What we expect EU chemical regulators to do in May 2024

Highlights of upcoming chemical regulatory activities

• This month, consultations concerning regulatory procedures under the REACH and CLP Regulations are coming to an end (REACH is the Registration, Evaluation, Authorization, and Restriction of Chemicals Regulation; CLP is the Classification, Labeling and Packaging Regulation).
• Under REACH, these address testing proposals for seven entries, including dibromomethane, diethyl succinate and triisobutyl phosphate. Likewise, comment periods are winding down for six substances – five put forward for first-time inclusion and one change to an existing entry – proposed for listing on Annex XIV of REACH (the authorization list).
• Under the CLP, seven substances, including 2-(2H-benzotriazol-2-yl)-p-cresol and diethanolamine, have been put forward for harmonized classification and labeling (CLH).
• Other consultations ending in May include one addressing a draft report for the pesticide active substance chlorpyrifos, which is being listed as a persistent organic pollutant (POP) under the Stockholm Convention, and one on a Commission proposal introducing a directive updating the rules for use of certain fertilizing materials from livestock manure (Renure).
• Multiple ECHA Committees will meet in May, and the agency will also be hosting a two-day IT event. The Risk Assessment Committee (RAC) working group on applications of authorizations (RAC AfA WG) will meet on May 7 and the Biocidal Products Committee (BPC) will meet on May 27-31. On May 29-30, the agency will host ECHA IT Days, a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.
• A number of other important chemicals-related events will also take place in May, including the Society of Environmental Toxicology and Chemistry (SETAC) Europe’s 34th annual meeting (May 5-9) and an ECHA webinar on format changes introduced with the latest major release of IUCLID 6 (May 16).

ECHA consultations under the REACH Regulation closing in May

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 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.

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.

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.

REACH: Recommendations related to 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 or amendment (for existing entries) in the authorization list (Annex XIV).

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.

ECHA consultations under the CLP Regulation closing in May

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.

ECHA consultations under BPR closing in May

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.

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

CAD/CMRD: Occupational exposure limit value (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.

ECHA consultations on persistent organic pollutants (POPs) proposals

• These eight-week consultations provide opportunity for interested parties to contribute feedback on draft reports for substances anticipated to be, or already proposed for, listing as POPs under the Stockholm Convention.

Meetings, trainings, webinars, calls for tenders and other events in May

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 May

• 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 ( sstephens@agencyiq.com).
To contact the editor of this analysis, please email Chelsey McIntyre ( cmcintyre@agencyiq.com).