57 Amendments of Pietro FIOCCHI related to 2023/0085(COD)
Amendment 65 #
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9 a) Within the context of the European Green Deal, the European Chemicals Strategy for Sustainability (COM/2020/667), the EU Action Plan Towards Zero Pollution for Air, Water and Soil (COM/2021/400) and European Union Strategic Approach to Pharmaceuticals in the Environment (COM/2019/128), the healthcare sector plays a relevant role in addressing the issue of environmental pollution reduction. In this perspective, establishing a proper regulatory framework for using claims relating to sustainability, circularity and origin of the product’s components both for medicinal products (according to Directive 2001/83) and medical devices (according to Regulations 2017/745), would be crucial for healthcare professionals and beneficial for patients enabling use these terms those company that may demonstrate their fairness.
Amendment 72 #
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14 a) Recognizing the importance of precision and transparency in environmental claims. Member states shall provide practical guidance for the interpretation of the definitions in this Directive. Claims that do not directly and primarily address the environmental impact of a product should not be categorised as explicit environmental claims. Claims solely related to product features should be distinguished from those that genuinely convey environmental benefits, ensuring that consumers are not misinformed and that the integrity of environmental marketing remains intact.
Amendment 87 #
Proposal for a directive
Recital 19
Recital 19
(19) It would be misleading to consumers if an explicit environmental claim pointed to the benefits in terms of environmental impacts or environmental aspects while omitting that the achievement of those benefits leads to negative trade-offs on other environmental impacts or environmental aspects. To this end the information used to substantiate explicit environmental claims should ensure that the interlinkages between the relevant environmental impacts and between environmental aspects and environmental impacts can be identified along with potential trade-offs. The assessment used to substantiate explicit environmental claims should identify if improvements on environmental impacts or environmental aspects lead to the kind of trade-offs that significantly worsen the performance as regards other environmental impacts or environmental aspects, for example if savings in water consumption lead to a notable increase in greenhouse gas emissions, or in the same environmental impact in another life-cycle stage of the product, for example CO2 savings in the stage of manufacturing leading to a notable increase of CO2 emissions in the use phase. For example, a claim on positive impacts from efficient use of resources in intensive agricultural practices may mislead consumers due to trade-offs linked to impacts on biodiversity, ecosystems or animal welfare. An environmental claim on textiles containing plastic polymer from recycled PET bottles may also mislead consumers as to the environmental benefit of that aspect if the use of this recycled polymer competes with the closed-loop recycling system for food contact materials which is considered more beneficial from the perspective of circularity.
Amendment 125 #
Proposal for a directive
Recital 32
Recital 32
(32) The Commission Recommendation (EU) 2021/2279 contains guidance on how to measure the life cycle environmental performance of specific products or organisations and how to develop Product Environmental Footprint Category Rules (PEFCRs) and Organisation Environmental Footprint Sectorial Rules (OEFSRs) that allow comparison of products to a benchmark. Such category rules for specific products or traders can be used to support the substantiation of claims in line with the requirements of this Directive. Therefore, the Commission should be empowered to adopt delegated acts to establish product group or sector specific rules where this may have added value. However, in case the Product Environmental Footprint method does not yet cover an impact category, which is relevant for a product group, the adoption of PEFCR may take place only once these new relevant environmental impact categories have been added. For example, as regards marine fisheries, the PEFCR should for example reflect the fisheries- specific environmental impact categories, in particular the sustainability of the targeted stock. Concerning space, the PEFCR should reflect defence and space- specific environmental impact categories, including the orbital space use. As regards food and agricultural products, biodiversity and nature protection, as well as farming practices, including positive externalities of extensive farming and animal welfare, should, for example, also be integrated before the adoption of PEFCR could be considered. As regards textiles, the PEFCR should for example reflect the microplastics release, before the adoption of PEFCR could be considered. To enable a clear, transparent and collaborative process, the Commission should publish a communication outlining the path towards further development of the PEF methodology, including regular updates of the rules to foster scientific progress and engagement of affected stakeholders.
