120 Amendments of Anja HAZEKAMP related to 2018/0088(COD)
Amendment 65 #
Proposal for a regulation
Recital 1
Recital 1
(1) Regulation (EC) No 178/2002 of the European Parliament and of the Council20 lays down the general principles and requirements of food law, so as to form a common basis for measures governing food law both at Union and Member State level. It provides, amongst others, that food law must be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure. __________________ 20 and it should be complemented by the precautionary principle. __________________ 20 Regulation (EC) No 178/2002 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, (OJ L 31, 1.2.2002, p. 1).
Amendment 72 #
Proposal for a regulation
Recital 3
Recital 3
(3) The evaluation of Regulation (EC) No 178/200221 , ,(“Fitness Check of the General Food Law”), found that risk communication is overall, not considered to be effective enough, which has an impact on consumers’ confidence on the outcome of the risk analysis process. and the different stakeholders. __________________ 21 Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)”, SWD(2018)38 final, dated 15.1.2018.
Amendment 73 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should regain citizens' trust that the whole process is underpinned by the objective of this Regulation, which is to ensure high level of human life and health and the protection of consumers' interests. Therefore it should be combined with an open dialogue between all interested parties, particularly the public to ensure the coherence and, consistency and accountability within the risk analysis process.
Amendment 81 #
Proposal for a regulation
Recital 6
Recital 6
(6) To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the expressed expectations of the citizens and the respective roles of risk assessors and managers.
Amendment 84 #
Proposal for a regulation
Recital 8
Recital 8
(8) The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the hazard, the different levels of risk, the nature of the risk and its potential public health, animal health and environmental impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to minimise or control risk and other factors that influence risk perception including the level of urgency as well as the applicableexisting or not legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.
Amendment 89 #
Proposal for a regulation
Recital 9
Recital 9
(9) TImproving transparency of the risk assessment process would contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, would increases their confidence in its work and would ensures that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.
Amendment 93 #
Proposal for a regulation
Recital 11
Recital 11
(11) Experience shows that the role of the Management Board of the Authority isapart from risk assessment is also focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States, as well from the Commission, the Parliament in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment and that the absence of any conflict of interest is avoided.
Amendment 95 #
Proposal for a regulation
Recital 12
Recital 12
(12) The Management Board should be selected in such a way as to secure the highest standards of competence, impartiality, independence, lack of conflict of interest and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and, the Commission and the civil society.
Amendment 100 #
Proposal for a regulation
Recital 13
Recital 13
(13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise. In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels. The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of independent experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise.
Amendment 104 #
Proposal for a regulation
Recital 14
Recital 14
(14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence, integrity and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests, who is the legal representative of EFSA and whose function is to be responsible for the performance of the works of the Authority and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently.
Amendment 109 #
Proposal for a regulation
Recital 15
Recital 15
(15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise. It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, including by requesting the Authority’s staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by the Panels.
Amendment 111 #
Proposal for a regulation
Recital 16
Recital 16
(16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health, animal health and the environment is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market and create relative advantage of those over its competitors. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectorial food law applicants are required to submit relevant, verifiable and reliable studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
Amendment 114 #
Proposal for a regulation
Recital 17
Recital 17
(17) Provisions exist on the content of applications for authorisations should be scrutinised and formulated in such a way that the application for authorisation meets the highest standards regarding transparency and reliability. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, access to practical info on the application compilation that would benefit all,, the advice of the Authority shouldwill be made public.
Amendment 117 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once aas soon as the corresponding application for authorisation or renewal has been made public in accordance with the applicable rules on transparency.
Amendment 122 #
Proposal for a regulation
Recital 19
Recital 19
(19) In the case of applications to request the renewal of an authorisation, the authorised substance or product has already been on the market for several years. Therefore experience and knowledge exist on this substance or product. It is therefore appropriate that the studies planned for supporting requests for renewals should be notified by the applicant to the Authority and that following a consultation of third parties on these planned studies, the Authority systematically provides advice to the applicants on the content of the intended renewal application, taking into account the received comments. and making public all information.
Amendment 125 #
Proposal for a regulation
Recital 20
Recital 20
(20) There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority alreadymust makes searches in scientific literature systematically to be able to consider other data and studies existing on the subject matter submitted to its assessment. In this respect, the Authority must implement the necessary means, structures and applications to provide access to all relevant scientific literature on the matter. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to also provide for a consultation of third independent parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
Amendment 130 #
Proposal for a regulation
Recital 21
Recital 21
(21) Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectorial food law usushally comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced control and auditing system whereby Member State and third countries controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.
