23rd Adaptation to technical and scientific progress (23rd ATP) to Regulation (EC) No 1272/2008 (CLP)

23rd Adaptation to technical and scientific progress (23rd ATP) to Regulation (EC) No 1272/2008 (CLP)

On June 20, the European Commission adopted Commission Delegated Regulation (EU) 2025/1222 of 2 April 2025 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances.

Link to EUR-lex: https://eur-lex.europa.eu/eli/reg_del/2025/1222/oj

It shall apply from 1 February 2027.

However, suppliers may classify, label and package substances and mixtures in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation from the date of entry into force of this Regulation.

In summary

– 22 new entries with an index number (α,α’-propylenedinitrilodi-o-cresol, ozone, dinitrogen oxide, barium chromate, 2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB], tetrahydrofurfuryl methacrylate, trimethyl phosphate, fluoroethylene and other.)

– 10 existing index number entries are replaced.

ECHA adds three hazardous chemicals to the Candidate List

The Candidate List of substances of very high concern (SVHC) now contains 250 entries for chemicals that can harm people or the environment. Companies are responsible for managing the risks of these chemicals and giving customers and consumers information on their safe use. 

Entries added to the Candidate List on 25 June 2025:

  • 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane
  • Decamethyltetrasiloxane
  • Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate; Reactive Brown 51

Link to ECHA News (ECHA/NR/25/20): https://echa.europa.eu/-/echa-adds-three-hazardous-chemicals-to-the-candidate-list#msdynmkt_trackingcontext=708f9ea9-76a9-4b19-8252-fdc024df0200

Ekotox CLP webpages: https://ekotox.eu/clp-regulation/

Ekotox SDS webpages: https://ekotox.eu/safety-data-sheet-sds/

Ekotox EU REACH webpages: https://ekotox.eu/reach-regulation/

REACH Conference 22-23.9.2025: https://ekotoxtraining.com/events/reach-conference-2025/

Project of Green Claims Directive can be withdrawn

Project of Green Claims Directive can be withdrawn

The European Commission is suggesting that the introduction of the Green Claims Directive should be withdrawn from the legislative trialogues. However, the main negotiators intend to continue their work with the hope of a successful conclusion and adoption of the directive. It is still unclear whether the decision to withdraw the proposal will be formally adopted, but it has already caused confusion.

Following the announcement of the European Green Deal, a study was conducted which found that more than half of the green claims in the European Union are misleading, and as many as 40% of the claims are used unfounded. In connection with the results ,in March 2023, a proposal was presented to unify the regulations on environmental claims and green marketing. The proposal included the introduction of minimum requirements for companies and entrepreneurs in the field of: justifying, communicating and verifying environmental claims, and obliged companies to ensure credibility by verifying and documenting the claims used. 

The draft of Green Claims Directive was aimed at combating unfair marketing called “greenwashing” by documenting and verifying environmental claims, as well as increasing the transparency of companies in communication with customers or protecting consumers against environmental misleading slogans.

Before starting negotiations, the Commission received a request to consider and withdraw a draft of directive which is an excessive burden on entrepreneurs and run counter to simplification of the rules and increase the competitiveness of European businesses. On Friday, 20.06.2025, a spokesperson for the Commission announced that “in the current situation, the Commission does indeed intend to withdraw the proposal for a directive”. The Commission did not confirm whether it would continue negotiations with the European Parliament and EU countries on this legislation, but added during the trilogue that “the European Parliament had not requested that the negotiations be stopped and would report on the next steps”.

We are therefore waiting for further information on the Green Claims Directive.

Ekotox website: https://ekotox.eu/

Controls of safety at work and chemicals export

Controls of safety at work and chemicals export

The Enforcement Forum sets out EU plans for the control of chemicals. At the June meeting, it was agreed that the future inspections under the REF-15 project will focus on workers safety. The Forum also agreed that the next pilot project will focus on the export of hazardous substances (PIC) from the EU.

