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
DIRECTIVE (EU) 2024/869 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 March 2024
amending Directive 2004/37/EC of the European Parliament and of the Council and Council Directive 98/24/EC as regards limit values for lead and its inorganic compounds and for diisocyanates.
Parliament has adopted new exposure limits for lead for the first time in forty years.
The amendment lowers the OEL and BEL values for lead and its inorganic compounds and introduces mandatory oil and BEL values for diisocyanates.
RICHTLINIE (EU) 2024/869 DES EUROPÄISCHEN PARLAMENTS UND DES RATES
vom 13. März 2024
zur Änderung der Richtlinie 2004/37/EG des Europäischen Parlaments und des Rates und der Richtlinie 98/24/EG des Rates hinsichtlich der Grenzwerte für Blei und seine anorganischen Verbindungen sowie für Diisocyanate
Das Europäische Parlament hat erstmals neue Expositionsgrenzwerte für Diisocyanate verabschiedet.
ECHA’s Enforcement Forum prepares a project to check if suppliers have notified hazardous chemical mixtures to the poison centres. The poison centre notifications allow appropriate emergency response.
The objective of the checks is to protect human health by enforcing the requirement that suppliers of chemicals notify information about hazardous mixtures to the national authorities. The national authorities make that information available to poison centres so that they can give advice to citizens or medical personnel in the event of an emergency. Poison centres must have correct information about hazardous mixtures to ensure that the emergency response is well informed and appropriate.
The inspectors will check that the notification has been submitted and verify labels of mixtures and – where needed – Safety Data Sheets. The exact scope of the checks will be defined in the coming months.
Inspections in this project will begin in January 2025 and continue for six months, with the project report to be published at the end of 2025.
Annex VIII of the CLP Regulation – as of 1 January 2024 all hazardous mixtures for industrial use only, placed on the EU market, must be notified in the harmonised format.
In the lead up to the second compliance date for industrial use mixtures, a small increase in industrial use only notifications was observed via the ECHA Submission portal. However, industrial use only notifications represent around 10% of all notifications covering consumer and professional use types.
Companies who have made their poison centre notification for industrial mixtures in a national format before 1 January 2024 must update their information in the harmonised format by 1 January 2025. The notification must be done immediately in the harmonised format if any changes are made to the mixture’s composition, product identifiers, classification (for health or physical hazards) or toxicological hazards.
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