Amendment 141 #
Proposal for a directive
Recital 40 a (new)
Recital 40 a (new)
(40 a) In cases where a trader or trader's product is awarded an environmental labelling scheme, the trader can use the verified environmental label in commercial communications based on the certificate of conformity obtained by the certification scheme. The trader can also make environmental claims based on the environmental aspects, impacts and performance of products certified by the verified label without having to apply for further verification. In that case, the information to be displayed should be that of the environmental labelling scheme, including the certificate of conformity,
Amendment 165 #
Proposal for a directive
Recital 54
Recital 54
(54) Small and medium-sized enterprises (SMEs) or recognized National Associations (EUIPO registered) should be able to benefit from the opportunities provided by the market for more sustainable products but they could face proportionately higher costs and difficulties with some of the requirements on substantiation and verification of explicit environmental claims. The Member States shouldand the Commission should, in their respective areas of responsibility, provide adequate information and raise awareness of the ways to comply with the requirements of this Directive, ensure targeted and specialised training, and provide specific assistance and support, including financial, to SMEs wishing to make explicit environmental claims on their products or as regards their activities. Member States actions should be taken in respect of applicable State aid rulesshould develop a tool that facilitates the substantiation of explicit environmental claims. This tool should, for example, calculate the environmental footprint of a product, even through voluntary certification model audited by third party.
Amendment 172 #
Proposal for a directive
Recital 64
Recital 64
(64) When setting penalties and measures for infringements, the Member States should foresee that, based on the gravity of the infringement, the level of fines should effectively deprive the non- compliant trader from the economic benefit derived from using the misleading or unsubstantiated explicit environmental claim or non-compliant environmental labelling scheme, including in cases of repeated infringements. The measures for infringements foreseen by the Member States should therefore also include confiscation of the relevant product from the trader or revenues gained from the transactions affected by this infringement or a temporary exclusions or prohibitions from placing products or making available services on the Union market. The gravity of the infringement should be the leading criterion for the measures taken by the enforcement authorities. The maximum amount of fines should be dissuasive and set at least at the level of 4% of the trader’s total annual turnover in the Member State or Member States concerned in case of widespread infringements with a Union dimension that are subject to coordinated investigation and enforcement measures in accordance with Regulation (EU) 2017/239488 . _________________ 88 Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).
Amendment 181 #
Proposal for a directive
Recital 73 a (new)
Recital 73 a (new)
(73 a) This proposal does not cover business-to-business environmental claims nor sustainability reporting.
Amendment 188 #
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Directive applies to explicit environmental claims made by traders about products placed on the market or put into service, including through online marketplaces, or traders in business-to- consumer commercial practices.
Amendment 192 #
2. This Directive does not apply to environmental claims in business-to- business commercial practices, to environmental labelling schemes or, to explicit environmental claims or to sustainability reporting regulated by or substantiated by rules established in:
Amendment 200 #
Proposal for a directive
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) Regulation (EU) 2018/848 of the European Parliament and of the Council96, _________________ 96 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). with regard exclusively to the deadlines laid down in Annex IV;
Amendment 211 #
Proposal for a directive
Article 1 – paragraph 2 – point o a (new)
Article 1 – paragraph 2 – point o a (new)
(o a) Directive (EU) 2022/2464 of the European Parliament and of the Council (CSDR);
Amendment 212 #
Proposal for a directive
Article 1 – paragraph 2 – point o a (new)
Article 1 – paragraph 2 – point o a (new)
(oa) Regulation (EU) No 1151/2012 of the European Parliament and of the Council
Amendment 214 #
Proposal for a directive
Article 1 – paragraph 2 – point o b (new)
Article 1 – paragraph 2 – point o b (new)
(o b) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources;
Amendment 231 #
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) ‘'environmental claim’statement' means environmental claim as defined in Article 2, point (o), of Directive 2005/29/EC;
Amendment 232 #
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘explicit environmental claim’ means an environmental claim that is in textual form or contained in an environmental labelwhere the specification of the claim is provided in clear and prominent terms on the same medium or through digital means;
Amendment 236 #
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘'explicit environmental claim’statement' means an environmental claim that is in textual form or contained in an environmental label;
Amendment 248 #
Proposal for a directive
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
Amendment 250 #
Proposal for a directive
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
Amendment 252 #
Proposal for a directive
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
(8) ‘environmental label’ means a sustainability label as defined in Article 2, point (r) of Directive 2005/29/EC, covering only or predominantly environmental aspects of a product, a process or a trader;
Amendment 269 #
Proposal for a directive
Article 2 – paragraph 1 – point 19 a (new)
Article 2 – paragraph 1 – point 19 a (new)
(19 a) "widely recognised scientific evidence” means evidence based on a scientifically valid reasoning which has been either subject to peer review and publication or has received widespread acceptance within a relevant scientific community, or international or European standards.
