EC Publishes Restrictions Roadmap, Prioritizing Group Restrictions for the Most Harmful Chemical Substances
On April 25, 2022, the European Commission (EC) published a Restrictions Roadmap under the Chemicals Strategy for Sustainability (Restrictions Roadmap) that provides detailed information on all ongoing work on future restrictions under the European Union (EU) chemical legislation. The Restrictions Roadmap prioritizes group restrictions for the most harmful substances to human health and the environment, as set out in the Chemicals Strategy for Sustainability (Strategy). According to the EC’s press release, the Restrictions Roadmap includes a rolling list (Rolling List) of substances that will become the basis for the multiannual planning under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The EC states that it will regularly review and update the Rolling List to ensure a balance between needed flexibility and commitment to ensure progress.
The EC notes that the Restrictions Roadmap is a deliverable under the Strategy that calls for action toward a toxic-free environment and forms part of the European Green Deal. According to the EC, one of the actions foreseen by the Strategy is a revision of REACH and other relevant product legislation to ensure that consumer and professional products do not contain the most harmful substances. Until REACH is amended, the Strategy aims to “prioritise carcinogenic, mutagenic and reprotoxic substances (CMRs), endocrine disruptors, persistent, bioaccumulative and toxic (PBT[)] and very persistent and very bioaccumulative (vPvB) substances, immunotoxicants, neurotoxicants, substances toxic to specific organs and respiratory sensitisers for (group) restrictions” for all uses. To facilitate this action, the EC prepared the Restrictions Roadmap to prioritize these substances for (group) restrictions under REACH.
Objectives of the Restrictions Roadmap
The Restrictions Roadmap has three main objectives:
- Ensure that the commitments under the Strategy can be fulfilled in a transparent and timely manner. The Rolling List sets out the restrictions that have been planned and prepared, and those that have progressed, in particular for the most harmful substances (i.e., those that meet the criteria for CMRs, PBTs, vPvBs, endocrine disruptors, immunotoxicants, neurotoxicants, respiratory sensitizers, and specific target organ toxicity (STOT) substances. The Restrictions Roadmap will be the cornerstone for multiannual planning under REACH Article 68 on introducing new and amending current restrictions and REACH Article 69 on preparing proposals for the period up to 2025-2027, until the new rules on the generic approach are put in place.
- Provide an overview, through the Rolling List, of the EC’s use of its available authority resources. The Rolling List contains (groups of) substances that are being considered for a risk management measure or for which an entry in the Registry of Intentions (RoI) has been submitted.
- Provide transparency to stakeholders on the restriction work by authorities and allow companies to anticipate (potential) upcoming restrictions, e.g., by already beginning substitution activities. According to the Restrictions Roadmap, in this context, and as part of the implementation of the Strategy, the EC “is also working with industry on the co-creation of a transition pathway for chemicals.”
The restrictions aim to maximize the reduction of unacceptable chemical risks with all available resources, by means of broader restrictions, through both grouping of substances and addressing a wider range of uses (industrial, professional, consumer uses, and uses in articles). The Restrictions Roadmap notes that in any given year, the European Chemicals Agency (ECHA) uses around ten to 13 full-time equivalents (FTE) for developing restrictions and for the opinion-making phase. This means ECHA can normally prepare three to four restrictions a year, depending on their complexity. ECHA’s scientific committees can currently manage four to five restrictions per year. The Restrictions Roadmap states that as more restrictions are likely to be processed, “this would require Member States to adequately resource including with experienced rapporteurs the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC).”
The Restrictions Roadmap states that two important conditions are to be emphasized:
- The EC will regularly review the Rolling List. Further investigations may lead to changes in the anticipated regulatory risk management action. Therefore, it is “rolling” in nature and substances covered by the Restrictions Roadmap may not be restricted in practice and may instead be removed from the list, while other substances may be added.
- The Restrictions Roadmap, including the Rolling List, will be established without affecting EU member state prerogatives under REACH. Thus, the Restrictions Roadmap does not affect the member states’ right to propose new restrictions, including those for substances not yet included in the Restrictions Roadmap.
The Rolling List of (Groups of) Substance(s) for Restriction
The Rolling List consists of three pools of (groups of) substances currently pointing toward the regulatory hypothesis of restriction. These pools are included in Annex I, which also provides an indicative timing, if available. The EC used information available on October 20, 2021, to prepare the Rolling List. The Annexes present the state of play as of March 18, 2022. The pools include:
- Pool 0: Restrictions already on the RoI for restrictions, mandate provided to ECHA or restriction dossier recently submitted: This pool contains those substances in the current pipeline for restrictions, i.e., where the substance or group of substances are already subject to the opinion-making procedure in the ECHA Risk Assessment and Socio-Economic Assessment Committees (with attributed resources); are included in the RoI for submission in 2021/2022; or where the EC has requested ECHA to prepare a restriction dossier.
- Pool 1: Planned restrictions not yet on the RoI for restriction: This pool contains substances for which work is already very advanced and that are under consideration by ECHA, EU member states, or the EC for a restriction proposal. For some of these substances, preparatory work toward a planned restriction proposal has already started. Furthermore, for some (groups of) substances, classification under the Classification, Labeling, and Packaging of Substances and Mixtures (CLP) regulation or substances of very high concern (SVHC) identification under REACH is discussed as the next regulatory action.
- Pool 2: Potential restrictions: This pool contains:
- (Groups of) substances where restrictions are discussed as a potential regulatory management option, e.g., in working groups involving EU member states, the EC, and ECHA. No decision has yet been taken on the potential restrictions, nor on who submits the dossier (an EU member state or ECHA on behalf of the EC). Similar to pool 1, for some (groups of) substances, classification under the CLP or SVHC identification under REACH is discussed as the next regulatory action.
- Substances for which review reports or previous assessments indicate that revising a restriction could be necessary (e.g., lead in consumer articles; nickel in articles intended to come into direct and prolonged contact with the skin).
- (Groups of) substances where restrictions are discussed as a potential regulatory management option, e.g., in working groups involving EU member states, the EC, and ECHA. No decision has yet been taken on the potential restrictions, nor on who submits the dossier (an EU member state or ECHA on behalf of the EC). Similar to pool 1, for some (groups of) substances, classification under the CLP or SVHC identification under REACH is discussed as the next regulatory action.
Commentary
The Restrictions Roadmap provides detailed information to stakeholders on all ongoing work on future restrictions under EU chemical legislation. The Rolling List of substances will become the basis for future planning under REACH and is intended to allow companies and other stakeholders to be prepared better for potential upcoming restrictions. These restrictions will address a wider range of their uses — industrial, professional, and in consumer products. The EC will review the Restrictions Roadmap regularly and update it as necessary to maintain flexibility and its commitment to ensure progress toward protecting human health and the environment from the most harmful chemical substances.