What we expect EU regulators to do in January 2024

The Periodic | By SCOTT STEPHENS, MPA

Dec. 22, 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

ECHA’s basic regulation

  • The European Chemicals Agency’s (ECHA) leadership is placing its hopes on a Commission proposal for a basic regulation that would update the agency’s role as the principal entity overseeing the regulation of chemicals in the EU. The ECHA executive director, SHARON MCGUINNESS, recently told European parliamentarians that such a law is crucial for ensuring that the agency continues to expand its remit beyond REACH, without sacrificing quality, transparency or efficiency. An important element of the envisioned legislation is the provision of greater funds to the agency, allowing it to take on its larger role in chemical regulation assigned in part by the Chemicals Strategy for Sustainability (CSS).
  • The Commission may be close to delivering this proposal, given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

Highlights of chemical regulatory activities

  • Consultations open under the REACH and CLP regulations are coming to an end in January. These cover, respectively, testing proposals for seven substances, 10 applications for authorization, and harmonized classification and labeling (CLH) for five substances, including methyl isothiocyanate.
  • Consultations closing in January on legislation proposed by the Commission include an update to the PFOS entry in the POPs Regulation and the initiative addressing microplastics unintentionally released into the environment.
  • Events happening next month include a meeting of ECHA’s committee for risk assessment working group on CLH.

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 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. Regulation Initiative entry

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

Draft act

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

Draft act

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

Related documents

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 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

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 – 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 January

  • 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

Persistent organic pollutants – PFOS limits and exemptions

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 an 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.

January 1, 2024

Initiative entry

Chemicals regulation – update of EU rules for test methods

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

January 9, 2024 Initiative entry

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

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.

January 15, 2024 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.

January 17, 2024 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. January 23, 2024 Initiative entry

ECHA consultations closing in January

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

17 testing proposals for seven entries

(See ECHA’s Current Testing Proposals webpage for details on individual substance entries and to provide comments.)

Various Various January 18, 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 restriction procedure. They do not replace them.
  • No calls for comments and evidence are ending in January.

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 January.

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 January.

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.
  • For links to each individual AfA consultation, including specific uses being applied for and the names of applicants, see ECHA’s dedicated page here.
Name CAS RN Number of AfAs Deadline
4-Nonylphenol, branched and linear, ethoxylated Various 5 January 10, 2024
Potassium dichromate 7778-50-9 1 January 10, 2024
Bis(2-ethylhexyl) phthalate 117-81-7 3 January 10, 2024
Tetraethyllead 78-00-2 1 January 10, 2024

ECHA consultations under the CLP Regulation closing in January

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
Exo-(+/-)-1-methyl-4-(1-methylethyl)-2-[(2-methylphenyl)methoxy]-7-oxabicyclo[2.2.1]heptane 87818-31-3 All hazard classes (physical hazards as well as hazards to human health and the environment), except for respiratory sensitization, aspiration hazard and hazardous to the ozone layer January 12, 2024
Ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate] 32509-66-3 Reproductive toxicity January 19, 2024
metam-sodium (ISO); sodium methyldithiocarbamate [1]; metam-potassium (ISO); potassium methyldithiocarbamate [2]

137-42-8[1]

137-41-7[2]

Explosives
Flammable liquids
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
Respiratory sensitization
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 to the ozone layer
January 19, 2024
Methyl isothiocyanate 556-61-6 Explosives
Flammable solids
Self-reactive substances and mixtures
Pyrophoric solids
Self-heating substances or mixtures
Substances or mixtures which in contact with water emit flammable gases
Oxidizing solids
Corrosive to metals
Acute toxicity – inhalation
Acute toxicity – dermal
Acute Toxicity – oral
Skin corrosion/irritation
Serious eye damage/eye irritation
Respiratory sensitization
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
January 19, 2024
tebuconazole (ISO); 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol 107534-96-3 Acute toxicity
Skin corrosion/Skin irritation
Serious eye damage/Eye irritation
Respiratory sensitization
Skin sensitization
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity – single exposure
Specific target organ toxicity – repeated exposure
Aspiration hazard
January 19, 2024

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

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.
Name Product type CAS RN Deadline for input
Dinotefuran 18 165252-70-0 January 4, 2024
Medetomidine(RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole (Racemic) 21 86347-14-0 January 4, 2024
N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine) 8 214710-34-6 January 4, 2024
2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin) 18 23031-36-9 January 22, 2024

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

  • 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
Boron and its compounds 10043-35-3
1332-77-0
1330-43-4
1303-86-2
January 12, 2024 ECHA scientific report

Open calls for tenders ending in January

Call for tender Purchasing entity Deadline for receipt of tenders Related link
Interim Services for ECHA and the European Commission representation in Finland European Food Safety Authority (EFSA) January 15, 2023 Single Electronic Data Interchange Area (SEDIA)

Upcoming meetings, webinars, and other events in January

Event title Hosting entity Date Type Related link
Future Of Chemical Recycling Europe 2024

ACI

January 31- February 1, 2024 In person Event description
Good practices and resources to improve the utility of research data in regulatory assessments of chemicals Joint Research Centre, Karolinska Institute, and Stockholm University January 31, 2024 Webinar Event description
Meeting of ECHA’s Committee for Risk Assessment Working Group on Harmonized Classification and Labeling (RAC-68 CLH WG) ECHA January 23-24, 2024 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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