal for a regulation
Annex 1
Annex 1
Regulation (EU) No 691/2011
Annex IV – section 6
Annex IV – section 6
For the implementation of the provisions of this Annex, the maximum duration of the transitional period is 2three years from the first transmission deadline.
Amendment 35 #
2013/0130(COD)
Proposal for a regulation
Annex 1
Annex 1
Regulation (EU) No691/2011
Annex V – Section 6
Annex V – Section 6
For the implementation of the provisions of this Annex, the maximum duration of the transitional period is 2three years from the first transmission deadline.
Amendment 49 #
2013/0130(COD)
Proposal for a regulation
Annex 1
Annex 1
For the implementation of the provisions of this Annex, the maximum duration of the transitional period is 2three years from the first transmission deadline.
Amendment 1 #
2012/2323(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises that the delegation of power is a choice for Parliament as a co- legislator, which it should exercise with care on a case-by-case basis having regard to the need to safeguard its prerogatives and to ensure transparencensure transparency, consistency and legal certainty in EU law- making;
Amendment 8 #
2012/2323(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Is of the opinion that the current arrangements concerning ithe European Parliament's oversight of implementing acts are inadequatesufficient and should not beremain limited to draft acts1; calls for Article 11 of the implementing acts Regulation to be __________________ 1 1 Article 291 TFEU does not provide for any involvement of the European Parliamendedt, so that (in principle and with the exception of acts adopted for reasons of urgency) Parliament has the right to scrutinise an implementing act within a period of one month following its adoptionamending the implementing acts regulation to provide for Parliament oversight would be contrary to the wording of the Treaty and indeed the concept of 'implementing' acts.
Amendment 8 #
2012/2259(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the fact that renewable energy is being developed in the Member States with a view to meeting the targets set for 2020, and to strengthen the competitiveness of Europe; calls on the Commission to propose rationalealistic goals up to 2030, which should take into account the proportion of electricity to be generated from renewable sources, energy efficiency, clean conventional energy technologies, and CO2 storage;
Amendment 15 #
2012/2259(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Points to the market potential for green technology; and underlines that green technologies should be seen as an opportunity to strengthen European industries, rather than something that necessarily requires public funding;
Amendment 24 #
2012/2259(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out that renewable energy is not being developed separately, but as part of the overall energy system; reiterates that funding needs to be allocated under the Connecting Europe programme to finance the development of ICT-based smart grids so as to enable renewable energy to be incorporated more comprehensively and improve the stability of transfer systems; underlines that this funding should not lead to an increase in the overall EU- budget;
Amendment 34 #
2012/2259(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Maintains that a transitional period is necessary in order to establish European support schemes; but underlines that these support schemes should come from diversion of existing funds rather than from budget increases; suggests that the Commission allow foconsider the effeimpacts of the economic crisis and countries' lower credit ratings, as reflected in the cutbacks – and the degree of risk involved – in renewable energy investment; stresses that the risks to those who invest in renewable energy have to be reduced by means of a clear long- term European strategy;
Amendment 53 #
2012/2259(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Points to the fact that the increased use of renewables and green technologies is not only an issue of meeting emissions targets but also improves energy security and reduces the need for imported fuels;
Amendment 57 #
2012/2259(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Stresses that research and development focusing on the efficient use of waste, including food waste and debris recovered from the marine environment, to produce electricity, gas, and heat are important from the point of view of meeting energy efficiency targets;
Amendment 63 #
2012/2259(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points to the fact that a lot can be achieved by the use of existing technologies, simply by increasing energy efficiency as well as by replacing out- dated power generating technologies with newer and less polluting versions;
Amendment 1 #
2012/2214(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. RecallDeplores that a number of agencies in the remit of this committee have had problems with regard to recruitment and selection procedures, highlighting in particular cases of conflict of interest and the so-called 'revolving doors' problem; is aware that each agency follows its own set of rules, proceedings and policies in accordance with the Staff Regulation;
Amendment 2 #
2012/2214(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Draws attention to the Health and Consumer Protection Commissioner's pledge to pursue an initiative for a common rulebook governing the auditing and management of EU agencies and to tackle the various instances of conflicts of interest, whilst examining the scope for cuts to its operating budget;
Amendment 2 #
2012/2203(DEC)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of ECHA and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 3 #
2012/2203(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Is convincedNotes that the ECHA is committed to the principle of annuality; however, considers it in this context unavoidable that carry- overs are needed for some degree and should not always be considered as bad planning;
Amendment 6 #
2012/2203(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Believes that the discharge decision for the ECHA should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
Amendment 4 #
2012/2196(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Thinks it is noteworthy in this context that the Special Report No 15/2012 , ‘Management of Conflict of Interest in Selected EU Agencies’, by the Court of Auditors is not taking into account to the full the latest developments and improvements put in place by the Authority; therefore, notes with satisfaction the improvement of all procedures related to transparency and possible conflict of interests in the Authority and will support the Executive Director in itsher further efforts;
Amendment 6 #
2012/2196(DEC)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of the Authority and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 7 #
2012/2196(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Reminds the Authority to respect in an improved way the principle of annuality; considers the year of 2011 as special due to the movement to the new headquarters and the delayed settlement of payments in this respect;
Amendment 9 #
2012/2196(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Is especially aware ofDraws particular attention to the public interest in the decision -making process within the Authority, which is done within its legal role and responsibilities; asks the Authority to pay further special interest to the public opinion but likes to remind in addition, that some possible shortcomings are due to a lack in the current legislation;
Amendment 12 #
2012/2196(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Believes that the discharge decision for the Authority should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
Amendment 2 #
2012/2195(DEC)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of ECDC and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 6 #
2012/2195(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Believes that the discharge decision for the ECDC should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common rulebook for all European institutions and bodies;
Amendment 2 #
2012/2190(DEC)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of the Agency and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 5 #
2012/2190(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Thinks it is noteworthy in this context that the special report on Conflict of Interests by the Court of Auditors is not taking into account to the full the latest developments and improvements put in place by the Agency; therefore, notes with satisfaction the improvement of all procedures related to transparency and possible conflicts of interest in the Agency and will support the Executive Director in hits further efforts;
Amendment 7 #
2012/2190(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Acknowledges the efforts by the executive level of the Agency to encourage a decision by the Management Board to revise the system of remuneration of Member States services based on real costs; is fully aware ofdeplores the fact that the littleits limited progress is due to the lack of any decision in the Management Board; welcomes therefore the approach by the Agency’s administration to call upon the European Commission for further assistance in this matter;
Amendment 10 #
2012/2190(DEC)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Believes that the discharge decision for the Agency should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
Amendment 1 #
2012/2187(DEC)
Draft opinion
Paragraph 1
Paragraph 1
1. Reiterates that the European Court of Auditors (Court of Auditors) considers the transactions underlying the annual accounts of the European Environment Agency (EEA) for the financial year 2011 as legal and regular in all material respects; underlines again that the discharge procedure shall focus on the preceding year; is fully aware ofwould like to underscore the difficult procedure granting discharge for the year 2010 but is of the opinion that any progress made since then should be duly noted and taken into account;
Amendment 4 #
2012/2187(DEC)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of EEA and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 6 #
2012/2187(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. Has been aware of the cooperation with Earthwatch since the discharge procedure 2010; has fully been informed by the EEA and its Executive Director on the collaboration; takes note that in future special attention willmust be paid to procurement procedures for training opportunities and that no additional expeditions will be organised; asks the EEA to provide further information on the new training procedures for EEA staff;
Amendment 10 #
2012/2187(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Believes that the discharge decision for the EEA should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
Amendment 1 #
2012/2167(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Is concerned, in this context, aboutDeplores, regarding the presentation of environment and health policy areas together with rural development and fisheries in the annual report of the Court of Auditors on the implementation of the Union budget , as it is stated, that the payments by year end were affected by material errors; takes careful notes that this conclusion concerns solely the area of rural development; requests that the Court of Auditors explore a different presentation in the future, which takes into account the good performance of the policy areas in the remit of the Committee on the Environment, Public Health and Food Safety;
Amendment 3 #
2012/2167(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Is aware that the payment rate of LIFE+ actions under the responsibility of DG CLIMA in the first year reached only 58,23%; takes note that this low consumption is due to the factis concerned, in this regard, that the preparation of the 2011 budget was too optimistic and the requested amounts were too high; notes, furthermore, that final payment settlements were only requested in 2012; highlights that unused payment appropriations have been transferred to other budget lines in the context of the global transfer exercise taking place each year in November; is aware that in 2011 those payment appropriations have been used for the shortfalls for Cohesion budget lines;
Amendment 4 #
2012/2167(DEC)
Draft opinion
Paragraph 13
Paragraph 13
13. Is of the opinion, on the basis of the data available and the implementation report, that discharge canshould not be granted to the Commission in respect of expenditure in the areas of environmental and climate policy, public health and food safety for the financial year 2011, until the general budget of the European Union is given an unqualified statement of assurance by the Court of Auditors.
Amendment 3 #
2012/2104(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
- having regard to the Interinstitutional Agreement on Better Lawmaking (2003/C 321/01),
Amendment 7 #
2012/2104(INI)
Motion for a resolution
Subheading 1
Subheading 1
General points: no Union acquis and shortcomings ofwith existing regulations
Amendment 22 #
2012/2104(INI)
Motion for a resolution
Recital C
Recital C
Amendment 33 #
2012/2104(INI)
Motion for a resolution
Recital E
Recital E
E. whereas Article 11 TEU calls for the European institutions to engage more actively in dialogue and consultation; whereas that article provides, de facto, the legal means of strengthening their role in EU policy-making;
Amendment 35 #
2012/2104(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the subsidiarity principle extends to the regional and local levels; whereas Article 5 of the Protocol on the application of the principles of subsidiarity and proportionality stipulates that draft legislative acts must include a financial impact assessment and set out the implications for the rules to be put in place by Member States, including regional legislation;
Amendment 41 #
2012/2104(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas the 6th Environmental Action Plan was undermined by persistent implementation failures in mature policy sectors such as air pollution control, waste management, water and waste water treatment, and nature conservation;
Amendment 43 #
2012/2104(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission communication entitled ‘Improving the delivery of benefits from EU environment measures: building confidence through better knowledge and responsiveness’ (COM(2012)0095), but deplores its failure to refer specifically to the key role which regional and local authorities are called upon to play when European environment regulations are put into effectexpresses concern that the Commission does not assess the ideas it sets out in terms of their compatibility with the subsidiarity principle;
Amendment 58 #
2012/2104(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points to the importance of providing regional and local authorities with financial support and technical guidance where environmental matters are concernedStresses the fundamental role of regional and local authorities, non- governmental organisations, academia, civil society and the private sector in promoting, implementing and evaluating effective environmental legislation;
Amendment 68 #
2012/2104(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Recognises that the implementation of environment legislation demands a considerable administrative and financial effort; points out, however, that a greater financial commitment in favour of regional and local authorities will speed up the development of incentive instruments making for more effective implementation;
Amendment 69 #
2012/2104(INI)
Motion for a resolution
Paragraph 4 – subparagraph 1 (new)
Paragraph 4 – subparagraph 1 (new)
Considers that full implementation and enforcement at all levels is critical, and may require, where appropriate, further strengthening; therefore emphasises the need for clear, consistent and non- duplicative environmental legislation;
Amendment 83 #
2012/2104(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 89 #
2012/2104(INI)
Motion for a resolution
Paragraph 6 – indent 1
Paragraph 6 – indent 1
Amendment 93 #
2012/2104(INI)
Motion for a resolution
Paragraph 6 – indent 3 a (new)
Paragraph 6 – indent 3 a (new)
- Encourages the European Parliament's Environment, Public Health and Food Safety Committee to convene regular hearings to evaluate progress in implementing environmental legislation;
Amendment 98 #
2012/2104(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 10 #
2012/2100(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Underlines that while restructuring of industrial areas can be expensive this should as far as possible be done in a budget-neutral manner, i.e. by focussing funds and support mechanisms already in place;
Amendment 14 #
2012/2100(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses that regional strategies for industrial areas should include, as a focus point, the cleaning-up of land and water, so that environmentally harmful substances do not continue to leak into nature; and that the regional strategies should therefore consider measures which support the aims and goals of the Waste Framework Directive and the Water Framework Directive;
Amendment 17 #
2012/2100(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Believes it is important that strategies for industrial areas include an integrated focus on the transport possibilities to and from the areas, both in the form of raw materials, goods and personnel, and that this can help reduce the environmental footprint of industrial areas as well as positively contribute to public health;
Amendment 19 #
2012/2100(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Believes that an increased focus on and the promotion of best practice regarding transport using internal waterways, ocean transport, railway goods transport and smart distribution centres and networks is essential for improving the environment of regional industrial areas;
Amendment 21 #
2012/2100(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the importance of an effective transposition by Member States of the SEVESO III Directive, in order to ensure that possible risks to citizens close to the industrial regions concerned are minimised, that they have adequate information regarding any possible risk, and that they are better involved in land- use planning decisions.; calls for the exchange of best practice of how best to separate industrial and residential areas with regards to this;
Amendment 23 #
2012/2100(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Notes that many former and out-dated industrial areas hold great possibilities for increasing energy efficiency by applying modern technology and building standards and that this will benefit both the regional economies and the environment;
Amendment 24 #
2012/2100(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Points to the possibility of acquiring funds for green investments by selling off former industrial properties in attractive locations, i.e. in port areas, along river banks, etc; and that this can reduce the need for public funding;
Amendment 110 #
2012/2056(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Emphasises that consumers should be offered a realistic overview and comprehensive information regarding the additional functionality and effects ofies or services linked to any private emergency call in- vehicle application they are choosing and the level of service which can be expectedand associated costs;
Amendment 121 #
2012/2056(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses that private eCall services should also ensure respect for the principles of privacy and data protection, providing in particular for informed consent and the possibility of opting out, in line with the recommendations of the Article 29 Working Party; consumers' informed consent should be based on full information about the amount of data gathered and the purpose to which it is gathered; additionally, consumers should be able to withdraw their consent at any time;
Amendment 1 #
2012/2041(INI)
Motion for a resolution
Citation 12
Citation 12
– having regard to the secon3rd revision of the WHO list of critically important antimicrobials for human medicine (rReport of the first3rd meeting of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance [AGISAR], Copenhagen, 2009), 14-17 June 2011, Oslo, Norway), and to the OIE List of Antimicrobial Agents of Veterinary Importance (OIE List, May 2007) and subsequent refinements,
Amendment 23 #
2012/2041(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas, despite farmers' primary objective to keep their livestock healthy and productive through good agricultural practices (hygiene, proper feed, appropriate husbandry and good animal management), animals can still become ill, and appropriate therapy and veterinary medicines should be available;
Amendment 29 #
2012/2041(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas the use of diagnostics have a vital role to play in combating AMR by encouraging more targeted approaches to treatment;
Amendment 31 #
2012/2041(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Considers that, while almost all Member States have developed national AMR strategies in accordance with the Council Recommendation on prudent use of antimicrobial agents in human medicine, progress with regard to meeting set objectives has been slow and uneven; calls for firm governmental commitment to full and timely implementation at national level;
Amendment 32 #
2012/2041(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Welcomes the Commission's five-year strategic Action Plan on tackling AMR, but expresses concern that many of the action points reiterate measures prescribed over a decade earlier in the Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine;
Amendment 35 #
2012/2041(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Underlines that the key objective of any AMR strategy is to maintain the efficiency of existing antimicrobials by using them responsibly at the correct therapeutic level only when strictly prescribed over a limitedspecific time at the appropriate dosage, and reducing the use of antimicrobials in general and especially of Critically- Important Antimicrobials (CIAs)14 in human and veterinary medicine thereby also taking into account the OIE List of Antimicrobial Agents of Veterinary Importance (OIE List);
Amendment 36 #
2012/2041(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Underlines that the key objective of any AMR strategy is to maintain the efficiency of existing antimicrobials by using them responsibly at the correct therapeutic level only when strictly prescribed over a limited time at the appropriate dosage, and reducing the use of antimicrobials in general and especially of Critically- Important Antimicrobials (CIAs) in human and veterinary medicine; we need to enhance surveillance of the use of antimicrobials in babies and young children, as well as in clinical treatment, where there is a need to control and measure antimicrobial use;
Amendment 37 #
2012/2041(INI)
Motion for a resolution
Paragraph 2 – footnote 14
Paragraph 2 – footnote 14
14. Report of the first3rd meeting of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR), Copenhagen, 2009, 14-17 June 2011, Oslo, Norway.
