The ACM has also issued Guidelines regarding collaborations between farmers (Leidraad samenwerking landbouwers).这些准则阐明了竞争规则允许农民之间合作的一些主要可能性。关于可持续性考量问题,准则分章专门探讨协作问题,作为可持续性倡议的一部分此类协作可采取横向或纵向协议形式(农商和供货商/买主之间协议形式)。协议甚至可以涉及售价或生产量,如果这样做是必不可缺的。协议必须是实现可持续性目标所必备的,否则是不允许的 。
com/2022/05/可持久性-european-commissions-此类协议无法引起竞争法问题如果协议会影响竞争参数,则会受第101条TFEU约束,但有可能从第101(3)条下的豁免中受益可能的免责因纯经济原因不足,例如保护牛奶生产者高收入,Bka前的拟议方案强调了这一点。可持久协议提供客观环境效益,即 i.e.最后,将可持续性福利视为全社会福利并将其纳入法律引入的反托拉斯框架可预示竞争分析和实践新时代的到来。 近些年来,为将可持续性考量纳入反托拉斯分析做出了重大努力。竞争管理委员会和国家竞争管理机构,特别是HCC似乎接受公司提出的可持续性倡议但也存在不同的决策实践风险国家竞争局批准可持续性协议的决定对另一个国家竞争局没有约束力,而协议可能产生效果的领土内则有争议。这就意味着由第二次NCA裁量权批准或拒绝争议协议中的可持续性考量万博体育app手机登录因此,委员会与国家竞争主管机构之间的互动似乎至关重要,因此应当加强。
Overall,鉴于决策实践不足,仍需要欧盟和国家一级的更多指导。竞争自评在这方面很重要,当公司制定可持续战略时,法律咨询是关键Covington团队准备提供此建议
Taxonomy Re-Cap
The Taxonomy Regulation establishes the EU's binary system to distinguish between economic activities that are "environmentally sustainable" and those that are not.
Together with other laws of the EU Sustainable Finance Package such as the Corporate Sustainability Reporting Directive ("CSRD") and the Sustainable Finance Disclosure Regulation ("SFDR"), the Taxonomy Regulation is designed to channel capital investments to sustainable economic activities.To this end, the Taxonomy Regulation provides criteria to allow companies and financial market participants to label specific economic activities and related investments as "environmentally sustainable," and EU rules require a growing number of companies and investors to report on the degree to which their economic activities and investments comply with the Taxonomy Regulation.
To be environmentally sustainable for purposes of the Taxonomy Regulation, an economic activity must fulfill the following four cumulative requirements:
- Substantially contribute to one of six environmental objectives (e.g., climate change mitigation, transition to a circular economy);
- Not significantly harm any of the other environmental objectives (e.g., by harming pollution prevention and control due to "a significant increase in the emissions of pollutants" or by harming protection and restoration of biodiversity and ecosystems due to its significant detrimental effects on the good condition and resilience of ecosystems).
- Be carried out in compliance with minimum safeguards, which are essentially the core human rights and labor obligations of the OECD, UN Guiding Principles of Business and Human Rights, the International Labor Organization, and those enshrined in the International Bill of Human Rights!和
- 兼容技术筛选标准>
技术筛选标准至关重要They set out the specific conditions that a particular economic activity (e.g., electricity generation from natural gas or construction of a nuclear power plant) must meet in order to be deemed environmentally sustainable for purposes of the Taxonomy Regulation.
The European Commission Is the Key Taxonomy Gatekeeper
Under the Taxonomy Regulation, the EU Member States and the European Parliament have delegated the authority to adopt the technical screening criteria to the European Commission, but Member States and Parliament retain the right to scrutinize and object to them.
The Commission has already successfully adopted Commission Delegated Regulation 2021/2139 (the so-called "Climate Delegated Act"), which sets out the technical screening criteria for dozens of economic activities that are deemed to substantially contribute to climate change mitigation or adaptation (ranging from "anaerobic digestion of sewage sludge" to "transport by passenger cars").
