The Commission plans to adopt a proposal for a revised Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals in the last quarter of 2022.
By Joachim Grittmann and Alexander Wilhelm
On 20 January 2022, the European Commission opened a public consultation on revising Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation). The REACH Regulation entered into force on 1 June 2007 and is to be fundamentally revised under the Commission’s Chemicals Strategy for Sustainability, which forms part of the European Green Deal. Until mid-April 2022, interested parties are encouraged to share their opinions on the most relevant aspects of the REACH Regulation to ensure the goals of the Commission on innovation for safe and sustainable chemicals and a high level of protection of health and the environment.
Chemicals Strategy for Sustainability
Against the background of the essential goal under the Green Deal to reduce pollution to zero, the Commission published a Chemicals Strategy for Sustainability on 14 October 2020. With this strategy the Commission wants to develop further criteria for safe and sustainable chemicals and introduce new legal requirements on the presence of substances of concern in products. The strategy also aims to consolidate the regulatory framework. Thus, the “one substance, one assessment” process is to be introduced to coordinate the hazard and risk assessment of chemicals, and the authorization and restriction process under the REACH Regulation is to be simplified.
Another goal of the official strategy is to strengthen the European regulatory framework to address urgent environmental and health concerns and increase the protection of consumers and workers from the most harmful chemicals, endocrine disruptors, and chemical mixtures. In addition, the Commission plans to support capacity building in third countries in the area of chemical assessment to ensure that banned hazardous chemicals are not produced for export into the EU.
Furthermore, the Commission wants to use the extensive knowledge base on chemicals to develop an early warning and action system for chemicals. Among other things, this strategy will enable the EU to respond to emerging chemical risks as soon as they are identified through monitoring and research. Several aspects of these main objectives will require amendments to the REACH Regulation.
The Commission is considering a range of possible measures to achieve a targeted revision of the REACH Regulation. In particular, it plans to revise the registration requirements, including increasing information requirements and establishing the obligation to register polymers. The Commission also wants to decide if so-called mixtures assessment factors are introduced and how the communication in the supply chains can be simplified. Furthermore, the Commission considers a reform of the authorisation and restriction process, including the extension of generic approaches to risk management and the introduction of the so-called essential use concept. Finally, the provisions for dossier and substance evaluation and the provisions for control and enforcement under the REACH Regulation are to be revised.
Therefore, the Commission has published a questionnaire with 14 general questions, to which interested parties are invited to respond during the consultation until mid-April:
- Regarding the increased information requirements, the questionnaire refers to the Chemicals Strategy for Sustainability, according to which the informational basis on critical hazards for all chemicals — such as carcinogenicity, endocrine disruption, mutagenicity and reproductive toxicity — must be increased. The questionnaire indicates that this means more chemicals need to be tested, and raises the question whether this increased testing can be achieved with non-animal testing. Another aspect of potentially revised information requirements is the limited knowledge of certain low tonnage substances. According to the questionnaire, the Commission reviews the exemptions that apply for lower volume substances, which means that higher burdens (such as the requirement to prepare chemical safety assessments) could be put on the manufacturers and importers of such substances, particularly small- and medium-sized enterprises. The broad exemptions for polymers under the REACH Regulation are also under review.
- The questionnaire also addresses the potential introduction of a mixtures assessment factor (MAF). According to the Commission, a MAF is a pragmatic approach to manage unknown unintentional co-exposures to chemicals. Typically a registrant is not aware of the other substances with which humans come into contact at the same time. Implementing a MAF would mean reducing the exposure levels that are considered sufficiently safe by a certain factor. The Commission aims to introduce different MAFs for classes of exposed subjects and types of chemicals.
- Furthermore, the questionnaire indicates that monitoring of whether registration dossiers are up to date will be increased in the future, and that a breach of the obligation to update the dossiers could even lead to a ban on production or marketing of the corresponding substances. According to the questionnaire, dossiers are not routinely checked and many companies only update them after chemical authorities request them to do so. Therefore, a revision of the dossier and substance evaluation process is very likely.
- The reform of the authorisation and restriction processes could include the introduction of the “essential use concept”. The Commission’s objective under the Chemicals Strategy for Sustainability in this respect is to “define criteria for essential uses to ensure that most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of the environment and health”. This approach requires a definition of the essential use of a chemical substance in the first place, based on which the nonessential use of harmful chemicals could be prevented. The debate goes hand in hand with the call for a generic risk management approach, which includes the creation of further hazard classes beyond the categories of carcinogenic, mutagenic, and reprotoxic. This addition of hazard classes would lead to an extended risk management which, for example, can lead to significant limitations of immunotoxic and neurotoxic substances or persistent, bioaccumaltive toxic substances (PBTs).
The public consultation is intended to help explore the implications for businesses and other stakeholders, and whether the Commission’s tight timetable can be met remains to be seen. Latham & Watkins will continue to monitor and report on developments regarding the revised REACH Regulation.