Amendment 41 #
2012/2041(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that more efforts are needed to control the use of antimicrobials in the veterinary sector; strongly disapproves of the uncontrolled prophylactic use of antimicrobials in animal husbandry; controls on, and the criteria for, imports of food from non-Member States should be enhanced, particularly owing to the potential that such imports may contain traces of antimicrobials;
Amendment 45 #
2012/2041(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that more efforts are needed to control the use of antimicrobials in the human and veterinary sectormedicine; strongly disapproves of the uncontrolled prophylactic use of antimicrobials in animal husbandry;
Amendment 53 #
2012/2041(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to come up with a legislative proposal for the veterinary sector to limit the use of third- and fourth-generation CIAs for humans; stresses that any such proposal must be founded on evidence-based European guidelines on the prudent use of antimicrobials in veterinary medicine;
Amendment 63 #
2012/2041(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Underlines that the increased use of diagnostics is necessary to improve the accuracy of diagnoses, leading to a reduction in the use of antimicrobials;
Amendment 68 #
2012/2041(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. With a view to limiting the use and easy availability of antimicrobial agents, welcomes Member States’ initiatives to review the legal status of all oral, inhaled and parenteral antibiotics (namely antimalarial, antiviral and antifungal drugs) that remain available to patients without a prescription; antibiotics should not be available in EU Member States without a prescription, i.e. sold freely, as this encourages people to self-treat, often on the basis of inaccurate assumptions;
Amendment 69 #
2012/2041(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. With a view to limiting the use and easy availability ofinappropriate use and uncontrolled access to antimicrobial agents, welcomes Member States' initiatives to review the legal status of all oral, inhaled and parenteral antibiotics (namelymicrobials (including antimalarial, antiviral and antifungal drugs) that remain available to patients without a prescription;
Amendment 76 #
2012/2041(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and Member States, in accordance with the competent EU Agencies, to devise and promote prudent use guidelines aimed at reducing non-essential and inappropriate exposure to antimicrobials in human and veterinary medicine, livestock farming, agriculture, aquaculture and horticulture;
Amendment 77 #
2012/2041(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Welcomes moves by public authorities in the Member States to use vaccination as a key intervention in their AMR strategies but believes this should not replace good farm management and animal husbandry systems;
Amendment 83 #
2012/2041(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Underlines that infection prevention and control is a vital cornerstone in the fight against AMR in human medicine; believes that research into the epidemiology of healthcare-associated infections (HAIs) due to MRSA and C. difficile and other emerging multidrug resistant organisms needs to be broadened out;
Amendment 85 #
2012/2041(INI)
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Calls on the Commission and Member States to increase the exchange of best practice on preventing and reducing healthcare associated infections (HAIs);
Amendment 92 #
2012/2041(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Notes the importance of access to rapid, reliable and affordable diagnostic tools in the development of new treatment strategies;
Amendment 95 #
2012/2041(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Calls on the Commission and Member States to strengthen incentives for public and private sector cooperation to reinvigorate antimicrobial research and development (R&D); believes that sharing knowledge and pooling resources through innovative public-private partnerships (PPPs) will be critical to ensuring the clinical efficacy and availability of existing antimicrobials;
Amendment 96 #
2012/2041(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Calls on the Commission to ensure that, as part of the EU 2020 strategy, farmers across all EU Member States can have access to smart, effective and alternative tools to cure their animals, including for minor uses and minor species (MUMS), which currently face a substantial lack of veterinary medicines;
Amendment 97 #
2012/2041(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Calls on the Commission to ensure the development and availability of more on farm tools for early, rapid diagnosis and control of diseases, as well as a broad and effective diagnostic system at Member State level which can ensure the timely delivery of results in case bacteriological examinations are performed;
Amendment 101 #
2012/2041(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of establishing an effective European network of national surveillance systems in the human health and veterinary sectors in order to facilitate the compilation of clear, comparable, transparent and timely reference data on antimicrobial drug usage; believes this should be based on the existing monitoring networks operated by EFSA, the ECDC European Surveillance of Antimicrobial Consumption Network (ESAC-nNet), the ECDC European Antimicrobial Resistance Surveillance Network (EARS-nNet), the ECDC Food- and Waterborne Disease Network (FWD-Net), and the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC);
Amendment 103 #
2012/2041(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of establishing an effective European network of national surveillance systems in the human health and veterinary sectors, based on uniform standards for all Member States, in order to facilitate the compilation of clear, comparable, transparent and timely reference data on antimicrobial drug usage; believes this should be based on the existing monitoring networks operated by EFSA, the ECDC European Surveillance of Antimicrobial Consumption Network (ESAC-net), the ECDC European Antimicrobial Resistance Surveillance Network (EARS-net), and the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC);
Amendment 105 #
2012/2041(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on Member States to promote closer inter-sectoral collaboration between relevant authorities and sectors to encourage a more integrated veterinary-human health approach and monitor the implementation of national antimicrobial resistance strategies;
Amendment 108 #
2012/2041(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls on the Commission and Member States to ensure that future measuring and reporting on the use of antimicrobials in both the human and veterinary sectors will be broadened out, showing not only the total amount of antimicrobials used but also types of antimicrobials, treatment times, etc.;
Amendment 110 #
2012/2041(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that the encouragement of appropriate antimicrobial use depends on a change of attitude and practice among patients, farmers and, medical doctors, veterinarians and other practitioners in the spheres of human and veterinary and human medicine; considers that more effective and continuous educational and training measures should be taken at both national and European level;
Amendment 113 #
2012/2041(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that the encouragement of appropriate antimicrobial use depends on a change of attitude and, practice and education among patients, farmers and practitioners in the spheres of veterinary and human medicine; considers that more effective and continuous educational and training measures should be taken at both national and European level;
Amendment 116 #
2012/2041(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the annual European Antibiotic Awareness Day (18 November) instituted to promote the responsible use of antimicrobials; considers, however, that its visibility and potential could be more effectively maximised through strengthened political support at national and European levels, a broader approach which covers also animals, and coordinated, innovative and high-impact campaigns based on the experience derived from successful European and international initiatives;
Amendment 122 #
2012/2041(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on the Commission to build on the work of the TATFAR and promote similar multilateral and bilateral commitments for the prevention and control of AMR with other global partners;
Amendment 124 #
2012/2041(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Urges Member States and the Commission to encourage and promote global risk management initiatives, such as the WHO list of CIAs for human medicine and the OIE List of Antimicrobials of Veterinary Importance;
Amendment 5 #
2012/2031(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Urges the Commission to ensure that veterinary controls of animals to be transported take place at the end of their transport.
Amendment 6 #
2012/2031(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Calls on the European Commission to submit a proposal for amending Regulation (EC) No 1/2005 so as to limit the transport of live animals to 8 hours;
Amendment 7 #
2012/2031(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers that reducing the volume of transport by transporting carcasses instead of live animals would have a positive impact on the environment, reducing pollution, improving the carbon footprint of the transport sector, anvia a reduction and/or limitation of journey times and the re-establishment of local abattoirs to reduce the distance for slaughter for many transported animals would have a positive impact on the environment, animal welfare, and disease control which in turn could encouraginge the development of local production and consumption;
Amendment 18 #
2012/2031(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a.(new) Calls for a reclassification of horses separately from other farm animals to reflect the specific physical, physiological and behavioural characteristics of horses as set out in the EFSA report1. Calls for a specific journey limit for horses (to slaughter) to have immediate effect. __________________ 1 EFSA Report on the Welfare of Animals during Transport (2011) pg. 86
Amendment 26 #
2012/2031(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Recalls that Article 32 of the Regulation states that the Commission report shall take into account ‘scientific evidence on the welfare needs of animals’, and may be accompanied if necessary by appropriate legislative proposals concerning long journeys; calls on the Commission and the Council, therefore, to review Regulation 1/2005 in order to establish a maximum 8- hour limit for the journeys of animals transported for the purpose of being slaughtered; and to improve the following: - vehicle specifications; - driver training to enable drivers to cope with the animals they transport especially in the case of an emergency; - the re-establishment of local abattoirs to encourage slaughter close to production. - the encouragement of mobile abattoirs.
Amendment 35 #
2012/2031(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Considers that the yearly reports submitted byearly by the Member States are essential forin understanding the impaclevel of application and enforcement of the legislation and in taking appropriate corrective action; calls on the Commission to adopt measures on controls and a more harmonised reporting structure by 1 January 2013measures where necessary;
Amendment 42 #
2012/2031(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Urges the Commission to take measures in order to increase cooperation and communication between competent authorities of different Member States; calls on the Commission to increasereview the number of FVO inspections focused on animal welfare and the transport of animals;
Amendment 44 #
2012/2031(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a.(new) Urges the Commission to ensure that veterinary controls of animals to be transported take place at the end of their transport.
Amendment 170 #
2012/0366(COD)
Proposal for a directive
Recital 29
Recital 29
(29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition . The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young peopleUpholds the ban on tobacco products for oral use, however, such a ban should not affect historically traditional tobacco products for oral use, which may be allowed by individual Member States. For other smokeless tobacco products that are not produced for the mass market, a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use.
Amendment 396 #
2012/0366(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 2 a (new)
Article 4 – paragraph 1 – subparagraph 2 a (new)
Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories monitored by the competent authorities of the Member States.
Amendment 456 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products with a characterising flavour as well as additives that are intended to be added to the tobacco product after its manufacture, for instance by the consumer.
Amendment 569 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, and roll-your-own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
Amendment 1018 #
2012/0366(COD)
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. This ban should, however, not affect historically traditional tobacco products for oral use, which may be allowed by individual Member States.
Amendment 1267 #
2012/0366(COD)
Proposal for a directive
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. When preparing delegated acts the Commission shall ensure proper consultation at both Member State and Union level adhering to Article 4 paragraph 7, and Article 5 paragraph 3 of the WHO Framework Convention on Tobacco Control (FCTC).
Amendment 1355 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 c (new)
Annex 1 – point 14 c (new)
(14 c) Children that are forced to smoke passive are more vulnerable to asthma and meningitis
Amendment 76 #
2012/0337(COD)
Draft legislative resolution
Citation 5 a (new)
Citation 5 a (new)
- having regard to its resolution of 19 January 2012 on how to avoid food wastage: strategies for a more efficient food chain in the EU1 (2011/2175(INI), __________________ 1 Texts adopted, P7_TA(2012)0014.
Amendment 84 #
2012/0337(COD)
Proposal for a decision
Recital 19
Recital 19
(19) Action to deliver the priority objectives should be taken at different levels of governance, in line with the principle of subsidiarity and the latest scientific developments.
Amendment 86 #
2012/0337(COD)
Proposal for a decision
Recital 20
Recital 20
(20) ETransparency based engagement with non-government actors is important in ensuring the success of the programme and the achievement of its priority objectives.
Amendment 88 #
2012/0337(COD)
Proposal for a decision
Recital 21
Recital 21
(21) Biodiversity loss and the degradation of ecosystems in the Union have not only important implications for the environment and are costly for society as a whole, particularly for economic actors in sectors that depend directly on ecosystem services, but also for future generations.
Amendment 90 #
2012/0337(COD)
Proposal for a decision
Recital 22
Recital 22
(22) There is significant scope for reducing greenhouse gas emissions and enhancing energy and resource efficiency in the Union. This will ease pressures on the environment and bring increased competitiveness and new sources of growth and jobs through cost savings from improved efficiency, commercialisation of innovations and better management of resources over their whole life cycle.
Amendment 92 #
2012/0337(COD)
Proposal for a decision
Recital 23
Recital 23
(23) Environmental problems and impacts continue toincreasingly pose significant risks for human health and wellbeing, whereas measures to improve the state of the environment can be beneficial and should be encouraged in all aspects of European Union policy.
Amendment 95 #
2012/0337(COD)
Proposal for a decision
Recital 24
Recital 24
(24) The full and even implementation of the environment acquis across the Union is a sound investment for the environment and human health, and also for the economy and for future generations.
Amendment 99 #
2012/0337(COD)
Proposal for a decision
Recital 25
Recital 25
(25) Union environment policy should continue to draw on a sound evidence base and therefore savings on the Union budget should, where possible, not be taken from research funds.
Amendment 102 #
2012/0337(COD)
Proposal for a decision
Recital 26
Recital 26
(26) Environmental objectives should be supported by adequate investments., and the use of Public Private Partnerships should be encouraged
Amendment 103 #
2012/0337(COD)
Proposal for a decision
Recital 27
Recital 27
(27) Environmental integration in all policy areas is essential to reduce pressures on the environment resulting from the policies and activities of other sectors and to meet environment and climate-related targets.
Amendment 109 #
2012/0337(COD)
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) to turn the Union into a resource- efficient, green, innovative and competitive low- carbon economy;
Amendment 113 #
2012/0337(COD)
Proposal for a decision
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) to secure private and public investment for environment and climate policy and get the prices right;
Amendment 119 #
2012/0337(COD)
Proposal for a decision
Article 2 – paragraph 3
Article 2 – paragraph 3
3. All measures, actions and targets set out in the programme shall be implemented in accordance with the principles of smart regulation, should be based on sound science and subject to comprehensive impact assessment where appropriate.
Amendment 121 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 2
Annex 1 – point 2
2. Emissions of pollutants to air, water and soil have been reduced significantly over the past decades, as have greenhouse gas (GHG) emissions in recent years. EU chemicals legislation has been modernised and the use of many toxic or hazardous substances such as lead, cadmium and mercury has been restricted in products found in most households. EU citizens enjoy some of the best water quality in the world, and over 18 % of the EU’s territory and 4 % of its seas have been designated as protected areas for nature. However there are still large problems with marine litter and pollution of the marine environment
Amendment 122 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 3
Annex 1 – point 3
3. The Union’s environment policyies of the Member States as well as the Union has stimulated innovation and investment in environmental goods and services, generating jobs and export opportunities. Successive enlargements have extended high standards of environmental protection across a large part of the European continent, and the Union’s efforts have contributed to increasing international commitment to combat climate change and biodiversity loss, and to successful global efforts to eliminate ozone-depleting substances and leaded fuels.
Amendment 123 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 4
Annex 1 – point 4
4. Considerable headway has also been made in integrating environmental objectives into other Union policies and activities. The reformed Common Agricultural Policy (CAP) has, since 2003, linked direct payments to requirements for farmers to maintain land in good agricultural and environmental condition and to comply with relevant environmental legislation. However when it comes to greening of the CAP there is unfortunately still much room for improvement. Fighting climate change has become an integral part of energy policy and progress is being made on integrating resource efficiency, climate change and energy efficiency concerns into other key sectors, such as transport and buildings.
