ECHA – Chromium (VI) restriction preparation: what you need to know · Chemicals, Webinars · ECHA – New ECHA chemical data availability system – Part ...
Rīga meeting brings together EMA, EEA, EU-OSHA, ECDC, ENISA, CEPOL, BEREC, ECHA ... chemical products, transportation, IT and cybersecurity solutions ...
Registration of chemical substances. Evaluation of the substances by the European Chemicals Agency (ECHA). Authorization for substances that are ...
The European Chemicals Agency (ECHA) has announced new testing of dozens of substances, including some used in cosmetics, personal care and fragrance.
The European Chemicals Agency (ECHA) has earmarked 13 substances for assessment due to their suspected harmful effects on health and the environment – ...
Dive Insight: This study, led by CLP's Center for the Circular Economy and the Closed Loop Foundation, is described as one of the most extensive ...
Final opinions from ECHA's scientific committees are expected in 2025, and a decision by the European Commission could follow soon thereafter. This ...
The European Chemicals Agency (ECHA) announced on February 26, 2025, that it has updated its annual statistics on evaluation progress.
This is the second year for implementation of our current strategy statement 2024-2028. Our vision, chemical safety through science, collaboration and knowledge, has informed the actions presented here and will continue to guide us as we deliver our strategy over the next four years. At the core of implementing our strategic goals is our legal mandate and the protection of health and the environment through our work on chemical safety. We will continue to implement our legal mandate by providing transparent, independent and high-quality scientific opinions and decisions, by collaborating with our EU institutional partners and Member States as well as industry and NGO stakeholders and by sharing and advancing knowledge and understanding on chemical safety.
Guidance for the application of the criteria covering effects on the aquatic compartment was developed by OECD and incorporated as Annexes 9 and 10 in the ‘Globally Harmonised System of classification and labelling of chemicals (UN GHS)’ (Fourth revised edition, 2011, https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev04/English/ST-SG-AC1030-Rev4e.pdf). The text in part 4, even more so in some of the Annexes to this chapter, is largely based on the text in UN GHS. The guidance given in Annexes 9 and 10 of UN GHS relates to substances, but not mixtures. Some parts have therefore been slightly revised to take into account recent developments and additional guidance documents provided by ECHA. Furthermore guidance on the classification of mixtures has been brought into this chapter as well as classification examples for both substances and mixtures.
Acute toxicity relates to effects occurring after a single or relatively brief exposure to a substance or mixture. The definition in CLP reflects the fact that the evidence for acute toxicity is usually obtained from animal testing. In particular, acute toxicity is usually characterised in terms of lethality and exposure times are based around those used in experimental protocols. However, classification for acute toxicity can also be based on human evidence which shows lethality following human exposure. There are different hazard classes covering effects after single or brief exposure – ‘Acute toxicity’ and ‘STOT-SE (Specific Target Organ Toxicity – Single Exposure)’, skin irritation/corrosion and eye damage. These are independent of each other and may all be assigned to a substance or a mixture if the respective criteria are met. However, care should be taken not to assign each class for the same effect, essentially giving a multiple classification, even where the criteria for different classes are fulfilled. In such a case the most appropriate (the most severe hazard) class should be assigned.
