What we expect EU regulators to do in January 2024

Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Key regulatory actions on the horizon

ECHA’s basic regulation

• The European Chemicals Agency’s (ECHA) leadership is placing its hopes on a Commission proposal for a basic regulation that would update the agency’s role as the principal entity overseeing the regulation of chemicals in the EU. The ECHA executive director, SHARON MCGUINNESS, recently told European parliamentarians that such a law is crucial for ensuring that the agency continues to expand its remit beyond REACH, without sacrificing quality, transparency or efficiency. An important element of the envisioned legislation is the provision of greater funds to the agency, allowing it to take on its larger role in chemical regulation assigned in part by the Chemicals Strategy for Sustainability (CSS).
• The Commission may be close to delivering this proposal, given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

Highlights of chemical regulatory activities

• Consultations open under the REACH and CLP regulations are coming to an end in January. These cover, respectively, testing proposals for seven substances, 10 applications for authorization, and harmonized classification and labeling (CLH) for five substances, including methyl isothiocyanate.
• Consultations closing in January on legislation proposed by the Commission include an update to the PFOS entry in the POPs Regulation and the initiative addressing microplastics unintentionally released into the environment.
• Events happening next month include a meeting of ECHA’s committee for risk assessment working group on CLH.

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 January

• 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.

ECHA consultations closing in January

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).

REACH: Call for comments and evidence

• These calls 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. Note that these calls supplement ECHA’s public consultations on restrictions conducted pursuant to REACH’s restriction procedure. They do not replace them.
• No calls for comments and evidence are ending in January.

REACH: Restrictions under consideration

• These consultations under the restriction process 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 January.

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 triggers certain legal obligations for affected companies, as well as represents the first step toward eventual inclusion in REACH’s Annex XIV, the authorization list.
• No such consultations are scheduled to close in January.

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. Below is an overview of the AfAs currently being consulted on, listed according to substance and number of corresponding AfAs.
• For links to each individual AfA consultation, including specific uses being applied for and the names of applicants, see ECHA’s dedicated page here.

ECHA consultations under the CLP Regulation closing in January

CLP: Harmonized classification and labeling (CLH)

• Consultations on classification and labeling harmonization (CLH) are open for 60 days and 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. · Visit the CLH entry where comments can be given by clicking on the substance name below.

ECHA consultations under Biocidal Products Regulation (BPR) closing in January

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.

• ECHA is also consulting until January 4, 2024 on a possible derogation to the exclusion criteria for 2,2-dibromo-2-cyanoacetamide (DBNPA).

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

• CAD/CMRD: Occupational exposure limit (OEL) 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.

Open calls for tenders ending in January

Upcoming meetings, webinars, and other events in January

To contact the author of this analysis, please email Scott Stephens.
To contact the editor of this analysis, please email Patricia Iscaro.