Amendment 132 #
Proposal for a regulation
Recital 22
Recital 22
(22) Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is importantprerequisite to establish an additional verification tool to address specific cases of high societal importance, as a minimum, cases where there is auncertainty or controversy on safety issues and potential risks, namely the commissioning of additional independent studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies, particularly so upon the request of civil society. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Amendment 139 #
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) In order to enhance the public participation and to give the right to the citizens to indicate to the decision-makers where their concerns are focused, the Commission with the same conditions as the European Citizens' Initiative, should create the mechanism that will allow the citizens, to request the commissioning of additional studies dealt by the Authority. After consultation with the initiators and the Authority, the specifications of the studies shall be established and the process of the commissioning will start immediately.
Amendment 142 #
Proposal for a regulation
Recital 23
Recital 23
(23) The Fitness Check of the General Food Law demonstrated that although the Authority has made considerablsome progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the agri- food chain, is not always perceived as fully transparent. This is also partly due to the differentlack of transparency and confidentiality rules that are laid down not only inregarding the risk assessment and the confidentiality rules that overrule the public interest. as laid down in Article 4 of Regulation (EC) No 178049/20021 but also in other Union legislative acts covering the agri-food chain. Their interplay can non-application of the general rule on access to documents and the interplay with the restricted transparency impact on the acceptability of the risk assessment by the general public.
Amendment 145 #
Proposal for a regulation
Recital 25
Recital 25
(25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner. Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process. However, this process should be without prejudice to existing intellectual propertThe provisions of this regulation should reflect the importance of the transparency prights or to any provisions of Union food law protectnciple in primary EU law and ing the investment made by innovators in gathering the information and data supporting relevant applications for authorisaternational treaties to which the EU is a party, including the Aarhus Conventions.
Amendment 147 #
Proposal for a regulation
Recital 26
Recital 26
Amendment 151 #
Proposal for a regulation
Recital 27
Recital 27
(27) To determine what level of disclosure strikes the appropriate balance, theis relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002gulation should take into account and fully implement the transparency provisions of the Aarhus Convention, providing clarity on how such provisions, and those of Regulation (EC) 1367/2006 apply in the context of EU food law.
Amendment 155 #
Proposal for a regulation
Recital 28
Recital 28
(28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures. It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosedit is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure is required in accordance with the Aarhus Convention and the principles set out in Regulation (EC) 1367/2006 or in view of protecting animal and human health.
Amendment 160 #
Proposal for a regulation
Recital 29
Recital 29
Amendment 161 #
Proposal for a regulation
Recital 30
Recital 30
(30) It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council24 and Regulation (EU) 2016/679 of the European Parliament and of the Council25 . Accordingly, no personal data should be made publicly available under this Regulation, unless whenever, it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interestsand the common interest being the highest level of protection of human health, animal health and the environment. __________________ 24 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 25 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 169 #
Proposal for a regulation
Recital 36
Recital 36
(36) To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention35 , against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out ine effectiveness of the transparency in the risk assessment process, including those flowing from the Aarhus Convention, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 in view of facilitating the prompt disclosure of specific health and environmental information relevant to these regulations. The new provisions on active dissemination are without prejudice to the rights to access information established by Regulations (EC) No 1781049/2001 and 1367/20026. __________________ 35 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p.13).
Amendment 186 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – introductory part
Article 8 a – introductory part
Risk communication shall contribute to the achievement of the general objective of the Regulation pursueing the following risk communication objectives, while taking into account the respective roles of risk assessors and risk managers:
Amendment 188 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point b
Article 8 a – point b
(b) promote consistency and transparency in formulating risk management recommendations in order to reach the highest level of protection of human and animal health and the environment;
Amendment 197 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c
Article 8 a – point c
(c) provide a sound scientific basis for understanding risk management decisions;
Amendment 213 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point e
Article 8 b – point e
(e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
Amendment 240 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1 a – point c
Article 25 – paragraph 1 a – point c
(c) fourFive members with the right to vote representing civil society and the food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmerspublic health non-governmental organisations and, one from industryanimal health organisations and one from the agri-food business industry. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Amendment 272 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 a (new)
Article 1 – paragraph 1 – point 3 a (new)
Regulation (EC) No 178/2002
Article 30 – paragraph 4 a (new)
Article 30 – paragraph 4 a (new)
(3a) In Article 30, the following paragraph is added after paragraph 4: “4a. Where a substantive divergence over scientific issues has been identified and the body in question is a body within the United Nations system, the Authority shall be obliged to cooperate with a view to either resolving the divergence in order to establish the exact scope of a potential risk for and impact on human health, animal health and the environment. or presenting a joint document to the Commission clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This clarification or investigation document shall be made public.“
Amendment 279 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a
Article 32 a
At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and the required content of the application for authorisation. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. To ensure the transparency of this process, the advise should be made public.