Amendment 272 #
Proposal for a directive
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
1. Member States shall ensure that traders carry out an assessment to substantiate explicit environmental claims. This assessmente assessment for explicit environmental claims related to environmental impacts, environmental aspects or environmental performance shall:
Amendment 283 #
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) rely on widely recognised scientific evidence, use accurate information and take into account relevant international standards; whose references have been included in Annex I of this Directive. The Commission may amend Annex 1 by adopting delegated acts establishing methodologies and standards that cover certain environmental performance, environmental aspects or environmental impacts in order to make sure that explicit environmental claims made in accordance with these methods and standards meet the substantiation requirement outlined in Article 3. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 18.
Amendment 293 #
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) rely on widely recognised scientific evidenceapproach , use accurate information and take into account relevant international or European standards;
Amendment 294 #
Proposal for a directive
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
Amendment 298 #
Proposal for a directive
Article 3 – paragraph 1 – point c
Article 3 – paragraph 1 – point c
(c) demonstrate that environmental impacts, environmental aspects or environmental performance that are subject to the claim are significant from a life- cycle perspective as defined in ISO 14001;
Amendment 307 #
Proposal for a directive
Article 3 – paragraph 1 – point d
Article 3 – paragraph 1 – point d
(d) where a claim is made on environmental performance, take into account allso environmental aspects or environmental impacts which are significant to assessing the environmental performancefrom a life-cycle perspective as defined in ISO 14001;
Amendment 315 #
Proposal for a directive
Article 3 – paragraph 1 – point e
Article 3 – paragraph 1 – point e
Amendment 319 #
Proposal for a directive
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
Amendment 324 #
Proposal for a directive
Article 3 – paragraph 1 – point g
Article 3 – paragraph 1 – point g
Amendment 326 #
Proposal for a directive
Article 3 – paragraph 1 – point g
Article 3 – paragraph 1 – point g
(g) identify whether improving environmental impacts, environmental aspects or environmental performance subject to the claim leads to significant harm in relation to environmental impacts on climate change, resource consumption and circularity, sustainable use and protection of water and marine resources, pollution, biodiversity, animal welfare and ecosystems. For those impacts for which there are no widely recognised scientific indicators, the trader making the claim shall provide a qualitative assessment to comply with the requirements referred to in paragraph 1;
Amendment 347 #
Proposal for a directive
Article 3 – paragraph 1 – point h
Article 3 – paragraph 1 – point h
(h) separate any greenhouse gas emissions offsets used from greenhouse gas emissions as additional environmental information, specify whether those offsets relate to emission reductions, avoidance or removals, and describe how the offsets relied upon are of high integrity and accounted for correctly to reflect the claimed impact on climate;
Amendment 353 #
Proposal for a directive
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
Amendment 365 #
(j) include relevant secondary information for environmental impacts, environmental aspects, or environmental performance which is representative of the specific value chain of the product or the trader on which a claim is made, in cases where no primary information is available.