This new guidance series re-presents the ‘Parts’ of the Guidance on the Application of the CLP by presenting them as a series of separate documents for ease of use. Besides this overview document, this new CLP Guidance series contains as separate guidance documents: Part 1: General Principles for Classification and Labelling (Including Annex I: Collection of Internet links for the users of the Guidance) Part 2: Physical Hazards (Including Annex I: Relation between Transport and CLP classification regarding Physical Hazards) Part 3: Health Hazards (Including Annex I: Background document to the guidance for setting specific concentration limits for substances classified for reproductive toxicity according to Regulation (EC) No 1272/2008) Part 4: Environmental Hazards and Part 5: Additional Hazards (Including Annexes: I. Aquatic Toxicity II. Rapid Degradation III. Bioacumulation IV. Metals and Inorganic Metal Compounds
This document is a comprehensive technical and scientific guidance on the application of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures10, hereafter referred to as CLP.CLP amended the Dangerous Substance Directive 67/548/EEC (DSD), the Dangerous Preparations Directive 1999/45/EC (DPD) and Regulation (EC) No 1907/200613 (REACH), and repealed DSD and DPD from 1 June 2015 (CLP Article 61). CLP was implemented based on the United Nations’ Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS) without lowering the protection of human health and the environment, compared to the classification, labelling and packaging system in DSD and DPD. The implementation of GHS into CLP followed various declarations made by the Community to confirm its intention to contribute to GHS development and to implement GHS into EU law.A core principle of CLP is self-classification of a substance or mixture by the manufacturer, importer or downstream user (CLP Article 4(3) and Recital 17), which involves identification of the hazards of the substance or mixture followed by classification as a result of the comparison of the hazard information with the criteria in CLP. This guidance will enable industry to self-classify chemicals and to provide appropriate hazard communication information to the target populations potentially handling the substance or mixture or exposed to it. For substances of particular concern (carcinogens, mutagens, substances toxic for reproduction (CMRs) and respiratory sensitisers) or for other substances where EU-wide action is needed, CLP sets out a system for formal harmonisation of classifications at EU level
The purpose of this chapter is to give some general guidance with respect to the classification of physical hazards, the generation of test data and their interpretation. The general principles of the classification process are explained Part 1 section 1.1.3, so this section refers to physical hazard specificities. Test methods for physical hazards are referred to in each physical hazard class chapter of CLP. Most of these test methods can be found in the UN Manual of Tests and Criteria11 (UN-MTC), see the website http://www.unece.org/trans/danger/publi/manual/manual_e.html. A few of these test methods are contained in standards which are also referred to in CLP (see particularly flammable gases, oxidising gases and flammable liquids). When test results, based on other methods or standards (which are not referred to in CLP) are available, then these data may still be used, provided they are adequate for the purpose of hazard determination. Expert judgement is necessary to conclude whether there is sufficient documentation to assess the suitability of the test method used, and whether the test was carried out using an acceptable level of quality assurance and thus on the adequacy of such data for the purposes of classification according to CLP. Please note that in practice the physical hazards of a substance or mixture may differ from those shown by tests, e.g., in case of certain ammonium-nitrate-based compounds (explosive / oxidising properties) and certain halogenated hydrocarbons (flammable properties). Such experience must be taken into account for the purpose of classification (CLP, Article 12(a)). The information available or generated must be checked to determine if it is directly comparable to the respective hazard criteria and if it is, then it can be used to derive the classification immediately. Where the criteria cannot be directly applied to the available data, expert judgement should be used for the evaluation of the available information in a weight of evidence determination (CLP, Article 9(3) and CLP Annex I, section 1.1.1.).
AOB for the meeting of the Council (Environment) on 17 December 2024 Key issues in the targeted revision of the REACH Regulation Information from Sweden, supported by Denmark, Finland and Luxembourg
Fertilisers may contain contaminants/impurities or intentionally added substances of concern that can impact human health and the environment, e.g., through contamination of groundwater, surface water and drinking water, accumulation in crops or animal stock, etc. Such contaminants/impurities and intentionally added substances of concern are partly addressed in the new Fertilising Products Regulation (EU) 2019/1009 that sets requirements for the different categories of products. Not all potential contaminants/impurities or intentionally added substances of concern are indeed covered. In addition, the Fertilising Products Regulation does not cover fertilising products marketed under national rules. In case considered necessary to address certain identified risks for human health and/or the environment, the idea is to assess whether the REACH Regulation (Registration, Evaluation, Authorisation and restriction of Chemicals) could be used. Previous activities being carried out by the European Chemicals Agency (ECHA) in the field of fertilisers (e.g., preparation of the Annex XV dossier for the restriction of calcium cyanamide) have raised some questions on how a regulatory management option analysis (RMOA) and analysis of alternatives (AOA) could be best conducted. Under that context, The European Commission – Directorate General Environment commissioned this study to Arcadis and Arcadia International E.E.I.G. together with DHI and Michel Vander Straeten Consulting Services. The study has three separated but interlinked objectives: 1) To assess the presence of contaminants/impurities in fertilisers and to produce a pre-RMOA and a pre-Annex XV dossier for the ones presenting potential risks to human health and the environment (Task 1). 2) To identify potential fertilisers of concern as a result of the effects of their constituents or their degradation products on the environment, including contamination of natural resources, or on human health via the environment; and to assess the possibilities for substitution (Task 2); and 3) To assess the challenges of an analysis of alternatives for fertilisers (Task 3).