Amendment 285 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b– paragraph 1
Article 32 b– paragraph 1
1. A Union register of studies commissioned by business operators to obtainin relation to an authorisation they seek to obtain under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned to supportrelated to a future application for an authorisation under Union food law. The register shall be managed by the Authority.
Amendment 287 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 2 a (new)
Article 32 b – paragraph 2 a (new)
2a. Data from a test commissioned but not registered shall not be used in a risk assessment.
Amendment 288 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 2 b (new)
Article 32 b – paragraph 2 b (new)
2b. The subject matter shall not be authorised unless all data from all registered studies are submitted.
Amendment 290 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 3
Article 32 b – paragraph 3
3. The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f.
Amendment 293 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 4
Article 32 b – paragraph 4
4. The Authority shall lay down in its internal rules the practical arrangements for implementing the notification obligations laid down in paragraphs 1 and 2, including consequences of non-compliance with the notification obligation. Those arrangements shall however be in accordance with the present Regulation and other Union sectoral food law. Business operators may rely in view of seeking an authorisation under Union food law, only on studies that they and the Union laboratories have duly notified to the Authority.
Amendment 300 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 c – paragraph 2
Article 32 c – paragraph 2
2. The Authority shall, within four months, consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process.
Amendment 303 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 d
Article 32 d
The Commission experts shall perform controls, including audits, to obtain assurancensure that testing facilities in the Union and in third countries, comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member Statconcerned countries.
Amendment 305 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 e
Article 32 e
Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.; The power of initiative for the commissioning of verification studies, shall also be given to the citizens under the same conditions as the European Citizen’s Initiative. Once the conditions are fulfilled and verified, the Commission shall consult with the initiators and the Authority, about the specifications of the studies and the process of the commissioning will start immediately. The studies many have a wider scope than the evidence subject to verification or the demand of the Citizens’ verification initiative, but the scope shall correspond at least to the request(s) and shall have the approval of the initiators. For this purpose the Commission shall create the platform and the mechanism that allow the public to submit their request for commissioning of verification studies;
Amendment 313 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EC) No 178/2002
Article 32 e a (new)
Article 32 e a (new)
(4a) The following Article 32ea is inserted: “Safety Mandatory Tests Safety testing of chemicals shall be paid for by the applicant of a substance and shall be managed by EFSA in cooperation with independent laboratories. EFSA shall define the set of mandatory laboratory tests based on legal requirements and additional concerns for hazards observed in scientific literature and put forward in public consultation.”
Amendment 322 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – introductory part
Article 38 – paragraph 1 – introductory part
The Authority shall carry out its activities with a high level of transparency in line with the Aarhus Convention and without prejudice to Regulations (EC) No 1049/2001 and (EC) No 1367/2006 and Directive 2003/4/EC. It shall in particular make public without delay:
Amendment 325 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point a
Article 38 – paragraph 1 – point a
(a) agendas, participants, observers and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
Amendment 329 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
(c) scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39fin accordance with Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment 338 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 1
Article 38 – paragraph 1 a – subparagraph 1
The disclosure of the information mentioned in paragraph (1)(c) to the public shall be without prejudice: take into account the Union’s interest to promote access to environmental information in accordance with Regulation (EC) No 1367/2002 on the application of the provisions of the Aarhus Convention, in particular when information relates to emissions in the environment.
Amendment 345 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Amendment 347 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 1 – point b
Article 38 – paragraph 1 a – subparagraph 1 – point b
Amendment 356 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 1
Article 39 – paragraph 1
1. By way of derogation from Article 38 and without prejudice to Regulation (EC) No 1049/2001, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article.
