Chemicals | Monthly bulletin | January 2025

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Europe

New update to Candidate List of Substances of Very High Concern (SVHCs)

On the 21^st of January 2025, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs with the addition of five new substances. The current list of SVHCs now contains 247 substances.

Update to the Dutch complete list of Substances of Very High Concern

On the 4^th of December 2024, the Dutch National Institute for Public Health and the Environment (RIVM) added 100 substances, including per- and polyfluoroalkyl substances (PFAS) and their classifications to its Substances of Very High Concern (ZZS) list.

The aim is to reduce PFAS use and emissions in the Netherlands. Dutch companies that are unable to eliminate PFAS emissions must submit a revised emissions reduction plan every five years.

For more information, consult the complete list of ZZS on the RIVM website here.

One of the PVC restrictions of Annex XVII to REACH is already effective

From the 29^th of November 2024, the restriction indicates in the Entry 63 of Annex XVII to Regulation (EC) Nº 1907/2006 is already applicable. It means that lead must not be placed on the market or used in articles produced from polymers or copolymers of vinyl chloride (PVC), if the concentration of lead is equal to or greater than 0.1% by weight of the PVC material.

For more information, consult the official publication of Regulation (EU) 2023/923 amending Annex XVII to Regulation (EC) No. 1907/2006 (REACH) here.

Recent publications on REACH Regulation

The following table provides a non-exhaustive summary of some recent updates regarding REACH Regulation (EC) No 1907/2006:

Summary of the most recent updates
Date	Subject	Link
03/12/2024	Publication of Forum of exchange of information on enforcement REF-11 project report on: Safety Data Sheets (SDS). The result is that 35 % of the checked safety data sheets (SDS) were non-compliant. Compliance has improved compared to earlier enforcement projects and for the future, it must continue to improve.	For more information, consult the ECHA’s website here.
04/12/2024	ECHA published tips for preparing simplified SCIP notifications. SCIP is the database for information on Substances of Concern In articles established under the Waste Framework Directive (WFD). Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA.	For more information, consult the ECHA’s website here.
18/12/2024	ECHA has published its concerns related to aromatic brominated flame retardants (ABFRs) because of their persistence, bioaccumulation and toxicity.	For more information, consult the ECHA’s website here.

Interesting resources on the REACH Regulation on the ECHA’s website

Recent publications regarding CLP Regulation

The following table provides a non-exhaustive summary of some recent updates regarding CLP Regulation (EC) No 1272/2008:

Summary of the most recent updates
Date	Subject	Link
10/12/2024	Following the updated Classification, Labelling and Packaging (CLP) regulation which started to apply on the 10^th of December 2024, the European Chemical Agency (ECHA) published an article with links to help with the application of it. It also indicates the upcoming guidance in 2025: guidance on labelling; guidance on Annex VIII (poison centres); practical guide on read across and grouping under CLH; and stakeholder workshops on new hazard classes.	For more information consult the ECHA’s website here.
10/12/2024	The updated Classification, Labelling and Packaging (CLP) regulation has made changes to the clarification of responsibilities of duty holders related to notification of hazardous mixtures to poison centres.	For more information consult the European Poison Centres website here.

Interesting resources on the CLP Regulation on ECHA’s website

New chemicals in Annex I and V of Regulation (EU) No 649/2012

On the 31st of December 2025, the European Commission published Delegated Regulation (EU) 2024/3199 amending Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals.

The main amendments are the addition of 40 chemicals in the Annex I and a subgroup of PFAS, perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds, have been added to Annex V.

The PIC Regulation governs the trade of certain hazardous chemicals that are banned or severely restricted in the EU. It places obligations on companies that wish to export these chemicals to non-EU countries or import them into the EU.

Recent publications regarding PIC Regulation

The following table provides a non-exhaustive summary of some recent updates regarding PIC (Prior Informed Consent) Regulation (EU) No 649/2012:

Summary of the most recent updates
Date	Subject	Link
16/12/2024	The ECHA published the report on exports and imports in 2023 of chemicals listed in Annex I to the Prior Informed Consent (PIC) Regulation. It indicates that substances containing benzene continued to dominate the trade in 2023.	For more information consult the ECHA’s website here.

Interesting resources on the PIC Regulation on the ECHA’s website

OEHHA finalises changes to Prop 65 Short-Form Warning Regulations

On the 6^th of December 2024, the California Office of Environmental Health Hazard Assessment (OEHHA) published amendments to Proposition 65 (Prop 65) Article 6 “Clear and Reasonable Warnings” regulations for “short-form” warnings. Approved by the Office of Administrative Law (OAL) on the 26^th of November 2024, these amendments will take effect on the 1^st of January 2025.