Amendment 131 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 5
Annex 1 – point 5
5. However, many environmental and biodiversity trends in the EU remain worrying, not least due to insufficient implementation of existing EU environment legislation. Only 17 % of species and habitats assessed under the Habitats Directive are in good status, and the degradation and loss of natural capital is jeopardising efforts to attain the EU’s biodiversity and climate change objectives. This has high associated costs which have not yet been properly valued in our economic or social system. Thirty per cent of the EU’s territory is highly fragmented, affecting the connectivity and health of ecosystems and their ability to provide services as well as viable habitats for species. While progress has been made in the EU to decouple growth from GHG emissions, resource use and environmental impacts, resource use is still largely unsustainable and inefficient, and waste is not yet properly managed. As a result, EU businesses are foregoing the significant opportunities that resource efficiency offers in terms of competitiveness, cost reductions, improved productivity and security of supply. Water quality and air pollution levels are still problematic in many parts of Europe, and EU citizens continue to be exposed to hazardous substances, potentially compromising their health and wellbeing. Unsustainable land use is consuming fertile soils, with impacts on food security and the achievement of biodiversity targets. Soil degradation continues largely unchecked.
Amendment 146 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 15
Annex 1 – point 15
15. In many cases, action to achieve these objectives will be required primarily at national, regional or local level, in line with the principle of subsidiarity. In others, additional measures at EU level will be needed. Since environment policy is a sphere of shared competence in the EU, one of the purposes of this programme is to create common ownership of shared goals and objectives and ensure a level playing field for businesses and public authorities. Clear goals and objectives and the exchange of Best Practice also provide policy makers and other stakeholders, including regions and cities, businesses and social partners, and individual citizens, with a sense of direction and a predictable framework for action.
Amendment 165 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 20
Annex 1 – point 20
20. In the case of the marine environment, while the maritime sector offers economic opportunities, from fishing, shipping and aquaculture to raw materials and offshore energy and marine biotechnology, care needs to be taken to ensure their exploitation is compatible with the conservation and sustainable management of marine and coastal ecosystems. Where possible the involved parties should be invited to come up with new ways to help protect the marine environment
Amendment 189 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 1 - point a
Annex 1 – point 26 – subparagraph 1 - point a
(a) The loss of biodiversity and the degradation of ecosystem services are halted and ecosystems and their services are, including fish stocks, are not only maintained andbut also enhanced.
Amendment 191 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 1 – point b
Annex 1 – point 26 – subparagraph 1 – point b
(b) The impacts of pressures on fresh, transitional and coastal waters are significantly reduced to achieve, maintain orand preferably enhance good status as defined by the Water Framework Directive.
Amendment 193 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 1 – point c
Annex 1 – point 26 – subparagraph 1 – point c
(c) The impacts of pressures on marine waters are reduced to achieve or maintain good environmental status as required by the Marine Strategy Framework Directive. This will also help safeguard the biodiversity of the marine environment
Amendment 196 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 1 – point e
Annex 1 – point 26 – subparagraph 1 – point e
(e) Land is managed sustainably in the EU, soil is adequately protected, farm land soil fertility is enhanced and the remediation of contaminated sites is well underway.
Amendment 204 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 26 – subparagraph 2 – point c
Annex 1 – point 26 – subparagraph 2 – point c
(c) Increasing efforts, inter alia, to ensure that healthy fish stocks are achieved by 2020 at the latest, starting by fishing at, or below, maximum sustainable yield levels as from 2015 in all fisheries, and establish an EU-wide quantitative reduction target for marine litter and actively support private and public initiatives to prevent and combat marine litter, including, but not limited to, initiatives in the category of "fishing for litter".
Amendment 222 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 27
Annex 1 – point 27
27. The Europe 2020 Strategy's ‘Resource- efficient Europe’ Flagship Initiative aims to support the shift towards an economy that is efficient in the way it uses all resources, decouples absolutely economic growth from resource and energy use and its environmental impacts, reduces GHG emissions, enhances competitiveness through efficiency and innovation and promotes greater energy security. The Roadmap to Resource Efficient Europe and, the Roadmap for moving to a competitive low- carbon economy and the exchange of best practice between Member States are key building blocks of the Initiative, setting out the framework for future actions to deliver on these objectives.
Amendment 256 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 36
Annex 1 – point 36
36. In addition to mandatory green public procurement requirements for certain product categories , most Member States have adopted voluntary action plans and many have set targets for specific product groups. There is, however, considerable scope for administrations at all levels to further reduce their environmental impact through their purchasing decisions. Member States and regions should take further steps to reach the target of applying European Union green procurement criteria to at least 50% of public tenders. The Commission will assess the possibility of introducing further sector-specific legislation to set mandatory green public procurement rules for additional product categories.
Amendment 360 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 52 – subparagraph 2 – point d
Annex 1 – point 52 – subparagraph 2 – point d
(d) Developing an EU strategy for a non- toxic environment, supported by a comprehensive chemical exposure and toxicity knowledge base built as much as possible through the use of alternative non-live animal test methods and testing strategies, and conducive to innovation of sustainable substitutes.
Amendment 361 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 52 – subparagraph 2 – point d a (new)
Annex 1 – point 52 – subparagraph 2 – point d a (new)
Amendment 394 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 68
Annex 1 – point 68
68. Further implementation of the Shared Environmental Information System principle of ‘produce once, use often’ and the common approaches and standards on acquisition and collation of spatial information under the INSPIRE and Copernicus (previously known as GMES65) systems, as well as other environmental information systems for Europe (such as BISE and WISE), will help avoid duplication of effort and eliminate unnecessary administrative burdens on public authorities, as will efforts to streamline reporting obligations under different pieces of legislation. Member States should make information gathered to assess environmental impacts of plans, programmes and projects (e.g. through Environmental or Strategic Impact Assessments) more accessible to the public.
Amendment 401 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 69 – indent 3
Annex 1 – point 69 – indent 3
– There are still uncertainties surrounding the human health and environmental implications of endocrine disruptors, mixtures, chemicals in products and nanomaterials. Filling these gaps can accelerate decision-making and enable the further development of the chemicals acquis to better target areas of concern, while stimulating more sustainable use of chemicals. An improved understanding of the environmental factors affecting human health would allow preventive policy actions to be taken. This should be done as much as possible through the use of alternative methods of testing with the aim to reduce the number of animals used.
Amendment 407 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 1 - point a
Annex 1 – point 71 – subparagraph 1 - point a
(a) Policy-makers and businesses have a better basis for developing and implementing environment and climate policies, including measuring costs and benefits of action or inaction.
Amendment 413 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 2 - point b
Annex 1 – point 71 – subparagraph 2 - point b
(b) Adopting a systematic and integrated approach to risk management, based on the precautionary principle and preventive action, the polluter-pays principle, the principle of rectification of pollution at source as well as the principle of proportionality.
Amendment 417 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 71 – subparagraph 2 – point c
Annex 1 – point 71 – subparagraph 2 – point c
(c) Simplifying, streamlining and modernising environmental and climate change data and information collection, management and sharing – including the development and implementation of a European Shared Environmental Information System.
Amendment 77 #
2012/0278(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The European Union recognises the interdependence of all countries with regard to genetic resources for food and agriculture, as well as their special nature and importance for achieving food security worldwide and for the sustainable development of agriculture in the context of poverty alleviation and climate change and acknowledging the fundamental role of the International Treaty on Plant Genetic Resources for Food and Agriculture and the FAO Commission on Genetic Resources for Food and Agriculture in this regard.
Amendment 78 #
2012/0278(COD)
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
(2b) It is recognised practice to exchange all plant genetic resources for food and agriculture for research, breeding and training purposes under the terms and condition of the Standard Material Transfer Agreement (SMTA) established under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) as determined in the Memorandum of Understanding for the establishment of the European Genebank Integrated System (AEGIS); in accordance with Article 4.3 of the Protocol, it is acknowledged that such a practice is supportive of, and does not run counter to, the objectives of the Convention and the Protocol.
Amendment 79 #
2012/0278(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) Competence and responsibility for the practical implementation of measures to safeguard indigenous and local communities in access and benefit sharing arrangements would remain with Member States and their courts.
Amendment 81 #
2012/0278(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol significantly expandfurther elaborates the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.
Amendment 91 #
2012/0278(COD)
Proposal for a regulation
Recital 13
Recital 13
Amendment 92 #
2012/0278(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.
Amendment 103 #
2012/0278(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The objectives of this Regulation are to minimise the risk that illegally genetic resources or traditional knowledge associated with genetic resources are used in the Union, and to support the fair and equitable sharing of benefits resulting from the use of genetic resources or traditional knowledge associated with genetic resources upon mutually agreed terms. These cannot be achieved by the Member States individually, and can therefore, by reasons of their scale and to ensure functioning of the internal market, be better achieved at Union level. The Union may therefore adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve its objectives.
Amendment 104 #
2012/0278(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources, in accordance with the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol).
Amendment 108 #
2012/0278(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
This Regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the use of such genetic resources and to traditional knowledge associated with genetic resources.
Amendment 116 #
2012/0278(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) "access" means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol in accordance with the applicable domestic access and benefit-sharing legislation or regulatory requirements of that Party.
Amendment 117 #
2012/0278(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) "user" means a natural or legal person using genetic resources or traditional knowledge associated with genetic resources;
Amendment 118 #
2012/0278(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) "mutually agreed terms" means the contractual arrangement concluded between a provider of genetic resources or of traditional knowledge associated with genetic resources and a user of such resources or knowledge, that sets out specific conditions for the fair and equitable sharing of benefits arising from such use, and that may also include further conditions and terms for the use of such resources or knowledge;
Amendment 119 #
2012/0278(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
Amendment 124 #
2012/0278(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that, where relevant, benefits are fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, and transfer to subsequent users information relevant for access and benefit- sharing.
Amendment 128 #
2012/0278(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point a – point 1
Article 4 – paragraph 2 – point a – point 1
(1) the date and place of access of genetic resources and traditional knowledge associated with such resources;
Amendment 130 #
2012/0278(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point a – point 2
Article 4 – paragraph 2 – point a – point 2
(2) the description of genetic resources or traditional knowledge associated with such resources used, including available unique identifiers;
Amendment 137 #
2012/0278(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Users acquiring a genetic resource from a collection listed in the Union register of trusted collections referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information relevant to access and benefit- sharing for genetic resources and traditional knowledge associated with genetic resources.
Amendment 149 #
2012/0278(COD)
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article, as well as to consider procedures for registering collections located in third countries that fulfil the criteria for Union Trusted Collections so as to support global implementation of the Nagoya Protocol. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).
Amendment 151 #
2012/0278(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Commission shall designate a focal point on access and benefit-sharing responsible for providing information to applicants seeking access to genetic resources and traditional knowledge associated with such resources in the Union and to liaise with the Secretariat of the Convention on Biological Diversity.
Amendment 153 #
2012/0278(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States and the Commission shall request all recipients of public research funding involving uses of genetic resources and traditional knowledge associated with genetic resources to declare that they will exercise due diligence in accordance with Article 4.
Amendment 157 #
2012/0278(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Users shall declare to the competent authorities established under Article 6(1) that they exercised due diligence in accordance with Article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or at the time of commercialisation where a market approval is not required.
Amendment 171 #
2012/0278(COD)
Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2
Article 9 – paragraph 7 – subparagraph 2
Additionally, depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities. These interim measures must be effective, proportionate and dissuasive.
Amendment 178 #
2012/0278(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established.
Amendment 185 #
2012/0278(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point c
Article 14 – paragraph 1 – point c
(c) support the development and use of cost-effective communication tools and systems in support of monitoring and tracking the use of genetic resources and traditional knowledge associated with genetic resources by collections and users;
Amendment 187 #
2012/0278(COD)
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. Every ten years after its first report the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation. In its reporting the Commission shall in particular consider the administrative consequences for public research institutions, small or medium-sized enterprises and micro-enterprises. It shall also consider the need for further Union action on access to genetic resources and traditional knowledge associated with genetic resources.
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 120 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 121 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
Article 2 – paragraph 1 – subparagraph 3 – point 21
(21) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;
Amendment 131 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 47 – indent 2 – point iii
Article 2 – paragraph 1 – subparagraph 5 – point 47 – indent 2 – point iii
(iii) hospitalisation or extending the duration ofprolongation of patient hospitalisation,
Amendment 144 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 148 #
2012/0267(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient,For Class D devices and as needed for companion diagnostics, where no harmonised standards exist or where there is a need to address a public health concern the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evidence and post-market follow-up set out in Annex XII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 84(3).
Amendment 149 #
2012/0267(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. The relevant scientific experts from the various interested parties shall be involved in the drafting of the common technical specifications.
Amendment 174 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 176 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least twofive years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
Amendment 178 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) five10 years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices as well as a proven in- depth knowledge of both the therapeutic area and the product type(s) concerned.
Amendment 180 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 4 – point a
Article 13 – paragraph 4 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least twofive years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
Amendment 181 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 4 – point b
Article 13 – paragraph 4 – point b
(b) fiveten years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices as well as a proven in- depth knowledge of both the therapeutic area and the product(s) concerned..
Amendment 189 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 195 #
2012/0267(COD)
Proposal for a regulation
Article 26 – paragraph 1 – subparagraph 2 (new)
Article 26 – paragraph 1 – subparagraph 2 (new)
Member States may decide that the assessment and monitoring referred to in the first subparagraph shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 208 #
2012/0267(COD)
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 1
Article 29 – paragraph 2 – subparagraph 1
The application shall specifybe accompanied by a description of the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Annex VI or supported by documentation proving compliance with all the requirements set out in Annex VI.
Amendment 259 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 260 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 3
Article 40 – paragraph 2 – subparagraph 3
For companion diagnostics intended to be used to assess the patient eligibility for treatment with a specific medicinal product, the notified body shall consult one of the competent authwhere a reference laboratory has been designated in accordance with Article 78, the notified body performing the conformities designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human usy assessment shall request that reference laboratory to verify compliance orf the European Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IXdevice with the applicable CTS, when available.
Amendment 262 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 3
Article 40 – paragraph 3 – subparagraph 3
For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal product, the notified body shall consult one of the competent authwhere a reference laboratory is designated in accordance with Article 78, the notified body performing the conformities designated by the Member States in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) in accordy assessment shall request that reference laboratory to verify compliance withof the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IXdevice with the applicable CTS, when available.
Amendment 272 #
Amendment 282 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1 a (new)
Article 49 – paragraph 2 – subparagraph 1 a (new)
In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned, and if appropriate taking advice from EMA.
Amendment 309 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 322 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point b
Article 77 – paragraph 1 – point b
Amendment 332 #
2012/0267(COD)
Proposal for a regulation
Article 78 – paragraph 2 – point b
Article 78 – paragraph 2 – point b
(b) to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 5.7 of Annex VIII and in Section 5.1 of Annex X; n request of competent authorities on samples collected during market surveillance activities under article 65 and of notified bodies on samples collected during unannounced inspections under Annex VIII section 4.4;
Amendment 391 #
2012/0267(COD)
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point c
Annex 8 – section 2 – point 6 – point 6.2 – point c
(c) For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal productBefore issuing an EU design- examination certificate, the notified body shall consult brequest a refoere issuing an EU design-examination certificate and on the basis of the draft summary of safety and performance and the draft instructions for use, one of the competent authorities designated by the Member States in accnce laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and perfordmance with Directive 2001/83/EC (that is at least equivalent. The reinafter referred to as ‘medicinal products competent authority’) or the European Medicines Agency (hereinafter referred to as ‘EMA’) establishference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible updates shall be included byin the Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, regarddocumentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed ing the suitability of the device in relation to tcientific opinion when medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMAaking its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable.
