What we expect EU regulators to do in November 2023

Key regulatory actions on the horizon

Glyphosate

• The Commission is expected to submit its proposal for reauthorization of the widely used herbicide to an appeal committee next month. On October 13, EU member-state representatives on the Committee on Plants, Animals, Food and Feed (PAFF) failed to reach the 55% threshold, representing at least 65% of the EU population, needed to secure a qualified majority to adopt or reject the draft Commission implementing regulation renewing the active substance for 10 more years.
• The meeting of the appeal committee, where EU nations will have one more chance to adopt (or block) glyphosate’s renewal until December 2033, is expected to take place in mid-November. Glyphosate’s current approval expires on December 15 of this year.
• The EU executive would be able to extend the glyphosate approval on its own if the vote at the Appeal Committee fails, though this may be legally challenged.
• If a qualified majority votes against the renewal, a 12- to 18-month grace period will commence before the herbicide’s authorization expires. [For more background on the glyphosate authorization, see our piece from October 12.]

Regulation on detergents and surfactants

• The expert working group on detergents is scheduled to hold a meeting on November 17. The meeting agenda includes a presentation and subsequent discussion of the Commission’s proposal for the Regulation on detergents and surfactants, which the EU executive published last April 28.

Highlights of ECHA’s activities

• Consultations are coming to an end in November under the REACH, CLP, and Biocides (BPR) regulations, as well as under occupational safety legislation (i.e., OELs). These include a call for evidence for a possible REACH restriction on diglyme, and a REACH restriction consultation on creosote and creosote-related substances. Harmonized classification and labeling (CLH) consultations for eight substances are closing, one for the active substance cholecalciferol as a potential candidate for substitution under BPR, as well as a consultation on 1,3-Butadiene under the chemical agents (CAD) and carcinogens, mutagens or reprotoxic substances (CMRD) directives.

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.
• 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.
• 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.

ECHA consultations closing in November

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.
• Click on the substance name to be taken to its corresponding entry where the link to give comments can be accessed.

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.

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 and hazard endpoint(s).

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 November.

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.
• No corresponding consultations are set to end in November. (See the status of AfAs and previous consultations here.)

ECHA consultations under the CLP Regulation closing in November

CLP: Harmonized classification and labeling (CLH)

• Consultations on classification and labeling harmonization (CLH) are open for 60 days and seek to elicit feedback from all interested parties on the hazard classes proposed by the dossier submitter, as well as on those that were not concluded to warrant classification.
• Click on the substance name below to be taken to its corresponding entry where the link to give comments can be accessed.

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

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

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.

ECHA committee meetings, hosted webinars, and other events in November

• Webinars hosted by ECHA are free to attend and, unless otherwise stated, require no registration, and are broadcast live on the agency’s website. RAC and SEAC committee meetings are usually closed to the public.

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