On February 2, the Commission complemented this Climate Delegated Act with the CCDA, which will still be subject to scrutiny by Member States and the European Parliament.The CCDA specifies the screening criteria for specific nuclear and gas activities, and also amends the specific disclosure rules established in Commission Delegated Regulation 2021/2178 to allow investors and other stakeholders to distinguish Taxonomy compliant gas and nuclear activities from other Taxonomy compliant activities such as the construction of off-shore wind parks (see Annex III to CCDA).
Gas Activities: The Commission's Sustainability Criteria
The CCDA includes three natural gas activities that can be Taxonomy compliant subject to strict conditions:
- Construction or operation of electricity generation facilities that produce electricity using fossil gaseous fuels (i.e., natural gas);
- Construction, refurbishment, and operation of combined heat/cool and power generation facilities using fossil gaseous fuels! 构建、翻新和运行热生成设施,使用与高效区热冷相连接的化石气燃料产生热/cool。
三大活动技术筛选标准大致相似Taking the example of the first activity, electricity generation from natural gas, the key conditions are as follows:
- The life-cycle greenhouse gas emissions from the electricity generation must not exceed 100g CO2e/kWh (the emissions are to be calculated based on the EU's 2013 life-cycle method or applicable ISO standards).
- The life-cycle emissions must be verified by an independent third party.
- For facilities relying on a form of abatement, such as carbon capture or use of low-carbon gases, the abatement activity must itself comply with the applicable technical screening criteria in the Climate Delegated Act.
We note that the life-cycle emission target of 100g CO2e/kWh in practice means that operators seeking to comply with it must rely heavily on abatement activities, such as carbon capture technologies or the blending of fuels.依据>Central研究 绿氢与天然气混合还有可能实现这些生命周期排放目标。
The laxer emission target is:
- Direct greenhouse gas emissions are lower than 270g CO2e/kWh of the output energy, or annual direct emissions do not exceed an average of 550kg CO2e/kW of the facility's capacity over 20 years.
The additional cumulative requirements are:
- The gas power plant replaces an existing high emitting electricity generation activity that uses solid or liquid fossil fuels;
- The power to be replaced cannot be generated from renewable energy sources, based on a comparative assessment with the most cost-effective and technically feasible renewable alternative for the same capacity;
- The newly installed production capacity does not exceed the capacity of the replaced facility by more than 15%;
- The gas power plant is designed and constructed to use renewable and/or low-carbon gaseous fuels (e.g., "green" or "blue" hydrogen) and the switch to the full use of such fuels must take place by December 31, 2035.责任公司管理者必须批准并承诺对开关实施可核查计划 。
- 替换现有电源活动导致在新建燃气厂使用寿命期间温室气体排放减少至少55%
- /li/p>如果天然气电厂位于使用煤发电的欧盟成员国内,该成员国公开承诺淘汰煤发电。
- 研究、开发、演示和部署闭合燃料循环先进技术以刺激未来技术在安全标准和废物最小化方面的创新。 新核电厂发电项目构建安全运行这些项目确认至2045年(批准建筑许可日期)。此类工厂的能量可用于生成氢 (即 pinkthy)
The European Commission claims that it has relied on extensive expert advice—including from the Joint Research Centre, the Scientific and Technical Committee under Article 31 of the Euratom Treaty, and the Scientific Committee on Health, Environmental and Emerging Risks ("SCHEER")—to ultimately make the controversial decision that nuclear energy that complies with the regulatory framework in the EU Member States "ensures a high level of protection for the environment and for people," and therefore, can meet the do no significant harm criteria.