Amendment 392 #
2012/0267(COD)
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point c a (new)
Annex 8 – section 2 – point 6 – point 6.2 – point c a (new)
(c a) Changes to the approved design shall receive further approval from the notified body which issued the EU design- examination certificate, wherever the changes could affect conformity with the general safety and performance requirements of this Regulation or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EU design- examination certificate of any planned changes to the approved design. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU design-examination report. Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU design examination certificate, the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. The reference laboratory shall provide a scientific opinion within 30 days. The approval of any change to the approved design shall take the form of a supplement to the EU design-examination certificate.
Amendment 394 #
2012/0267(COD)
Proposal for a regulation
Annex 9 – point 3 – paragraph 1 – point 3.5
Annex 9 – point 3 – paragraph 1 – point 3.5
3.5. in the case of devices classified as class D, or for companion diagnostics, request a reference laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The reference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable;
Amendment 395 #
2012/0267(COD)
Proposal for a regulation
Annex 9 – point 3 – paragraph 1 – point 3.6
Annex 9 – point 3 – paragraph 1 – point 3.6
Amendment 396 #
2012/0267(COD)
Proposal for a regulation
Annex 9 – point 5 – point 5.4
Annex 9 – point 5 – point 5.4
Amendment 166 #
2012/0266(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) To ensure that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by medical devices, manufacturers shall be obliged to take liability insurance with appropriate coverage.
Amendment 174 #
2012/0266(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) Patients who are implanted with a device should be given where possible in advance essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
Amendment 181 #
2012/0266(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) Transparency and better information that is understandable, reliable, objective, easily accessible and non-promotional are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 189 #
2012/0266(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) For high risk medical devices, competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body.
Amendment 197 #
2012/0266(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.
Amendment 198 #
2012/0266(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations on medical devices should be interoperable with the EU database, as well as the www.clinicaltrials.gov database of the USA FDA to be set up for clinical trials on medicinal products for human use.
Amendment 201 #
2012/0266(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) Sponsors should report certain adverse events, including Serious adverse Device Effects, device effects and device deficiencies occurring during clinical investigations to the Member States concerned, which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information should be communicated to the other Member States.
Amendment 227 #
2012/0266(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point f a (new)
Article 1 – paragraph 2 – point f a (new)
(fa) To devices that are composed of substances or combination of substances intended to be ingested and that are absorbed by or dispersed in the human body that based on robust scientific evidence pose no adverse health implications to patient safety.
Amendment 240 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2
Article 2 – paragraph 1 – subparagraph 1 – point 2
(2) ‘'accessory to a medical device’' means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s) or to specifically assist the medical functionality of the device(s) in view of its/their intended purpose(s);
Amendment 258 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 24
Article 2 – paragraph 1 – subparagraph 1 – point 24
(24) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;
Amendment 259 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part
(27) ‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; routine device maintenance service activities are not included in this definition;
Amendment 267 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii
(iii) hospitalisation or extending the duration ofprolongation of patient hospitalisation,
Amendment 275 #
2012/0266(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State, or after consultation wits own initiativeh the Member States, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 279 #
2012/0266(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Commission shall ensure the sharing of expertise between Member States and relevant stakeholders including patient groups in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products.
Amendment 282 #
2012/0266(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to, 26 and 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system.
Amendment 288 #
2012/0266(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 306 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 2
Article 8 – paragraph 6 – subparagraph 2
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures, including the immediate reporting to the European databank on medical devices (Eudamed)set up by the Commission Decision 2010/227/EU.
Amendment 310 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority, or from a legitimate health institution or association, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
Amendment 317 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
Amendment 347 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point a
Article 13 – paragraph 1 – subparagraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least twofive years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
Amendment 352 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b
Article 13 – paragraph 1 – subparagraph 1 – point b
(b) fiveten years of professional experience in regulatory affairs or in quality management systems relating to medical devices as well as a proven in-depth knowledge of both the therapeutic area and the product type(s) concerned.
Amendment 364 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point c
Article 13 – paragraph 2 – point c
(c) that the reporting obligations in accordance with Articles 59 and 61 to 66 are fulfilled;
Amendment 367 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
(d) in the case of investigational devices, that the statement referred to in point 4.1 of Chapter II of Annex XIV is issued and the obligations on Serious Adverse Events reporting are fulfilled.
Amendment 372 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 4 – point a
Article 13 – paragraph 4 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least twofive years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
Amendment 374 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 4 – point b
Article 13 – paragraph 4 – point b
(b) fiveten years of professional experience in regulatory affairs or in quality management systems relating to medical devices as well as a proven in-depth knowledge of both the therapeutic area and the product(s) concerned.
Amendment 376 #
2012/0266(COD)
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 – point c
Article 14 – paragraph 1 – subparagraph 1 – point c
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected; this includes the reuse of a device outside of the specifications set out in the manufacturer's instructions for use.
Amendment 385 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person, including health institutions as specified at Art. 4.4, who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 388 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Only single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed, and only if this allowed under national legislation as well as can be proved by the reprocessor to be safe for the patient.
Amendment 394 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3a. In case of reprocessing of single-use medical devices the legal or natural person referred to in paragraph 1 shall ensure the traceability of each reprocessed device, including clear indications for how many times the device has already been reprocessed.
Amendment 395 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 3 b (new)
Article 15 – paragraph 3 b (new)
3b. The legal or natural person referred to in paragraph 1 shall establish a maximum number of times a single-use device can be reprocessed and shall ensure that the device is not reprocessed more times than this level.
Amendment 401 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 6 a (new)
Article 15 – paragraph 6 a (new)
6a. Patients shall always be informed when reprocessed single-use devices are used.
Amendment 459 #
2012/0266(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summaryprovide a report of safety and clinical performance, including full results of clinical studies and trials. It shall be written in a way that is clear to the intended user, differentiating between the information needs of patients and healthcare professionals. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body. The summary shall also be made public.
Amendment 468 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) to enable the public to be adequately informed via a central information point where patients can ask, seek and find information about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators; The Commission should develop guidelines in consultation with stakeholders, including Member State competent authorities, the research community and patient and consumer organisations, and to specify the exact content and format of the information that should be published.
Amendment 477 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, healthcare professionals, sponsors and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 481 #
2012/0266(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point 1 (new)
Article 28 – paragraph 1 – point 1 (new)
(1) Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 492 #
2012/0266(COD)
Proposal for a regulation
Article 31 – paragraph 2 – subparagraph 1
Article 31 – paragraph 2 – subparagraph 1
The application shall specifybe accompanied by a description of the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Annex VI or supported by documentation proving compliance with all the requirements set out in Annex VI.
Amendment 506 #
2012/0266(COD)
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. Details of the notification, such as the class and the typology of devices shall be made publicly available.
Amendment 527 #
2012/0266(COD)
Proposal for a regulation
Article 37 – paragraph 3 – subparagraph 1
Article 37 – paragraph 3 – subparagraph 1
Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. A report with the opinions of Member States should be made publicly available by the European Commission after the assessment.
Amendment 533 #
2012/0266(COD)
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. The fees shall be transparent and proportionate in nature and be subject to member state labour markets.
Amendment 562 #
Amendment 563 #
Amendment 623 #
2012/0266(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) the exchange of information between the Member States and between them and the Commission in accordance with Article 56; All relevant updates to the information concerning an investigation should be posted on the database, such as measures taken by Member States to terminate, suspend or modify an investigation, as well as updated information on the benefit-risk balance or any urgent safety measures taken.
Amendment 631 #
2012/0266(COD)
Proposal for a regulation
Article 59 – paragraph 1 – point d
Article 59 – paragraph 1 – point d
(d) new findings in relation to any event referred to in points (a) to (c). Information regarding incidents that are caused by user errors should also be collected, as they are a major source of incidents with medical devices. This information can contribute to improve the safety and knowledge of the device. The Regulation should also provide for Member States to put in place non- electronic formats of reporting to ensure that patients who do not have online access are able to report.
Amendment 675 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourtwo years and the results thereof shall be communicated to the other Member States and the Commission. The Member State concerned shall make a summary of the results accessible to the public.
Amendment 717 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 895 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – point 5 a (new)
Annex 13 – point 5 a (new)
5 a. All clinical data collected by the manufacturer as part of a PMCF should be made accessible to health professionals.
Amendment 897 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part I – point 1 – paragraph 1
Annex 14 – part I – point 1 – paragraph 1
Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008any subsequent amendments.
Amendment 4 #
2012/0216(COD)
Proposal for a regulation - amending act
Recital 6 a (new)
Recital 6 a (new)
(6 a) With regard to the shortcomings of the Regulation (EC) No 812/2004 and the failures in implementation as indicated in COM(2009)0368 and the related 2010 ICES scientific advice and the lacking of integration of the Habitats Directive 92/43/EEC and the requirement by Member States to take the requisite measures to establish a system of strict protection for cetaceans, the Commission should no later than 31 December 2015 assess the shortcomings of Regulation (EC) No 812/2004 and make a legislative proposal for a coherent, overarching legislative framework for ensuring the effective protection of cetaceans from all threats.
Amendment 5 #
2012/0216(COD)
Proposal for a regulation
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Regulation (EC) No 812/2004
Article 7 – paragraph 3 (new))
Article 7 – paragraph 3 (new))
(1a) In Article 7, the following paragraph is added: "3. The Commission shall no later than 31 December 2015 review the effectiveness of the measures laid down in this Regulation and accompany this review with an overarching legislative proposal for ensuring the effective protection of cetaceans."
Amendment 76 #
2012/0192(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and, rights and health of subjects should be protected and the data generated should be reliable and robust.
Amendment 79 #
2012/0192(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation and it should be ensured that those granting the authorisation do not have conflicts of interest and are independent of the sponsor, the institution of the trial site and the investigators involved.
Amendment 80 #
2012/0192(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 121 #
2012/0192(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) It should be left to Member States to establish the language requirements for the application dossier. To ensure that the assessment of the application for authorisation of a clinical trial functions smoothly, Member States should considerwork towards accepting a commonly understood language in the medical field as the language for the documentation not destined to the subject, such as the Patient Information and the Informed Consent Sheet.
Amendment 129 #
2012/0192(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) In accordance with international guidelines, the free and informed consent of the subject should be in writing, save in exceptional situations. It should be based on information which is clear, relevant and understandable to the subject, and should be in the subject's own language.
Amendment 132 #
2012/0192(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) In order for the sponsor to assess all potentially relevant safety information, the investigator should report to him all serious adverse events. and all suspected serious adverse events.
Amendment 134 #
2012/0192(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The Agency should as soon as possible forward this information to the Member States for them to assess this information.
Amendment 142 #
2012/0192(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial. This should be reported to the Member States concerned, as well as to the Agency, in order for action to be taken by those Member States, where necessary.
Amendment 176 #
2012/0192(COD)
Proposal for a regulation
Recital 64 a (new)
Recital 64 a (new)
(64a) As stated in the Commission Communication on "An Integrated Industrial Policy for the Globalisation Era-Putting Competitiveness and Sustainability at Centre Stage", systematic evaluations of legislation should become an integral part of smart regulation. To ensure that this Regulation keeps pace with scientific and technological progress with regard to the organization and conduct of clinical trials and that it interfaces with other legal provisions, the Commission should periodically report on the experience with and functioning of the Regulation, and present its conclusions thereof.
Amendment 205 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point a
Article 2 – paragraph 2 – point 3 – point a
(a) the investigational medicinal products, or the placebos, are authorised;
Amendment 222 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) 'Reporting Member State': the Member State coordinating and documenting the assessment of an application for authorisation or of a substantial modification, which involves three or more Member States, and which has been submitted under Chapters II and III of this Regulation.
Amendment 253 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 265 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Where the proposed reporting Member State does not wish to be the reporting Member State, it shall agree with another Member State concerned that the latter will be the reporting Member State. If no Member State concerned accepts to be the reporting Member State, the proposed reporting Member State shall be the reporting Member State, unless the proposed reporting Member State can justify that it does not have sufficient capacity to fulfil the task in a satisfactory manner.
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 280 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 307 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph -1 (new) and sub-paragraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph -1 (new) and sub-paragraph 1 – introductory part
4. The assessment date shall, for the purposes of this Chapter, be the date on which the assessment report is submitted to the other Member States concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other Member States concerned. The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within the following time periods, which shall include periods for initial assessment, for joint assessment and for consolidation of the final report:
Amendment 310 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 324 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2
Article 6 – paragraph 6 – subparagraph 2
For the purpose of obtaining those additional explanations, the reporting Member State may suspextend the time period referred to in paragraph 4 for a maximum of 120 days for low-intervention clinical trials and for a maximum of 230 days for trials other than low-intervention clinical trials.
Amendment 327 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 3
Article 6 – paragraph 6 – subparagraph 3
Amendment 328 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 5 a (new)
Article 6 – paragraph 6 – subparagraph 5 a (new)
The reporting Member State may also extend the time referred to in paragraphs 4 and 6 with a further 60 days for trials involving Advanced Therapy Medicinal Products or other novel therapies, for the purpose of consulting with expert committees.
Amendment 359 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 370 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, the institution of the trial site and the investigators involved, as well as free of any other undue influence. Where possible, the persons validating the applications shall therefore publish in the EU database a declaration of their interests, or a statement that they have none.
Amendment 375 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 377 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account. An independent Ethics Committee, as referred to in the Declaration of Helsinki and the ICH-GCP, shall be involved in the assessment of each clinical trial.
Amendment 396 #
2012/0192(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. TheWhere there was a reporting Member State for the application referred to in paragraph 1initial authorisation procedure, it shall be the reporting Member State for the initial authorisation procedureapplication referred to in paragraph 1.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 425 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 454 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 474 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;
Amendment 491 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 507 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point a
Article 32 – paragraph 1 – point a
(a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, it is impossible to obtain prior informed consent from the subject or its legal representative (parent or guardian) and it is impossible to supply prior information to the subject or its legal representative (parent or guardian);
Amendment 509 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point c
Article 32 – paragraph 1 – point c
(c) the subject or legal representative has not previously expressed objections known to the investigator;
Amendment 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 532 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database and to the public EudraPharm database a summary of the results of the clinical trial.
Amendment 564 #
2012/0192(COD)
Proposal for a regulation
Article 39 – paragraph 1 a (new)
Article 39 – paragraph 1 a (new)
1a. Where the sponsor does not have access to certain information and, therefore, is not able to submit a complete report, this shall be stated in the report. In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may submit a single safety report on all investigational medicinal products used in the trial. The sponsor shall provide the reasons for this decision in the report.
Amendment 565 #
2012/0192(COD)
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. The obligation for a particular sponsor referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation for that sponsor. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product. The annual reporting obligation shall not apply when a sponsor is not currently conducting any clinical trials with the investigational medicinal product.
Amendment 570 #
2012/0192(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 34 #
2012/0186(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Roadworthiness testing is a part of a wider regime ensuring that vehicles are kept in a condition which complies with the existing safety and environmentally acceptable condition during their use legislative framework. This regime should cover periodic roadworthiness tests for all vehicles and roadside technical inspection for vehicles used for commercial road transport activities as well as provisions on a vehicle registration procedure to ensure that vehicles which constitute an immediate risk to road safety are not used on roads.
Amendment 37 #
2012/0186(COD)
Proposal for a regulation
Recital 6
Recital 6
Amendment 44 #
2012/0186(COD)
Proposal for a regulation
Recital 10
Recital 10
Amendment 48 #
2012/0186(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) In order to allow a monitoring of the roadside inspection regime implemented in the Union Member States should communicate on a biannual basisbefore 31 March of every second year to the Commission the results of the roadside inspections performed. The Commission should report the data collected to the European Parliament.
