Winter 2021
The European Union’s chemical regulation requirements under REACH have global impacts on chemical management and information, with the ultimate goal of protecting human health and the environment.
In 2006, the European Union (EU) adopted an overarching chemicals regulation called Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The overall objective of REACH is to enhance the protection of human health and the environment through the proactive evaluation of chemical hazards and management of potential risks. Notably, REACH shifted the primary responsibility for chemicals management from public authorities to industry, so that companies that manufacture or market substances in the EU must submit chemical information (e.g., toxicity data) in the form of a registration dossier. Not only does REACH affect nearly every company that does business in the EU, the regulation has fundamentally altered how chemical data are generated and shared, resulting in significant impacts that extend globally across jurisdictions and industry sectors.
Over 21,000 chemical substances have been registered under REACH, including those used in both industrial processes and consumer products (ECHA, 2019). This has resulted in a huge collection of data that is publicly available on the European Chemicals Agency (ECHA) website. Due to the phased approach of the regulation, changes to specific testing requirements, and pipeline of novel chemicals in commerce, new data will continue to be generated for registered substances. REACH has also promoted pragmatic approaches related to the generation of toxicity data, such as the use of alternative test methods (e.g., in silico programs and read-across) and the development of chemical groupings.
REACH shifted the primary responsibility for chemicals management from public authorities to industry.”
In addition to the registration of new substances, the generation of new data may be initiated by a number of specific regulatory activities under REACH. During the compliance check process, ECHA audits registration dossiers and determines whether any planned animal studies are warranted given the REACH requirement to avoid unnecessary testing on vertebrates. ECHA then requests or approves new studies to be conducted, which often involve toxicological endpoints with important human health implications. For 2020 alone, ECHA expects new information to be submitted on the carcinogenicity, mutagenicity, or reproductive toxicity (CMR) of almost 100 substances (ECHA, 2019). In general, this increase in available information serves to advance our collective understanding of chemicals and to better protect humans and the environment.
With the continual development and evaluation of new toxicity data, changes to hazard classifications and subsequent regulatory activities for registered substances inevitably occur. A new hazard classification (e.g., Suspected human reproductive toxicant) under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) may require updates to both chemical and product safety data sheets (SDS), which communicate hazards and precautionary measures to users. Companies may also carefully consider their use of the substance and explore options to reduce or substitute a hazardous substance with a safer alternative. In addition, formal regulatory activities under REACH, such as harmonized (i.e., agency-mandated) hazard classifications and persistent, bioaccumulative, and toxic (PBT) assessments, may similarly drive stakeholders to evaluate potential health risks and business liabilities associated with the use of a particular substance.
Although companies outside of the EU are not directly regulated by REACH, the impact of new data generated to meet the regulation’s requirements can still be profound. As a hypothetical example, take the case of a 3D printing company in the United States with an evolving portfolio of several hundred chemicals. For a given chemical in the company’s portfolio, a new study submitted under REACH indicates the substance may be a skin sensitizer. Even though the 3D printing company is not active in the EU, the availability of this new data may trigger the chemical supplier or the company itself to classify the substance as a skin sensitizer. In addition to new workplace safety measures, this hazard information may lead to concern surrounding potential consumer exposure to 3D-printed materials. Furthermore, the possibility of new hazard assignments may significantly impact industry sectors with particular regulations and restrictions. For example, the use of carcinogenicity, mutagenicity, or reproductive toxicity (CMR) substances is generally prohibited in cosmetic products in the EU.
Thus, for the cosmetics industry in particular, a new CMR hazard designation could result in costly, widespread reformulations or even product recalls.
The large and continuous aggregation of publicly available chemical data submitted under REACH is unprecedented. As a result, registration dossiers now serve as an important source of toxicity data for companies around the world. Companies and product stewardship professionals can anticipate which chemicals may be affected by new data by monitoring ongoing information requests and regulatory activities on the ECHA website. While not a simple endeavor, a thorough assessment of a company’s chemical portfolio is crucial to navigate product stewardship challenges, including those associated with new information submitted under REACH.
The authors can be reached at cmarsh@gradientcorp.com and ibamgbose@gradientcorp.com.
European Chemicals Agency (ECHA). 2019. Mapping the chemical universe to address substances of concern. Integrated Regulatory Strategy Annual Report 2019. Accessed at https://echa.europa.eu/documents/10162/27467748/irs_annual_report_2018_en.pdf/69988046-25cc-b39e-9d43-6bbd4c164425.