To be Taxonomy compliant, these nuclear activities must meet detailed regulatory conditions that cover requirements beyond the existing EU and national law regulatory frameworks for nuclear power plants.附加条件包括操作处置设施确定日期和禁止输出放射性废物供非欧盟国家处置。
根据分类规则第23(6)条,欧洲议会和理事会有四个月时间阻塞欧盟公报发布CCDA并避免它生效四个月审查周期正式启动后,欧盟委将CCDA译为欧盟各种正式语文提交欧洲议会和理事会,并可在欧洲议会或理事会的倡议下再延长两个月。极可能持续到2022年夏末。
议会议事规则建议将翻译的CCDA提交议会经济和货币事务委员会(ECON)和环境、公共卫生和安全委员会(ENVI)。这两个机构可决定提出一项动议并附理由,要求议会反对CCDA政治集团或代表5%MEPs的集团也可以提出这样的动议阻塞CCDA的任何决议均需由欧洲议会全体会议表决,并只有在705MEPs中至少353支持才能成功。
经济和金融事务理事会配置集欧盟经济和财政部长为一体,总体负责欧盟可持续金融包件。
更多,成员国和欧洲议会也可以向欧盟总法院挑战CCDA私人方,包括非政府组织,如果能证明直接与CCDA相关,也有可能拥有向欧盟普通法院质疑CCDA的法律资格。 2023年1月1日预计CCDA生效,如果议会和理事会不反对它,欧盟法院不中止它时点,符合上述条件的核能和天然气投资将算作分类规则中的“环境可持续性”,从而打开绿化投资者和耳记公共资金的大门,用于欧盟下一代欧盟投资程序。
As of July 3, single-use plastic products marketed in the EU/EEA must comply with the requirements and restrictions of Directive 2019/904 on the Reduction of the Impact of Certain Plastic Products on the Environment ("Single-Use Plastic Directive" – "SUPD"). To help Member States implement the SUPD into their national laws and apply its requirements, on May 31, 2021, the European Commission published its long-awaited Guidelines on the Scope of the SUPD. The Guidelines take different and controversial approaches on the scope the SUPD and the nature of plastics and continue to leave important issues unanswered.
The Requirements of the SUPD
The Single-Use Plastic Directive imposes restrictions and requirements on: (i) single-use plastic products that fall within the scope of the specific categories listed in the different Parts of the Annex to the SUPD, and (ii) all products made of oxo-degradable plastic (i.e., made of "plastic materials that include additives which, through oxidation, lead to the fragmentation of the plastic material into micro-fragments or to chemical decomposition").
In particular, the SUPD imposes the following requirements and restrictions on oxo-degradable plastic products and single-use plastic products marketed in the EU/EEA:
- Prohibition on Placing on the Market: The SUPD prohibits the placing on the market of all products that contain oxo-degradable plastic, as well as single-use plastic products listed in Part B of the Annex to the SUPD. Part B includes plastic cutlery and plates, beverage stirrers, beverage containers made of expanded polystyrene, including their caps and lids.
- Consumption Reduction Obligations: The SUPD requires Member States to ensure a reduction of the consumption of single-use plastic products listed in Part A of the Annex to the Directive. Part A of the Annex lists cups for beverages (with their covers and lids) and specific food containers as single-use plastic products that are subject to this consumption reduction obligation. To achieve this objective, Member States may impose different measures, such as national consumption targets, bans on the offer of the products free of charge at the point of sale, obligations to replace the products with reusable alternatives, and even outright bans on the marketing of the products.
- Product and Design Requirements: The lids and caps of single-use plastic products listed in Part C of the Annex, e, plastic beverage containers of up to three liters, must be designed in such a way that they remain attached to the container during the product's intended use.
- Minimum Recycled Content: The single-use plastic products listed in Part F of the Annex to the SUPD, e., beverage containers of up to three liters that are produced from polyethylene terephthalate as their major component, must be made of at least 25% recycled plastic by 2025 and 30% by 2030.
- Marking and Labelling Requirements: Sanitary towels, tampons, tampon applicators, wet wipes, tobacco products (g., plastic filters) and cups for beverages, as listed in Part D of the Annex to the SUPD, must carry a mark/label in accordance with Commission Implementing Regulation 2020/2151 informing consumers of the presence of plastic in the product, the negative impact of littering, and the product's appropriate waste disposal options. Implementing Regulation 2020/2151 imposes specific requirements on the wording, design, size, color, and position of the marking. It also allows producers to comply with the requirements by means of a sticker if the single-use plastic products are marketed before July 4, 2022.
