December 2024 European Chemicals Monthly Bulletin

I. Update on the Progress of PFAS Restrictions in Europe

On November 20, 2024, the European Chemicals Agency (ECHA), together with five relevant competent authorities (dossier submitters), updated the progress report on the restriction of per- and polyfluoroalkyl substances (PFAS) in Europe. The core contents include:

1. Expansion of covered restricted uses: Clarified uses not mentioned in the initial restriction draft, such as technical textiles, sealing, punting, and medical applications, with special attention to fluoropolymers;

2. Exploration of alternative restriction schemes: Instead of focusing solely on "full bans" or "phased bans", more alternative restriction options are being explored based on the availability of substitutes.

In addition, on November 8, 2024, the European Commission issued an initiative related to chemical contaminants - Limit Values and Exemptions for Perfluorooctanoic Acid (PFOA), aiming to seek comments on "delaying the date of banning fire-fighting foams" and propose new concentration limit requirements for "unintentionally present trace contaminants".

II. New Requirements for Substances and Mixtures (Revision of CLP Regulation)

On November 20, 2024, the European Commission issued Regulation (2024/2865), which amends Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (referred to as the "CLP Regulation" for short). This amended regulation officially came into force on December 10, 2024, and the application dates for each clause are as shown in the table below:

III. Release of the New Version of CLP Standard Application Guidelines

On November 13, 2024, the European Chemicals Agency (ECHA) released 5 documents related to the application of the CLP Standard (Classification, Labelling and Packaging Standard for Substances and Mixtures), aiming to provide detailed guidance for the application of the CLP Standard to substances with "physical hazards, health hazards, and environmental hazards". The specific documents include:

1. Overview of the CLP Standard Application Guidelines Series [PDF]

2. Part 1: General Principles of Classification and Labelling [PDF]

3. Part 2: Physical Hazards [PDF]

4. Part 3: Health Hazards [PDF]

5. Part 4/5: Environmental Hazards and Other Hazards [PDF]

IV. European Chemicals-Related Registration and Consultation Platforms (Summary of ECHA Links)

1. Classification and Labelling Harmonization (CLH) Intent Registration (until outcome announcement): [Registry of CLH intentions until outcome - ECHA (europa.eu)]

2. Harmonized Classification and Labelling Consultations: [Harmonised classification and labelling consultations - ECHA (europa.eu)]

3. Restriction Intent Registration (until outcome announcement): [Registry of restriction intentions until outcome - ECHA (europa.eu)]

4. Substances of Very High Concern (SVHC) Intent Registration (until outcome announcement): [Registry of SVHC intentions until outcome - ECHA (europa.eu)]

5. Substance Evaluation (CoRAP): [Substance evaluation - CoRAP - ECHA (europa.eu)]

6. Adopted Opinions and Previous Consultations on Applications for Authorisation: [Adopted opinions and previous consultations on applications for authorisation - ECHA (europa.eu)]

7. Applications for Authorisation (Current Consultations): [Applications for authorisation - current consultations - ECHA (europa.eu)]

8. Current Calls for Comments and Evidence: [Current calls for comments and evidence - ECHA (europa.eu)]

9. Authorisation List: [Authorisation List - ECHA (europa.eu)]

10. Completed Restriction Activities by ECHA

11. Submitted Restriction Proposals Pending Consideration

12. Regulatory Need Assessment List

V. Chemical-Related Developments in Other Countries

(I) United Kingdom: 2024 Persistent Organic Pollutants (POPs) Proposal

On October 28, 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) launched a call for information on the Draft Risk Profile and Draft Risk Management Evaluation for two substances proposed to be classified as "Persistent Organic Pollutants (POPs)". This classification is based on the United Nations Stockholm Convention, and the substances involved include:

1. Polyhalogenated dibenzo-p-dioxins and dibenzofurans (PXDD/Fs)

2. Chlorinated paraffins with a carbon chain length in the C14-17 range

(II) Brazil: New Regulations on Chemical Management Law

On November 14, 2024, the Brazilian government issued Law No. 15022 of November 13, 2024 (related to chemical management). With the goal of "reducing adverse impacts on health and the environment", this law establishes a "National List of Chemical Substances" and implements risk assessment and risk control for "chemicals used, produced, or imported within Brazil", while including other relevant provisions.

1. Core Requirements

• Registration Requirement: If the annual production or import volume of a substance reaches 1 ton or more, chemical registration is required;

• Safety Data Sheet (SDS): Must comply with the Globally Harmonized System (GHS) standards;

• Risk Assessment: Risk assessment analysis must be conducted based on the recommended use of the substance;

• Substance Identification: Identification information of the substance (such as CAS number) must be provided.

2. Implementation Timeline

This law is aligned with the international chemical management framework (REACH Regulation).

VI. Developments Related to Sustainable Development, Circular Economy and the Environment

The following is a summary of important recent releases (non-exhaustive) in the fields of sustainable development, circular economy, and the environment: