If you are a downstream user of a substance listed on the Authorisation List (Annex XIV) and are using it under an authorisation granted to a supplier further up your supply chain, you must notify ECHA of your use. Additionally, when using the substance, you must adhere to the conditions of the authorisation, which your supplier is required to outline in the safety data sheet.
To verify whether your use of an Annex XIV substance is authorized, follow these steps:
Check the Safety Data Sheet (SDS): The authorisation number is provided in the SDS that your supplier gives you.
Examine the Label: The authorisation number is also displayed on the substance or mixture label. It follows the format “REACH/x/x/x”.
Contact your Supplier: If you cannot find the authorisation number in either place, reach out to your supplier for confirmation.
You must notify ECHA within three months of the first delivery of the substance. This obligation starts after the authorisation decision is published in the Official Journal.
You need to submit the following information:
Your company’s identity
The authorization number
Contact information
You may also provide details about the typical annual volume and the number of staff using the substance. Additionally, you can include a brief description of your use and any involvement in potential substitution activities.
If the authorisation decision requires specific data, such as exposure information, you must attach a file to your notification by the deadline set in the decision.
Create Your Notification Dossier in IUCLID
Create an IUCLID dossier to notify your use to ECHA. You can do this on your local computer or use IUCLID on ECHA Cloud Services. IUCLID 6 on our Cloud Services is free and always up to date.
Submit Your Notification
You need an active REACH-IT account to submit your notification. Links to REACH-IT are on the right-hand side of this page.
Sign up in REACH-IT (skip this step if your company already has an account). Log into REACH-IT. From the Menu, select “Upload a IUCLID dossier” under “Downstream user notification of authorised uses.” Follow the submission wizard.
COMMISSION REGULATION (EU) 2024/1328 of 16 May 2024
Entry 70 of Annex XVII to Regulation (EC) No 1907/2006 is replaced by the following:
The substances shall not be placed on the market as a substance on its own, as a component of other substances, or in mixtures, if its concentration is equal to or greater than 0.1% by weight after June 6, 2026 (paragraph 1).
Additionally, the substance shall not be used as a solvent for the dry cleaning of textiles, leather, and fur after June 6, 2026 (paragraph 2).
By way of derogation (among others):
– For D4 and D5 in wash-off cosmetic products if it is in mixtures, it shall apply after January 31, 2020.
– For all cosmetic products other than those mentioned above, paragraph 1 shall apply after June 6, 2027.
– Paragraph 1 will take effect after June 6, 2031, for medical devices and their accessories.
– For medicinal products and for veterinary medicinal products, paragraph 1 shall apply after June 6, 2031.
– Regarding the use of D5 as a solvent in dry cleaning textiles, leather, and fur, paragraphs 1 and 2 will take effect after June 6, 2034.
European Parliament adopted new measures to make packaging more sustainable and reduce packaging waste in the EU.
The rules, which have been provisionally agreed on with the Council, include packaging reduction targets (5% by 2030, 10% by 2035 and 15% by 2040) and require EU countries to reduce, in particular, the amount of plastic packaging waste. To reduce unnecessary packaging, a maximum empty space ratio of 50% is set for grouped, transport and e-commerce packaging; manufacturers and importers will also have to ensure that the weight and volume of packaging are minimised.
Certain single use plastic packaging types will be banned from 1 January 2030. These include packaging for unprocessed fresh fruit and vegetables, packaging for foods and beverages filled and consumed in cafés and restaurants, individual portions (for e.g. condiments, sauces, creamer, sugar), accommodation miniature packaging for toiletry products and very lightweight plastic carrier bags (below 15 microns).
To prevent adverse health effects, the text includes a ban on the use of so called “forever chemicals” (per- and polyfluorinated alkyl substances or PFASs) above certain thresholds in food contact packaging.
The proposed regulation would set out provisionson sustainability (e.g. on substances of concern, recyclability, and mandatory recycled content and packaging minimisation); labelling, marking and information (e.g. on the material composition of packaging); obligationsfor economic operators (e.g. prohibition of certain packaging formats and setting reuse and refill targets); management of packaging and packaging waste (e.g. targets for packaging waste reduction and on deposit and return systems for single-use plastic beverage bottles and metal beverage containers); and green public procurement.
The European Commission has requested ECHA to broaden the scope of the REACH restriction proposal to cover at least 12 chromium (VI) substances.
Helsinki, 8 May 2024 – ECHA has received an updated mandate from the Commission to prepare a proposal for a possible restriction on chromium (VI) substances. This update complements the original request from September 2023, which focused on two entries currently listed on the REACH Authorisation List, namely chromium trioxide (entry 16) and chromic acids (entry 17).
The updated mandate now includes the chromium (VI) substances specified in entries 16 to 22 and 28 to 31 of the REACH Authorisation List. In addition, ECHA has been requested to consider in the restriction proposal other chromium (VI) substances not listed on the Authorisation List, in particular barium chromate (EC number 233-660-5). These substances may pose risks to workers and the public if used as substitutes for chromium (VI) substances subject to authorisation.
