What we expect EU regulators to do in March 2024

Highlights of upcoming chemical regulatory activities

• Consultations under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and Biocidal Products (BPR) Regulations are coming to an end in March and early April. Under REACH, two calls for information in support of possible restrictions are winding up on April 3 and 5, respectively, for the substance groups: (1) 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and 4-Nonylphenol, branched and linear, ethoxylated and related substances; and (2) aromatic brominated flame retardants. Under the BPR, one substance, cholecalciferol (CAS RN 67-97-0), is being considered for an exemption from the regulation’s exclusion criteria.
• Many events are slated to take place in March. Several of ECHA’s committees will meet to take chemical management-related decisions and discuss other regulatory developments. The meetings of the Risk Assessment and Socio-economic Analysis Committees, for example, will include agenda items concerning the draft opinion on the proposed universal restriction of poly- and perfluoroalkyl substances (PFAS), with focus on consumer mixtures, cosmetics, and ski wax.
• ECHA will hold two webinars, the first introducing the agency’s guidance on assessing biocide risks to bees, and the second providing insight into the OECD QSAR assessment framework in REACH’s dossier evaluation procedure.
• Two of the European Commission’s “Have your say” consultations regarding chemical legislation are ending in March. One is a proposal to ban bisphenol A (BPA) and other bisphenols in food contact materials, while the other is an evaluation of the overall effectiveness of the EU’s Nitrates Directive 91/676/EEC, which targets the reduction and prevention of nitrate pollution from agricultural sources.

ECHA consultations closing in March

• ECHA is tasked with conducting public consultations throughout the year under various regulatory procedures pursuant to EU chemical law (e.g., REACH restriction and authorization, and CLP harmonized classification). These actions are mandated under the specific chemical legislation that ECHA is responsible for administering, including the REACH, CLP, and Biocidal Products regulations, as well as occupational safety and health (OSH) rules (e.g., occupational exposure limit value (OELV) assessments), among others.
• Public consultations comprise an important part of the agency’s activities, ensuring that the perspectives of as many stakeholders as possible are heard and their views are considered in the regulatory risk management (RRM) assessments and subsequent opinions that ECHA issues under the respective chemicals-related regulatory frameworks.
• Below is the list of ECHA’s consultative actions for this month, grouped according to legal framework (e.g., REACH, CLP, BPR, OSH) and then regulatory procedure.

REACH: Testing proposals

• Testing proposals are part of registration requirements under REACH. They are subject to 45-day consultations during which third parties are invited to submit relevant scientifically valid data addressing the substance(s) and hazard endpoint(s).
• Currently, no consultations on testing proposals are closing in March.

REACH: Call for comments and evidence

• These actions are intended to offer stakeholders opportunity to contribute to the preparatory phase of a REACH Annex XVII restriction before the competent authorities, i.e., member states or ECHA, have completed and published the restriction proposal.
• They are meant for parties who ECHA did not initially identify or consult with and, therefore, would not otherwise be able to contribute to shaping the proposed restriction.
• The calls supplement ECHA’s public consultations on restrictions conducted pursuant to REACH’s Title VIII restriction procedure. They do not replace them.
• No calls for evidence are closing in March. However, ending in early April are the comment periods for calls concerning two substance groups.

REACH: Restrictions under consideration

• These comment periods under REACH’s Title VIII restriction procedure allow interested parties to weigh in on the opinions authored by ECHA’s risk assessment (RAC) and socio-economic analysis (SEAC) committees on restriction proposals.
• Currently, no consultations on proposed restrictions are closing in March.

REACH: Identification of substances of very high concern (SVHCs)

• Interested parties are invited to provide feedback on the chemicals put forward for identification as SVHCs. Once identified as SVHCs, these chemicals are added to the Candidate List. Being placed on this list represents the first step toward eventual inclusion in REACH’s Annex XIV, the authorization list, and triggers certain legal obligations for affected companies.
• No such consultations are scheduled to close in March.

REACH: Recommendations for the Authorization List

• These consultations provide interested parties a way to contribute to ECHA’s regular assessment of the substances on the Candidate List that are prioritized and, subsequently, recommended for inclusion in the authorization list (Annex XIV).
• No such consultations are scheduled to close in March.

REACH: Applications for authorization (AfAs)

• Each application for authorization under REACH involves an eight-week public consultation inviting interested third parties to provide information on alternative substances or technologies for the uses of the Annex XIV substances included in the AfA.
• Currently, no AfA consultations are closing in March. Visit this page to consult adopted opinions and previous AfA consultations.

ECHA consultations under the CLP Regulation closing in March

CLP: Harmonized classification and labeling (CLH)

• Consultations on classification and labeling harmonization (CLH) are open for 60 days. They seek to elicit feedback from interested parties on the hazard classes proposed by the dossier submitter, as well as on any others that the dossier submitter did not find warranted classification.
• No such consultations are scheduled to close in March.

ECHA consultations under BPR closing in March

BPR: Potential candidates for substitution

• These consultations support the evaluating competent authority in assessing the availability of substitutes or alternatives to active substances found to be potential candidates for substitution in accordance with Article 10 of the BPR.
• There are currently no related consultations ending in March.

BPR: Exemptions to the exclusion criteria

• These consultations elicit feedback on substances that are being considered for exemptions under the biocides framework from the criteria that normally excludes carcinogens, mutagens, reproductive toxicants (CMRs), endocrine disruptors, as well as persistent, bioaccumulative and toxic (PBT), and very persistent and very bioaccumulative (vPvB) substances from gaining approval as active substances for use in biocidal products.
• ECHA is receiving comments until the end of March on one substance being considered for exemption.

ECHA consultations closing in March under occupational, safety and health (OSH) rules

CAD/CMRD: OELV proposals

• ECHA contributes to establishing OELs in support of the Chemical Agents Directive (CAD) and the Carcinogens, Mutagens or Reprotoxic substances Directive (CMRD). Consultations are held to allow interested parties to contribute to this process.
• There are currently no such consultations ending in March.

Upcoming meetings, webinars, and other events in March

Chemical legislation that the Commission is preparing

• The European Commission is responsible for proposing legislation under EU law. Below is a list of the yet-to-be-published legal acts that the Commission has flagged on its ‘Have your say’ initiatives portal for future adoption.
• Under ordinary legislative procedure (OLP), once adopted, a Commission proposal is forwarded to the EU’s co-legislators, the Council of the EU, representing the bloc’s 27 member states, and the European Parliament (EP).
• Each co-legislator takes up the proposed legislation for discussion and debate, possibly amends it, and adopts a position on the (amended) proposal. The legislation can only be finalized and, subsequently, published in the Official Journal if the co-legislators are able to come to an agreement on the final text and adopt the common version agreed to by both institutions.
• Delegated and implementing legal acts, conversely, are not taken up by the co-legislators after they are proposed by the Commission. Unlike under OLP, such legislation is subject to a faster procedure. For delegated acts, the EP and Council usually have two months to object to the proposals, but are not allowed to amend them. For implementing acts, the Commission is required to consult with a committee, on which every EU member state is represented, before adopting them.
• An important caveat: The adoption timeframes that the EU executive indicates on the ‘Have your say’ portal are not always strictly adhered to and may be subject to delay.

European Commission ‘Have your say’ consultations closing in March

• A public feedback period is launched to elicit feedback once the Commission proposes a legal act (e.g., regulation, directive, decision). Below are open consultations related to proposed chemicals legislation that are ending this month.

To contact the author of this analysis, please email Scott Stephens ( [email protected]).
To contact the editor of this analysis, please email Kari Oakes ( [email protected]).