EUROPEAN UNION (EU)

European Focus On PMT And vPvM Substances Increases: On May 9, 2020, the European Commission (EC) began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” The roadmap states that the regulatory framework on chemicals needs to be strengthened to increase further the level of protection of human health and the environment -- in particular from exposure to endocrine disruptors; combinations of chemicals; hazardous chemicals in products, including in imports; and very persistent chemicals. The regulatory framework also needs “to rapidly reflect scientific evidence on the risk posed by endocrine disruptors, hazardous chemicals in products including imports, combination effects of different chemicals and very persistent chemicals.” Comments were due June 20, 2020, and the EC is working to adopt a communication on the “Chemicals Strategy for Sustainability” in the third quarter of 2020.

The European Chemicals Agency (ECHA) notes on its website that the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation pays specific attention to the management of persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances. According to ECHA, one aim of REACH is the substitution of PBT and vPvB substances where suitable technically and economically viable alternatives are available. REACH does not address persistent, mobile, and toxic (PMT) and very persistent and very mobile (vPvM) substances, however. To address this, in 2019 the German Federal Environment Agency (UBA) submitted to the EC a document on the criteria for identifying PMT and vPvM substances under REACH. The EC’s “Chemicals Strategy for Sustainability” communication could address the issue of PMT/vPvM substances by designating them as substances of very high concern (SVHC) under REACH. Even if the forthcoming communication does not address PMT/vPvM substances, companies should continue to monitor activity in the EU to regulate them. More information is available in Acta’s July 20, 2020, memorandum.

EC Publishes Notice Regarding Withdrawal Of UK And EU Rules In Field Of Biocidal Products: The EC published a June 17, 2020, notice to stakeholders regarding withdrawal of the United Kingdom (UK) and EU rules in the field of biocidal products. To address the consequences in the notice, the EC advises that:

• UK-based suppliers included in the list established under Article 95 of Regulation (EU) No 528/2012 should appoint a representative established within the EU and communicate this to ECHA in due time, so that the information on the Article 95 list is updated before the end of the transition period;

• Suppliers included in the Article 95 list and located in third countries with a representative in the UK should appoint a new representative established within the EU and communicate this to ECHA in due time, so that the information on the Article 95 list is updated before the end of the transition period; and

• UK-based holders of authorizations should transfer the authorization to a new holder established within an EU Member State. UK-based authorization holders can trigger the amendment of their existing authorizations by means of an administrative change requiring prior notification before implementation. Such a change has to be submitted sufficiently in time before the end of the transition period.

Four Substances Added To Candidate List Of SVHCs: On June 25, 2020, ECHA announced that four chemicals were added to the Candidate List of SVHCs. One is an endocrine-disrupting substance used in consumer products, such as cosmetics. The three others are used in industrial processes to produce polymers, coating products, and plastics. The substances are:

ECHA urges companies to check their legal obligations relating to the safe use of their substances. Starting January 2021, companies will also have to notify products containing SVHCs to ECHA’s upcoming Substances of Concern In articles as such or in complex objects (Products) (SCIP) database on substances of concern in articles and products. The database aims to ensure transparent information on articles containing hazardous chemicals throughout their whole life cycle.

EC Amends REACH Annex II To Include SDS Requirements For Nanoforms: On June 26, 2020, the EC published a regulation in the Official Journal of the European Union that amends REACH Annex II. Annex II describes the requirements for compiling safety data sheets (SDS). The EC notes that specific requirements for nanoforms of substances took effect on January 1, 2020, and that information related to those requirements is to be provided in SDSs. The Annex II amendments include provisions regarding nanoforms. Other Annex II amendments include aligning the SDS requirements with the sixth and seventh editions of the GHS. The Annex II amendments will apply beginning January 1, 2021. SDSs not complying with the amended Annex II requirements may be used until December 31, 2022. More information is available in our July 1, 2020, blog item.

