Chemicals | Monthly bulletin | December 2025

Eurofins newsflash Chemical

Europe

EU Council postpones chemical labelling rules to 2028 to ease industry burden

On the 17^th of November 2025, the Council of the European Union officially adopted a mechanism delaying the implementation of key provisions in the Classification, Labelling and Packaging (CLP) Regulation until the 1^st of January 2028. This decision aims to provide businesses, particularly SMEs, with more time and legal certainty while maintaining high safety standards.

The postponed provisions include requirements for:

Relabelling and mandatory formatting
Advertisements and online/distance sales
Labelling of fuel pumps

The move is part of the “Omnibus VI” package, introduced by the European Commission in July 2025, which seeks to simplify EU chemical legislation without compromising consumer health or environmental protection.

The Council will continue negotiations on the second part of the Omnibus VI package, which includes further substantive changes to chemical regulations.

The legislative act, Regulation (EU) 2025/2439, was published in the EU Official Journal on the 3^rd of December 2025 and enter into force on the 23^rd of December 2025.

ECHA Releases Draft PFAS Use Mapping Ahead of SEAC consultation

On the 5^th of November 2025, The European Chemicals Agency (ECHA) has published a preliminary mapping of PFAS uses across 14 sectors, including textiles, cosmetics, medical devices, and electronics. This draft aims to help stakeholders prepare for the upcoming consultation on the SEAC draft opinion regarding PFAS restrictions, expected in March 2026. Updated mappings will follow after SEAC finalizes its evaluations later this year. Stakeholders are encouraged to review sector-specific details and provide input during the consultation phase.

For more details and to access the draft mapping, visit ECHA’s official website here.

EU Proposal Targets MCCPs as a persistent organic pollution

On the 21^st of November 2025, the European Commission opened a European initiative which would add medium-chain chlorinated paraffins (MCCPs) to the list of persistent organic pollutants under Regulation (EU) 2019/1021.

What this means:

MCCPs will be banned in substances, mixtures, and articles, with some temporary exemptions for specific uses (e.g., industrial or professional use, machinery, vehicles, medical devices, aerospace, defence).
Manufacturers must ensure MCCPs are not present above 0.1% by weight as unintentional trace contaminants.
The maximum duration of the exemptions should be five years, with the possibility to extend them for an additional period of five years, in accordance with the Convention.
Manufacturers, suppliers and importers will need to update compliance processes and documentation accordingly and provide downstream users with information on the presence of certain linear C14-17 chloroalkanes in in their products in accordance with Article 31 of Regulation (EU) 1907/2006 in the Safety Data Sheet.

This will impact sectors using MCCPs in PVC cables, coatings, adhesives, and sealants, and will require substitution over time.

The feedback period for this draft is open until the 19^th of December 2025, and the Commission adoption is planned for the second quarter of 2026.

For further details, please refer to the European Commission’s proposal here.

European Commission proposes new restrictions on long-chain perfluorocarboxylic acids

On the 21^st of November 2025, the European Commission announced a draft delegated regulation to amend Regulation (EU) 2019/1021 on persistent organic pollutants (POPs), introducing stricter controls on long-chain perfluorocarboxylic acids (C9–21 PFCAs), their salts, and related compounds. This initiative aligns EU legislation with the latest global commitments under the Stockholm Convention on POPs.

The proposed regulation will:

Add C9–21 PFCAs to Annex I, prohibiting their production, use, import, and export.
Establish trace contaminant limits in substances, mixtures, and articles:
- ≤025 mg/kg for PFCAs
- ≤26 mg/kg for related compounds.
- ≤ 10 mg/kg (0,001 % by weight) in a substance to be used as a transported isolated
Remove outdated exemptions and introduce limited derogations for semiconductor manufacturing until the 31^st December 2030.

Once adopted, the regulation will enter into force 20 days after publication in the Official Journal of the European Union, becoming directly applicable across all Member States.

The European Commission launched a public consultation which is open for feedback until the 19^th of December 2025. The Commission adoption is planned for the first quarter of 2026.

For complete information, check out the European initiative here.

EU opens public consultation on chlorpyrifos ban under POPs regulation

On the 21^st of November 2025, the European Commission launched a public feedback period on a draft delegated regulation to amend Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs). The proposed measure aims to include chlorpyrifos, a pesticide known for its persistence and harmful effects, in Annex I of the regulation, subjecting it to strict restrictions in line with the EU’s international commitments under the Stockholm Convention.