Key revisions

Chemical Name Inclusion
The amendments require businesses to include at least one chemical name for each applicable endpoint (cancer and/or reproductive toxicity) in short-form warnings. This change promotes transparency for consumers by identifying the specific substances triggering the warning.
Transition Period
Businesses have until the 1^st of January 2028, to transition to the updated short-form warning requirements. This extended timeline allows sufficient time for label updates and compliance planning.
Unlimited Sell-Through Allowance
Products labelled with the existing short-form warnings before or during the transition period may continue to be sold indefinitely without the need for relabelling, ensuring minimal disruption to existing inventory.
Flexibility in Label Size and Warning Methods
Label size restrictions for short-form warnings have been removed. Businesses can now apply short-form warnings to any label size, provided the text remains at least 6-point font and is conspicuous.
Internet and Catalogue Warnings
Retailers must ensure Proposition 65 warnings for online sales are accessible both prior to purchase and before product exposure. A 60-day grace period allows for updates to online warnings upon receiving revised content from manufacturers.
Tailored Warnings
New tailored safe harbour warnings have been introduced for specific product categories, such as vehicle and recreational marine vessel parts, offering businesses compliance flexibility and clarity for these specialised products.

Resources and next steps

The OEHHA announcement as well as the final rule can be reviewed here.

Manufacturers, brands, and retailers are strongly encouraged to review these regulatory updates, evaluate their product lines, and begin implementing necessary changes within the transition period.

EPA amends TSCA rules for Deca-BDE and PIP(3:1)

On November 19^th , 2024, the US Environmental Protection Agency (EPA) published a final rule in the Federal Register to amend Subpart E of 40 CFR 751, related to the persistent, bioaccumulative, and toxic (PBT) chemicals regulations under Section 6 of the Toxic Substances Control Act (TSCA).

The final rule makes revisions to the rules for Deca-BDE and PIP(3:1) and will come into effect on January 21^st , 2025. Please see Table 1 below for a summary of the key revisions.

Table 1:

Substance	Revisions
Deca-BDE	Requires the use of personal protective equipment (PPE) during certain activities involving Deca-BDE. Prohibits the releases to water during manufacturing, processing, and distribution in commerce of Deca-BDE and Deca-BDE containing products. Extends the compliance date for the phase-out of processing and distribution in commerce of Deca-BDE-containing wire and cable insulation for nuclear power generation facilities. Requires export notification for Deca-BDE containing wire and cable for nuclear power generation facilities. Allows for unintentional amounts of Deca-BDE present in products and articles at concentrations less than 0.1% by weight. Extends record keeping from 3 years to 5 years .
PIP(3:1)	Requires the use of PPE for domestic manufacturing and processing of PIP(3:1) and certain PIP(3:1)-containing products and articles. Finalizes phaseouts on processing and distribution for certain uses. Excludes from the prohibitions on processing and distribution in commerce of PIP(3:1) for use in wire harnesses and electric circuit boards and for the processing and distribution in commerce of such PIP(3:1)-containing harnesses and circuit boards. Allows for distribution in commerce of new and replacement parts containing PIP(3:1). Allows unintentional amounts of PIP(3:1) present in products and articles at concentrations less than 0.1% by weight. Extends record keeping from 3 years to 5 years .

Sustainability, circular economy and environment

Miscellaneous technical publications relating to environmental, plastics, packaging and waste

The table below summarises the most recent publications regarding sustainability, the circular economy, and the environment (non-exhaustive):

Entity	Date	Publication
European Commission	22/11/2024	National Notification: 2024/0635/DK (Denmark) Draft Order on the entry into force of Section 2(3) to (6) and Section 6(5) and (6) of the Act on the taxation of CO2e-emissions from ETS sectors (the Emission Tax Act) It introduces a new tax on emitted CO2 for enterprises covered by the EU Emissions Trading System (EU ETS 1). The tax is DKK 375 per tonne of CO2 emitted for the enterprises covered by the EU Emissions Trading System (ETS I) and DKK 125 per tonne of CO2 emitted for mineralogical processes, etc.
European Parliament	26/11/2024	European Parliament published a press release indicating the environmental targets for the years to come with the aim of improving its environmental performance. For more information, consult the official publication in the European Parliament website here.
European Commission	06/12/2024	Publication of the Commission Implementing Regulation (EU) 2024/3084 of 4 December 2024 on the functioning of the information system pursuant to Regulation (EU) 2023/1115 of the European Parliament and of the Council on the making available on the Union market and the export from the Union of certain commodities and products associated with deforestation and forest degradation.
European Commission	10/12/2024	Publication of the COMMISSION STAFF WORKING DOCUMENT Simplification measures for farmers Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2021/2115 and (EU) 2021/2116 as regards good agricultural and environmental condition standards, schemes for climate, environment and animal welfare, amendments to CAP Strategic Plans, review of CAP Strategic Plans and exemptions from controls and penalties.
European Commission	12/12/2024	Publication of Regulation (EU) 2024/3015 of the European Parliament and of the Council of 27 November 2024 on prohibiting products made with forced labour on the Union market and amending Directive (EU) 2019/1937.
European Commission	23/12/2024	Publication of Regulation (EU) 2024/3234 of the European Parliament and of the Council of 19 December 2024 amending Regulation (EU) 2023/1115 as regards provisions relating to the date of application.