- Extended Producer Responsibility: Member States must impose extended producer responsibility schemes on producers of single-use plastic food containers, cups for beverages, wet wipes, tobacco products, and all other products listed in Part E of the Annex to the SUPD.生产这些产品者需要支付收集、运输和处理垃圾的费用,以及清理垃圾和组织公众认识运动的费用。their caps and lids), through the implementation of deposit-refund schemes or separate collection targets for producers. The target is set at 90% by 2029. In practice, this obligation means that producers will have to increase the collection of their waste single-use plastic bottles and/or increase their contributions to the waste take-back schemes of which they are members.
- Awareness Raising: Member States must also take measures to inform consumers of re-use systems and waste management options at their disposal, and the impact of littering and other inappropriate waste disposal for all single-use plastic products listed in the Annex to the SUPD and for fishing gears containing plastic.
The European Commission's Guidelines: What is a Single-Use Plastic Product?
As explained above, most of the requirements of the SUPD apply to single-use plastic products that fall within the categories of products listed in the different Parts of the Annex to the Directive. The SUPD defines a "single-use plastic product" as a "product that is made wholly or partly from plastic and that is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-used for the same purpose for which it was conceived." It also defines "plastic" as a "material consisting of a polymer [as defined by the EU REACH Regulation 1907/2006 on Chemicals], to which additives or other substances may have been added, and which can function as a main structural component of final products, with the exception of natural polymers that have not been chemically modified" (Art.3(1)SUPD.
这些定义表示,如果满足下列条件,产品即为单用塑料产品:- A产品由“塑料化”。取决于制作产品所用材料:(一) 聚合物或聚合物混合体除自然聚合物外“非化学修改;”和(三)可起产品主结构组件作用and
- The plastic product is "single-use."
The European Commission's Guidelines on the Scope of the SUPD provide different controversial clarifications on the concept of a single-use plastic product.
Polymer
To be a plastic product, the product must be made of polymers or mixtures of polymers. The SUPD refers to the definition of polymer included in the REACH Regulation 1907/2006, which states that a polymer is substance that meets the following criteria: (i) over 50 percent of the weight for that substance consists of polymer molecules (i.e., of molecules that contain a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant)!万博体育app手机登录and (ii) the amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance.
Polymers will be considered to be plastic materials unless they are "natural" and they "are not chemically modified" (and they function as a main structural component of the products).
"Natural" Polymer
The Commission's Guidelines take the view that a polymer will only be natural if its polymerization process actually takes place in nature (i.e., it may not be the result of an industrial process even if it involves living organisms). According to the Guidance, this means that cellulose and ligning extracted from wood are natural polymers, while polymers resulting from biosynthesis via artificial industrial fermentation are not.
Natural Polymer that Are "not Chemically Modified"
Even if the substances used in the products are natural polymers, they will be considered plastic if they are chemically modified (and the substances function as a main structural component of the products).
The European Commission's Guidelines take the view that whether or not a natural polymer is chemically modified during its production process depends on whether the chemical structure of the polymer resulting from the production process (i.e., outgoing polymer) is different from that of the ingoing polymer.
Following this reasoning, the Guidelines argue that regenerated cellulose, in the form of lyocell, viscose and cellulosic film, is not considered chemically modified because the outgoing polymer is not chemically modified in comparison to the ingoing polymer. By contrast, cellulose acetate is regarded as a chemically modified polymer because the chemical modifications of the polymer occurring during the production process remain present at the end of the process (i.e., the chemical structure of the outgoing polymer is different to that of the ingoing polymer).
The Guidelines also clarify that if the chemical modifications result from reactions that are only taken place during the extraction process of natural polymers, the polymers will not be considered chemically modified.万博体育app手机登录The Guidelines especially mention cellulose and ligning that are extracted from a wood pulping process as examples of such natural polymers.
The Polymer Functions as a Structural Component of the Product
The last condition to qualify as a plastic product is that the polymer (other than a natural polymer that is not chemically modified) must function as a structural component of the product. The Guidelines state that this condition is a generic concept and clarify that the definition of plastic of the SUPD does not restrict or specify the type of product or the amount of polymer required to qualify as a plastic. Thus, for example, cardboard coated with plastic and paper cups with a plastic lining are single-use plastic products. In contrast, the recitals of the SUPD and the Guidelines make clear that the use of plastic paints, inks and adhesives do not render a product a plastic product.
The Plastic Product Is "Single-Use"
To be a single-use plastic product subject to the SUPD, the product must also be "single-use."
The SUPD will only apply to plastic products that: (i) are designed to be disposed of after one use, or (ii) consumers usually throw away after one use, even if the products are not initially designed/conceived as such.
The Guidelines provide various criteria to assess whether a plastic product is single-use or multi-use, including the product's washability or the possibility to empty and refill a product without damaging it. For example, plastic cups that can be reused after being washed will not be considered single-use plastic products.
The Guidelines also add that meeting the criteria on reusable packaging outlined in Article 3(2) of Directive 94/62 on Packaging and Packaging Waste ("Packaging and Packaging Waste Directive" – "PPWD") will demonstrate that a plastic packaging or product is not single-use (unless consumers typically perceive or use it otherwise).
Application of the SUPD and National Implementation
The requirements of the SUPD apply to products made of oxo-degradable plastic materials and to single-use plastic products listed in the Annex to the Directive that are placed on the market as from July 3, 2021. In contrast to other EU product legislation, the SUPD defines the concept of placing on the market within the context of the particular Member State, and not the EU/EEA as a whole. According to the Directive, "placing on the market" is "the first making available of a product on the market of a Member State" (emphasis added). In general terms, this essentially means that single-use plastic products (listed in the Annex) that are marketed in a particular Member State as of July 3 will have to comply with the requirements of the Directive even if they were already marketed in another Member State (for example, imported into the EU via another Member State) before that date. The European Commission is expected to publish Guidance providing further clarification on the concept of placing on the market for purposes of the SUPD.
To date, several EU Member States have already at least transposed some of the requirements of the SUPD into their national law. This is the case of France, Germany and Portugal. Many other Member States, such as Belgium, Italy, Poland and Spain are currently in the process of finalizing and adopting their draft national implementing laws.
On April 21, 2021, the European Commission approved "in principle" a Delegated Regulation establishing the criteria under which different economic activities substantially contribute to climate change mitigation and adaptation under Regulation 2020/852 on the Establishment of a Framework to Facilitate Sustainable Investment ("Taxonomy Regulation"). Among other things, the Delegated Regulation defines the climate mitigation and adaptation criteria that the manufacture of hydrogen must meet to be considered a "sustainable investment" in the European Union.
The Delegated Regulation's criteria on hydrogen constitute an additional step in the implementation of the European Commission's Hydrogen Strategy.While the European Commission must still adopt detailed rules on what should be defined as renewable (green) and low-carbon (blue) hydrogen, the Delegated Regulation sets the "gold standard" for the sustainable production of hydrogen.
Sustainable Finance: the EU Taxonomy Regulation
The Taxonomy Regulation implements the European Commission's European Green Deal and follows up on an earlier Commission's Action Plan on ‘Financing Sustainable Growth'. The Regulation is intended to provide companies and investors with uniform criteria on economic activities that can be considered to be environmentally sustainable, in order to redirect capital flows and generate sustainable economic growth in Europe. The Regulation's criteria are expected to increase transparency on the classification of economic activities that can be considered environmentally sustainable and, therefore, to limit the risk of greenwashing and fragmentation.
