Significant changes are expected to the EU REACH Regulation. Elaine Campling from ESMA HSEP Committee explains how ESMA members could be affected.
The European Commission public consultation on the targeted revision to the REACH Regulation closed on 15 April 2022, but that is not the end of the story. The consultation follows on from the Roadmap issued by the Commission in 2021, with significant changes expected to impact the chemical industry.
The targeted revision to REACH is one of the actions announced in the EU’s Chemical Strategy for Sustainability, which is focused on tightening controls on chemicals for a ‘safe and sustainable’, ‘toxic free’ environment. According to the Commission, the following changes are planned:
- Revising registration requirements and increasing information requirements, including a new obligation to register certain polymers;
- Introducing mixture assessment factors;
- Simplifying communication in supply chains;
- Changing the provisions for dossier and substance evaluation;
- Extending generic approaches to the risk management of chemicals;
- Introducing an ‘essential use’ concept;
- Reforming the authorisation and restriction processes; and
- Revising the provisions for control and enforcement, including customs controls.
The specific questions set out in the Public Consultation indicate the areas of the regulation that are likely to be revised. For example, respondents were asked to indicate their level of concern with the available information on low tonnage substances (1-10 tonnes) to require a chemical safety assessment (CSA) to be produced for this tier, along with the chemical safety report.
The CSA is currently required as part of the REACH registration process for substances that are manufactured or imported in volumes equal to or greater than 10 tonnes per year. The chemical safety report documents the detail obtained and is the key source from which the registrant provides information to all users through exposure scenarios. An exposure scenario is a set of conditions that describe how a substance is manufactured or used, along with the measures necessary to control exposure to humans and the environment. Exposure scenarios are communicated to downstream users via extended safety data sheets.
The Commission generally describes inadequacies and inefficiencies in supply chain communication, for example between suppliers and manufacturers which ‘lacks accuracy and clarity’, negatively impacting risk management. One benefit of the revision to ESMA members may be the introduction of harmonised electronic formats for the transmission of hazard information. Respondents were asked to indicate their level agreement on whether electronic tools for the preparation and exchange of safety data sheets would improve supply chain communication.
However, many ESMA members will be significantly impacted if the existing exemption for polymers is removed from the regulation, which is likely to some extent. A general question is posed on whether certain polymers should be registered, with a more detailed examination following in the questions posed for experts. For example, on whether there should be alignment with polymer registration schemes in other regions, or whether certain polymer types should be subject to registration:
- Cationic polymers or polymers that can be reasonably expected to become cationic in a natural environment;
- Polymers with low molecular weight ( ≤1000 Da) which are expected to behave similarly to non-polymeric substances;
- Polymers classified for certain hazards – carcinogenic, mutagenic, reprotoxic (CMR) or classified with acute toxicity to health or environment.
Another significant change being investigated is the concept for ‘essential uses’: “….to ensure that the 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 environment and health.”
The Commission is working on establishing a definition of ‘essential use,’ as it is seen as critical to achieving the intended policy to phase out chemicals with non-essential uses through available mechanisms, such as the restriction and authorisation processes.
This is a big shake up to a significant piece of legislation governing chemicals and will be a necessary focus for attention at the ESMA Health, Safety and Environmental Protection (HSEP) Committee meetings. Please join us there for discussions on this revision to the REACH regulation and other important topics: www.esma.com/committees/hsep