EU Inspectors Will Check Consumer Products For Hazardous Substances: ECHA announced on July 1, 2020, that under the REF-10, the Enforcement Forum’s major enforcement project planned for 2022, inspectors will check that the products comply with restrictions for selected hazardous substances under REACH. The inspectors will also check whether products comply with restrictions for the presence of persistent organic pollutants (POP). According to ECHA, specific substances to be covered by these checks will be decided in 2021 and could potentially include substances such as phthalates or perfluorooctane sulfonate (PFOS). Inspectors will also check REACH duties for substances in articles requiring that information on SVHCs in products is being communicated in the supply chain. This enforcement project will be prepared in 2021, with inspections conducted in 2022, and the report expected at the end of 2023. The Forum also set timelines for the pilot project on the classification of mixtures, which will focus on classification of detergents and cleaning products. The preparation for this project will start at the end of 2020, with inspections taking place in 2021 and 2022, and the report expected in 2023.

The Forum’s Biocidal Products Regulation Subgroup (BPRS) re-assessed Member States’ ongoing enforcement activities to address non-compliant (hand) disinfectants, which have appeared on the market during the ongoing COVID-19 pandemic. According to the press release, BPRS concluded that “current intensified enforcement actions at the national level are sufficient to address these cases.” BPRS also agreed to work with the EC to address any questions related to the borderline between the Biocidal Products Regulation (BPR) and the Cosmetics Regulation.

ECHA Reports Examine Direct And Indirect Effects Of REACH In Driving Replacement Of Harmful Chemicals: ECHA announced on July 8, 2020, publication of two reports that examine the direct and indirect effects of REACH in driving substitution. According to ECHA, based on a survey of industry associations and more than 80 companies, many of which were affected by authorization or restriction, around 19 percent indicated that restriction is their main reason for replacing hazardous chemicals with safer alternatives. Adding a substance to the Candidate List or Authorization List were the next most significant triggers for companies, with authorization selected by 15 percent of the companies responding. ECHA states that some companies have reportedly substituted when a regulatory management option analysis was still under development, and especially when the assessing Member State had, following the outcome of the analysis, proposed a further regulatory risk management activity, such as identification of SVHCs. ECHA notes that aside from regulation, companies also highlighted demands from their customers, enhancing their public image, and adopting their own corporate sustainability policies as their main drivers to substitute hazardous substances with safer alternatives.

EP Calls On EC To “Step Up” Action Against Dangerous Chemicals: As reported in our June 19, 2020, Global Regulatory Update, on May 9, 2020, the EC began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” On July 10, 2020, the European Parliament (EP) issued a press release announcing that it adopted a resolution calling on the EC to “step up” action against dangerous chemicals. According to the EP, the Chemicals Strategy “must fully reflect the precautionary principle and the polluter-pays principle, and ensure more transparent approval processes. It should also stimulate competition for developing safe and sustainable alternatives, e.g. by committing to securing funds for research.” The press release states that the EP believes in the “one substance -- one hazard assessment” principle: substances should be reviewed by only one EU agency to speed up the process and make chemicals regulation more consistent. The resolution calls for a comprehensive framework on endocrine disruptors to minimize the extent to which humans and the environment are exposed to endocrine disruptors. The resolution states that specific provisions on toys, food contact materials, and cosmetics should be inserted into legislation to treat endocrine disruptors in the same way as substances that are carcinogenic, mutagenic, and reprotoxic (CMR). The resolution also calls on the EC to heed the various calls of the EP to improve the EU’s authorization procedure for pesticides and accelerate the transition towards low-risk pesticides. The EP calls on the EC to develop EU criteria for sustainable chemicals to provide incentives for sustainable chemistry, materials, and technologies, especially non-chemical alternatives that are safe.