The initiative follows the recent decision to list chlorpyrifos under the Convention due to its ability to accumulate in the environment and pose significant risks to human health and ecosystems.

The Feedback period is from the 21^st of November until the 19^th of December 2025, and the Commission adoption is planned the first quarter of 2026.

The draft act and annex are available for download in European initiative website.

For more information and to give feedback, visit the European Commission’s official page here.

European Parliament and Council adopt the legislative package OSOA

As of the 13^th of November 2025, the European Union has taken a major step toward improving chemical safety and transparency with the adoption of the “One Substance, One Assessment” (OSOA) legislative package. This reform, proposed in December 2023, approved by the European Parliament on October 21^st and formally adopted by the Council on November 13th, aims to streamline chemical safety assessments across EU laws. The OSOA package is part of the EU Chemicals Strategy for Sustainability under the European Green Deal’s Zero Pollution Vision for 2050.

The main points of the Reform are:

Common data platform: a centralised database managed by ECHA will serve as a “one-stop shop” for chemical information, integrating data from over 70 EU laws. It will include details on hazards, environmental presence, emissions, uses, and safer alternatives.
Early risk detection: updated mechanisms will allow faster identification and response to emerging chemical risks.
Transparency and research sharing: companies must notify studies conducted for regulatory compliance, reducing duplication and improving public trust.
Enhanced agency cooperation: stronger collaboration between EU agencies such as ECHA, EFSA, EMA, and EEA to improve scientific and technical work and avoid overlaps.

The OSOA package consists of:

A regulation establishing the common data platform on chemicals.
A regulation and a directive improving cooperation and reallocating scientific and technical tasks among EU agencies.

The legislative acts will be published in the EU Official Journal and enter into force 20 days thereafter. The common data platform is expected to become operational within three years of entry into force.

EU Council adopts measures to simplify chemical regulations

On the 5^th of November, the Council of the European Union has approved a series of legislative updates designed to streamline chemical regulations, reduce compliance costs, and strengthen the competitiveness of the EU chemical sector. These measures form part of the European Commission’s sixth “omnibus” package, introduced in July 2025.

The adopted initiatives include:

Postponement of CLP Regulation: new classification, labelling, and packaging requirements will now apply from the 1^st of January 2028, giving businesses more time to adapt.
One Substance, One Assessment (OSOA): a framework to harmonise chemical safety evaluations, improve data sharing, and accelerate innovation in sustainable chemicals.
Detergents regulation update: enhancements to biodegradability standards and a ban on animal testing, agreed in June 2025.
Digital labelling for fertilising products: promoting transparency and reducing environmental impact through digital solutions.

These reforms aim to maintain high health and environmental standards while fostering innovation and sustainability. The proposals will now move to discussions with the European Parliament.

Find additional information on the Council of the European Union website here.

Standard updates

The table below summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

(*) Date of withdrawal: latest date by which national standards conflicting with a European Norm (EN) (and Harmonisation Document (HD) for the European Committee for Electrotechnical Standardisation (CENELEC)) must be withdrawn.

The European Committee for Standardisation (CEN)/CENELEC

Reference

Title

Date of withdrawal

(*)

Supersedes

EN 16128:2025

Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release

2026-04-30

EN 16128:2015

European initiatives related to hazardous chemicals

The table below summarises recent publications on European Commission initiatives and their status:

Date	Title
13/11/2025	Waste batteries - format to be used by national authorities reporting on collection and treatment This initiative will establish the formats to be used, to ensure uniform conditions for the reporting.
12/11/2025	Common data platform on chemicals – implementation plan and governance This initiative sets out: the governance for setting up and running the platform an implementation plan to populate it with chemicals data.
12/11/2025	Common data platform on chemicals – set up of the steering committee To manage that platform, the Commission must set up a steering committee responsible for advising on the development of a governance framework. This initiative sets up that steering committee.
12/11/2025	Selection of chemicals with the potential to contribute to emerging chemical risks Under the One Substance One Assessment package, an observatory for specific chemicals is established to contribute to knowledge building on emerging chemicals risks. The observatory will replace the current EU Observatory for Nanomaterials. This act lists several chemicals which are to be further scrutinised in the observatory so reliable information on the properties, safety, uses and market presence of those chemicals is obtained
12/11/2025	Chemicals classification & labelling – endocrine disruptors & persistent pollutants This is in line with the Commission's 'one substance, one assessment' chemicals assessment reform and is required under Article 37(7) of the CLP Regulation.