Amendment 84 #
2012/0186(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Each Member State shall carry out in every calendar year a total number of initial roadside inspections, corresponding to at least 53% of the total number of vehicles referred to in Article 3(1) that are registered in its territory.
Amendment 89 #
2012/0186(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
Amendment 91 #
2012/0186(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 92 #
2012/0186(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 103 #
2012/0186(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
Amendment 128 #
2012/0186(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. A more detailed roadside inspection shall be carried out using a mobile inspection unit, or in a testing centre as referred to in Regulation (EU) NO XXX/XXX of the European Parliament and of the Council of [date] on roadworthiness tests for motor vehicles and for their trailers. In the case of an inspection carried out in a testing centre, controllers shall book in advance a free capacity in the centre so that periodic inspections already scheduled will not be affected.
Amendment 139 #
2012/0184(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – indent 2
Article 3 – paragraph 1 – point 7 – indent 2
– It is maintained by use of replacement parts which reproduce theWhich is preserved and maintained in a historical components of the vehiclerrect condition;
Amendment 142 #
2012/0184(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – indent 3
Article 3 – paragraph 1 – point 7 – indent 3
Amendment 148 #
2012/0184(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – indent 4
Article 3 – paragraph 1 – point 7 – indent 4
Amendment 191 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 1 – indent 1
Article 5 – paragraph 1 – indent 1
– Vehicles of categories L1e, L2e, L3e, L4e, L5e, L6e and L7e: four: six years after the date on which the vehicle was first registered, then two years and thereafter annually and thereafter every four years;
Amendment 202 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 1 – indent 2
Article 5 – paragraph 1 – indent 2
– Vehicles of category M1, N1, O2, L5e, L6e and O2L7e: four years after the date on which the vehicle was first registered, then two years and thereafter annuallyevery two years;
Amendment 214 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 16 #
2012/0179(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Union is committed to implementing the Resolutions adopted by the General Assembly of the United Nations, in particular Resolutions 61/105 and 64/72, which call on States and Regional Fisheries Management Organisations to ensure the protection of vulnerable deep-sea marine ecosystems from the destructive impact of bottom fishing gears, as well as the sustainable exploitation of deep-sea fish stocks. Furthermore the Union should act as a leader in the establishment and implementation of good governance measures for the sustainable management of deep-sea fisheries within international fora in line with the UNGA and FAO resolutions adopted in this Regulation.
Amendment 36 #
2012/0179(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b a (new)
Article 10 – paragraph 2 – point b a (new)
ba) There shall be no fishing opportunities allocated for targeted fishing or by-catch of those deep-sea species identified in accordance with Article 3(e) as being most vulnerable.
Amendment 146 #
2012/0179(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU to modify the conditions under which fishing activities are considered as deep sea fishing, in order to take into account varying exploitation patterns by the Member States and new scientific information on the stock structure and distribution of deep sea species and areas where vulnerable marine ecosystems are known or likely to occur. The same powers should be granted to the Commission to modify the conditions for landing and transhipment allowances for vessels not holding a deep sea fishing authorisation where this is necessary to take into account varying exploitation patterns in the Member States, to require review and revision of bottom fisheries impact assessments, and to specify measures accompanying annual effort limits if Member States fail to take them or if the measures they adopt are deemed not to be compatible with the objectives of this regulation or insufficient in respect of the aims indicated in this regulation.
Amendment 162 #
2012/0179(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point d
Article 3 – paragraph 2 – point d
(d) ‘deep-sea species’ means the species listed in Annex I, which, provides an indicative and non-exclusive list, and other species recognised as deep-sea species, based on advice by the scientific advisory body;
Amendment 166 #
2012/0179(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point e
Article 3 – paragraph 2 – point e
(e) ‘most vulnerable species’ means the deep-sea species indicatdeep sea species that qualify as vulnerable, endangered or critically endangered under the IUCN Red List criteria, rare species or species which a scientific advisory body has determined as highly susceptible to depletion or for which the scientific advisory body has recommended minimal or zero bycatch. All those species shall be included in the third column ‘'Most vulnerable (x)’' of the table in Annex I. All species of deep-sea sharks shall fall under this category";
Amendment 168 #
2012/0179(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point e a (new)
Article 3 – paragraph 2 – point e a (new)
(ea) In accordance with the IUCN Red List, the list of species in Annex I, including those identified as the most vulnerable species pursuant paragraph 2 e) will be revised every two years by the Commission by delegated acts in accordance with Article 20.
Amendment 174 #
2012/0179(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point j a (new)
Article 3 – paragraph 2 – point j a (new)
(ja) "significant adverse impacts" has the same meaning and characteristics as those described in paragraphs 17 -20 of the 2008 FAO International Guidelines for the Management of Deep-Sea Fisheries in the High Seas;
Amendment 176 #
2012/0179(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point j b (new)
Article 3 – paragraph 2 – point j b (new)
(jb) "vulnerable marine ecosystems" means marine ecosystems, which fit the criteria established in paragraph 42 of the 2008 FAO International Guidelines for the Management of Deep-Sea Fisheries in the High Seas.
Amendment 193 #
2012/0179(COD)
Proposal for a regulation
Article 4 – paragraph 4 a (new)
Article 4 – paragraph 4 a (new)
4a. Fishing authorisations referred to in paragraph 1 for vessels using bottom trawls or bottom-set gillnets shall expire at the latest two years after the entry into force of this Regulation. After that date, fishing authorisations targeting deep-sea species with bottom trawls or bottom-set gillnets shall neither be issued nor renewed.
Amendment 239 #
2012/0179(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Any fishing authorisation issued on the basis of an application made in accordance with paragraph 1 shall specify the characteristics, type and dimensions of the bottom gear to be used and limit the fishing activities authorised to the area in which the intended fishing activity, as set out in paragraph 1(a), and the existing fishing activity, as set out in paragraph 1(b), overlap. However, the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the Member State has assessed and documented, based on best available scientific advice, that such extension would not have significant adverse impacts on vulnerable marine ecosystems. This assessment shall be conducted in accordance with Annex IIa and the 2008 FAO International Guidelines for the Management of Deep-Sea Fisheries in the High Seas and shall be made publicly available. The Commission, in consultation with the Member State and the scientific advisory body, shall review this assessment to ensure that all areas where VMEs are known or likely to occur have been identified and that the proposed mitigation and management measures are sufficient to prevent significant adverse impacts on vulnerable marine ecosystems.
Amendment 247 #
2012/0179(COD)
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
Amendment 272 #
2012/0179(COD)
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. When allocating the fishing opportunities for deep-sea species available to them Member States shall use transparent and objective criteria that shall include, inter alia: (a) selectivity of fishing methods, gears and practices with low by-catch and low impact on the marine ecosystem, with a particular focus on most vulnerable species and vulnerable marine ecosystems; (b) record of compliance with the rules of the Common Fisheries Policy and EU environmental requirements and with respecting catch and/or fishing effort limits designated by scientific advice; (c) quality employment (d) fuel emissions and energy efficiency of the fishing operation; and (e) use of video surveillance or an equivalent electronic monitoring equipment, (f) working conditions that comply with relevant international standards, notably the 2007 ILO Work in Fishing Convention.
Amendment 273 #
2012/0179(COD)
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Obligation to land all deep sea catches All catches of fish and non fish species made by a fishing vessel holding an authorisation to catch deep sea species shall be brought and retained on board the fishing vessel, recorded in the logbook and landed.
Amendment 306 #
2012/0179(COD)
Proposal for a regulation
Article 19 – paragraph 1 a (new)
Article 19 – paragraph 1 a (new)
1a. Member States shall establish a programme of observer coverage to ensure the collection of reliable, timely and accurate data on the catch and bycatch of deep-sea species, encounters with vulnerable marine ecosystems and other relevant information for the effective implementation of the provisions of this regulation. Vessels using bottom trawls or botom-set gillnets with a fishing authorisation to catch deep-sea species, whether as target or by-catch shall carry 100% observer coverage. The rest of the vessels with an authorisation to catch deep-sea species shall carry 10% observer coverage.
Amendment 141 #
2012/0055(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Since the objective to prevent, reduce or eliminate adverse effects on human health and the environment caused by the recycling, operation and maintenance of ships flying the flag of a Member State cannot always be sufficiently achieved by the Member States alone due to the international character of shipping and ship recycling, and can therefore in some cases be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Amendment 2 #
2011/2226(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Has addressed already in the past certainNotes that concerns remain over the institutional failings that led to shortcomings in connection with Conflict of Interest, Declaration of Interest and transparency; would like to specify that the former Chair of the Management Board failed, in 2010, to declare her membership of the board of the International Life Sciences Institute (ILSI); considers it noteworthy, however, that the members of the EFSA Management Board are not appointed by the Executive Director (ED) and can hence not be dismissed by the ED;
Amendment 12 #
2011/2226(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Is informed about the detailed correspondence between the administration level of the EFSA and the CONT rapporteur both before and after the plenary decision tof postponinge the granting of thedecision to grant discharge;
Amendment 14 #
2011/2226(DEC)
Draft opinion
Paragraph 9
Paragraph 9
9. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up; believstresses that the roadmap on the follow-up to the Common Approach willmust duly take dueinto account of those issues;
Amendment 16 #
2011/2226(DEC)
Draft opinion
Paragraph 10
Paragraph 10
10. Believes, however, that the discharge decision for the Authority cannotshould be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially called for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedureOECD guidelines to ensure high quality, internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to examine if it is advisable to incorporate and to commit to additionalintroducing OECD guidelines within a possible commoncommon working framework for all European institutions and bodies;
Amendment 18 #
2011/2226(DEC)
Draft opinion
Paragraph 11
Paragraph 11
11. Is therefore of the opinion that, on the basis of the information available, discharge canshould not be granted to the Executive Director of the European Food Safety Authority in respect of the implementation of the Authority's budget for the financial year 2010.
Amendment 3 #
2011/2220(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Has already addressed the problematic ofNotes that concerns remain over the institutional failings that led to high carry- overs, doubts over the propriety of the subsequent professional activities of the former Executive Director, the missing Declarations of Interests by a number of experts involved in the evaluation of medicinal products also mentioned in the Internal Audit Service follow-up report and the overdue decision by the Management Board to reform the payment system for services provided by Member States' authorities in its first opinion to the responsible committee; is of the opinion that EMA has already made significant efforts to strengthen its internal procedures to assure the independence of its experts andrequests that the European Parliament its staff and has asked to be informed twice a year about the improved implementation of theremedial measures that are being taken in this regard;
Amendment 8 #
2011/2220(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Points out again that the Court of Auditors made observations on carryovers, IT contracts and the payment system for services provided by national authorities but despite these inconsistencies, considered the Agency's accounts of 2010 reliable, legal and regular;
Amendment 9 #
2011/2220(DEC)
Draft opinion
Paragraph 8
Paragraph 8
8. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up; believstresses that the roadmap on the follow-up to the Common Approach willmust duly take dueinto account of those issues;
Amendment 11 #
2011/2220(DEC)
Draft opinion
Paragraph 9
Paragraph 9
9. Believes that the discharge decision for the EMA cannotshould be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially asked for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedureOECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to examine whether it is advisable to incorporate and to commit to additionalintroducing OECD guidelines within a possible commoncommon working framework for all European institutions and bodies;
Amendment 13 #
2011/2220(DEC)
Draft opinion
Paragraph 10
Paragraph 10
10. Is of the opinion that, on the basis of the information available, discharge canshould not be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency's budget for the financial year 2010.
Amendment 4 #
2011/2217(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Has taken careful note of the extensive and detailed correspondence between the different decision taking levels in the EEA, i.e. the Management Board and the Executive Director, and the CONT rapporteur both before and after the plenary decision tof postponinge the granting of thedecision to grant discharge;
Amendment 7 #
2011/2217(DEC)
Draft opinion
Paragraph 10
Paragraph 10
10. Welcomes, in a general context, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up; believes that the roadmap on the follow-up to the Common Approach will take due account of those issues;
Amendment 8 #
2011/2217(DEC)
Draft opinion
Paragraph 11
Paragraph 11
11. Believes that the discharge decision for the EEA cannotshould be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially required by the EU legislator nor by specific arrangements within the Agency during the respective discharge procedureOECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to examine whether it is advisable to incorporate and to commit to additionalintroducing OECD guidelines within a possible commoncommon working framework for all European institutions and bodies;
Amendment 10 #
2011/2217(DEC)
Draft opinion
Paragraph 12
Paragraph 12
12. IRemains of the opinion that on the basis of the information available now the Executive Director of the European Environmental Agency canshould not be granted discharge in respect of implementation of the budget of the EEA for the financial year 2010.
Amendment 19 #
2011/2175(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that (food-) waste should be recognised as a resource. If it under no circumstances can be used as foods, the opportunities to use waste in biogas plants should be improved and biogas production should be further supported.
Amendment 30 #
2011/2175(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Is of the opinion that packaging must be optimised and reduced. Research and innovation in the field of intelligent packaging should be promoted to explore good solutions for the actual use by date for individual products.
Amendment 34 #
2011/2175(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Believes that sales by loose weight and in customised portions in supermarkets should be encouraged to delimit that customers purchase excess food.
Amendment 35 #
2011/2175(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Stresses that clearly indicated 'sell by' and 'use by' dates on foods should be introduced on food packaging in order to guide consumers regarding the shelf life of a product, before and after purchase.
Amendment 36 #
2011/2175(INI)
Draft opinion
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Calls for investigation into whether previously issued regulations cause unnecessary rules that forces supermarkets and food shops to throw away perfectly usable food.
Amendment 37 #
2011/2175(INI)
Draft opinion
Paragraph 2 e (new)
Paragraph 2 e (new)
2e. Considers that, where possible, the regulation should be adjusted, to ease food banks, charity organisations', public institutions etc. possibilities for collecting and redistributing leftover food to the needy, without compromising food security.
Amendment 51 #
2011/2175(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Underlines that concrete initiatives for more and better consumer information and education should be introduced, in order to raise awareness and knowledge among the public about sound food handling and how to delimit food waste to a minimum.
Amendment 54 #
2011/2175(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Is of the opinion that education and awareness raising about food as a precious resource should be introduced from early age.
Amendment 65 #
2011/0461(COD)
Proposal for a decision
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The Union Civil Protection Mechanism (hereinafter referred to as ‘the Mechanism’) shall aim to support, coordinate and supplement the actions of thetrengthen cooperation between Member States and the Union in the field of civil protection in order to improvinge the effectiveness of systems for preventing, preparing for and responding to natural and man-made disasters.
Amendment 69 #
2011/0461(COD)
Proposal for a decision
Article 1 – paragraph 2
Article 1 – paragraph 2
2. The protection to be ensured by the Mechanism shall cover primarily people, but also the environment and property, including cultural heritage, against all natural and man-made disasters, including actboth acts and consequences of terrorism, technological, radiological or environmental accidents, marine pollution and acute health emergencies, occurring inside or outside the Union.
Amendment 72 #
2011/0461(COD)
Proposal for a decision
Article 1 – paragraph 3
Article 1 – paragraph 3
3. The Union intervention enhances prevention, preparedness and response capacity of Member States to face major disasters minimising human and material loss where appropriate. The objective of this Decision cannot always be sufficiently achieved by Member States operating alone and can sometimes be better achieved at Union level by reason of the scale or effects of the proposed action.
Amendment 81 #
2011/0461(COD)
Proposal for a decision
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Decision shall apply to actions to assist with the response to immediate adverse consequences of a major disaster regardless of its nature, inside or outside the Union, where a request is made for assistance in accordance with this Decision.
