Until 15 April 2022, the European Commission (“EC”) is consulting on proposed revisions of REACH, (Regulation (EC) No 1907/2006 as amended), the cornerstone of EU chemicals regulation. REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. REACH also aims to enhance innovation and competitiveness of the EU chemicals industry.
The consultation proposes revising requirements in relation to:
Revision of the registration requirements, including increased information requirements to enable effective identification of all carcinogenic substances and substances with critical hazard properties (including effects on the nervous and the immune systems), registration of certain polymers of concern, and information on the overall environmental footprint of chemicals including GHG emissions.
Introduction of Mixtures Assessment Factor(s) (MAF).
Simplifying communication in supply chains.
Revision of the provisions for dossier and substance evaluation.
Including the concept of essential use in authorisations and restrictions
The extension of the generic approach to risk management under REACH to further hazard classes
Revision of provisions for control and enforcement including stronger border controls and the creation of a European Audit Capacity for REACH.
Provision of sufficient and appropriate standard information requirements on the intrinsic properties of a substance to identify endocrine disruptors.
These are significant proposals which should be considered in detail by all those affected throughout the supply chain.
Details of the Proposed Revisions
In line with the EC’s Chemicals Strategy for Sustainability, the consultation, proposes revising a number of measures initiating substantive changes.
Registration requirements are proposed to include information on the overall environmental footprint of chemicals, and critical hazards. This could mean that products falling under REACH will incur additional testing and informational burdens.
Increased reporting requirements are suggested for critical hazards and polymers, with critical hazards being carcinogenicity, mutagenicity and reproductive toxicity, and endocrine disruption. The EC proposes that including increased information at registration will reduce the risk that substances with these properties pose.
Currently, there is a lesser reporting burden on the manufacture and import of lower volume (1-10 tonnes). The EC is investigating whether additional information requirements should be introduced for certain low tonnage substances.
The EC states that comprehensive information on the hazardous properties of polymers is generally not readily available in the public domain. Although the overall risk of polymers in general is expected to be lower than that of non-polymer substances, a prioritised sub-set of polymers may present similar hazards as other chemicals, although there are large uncertainties associated with the available data. The EC is proposing to extend REACH to cover this sub-set of polymers in order to manage this risk more effectively, in a way that limits the burden on industry.
Similarly, the critical hazards of carcinogenicity, mutagenicity and reproductive toxicity, and endocrine disruption are also under scrutiny. The EC proposes to increase registration requirements for materials with these properties in order to better protect human health and the environment. The consultation asks for opinions on the speed of implementation and the use of animals in meeting testing requirements.
In line with this initiative to improve safety, the EC proposes the introduction of a Mixture Assessment Factor. This would be a numerical value factored into the maximum risk quotient to demonstrate a safe-exposure level to account for the possibility of mixing with unknown substances. The idea is to increase safety without requiring testing of the substance with an exhaustive list of possible mixers.
Another proposal is to require information on the environmental footprint of all substances placed on the market. Should this proposal be adopted, this will increase the information burden on all those dealing with substances that fall under REACH. It may also require additional testing beyond that which is currently done.
One of the commitments of the EC's Chemicals Strategy for Sustainability is to define criteria for essential uses. This is 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. The new requirements under REACH aim to introduce and define the ‘essential use’ concept. This is intended to lead to the prevention of the non-essential use of the most harmful chemicals.
Following the adoption by a EU high-level roundtable of a joint report on enforcement and compliance which recommended harmonising and coordinating enforcement, the consultation considers the creation of a European Audit Capacity for REACH and enhancing the enforcement of national controls, including stricter border controls.
The proposals have significant ramifications, and it is important that industry actively responds to the consultation. The EC are expected to adopt revisions to REACH in the fourth quarter of 2022 following the closure of this consultation on the 15 April 2022 and subsequent publication of its results.
The proposed changes should be worked through by all aspects of the supply chain to ensure that there is a clear understanding of effects, additional hurdles and benefits.
Article co-authored by Josh Vickery, Trainee Solicitor at CMS.