Given the wider scope, ECHA will submit the restriction proposal by 11 April 2025.
The essential use concept in EU legislation addressing chemicals is a framework designed to determine when the use of certain substances is necessary for societal needs. It aims to balance health, safety, and environmental concerns with societal demands. This concept entails identifying uses that are critical for health, safety, or societal functioning, while also assessing the availability of alternatives.
Through structured assessments, non-essential uses can be filtered out, simplifying regulatory processes and promoting the transition to safer alternatives. The implementation of this concept requires careful consideration of specific criteria and procedures within individual legislative frameworks to ensure its effectiveness and applicability across various sectors.
1. Use of a most harmful substance is necessary for health or safety for one or more of the following elements:
– Addressing sickness and comparable health issues;
– Sustaining basic conditions for human or animal life and health;
– Managing health crises and emergencies;
– Ensuring personal safety;
– Ensuring public safety.
2. Use of a most harmful substance is critical for the functioning of society for one or more of the following elements:
– Providing resources or services that must remain in service for society to function;
– Providing resources such as infrastructure and equipment to ensuredefence and security to society in the face of conventional, nonconventional and hybrid threats;
– Managing societal risks and impacts from natural crises and disasters;
– Protecting and restoring the natural environment;
– Performing scientific research and development;
– Protecting cultural heritage.
The European Commission has published six new legal acts under the Drinking Water Directive. These set out the framework for minimum hygiene requirements for materials and for the certification of products that come in contact with our drinking water.
This new regulatory framework includes:
European positive lists of starting substances, compositions and. constituents that are authorised for use in the manufacturing materials in contact with drinking water.
Risk assessment methodologies and information requirements for reviewing starting substances, compositions and constituents that could be added to the positive lists.
Administrative procedures for updating the positive lists.
At the end of 2025, economic operators and national authorities can start notifying ECHA. of their intentions to propose modifications to the European positive lists. From the end of 2026, they can start submitting to ECHA their applications to add new entries and to amend or remove existing entries from the European positive lists.
The chemicals strategy for sustainability towards a toxic-free environment (CSS) embraces two overarching goals of the chemicals legislation: preventing harm to people and the planet from hazardous chemicals and their toxic effects and supporting EU industry in the production of safe and sustainable chemicals.
As one of the CSS actions, the European Environment Agency (EEA), the European Chemicals Agency (ECHA) and the European Commission (EC) have developed an indicator framework on chemicals to support these goals. The aims of the framework are to monitor the drivers and impacts of chemical pollution and measure the effectiveness of chemicals legislation.
The framework has an online dashboard available here:
COMMISSION REGULATION (EU) 2024/858 (March 14, 2024) of European Parliament and Council Regulation 1223/2009/EC on styrene/acrylate copolymer, sodium styrene/acrylate copolymer, copper, copper colloid, hydroxyapatite, on the modification of gold, gold colloid, gold thioethylaminohyaluronic acid, acetyl heptapeptide-9 gold colloid, platinum, platinum colloid, acetyl tetrapeptide-17 platinum colloid and silver colloid nanomaterials in cosmetic products
The investigation of the Scientific Committee for Consumer Safety on the safety of nanomaterials in cosmetic products states that the aforementioned nanomaterials may pose a health risk to consumers if they are used in cosmetic products.
The latest update, the 21st Adaptation to Technical Progress (ATP) to the Classification, Labelling, and Packaging (CLP) Regulation, is now in effect. It introduces several significant changes to the existing regulations. This revision brings significant alterations to the classification and labeling of hazardous chemicals. The aim is to bolster safety measures and safeguard both human health and the environment.
Key highlights of the 21st ATP to CLP Regulation include:
Revised Classification Criteria: Updated criteria are introduced to ensure the classification of hazardous chemicals aligns with the latest scientific knowledge and international standards. These changes aim to enhance safety and consistency in chemical handling and management.
Harmonized Labeling Requirements: Changes to labeling requirements aim to provide clearer and more standardized information regarding chemical hazards. This facilitates safer handling and storage practices for individuals and businesses alike.
Updated Hazard Communication: Enhanced hazard communication is achieved through the introduction of new pictograms and hazard statements, improving the clarity and effectiveness of safety information on chemical products.
Annex VI Harmonized Classifications will be applicable in the EU (and Northern Ireland) starting from September 1st, 2025.
There is notable divergence between the EU and GB for the 28 substances added and 24 amended substances, posing challenges for companies trading in both markets in managing Safety Data Sheets and Labels.
If you have any inquiries or need assistance understanding the impact of the 21st ATP to CLP Regulation on your chemical management processes, feel free to contact us at ekotox@ekotox.sk.
COMMISSION REGULATION (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Genistein, Daidzein, Kojic Acid, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products
EU restricts vitamin A, alpha-arbutin and arbutin, Genistein, Daidzein, Kojic Acid, triclocarban and triclosan in cosmetics products
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