Amendment 85 #
2011/0461(COD)
Proposal for a decision
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
1. The Mechanism shall support, coordinate or supplement reinforced cooperation between the Union and and complement the efforts of the Member States in pursuit of the following specific objectives:
Amendment 87 #
2011/0461(COD)
Proposal for a decision
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) to enhance the Member States' and the European Union's state of preparedness to respond to disasters;
Amendment 90 #
2011/0461(COD)
Proposal for a decision
Article 3 – paragraph 1 – point c
Article 3 – paragraph 1 – point c
(c) to facilitate rapid and efficient emergency response intervenactions in the event of major disasters or their imminence.
Amendment 94 #
2011/0461(COD)
Proposal for a decision
Article 3 – paragraph 2 – subparagraph 1 – point a
Article 3 – paragraph 2 – subparagraph 1 – point a
(a) progress in implementing the disaster prevention framework measured by the number of Member States with disaster management plans as set out in Article 4;
Amendment 108 #
2011/0461(COD)
Proposal for a decision
Article 4 – point 4
Article 4 – point 4
4. ‘preparedness’ means a state of readiness and capability of human and material means enabling them to ensure an effective rapid response to an emergency disaster, obtained as a result of action taken in advance;
Amendment 110 #
2011/0461(COD)
Proposal for a decision
Article 4 – point 6
Article 4 – point 6
6. ‘early warning’ means the timely and effective provision of information that allows action to be taken to avoid or reduce risks and ensurfacilitate preparedness for an effective response;
Amendment 112 #
2011/0461(COD)
Proposal for a decision
Article 4 – point 9
Article 4 – point 9
9. ‘risk management plan’ means planning instrument prepared by a Member State to foreseeat either national or sub-national level to identify risks, to estimate their impacts, and to develop, select and implement measures to reduce, adapt to and mitigate the risks and their impacts cost-effectively, as well as to set the framework for integrating different sector or hazard- specific risk management instruments into a common overall plan;
Amendment 116 #
2011/0461(COD)
Proposal for a decision
Article 5 – point c
Article 5 – point c
(c) establish and regularly update an overview of natural and man-made rdiskasters the Union may face taking into account the future impact of climate change;
Amendment 121 #
2011/0461(COD)
Proposal for a decision
Article 5 – point d
Article 5 – point d
(d) promote and support the development and implementation of Members States’of Members States’ description of their risk management planscapabilities, including guidelines on their content and provide for adequate incentives, where needed;
Amendment 127 #
2011/0461(COD)
Proposal for a decision
Article 6 – paragraph 1
Article 6 – paragraph 1
1. In order to ensure an effective cooperation within the Mechanism, Members States shall communicate to the Commission a description of their risk management plancapabilities.
Amendment 131 #
2011/0461(COD)
Proposal for a decision
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The description of their risk management plancapabilities shall take into account the national risk assessments, where applicable, and other relevant risk assessment and shall be coherent with other relevant plans in force in that Member State.
Amendment 139 #
2011/0461(COD)
Proposal for a decision
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Member States shall ensure by the end of 2016 at the latest that descriptions of their risk management plancapabilities are ready and communicated to the Commission in their most up-to-date form.
Amendment 145 #
2011/0461(COD)
Proposal for a decision
Article 7 – point a
Article 7 – point a
(a) establish and manage the EmergencyDisaster Response Centre (EDRC), ensuring 24/7 operational capacity, and serving the Member States and the Commission for the purposes of the Mechanism; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Se Articles 1 and 4 in this Decision)
Amendment 147 #
2011/0461(COD)
Proposal for a decision
Article 7 – point b
Article 7 – point b
(b) manage a Common EmergencyDisaster Communication and Information System (CEDCIS) to enable communication and sharing of information between the EDRC and contact points of the Member States; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 149 #
2011/0461(COD)
Proposal for a decision
Article 7 – point d – indent 2
Article 7 – point d – indent 2
– facilitating, when necessary, the coordination of emergencydisaster response assistance operations on site and liaising, when necessary and appropriate, with the competent authorities of the state requesting assistance,
Amendment 151 #
2011/0461(COD)
Proposal for a decision
Article 7 – point e
Article 7 – point e
(e) establish and maintain a capability to provide logistical support and assistance for expert teams, modules and other response capacities deployed under the Mechanism, as well aswhich supports and complements the efforts of other actors on the ground including Member States;
Amendment 152 #
2011/0461(COD)
Proposal for a decision
Article 7 – point f
Article 7 – point f
Amendment 157 #
2011/0461(COD)
Proposal for a decision
Article 7 – point g
Article 7 – point g
Amendment 166 #
2011/0461(COD)
Proposal for a decision
Article 9 – paragraph 6
Article 9 – paragraph 6
6. Member States shall designate the contact points and inform the Commission accordingly.
Amendment 168 #
2011/0461(COD)
Proposal for a decision
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The Commission and Member States shall work together to improve the planning of disaster response operations under the Mechanism. For this purpose:
Amendment 169 #
2011/0461(COD)
Proposal for a decision
Article 10 – paragraph 1 – point a
Article 10 – paragraph 1 – point a
(a) the Commission, in cooperation with Member States, shall produce reference scenarios forensure that lessons are learned from disasters inside and outside the Union, taking into account the risk management plans, where applicable, referred to in Article 6;
Amendment 172 #
2011/0461(COD)
Proposal for a decision
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The Commission and the Member States shall identify and ensurfacilitate synergies between in-kind assistance and humanitarian aid funding provided by the Union and Member States in the planning of response operations outside the Union.
Amendment 173 #
2011/0461(COD)
Proposal for a decision
Article 11 – title
Article 11 – title
European EmergencyDisaster Response Capacity (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 174 #
2011/0461(COD)
Proposal for a decision
Article 11 – paragraph 1
Article 11 – paragraph 1
1. A European Emergency Response Capacity in the form of a voluntary pool of pre-committidentified response capacities of Member States shall be established.
Amendment 186 #
2011/0461(COD)
Proposal for a decision
Article 12 – paragraph 2 – introductory part
Article 12 – paragraph 2 – introductory part
2. The Commission shall support Member States in addressing the capacity gaps and, if desired by the Member States, in filling these gaps in the most appropriate and cost-effective way, including by:
Amendment 187 #
2011/0461(COD)
Proposal for a decision
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) facilitating access to or developing response capacities at Union level, wheren it is more cost- effective, that can serve as a common buffer against shared risks.
Amendment 192 #
2011/0461(COD)
Proposal for a decision
Article 13 – paragraph 1 – introductory part
Article 13 – paragraph 1 – introductory part
1. The Commission, in cooperation with the Member States, shall carry out the following tasks in the field of training, exercises, lessons learnt and knowledge dissemination:
Amendment 194 #
2011/0461(COD)
Proposal for a decision
Article 14 – paragraph 2
Article 14 – paragraph 2
2. In the event of a major disaster within the Union, or of the imminence thereof, which may result in a call for assistance from one or more Member States, the Member State in which the emergencydisaster has occurred or is likely to occur shall, without delay, notify the Commission, when a possible request for assistance through the ERC can be anticipated, in order to enable the Commission, as appropriate, to inform the other Member States and activate its competent services.
Amendment 197 #
2011/0461(COD)
Proposal for a decision
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Where a major disaster occurs within the Union, or in the imminence thereof, affected Member States may request assistance through the ERC. The request shall be as specific as possible.
Amendment 199 #
2011/0461(COD)
Proposal for a decision
Article 15 – paragraph 2
Article 15 – paragraph 2
2. In situationUnder exceptional circumstances of increased risk a Member State may also request assistance in the form of temporary pre-positioning of response capacities.
Amendment 202 #
2011/0461(COD)
Proposal for a decision
Article 15 – paragraph 3 – point c
Article 15 – paragraph 3 – point c
(c) together with the requesting Member State(s) propose a response plan based on the needs on the ground and pre-developed contingency plans, and invite Member States to deploy specific capacities from the European Emergency Response Capacity in accordance with the plan;
Amendment 213 #
2011/0461(COD)
Proposal for a decision
Article 16 – paragraph 2 – point a – introductory part
Article 16 – paragraph 2 – point a – introductory part
(a) maintaining a continuous dialogue with Member States‘ contact points in order to ensure an effective and coherent European emergencydisaster response contribution through the Mechanism to the overall relief effort, in particular by:
Amendment 226 #
2011/0461(COD)
Proposal for a decision
Article 17 – paragraph 5
Article 17 – paragraph 5
Amendment 238 #
2011/0461(COD)
Proposal for a decision
Article 21 – point c
Article 21 – point c
(c) developing and maintaining a surge capacity through a network of trained experts of Member States, who can be available at short notice to assist in the monitoring, information and coordination tasks of the ERC;
Amendment 240 #
2011/0461(COD)
Proposal for a decision
Article 21 – point g – subparagraph 2
Article 21 – point g – subparagraph 2
The Union financial contribution for actions under this point shall take the form of unit costs determined per type of capacity and shall not exceed 2510% of the total eligible costs.
Amendment 242 #
2011/0461(COD)
Proposal for a decision
Article 21 – point h – sub-paragraph 2
Article 21 – point h – sub-paragraph 2
Actions taken in accordance with this point shall be based on a thorough needs and cost-benefit analysis per type of capacity, taking into account the probability and impact of the relevant risks. The Union financial contribution for the actions under this point shall not exceed 850% of the total eligible costs;
Amendment 244 #
2011/0461(COD)
Proposal for a decision
Article 21 – point i
Article 21 – point i
(i) ensuring the availability of necessarybasic logistical capacities to provide technical assistance and support to the European Emergency Response Capacity,support for expert teams, other modules and response capacities dispatched under the Mechanism, as well as other actors on the ground;
Amendment 245 #
2011/0461(COD)
Proposal for a decision
Article 21 – point j
Article 21 – point j
(j) assisting Member States in prepositioning emergency aid assets in logistical hubdisaster response assets inside the Union.
Amendment 246 #
2011/0461(COD)
Proposal for a decision
Article 22 – point b
Article 22 – point b
(b) deploying the capacities referred to in points (g), (h) and (i) of Article 21 in the event of major disasters, at the request of the Commissionin response to a request through the ERC;
Amendment 250 #
2011/0461(COD)
Proposal for a decision
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) providing and sharing information on equipment and transport resources that can beMember States madke available by Member States, with a view to facilitating the pooling of such equipment or transport resources;
Amendment 252 #
2011/0461(COD)
Proposal for a decision
Article 23 – paragraph 2 – introductory part
Article 23 – paragraph 2 – introductory part
2. The amount of Union financial support for transport resources and related logistics shall not exceed 85% of the total eligible cost. The Union financial support for transport resources and related logistics may cover a maximum of 100% of the total eligible cost when one of the following criteria is met:50% of the total eligible cost.
Amendment 253 #
2011/0461(COD)
Proposal for a decision
Article 23 – paragraph 2 – point a
Article 23 – paragraph 2 – point a
Amendment 254 #
2011/0461(COD)
Proposal for a decision
Article 23 – paragraph 2 – point b
Article 23 – paragraph 2 – point b
Amendment 255 #
2011/0461(COD)
Proposal for a decision
Article 23 – paragraph 2 – point c
Article 23 – paragraph 2 – point c
Amendment 34 #
2011/0421(COD)
Proposal for a decision
Recital 3
Recital 3
(3) Apart from communicable diseases, a number of other sources of danger to health, notably threlated to others, of biological agents, chemical agents or environmental events, which include hazards related to climate changeorigin or arising from an increased prevalence of antimicrobial resistance or defective implantable medical devices, may, by reason of their scale or severity, endanger the health of citizens in the entire Union, lead to the malfunctioning of critical sectors of society and economy and jeopardise individual Member State's capacity to react. Therefore, the legal framework set up under Decision No 2119/98/EC should be extended to cover these other threats and provide for a coordinated wider approach to health security at Union level.
Amendment 40 #
2011/0421(COD)
Proposal for a decision
Recital 11
Recital 11
(11) Contrary to communicable diseases, whose surveillance at the Union level is carried out on a permanent basis by the ECDC, other serious cross-border threats to health, with perhaps the exception of antimicrobial resistance, do not currently necessitate a systematic monitoring. A risk-based approach, whereby monitoring networks are set up ad hoc and on a temporary basis, is therefore more appropriate to those other threats.
Amendment 189 #
2011/0380(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) It is paramount to better integrate environmental concerns into the CFP which should deliver on the objectives and targets of the Union's environmental policy and the Europe 2020 Strategy. The CFP is aimed at an sustainable exploitation of living marine biological resources that restores and maintains fish stocks at levels which can produce the maximum sustainable yield, not later than 2015. The CFP shall implement the precautionary andan eco- system-based approaches to fisheries and aquaculture management. Consequently the EMFF should contribute to the protection of the marine environment as set out in the Directive 2008/56/EC of the European Parliament and the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive).
Amendment 219 #
2011/0380(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) In order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship. Therefore the EMFF should support innovative operations and business development which add value to the industry and food production and offer adequate environmental protection. All such operations should be economically viable.
Amendment 262 #
2011/0380(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) As a result of the establishment of systems of transferable fishing concessions envisaged in Article 27 of the [CFP Regulation] and iIn order to support Member States in the implementation of these new systems to allocate access to fishing resources, the EMFF should grant support in terms of capacity building and exchange of best practices.
Amendment 286 #
2011/0380(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) The objective of the Common Fisheries Policy is to ensure a sustainable exploitation of fish stocks. Overcapacity has been identified as a major driver for overfishing. It is therefore paramount to adapt the Union fishing fleet to the resources available. The removal of overcapacity through public aid such as temporary or permanent cessation and scrapping schemes has proven ineffective. The EMFF will therefore support the establishment and management of systems of transferable fishing concessions aiming at the reduction of overcapacity and increased economic performance and profitability of the operators concerned.
Amendment 345 #
2011/0380(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) New forms of income combined with aquaculture activities have already shown their added value for business development. Therefore the EMFF should support these complementary activities outside aquaculture such as angling- tourism, educational or environmental activities. In particular innovations that contribute to the use of waste materials including dissolved nutrients, the production of renewable energy and the integration of different trophic levels (IMTA) such as fish alongside shellfish and algae should be supported.
Amendment 349 #
2011/0380(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Another important form of increasing the income of aquaculture enterprises is adding value to their products by processing and marketing their own production, as well as introducing new species with good market and environmental prospects and thus diversifying their production.
Amendment 371 #
2011/0380(COD)
Proposal for a regulation
Recital 54
Recital 54
Amendment 391 #
2011/0380(COD)
Proposal for a regulation
Recital 62
Recital 62
Amendment 531 #
2011/0380(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) promoting sustainable and competitive fisheries and aquaculturfisheries and aquaculture which are competitive, economically viable and socially and environmentally sustainable;
Amendment 641 #
2011/0380(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point 3 – introductory part
Article 6 – paragraph 1 – point 3 – introductory part
(3) Fostering sustainable, innovative, competitive and knowledge based aquaculture through the focus on the following areas:
Amendment 833 #
2011/0380(COD)
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
Amendment 940 #
2011/0380(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point o – point i – indent 3
Article 20 – paragraph 1 – point o – point i – indent 3
– an evaluation of the effects of the fishing and aquaculture sectors on the ecosystem.
