What we expect EU regulators to do in March 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 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and Biocidal Products (BPR) Regulations are coming to an end in March and early April. Under REACH, two calls for information in support of possible restrictions are winding up on April 3 and 5, respectively, for the substance groups: (1) 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and 4-Nonylphenol, branched and linear, ethoxylated and related substances; and (2) aromatic brominated flame retardants. Under the BPR, one substance, cholecalciferol (CAS RN 67-97-0), is being considered for an exemption from the regulation’s exclusion criteria.
- Many events are slated to take place in March. Several of ECHA’s committees will meet to take chemical management-related decisions and discuss other regulatory developments. The meetings of the Risk Assessment and Socio-economic Analysis Committees, for example, will include agenda items concerning the draft opinion on the proposed universal restriction of poly- and perfluoroalkyl substances (PFAS), with focus on consumer mixtures, cosmetics, and ski wax.
- ECHA will hold two webinars, the first introducing the agency’s guidance on assessing biocide risks to bees, and the second providing insight into the OECD QSAR assessment framework in REACH’s dossier evaluation procedure.
- Two of the European Commission’s “Have your say” consultations regarding chemical legislation are ending in March. One is a proposal to ban bisphenol A (BPA) and other bisphenols in food contact materials, while the other is an evaluation of the overall effectiveness of the EU’s Nitrates Directive 91/676/EEC, which targets the reduction and prevention of nitrate pollution from agricultural sources.
ECHA consultations closing in March
- ECHA is tasked with conducting public consultations throughout the year under various regulatory procedures pursuant to EU chemical law (e.g., REACH restriction and authorization, and CLP harmonized classification). These actions are mandated under the specific chemical legislation that ECHA is responsible for administering, including the REACH, CLP, and Biocidal Products regulations, as well as occupational safety and health (OSH) rules (e.g., occupational exposure limit value (OELV) assessments), among others.
- Public consultations comprise an important part of the agency’s activities, ensuring that the perspectives of as many stakeholders as possible are heard and their views are considered in the regulatory risk management (RRM) assessments and subsequent opinions that ECHA issues under the respective chemicals-related regulatory frameworks.
- Below is the list of ECHA’s consultative actions for this month, grouped according to legal framework (e.g., REACH, CLP, BPR, OSH) and then regulatory procedure.
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).
- Currently, no consultations on testing proposals are closing in March.
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.
- No calls for evidence are closing in March. However, ending in early April are the comment periods for calls concerning two substance groups.
Name | CAS RN | Subject of the call | Deadline |
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and 4-Nonylphenol, branched and linear, ethoxylated and related substances, as listed in the respective Annex XIV (authorization list) entries | Various | Call for comments on the draft screening report on the presence and risk of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated and 4-Nonylphenol, branched and linear, ethoxylated in articles. | April 3, 2024 |
Aromatic brominated substances | Various | Call for evidence on aromatic brominated flame retardants | April 5, 2024 |
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.
- Currently, no consultations on proposed restrictions are closing in March.
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.
- No such consultations are scheduled to close in March.
REACH: Recommendations for 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 in the authorization list (Annex XIV).
- No such consultations are scheduled to close in March.
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 March. Visit this page to consult adopted opinions and previous AfA consultations.
ECHA consultations under the CLP Regulation closing in March
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.
- No such consultations are scheduled to close in March.
ECHA consultations under BPR closing in March
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 related consultations ending in March.
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), 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 is receiving comments until the end of March on one substance being considered for exemption.
Name | CAS RN | Product type | Deadline |
Cholecalciferol | 67-97-0 | Rodenticides (PT 14) | March 31, 2024 |
ECHA consultations closing in March under occupational, safety and health (OSH) rules
CAD/CMRD: 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.
- There are currently no such consultations ending in March.
Upcoming meetings, webinars, and other events in March
Event title | Hosting entity | Date | Type | Related link |
Substitution of targeted hazardous chemicals | European Commission in cooperation with Logika Group | 1 March | In person workshop, Brussels, Belgium | Event webpage |
Getting familiar with ECHA’s guidance to assess risks of biocides to bees | ECHA | March 5 | Free webinar, registration not necessary | Event webpage |
State of play and possible future developments of the Digital Product Passport (DPP) | Cirpass | March 5 | Free webinar | Event webpage |
Meeting of the Risk Assessment Committee (RAC-68) | ECHA | March 11-14 | Closed to public | Draft Agenda |
Meeting of the Socio-economic Analysis Committee (SEAC-62) | ECHA | March 12-15 | Closed to public | Draft Agenda |
3rd Drinking Water Directive Working Group meeting (reports to RAC) | ECHA |
March 14-15 |
Closed to public | Draft Agenda |
Management Board meeting | ECHA | March 21-22 | Closed to public | ECHA webpage |
Meeting of the Enforcement Forum (Forum-46) | ECHA | March 18-22 | Closed to public | ECHA webpage |
Advancing Exposure Science in Europe – today‘s results for a safer future | International Society of Exposure Science (ISES Europe) in cooperation with German Federal Institute for Risk Assessment (BfR) | March 19-21 | Fee-based workshop, Berlin, Germany (plenary sessions to be live streamed) | Event webpage |
OECD QSAR Assessment Framework in REACH dossier evaluation: what you need to know | ECHA | March 21 | Free webinar, registration not necessary | Event webpage |
Chemical, biological, radiological, nuclear, explosive (CBRNE) Research & Innovation Day | Community for European Research and Innovation for Security (CERIS) | March 21 | Conference, Fee-based participation | Commission webpage |
Webinar series on REACH restriction – Basics on REACH restriction process | REACH&CLP Luxembourg Helpdesk | March 21 | Free webinar upon registration | Event webpage |
European Gas Conference | The Energy Council | March 26-28 | Conference, fee-based participation | Event webpage |
Public Hearing: Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices | European Commission | Registration deadline is March 17; event scheduled for April 11 | Public hearing, Brussels, Belgium | Event webpage |
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 |
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 |
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 |
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; and refine certain tests to obtain more reliable/precise results on chemical hazards. |
Proposal for Regulation | Initiative entry |
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 | |
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 |
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 |
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 |
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 | |
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 | |
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 |
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 |
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 |
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 Regulation | Initiative entry |
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 |
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 |
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 |
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: (1) Annex III of the Directive on the care and accommodation requirements, and (2) Annex IV 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 Delegated Directive | Initiative entry |
European Commission ‘Have your say’ consultations closing in March
- 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 |
Food safety – restrictions on bisphenol A (BPA) and other bisphenols in food contact materials |
This initiative will impose a ban on the use of BPA in food contact materials (FCMs), including plastic and coated packaging. This follows the publication of the European Food Safety Authority’s opinion, which indicates a concern for human health. The measure will also: address the use of other bisphenols in FCMs to avoid replacing BPA with other harmful substances; and set out derogations and transitional periods that may apply to businesses. |
March 8 | Initiative entry |
Protecting waters from pollution caused by nitrates from agricultural sources – Evaluation | EU rules on nitrates protect water quality by reducing and preventing pollution caused by nitrates from agriculture. Water quality has improved in the EU, but pollution by nitrates can still be a serious problem. This evaluation will assess how well these rules have worked and whether they are still fit for purpose in light of the EU’s ambition on environmental and climate policy, and its goals to achieve a sustainable and resilient agriculture and food security. | March 8 | Initiative entry |
To contact the author of this analysis, please email Scott Stephens ( sstephens@agencyiq.com).
To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com).