On June 10-12, 2025, the ECHA’s Enforcement Forum, which is responsible for coordinating the enforcement of REACH, CLP, PIC, POP and biocidal products, had a meeting. At the meeting, another draft was agreed that sets out a programme for: the control of chemicals, their use and also export of chemicals from EU to third parties.   

Safety at work

The REF-15 project assumes combining the provisions of REACH and CLP with the regulations on occupational health and safety. The inspections will focus in particular on industrial and production companies, but not only. The inspections will take place in 2027-2028.

As part of occupational safety and health, inspectors will verify the following areas:

  • implementation of the principles of safe use of substances, specified in the safety data sheet
  • implementation of appropriate risk management measures in the workplace
  • REACH substance authorisation and required conditions to use authorised substances
  • REACH substance restrictions for which special conditions apply for use in the workplace

Export of chemicals

In addition, in 2026, the conditions for compliance with EU Regulation 649/2012 regarding the export and import of hazardous chemicals will be checked, including:

  • Are banned chemicals exported from the EU?
  • Is export reported in accordance with PIC regulations?
  • Has the export been approved by non-EU operators?

EKOTOX OFFER

If you want to prepare for the planned inspections, we offer an audit of the company, as part of which we will:

  1. Prepare a list of hazardous substances and mixtures
  2. Verify substances subject to restrictions or authorisations under REACH
  3. Verify the need to register your substance under REACH
  4. Check the compliance of the safety data sheets
  5. Check the compliance of the classification and labelling of chemicals in the company
  6. Determine the role of the entity in the supply chain
  7. Verify other areas in accordance with the individual needs of the company

You can contact us to receive more details about the audit.

ECHA website: https://echa.europa.eu/sl/-/next-eu-wide-reach-enforcement-project-on-safe-use-of-chemicals-in-workplaces#msdynmkt_trackingcontext=f99fc55e-d1d5-4313-a5b6-11ce22080300
Ekotox website: https://ekotox.eu/chemicals-management/

Amendments to the annexes to the Cosmetics Regulation

Amendments to the annexes to the Cosmetics Regulation

The European Commission has presented another proposal to amend the annexes of the Cosmetics Regulation 1223/2009 as part of the Omnibus programme, which proposes amendments to the annexes II, III, IV, V. The amendment implements the opinions of the SCCS Committee on the safety of cosmetic ingredients and also implements Delegated Regulation (EU) 2024/2564 on substances classified as CMR.

On 21 May 2025, the European Commission published a proposal for Omnibus VIII to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. The amendment takes into account the latest opinions of the Scientific Committee on Consumer Safety (SCCS) on the safety of individual cosmetic ingredients and their concentration limits for use in different product types. In addition, the amendment implements substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) contained in Delegated Regulation (EU) 2024/2564.

The proposed changes include:

  1. Annex II – prohibition of the use of another 15 cosmetic ingredients.
  2. Annex III – restrictions on the use of silver (CAS: 7440-22-4) and hexyl salicylate (CAS: 6259-76-3).
  3. Annex IV – inclusion of silver powder (CAS: 7440-22-4) as a colouring agent, permitted for use only in lip and eye shadow products, with an appropriate concentration level of 0.2%.
  4. Annex V – update of the list of permitted preservatives.

The draft is a proposal, so it is not yet a binding legal act. However, the proposal assumes that the regulation will apply from 1 May 2026, which in practice means that cosmetic products that do not meet the requirements cannot be sold on the EU market.

Entrepreneurs can already prepare for the proposed changes and:

  • Verify the composition of cosmetic products and their compliance with the proposed changes.
  • Plan the modification of the composition and take into account the time for updating: the product tests, its documents, notification in the CPNP and the label.
  • Plan to sell out by May 1, 2026 to minimize disposal of non-compliant products.