Amendment 1204 #
2011/0380(COD)
Proposal for a regulation
Article 34 – title
Article 34 – title
Support to systems of transferable fishing concessions of the CFPallocation of fishing opportunities
Amendment 1212 #
2011/0380(COD)
Proposal for a regulation
Article 34 – paragraph 1 – introductory part
Article 34 – paragraph 1 – introductory part
1. In order toThe EMFF may support the establishment or modify systems of transferable fishing concessions under Article 27 of the [Regulatiication of systems that improve the allocation of fishing opportunities among on the CFP], the EMFF may supportperators, such as:
Amendment 1218 #
2011/0380(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point a
Article 34 – paragraph 1 – point a
(a) the design and development of technical and administrative means necessary for the creation or functioning of a transferable fishing concessions systeminnovative system for the allocation of fishing opportunities;
Amendment 1227 #
2011/0380(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) stakeholder participation in designing and developing transferable fishing concessions systemsinnovative systems as referred to in paragrahp 1 (a);
Amendment 1232 #
2011/0380(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) the monitoring and evaluation of transferable fishing concessions systemssystems referred to in paragraph 1 (a);
Amendment 1236 #
2011/0380(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) the management of transferable concessions systemssystems referred to in paragraph 1 (a).
Amendment 1241 #
2011/0380(COD)
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. Support under paragraph 1 (a), (b) and (c) shall only be granted to public authorities. Support under paragraph 1 (d) of this Article shall be granted to public authorities legal or natural persons or recognized producer organizations involved in collective management of pooled transferable fishing concessions in accordance with Article 28(4) of the Regulation on Common Fisheries.
Amendment 1276 #
2011/0380(COD)
Proposal for a regulation
Article 36 – paragraph 1 – introductory part
Article 36 – paragraph 1 – introductory part
1. In order to reduce the impact of fishing on the marine environment, foster the elimination of discards and facilitate the transition to the exploitation of living marine biological resources that levels capable of restoresing and maintainsing populations of harvested species above levels which can produce the MSY, the EMFF may support research and investments in equipment aimed at:
Amendment 1278 #
2011/0380(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point a a (new)
Article 36 – paragraph 1 – point a a (new)
(a a) changing of fishing gear and the related vessel modification, necessary know-how and training, provided that the new gear has demonstrably better size and species selectivity, a limited impact on the marine environment and vulnerable marine ecosystems and does not increase the ability of the fishing vessel to catch fish;
Amendment 1523 #
2011/0380(COD)
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Support under this Chapter shall be limited to aquaculture enterprises unless otherwise expressly established.that are ecologically sustainable and adhere to European Union environmental legislations
Amendment 1612 #
2011/0380(COD)
Proposal for a regulation
Article 47 – paragraph 1 – point b
Article 47 – paragraph 1 – point b
(b) diversification of the income of aquaculture enterprises through the development of new aquaculture species with good market and environmental prospects;
Amendment 1700 #
2011/0380(COD)
Proposal for a regulation
Article 51 – paragraph 2 – point c
Article 51 – paragraph 2 – point c
(c) submit an economically and environmentally viable business plan for the development of their aquaculture activities.
Amendment 1719 #
2011/0380(COD)
Proposal for a regulation
Article 52 – paragraph 1 - point e a (new)
Article 52 – paragraph 1 - point e a (new)
(e a) that promote the research of aquaculture techniques with low environmental impact.
Amendment 1736 #
2011/0380(COD)
Proposal for a regulation
Article 54 – paragraph 1 – point a
Article 54 – paragraph 1 – point a
(a) aquaculture methods that use existing structures like natural ponds, and aim to create an activity that is semi-natural and compatible with specific environmental needs and subject to specific management requirements resulting from the designation of NATURA 2000 areas in accordance with Council Directive 92/43/EEC and Council and European Parliament Directive 2009/147/EC;
Amendment 1779 #
2011/0380(COD)
Proposal for a regulation
Article 57
Article 57
Amendment 1984 #
2011/0380(COD)
Proposal for a regulation
Article 71 – paragraph 1 – point f
Article 71 – paragraph 1 – point f
(f) conducting regional, national or transnational promotional campaigns for environmentally sustainable fishery and aquaculture products.
Amendment 2206 #
2011/0380(COD)
Proposal for a regulation
Article 94 – paragraph 3 – point a
Article 94 – paragraph 3 – point a
Amendment 64 #
2011/0280(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) With a view to strengthening their rural development policy, Member States should be given the possibility to transfer funds from their direct payments ceiling to their support assigned for rural development. At the same time, Member States where the level of direct support remains lower than 90 % of the Union average level of support should be given the possibility to transfer funds from their support assigned for rural development to their direct payments ceiling. Such choices should be made, within certain limits, once and for the whole period of application of this Regulation.
Amendment 28 #
2011/0218(COD)
Proposal for a regulation
Article 1 – point 1 b (new)
Article 1 – point 1 b (new)
Regulation (EC) No 1967/2006
Article 7 − paragraphs 4 and 5
Article 7 − paragraphs 4 and 5
Amendment 29 #
2011/0218(COD)
Proposal for a regulation
Article 1 – point 2 c (new)
Article 1 – point 2 c (new)
Regulation (EC) No 1967/2006
Article 19 − paragraphs 8 and 9
Article 19 − paragraphs 8 and 9
(2c) Article 19 is amended as follows: (a) Paragraph 8 is replaced by the following: "8. If the Commission, on the basis of the notification referred to in paragraph 7 or of new scientific advice, considers that a management plan adopted under either paragraph 1 or paragraph 2 is not sufficient to ensure a high level of protection of resources and the environment, it may, after consulting the Member State concerned, request it to amend the plan within three months from the date of notification of the request. If the Commission considers that the Member State's management plan has not been changed, or has been amended inappropriately, and is still not sufficient to ensure a high level of protection of resources and of the environment, it shall be empowered to adopt delegated acts, in accordance with Article 30a, amending the management plan in order to ensure the protection of the resources and of the environment." (b) Paragraph 9 is replaced by the following: "9. Where a Member State proposes to adopt a management plan that is liable to affect the vessels of another Member State, it shall notify the Commission, that other Member State and the Regional Advisory Council concerned, before adopting that management plan. The Member States and Regional Advisory Council concerned may submit their written comments to the Commission on the proposed management plan within 30 working days from the date of notification of the proposed adoption. After considering any such comments submitted, the Commission shall be empowered to adopt delegated acts, in accordance with Article 30a, that confirm, cancel or amend the plan within 60 working days from that date of notification of the proposed management plan."
Amendment 22 #
2011/0206(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a multiannual plan for the Baltic salmon stock and the fisheries exploitmanaging that stock
Amendment 36 #
2011/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
a) the Baltic salmon stock is exploitmanaged in a sustainable way according to the principle of maximum sustainable yield;
Amendment 45 #
2011/0206(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. The annual TAC for the salmon stocks at sea shall not exceed the level corresponding to a fishing mortality rate of 0.1. Harvesting of salmon that takes place in rivers and at sea within the baselines shall be reduced within six years of the entry into force of this Regulation and evaluated within eight years of the entry into force of this Regulation. In order to allow the wild salmon populations to grow beyond levels of maximum sustainable yields the harvesting of salmons in the spawning period should be prohibited in the natural spawning areas.
Amendment 69 #
2011/0206(COD)
Proposal for a regulation
Annex 3 – paragraph 1 – introductory part
Annex 3 – paragraph 1 – introductory part
Amendment 146 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 2 – paragraph 2 – j
Article 2 – paragraph 2 – j
Amendment 158 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 3 a (new)
Article 3 a (new)
Article 3a Essential requirements 1. Tacographs, tachograph cards and record sheets must comply with stringent technical, functional and other requirements so as to ensure that they fulfil the essential requirements set out in paragraph 2 and that they achieve the objectives of this Regulation. 2. To allow for efficient control of compliance with the applicable social legislation the tachograph shall comply with the following essential requirements: (a) to record accurate and reliable data related to the driver activity and the vehicle; (b) to be secure, in order to guarantee the integrity and the origin of the source of data recorded by and retrieved from vehicle units, motion sensors and tachograph cards; (c) to be interoperable; (d) to be user friendly; 3. Tachographs must be designed and used in such a way as to ensure privacy and personal data protection. 4. Tachographs shall be positioned in the vehicle at the driver's field of vision and in such a way as to allow the driver to access the necessary functions from his seat. 5. Downloading of data shall be performed with the minimum delay to transport undertakings or drivers. 6. Downloading of data may not alter or delete stored data. The downloading of the detailed speed file may not be necessary to ensure compliance with Regulation (EC) No 561/2006, but may be used for other purposes, such as accident investigation.
Amendment 172 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 4 – Title
Article 4 – Title
Recording of location data Recording of the starting and ending place of the daily working period
Amendment 176 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Amendment 185 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2 a. The specifications shall establish the type of events that may trigger an automatic record of position and the situation for which a manual record should remain possible. They shall confirm the location data format, including the UTC data format (legal time). The specification shall specify how to correlate GNSS with other vehicle motion data.
Amendment 190 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In order to facilitate targeted (roadside) checks by the competent control authorities, the recording equipmenttachograph installed in vehicles put into service for the first time [4836 months after the entry into force of this Regulation] shall be able to communicatspecifications referred to in this Article shall be able to communicate through an external or internal device while the vehicle is in motion to those authorities.
Amendment 193 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 5 – paragraph 2
Article 5 – paragraph 2
2. CThe communication referred to in paragraph 1 shall be established with the recexternal ord ing equipmentternal device connected with the tachograph only when so requested by the equipment of the control authorities. It shall be secured to ensure data integrity and authentication of the recording and control equipment.
Amendment 204 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 5 – paragraph 8
Article 5 – paragraph 8
8. The Commission shall be empowered to adopt delegated acts in accordance with Article 39 concerning the suppledevelopmenting of Annex IB with the detailed technical specifications necessary to enable remote communication between the recexternal ord ing equipmentternal device connected with the tachograph and the competent control authorities as set out in this Article.
Amendment 208 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 6 – paragraph 2
Article 6 – paragraph 2
2. For the purpose of paragraph 1, vehicles put into service for the first time [4836 months after the entry into force of this Regulation] shall be fitted with recording equipment equipped withe technical specifications referred to in this Article shall be fitted with a tachograph equipped or connected to a harmonised interface allowing the data recorded or produced to be used for intelligent transport systems applications.
Amendment 326 #
2011/0196(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
Council Regulation (EEC) No 561/2006
Article 13(1) – (d), (f), (p)
Article 13(1) – (d), (f), (p)
The distance of ‘50 km’ referred to in points (d), (f) and (p) of Article 13(1) is replaced by ‘1050 km’.
Amendment 109 #
2011/0195(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The Common Fisheries Policy should ensure that fishing and aquaculture activities contribute to long-term sustainable environmental, economic, and social conditions. It should contribute moreover to increased productivity, a fair standard of living for the fisheries sector, stable markets, ensure the availability of resources and that supplies reach consumers at reasonable prices.
Amendment 118 #
2011/0195(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Sustainable exploitationmanagement of marine biological resources should be based on the precautionary approach, which is to be derived from the precautionary principle referred to in the first subparagraph of Article 191(2) of the Treaty. The precautionary principle applies where scientific evidence is insufficient, inconclusive or uncertain.
Amendment 129 #
2011/0195(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In view of the precarious economic state of the fishing industry and the dependence of certain coastal communities on fishing activities, it is necessary to ensure the relative stability of fishingmaritime related activities by allocating fishing opportunities among Member States, based on a predictable share of stocks for each Member State.
Amendment 134 #
2011/0195(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) The Union should promote the objectives of the Common Fisheries Policy internationally. To this end, the Union should strive to improve the performance of regional and international organisations in conservation and sustainable management of international fish stocks, by promoting decision-making based on science and improved compliance, increased transparency and stakeholder participation, and by combating illegal, unreported and unregulated (IUU) fishing activities.
Amendment 138 #
2011/0195(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Aquaculture should contribute to the preservation of the food production potential on a sustainable basis throughout the Union so as to guarantee long-term food security for European citizens and to contribute to the growing world aquatic food demand. Aquaculture should not increase the fishing pressure on wild stocks and should be subjected to environmental impact assessment prior to any expansion.
Amendment 145 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 1 – paragraph 1 – point a
Part 1 – article 1 – paragraph 1 – point a
(a) conservation, management and exploitationuse of marine biological resources; and
Amendment 162 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 2 – paragraph 3
Part 1 – article 2 – paragraph 3
3. The Common Fisheries Policy shall implement the ecosystem-based approach to fisheries and aquaculture management to ensure that the impacts of fishing activities on the marine ecosystem are limited.
Amendment 323 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 11 – paragraph 1 a (new)
Part 3 – article 11 – paragraph 1 a (new)
1a. a description of the role, abundance and diversity of fish in relation to biodiversity and marine food webs and measures to restore and maintain the functionality of such food webs, where they are impacted on by fishing activities;
Amendment 344 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 14 – paragraph 1 – point a
Part 3 – article 14 – paragraph 1 – point a
(a) contribute to maintaining or restoring fish stockpopulations of harvested species above levels capable of producing maximum sustainable yield through improvements in size-selection and where appropriate species selection;
Amendment 345 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 14 – paragraph 1 – point b
Part 3 – article 14 – paragraph 1 – point b
(b) reduce catches of undersizedimmature individuals from fish stocks;
Amendment 411 #
2011/0195(COD)
Proposal for a regulation
Part 4 – article 27 – paragraph 1 – introductory part
Part 4 – article 27 – paragraph 1 – introductory part
1. Each Member State shallmay establish a system of transferable fishing concessions no later than 31 December 2013 for
Amendment 512 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point c
Part 8 – article 43 – paragraph 4 – point c
(c) indicators for environmental, economic and social sustainability, food safety, animal health and welfare, sustainable environment;
Amendment 515 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point d
Part 8 – article 43 – paragraph 4 – point d
(d) assessment of other possible cross- bordering effects on neighbouring Member States, standardisation and consistency of Environmental Impact Assessment (EIA) Directive in order to reduce environmental impacts and the effects of climate change.
Amendment 522 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 -point d a (new)
Part 8 – article 43 – paragraph 4 -point d a (new)
Amendment 532 #
2011/0195(COD)
Proposal for a regulation
Part 11 – article 51 – paragraph 3
Part 11 – article 51 – paragraph 3
3. Member States shall ensure that Union financial assistance is granted only if no sanctions for serious infringements haves been imposcommitted toby the concerned operator within a period of 15 year prior to the date of application for Union financial assistance.
Amendment 578 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 1 – paragraph 1 – point a
Part 1 – article 1 – paragraph 1 – point a
(a) conservation, management and exploitationsustainable use of marine biological resources; and
Amendment 599 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 1 – paragraph 2 a (new)
Part 1 – article 1 – paragraph 2 a (new)
2 a. Contribute to a fair standard of living for those who depend on fishing activities within and outside the Union.
Amendment 671 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 2 – paragraph 4 a (new)
Part 1 – article 2 – paragraph 4 a (new)
4 a. The Common Fisheries Policy shall promote a shift towards low-impact fishing methods and ensure that the fishing capacity of the fleets is aligned with exploitation levels that comply with paragraph 2.
Amendment 797 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 4 – paragraph 1 – point b
Part 1 – article 4 – paragraph 1 – point b
(b) establishment of fishing opportunities and other measures in accordance with the best available scientific advice;
Amendment 819 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 4 – paragraph 1 – point f
Part 1 – article 4 – paragraph 1 – point f
(f) consistence with the integrated maritime policy, and withobligation in the field of environment, development and other Union policies.
