The EU Green Deal announces a zero pollution ambition for a toxic-free environment that should be achieved, among other ways, through ambitious actions against the most hazardous chemicals and enhanced engagement in innovation for the development of safe and sustainable alternatives. One of the first deliverables of this far-reaching policy program is the Chemicals Strategy for Sustainability (CSS), which involves important revisions of the existing EU chemicals legislation including the Chemicals Control Regulation (REACH) and the Classification, Labelling and Packaging Regulation (CLP).
REACH and the CLP are the two main instruments and actual cornerstones of the EU chemicals legislation. They will be simultaneously reopened and revised between now and the end of 2022, with the affirmed objective to improve the protection of people and the environment in line with the Green Deal’s ambition. While the CSS announces this revision and the reinforcement of the existing provision, it provides little clarity as to the exact scope of the revision plan. It is thus rather unclear how important such revisions are intended to be.
On May 4, 2021, the European Commission published two important roadmaps that provide insights on the intentions of the EU executive on the framework for the revised REACH and CLP. The Commission elaborates on the legal and regulatory options that it can consider. Although targeted, the options envisaged by the Commission will certainly lead to significant revisions to the REACH and CLP, and in fact may in some instances constitute a real shift in paradigm.
Continue reading for additional background on the roadmaps and the implications for REACH and CLP in the future.
Roadmap on REACH
With this first roadmap, the Commission unveils options for a targeted revision of REACH to improve each of its components from the registration and evaluation to the authorization and restriction of chemicals. At this stage, the Commission outlines that the envisaged proposals are preliminary and may evolve with the analysis.
Among the key measures, the roadmap considers the introduction of a mixture assessment factor (MAF) that would be developed to address the risks of exposure to several substances to apprehend their combination effects.
It foresees the rework of the registration requirements to cover the registration of certain polymers and rethink some of the information requirements (e.g., increased information on hazard of concern, new information on the environmental footprint and document of safe use), as well as the dossier and substance evaluation processes.
The restriction and authorization processes would also be substantially “reformed” by the envisaged revision. An option considered by the Commission would see the authorization and restriction processes being merged for integration into some single restriction system, with an improved interface with other legislation, to fit the “One Substance One Assessment” principle supported in the CSS. The Commission also foresees to extend the generic approach to restrictions for some categories of hazardous substances (including Endocrine Disruptors or PBT/vPvB substances). The Commission also confirms its willingness to operationalize the concept of “essential use” that appeared with the CSS. This will most likely be used when adopting restrictions.
Moreover, the enforcement measures by Member States could be reinforced based on minimum requirement for national controls, stricter border controls and the possible establishment of a European Audit Capacity to assess Member States.
Roadmap on CLP
In this second roadmap, the Commission takes note of the need for the CLP to keep up with scientific or technical progress, as well as to clarify certain ambiguous provisions of this regulation.
Among other substantial amendments to the CLP, the proposal for revision considers the introduction of new hazard classes such as Endocrine Disruptors and some further labelling obligations of products for hazard classes yet outside the scope of the CLP. It would also address the issue of the classification of mixtures and complex substances.
The Commission also envisages what may lead to a revision to the Harmonized Classification process, considering giving a mandate to the Commission to request ECHA, the European Chemicals Agency, to develop a Harmonized Classification dossier or prioritization criteria for harmonized classifications.
In addition, without providing much detail, the Commission announces specific rules regarding online sale.
The roadmaps are open for comment for until June 1, 2021, and can be accessed here. The Commission will then summarize the feedback received in a synopsis report, explaining how it will be taken on board or, if applicable, why certain suggestions can’t be taken up. The feedback will also be published on the Commission’s website and will be used to start developing the actual legislative proposals. Then, another formal public consultation will be held for 12 weeks in all the languages of the EU, likely in the second half of 2021. The REACH revision is announced for Q4 of 2022 and the CLP revision for Q2 of 2022.
How Can We Help ?
The Mayer Brown regulatory team has longstanding experience on chemicals legislation, with expertise dating back long before the development of REACH. We have a holistic understanding in this field, which we can put in service of companies facing the challenges caused by this new revision of the EU chemicals legislation.