What we expect EU regulators to do in December 2023

The Periodic | By SCOTT STEPHENS, MPA

Nov. 27, 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.
Planned legislation Description Type of act Link

Restriction updating Annex XVII REACH regarding CMRs (2023)

Adoption planned for fourth quarter of 2023

The initiative aims to protect consumers by adding newly classified CMR (carcinogenic, mutagenic, toxic to reproduction) substances to the lists of CMR substances restricted for consumer use under the Regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH). Regulation Initiative entry

Persistent organic pollutants – dechlorane plus

Adoption planned for fourth quarter of 2023

Regulation (EU) 2019/1021 on persistent organic pollutants implements the EU’s international commitments under the Stockholm Convention on persistent organic pollutants (chemical substances). Following a decision to add dechlorane plus to the Convention, this initiative amends Annex I to the Regulation to include dechlorane plus as a substance subject to certain restrictions. Proposal for Delegated regulation Initiative entry

Persistent organic pollutants – UV-328

Adoption planned for fourth quarter of 2023

Following a decision to add UV-328 to the Convention, this initiative amends Annex I to the Regulation to include UV-328 as a substance subject to certain restrictions. Proposal for Delegated regulation Initiative entry

Persistent organic pollutants – methoxychlor

Adoption planned for fourth quarter of 2023

Following a decision to add methoxychlor to the Convention, this initiative amends Annex I to the Regulation to include methoxychlor as a substance subject to certain restrictions. Proposal for Delegated regulation Initiative entry

Persistent organic pollutants – PFOS limits and exemptions

Adoption was planned for first quarter of 2023

Perfluorooctanesulfonic acid (PFOS) and its derivatives are listed in Annex I to Regulation (EU) 2019/1021.

This measure will reduce the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and will remove the last specific exemption allowed in the EU since it is no longer needed.

Proposal for Delegated regulation Initiative entry

Persistent organic pollutants – hexabromocyclododecane (HBCDD)

Adoption was planned for first quarter of 2022

This act concerns HBCDD (included in Annex I of Regulation (EU) 2019/1021). It amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles. Proposal for a regulation Initiative entry

Persistent organic pollutants – polybrominated diphenyl ethers (PBDEs)

Adoption was planned for first quarter of 2022

This act concerns PBDEs (included in Annex I of Regulation (EU) 2019/1021). It amends the limit value for the presence of PBDEs in mixtures or articles. Proposal for a regulation Initiative entry

Chemicals regulation – update of EU rules for test methods

Adoption planned for fourth quarter of 2023

EU legislation on chemicals provides for checks on chemicals that may be hazardous for humans, animals or the environment. The current rules include a list of approved methods for testing chemicals.

This initiative will add new/updated methods to that list. These methods could:

· reduce the number of animals needed to test for chemical hazards

· refine certain tests to obtain more reliable/precise results on chemical hazards.

Proposal for a regulation Initiative entry

EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision)

Adoption was planned for fourth quarter of 2022

This initiative will likely be postponed until the next Commission after June 2024.

The EU chemicals strategy for sustainability aims to better protect human health and the environment as well as boost innovation for safe and sustainable chemicals.

This initiative focuses on cosmetic products, in particular on various actions and potential measures to improve the efficiency and effectiveness of the current rules on cosmetic products.

Proposal for a regulation Initiative entry

Animal welfare – Animals used for scientific purposes (adaptation of standards on care, accommodation and killing)

Adoption is planned for third quarter of 2023

This initiative will likely be postponed until the next Commission after June 2024.

The initiative is to adapt two annexes of Directive 2010/63/EU on the protection of animals used for scientific purposes:

· Annex III of the Directive on the care and accommodation requirements

· Annex IV of the Directive on the killing methods

The changes include standards for species currently not covered by the annexes but within the scope of the Directive.

Proposal for a directive Initiative entry

Preventing terrorism – new rules on the marketing and use of high-risk chemicals

Adoption was planned for third quarter of 2023

This initiative establishes rules on the marketing and use of high-risk chemicals.

It aims to increase security in the EU by reducing the risk of dangerous chemicals being acquired by terrorists or other criminals to carry out attacks.

Proposal for a regulation Initiative entry

Revision of EU rules on food contact materials

Adoption was planned for second quarter of 2023

This initiative will likely be postponed until the next Commission after June 2024.

EU food safety policy includes rules on food contact materials (e.g., food packaging, kitchen and tableware and food processing equipment).

This initiative aims to modernize the rules, to:

ensure food safety and a high level of public health protection; reduce the presence and use of hazardous chemicals; take account of the latest science and technology; support innovation and sustainability by promoting safe reusable and recyclable solutions; and help reduce the sector’s environmental impact.