European Comission Drafts: https://docs.wto.org/dol2fe/Pages/FE_Search/ExportFile.aspx?id=315611&filename=2025/TBT/EEC/25_03493_01_e.pdf&Open=True

https://docs.wto.org/dol2fe/Pages/FE_Search/ExportFile.aspx?id=315611&filename=2025/TBT/EEC/25_03493_00_e.pdf&Open=True
Ekotox website: https://ekotox.eu/cosmetics-2/

CLP simplification meeting

CLP simplification meeting

The European Commission held a meeting on CLP regulation simplification to reduce burdens on companies, especially SMEs. Topics included label changes, digitalisation, simplification of advertising, and notification processes. Submitted comments will be used to prepare a report for further decision-making.

As part of the EU simplification package (Omnibus package), the European Commission is taking action also for the chemical sector, which aims to reduce the regulatory burden on businesses and administrations. Simplification measures are intended to benefit small and medium-sized enterprises (SMEs) by reducing their compliance burden.

On May 16, 2025, the European Commission organized a meeting to discuss potential simplifications of the requirements imposed by the new CLP Regulation [Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.] The Commission has invited industry, NGOs and all interested parties to discuss and submit their comments and proposals for simplification of the CLP Regulation.

The participants of the meeting raised the following issues:

  • New label formatting – it was pointed out that font size and mandatory space are difficult to use with a limited label or packaging size. These requirements are associated with additional costs of creating more expensive labels, larger packaging, and thus generating more waste.
  • Digitization of information – some participants supported the replacement of information on labels with QR codes. The issue of extending the legal basis for digital labelling was also discussed.
  • Simplification of information for professional products – it was indicated that most of the necessary information is included in safety data sheets, which are made available to professional users.
  • Information included in advertisements and marketing materials – difficulties in including all information about the danger in marketing materials and the possible overwhelming of the consumer with the amount of information were indicated. The generic sentence was suggested: “Always follow the instructions and information on the product label.”
  • Clarification of key definitions – in particular “placing on the market” and “making available on the market”.
  • Improvements to notification processes – the issues of notification to the (PCN) poison centre and the harmonised classification and labelling process for (CLH) were addressed.
  • Caution in the classification of mixtures – it has been pointed out that expert judgement and the weight of evidence may lead to disproportionate classifications. 
  • The level of safety – it was indicated that simplifications must not reduce the level of safety of consumers and employees.
  • Stop the time of mandatory implementation of the new provisions of Regulation (EU) 2024/2865.

After the meeting, written comments were asked to be sent by the end of May. The European Commission will now prepare a report that will form the basis for further political decisions.

Meeting notes: https://circabc.europa.eu/rest/download/1baa8979-3a3d-4bcf-ac80-89e8afad17ee?ticket=
New CLP requirements: https://ekotox.eu/changes-to-the-clp-regulation-2024-2027-and-new-obligations/

EkotoxInfo 2025 

EkotoxInfo 2025 

Current issue of EkotoxInfo news  

We provide a selection of important information in the field of EU legislation on chemicals and products, chemical management: 

“Chemical Management – REACH Conference 2025” will be held in Katowice, Poland on September 22 – 23, 2025. 

Agenda: 
  • Detergent Regulation revision 
  • REACH 2.0 
  • New CLP regulation in EU 
  • Ukrainian REACH and CLP 
  • New Customs Reform 
  • Product safety and safe use of chemicals 

“Chemical Management – REACH Conference 2025”  

Katowice, Poland, 22 – 23 September 2025. 

Ekotox Centers in collaboration with DUCC partner, would like to invite You to our REACH Conference 2025, which will be held in Poland 22 – 23th of September 2025. 

The REACH Conference is an event that brings together representatives of business, industry organizations, institutions, inspections, science and non-governmental organizations in one place. This is a great opportunity to discuss, share observations and knowledge, view chemicals management issues in an increasingly regulated environment from different perspectives.  

