#CLP, #Omnibus, #Deregulation 

The Council of the European Union has approved “stop the clock” and postponed the entry into force of the provisions of the updated CLP Regulation to 1 January 2028. 

The Council of the European Union has approved “stop the clock” for the provisions arising from the Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024, amending the CLP Regulation. 

The new CLP regulations from 2024 include: 

• Labeling regulations 
• New label format 
• Advertising of chemical products 
• Distance selling rules / online sale 
• Requirements for refill stations 
• Distributor PCN obligations 

The regulations postpone all application dates until January 1, 2028. This means that the June 1, 2026, and January 1, 2027 deadlines will no longer apply, giving businesses more time to adapt to the changes, implement the appropriate deadlines, and utilize existing chemical product label stocks. 

The regulation is part of Omnibus VI, a comprehensive package of simplifications for existing regulations in the European Union. 

The legislative act will be published in the Official Journal of the EU in the coming days. 

Source: https://www.consilium.europa.eu/en/press/press-releases/2025/11/17/council-signs-off-postponing-rules-on-classification-labelling-and-packaging-of-chemicals-to-2028/  

Ekotox website: https://ekotox.eu/changes-to-the-clp-regulation-2024-2027-and-new-obligations/

#PCN #Guidance 

 ECHA has updated the guidance on hazardous mixtures notifications in the Poison Center Notification, which is available on their website. 

 The European Chemicals Agency has published on its website an updated guidance on harmonised information relating to emergency health response, in accordance with Annex VIII of Regulation (EC) No 1272/2009 on classification, labelling and packaging of substances and mixtures (CLP). 

This is the sixth edition of ECHA’s guidance.  

The guide is available on the website with the update date: October 2025. 

 Source: ECHA Guidance on Annex VIII to CLP  

Ekotox Website: https://ekotox.eu/reporting-hazardous-mixtures-to-echa/ 

#EUDR, #Simplification 

European Commission published a proposal to simplify the EUDR regulation, which will mainly include a reduction in obligations for micro and small enterprises and a 6-month transition period. 
The European Commission has presented a formal proposal to simplify the EU’s EUDR deforestation regulation. Simplification mainly covers 3 sectors: 

1. Reduction of obligations for micro and small enterprises 

As part of this new approach, micro and small entrepreneurs based in low-risk countries will no longer have to submit a full due diligence statement, but only a simplified statement, foldable only once. It will include: 

• Entity data 
• Product code 
• Description of wood products 
• Production volume on an annual scale 
• Geolocation of origin of the raw material. 

After submitting a simplified statement, entities will receive an identifier, which is a mandatory element to pass on in the supply chain.  

2. Limitation of obligations for downstream users 

Downstream users at the bottom of the supply chain do not need to submit new due diligence statements. They only need to use the identifier assigned by the previous entity in the supply chain to ensure the traceability of the goods. 

3. Changes in the dates of the regulations 

• The general principles of application of the EUDR remain unchanged and their implementation date is 30 December 2025.  

• Enforcement f the regulations will not take place until six months later – from mid-2026.  

• Small and micro entrepreneurs will be obliged to apply the EUDR regulations a year later – from December 2026. 

Simplifications are a proposal for the time being and have no legal force. 

What does it mean? 

If the proposal becomes legal, the first thing to do is to determine your position in the supply chain: whether you belong to a group of entrepreneurs: micro and small; whether to medium and large; whether you are a downstream user of the goods. Then check the implementation date and possible simplifications that will cover a specific group. 

Source: https://environment.ec.europa.eu/document/download/15e6d00c-28bc-48db-9b32-b485742d372b_en?filename…  

Ekotox website: https://ekotox.eu/products-contributing-to-deforestation/   

#REACH, #SME, #Fees 

The Commission published a regulation increasing the fees in REACH for large companies and changed the way the SME status is verified. From now on, 2 months before applying for registration of a substance, the SME status must be confirmed and is valid for only 3 years. 

On 16  October, the European Commission published COMMISSION IMPLEMENTING REGULATION (EU) 2025/2067 of 15 October 2025 amending Regulation (EC) No 340/2008 on fees and charges payable to the European Chemicals Agency under REACH.  

The content of the regulation introduces two changes: 

1. Fees for registering substances under REACH 

As part of the announced increase to equalise the inflation rate from 2021, fees paid to ECHA will increase by 19.5%. Micro, small and medium-sized enterprises that meet the criteria of SMEs will be exempt from the above fee increase. 

2. Verification of SME status 

The European Chemicals Agency is changing the way the status of a company’s size is verified. Companies that declare their company size as an SME must now apply for SME status with ECHA to benefit from lower registration fees before start to register their substance in REACH.  

Two months before submitting their registration documents to ECHA, companies must confirm the size of their company using an official document. Once they have applied for SME status, the European Chemicals Agency will issue a formal decision with a validity period of 3 years. If an application for SME status is rejected, ECHA may charge an administrative fee for processing the application. 

The changes come into force on February 5, 2027, so entrepreneurs have 15 months to prepare for the changes.  

What does it mean? 

