The draft CoRAP contains 31 substances, including 13 new substances compared to the current CoRAP 2024-2026; 8 substances are being planned for evaluation in 2025, including two groups of 2 substances, 15 substances for evaluation in 2026 and 5 substances for evaluation in 2027. Three are proposed to be withdrawn.
Reaction mass of Octyl-3-[3- tert-butyl-4-hydroxy-5-(5- chloro-2H-benzotriazole-2- yl)phenyl]propionate and 2- Ethylhexyl-3-[3-tert-butyl-4- hydroxy-5-(5-chloro-2Hbenzotriazole-2- yl)phenyl]propionate
Summary of the REF-11 Project Report on Safety Data Sheets (SDS)
Executive Summary: The REF-11 project, conducted in 2023, aimed to assess compliance with the new requirements introduced by Regulation (EU) 2020/878 for Safety Data Sheets (SDS). The project involved inspections across 28 EU/EEA countries, covering 2528 SDS. The primary focus was on the completeness and quality of the information provided in the SDS, including new requirements for nanoforms, endocrine-disrupting properties, and specific concentration limits (SCL), acute toxicity estimates (ATE), and M-factors.
Key Findings:
Compliance: 87% of the SDS reviewed complied with the new format required by Regulation (EU) 2020/878. However, a non-compliance rate of 35% was reported, indicating room for improvement.
Nanoforms: 67% of the SDS requiring information on nanoforms did not provide it.
Endocrine Disruptors: 52% of the SDS for substances with endocrine-disrupting properties contained the required information.
SCL, ATE, M-factors: Compliance rates were 82% for SCL, 65% for ATE, and 79% for M-factors.
Specific concentration limits (SCL), multiplication factors for acute and chronic aquatic hazards (M-factors) and acute toxicity estimates (ATE) according to Regulation (EC) 1272/2008 (CLP Regulation)
Quality Issues: Common issues included incorrect or implausible information in sections 1, 2, 3, 8, and 9 of the SDS.
Enforcement Actions:
Measures: Enforcement measures included written advice (69%), administrative orders (11%), fines (11%), and criminal complaints (6%).
Follow-up: 59% of follow-up activities were completed during the operational phase.
Recommendations:
Dutyholders: Ensure SDS compliance with the latest requirements and improve understanding of SDS obligations.
ECHA/COM: Develop further Q&A and raise awareness among stakeholders, especially SMEs.
NEAs: Continue quality controls on SDS and organize awareness-raising measures.
Forum: Consider a follow-up project to monitor SDS quality improvements.
Graphs:
Compliance Rate for SDS Format:
Non-compliant SDS Identified Through Different Enforcement Projects:
The report highlights the need for ongoing efforts to improve the quality and compliance of SDS to ensure safe handling of hazardous substances and mixtures.
The CLP Regulation requires all supply chain entities to comply with the provisions of Annex VIII to the CLP Regulation when placing a hazardous mixture on the market. The recently revised Classification, Labelling and Packaging (CLP) Regulation clarifies distributors’ obligations to notify Poison Centers of mixtures classified as hazardous.
WHO?
Any entity that: modifies the product labeling; changes packaging or making confection; rebranding; sells the product at retail, including selling the product by the Internet.
WHAT TO DO?
Distributors must ensure that the hazardous mixture has been reported to the appropriate poison centre. The product must be notified in each Member State where the mixture is placed on the market. If the distributor has made sure that all the required information has been reported by upstream users in the supply chain, he is exempt from the obligation to provide the same information to the poison centre concerned.
WHAT IF NOT NOTIFIED?
If:
the hazardous mixture notification has not been submitted at all;
the mixture has not been declared in the Member State where the mixture is placed on the market;
the label contains new product identifiers, e.g. a different UFI code
Then:
The distributor must ask upstream users in the supply chain to make a new notification or update the existing one. He must provide the original notifier with all the necessary information to be included in the poison centre notification. A confirmation of notification or update by the notifier must be received to meet the ‘make sure’ requirement.
If the distributor does not have knowledge or confirmation that the mixture he is placing on the market has been correctly notified or updated, he must submit his own notification to the appropriate national poison centre.