At this year’s conference, we plan to discuss topics concerning:  

  • Revision of the REACH 2.0 Regulation  
  • New requirements and update of the CLP Regulation  
  • Detergents Regulation revision  
  • New regulations in Ukraine – REACH and CLP  
  • General consumer product safety – GPSR  
  • Customs reforms  

  and other topics related to the management and safety of chemicals.   

More information with the registration form can be found on our website:  https://ekotoxtraining.com/events/reach-conference-2025

Detergent Regulation revision 

The ongoing revision is expected to end with the publication of a legal act, scheduled for the end of June. The proposals for the act include: 

  • biodegradation tests of detergent ingredients, 
  • regulations on cleaning products based on microorganisms, 
  • changes in phosphorus limits, 
  • introduction of a digital product passport, 
  • introduction of changes in product dosing, 
  • notification of all detergent products to the PCN database, 
  • appointment of the Only Representative in the EU. 

At the REACH 2025 Conference, we will discuss the published content of the Detergents Regulation Revision, how the changes will affect detergent products, and look at the additional obligations for entrepreneurs. 

REACH 2.0 

Currently, work is underway to revise the REACH 2.0 regulation, which is planned to be completed by the end of 2025, but proposals for the content of the legal act are expected to appear September this year. It is suggested that the revision will bring: 

  • introduction of the Mixture Allocation Factor, 
  • registration of polymers over 1 tonne per year, 
  • introduction of rules for grouping substances, 
  • changes in safety data sheets, 
  • Provision of information on SVHCs in articles 
  • changes to authorisation and restriction process. 

During the REACH 2025 Conference, our experts will present the proposed suggestions and discuss their effects on the chemical industry. 

New CLP regulation in EU 

During the REACH 2025 conference, we will summarise the latest changes and obligations resulting from the update of the CLP Regulation, including: 

  • new label format, 
  • distance sales and product advertising, 
  • new CLP hazard classes, 
  • general obligations for distributors. 

Ukrainian REACH and CLP 

In connection with the introduction of the new chemical law in Ukraine, all entities introducing substances and products to the Ukrainian market have new obligations. At the REACH 2025 Conference, we will introduce the subject of the new regulations, discuss new obligations for European entrepreneurs doing business in Ukraine, and look at the system of notifications of substances and mixtures and its status.  

New Customs Reform 

A representative of the Customs Office will present the new regulatory program regarding the reform of customs regulations and strengthening the control of chemical goods at the border.  

Product safety and safe use of chemicals 

Representatives of control authorities from various European Union countries will talk about the safety of chemical products, as well as raise issues related to the GPSR regulation. 


Sounds interesting? Join our REACH 2025 Conference and find out about the upcoming changes in legal regulations. Stay up to date, prepare your business to meet all requirements and stay ahead of the competition. Meet with representatives of the control bodies, ask them direct questions, take part in the discussion and connect with the people from chemical sector.  

Participation in the event is possible both stationary and online.  

https://ekotoxtraining.com/events/reach-conference-2025

New simplification package

New simplification package

The European Commission has proposed a new package of proposals to simplify EU rules, boost competitiveness, and unlock additional investment capacity. This is a continuation of the European Union’s activities as part of the implementation of a package of simplifications called “Simplifying the Single Market”.

This proposal is called the fourth simplification Omnibus package and include:

  • two-year postponement of implementation of new Battery Regulation requirements,
  • simplification of the rules for small businesses that import or export products containing fluorinated greenhouse gases,
  • digitalization of paper documents to provide product information in digital form,
  • reduction of data obligations for small and medium enterprises – General Data Protection Regulation,
  • introduction a new category for small mid-caps.

The previous 3 Omnibuses introduced changes and simplifications i.e.:

  • in sustainability reporting – remove a lot of SMEs companies from the scope of CSRD reporting and postpone reporting by 2 years,
  • in the carbon border adjustment mechanism (CBAM) – exempt small importers from CBAM obligations and simplify the rules for companies that remain in CBAM scope.