Before applying for registration of a substance in REACH, you must apply for SME status 2 months before submitting the documents, which may affect the total time of the registration process for the substance. In addition, after 3 years, you must apply for the renewal of the company’s status as an SME. 

Source: https://eur-lex.europa.eu/eli/reg_impl/2025/2067/oj/eng 

Ekotox Website: https://ekotox.eu/reach-regulation/ 

# POPs, #Dechlorane, #Restriction 

From 15 October, new restrictions on the amount of Dechlorane Plus in substances, mixtures and articles are in force, due to their inclusion in the POPs regulation. 

Dechlorane Plus is a chlorine-based chemical compound used to reduce the flammability of materials in: adhesives, lubricants, tapes, plastics, insulation, cables, sealants.  

The European Chemicals Agency (ECHA) and the European Commission have decided to completely reduce the use of Dechlorane due to its bioaccumulation potential and toxicity. In September 2025, Regulation (EU) 2025/19301 amending the Persistent Organic Pollutants (POP) Regulation was published, which includes Dechloran Plus in Annex I. 

The entry in the annex prohibits its manufacture, use and placing on the market, with limited exceptions for critical applications such as: aerospace, defence, with an exception valid until February 2030. In addition, it sets limit values for concentrations and trace impurities in substances, mixtures and finished products. 

Dechlorane Plus may be present in substances, mixtures and articles: 

– from 15 October 2025 to 15 April 2028 in an amount of up to 1,000 mg/kg (0.1% by weight) 

– from 15 April 2028 in an amount of up to 1mg/kg (0.0001% by weight) 

What does this mean? 

The supply chain and the presence of Dechlorane Plus in mixtures and finished products should be assessed and the indicated limits should be followed. 

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501930  

Ekotox website: https://ekotox.eu/chemicals-management/  

#PFAS, #Restrictions, #REACH 

The European Commission has published a regulation on restrictions on the use of PFAS in firefighting foams. The regulation provides for appropriate transitional deadlines, imposes additional obligations on users of foams and fire extinguishers, and introduces additional requirements for the labelling of foams, fire extinguishers and wastewater. 

On 3rd October 2025 the European Commission published the legal act restricting the use of PFAS substances (perfluoroalkyl and polyfluoroalkyl substances). Commission Regulation (EU) 2025/1988 amends Annex XVII to REACH by restricting the use of PFAS substances in firefighting foams. 

According to the regulation, PFAS substances may not be placed on the market or used in extinguishing foams in a concentration equal to or greater than 1 mg/l, from 23 October 2030.  

The regulation enters into force 20 days after its publication (from 23 October 2025), but the restriction includes transitional periods ranging from 12 months to 10 years – depending on the situation.  

Dates of application: 

• until 23 October 2026 in extinguishing foams used in portable fire extinguishers; 

• until 23 April 2027 in extinguishing foams and alcohol-resistant foams in portable fire extinguishers; in fire extinguishers used for training and testing and fire extinguishers used by fire brigade units; 

• until 23 October 2035 in fire-fighting foams used in the military or civil sector; 

• until 31 December 2030 in portable fire extinguishers;  

Obligations of users: 

From 23 October 2026, a user using foams and fire extinguishers with PFAS substances in a concentration equal to or greater than 1 mg/l has additional obligations: 

• meets the conditions of the restrictions of the Regulation 

• uses foams only to extinguish fires of flammable liquids (fire class B) 

• reduces emissions and indirect exposure to a minimum 

• ensures the selective collection of foams, waste and wastewater from the use of foams 

• develops a management plan for foams and fire extinguishers containing PFAS 

• carry out an appropriate risk assessment 

The management plan shall be reviewed annually and kept for at least 15 years for making available to the competent authorities for control purposes upon request. 

Additional labelling: 

Fire extinguishers and foams containing PFAS must be labelled in the official languages of the Member States where the extinguishing foam is placed on the market, unless otherwise agreed by the Member States concerned. 

Both foams, fire extinguishers and wastewater must be appropriately labelled and contain the wording: “WARNING: Contains per- and polyfluoroalkyl substances (PFAS) with a concentration equal to or greater than 1 mg/l in relation to the sum of all PFAS”. This information must be marked in a visiable, legible and durable manner. 

Next steps: 

The European Commission plans to develop a single, universal restriction or piece of legislation on PFAS substances that would cover all uses of PFAS except for that used in firefighting foams. 

Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_2286  

Ekotox website: https://ekotox.eu/chemicals-management/  

#Medicines, #Pregnancy, #Paracetamol  

Due to the emergence of information about the impact of paracetamol use by pregnant women, and the risk of autism and ADHD in children, the European Medicines Agency has published an official statement in which it maintains that paracetamol is safe.  

In August 2025, a publication appeared that suggested the effect of the use of paracetamol by pregnant women on neurodevelopmental disorders and the occurrence of ADHD and autism in children. The publication considered the potential link between paracetamol use and the risk of autism in children, but made it clear that the evidence does not support that paracetamol causes autism. 

