What we expect EU regulators to do in December 2023

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

Glyphosate

• The Commission confirmed on November 16 that it will take the unilateral step of reauthorizing the approval of the herbicide glyphosate for a period of 10 more years.
• The EU executive will issue legislation in the first half of December at the latest renewing glyphosate’s approval, since its current approval expires on December 15.
• This confirmation came after member states’ final vote fell short of a qualified majority, leaving the fate of the controversial herbicide’s reapproval in the hands of the Commission.
• A Q&A document accompanied the Commission’s statement, offering further details on the conditions and restrictions of use the EU executive intends to build into the renewal. [For more background on the glyphosate authorization, see AgencyIQ’s October 12 article.]

Highlights of chemical regulatory activities

• Consultations open under the REACH and CLP regulations are coming to an end in December.These cover, respectively, testing proposals for three substances, and harmonized classification and labeling (CLH) for acetophenone and 2-pyrrolidone.
• Consultations closing in December on legislation proposed by the Commission address rules updating the end-of-life vehicles directive, provisions supplementing the plant protection products regulation, and an amendment to the biocidal products regulation.
• Events happening next month include two ECHA meetings (i.e., for the member state and socio-economic analysis committees), a meeting of the REACH Committee, and a safe-and-sustainable-by-design (SSbD) workshop hosted by the Joint Research Centre (JRC), among others.

Chemicals 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, on the other hand, 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 which allows the EP and Council only to scrutinize the proposed legal acts, but not to amend them.
• An important caveat: The adoption timeframes which the EU executive indicates on the ‘Have your say’ portal are not always followed strictly and may be subject to delay.

European Commission “Have your say” consultations closing in December

• A public consultation 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 December

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 December.

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 December.

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 December.

REACH: Applications for authorization (AfAs)

• Each application for authorization under REACH involves an eight-week public consultationinviting 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.
• No corresponding consultations are set to end in December. (See the status of AfAs and previous consultations here.)

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.

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.
• Currently, no consultations of this kind are closing in December.

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.
• No corresponding consultations are scheduled to end in December.

Open calls for tenders ending in December

Upcoming meetings, webinars, and other events in December

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