The next simplification package is planned for June 2025 and will focus on defence.

More information: https://commission.europa.eu/news/simplification-measures-save-eu-businesses-eu400-million-annually-2025-05-21_en

Catalogue of Borderline Cases Between Articles and Substances/Mixtures

Catalogue of Borderline Cases Between Articles and Substances/Mixtures

European Chemicals Agency (ECHA)

The Catalogue of Borderline Cases Between Articles and Substances/Mixtures, published by the European Chemicals Agency (ECHA), is a practical tool designed to support stakeholders in correctly classifying products under the REACH Regulation. This classification — whether as an article or a substance/mixture — is crucial in determining the applicable legal obligations.

Purpose and scope

The catalogue aims to assist authorities, manufacturers, importers, and downstream users in evaluating products that are challenging to classify. By providing a collection of agreed-upon cases, it offers clarity on how to apply REACH definitions in practice. The document is considered a “living” resource, intended to be updated periodically as new cases are assessed and consensus is reached among the members of the Borderline Working Group (BWG).

Key features

  • Case studies: The catalogue presents real-world examples of products with detailed reasoning for their classification as either articles or substances/mixtures.
  • Decision criteria: It outlines the factors considered in determining the classification, such as the product’s function, shape, surface, and design, which are pivotal in defining an article under REACH.
  • Regulatory guidance: By illustrating how specific cases are assessed, the catalogue aids stakeholders in understanding their obligations, including registration, notification, and communication duties under REACH.

Example for an “agreed case”: Coated electronic wax candle

Scenario: An electronic wax candle is a battery-operated device designed to simulate a real candle’s appearance and flickering light. The body is typically made of molded wax to resemble real candle material. It may also be coated or infused with fragrance (e.g., scented wax layer).

Classification challenge: Determining whether the wax (especially if scented or containing additives) should be classified as an integral part of the article or a mixture intentionally released from the article.

ECHA’s Assessment:

  • The electronic candle itself is clearly an article, as it has a defined shape, surface, and design that determines its function—to emit light and simulate a candle.
  • The wax coating, though composed of a mixture (waxes, pigments, and possibly fragrances), is shaped and solidified to maintain the candle-like appearance. In this context, the wax also qualifies as part of the article.
  • If the candle is scented, the fragrance is a mixture intentionally added to impart smell during use (passive release through evaporation).

Conclusion: The electronic wax candle is classified as an article that may contain a substance/mixture (e.g., fragrance). The primary function of the candle is decorative and for lighting simulation. The fragrance is a secondary function that could trigger REACH obligations if released.

Regulatory implications:

·   If the fragrance substances meet the criteria of Substances of Very High Concern (SVHC) and are present in concentrations above 0.1% w/w, then notification obligations under REACH Article 7(2) may apply.

·   If the fragrance is intentionally released, REACH Article 7(1) may also be relevant, and registration of the fragrance substances could be required.

This case exemplifies the importance of assessing both the primary function of a product and the purpose to determine the correct classification under REACH. Proper classification ensures compliance with regulatory obligations and promotes the safe use of chemical substances in consumer products.

ECHA | Catalogue of borderline cases between articles and substances/mixtures

Ekotox REACH webpage: https://ekotox.eu/reach-regulation/
Ekotox GPSR webpage: https://ekotox.eu/eu-general-product-safety-regulation-gpsr-strengthening-consumer-protection-in-a-digital-market/

Synthetic Polymer Microparticles (SPMs)

Synthetic Polymer Microparticles (SPMs)

The European Union (EU) has recently adopted a restriction regulating Synthetic Polymer Microparticles (SPMs) intentionally added to products under the EU chemical legislation REACH.

Entry 78 of Annex XVII REACH: https://echa.europa.eu/documents/10162/a5eaa862-fa4d-2e18-f5a5-3bda98e09ee7

The  aim of this restriction is to prevent the release of SPMs into the environment .