Amendment 362 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – introductory part
Article 39 – paragraph 2 – introductory part
2. The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemedit concludes, upon verifiable justification, towould significantly harm the interests concerned:
Amendment 363 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 1
Article 39 – paragraph 2 – point 1
Amendment 367 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 1
Article 39 – paragraph 2 – point 1
(1) the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;
Amendment 368 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 2
Article 39 – paragraph 2 – point 2
Amendment 369 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 3
Article 39 – paragraph 2 – point 3
Amendment 372 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 4
Article 39 – paragraph 2 – point 4
Amendment 377 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – introductory part
Article 39 – paragraph 4 – introductory part
4. Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made publicThe Authority shall not provide confidential treatment to the following information:
Amendment 380 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Article 39 – paragraph 4 – point a
(a) Where urgent action isInformation that may be deemed essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,
Amendment 383 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Article 39 – paragraph 4 – point a
(a) Where urgent action is essential to protect public health, animal health or the environment, such asincluding in emergency situations, the Authority maywill disclose theany information referred to paragraphs 2 and 3; and,necessary;
Amendment 385 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b
Article 39 – paragraph 4 – point b
(b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effe(human and animal) health effects and/ or environmental impacts.
Amendment 391 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b a (new)
Article 39 – paragraph 4 – point b a (new)
(ba) when an overriding public interest in the disclosure exists.
Amendment 392 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b a (new)
Article 39 – paragraph 4 – point b a (new)
(ba) information relating to potential emissions in the environment.
Amendment 394 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 a – paragraph 1
Article 39 a – paragraph 1
Amendment 398 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 a – paragraph 2
Article 39 a – paragraph 2
2. Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall be withouthide in black the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39. The confidential version shall contain all information submitted, including information the applicant deems confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.
Amendment 405 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1– point e a (new)
Article 39 b – paragraph 1– point e a (new)
(ea) In case the Authority considers that the applicant misuses of the confidentiality claims, a proportionate, effective and dissuasive fine maybe charged for the additional administrative burden creating by respective application.
Amendment 406 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – subparagraph 2
Article 39 b – paragraph 1 – subparagraph 2
Amendment 410 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 c
Article 39 c
Before the Authority issues its scientific outputs, including scientific opinions, it shall review whether information that has been previously accepted as confidential mayshall nevertheless be made public in accordance with paragraph 4(b) and (c) of Article 39. Should that be the case, the Authority shall follow the procedure laid down in Article 39b, which shall apply mutatis mutandis.
Amendment 412 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 2
Article 39 d – paragraph 2
2. The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive, unless it concerns information that may be deemed essential to protect public health, animal health or it is clear that such information relates to emissions in the environment. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public.
Amendment 415 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 e – paragraph 1 – point c
Article 39 e – paragraph 1 – point c
(c) the names of all participants and observers in meetings of the Scientific Committee and the Scientific Panels and, their Working Groups and any other ad hoc Group meeting on the subject..
Amendment 419 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Article 41 – paragraph 1
Amendment 420 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – introductory part
Article 1 – paragraph 1 – point 9 – introductory part
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Article 41 – paragraph 1
(9) in Article 41, the following sentence is added at the end of paragraph 1: is amended as follows: 1. The Authority shall ensure wide access to the documents which it possesses, in accordance with Regulations (EC) No 1049/2001 and No 1367/2006 of the European Parliament and of the Council. 2. The Management Board, acting on a proposal from the Executive Director, shall adopt the provisions applicable to access to the documents referred to in paragraph 1, in accordance with the general principles and conditions governing the right of access to the Community institutions’ documents. 3. The proactive disclosure mechanisms set out in Articles 38 and 39 are without prejudice to the rights to access conferred on the public by Regulations (EC) 1049/2001 and No 1367/2006 of the European Parliament and of the Council.
Amendment 422 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Article 41 – paragraph 1
Amendment 433 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 2
Article 61 – paragraph 2
2. Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’scommission an independent external evaluation of the Authority’s achievements and performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines and the Management Board’s work programme. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.
Amendment 436 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 3
Article 61 – paragraph 3
3. Where the CommissionManagement Board considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose to the Commission to initiate the legislative process so that the relevant provisions of this Regulation be amended accordingly or repealed.
Amendment 437 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 4
Article 61 – paragraph 4
4. The Commission shall report toexternal evaluator shall report to the Commission, the European Parliament, the Council and the Management Board on the evaluation findings. The findings of the evaluation shall be made public.