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
24/10/2025	The European Chemicals Agency (ECHA) and the European Union Aviation Safety Agency (EASA) have strengthened their partnership by signing an updated Memorandum of Cooperation. This renewed agreement underscores the agencies’ shared commitment to advancing sustainability, innovation, and safety across the aviation and chemical sectors.	For more information, consult the ECHA website here.
11/11/2025	ECHA Launches Updated SME Hub to Support Compliance with EU Chemical Legislation. This initiative is part of ECHA’s broader strategy to explore artificial intelligence in regulatory support, aiming to make compliance easier and more efficient for smaller companies.	For more details, visit ECHA’s SME hub on its official website here.
12/11/2025	Call for Evidence for Substances in Batteries regulation. The objective of this call is to gather information from relevant stakeholders to help ECHA identify substances of concern in batteries, including substances that hamper recycling of end-of-life batteries. Additional information is being collected on recycling technologies, emissions and exposures, substances that hamper recycling and substances used in batteries that have already been identified by ECHA.	For more information, consult the ECHA website here.
12/11/2025	Publication of screening report for RP-HP in articles. Assessment of the use of reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) in articles should be restricted in accordance with REACH Article 69(2).	For more information, consult the screening report here.
18/11/2025	ECHA Recommends Adding Four Substances to REACH Authorisation List. The European Chemicals Agency (ECHA) has recommended that the European Commission include four substances in the REACH Authorisation. Once listed, companies will need to apply for authorisation to continue using these substances. Substances Recommended for Authorisation are: Barium diboron tetraoxide S-(tricyclo[5.2.1.0²,⁶]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide Melamine	For more details, visit ECHA’s official website here.

Interesting resources on REACH Regulation on the ECHA’s website

Recent publications on 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
22/10/2025	Guidance on harmonised information relating to emergency health response –Annex VIII to CLP	For more information, consult the ECHA website here.
23/10/2025	Opinion - European Economic and Social Committee - Omnibus on chemicals The European Economic and Social Committee (EESC) has adopted its opinion on the European Commission’s latest proposals to simplify regulatory requirements for chemicals, cosmetics, and fertilising products. The initiative, known as the Omnibus VI, aims to reduce compliance burdens while maintaining high standards of health and environmental protection. The proposals include amendments to several key regulations, such as Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008, and Regulation (EC) No 1223/2009, focusing on clearer labelling rules, improved consumer communication, and streamlined procedures for industry.	For more information, consult the European Commission website here.

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

UK proposes adding three reproductive toxic substances to UK REACH authorization list

On the 4^th of November 2025, the UK Health and Safety Executive (HSE) has announced several proposals to include substances in the UK REACH Authorization List (Annex 14). This marks the first time the UK has proposed additions to the list since Brexit. The substances under consideration are:

REACH - Publication of HSE’s draft recommendation (2025) for Annex 14 (the Authorisation List)
Substance name	CAS Number	EC Number
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4[[2[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)	-	915-270-3
4,4’-bis(dimethylamino)-4”-(methylamino)trityl alcohol [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)],	561-41-1	209-218-2
2-ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5- dithia-4- stannatetradecanoate (DOTE)	15571- 58-1	239- 622-4
Reaction products of 1,3,4- thiadiazolidine-2,5-dithione, formaldehyde and 4- heptylphenol, branched and linear (RP-HP) [with ≥ 0.1% w/w 4-heptylphenol, branched and linear]	Representative identifiers include 1471311-26-8 and 93925-00-9	Representative identifiers include 939-460-0 and 300-298-5
Tetraethyllead	78-00-2	201-075-4

Once included, companies will need to apply for authorization to continue using these substances beyond the specified sunset dates.

The public consultation on this proposal is open until 4 February 2026.

