What we expect EU chemical regulators to do in May 2024

Chemicals | By SCOTT STEPHENS, MPA

Apr. 29, 2024

Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. This recurring 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

  • 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).

 

Name CAS RN Hazard endpoint proposed for vertebrate testing Deadline

10 testing proposals for seven chemical entries, including for dibromomethane, diethyl succinate, and triisobutyl phosphate.

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

Various Various May 27, 2024

 

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.

 

Name CAS RN Subject of the call Deadline

 

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.

 

Name CAS RN Restriction Information Deadline

 

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.

 

Name CAS RN Reason for proposing Deadline

 

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).

 

Name CAS RN Deadline
Barium diboron tetraoxide 13701-59-2 May 7, 2024
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof May 7, 2024
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide 75980-60-8 May 7, 2024
Melamine 108-78-1 May 7, 2024
S-(tricyclo[5.2.1.0-(2,6)]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate 255881-94-8 May 7, 2024
Dibutyl phthalate (amendment to existing Annex XIV entry) 84-74-2 May 7, 2024

 

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.

 

Name CAS RN Number of AfAs Deadline

 

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.

 

Name CAS RN Hazard classes open for commenting Deadline
2-(2H-benzotriazol-2-yl)-p-cresol 2440-22-4

Skin Sens. 1; H317
Aquatic Chronic 1; H410,
Aquatic Chronic1,

M-factor=10

May 3, 2024
2-ethylhexyl (2E)-3-(4-methoxyphenyl)acrylate 83834-59-7 Hazardous to the aquatic environment May 3, 2024
benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene 68411-46-1 Reproductive toxicity
Hazardous to the aquatic environment
May 3, 2024
Reaction products of diphenylamine with nonene, branched

Reproductive toxicity

Hazardous to the aquatic environment

May 3, 2024
2,2′-iminodiethanol; diethanolamine 111-42-2

Carcinogenicity

Germ cell mutagenicity

Reproductive toxicity

Acute toxicity – inhalation

Acute toxicity – dermal

Acute toxicity – oral

Specific target organ toxicity – repeated exposure

May 10, 2024
1,3-diphenylguanidine 102-06-7

Acute Toxicity – oral

Serious eye damage/eye irritation

Skin sensitization

Reproductive toxicity

Specific target organ toxicity — repeated exposure

Hazardous to the aquatic environment

May 17, 2024
propyl [3-(dimethylamino)propyl]carbamate monohydrochloride; propamocarb hydrochloride 25606-41-1 Explosives
Flammable liquids
Self-reactive substances
Pyrophoric liquids
Self-heating substances or mixtures
Oxidising 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
May 24, 2024

 

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.

 

Name CAS RN Proposed substitution Deadline

 

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.

 

Name CAS RN Product type Deadline

 

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.

 

Name CAS RN Deadline
1,2-dihydroxybenzene,pyrocatechol 120-80-9 June 3, 2024
Silicon carbide fibers 409-21-2;
308076-74-6
June 3, 2024

 

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.

 

Name CAS RN Deadline
Chlorpyrifos 2921-88-2 May 5, 2024

 

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

 

Event title (+ link) Hosting entity Date/Deadline Type
The PFAS dilemma – outright ban vs essential utility? Queens University Belfast May 2 In person (Belfast, NI-UK)
SETAC Europe 34th Annual Meeting Society of Environmental Toxicology and Chemistry (SETAC) May 5-9 In person (Seville, Spain)

Meeting of the Committee for Risk Assessment – Applications for Authorization Working Group

(RAC AFA WG) reporting to RAC-69

ECHA May 7 In person (closed to public)

Reducing pollutants – the economy is taking action
(Deadline to register is May 3)

Note: Event will be held in German

Chamber of Commerce and Industry for Munich and Upper Bavaria

(IHK Umweltdialog)