Amendment 441 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
(a) the notifier/applicant may request certain information, the disclosure of which could harm his/her competitive position and submitted under this Directive to be kept confidential, accompanied by verifiable justification; and,
Amendment 442 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 1 – point b a (new)
Article 25 – paragraph 1 – point b a (new)
(ba) In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential: – general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses; – methods and plans for monitoring of the GMO or GMOs and for emergency response; – environmental risk assessment.
Amendment 443 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2
Article 25 – paragraph 2
Amendment 445 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2
Article 25 – paragraph 2
Amendment 446 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
Amendment 447 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2 – point b
Article 25 – paragraph 2 – point b
Amendment 450 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point b
Article 3 – paragraph 1 – point 1 – point b
Regulation (EC) No 1829/2003
Article 5 – paragraph 3 – point e
Article 5 – paragraph 3 – point e
(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be kept confidential, accompanied by verifiable justification on how the disclosure of those would have his/hers competitive advantage, pursuant to Articles 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002; ;
Amendment 455 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2
Article 30 – paragraph 2
Amendment 457 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2
Article 30 – paragraph 2
2. In addition to Article 39(2) and pursuant toformation relating to the following shall not be considered confidential: (a) name and composition of the GMO, food or feed referred to in Articles 39(3) of Regulation (EC) No 178/2002, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (b) breeding patterns and strategies. (1) and 15(1) and, where appropriate, indication of the substrate and the micro- organism; (b) general description of the GMO and the name and address of the authorisation-holder; (c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and15(1); (d) effects of the GMO, food or feed referred to in Articles 3(1) and15(1) on human and animal health and on the environment; (e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties; (f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1); (g) information on waste treatment and emergency response.
Amendment 458 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2 – point a
Article 30 – paragraph 2 – point a
Amendment 459 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2 – point a
Article 30 – paragraph 2 – point a
Amendment 460 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) 1829/2003
Article 30 – paragraph 2 – point b
Article 30 – paragraph 2 – point b
Amendment 461 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2 – point b
Article 30 – paragraph 2 – point b
Amendment 467 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 2
Article 18 – paragraph 2
2. In accordance with the conditions and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and this Article, the applicant may request certain information which might significantly harm his competitive position submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and, the Authority shall assess the confidentiality request submitted by the applicant.
Amendment 469 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 470 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3 - introductory part
Article 18 – paragraph 3 - introductory part
3. In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to signifConfidential treatment may not be accepted with respect to the following information, in light of their relevance for the protection of public antly harm the interests concernedd animal health:
Amendment 471 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) 1831/2003
Article 18 – paragraph 3 – point b
Article 18 – paragraph 3 – point b
(b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
Amendment 473 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraphs 3 a to 3 e (new)
Article 18 – paragraphs 3 a to 3 e (new)
3a. Notwithstanding paragraph 2, the following information shall not be considered confidential: (a) name and composition of the feed additive and, where appropriate, indication of the production strain; (b) physico-chemical and biological characteristics of the feed additive; (c) the conclusions of the study results on effects of the feed additive on human and animal health and on the environment; (d) the conclusions of the study results on effects of the feed additive on the characteristics of animal products and its nutritional properties; (e) methods for detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring. 3b. Notwithstanding paragraph 2, the Authority shall, on request, supply the Commission and Member States with all information in its possession, including any identified as confidential pursuant to that paragraph. 3c. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council 1a when handling applications for access to documents held by the Authority. 3d. The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraphs 2 and 3 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001. 3e. If an applicant withdraws or has withdrawn an application, the Member States, the Commission and the Authority shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the Commission and the applicant disagree as to its confidentiality. ___________________________ 1a Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 475 #
Proposal for a regulation
Article 5 – paragraph 1 – point 1 – point a
Article 5 – paragraph 1 – point 1 – point a
Regulation (EC) No 2065/2003
Article 7 – paragraph 2 – point c – point ii
Article 7 – paragraph 2 – point c – point ii
(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15the principles of Regulation 1049/2001.
Amendment 478 #
Proposal for a regulation
Article 5 – paragraph 1 – point 3
Article 5 – paragraph 1 – point 3
Regulation (EC) No 2065/2003
Article 15
Article 15
Amendment 486 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 1 – point b a (new)
Article 20 – paragraph 1 – point b a (new)
(ba) the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.