Washington state adopts new PFAS restrictions and reporting requirements under updated Safer Products rule

On November 20^th, 2025, the Washington State Department of Ecology finalised amendments to Chapter 173-337 WAC – Safer Products Restrictions and Reporting, significantly expanding regulatory requirements related to per- and polyfluoroalkyl substances (PFAS) in consumer products. These updates introduce new restrictions, broaden reporting obligations, and clarify several key definitions as part of the state’s ongoing effort to reduce toxic chemicals in consumer goods.

Earlier PFAS restrictions and reporting requirements adopted in prior rulemakings remain in place, such as the restrictions on aftermarket stain- and water-resistance treatments, carpets, and rugs (for both indoor and outdoor use), which took effect on January 1^st, 2025, and the restrictions on leather and textile furniture and furnishings intended for indoor use which are due to take effect January 1^st, 2026. Reporting requirements for leather and textile furniture and furnishings intended for outdoor use came into force on January 1^st, 2024, with the first report due on January 31^st, 2025, with ongoing annual submissions thereafter.

New restrictions on products containing intentionally added PFAS

Under the revised rule, Washington adds three new product categories to the existing list of PFAS-restricted products. For these newly covered categories, manufacturers, suppliers, and retailers are prohibited from manufacturing, selling, or distributing certain consumer products in Washington if they contain intentionally added PFAS. These restrictions apply to the following product categories:

Apparel and accessories, excluding certain specialty PPE and extreme-use categories.
Automotive washes
Cleaning products

For these categories, the PFAS restrictions apply to products manufactured on or after January 1^st, 2027; products manufactured before that date may continue to be sold.

Expanded PFAS reporting requirements

In addition to the new restrictions, manufacturers must also report the intentional use of PFAS in nine additional product categories:

Apparel designed for extreme or long-term use
Footwear
Recreation and travel gear
Automotive waxes
Cookware and kitchen tools
Firefighting personal protective equipment
Floor waxes and polishes
Hard-surface sealers
Ski waxes

For these categories, manufacturers must file annual reports with the Washington State Department of Ecology detailing products manufactured on or after January 1^st, 2026, wherein PFAS are intentionally added. The first report is due by January 31^st, 2027, and annually thereafter.

Key revisions between the proposed and final rule

Following further analysis and consideration of feedback gathered during the public comment period, the Washington State Department of Ecology incorporated several important refinements before finalising the regulation:

De minimis threshold added: a total fluorine concentration above 50 ppm now triggers the presumption of intentionally added PFAS across all 12 regulated product categories.
Updated definitions: clarifications were made to the definitions of extreme and extended use apparel, cookware and kitchen supplies, and recreation and travel gear.
Clarified applicability for cleaning products: revisions were made to how restrictions apply to cleaning products and expemtions were further refined by:
- Defining the scope of “industrial” use, and
- Excluding pesticidal products that are not marketed as cleaning products.

Who is affected?

The amended rule applies to all entities involved in manufacturing, distributing, or selling the covered products within the state of Washington —including online and brick-and-mortar retailers. Businesses will need to evaluate their product lines to determine which items fall under the new restrictions or reporting requirements.

Important timeline for compliance

Existing PFAS obligations (unchanged):

January 1^st, 2024 – reporting began for leather and textile furniture and furnishings intended for outdoor use; first report due January 31^st, 2025, then annually by January 31^st.
January 1^st, 2025 – restrictions on aftermarket stain- and water-resistance treatments and on carpets and rugs (indoor and outdoor) took effect for products manufactured on or after this date.
January 1^st, 2026 – restrictions on leather and textile furniture and furnishings intended for indoor use take effect for products manufactured on or after this date.

New PFAS reporting obligations:

Companies should be aware of the following implementation deadlines:

November 20^th, 2025: rule officially adopted
December 21^st, 2025: rule becomes effective
January 1^st, 2026: coverage period begins for new PFAS reporting categories (extreme/extended-use apparel, footwear, gear for recreation and travel, automotive waxes, cookware and kitchen supplies, firefighting PPE, floor waxes and polishes, hard surface sealers, ski waxes).
January 31^st, 2027: first PFAS reporting submissions for these new categories due; thereafter, reports must be filed annually by January 31^st.