Amendment 440 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure that a trader, including online marketplaces, is required to communicate an explicit environmental claim in accordance with the requirements set out in this Article.
Amendment 537 #
Proposal for a directive
Article 8 – paragraph 2 – point d
Article 8 – paragraph 2 – point d
(d) the requirements for the environmental labelling scheme have been developed by experts that can ensure their scientific robustness and have been submitted for consultation to a heterogeneous group of stakeholder, where relevant and necessary, for consultation to stakeholders that apply or are impacted by the labelling scheme or their representatives that has reviewed them and ensured their relevance from a societal perspective;
Amendment 554 #
From [(OP: Please insert the date = the date of transposition of this Directive] no new national or regional environmental labelling schemes shall be established by public authorities of the Member States. However, national or regional environmental labelling schemes established prior to that date may continue to award the environmental labels on the Union market, provided they meet the requirements of this Directiveaffording priority to their application.
Amendment 559 #
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 2
Article 8 – paragraph 3 – subparagraph 2
From the date referred to in the first subparagraph, environmental labelling schemes may only be established under Union law. Member States may, however, set up new national or regional environmental labelling schemes for types or categories of products for at least one of the following reasons: the protection of public health; consumer protection; the prevention of fraud; the protection of organically produced agri-foodstuffs; the protection of industrial and commercial property rights, indications of provenance, indications of origin and the prevention of unfair competition.
Amendment 600 #
In order to ensure a uniform application across the Union, the Commission shall adopt 12 months after the date of transposition of this Directive implementing acts to:
Amendment 630 #
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The verification of environmental labeling schemes shall be undertaken by a verifier fulfilling the requirements set out in Article 11, in accordance with the procedures referred to in paragraphs 1 and 2, before the environmental claim is made public or the environmental label is displayed by a trader. Before a trader makes an environmental claim public or displays an environmental label, they shall ensure that the explicit environmental claim complies with the requirements outlined in Article 12 and follows the procedures mentioned in paragraph 1.
Amendment 632 #
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The verification of environmental labeling schemes shall be undertaken by a verifier fulfilling the requirements set out in Article 11, in accordance with the procedures referred to in paragraphs 1 and 2, before the environmental claim is made public or the environmental label is displayed by a trader. Before a trader makes an environmental claim public or displays an environmental label, they shall ensure that the explicit environmental claim complies with the requirements outlined in Article 12 and follows the procedures mentioned in paragraph 1.
Amendment 638 #
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The verification shall be undertaken by a verifier fulfilling the requirements set out in Article 11, in accordance with the procedures referred to in paragraphs 1 and 2, before the environmental claim is made public or the environmental label is displayed by a trader, including online marketplaces.
Amendment 639 #
Proposal for a directive
Article 10 – paragraph 4 a (new)
Article 10 – paragraph 4 a (new)
4 a. Environmental labels substantiated on the PEF textile methodology and relying on PEFCRs for textile developed by a Commission delegated act under Article 3(4) point (c) shall be granted a presumption of conformity and be excluded from the verification process of this Directive.
Amendment 663 #
Proposal for a directive
Article 10 – paragraph 9 a (new)
Article 10 – paragraph 9 a (new)
9 a. Member States shall set up procedures to prioritize the verification of existing environmental claims made before the entry into force of this Directive and introduce a transition period during which existing claims, submitted for verification, can continue to be used.
Amendment 696 #
Proposal for a directive
Article 11 a (new)
Article 11 a (new)
Article 11a Protection of trade secrets Member states shall ensure that measures adopted in accordance with this Directive are without prejudice to the protection of sensitive information and business secrets foreseen in Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016.
