The Commission plans to adopt a proposal for a revision Registration, Evaluation, Authorization and Restriction of Chemicals Regulations in the last quarter of 2022.

On January 20, 2022, the European Commission opened a public consultation on the revision of Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorization and restriction of chemical substances (REACH regulation). The REACH regulation entered into force on June 1, 2007 and is to be fundamentally revised as part of the Commission’s chemicals strategy for sustainability, which is part of the European Green Deal. Until mid-April 2022, interested parties are encouraged to share their views on the most relevant aspects of the REACH Regulation to ensure the Commission’s innovation targets for safe and sustainable chemicals and a high level protection of health and the environment.

Chemicals Strategy for Sustainability

In the context of the essential objective of the Green Deal to reduce pollution to zero, the Commission published on 14 October 2020 a strategy on chemicals for sustainability. With this strategy, the Commission wants to develop new 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 should be introduced to coordinate the hazard and risk assessment of chemicals, and the authorization and restriction process under REACH should be simplified.

Another objective of the official strategy is to strengthen the European regulatory framework to address pressing environmental and health concerns and increase the protection of consumers and workers against 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 to the EU.

In addition, the Commission wants to use the vast knowledge base on chemicals to develop an early warning and action system for chemicals. Among other things, this strategy will enable the EU to react 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.

Content of the consultation

The Commission is considering a series of possible measures to achieve a targeted revision of the REACH Regulation. In particular, it plans to revise registration requirements, including increasing information requirements and establishing the obligation to register polymers. The Commission also wants to decide whether so-called mixture assessment factors are introduced and how communication in supply chains can be simplified. In addition, the Commission is considering a reform of the authorization and restriction process, including the extension of generic risk management approaches and the introduction of the so-called essential use concept. Finally, the provisions relating to the evaluation of dossiers and substances and the provisions relating to control and enforcement under the REACH regulation must be revised.

Therefore, the Commission has published a questionnaire with 14 general questions, which interested parties are invited to answer during the consultation until mid-April:

• With regard to increased information requirements, the questionnaire refers to the Strategy for the Sustainability of Chemicals, according to which the information base on critical hazards for all chemicals – such as carcinogenicity, endocrine disruption, mutagenicity and reproductive toxicity – should be increased. The questionnaire says this means more chemicals need to be tested and raises the question of whether this increased testing can be achieved with non-animal testing. Another aspect of the potentially revised information requirements is the limited knowledge of certain low tonnage substances. According to the questionnaire, the Commission is reviewing the exemptions that apply to low-volume substances, which means that heavier burdens (such as the obligation to prepare chemical safety assessments) could be imposed on manufacturers and importers of these substances, especially small and medium-sized enterprises. The broad exemptions for polymers under REACH are also being revised.
• The questionnaire also addresses the possible introduction of a mixture assessment factor (MAF). According to the Commission, a CRG is a pragmatic approach to manage unknown unintentional co-exposures to chemicals. Typically, a registrant is unaware of other substances that humans come into contact with at the same time. Implementing a MAF would mean reducing exposure levels considered safe enough by some factor. The Commission aims to introduce different CRGs for the categories of subjects exposed and the types of chemicals.
• Furthermore, the questionnaire indicates that the monitoring of the updating of registration dossiers will be reinforced in the future, and that failure to comply with the obligation to update dossiers could even lead to a ban on production or marketing of the corresponding substances. According to the questionnaire, the dossiers are not systematically checked and many companies only update them after the chemical authorities have asked them to do so. Therefore, a revision of the dossier and substance evaluation process is very likely.
• Reform of authorization and restriction processes could include the introduction of the “essential use concept”. In this regard, the Commission’s objective under the Chemicals Strategy for Sustainability is to “define criteria for essential uses to ensure that most harmful chemicals are only permitted if their use is necessary for health, safety or critical to the functioning of society and if there are no acceptable alternatives from an environmental and health point of view”. This approach first requires a definition of the essential use of a chemical substance, on the basis of which the non-essential use of harmful chemicals could be avoided. The debate goes hand in hand with the call for a generic approach to risk management, which includes the creation of new hazard classes beyond the carcinogenic, mutagenic and reprotoxic categories. 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 and bioaccumulative toxic substances (PBT).

Conclusion

The public consultation aims to help explore the implications for business and other stakeholders, and it remains to be seen whether the Commission’s tight timetable can be met. Latham & Watkins will continue to monitor and report on developments regarding the revised REACH regulations.