Current issue of EkotoxInfo news
We provide a selection of important information in the field of EU legislation on chemicals and products, chemical management:
- “Stop-the-clock” CLP simplification package approved
- “One Substance, One Assessment” (OSOA) legislative package approved
- DBDPE added to the Candidate List
- REACH fees and changes the way SMEs are verified
- EUDR simplification proposal
- PCN guidance has been updated
- Ukraine REACH new deadlines
- “Stop-the-clock” CLP simplification package approved
‘Stop-the-clock’ legislation is the first part of the ‘Omnibus VI’ package submitted by the Commission in July 2025.
The newly adopted law provides more time and legal certainty to businesses. The new regulation also gives more time to the co-legislators to agree on the other substantive changes to the CLP regulation in the second part of the ‘Omnibus VI’ package, which is currently under negotiation and for which Council agreed on a mandate on 5 November 2025. The ‘stop-the-clock’ legislation postpones all the dates of application of transitional provisions for relabelling, mandatory formatting requirements, advertisements, online and distance sales, and labelling of fuel pumps to 1 January 2028.
Ekotox news webpages: https://ekotox.eu/news/new-deadlines-for-eu-clp-regulation-omnibus-vi/
Ekotox EU CLP webpages: https://ekotox.eu/clp-regulation/
- ‘One Substance, One Assessment’ (OSOA) legislative package approved
The Council formally adopted the legislative package on ‘one substance, one assessment’ (OSOA). The new rules streamline the EU’s approach to the assessment of chemicals and shorten the gap between the identification of a possible risk and the necessary regulatory action ultimately leading to better and faster protection of people’s health and the environment.
The package creates a new common data platform, to be managed by ECHA, that will serve as a one-stop shop for information on chemicals. It will integrate existing data from over 70 pieces of EU legislation, covering aspects such as hazards, physico-chemical properties, presence in the environment, emissions and uses. The platform will also include a database of safer alternatives to chemicals of concern, helping to promote a transition towards safer and more sustainable substances.
The new rules will also allow a more efficient use of the scientific expertise available in EU agencies by clarifying which agency is responsible for which scientific and technical tasks and improving cooperation between them, while avoiding overlaps.
The package consists of three legislative acts:
a regulation establishing a common data platform on chemicals
a regulation and a directive improving cooperation and reallocating scientific and technical tasks among the EU agencies active in the field of chemicals, including the European Chemicals Agency (ECHA)
More information: https://www.consilium.europa.eu/en/press/press-releases/2025/11/13/chemicals-council-greenlights-legislative-package-to-streamline-chemical-safety-assessments/
Ekotox EU REACH webpages: https://ekotox.eu/reach-regulation/
- DBDPE added to the Candidate List
ECHA has updated the Candidate List and added DBDPE, which may entail additional obligations for businesses.
The European Chemicals Agency has updated the Candidate List and added one substance:
1,1′-(ethane-1,2-diyl)bis[pentabromobenzene] (DBDPE) – CAS: 84852-53-9
identified as a substance of very high concern (SVHC). This substance is characterized by very persistent and highly bioaccumulative properties.
More information: https://echa.europa.eu/-/echa-adds-one-hazardous-chemical-to-the-candidate-list-2
Ekotox webpages Chemicals Management: https://ekotox.eu/chemicals-management/
- REACH fees and changes the way SMEs are verified
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.
More information: https://ekotox.eu/news/reach-fees-and-changes-the-way-smes-are-verified/
Ekotox EU REACH webpages: https://ekotox.eu/reach-regulation/
- EUDR simplification proposal
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.
More information: https://ekotox.eu/news/eudr-simplification-proposal/
- PCN guidance has been updated
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).
More information: https://ekotox.eu/news/pcn-guidance-has-been-updated/
- Ukraine REACH new deadlines
The regulation entered into force on 26 January 2025 and the provisional registration will last until 26 January 2027.
After that, the registration will have to be completed within the following deadlines, depending on the volume and hazard of the substance:
before October 1, 2028: CMR 1A and 1B substances (carcinogenic, mutagenic, toxic to reproduction) with a volume of ≥1 t/year, substances very toxic to aquatic organisms with a volume of more than 100 t/year.
before October 1, 2029: substances above 1,000 t/year.
before 1 June 2031: substances with a volume of 100-1 000 tonnes/year.
before 1 March 2033: substances with a volume of 1-100 tonnes/year.
More information: https://ekotox.eu/reach-in-ukarine/
EKOTOX CENTERS – a consultation and advisory group focused primarily on legal requirements on the EU market for products (products), mixtures and chemicals, hazard and risk assessment. We cover a wide range of regulatory areas to help our customers meet the specific requirements of their products in the EU market.
EKOTOX CENTERS:
Ekotox Hungary Kft., HUNGARY
CENTRUL EKOTOX S.R.L. ROMANIA
Centrum Ekotoksykologiczne Sp. z o.o., POLAND
Ecotoxicologické Centrum Bratislava s.r.o., SLOVAKIA
Ecotoxikologicke centrum CZ s.r.o., CZECH REPUBLIC
“ЕКОТОКС ЦЕНТР УКРАЇНА”, Ekotox Center Ukraine LLC., UKRAINE
Advisory support of EKOTOX CENTERS: https://ekotox.eu/
E-mail: ekotox@ekotox.eu
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