Amendment 872 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 5 – paragraph 1 – indent 8
Part 1 – article 5 – paragraph 1 – indent 8
– ‘ecosystem-based approach to fisheries management’ means an approach ensuring that benefits from living aquatic resources are high while the direct and indirect impacts of human activities, including fishing operations on marine ecosystems, are low andavoided or minimised and where possible eliminated and are not detrimental to the future functioning, diversity and integrity of those ecosystems;. Fish populations are maintained within the ecologically viable levels, biological diversity is preserved, functions of the ecosystem are kept at acceptable levels.
Amendment 895 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 5 – paragraph 1 – indent 12
Part 1 – article 5 – paragraph 1 – indent 12
– ‘conservationlimit reference point’ means values of fish stock population parameters (such as biomass or fishing mortality rate) used in fisheries management, for example with respect to an acceptable level of biological riskthat set a limit biological reference point for the fixing of fishing opportunities which is equal to maximum sustainable yield, as adjusted by the imposition orf a desired level of yieldprecautionary buffer that increases as scientific uncertainty increases;
Amendment 942 #
2011/0195(COD)
Proposal for a regulation
Part 1 – article 5 – paragraph 1 – indent 19
Part 1 – article 5 – paragraph 1 – indent 19
– ‘fishing capacity’ means a vessel's tonnage in GT (Gross Tonnage) and its power in kW (Kilowatt) as defined in Articles 4 and 5 of Council Regulation (EEC) No 2930/8635 in addition to characteristics of onboard equipments;
Amendment 1066 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 7 – paragraph 1 – point c a (new)
Part 3 – article 7 – paragraph 1 – point c a (new)
(ca) adopting measures to meet requirements under environmental legislation;
Amendment 1143 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 8 – paragraph 1 – point e
Part 3 – article 8 – paragraph 1 – point e
(e) requirements for fishing vessels to cease operating in an area for a defined minimum period in order to protect aessential fish habitats and temporary aggregations of a vulnerable marine resource;
Amendment 1183 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 9 – paragraph 2 – point a
Part 3 – article 9 – paragraph 2 – point a
(a) the basis for fixing fishing opportunities for the fish stocks concerned on the basis of predefined conservation reference pointslimit reference points consistent with the objectives set out in Article 2 and without ever exceeding the level specified by the scientific advice; and
Amendment 1186 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 9 – paragraph 2 – point b
Part 3 – article 9 – paragraph 2 – point b
(b) measures capable of effectively preventing conservationlimit reference points from being transgressed.
Amendment 1208 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 9 – paragraph 3
Part 3 – article 9 – paragraph 3
3. Multiannual plans shall, where possible, cover either fisheries exploiting single fish stocks or fisheries exploiting a mixture of stocks, taking due account of interactions between stocks and fisheries. , fisheries and the marine ecosystem and regional marine strategies for the restoration and maintenance of a good environmental status;.
Amendment 1218 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 9 – paragraph 4
Part 3 – article 9 – paragraph 4
4. Multiannual plans shall comply with the objectives in Articles 2 and 3, be based on the precautionary approach to fisheries management and shall take into account the limitations of the available data and assessment methods and all quantified sources of uncertainty in a scientifically valid manner, so that so that where scientific evidence is uncertain, fisheries management will act more cautiously but absence of adequate scientific information shall not be used as justification for not taking action.
Amendment 1252 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 10 – paragraph 1
Part 3 – article 10 – paragraph 1
1. Multiannual plans shall provide for adaptations of the fishing mortality rate, resulting in a fishing mortality rate thatthe restoration and maintenance of all stocks of harvested species above levels capable of producing maximum sustainable yield by 2015. Where this is not biologically possible, or where there is a failure to achieve that stock level by 2015, the fishing mortality rate shall be adjusted to that which will restores and or maintains all stocks above levels capable of producing maximum sustainable yield by 201520, and if that is not possible, by the earliest biologically possible date thereafter.
Amendment 1282 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 11 – paragraph 1 – point a
Part 3 – article 11 – paragraph 1 – point a
(a) the geographical scope, in terms of stocks, fishery and the marine ecosystem to which the multiannual plan shall be applied;
Amendment 1373 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 11 – paragraph 1 – point j a (new)
Part 3 – article 11 – paragraph 1 – point j a (new)
(ja) New point (k) a description of the role, abundance and diversity of fish in relation to biodiversity and marine food webs and measures to restore and maintain the functionality of such food webs, where they are impacted on by fishing activities;
Amendment 1377 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 11 – paragraph 1 – point j b (new)
Part 3 – article 11 – paragraph 1 – point j b (new)
(jb) measures to protect species listed in Annex IV of Directive 92/43/EEC and Directive 2009/147/EC from the impacts of fishing.
Amendment 1433 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 14 – paragraph 1 – introductory part
Part 3 – article 14 – paragraph 1 – introductory part
Technical measures frameworks to ensure the protection of marine biological resources and the reduction of the impact of fishing activities on fish stocks and on marine eco-systems shall be established in relation to fishing activities in and outside of EU waters. Technical measures frameworks shall:
Amendment 1442 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 14 – paragraph 1 – point a
Part 3 – article 14 – paragraph 1 – point a
(a) contribute to maintaining or restoring fish stockpopulations of harvested species above levels capable of producing maximum sustainable yield through improvements in size-selection and where appropriate species selection;
Amendment 1448 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 14 – paragraph 1 – point b
Part 3 – article 14 – paragraph 1 – point b
(b) reduce catches of undersized individuals from fish stockjuvenile species;
Amendment 1485 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 15 – paragraph 1 – introductory part
Part 3 – article 15 – paragraph 1 – introductory part
1. All catches of the following fish stocks subject to catch limits caughtharvested species including bycatch caught in the following fisheries during fishing activities in Union waters or by Union fishing vessels outside Union waters (i) shall be recorded, and as regards fish stocks subject to fishing opportunities, shall be deducted from a fishing vessel's allocated individual fishing opportunities and a Member States' fishing opportunities, with immediate effect; and (ii) shall be brought and retained on board the fishing vessels and recorded and landed, except when used as live bait, , in accordance with the following timeframe:
Amendment 1544 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 15 – paragraph 2
Part 3 – article 15 – paragraph 2
2. Minimum conservation reference sizes based on the best available scientific advice shall be established for the fish stocks set out in paragraph 1. The sale of catches of such fish stocks below the minimum conservation reference size shall be restricted for reduction to fish meal or pet food onlywhich are subject to the obligation to land all catches set out in paragraph 1, in cases where the landing obligatio fails to induce sufficient avoidance of juvenile catches. The sale of catches of such fish stocks below the minimum conservation reference size shall be prohibited. Minimum conservation reference sizes shall not exceed any dimensions and sizes determined by existing EU legislation including in particular those in Article 17.
Amendment 1569 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 15 – paragraph 4
Part 3 – article 15 – paragraph 4
4. Member States shall ensure that Union fishing vessels flying their flag are equipped to ensurprovide full documentation, including video surveillance or other equivalent electronic monitoring systems on the vessels to monitor all catches, of all fishing and processing activities for the purpose of monitoring compliance with the obligation to land all catches. For a transitional period, Member States shall promote voluntary full documentation by CCTV, and comparable means, by granting additional fishing opportunities in accordance with Article 29(4), leading to the mandatory use of such technology [for all vessels] by [2014]. Member States shall publish records of all catches, and shall make this information publicly accessible by publishing it on appropriate websites or providing a direct link to it. With regard to access to environmental information, Directive 2003/4/EC shall apply.
Amendment 1613 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 16 – paragraph 3
Part 3 – article 16 – paragraph 3
3. Fishing opportunities shall not exceed the level specified in the scientific advice and shall comply with quantifiable targets, time frames and margins established in accordance with Article 9(2) and 11(b), (c) and (h).
Amendment 1620 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 16 – paragraph 3 a (new)
Part 3 – article 16 – paragraph 3 a (new)
3a. If no corresponding multiannual plan has been adopted for a commercially used fish stock in EU waters, an exploitation rate shall be established at the latest by 2015 in order to restore and maintain the population well above levels capable of producing the maximum sutainable yield by 2020 at the latest.
Amendment 1625 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 16 – paragraph 4 a (new)
Part 3 – article 16 – paragraph 4 a (new)
4 a. The Commission shall present to the European Parliament and to the Council an annual report assessing whether current fishing opportunities are proving effective in restoring and maintaining populations of harvested species at levels above those which can produce the target laid down in Article 2.2.
Amendment 1696 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 19 – paragraph 1 – subparagraph 1 (new)
Part 3 – article 19 – paragraph 1 – subparagraph 1 (new)
The Commission shall assess whether the measures are consistent with the multiannual plans and comply with the provisions set out in Article 17 and the objectives set out in Articles 2 and 3.
Amendment 1745 #
2011/0195(COD)
Proposal for a regulation
Part 3 – article 21 – paragraph 1 – point d a (new)
Part 3 – article 21 – paragraph 1 – point d a (new)
(d a) measures to protect species listed in Annex IV of Directive 92/43/EEC and Directive 2009/147/EC from the impact of fishing;
Amendment 1809 #
2011/0195(COD)
Proposal for a regulation
Part 4 – article 27 – paragraph 1 – introductory part
Part 4 – article 27 – paragraph 1 – introductory part
1. Each Member State shallmay establish a system of transferable fishing concessions no later than 31 December 2013 for
Amendment 2051 #
2011/0195(COD)
Proposal for a regulation
Part 5 – article 34 – paragraph 4
Part 5 – article 34 – paragraph 4
4. Member States shall ensure that from 1 January 2013 the fishing capacity of their fleet does not exceed at any time the fishing capacity ceilings established in accordance with Article 35.
Amendment 2054 #
2011/0195(COD)
Proposal for a regulation
Part 5 – article 34 – paragraph 4 a (new)
Part 5 – article 34 – paragraph 4 a (new)
4 a. The Commission shall be empowered to adopt delegated acts in accordance with Article 55 concerning the re-calculation of the fishing capacity ceilings as referred to in paragraphs 1 and 2.
Amendment 2266 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 1 – point a
Part 8 – article 43 – paragraph 1 – point a
(a) improving the quality, competitiveness and ecological sustainability of the aquaculture industry andby supporting its development and innovation;
Amendment 2292 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 1 – point d a (new)
Part 8 – article 43 – paragraph 1 – point d a (new)
(d a) phasing-out of unsustainable feed, especially those obtained from wild capture fisheries.
Amendment 2320 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point b
Part 8 – article 43 – paragraph 4 – point b
Amendment 2332 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point d a (new)
Part 8 – article 43 – paragraph 4 – point d a (new)
(d a) Requirements for coherent management of capture based aquaculture and the related wild stocks ensuring sustainability in both phases of the production aiming at a progressive phasing out of this type of activity.
Amendment 2335 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point d b (new)
Part 8 – article 43 – paragraph 4 – point d b (new)
(d b) provisions for the use of sustainable feeds;
Amendment 2338 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point d c (new)
Part 8 – article 43 – paragraph 4 – point d c (new)
(d c) food safety, animal health and welfare, sustainable environment;
Amendment 2340 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point d d (new)
Part 8 – article 43 – paragraph 4 – point d d (new)
(d d) the requirement to use sustainable feeds, the potential to use animal by- products and the development of alternatives to fish meal and oil;
Amendment 2341 #
2011/0195(COD)
Proposal for a regulation
Part 8 – article 43 – paragraph 4 – point d e (new)
Part 8 – article 43 – paragraph 4 – point d e (new)
(d e) standardisation and consistency of Environmental Impact Assessment (EIA) Directive in order to reduce environmental impacts and the effects of climate change
Amendment 2442 #
2011/0195(COD)
Proposal for a regulation
Part 11 – article 50 – paragraph 2 a (new)
Part 11 – article 50 – paragraph 2 a (new)
The Union shall ensure that detailed and timely information on the objectives and administration of financial assistance, including relevant budgets and evaluations, are publicly available.
Amendment 2505 #
2011/0195(COD)
Proposal for a regulation
Part 12 – article 54 – paragraph 1
Part 12 – article 54 – paragraph 1
1. Advisory Councils shall be composed of organizations representing the fisheries operators and other interest groups affected by the Common Fisheries Policy as well as scientists and representative of relevant national and regional administrations.
Amendment 2538 #
2011/0195(COD)
Proposal for a regulation
Part 14 – article 57 – paragraph 4
Part 14 – article 57 – paragraph 4
Amendment 2544 #
2011/0195(COD)
Proposal for a regulation
Part 14 – article 58 – paragraph 1 a (new)
Part 14 – article 58 – paragraph 1 a (new)
The Commission shall report to the European Parliament and the Council on the operation of the Common Fisheries Policy by the end of 2022.
Amendment 16 #
2010/2158(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Strongly supports the use and promotion of integrated urban mobility plans (urban travel plans) and regular connections to surrounding and rural areas;
Amendment 39 #
2010/2158(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the vital importance of transport infrastructure to the regions and cities of Europe and calls on the Commission to provide innovative financing solutions for its development without disadvantaging the connections to the rural districts;
Amendment 49 #
2010/0377(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Major accidents often have serious consequences, as evidenced by accidents like Seveso, Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield. Moreover the impact can extend beyond national borders. This underlines the need to ensure that appropriate precautionary action is taken to ensure a high level of protection throughout the Union for citizens, communities and the environment.
Amendment 71 #
2010/0377(COD)
Proposal for a directive
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) military establishments, installations or storage facilities used solely for military purposes;
Amendment 75 #
2010/0377(COD)
Proposal for a directive
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) the transport of dangerous substances and intermediate temporary storage by road, rail, internal waterways, sea or air, outside the establishments covered by this Directive, including loading and unloading and transport to and from another means of transport at docks, wharves or marshalling yards; areas used for such storage purposes shall not be exempted from this Directive if hazardous substances are stored in the area on a regular basis or for long consecutive periods;
Amendment 77 #
2010/0377(COD)
Proposal for a directive
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
Amendment 89 #
2010/0377(COD)
Proposal for a directive
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
Amendment 92 #
2010/0377(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
3a. 'neighbouring establishment' or 'neighbouring site' means an establishment or site that is operating within the impact zone of an establishment;
Amendment 130 #
2010/0377(COD)
Proposal for a directive
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) for existing establishments, one yearthree months from the date laid down in the second subparagraph of Article 28(1),
Amendment 131 #
2010/0377(COD)
Proposal for a directive
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
(c) for subsequent establishments, one yearthree months from the date on which this Directive applies to the establishment concerned.
Amendment 421 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml or, subject to Article 32(2) and (3), per. In addition the amount of energy and nutrients may also be expressed per pack. This applies both to foods prepacked as individual portions and packages containing multiple portions.
Amendment 433 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The mandatoryIf a nutrition declaration shall be expressed, as appropriate, as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or per portion. When provided, the declaration on vitamins and minerals shall alsoincludes a percentage of a reference intake, the reference intakes set out in Annex XI shall be used, and the calculated percentages may only be expressed as a percentage of the reference intakes set out in point 1 of Part A of Annex XIented in the back-of-pack nutrition declaration.
Amendment 446 #
2008/0028(COD)
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
Amendment 447 #
2008/0028(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
Amendment 450 #
2008/0028(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The expression on a per portion basis alone for foodIf a food consists of more than one smaller packages presented in packaside a largesr containing multiple portions of the food, that have not been prepacked as individual portions,er the amount of energy and nutrients shall be establishdetermined by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3)size of the actual package on which the information is given even though there will be differences between the information on the outer and inner packages.
Amendment 571 #
2008/0028(COD)
Proposal for a regulation
Annex XI – part B – table – row 6 a (new)
Annex XI – part B – table – row 6 a (new)
Added sugar 1 45 g __________________________________ 1If refined sugars have been added to a food the content and percent of reference values thereof shall also be specified.