The Taxonomy Regulation establishes the principles, and requires the Commission to adopt specific criteria for the following environmental objectives: (i) climate change mitigation!二) 适应气候变化可持续利用和保护水和海洋资源向循环经济过渡防污控制保护并恢复生物多样性和生态系统。
委托规范:可持续氢活动标准
4月21日批准的委托规范建立技术筛选标准以评估所列经济活动是否有资格为减缓和适应气候变化做出重大贡献。 关于氢问题,委托规范建立以下标准:
The Delegated Regulation also requires that the GHG emissions savings be calculated using the methodology of the international standard ISO 14067:2018 or ISO 14064-1:2018the methodology that the Commission must adopt under Article 28(5) of the Renewable Energies Directive ("RED II"), i.e., the methodology for assessing GHG emissions savings from renewable liquid and gaseous transport fuels of non-biological origin.
- Adaptation. The manufacture of hydrogen will meet the taxonomy criteria for climate change adaptation if it complies with four requirements:
-
- The economic activity must implement physical and non-physical solutions ("adaptation solutions") that substantially reduce the most important physical climate risks related to the manufacture of hydrogen;
- The physical climate risks that are material to the activity must be identified by performing a robust climate risk and vulnerability assessment;
- The climate projections and assessment of impacts must be based on best practice and available guidance and take into account the state-of-the-art science for vulnerability and risk analysis and related methodologies (e.g., the Intergovernmental Panel on Climate Change reports)!
- 适应解决方案不得对其他人、自然、文化遗产、资产和其他经济活动的适应努力产生不利影响解决方案必须尽可能依赖蓝绿色基础设施and must be consistent with regional or sectoral adaptation plans. Finally, the solutions must be monitored and measured against pre-defined indicators and remedial action must be considered where those indicators are not met.
The Delegated Regulation Within the Broader EU Hydrogen Strategy
The Delegated Regulation's criteria for sustainable hydrogen are part of the Commission's broader Hydrogen Strategy, which the Commission is still trying to define and implement. While the Delegated Regulation sets the "gold standard" for what is considered sustainable manufacture of hydrogen, it does not necessarily define what is green or blue hydrogen.
The Hydrogen Strategy that the Commission presented in July 2020 announced that the Commission will adopt a "common low-carbon threshold/standard for the promotion of hydrogen production installations based on their full life-cycle greenhouse gas performance, which could be defined relative to the existing [benchmark under the EU Emissions Trading System Directive]" and "a comprehensive terminology and European-wide criteria for the certification of renewable and low-carbon hydrogen."
The Commission may take into account these aspects of its Hydrogen Strategy during its full review of RED II, which is likely to result in a legislative proposal to significantly amend, and perhaps adopt a new, RED.
Moreover, in 2021, the Commission must also adopt two Delegated Regulations under RED II and establish:
- a methodology to assess GHG emissions savings from renewable liquid and gaseous transport fuels of non-biological origin (which include hydrogen)!and
- a methodology with detailed rules on how electricity obtained from direct connection to an installation generating renewable electricity may be fully counted as renewable electricity where it is used for the production of "renewable liquid and gaseous transport fuels of non-biological origin" (which includes hydrogen) and on how electricity that has been taken from the grid may be counted for this purpose ("additionality requirements").
The Commission may also consider the different aspects of its Hydrogen Strategy, including the regulation of low carbon hydrogen as part of its upcoming proposal for a Gas Regulation. This proposal is intended to replace Directive 2009/73/EC on the Common Rules for the Internal Market in Natural Gas, and could introduce a detailed regulation of hydrogen and hydrogen infrastructure.
Next Steps
The Commission has approved the Delegated Regulation "in principle." Its official adoption will only take place once it will be published in all the official languages of the EU. This means that the criteria under the Delegated Regulation may still be subject to changes. This is because (i) the Parliament and Council of the EU may oppose the content of the Delegated Regulation within a period of four to six months after its official adoption (expected in the coming weeks)!和二)可能需要作一些修改,以确保一致性,即将对REDII进行审查,定于2021年6月进行。
Since July 4, 2020 the manufacture, marketing and use of perfluorooctanoic acid ("PFOA"), its salts and PFOA-related compounds (collectively, "PFOAs"), and products containing them, is significantly restricted in the European Economic Area ("EU/EEA"). The restrictions were introduced by a Commission Delegated Regulation amending Annex I to the EU POPs Regulation, and are intended to implement a decision of the ninth meeting of the Conference of the Parties to the Stockholm Convention that was held from April 29 to May 10, 2019.
