European Union chemical regulatory and policy initiatives are often influential far beyond their jurisdictional limits. Two such initiatives are noteworthy, and U.S. chemical stakeholders can expect to experience the tremors of these explosive initiatives soon.
EU Green Deal and Chemicals Strategy for Sustainability
One seismic EU development is the European Green Deal, reflecting the EU Commission’s commitment to be the first continent to be carbon neutral by 2050. Under the plan, chemicals are identified as critical components to achieving low-carbon, zero pollution, and energy- and resource-efficient technologies.
The European Commission in October 2020 issued its chemicals strategy for sustainability, a core component of the European Green Deal, and companion action plan that sets forth specific initiatives intended to achieve the goals of the strategy, including amendments to existing legislation.
Chemical product approval in the EU henceforth will be anchored in criteria that favor sustainable-by-design chemicals and related considerations that include restricting the use of substances of very high concern and offering preferential treatment of products that offer the greatest potential for circularity.
Changes in EU Safety Data Sheets
The other development, in July 2020, was the amending of Annex II of the EU Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). Annex II provides requirements for the compositional elements of a safety data sheet (SDS) for chemical substances and mixtures. It includes the format, content, and section-by-section directions for the development of an SDS. All EU SDSs authored starting Jan. 1, 2021, must comply with the amendments.
Typically, news of SDS amendments rarely inspires great interest in the country where they apply, let alone in regions far from there. These changes, however, are consequential. The amendments will require extensive format changes to SDS templates that will drive most regulatory experts in this space crazy.
Amended Annex II requirements will do more than that, however. They will force the disclosure of information on EU SDSs that will almost certainly have global impacts, for two reasons.
First, nanoforms specifications must be explicitly stated on the SDS. Under the amended rules, if a chemical substance exists in different nanoforms, the nanoform specifications must be provided in Section 1 of the SDS, and certain particle characteristics must be specified in Sections 3 and 9 of the SDS.
If the SDS pertains to one or more nanoforms, or substances that include nanoforms, this fact must be indicated by using the word “nanoforms.” If the substance is registered and it covers one nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, must be indicated. If the substance is not registered but the SDS covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics must be indicated. Other details must be disclosed.
Second, if a chemical substance has an endocrine-disrupting property, that attribute must now be provided in Subsection 2.3 of the SDS. Whether a chemical has an endocrine-disrupting property will be determined based on a list developed in accordance with REACH Article 59(1), EU Regulation 2017/2100, and EU Regulation 2018/605 (both EU regulations set out scientific information for identifying endocrine-disrupting properties). Substances in mixtures present at or above 0.1% and identified as having endocrine-disrupting properties are also subject to the new requirement.
Why These Initiatives Are a Big Deal
The European Green Deal and the chemicals strategy for sustainability are significant policy initiatives. Legacy chemicals of very high concern will be restricted and likely increasingly deselected on the commercial front. It will not take long for the consequences of these actions to be felt globally. New chemical innovation will need to align with the goals of the sustainability initiative or risk being denied access to EU markets.
Entities placing products in the EU market must revise SDS templates and include significant substantive additions, including whether a chemical exists in nanoforms and whether a chemical possesses an endocrine-disrupting property. These new disclosures are likely not features marketers are enthusiastic about emphasizing.
The Annex II amendments increase considerably the complexity chemical producers and other product manufacturers face when placing products in the EU market and may complicate assessing the hazards of a product on a global scale.
Another challenge many will face in this new framework is the increasing difficulty of protecting confidential business information. U.S. approaches to trade secret provisions on the SDS are generous, but EU law is less indulgent.
These initiatives are in the EU, but their impact will be felt much closer to home domestically. U.S. chemical stakeholders may wish to take note and prepare accordingly.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
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Lynn L. Bergeson is managing partner of Bergeson & Campbell P.C. She has a deep understanding of the TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies.
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