Source: https://ehjournal.biomedcentral.com/articles/10.1186/s12940-025-01208-0    

Due to growing social concern, the European Medicines Agency (EMA) published a statement confirming the safety of the use of paracetamol in pregnant women, as well as the lack of evidence of potential neurodevelopmental disorders. 

Historical outline and literature review: 

1. In 2019, the European Medicines Agency’s Committee for Risk Assessment assessed the potential negative effects of paracetamol on the urinary system, reproductive system and brain development. The evidence was found to be inconclusive to confirm the risk, however, updates to the information were recommended. 

Source: https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-12-15-march-2019-prac-meeting_en.pdf    

2. In 2022, the UK Medicines Commission reviewed the use of drugs used in pregnant women, including paracetamol. She stated that there was no need for changes or restrictions on the use of paracetamol, however, she introduced a warning about ibuprofen recommending that it should not be used because of the risk of heart and kidney disorders in children.  

Source: https://www.gov.uk/drug-safety-update/non-steroidal-anti-inflammatory-drugs-nsaids-potential-risks-following-prolonged-use-after-20-weeks-of-pregnancy   

3. In 2024, an analysis of births and data from the registries of 2.4 million children born in Sweden was carried out, in which more than 180 thousand children were exposed to paracetamol. There was no evidence that the use of the drug during pregnancy increases the risk of autism. 

Source: https://jamanetwork.com/journals/jama/fullarticle/2817406   

4. In February 2025, a global review of patients with a documented diagnosis of ADHD or autism was conducted. It was stated that there is no reason to worry.  

Source:https://journals.lww.com/greenjournal/abstract/2025/02000/acetaminophen_in_pregnancy_and_attention_deficit.8.aspx#ContentAccessOptions     

5. In September 2025, the European Medicines Agency will issue a communication on the safety of paracetamol in pregnant women. 

Source: https://www.ema.europa.eu/en/news/use-paracetamol-during-pregnancy-unchanged-eu#footnotes-79612    

#OECD, #Chemicals, #Data, #Supply chain, #REACH  

The OECD has developed a guide that sets out the rules for cooperation, data sharing and intellectual property for chemical industry and chemical operators. The guide can help stakeholders to prepare and submit data together, reduce animal testing and also reduce costs. 

On 25 September 2025, the Organisation for Economic Co-operation and Development (OECD) has published “Best Practice Guide on Chemical Data Sharing Between Companies”, which sets out the rules for cooperation in the exchange of information on chemical safety and intellectual property risks. 

The guide outlines case models for joint data generation, cost allocation in regulatory notifications, and model contracts between cooperating entities. The document suggests how animal testing or duplication of the same tests can be avoided.  

Best Practise Guide addresses data-sharing associated with regulatory compliance and meeting non-regulatory needs. It focuses specifically on industrial and consumer chemical management regulations. It does not encompass other sectors such as pharmaceuticals, pesticides, biocides, medical devices, cosmetic products, food additives, food packaging, or veterinary medicines. 

The content presents two overarching scenarios relevant to data ownership and usage rights: 

• Scenario 1: A party is legally required to either own, have access to, the right to refer to data (e.g. a 

full study report) or the right to use data (including summaries/robust study summaries of the data). 

• Scenario 2: A party is NOT legally required to either own, have access to, the right to refer to or the 

right to use data. 

The guide can help companies in terms of the conditions for cooperation between them when registering substances in REACH or in fulfilling the obligations imposed by EU regulations on chemicals. This can reduce the costs associated with registering substances or complying with regulations, as well as increasing the security and transparency of the supply chain.  

OECD document also addresses the issue of intellectual property, including data ownership and confidentiality. 

Source: https://www.oecd.org/en/publications/best-practice-guide-on-chemical-data-sharing-between-companies_c5f3c668-en.html  

Ekotox website: https://ekotox.eu/chemicals-management/  

#GHS, #CLP, #SDS 

A new GHS system has been in force since September 2025, which contains harmonized criteria for the classification of chemical substances and mixtures. 

The GHS (Globally Harmonized System of Classification and Labelling of Chemicals) is a standard developed by the United Nations to harmonize the classification and labeling of chemical substances. This system provides harmonised criteria for the classification of substances and mixtures according to health, environmental and physical hazards, as well as harmonised hazard communication elements, including labelling requirements. 

The global GHS is used as a basis for the development of international and national regulations for the transport of hazardous materials, and is also the starting point for Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (CLP). 

In December 2024, the United Nations adopted the 11th revision of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), which has been in force worldwide since September 2025.  

Version 11 of the GHS introduces: 

• provisions further clarifying the criteria for the classification of aerosols and pressurised chemicals (Chapter 2.3); 

• new guidelines for the classification of skin sensitisation using non-animal methods (Chapter 3.4); 

• the classification of hazardous substances and mixtures that contribute to global warming (Chapter 4.2);  

• a new section in Annex 11 providing guidance on the identification of simple asphyxiants. 

What does that mean? 

When working with non-EU or GHS operators, the update of the classification and labelling of chemicals should be taken into account. 

Source: https://unece.org/transport/dangerous-goods/ghs-rev11-2025   

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