Amendment 714 #
Proposal for a directive
Article 12 a (new)
Article 12 a (new)
Article12a 1. For the purpose of this Directive, an explicit environmental claim shall be presumed to be in conformity with the substantiation requirement laid down in Article 3 of this Directive, if it aligns to relevant standards or methodologies or parts thereof as far as the environmental performance, the environmental aspects, or environmental impact covered by those standards are concerned, whose references were included in Annex I to this Directive. Explicit environmental claims that comply with this Article are exempted from the pre-verification requirement laid down in Article 10. 2. The Commission may amend Annex I by adopting delegated acts establishing methodologies and standards that cover certain environmental performance, environmental aspects or environmental impacts as to make sure that explicit environmental claims made in accordance with these methods and standards meet the substantiation requirement outlined in Article 3. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 18. 3. Member States shall make sure that a trader communicating an explicit environmental claim in accordance with this Article shall prepare substantiation documentation outlining the conformity of the explicit environmental claim with this Article. 4. Member States shall ensure that the substantiation documentation referred to in paragraph 3 is updated. Traders shall keep that documentation at disposal for market surveillance authorities for a period of 2 years following the placement of the product on the market and make that documentation available to those authorities upon reasoned request. 5. Member States shall make sure that traders have procedures in place for products produced in series and bearing the explicit environmental claim to remain in conformity with the substantiation requirement outlined in Article 3.
Amendment 724 #
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Where, further to the evaluation referred to in the first subparagraph, the competent authorities find that the substantiation and communication of the explicit environmental claim or the environmental labelling scheme does not comply with the requirements laid down in this Directive, they shall invite the trader to provide appropriate reasons for the anomalies found. If the competent authorities do not consider the reasons given sufficient, they shall notify the trader making the claim about the non- compliance and require that trader to take all appropriate corrective action within 3045 days to bring the explicit environmental claim or the environmental labelling scheme into compliance with this Directive or to cease the use of and references to the non-compliant explicit environmental claim. Such action shall be as effective and rapid as possible, while complying with the principle of proportionality and the right to be heard.
Amendment 747 #
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 750 #
Proposal for a directive
Article 17 – paragraph 2 – point b
Article 17 – paragraph 2 – point b
(b) the intentional or negligent character of the infringement and any action taken by the trader, including online marketplaces, to mitigate or remedy the damage suffered by consumers, where applicable;
Amendment 758 #
Proposal for a directive
Article 17 – paragraph 2 – point g
Article 17 – paragraph 2 – point g
(g) penalties imposed on the trader, including online marketplaces, for the same infringement in other Member States in cross-border cases where information about such penalties is available through the mechanism established by Regulation (EU) 2017/2394, where applicable.
Amendment 759 #
Proposal for a directive
Article 17 – paragraph 2 – point g a (new)
Article 17 – paragraph 2 – point g a (new)
(g a) related impacts on micro, small and medium sized companies and their competitiveness.
Amendment 763 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
Amendment 774 #
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 2
Article 17 – paragraph 3 – subparagraph 2
For the purposes of point (a), Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/2394115 , the maximum amount of such fines being at least at 4 % of the trader’s annual turnover in the Member State or Member States concernedeffective, proportionate and dissuasive. _________________ 115 OJ L 345, 27.12.2017, p. 1.
Amendment 785 #
Proposal for a directive
Article 20 – paragraph 3
Article 20 – paragraph 3
3. Member States shall provide the information referred to in paragraph 1 to the Commission on an biannual basis.
Amendment 797 #
Proposal for a directive
Article 21 – paragraph 3 – point b
Article 21 – paragraph 3 – point b
(b) facilitating transition towards toxic free environment by considering introducing, on the basis of an impact assessment, a prohibition of environmental claims for products containing hazardous substances of very high concern, except where their use is considered essential for the society in line with the criteria to be developed by the Commissionsafe and improves the sustainability of the product;
Amendment 810 #
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
They shall apply those measures from [OP please insert the date = 2436 months after the date of entry into force of this Directive] to products, informational and packaging material placed on the market after this date.
Amendment 821 #
Proposal for a directive
Article 25 a (new)
Article 25 a (new)
Article25a Transitional provision Products placed on the market or labelled prior to [date of entry into force of the national legislation transposing this Directive] which do not comply with the requirements of this Directive may be marketed until the stocks of the products are exhausted.