New PFAS restrictions:

January 1^st, 2027: PFAS restrictions take effect (for products manufactured on or after this date) for:
Apparel and accessories
Automotive washes
Cleaning products

Adopted Rule: 337_C1-5_c_RDS-6288-3ForFiling.pdf

EPA proposes major revisions to PFAS reporting rule under TSCA Section 8(a)(7)

On November 13^th, 2025, the U.S. Environmental Protection Agency (EPA) published a Proposed Rule to revise its October 2023 PFAS reporting and recordkeeping requirements under TSCA Section 8(a)(7) (40 CFR Part 705).

The proposal responds to extensive stakeholder concerns and implementation challenges and would significantly reduce reporting obligations, particularly for article importers, small businesses, and entities handling PFAS at low concentrations.

EPA estimates industrywide cost savings of $786–$843 million if the proposed changes are finalized.

Key proposed revisions

Provision	Current (2023 Final Rule)	Proposed Amendment (Nov 2025)
Imported Articles	Reporting required for PFAS in imported articles (2011–2022).	Full exemption for PFAS contained in imported articles.
De Minimis Threshold	No threshold; any PFAS triggers reporting.	0.1% de minimis exemption for PFAS in mixtures or articles.
R&D Activities	Not exempt.	PFAS manufactured/imported solely for research & development exempted.
Impurities & Byproducts	Impurities and certain byproducts required to be reported.	Exemption for impurities, non-isolated intermediates, and certain byproducts.
Submission Deadline	April 13–October 13, 2026 (with small article importer deadline of April 13, 2027).	Removes small importer deadline due to article exemption. New reporting window opens 60 days after final rule → remains open 3 months.

EPA states that these changes better align the rule with the TSCA standard requiring reporting of information that is “known to or reasonably ascertainable by” the manufacturer or importer.

Impact on industry

~127,000 article importers would be relieved of reporting obligations.
Companies would no longer need to obtain retrospective PFAS composition data from suppliers for the 2011–2022 lookback period.
Reduced need for testing, documentation review, and historical supply chain reconstruction.
Domestic PFAS manufacturers still must report processing and use information, including incorporation of PFAS into articles.

Public comment opportunities

EPA is seeking comment on:

The scope and legal basis of the imported article exemption.
Whether the proposed 1% de minimis threshold is appropriate (EPA requests input on alternatives, including 1%).
Whether EPA should add a production-volume threshold (e.g., 2,500 lbs/year), similar to TSCA Chemical Data Reporting (CDR).

Public comment deadline: December 29^th, 2025.

Next Steps for Regulated Entities

Review whether your organization may still have reporting obligations under the revised rule.
Prepare and submit comments supporting or opposing specific exemptions.
Monitor for EPA’s issuance of the Final Rule in 2026, which will trigger the 60‑day countdown to the revised submission window.
Ensure systems are ready to report via EPA’s Central Data Exchange (CDX) once the final rule is published.

Canada

Health Canada adds button/coin-battery products to CCPSA “Table 2”

On November 24^th, 2025, Health Canada formally updated Table 2 of its “General Prohibitions” process under the CCPSA to include consumer products containing button or coin batteries, as well as their packaging.

This change marks a major shift — it means that these battery-containing products and their packaging are now under active hazard review. While the update does not immediately prohibit sale or import, it triggers a formal comment period, after which Health Canada may impose restrictions under the general prohibition clauses of the CCPSA (sections 7(a) and 8(a)) if the hazard is confirmed.

With the November 24^th, 2025 update, Health Canada added:

Products that contain button or coin batteries (e.g., toys, gadgets, small electronics)
The packaging of those batteries

The key hazard identified: internal injury after ingestion (i.e., if a small battery is swallowed).

Health Canada has also identified performance criteria (i.e., safety standards) that may mitigate the hazard — if products meet those standards, risk may be considered sufficiently managed for:

Non-toy consumer products with button batteries: ANSI/UL 4200A-2023 (or equivalent)
Toys with button batteries: ASTM F963-23 — the widely used toy-safety standard.
Packaging of button/coin batteries: “child-resistant package” standards — e.g., reconciled Canadian or international standards such as CSA C22.2 No. 60086-4:19 or ISO 8317:2015 depending on package type.

The formal public comment period runs through to January 22^nd, 2026. Thereafter, Health Canada will decide whether to advance the hazard to Table 3 — which would trigger a full prohibition under CCPSA for non-compliant products.

Access the Consultation Document in the Government of Canada’s website here.