This restriction prohibits the sale of SPMs as such, as well as of products to which SPMs have been intentionally added. Where justified, derogations apply to  users of SPMs  affected by these new rules.

Although derogations for SPMs users exist, reporting obligations to both  clients and  authorities are still required.

European Commission published Explanatory Guide

The purpose of the Explanatory Guide is to explain the provisions and facilitate the implementation of entry 78 of Annex XVII of REACH (as introduced by Commission Regulation (EU) 2023/2055) restricting synthetic polymer microparticles (commonly known as “the microplastics restriction”).

The document includes a narrative part (Part I), a set of ‘questions and answers’ (Q&As) (Part II) and several Annexes (Part III) with workflows and illustrative examples.

Part II compiles  responses (in the form of Q&As) provided to Member States and stakeholders during the 5 ½ year-long process leading up to the adoption of the restriction on 25 September 2023,  as well as the 3 months following its adoption.

The document was prepared by the Commission´s technical services in consultation with the European Chemicals Agency (ECHA) and the Member States. As such, it does not necessarily represent the views of the European Commission.

It has been endorsed by Member States by consensus, except  on the issue of whether the  articles with glitter affixed on their surface  fall within the scope of the restriction (see Part I, Section 5; Part II, Q&A 2.25, 17.2, 17.6, 17.7, 17.8, 19.1, 19.3; Part III, Annex 3, A3.3), where AT, BE, DE and NL expressed the position that the restriction applies to glitter not permanently affixed on the surface of articles.

Explanatory Guide: https://webgate.ec.europa.eu/circabc-ewpp/d/d/workspace/SpacesStore/a4b3c599-db77-4210-8ca1-430e88c59bb1/file.bin
Ekotox Chemicals Management webpages: https://ekotox.eu/chemicals-management/
REACH Conference 2025: https://ekotoxtraining.com/events/reach-conference-2025/

ECHA Proposes Restrictions on Chromium(VI) Compounds to Protect Health

ECHA Proposes Restrictions on Chromium(VI) Compounds to Protect Health

ECHA/NR/25/11

The European Chemicals Agency brings forward a proposal for an EU-wide restriction on certain hexavalent chromium, Cr(VI), substances. The aim is to reduce the harmful effects of these carcinogenic chemicals for both workers and the public.

Helsinki, 29 April 2025 – At the request of the European Commission, ECHA has assessed the risks posed by certain Cr(VI) substances to workers and the public as well as the socio-economic impacts of potential restrictions.

The Agency concluded that an EU-wide restriction is justified as Cr(VI) substances are among the most potent workplace carcinogens and pose a serious risk to workers’ health. People living near industrial sites that release these substances into the environment are also at risk of lung and intestinal cancers.

ECHA proposes to introduce a ban on Cr(VI) substances, except in the following use categories when they meet defined limits for worker exposure and environmental emissions:

  1. Formulation of mixtures
  2. Electroplating on plastic substrate
  3. Electroplating on metal substrate 
  4. Use of primers and other slurries
  5. Other surface treatment
  6. Functional additives/process aids

Chromium(VI) compounds are known carcinogens and pose severe risks to respiratory health, skin, and internal organs, especially in workplaces with prolonged exposure.

Industry Impact

These proposed restrictions will significantly affect sectors such as:

  • Metallurgy & Surface Treatment:
    Use in electroplating and metal finishing.
  • Paints & Pigments:
    Use as pigment components in coatings.
  • Aerospace & Automotive:
    Use in part manufacturing and corrosion protection.

Companies using Chromium(VI) should begin reviewing their supply chains and identifying safer alternatives.

Ekotox Chemicals Management webpage: https://ekotox.eu/chemicals-management/
REACH Conference 2025: https://ekotoxtraining.com/events/reach-conference-2025/