In addition to the changes within the notification authorisation holders, the new CLP regulation clarifies that companies must update their notifications in the Poison Center and include all the information necessary to respond to health emergencies. These changes concern for example: contact details, changes in product classification, toxicological data in section 11 of the safety data sheet, as well as changes in the type of packaging or change in the EuPCS product category.
In 2025, the European Chemicals Agency is expected to publish guidelines on updating hazardous mixtures notifications at the Poison Center.
The revised Classification, Labelling and Packaging (CLP) regulation officially takes effect as of December 10, 2024, with the European Chemicals Agency (ECHA) urging companies to reassess their substance portfolios and update classifications where required.
– Simplified guidelines for classifying mixtures and substances with multiple components.
– Greater emphasis on grouping substances for harmonised classifications.
– Introduction of clearer hazard labels, including provisions for digital labelling.
– New requirements for the sale of chemicals at refill stations.
– Clarification on distributors’ obligations regarding poison centre notifications.
– The European Commission can now request harmonised classification proposals from ECHA or EFSA.
New Hazard Classes:
Hazard classes for endocrine disruptors, persistent and bioaccumulative substances (PBT/vPvB), and persistent, mobile, and toxic substances (PMT/vPvM) were introduced earlier. These are now considered hazards of highest concern and require companies to update their REACH dossiers or CLP notifications accordingly.
Guidance and Resources for Compliance:
ECHA provides resources to support companies, including:
Guidance on classifying substances like endocrine disruptors and PBT/vPvB substances.
Enforcement guidelines for mixture classification.
Webinars addressing new hazard classes.
Upcoming Resources in 2025:
Guidance on labelling and Annex VIII (poison centres).
Practical guides on grouping and read-across methods for classification.
Stakeholder workshops focusing on newly introduced hazard classes.
These changes aim to enhance hazard identification and improve communication on chemical risks, ensuring safer handling and use of hazardous substances across the EU.
We provide a selection of important information in the field of EU legislation on chemicals and products, chemical management:
PUBLICATION OF THE REVISION OF THE CLP REGULATION
Regulation (EU) No 2024/2865 amending the CLP Regulation was published in the Official Journal of the European Union (OJ 2024) on 20 November 2024.
This revision of the CLP Regulation brings the following improvements:
Update of the classification rules for substances
Addition of new hazard classes as priority classes for harmonised classification;
Case definition of complex substances (substances containing more than one constituent or ‘MOCS’);
Update of classification procedures: In addition to Member States and industry, the Commission will also have the right to prepare a dossier on the draft harmonised classification. This will make it possible to accelerate the pace of identification of the most hazardous substances;
Hazard Notification Update
Revised formatting requirements for labels (including online sales), including: minimum font size, line spacing;
Clarification of label update dates: no more than 6 months in case of stricter classification;
extending the use of fold-out labels and introducing voluntary digital labelling (except for the physical label);
Definition of new rules for bulk/refillable chemicals.
Other updates:
Clarification of the rules for online sales: websites will have to display dangerous properties of products.
It introduces the need for a European supplier to ensure that a substance or mixture meets the requirements of the CLP Regulation, so that consumers who shop online are no longer considered importers.
Explicit introduction of an obligation to inform the Poison Centre for distributors who change brands, brand modifiers or simply distributors who place on the market in another Member State.
The regulation will enter into force on 10 December 2024 and will apply within 18 months or 2 years, as the case may be.
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., MAĎARSKO
CENTRUL EKOTOX S.R.L. ROMANIA
Centrum Ekototoxiclogiczne Sp. z o.o., POĽSKO
Ecotoxicological Centre CZ s.r.o., CZECH REPUBLIC
ECOTOX CENTER UKRAINE, Ekotox Center Ukraine LLC., UKRAINE
Ekotoxicologické centrum Bratislava s.r.o., SLOVAKIA
The CLP Revision has been officially published as Regulation (EU) 2024/2865 in the Official Journal of the European Union. This amendment, dated 23 October 2024, updates the original Regulation (EC) No 1272/2008 on the classification, labelling, and packaging (CLP) of substances and mixtures.
Key changes include the introduction of new hazard classes, updates to criteria for classification, and enhanced requirements for labelling. These revisions aim to align with the latest scientific understanding and global standards, ensuring better protection of human health and the environment. The amendment also facilitates improved communication of hazards throughout supply chains.