Amendment 487 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2
Article 20 – paragraph 2
Amendment 488 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2 – introductory part
Article 20 – paragraph 2 – introductory part
2. In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatmenConfidential treatment may not be accepted with respect to the following information, twhe disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concernedn it may be deemed to relate to emissions in the environment or may be deemed relevant to protect public health and/or animal health:
Amendment 494 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
2a. Information relating to the following shall not be considered confidential: (a) the name and address of the applicant and the chemical name of the substance; (b) information of direct relevance to the assessment of the safety of the substance; (c) the analytical method or methods.
Amendment 495 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2 b (new)
Article 20 – paragraph 2 b (new)
2b. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health.
Amendment 497 #
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11
Article 11
Amendment 499 #
Proposal for a regulation
Article 7 – paragraph 1 – point 3
Article 7 – paragraph 1 – point 3
Regulation (EC) No 1331/2008
Article 12
Article 12
Amendment 502 #
Proposal for a regulation
Article 8 – paragraph 1 – point 1 – point b
Article 8 – paragraph 1 – point 1 – point b
Regulation (EC) No 1107/2009
Article 7 – paragraph 3 – subparagraph 1
Article 7 – paragraph 3 – subparagraph 1
When submitting the application, the applicant may pursuant to Article 63 request for certain information, including certain parts of the dossier that may significantly harm its commercial interests, to be kept confidential and shall physically separate that information.
Amendment 503 #
Proposal for a regulation
Article 8 – paragraph 1 – point 1 – point b
Article 8 – paragraph 1 – point 1 – point b
Regulation (EC) No 1107/2009
Article 7 – paragraph 3 – subparagraph 2
Article 7 – paragraph 3 – subparagraph 2
Amendment 504 #
Proposal for a regulation
Article 8 – paragraph 1 – point 2
Article 8 – paragraph 1 – point 2
Regulation (EC) No 1107/2009
Article 10
Article 10
The Authority shall without delay make the dossiers referred to in Article 8 of this Regulation including any supplementary information supplied by the applicant, available to the public, excluding any information in respect of which confidential treatment has been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant to Article 63 of this Regulation.;, unless there is an overriding public interest in its disclosure.
Amendment 506 #
Proposal for a regulation
Article 8 – paragraph 1 – point 4
Article 8 – paragraph 1 – point 4
Regulation (EC) No 1107/2009
Article 16
Article 16
The Authority shall assess, without delay, any request for confidentiality and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant to Article 63 of this Regulation.; unless there is an overriding public interest in its disclosure.
Amendment 508 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5 – introductory part
Article 8 – paragraph 1 – point 5 – introductory part
(5) in Article 63, paragraphs 1, 2 and 23 are replaced by the following:
Amendment 509 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5 – introductory part
Article 8 – paragraph 1 – point 5 – introductory part
(5) in Article 63, paragraphs 1 and 2 areis replaced by the following:
Amendment 512 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 1
Article 63 – paragraph 1
1. In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this article, the applicant may request certain information submitted under this Regulation to be kept confidential, if the accompanied by verifiable justification proves that the disclosure of those might undermine commercial interests, the protection of privacy and the integrity of the individual.
Amendment 513 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 516 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 2 – point a
Article 63 – paragraph 2 – point a
Amendment 517 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 2 – point b
Article 63 – paragraph 2 – point b
Amendment 520 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 2 – point c
Article 63 – paragraph 2 – point c
Amendment 521 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5 a (new)
Article 8 – paragraph 1 – point 5 a (new)
Regulation (EC) No 1107/2009
Article 63 – paragraph 3
Article 63 – paragraph 3
(5a) in Article 63, paragraph 3 is replaced by the following: “3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents.”
Amendment 524 #
Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point a
Article 9 – paragraph 1 – point 1 – point a
Regulation (EC) No 2015/2283
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission’s initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States and the summary of the application publicly available without delay;
Amendment 526 #
Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point b
Article 9 – paragraph 1 – point 1 – point b
Regulation (EC) No 2015/2283
Article 10 – paragraph 3
Article 10 – paragraph 3
3. WhereFor every update, the Commission shall requests an opinion from, the European Food Safety Authority (‘the Authority’), to give its opinion as to whether the update is liable to have an effect on human health. The Authority shall ensure public access to the application and its opinion in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health;.
Amendment 530 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, tThe Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article.
Amendment 532 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 3
Article 23 – paragraph 3
3. Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, tThe Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.
Amendment 533 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 4
Article 23 – paragraph 4
Amendment 535 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 4 a (new)
Article 23 – paragraph 4 a (new)