What we expect EU regulators to do in February 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.
Highlights of upcoming chemical regulatory activities
- Consultations under the REACH and CLP regulations are coming to an end in February. Under REACH, these cover testing proposals for seven substances and calls for comments and evidence on the substances octocrilene and chromium trioxide, acids generated from chromium trioxide and their oligomers. Under the CLP, one substance, the herbicide clethodim, has been put forward for harmonized classification and labeling (CLH).
- A consultation on amending occupational exposure limits (OEL) legislation for bisphenol A closes in mid-February.
- One consultation closes on February 1 on an amendment to Directive 2010/63/EU on the protection of animals used for scientific purposes, updating standards on care, accommodation and killing.
- Events happening in February include ECHA’s Shaping Tomorrow Conference 2024.
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.
| Planned legislation | Description | Type of act | Link |
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European Chemicals Agency – proposal for a basic regulation Adoption was planned for second quarter 2023 |
This initiative will propose a basic regulation for ECHA. It aims to: strengthen ECHA governance and adapt it to its future role, as well as to streamline the working methods of ECHA bodies and make their financing more sustainable. | Proposal for Regulation | Initiative entry |
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Restriction updating Annex XVII REACH regarding CMRs (2023) Adoption was 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, authorization and restriction of chemicals (REACH). | Proposal for Regulation | Initiative entry |
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Chemicals regulation – update of EU rules for test methods Adoption was 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 Regulation | Initiative entry |
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Persistent organic pollutants – dechlorane plus Adoption was 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 | |
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Persistent organic pollutants – hexabromocyclododecane (HBCDD) Adoption was planned for first quarter of 2022 |
This act amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles. | Proposal for Delegated Regulation | Initiative entry |
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Persistent organic pollutants – PFOS limits and exemptions Adoption was planned for first quarter of 2023 |
This act reduces the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and removes the last specific exemption allowed in the EU since it is no longer needed. | Proposal for Delegated Regulation | Initiative entry |
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Persistent organic pollutants – UV-328 Adoption was 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 |
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Persistent organic pollutants – methoxychlor Adoption was 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 | |
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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 Regulation | |
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Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment This initiative will likely be postponed until the next Commission after June 2024. |
The European Green Deal sets out the ambition to reach zero pollution for a toxic-free environment. As part of this ambition, the chemicals strategy for sustainability announces actions to revise the rules governing the registration, evaluation, authorization and restriction of chemicals in the EU |
Proposal for Regulation | Initiative entry |
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EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) 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 |
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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 Regulation | Initiative entry |
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Revision of EU rules on food contact materials 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 Regulation | Initiative entry |
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Hazardous substances in electrical and electronic equipment – exemption for cadmium in quantum dots for LED applications Adoption was planned for second quarter 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 Delegated Directive | Initiative entry |
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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 |
| Protecting workers from exposure to carcinogens, mutagens or reprotoxic substances – codification of Directive 2004/37/EC (CMRD) | This initiative codifies the 2004 directive, which has been frequently amended over the years, to render this legislation clearer and more transparent. | Proposal for Directive | Initiative entry |
| Microplastics pollution – measures to reduce its impact on the environment | This initiative aims to tackle microplastics unintentionally released into the environment. It will focus on labeling, standardization, certification, and regulatory measures for the main sources of these plastics. It seeks to reduce environmental pollution and potential health risks, while respecting the principles of the single market and encouraging competitiveness and innovation. | Proposal for Regulation | Initiative entry |
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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 Delegated Directive | Initiative entry |
European Commission ‘Have your say’ consultations closing in February
- 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.
| Issue area or planned legislation | Description | Deadline | Link |
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Animal welfare – Animals used for scientific purposes (adaptation of standards on care, accommodation and killing) Adoption was planned for third quarter of 2023 |
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. |
February 1, 2024 | Initiative entry |
ECHA consultations closing in February
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 | Hazard endpoint proposed for vertebrate testing | Deadline |
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10 testing proposals for seven entries containing substances and substance groups (See ECHA’s Current Testing Proposals webpage for details on these entries and to provide comments.) |
Various | Various | February 29, 2024 |
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 Title VIII restriction procedure. They do not replace them.
- Two calls for evidence are closing in February.
| Name | CAS RN | Subject of the call | Deadline |
| Octocrilene | 6197-30-4 |
This call for evidence aims to collect information on the manufacture, import, use and placing on the market of the substance, as well as on the possibility for its substitution and potential alternatives as part of the production articles/mixtures, in particular of the following: · Plastisol · Cosmetic products (perfumes, fragrances, etc.) including sunscreens Additionally, information on life cycle, emissions/risks to the environment and socio-economic impacts of a potential restriction for the above-mentioned uses is also of interest. |
February 12, 2024 |
| Chromium trioxide, acids generated from chromium trioxide and their oligomers | — | Call for evidence on certain chromium (VI) substances to support the preparation of a restriction proposal | February 13, 2024 |
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 February.
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 February.
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.
- Currently, no AfA consultations are closing in February. Visit this page to consult adopted opinions and previous AfA consultations.
ECHA consultations under the CLP Regulation closing in February
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.
- 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 |
| clethodim (ISO); (5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one | 99129-21-2 |
Explosives Flammable liquids Flammable solids Self-reactive substances and mixtures Pyrophoric liquids Self-heating substances or mixtures Substances or mixtures which in contact with water emit flammable gases Oxidizing liquids Corrosive to metals Acute toxicity – inhalation Acute toxicity – dermal Acute Toxicity – oral Skin corrosion/irritation Serious eye damage/eye irritation Skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity — single exposure Specific target organ toxicity — repeated exposure Hazardous to the aquatic environment Hazardous for the ozone layer |
February 9, 2024 |
ECHA consultations under Biocidal Products Regulation (BPR) closing in February
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.
- There are currently no ongoing BPR-related consultations.
ECHA consultations under occupational, safety and health (OSH) rules closing in February
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.
| Name | CAS RN | Deadline | Consultation subject |
| 4,4-Isopropylidenediphenol (Bisphenol A) | 80-05-7 | February 19, 2024 | ECHA scientific report |
Upcoming meetings, webinars, and other events in February
| Event title | Hosting entity | Date | Type | Related link |
| Applications for Authorization (AfA) Working Group Meeting (under Risk Assessment Committee – RAC) (RAC-68) | ECHA |
February 6-7 |
Closed to public | ECHA webpage |
| ECHA Member State Committee Meeting (MSC-85) | ECHA |
Tentatively planned for February 12-16 |
Closed to public | ECHA webpage |
| Biocidal Products Committee Meeting (BPC-50) | ECHA | February 26-27, 29 | Closed to public | ECHA webpage |
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Shaping Tomorrow Conference 2024 (Today’s implementation, tomorrow’s innovation: the future of EU chemicals) |
ECHA | February 28 | In person (Helsinki, Finland) and online | Event website |
| Silicone Expo Europe | SGE | February 28-29 | In person (Amsterdam, Netherlands) | Event website |
To contact the author of this analysis, please email Scott Stephens.
To contact the editor of this analysis, please email Patricia Iscaro.