The updated regulation affects manufacturers, importers, and downstream users of chemicals across the EU, requiring compliance with new provisions for classification and labelling. Companies must ensure timely adaptation of their processes to meet these updated requirements.
For further details, refer to the Official Journal of the EU.
The transitional period that allowed businesses to introduce hazardous mixtures based on notifications to the national poison centres in the non-harmonised system expires at the end of this year. After 31 December 2024, the notification of mixtures is no longer covered by the transitional period, and all hazardous mixtures placed on the EU market must be notified in the harmonised format in accordance with Annex VIII to the CLP Regulation.
This means that all manufacturers, importers and downstream users placing relevant mixtures on the market for consumer, professional and industrial use who have not yet notified their mixtures in the new European PCN system must immediately submit a notification in accordance with the requirements of Annex VIII (PCN) and include a unique formula identifier (UFI) on the label.
Inspections
ECHA’s published that “the Forum will also prioritise action to harmonise enforcement of new provisions that have fully entered into force. This includes the duties related to notification of information on hazardous mixtures to national appointed bodies and poison centres according to Annex VIII of the CLP Regulation, for which the transitional period ends in 2025.” – This means that PCN notifications and the information submitted may be checked by national inspections.
Know your obligations
Notifications need to be submitted by importers and downstream users placing mixtures classified for human health or physical hazards on the market.
If you do not know whether these obligations apply to you, you do not know what information to prepare and how to submit the notification – we will help you with the whole process of Poison Center Notification to be in compliance with legal requirements. https://ekotox.eu/ufi-pcn/
Conference “Chemical Management – REACH 2024” on October 15-16, 2024 in Bratislava.
What we took home from the REACH 2024 conference:
* Everyone is waiting for direction within the new Commission – chemical management is becoming an interdisciplinary issue regulated by different areas of EU legislation – like an eruption from the misty steam of a hidden volcano
* The simplification promised by the 2024-2029 policy guidelines could probably be possible, but “optimization” could work better. Optimization will require a lot of discussion, data/information, and a willingness to compromise
* The most commonly used words “uncertainty” and “competitiveness”
* Substances of very high concern (SVHCs) will be expanded to include “substances of high concern” = substances of concern < SoCs… and that “horse” will be managed by different groups / legislation and for different purposes…
* REACH 2.0 needed for everyone, expectations are high, it is not clear what will be in it – the need for speed
* The story of PFAS becomes difficult to understand and follow. It seems that the resources already used are not sufficient and much more will be needed, but is it well targeted and is it developing in the right direction?
* All players try to organize themselves to better cope with the challenges of the rapid changes that are coming. 1S1A is one of the very important pieces of the mosaic
* Battery regulation seeks to control all aspects of a single product group. That is very ambitious. Maybe in the right direction. But as we have heard, we are losing competitiveness, investment, dynamism…
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.
Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
The regulation will enter into force on the 20th of October 2024 and will be mandatory from the 1st of May 2026.
It introduces:
• 27 new entries with harmonized classification, • 16 modifications to the classifications of existing entries, • and the removal of 7 entries.
Some common chemicals, such as formaldehyde, formic acid, n-hexane, and hexyl salicylate, are affected by this ATP.
It is also worth noting that the classification of silver is now harmonized in three ways based on particle size. The Commission opted classification for reproductive toxicity Category 2, H361f.
The harmonized classification and labeling of hazardous substances is outlined in Regulation (EC) No 1272/2008, enacted by the European Parliament and Council on December 16, 2008, concerning the classification, labeling, and packaging of substances and mixtures (CLP). This classification is regularly updated through an “Adaptation to Technical Progress” (ATP). The latest update, known as the 21st ATP, was published on January 5, 2024, in the Official Journal of the European Union, titled “Commission Delegated Regulation (EU) 2024/197 of October 19, 2023, amending Regulation (EC) No 1272/2008 regarding the harmonized classification and labeling of certain substances.”
In the 21st ATP, the EU sanctioned a set of harmonized classification updates proposed between March and November 2021. This ATP introduces 28 new substances and includes 24 amendments, with no substances being deleted. Certain classifications feature specific M-factors, concentration limits, and substance ATE values as part of the comprehensive classification.
The ATP will come into effect on January 25, 2024; however, the new classifications will be applicable starting September 1, 2025. Suppliers may choose to classify, label, and package substances and mixtures according to the new classifications before this effective date.
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