ECHA Publishes Results Of Survey On OSH-REACH Enforcement Interactions: ECHA has published the results from an Enforcement Forum survey on how national occupational safety and health (OSH) and REACH enforcement inspectors across 31 EU and European Economic Area (EEA) countries interact with each other. The survey examined the distribution of responsibilities and cooperation between inspectors to check compliance under their respective pieces of legislation. The report states that the findings from the survey show that there are many positive interactions between REACH and OSH inspectors already in existence, and there are established methods of cooperation in place, which allow both inspectorates to address safe use. According to the report, there are still some improvements to be made in certain areas such as increasing knowledge on derived no exposure limits (DNEL)/derived minimal effect levels (DMEL) and exposure scenario checks. There report states that there is also scope for more engagement between REACH and OSH inspectors in checking compliance requirements under authorization. The report notes that further developments, as outlined in the recommendations section, should help further strengthen interactions and collaboration between both inspectorates.

ECHA Board Of Appeal Publishes Decisions On Data And Cost-Sharing: On July 28, 2020, ECHA announced that the Board of Appeal published two decisions, covering nine appeals (A-013-2018 and Joined Cases A-014 to A-021-2018), concerning data and cost-sharing. According to ECHA, the nine appeals were filed by a potential registrant of nine substances. The appellant had applied to ECHA for permission to refer to vertebrate animal studies from registrations of the substances. ECHA states that it refused permission to refer on the grounds that the appellant’s behavior during the data and cost-sharing negotiations “did not show a real intention to find an agreement.” The appellant argued before the Board of Appeal that ECHA should have granted it permission to refer because the previous registrants for the nine substances proposed terms for data and cost-sharing that it claimed were not fair, transparent, and non-discriminatory. The Board of Appeal held that the previous registrants had failed to comply with the requirements of transparency (the itemization of data and costs) and the requirement for the terms to be non-discriminatory (the exemption of registrants’ affiliates from paying for data). The Board of Appeal therefore annulled ECHA’s nine decisions and granted the appellant permission to refer to the requested vertebrate animal studies.

ECHA Publishes Training Videos On Analysis Of Alternatives: ECHA announced in July 2020 that given the increasing interest in its online training on analysis of alternatives, it has posted the training videos for “easy and continuous access.” The training includes tools, guidance, and information for practitioners of analysis of alternatives. It consists of an introduction and five sessions: scoping an assessment; identifying and screening alternatives; hazard and exposure; cost and technical performance; and making and implementing decisions.

EC Publishes 15th ATP To The CLP: On August 11, 2020, the EC published the 15th adaptation to technical progress (ATP) to the Classification, Labeling and Packaging (CLP) Regulation. It amends CLP Annex VI, adding 37 new entries, revising 21 entries, and deleting two entries. The updated harmonized classifications will apply beginning March 1, 2022, to allow suppliers to adapt the labeling and packaging of substances and mixtures to the new or revised classifications and to sell existing stocks.

ECHA Begins Consultation On Applications For Authorization: ECHA has begun a public consultation on six applications for authorization covering 11 uses of:

• Chromium trioxide used in etching as a pre-treatment step in the electroplating processes of plastic substrates; in functional chrome plating of different types of substrates (including functional chrome plating for decorative purposes); and as a coloring and hardening agent for stainless steel plates; and

• Bis(2-methoxyethyl) ether (Diglyme) used as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification.

More information is available on ECHA’s website. Comments are due October 7, 2020.

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)

OECD Will Hold Green Talks LIVE Webinar On eChemPortal: On September 16, 2020, OECD will hold a webinar on “Green Talks LIVE -- eChemPortal: the Global Portal to Information on Chemical Substances.” OECD states that to meet public health and environmental objectives for the safe use of chemicals under proper conditions, increasing understanding of chemical hazards and risks is key. Increasing access to data and information allows governments and industry to work to reduce or eliminate adverse health effects from exposures to chemicals. The OECD eChemPortal provides direct access to scientific information on chemical substances of regulatory relevance with over 800,000 substance records from more than 34 databases. According to OECD, the portal allows countries and companies to share work, ensure resource efficiencies, and, subsequently, reduce animal testing. Gerlinde Knetch (Germany) and Jake Sanderson (Canada)  will share their experience in improving chemical safety and how the eChemPortal supported this process.