The new PFOA restrictions will have significant impact on a wide variety of products marketed, and businesses operating, in the EU/EEA, including semiconductors, textiles, firefighting products, pharmaceuticals, medical devices, and materials used in the life sciences industry. In effect, the new restrictions implementing the Stockholm Convention are significantly broader than the restrictions on PFOAs that were introduced under the EU REACH Regulation in 2017, and which the Commission now intends to repeal.
The new restrictions prohibit the manufacturing, placing on the market and use of PFOAs on their own, in mixtures, or in articles (i.e., objects). The restrictions only allow the unintended presence of trace contaminants up to the following thresholds:
- (i) 0,025 mg/kg for PFOA or any of its salts;
- (ii) 1 mg/kg for individual PFOA-related compounds or combination of PFOA-related compounds;
- (iii) 20 mg/kg for PFOA-related compounds where they are present in a substance to be used as a transported isolated intermediate and fulfilling the strictly controlled conditions for the product of a carbon chain equal to or shorter than six atoms!PFOA及其盐类使用1 mg/kg/kgIn particular, products containing PTFE, which is widely used in domestic and commercial applications, may be affected, including cookware, wiper blades, fabric and carpet protection, electrical insulation, lubricants, piping systems, laboratory containers, and medical devices.
Unlike the prior PFOA restrictions under the REACH Regulation, the new restrictions only provide for a reduced number of exemptions that are also time limited. The restrictions exempt:
- (i) photolithography or etch processes in semiconductor manufacturing until July 2025;
- (ii) photographic coatings applied to films until July 2025;
- (iii) textiles for oil- and water-repellency for the protection of workers until July 2023;
- (iv) invasive and implantable medical devices until July 2025;
- (v) until July 2023, the manufacture of PTFE and PVDF for the production of high performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles, industrial waste heat exchanger equipment and industrial sealants;
- (vi) different types of fire-fighting foam products until July 2025 at the latest!并
- /li>iIn particular, the amendment would exempt concentrations of PFOAs in concentrations of not more than 2 mg/kg where they are present in non-invasive and non-implantable medical devices. The amendment is intended to address the possible presence of impurities of PFOAs in short-chain PFAS alternatives used in the production of medical devices.
Are Articles in Use Before July 4, 2020 Covered?
The new restrictions also exempt the "use of articles already in use" in the EU/EEA before July 4, 2020. Moreover, the second subparagraph of Article 4(2) of the EU POPs Regulation provides an additional exemption as it states that the restrictions on the manufacture, placing on the market and use of the Regulation "shall not apply in the case of a [PFOA] present in articles already in use before or on the date" (emphasis added) the restrictions entered into force (i.e., July 4, 2020).
A Commission Note on the Implementation of Article 4(2) of the POPs Regulation confirms that the exemption of the second subparagraph of Article 4(2) of the POPs Regulation exempts from the manufacture, marketing and use restrictions articles that were produced and also used in the EU/EEA by July 4, 2020. In effect, this should not be otherwise as Article 2(6) of the POPs Regulation states that the term "use" must be defined in accordance with Article 3(24) of the REACH Regulation.That Article defines "use" as "any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation" (emphasis added).
Thus, articles that contain PFOAs will be exempted from the restrictions if their manufacturer can prove that they were produced and stored or subject to any other utilisation before July 4, 2020. Companies wishing to benefit from this exemption should have documentation readily available and at the disposal of enforcement authorities proving that the articles were in use before July 4, 2020.
The recent case law of the Court of Justice on the concept of an "article" under the REACH Regulation (and EU POPs Regulation) also means that, in practice, articles produced and used before July 4, 2020 may be used to produce complex objects after that date.只有当豁免物品被用于制造复杂对象时,这种豁免才适用,而这种生产过程不会改变豁免物品的形状、表面或设计。换句话说,免用文章应成为新生成复合对象的组成部分,不失形状、表面或设计。