Proposal for a regulation Initiative entry

Review: Restriction of the use of hazardous substances in electronics

Adoption was planned for fourth quarter of 2022

See the Commission’s RoHS page for an update on this initiative (under heading “RoHS 2 review”).

EU rules limit the use of certain harmful substances in electrical and electronic equipment to protect human health and the environment and ensure proper functioning of the internal market. The initiative is intended to simplify and increase the efficiency of the current rules and improve their enforcement. Proposal for a directive Initiative entry

Hazardous substances in electrical and electronic equipment – list of restricted substances (update)

Adoption planned for fourth quarter 2023

Following a technical assessment, this initiative proposes adding tetrabromobisphenol A (TBBP-A) and medium-chain chlorinated paraffins (MCCPs) to the list of restricted substances. Proposal for a Delegated directive Initiative entry

Hazardous substances in electrical and electronic equipment – exemption for cadmium in quantum dots for LED applications

Adoption was planned for second quarter of 2023

Under EU rules, certain hazardous substances cannot be used in electrical and electronic equipment. Businesses can request exemptions where the substance cannot (yet) be replaced.

The Commission has assessed three exemption requests on the use of cadmium in quantum dots in LED lighting and displays.

This initiative proposes amending the list of restricted substances in Annex III to Directive 2011/65/EU.

Proposal for a Delegated directive Initiative entry

Hazardous substances – exemption for use of lead to create superconducting magnet circuits in specific devices

Adoption was planned for third quarter of 2021

This initiative allows lead to be used in metallic bonds to create superconducting magnetic circuits in superconducting quantum interference device (SQUID) detectors. Proposal for a Delegated directive Initiative entry

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.
Issue area or planned legislation Description Deadline Link
End-of-life vehicles – revision of EU rules This initiative proposes improved collection, treatment and recycling of end-of-life vehicles (ELVs). It aims to ensure consistency with European Green Deal objectives by encouraging the car industry to adopt a sustainable model for the design and production of cars. December 4, 2023 Initiative entry
Plant protection products – data requirements and gradual review of safeners and synergists The initiative would define data requirements for the approval of safeners and synergists, like those for active substances under Regulation (EC) No 1107/2009, but with additional criteria. Furthermore, a work program is needed for the systematic, phased reassessment of safeners and synergists that were already on the market when the Regulation entered into force. December 20, 2023 Initiative entry
Existing active substances in biocidal products – extension of review period This initiative extends the review period because the review cannot be finalized by the current deadline of 31 December 2024. December 21, 2023 Initiative entry

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).
Name

CAS RN

(or EC No.)

Hazard endpoint proposed for vertebrate testing Deadline
1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride 25134-21-8

Reproductive toxicity (extended one-generation reproductive toxicity study);

Reproductive toxicity (pre-natal developmental toxicity)

December 18
Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol (952-795-7) Long-term toxicity to fish December 18
Lithium chloride 7447-41-8 Genetic toxicity in vivo December 18

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.
Name CAS RN Hazard classes open for commenting Deadline

acetophenone

(proposed update to existing CLP Annex VI entry)

98-86-2 Acute toxicity – oral
Reproductive toxicity
Specific target organ toxicity — single exposure
December 1

2-pyrrolidone; pyrrolidin-2-one

(new CLP Annex VI entry)

616-45-5 Reproductive toxicity December 15

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

Call for tender Purchasing entity Deadline for receipt of tenders Related link
Assistance on R Programming, Shiny Applications, Ad-hoc Support and Statistical Programming Trainings to EFSA European Food Safety Authority (EFSA) December 11, 2023 Ted entry
Banking services for ECHA’s current accounts ECHA December 22, 2023 Ted entry

Upcoming meetings, webinars, and other events in December

Event title Hosting entity Date Type Related link
Process Safety and Cyber Security in a Digitalized World: How to Manage Risks at Production Sites?

European Chemical Industry Council

(Cefic)

December 5, 2023 Hybrid Event description
EU REACH – Purchasing from and supplying to the EU under the current legislation (30-minute webinar examining implications EU REACH could have for industry in Great Britain) EcoOnline December 6, 2023 Online Event description
Safe-and-sustainable-by-design (SSbD) workshop on feedback from the first reporting period (Registration required by December 1, 2023) Joint Research Centre (JRC) December 6-7, 2023 Hybrid Event description
Putting Science into Standards (PSIS) workshop – Circular Technologies for construction industry European Committee for Standardization, JRC December 12-13, 2023 Online Event description
61st meeting of ECHA’s Committee for Socio-economic Analysis (SEAC) ECHA Nov 28-Dec 1, 2023 Closed Agenda

84th meeting of ECHA’s Member State Committee (MSC)

ECHA December 13-14, 2023 Closed Agenda
REACH Committee meeting Committee established under REACH (Joint responsibility with Directorate-General for Environment – ENV) December 14, 2023 Closed Agenda

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

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