May 8 In person (Munich, Germany)
Refill & Reuse Trade Fair Réseau Vrac & Réemploi; New European Reuse Alliance; R Cube; French Ecology Ministry May 13-14 In person (Paris)
Sustainable Plastics: Europe 2024 iQ-Hub May 13-14 In person (Frankfurt, Germany)
8th Green & Sustainable Chemistry Conference Elsevier Foundation May 13-15 In person (Dresden, Germany)
PFAS-free solutions: The challenge ahead Orgalim: Europe’s technology industries May 15 Hybrid
CHEM UK 2024 UK Industry Events Ltd May 15-16 In person (Birmingham, UK)
European Food & Beverage Plastic Packaging 2024 ACI May 15-16 In person (Porto, Portugal)
Major release of IUCLID 6 with format changes ECHA May 16 Webinar
Unpacking the new EU rules on packaging and packaging waste FECC/Steptoe May 21 Webinar
Future of Surfactants Summit ACI May 22-23 In person (Seville, Spain)
Promoting sustainable materials and circularity in construction Interreg Europe May 22 In person (Vienna, Austria)
Customer Support Service for the ECHA Information Desk ECHA May 24 (deadline) Contract to provide external resources for the ECHA Information Desk

ECHA IT Days

(Register by May 15)

ECHA May 29-30 In person (Helsinki, Finland)

Webinar series on REACH restriction – Restriction on phthalates

Note: Webinar will be held in French

REACH&CLP Luxembourg Helpdesk May 30 Webinar
51st meeting of the Biocidal Products Committee (BPC) ECHA May 27-31 Hybrid (closed to public)

 

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 (ECHA) – updated fees and charges

Adoption planned for Q1 2024

Initiative amends Commission Regulation 340/2008 on the fees and charges payable to ECHA. It will:

– Adjust fees in line with inflation
– Introduce other measures to increase sustainability of ECHA financing by reducing administrative burden on ECHA linked to the ex post verification of the size of companies (used to determine their eligibility for SME fees and charge rebates).

Proposal for Implementing Regulation Initiative entry

European Chemicals Agency – proposal for a basic regulation

Adoption was planned for Q2 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 Q4 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 Q4 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

Ecodesign – European Commission to examine need for new rules on environmental impact of photovoltaics

Adoption planned for Q1 2024

Given the role that photovoltaic products are expected to have in decarbonizing the EU’s energy system, it is essential that newly installed products in the EU are environmentally friendly.

Therefore, the Commission is assessing the need for regulation to manage the environmental impacts of photovoltaic products.

Proposal for Regulation Initiative entry

Persistent organic pollutants – dechlorane plus

Adoption was planned for Q4 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 – PFOS limits and exemptions

Adoption was planned for Q1 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 Q4 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 Q4 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 Q1 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

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 Regulation Initiative entry

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

Adoption was planned for Q4 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 Regulation Initiative entry

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

Adoption was planned for Q3 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 Q2 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 – list of restricted substances (update)

Adoption was planned for Q4 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)

Expected Commission adoption not provided

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

Protecting workers against cancer-causing substances at work (CMRD Revision)

Adoption planned for Q1 2024

Sixth revision of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens, mutagens and reprotoxic substances at work.

Latest scientific and technical developments considered for the following chemicals, groups of chemicals or process-generated substances:

– welding fumes
– polycyclic aromatic hydrocarbons
– isoprene
– 1,4-dioxane
– cobalt and inorganic cobalt compounds

Proposal for Directive Initiative entry

Export and import of hazardous chemicals – review of the list of chemicals subject to international trade rules

Adoption planned for Q2 2024

The Commission intends to update the list of hazardous chemicals subject to certain rules when internationally traded.

The aim is to support non-EU countries in preventing unwanted imports, and to ensure that information on hazards, risks and safe handling is exchanged when these chemicals are exported. Once a chemical has been put on the list, it can only be exported if certain conditions are met.

Proposal for Delegated Regulation Initiative entry

Microplastics pollution – measures to reduce its impact on the environment

Expected Commission adoption not provided

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 Q3 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

EU fertilizing products – biodegradability criteria for polymers and other technical amendments

Adoption planned for Q2 2024

This initiative aims at introducing biodegradability criteria for polymers (coating agents, water retention agents, mulch films and other polymer-based technical additives) in EU fertilizing products. It also introduces other technical amendments. Proposal for Delegated Regulation Initiative entry

 

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.

 

Issue area or planned legislation Description Deadline Link
Nitrates – RENURE This directive is intended to update the rules on the use of certain fertilizing materials from livestock manure (RENURE) May 17 Initiative entry

 

To contact the author of this analysis, please email Scott Stephens ( [email protected]).
To contact the editor of this analysis, please email Chelsey McIntyre ( [email protected]).

Get an insider’s view on regulatory movements.

Sign up for AgencyIQ’s newsletters to receive exclusive regulatory updates and analysis impacting the life sciences or chemical industry.

Copy link
Powered by Social Snap