The general rule is that only one bridging principle can be applied per hazard class evaluated for the untested mixture. The ECHA Guidance on the application of the CLP criteria6 states that: “[..] only one bridging principle could be applied in the evaluation of a hazard class with the exception of aerosols, where a mixture classified based on another bridging principle is used in an aerosol container. However, different bridging principles may apply to different hazard classes [..]”. Due to the similarity requirements of the bridging principle ‘substantially similar mixtures’ for the composition of the two concerned mixtures i.e. identity of ingredients and concentrations any approach that leads to apply more than one bridging principle per hazard class cannot be implemented by duty holders and such approach constitutes a breach with existing rules for the bridging principle ‘substantially similar mixtures. For example, applying the bridging principle ‘dilution’ for a defined sub-set of ingredients from the mixture composition together with the bridging principle ‘substantially similar mixtures’ is not possible.
A company based in the EU/EEA who makes or imports candles (including wax melts) needs to be aware that they may have legal obligations under EU chemicals regulations, and they need to consider these obligations before they place the candles on the EU market. Candle products are chemical mixtures under the EU regulations REACH and CLP. If a candle is classified as hazardous based on the CLP criteria (due to an added fragrance, for example), then the candle must comply with both the REACH Regulation as well as all the requirements of the CLP Regulations before it is placed on the market.
This document is the Guidance on the Application of the CLP Criteria. It is a comprehensive technical and scientific document on the application of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP), which replaced the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD) in a staggered way. CLP is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and is implementing the provisions of the GHS within the EU. The objective of this document is to provide detailed guidance on the application of the CLP criteria for physical, health and environmental hazards. The guidance is developed to primarily assist manufacturers, importers and downstream users in applying the classification and labelling criteria, and it also includes practical examples. It is also assumed to be the guidance on classification and labelling for Competent Authorities in the Member States (MS CA), for the Commission services and the European Chemicals Agency (ECHA).
The present document gives an overview of the legal provisions covered by the harmonised enforcement projects coordinated by the Forum for Exchange of Information on Enforcement (the Forum). Its sole intention is to inform the interested parties on the various articles of the REACH, CLP, PIC, POPs and Biocidal Product Regulations covered up to now by the harmonised enforcement campaigns undertaken by the Forum. Those campaigns are projects adopted for execution by the Forum. There are 3 types of projects: REF-projects, BEF-projects and pilot projects. The main difference between the two types is that in principle all countries of the European Economic Area participate in REF-projects while this is not necessarily the case for pilot projects. An enforcement campaign is to be understood as inspecting duty holders to investigate if they comply with selected legal provisions and enforce compliance where necessary.
This document describes how to name and identify a substance under REACH and CLP. It is part of a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH and CLP Regulations. These documents cover detailed guidance for a range of essential REACH and CLP processes as well as for some specific scientific and/or technical methods that industry or authorities need to make use of under REACH and CLP.
This document describes how to name and identify a substance under REACH and CLP. It is part of a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH and CLP Regulations. These documents cover detailed guidance for a range of essential REACH and CLP processes as well as for some specific scientific and/or technical methods that industry or authorities need to make use of under REACH and CLP.
The present document gives an overview of the legal provisions covered by the harmonised enforcement projects coordinated by the Forum for Exchange of Information on Enforcement (the Forum). Its sole intention is to inform the interested parties on the various articles of the REACH, CLP, PIC, POPs and Biocidal Product Regulations covered up to now by the harmonised enforcement campaigns undertaken by the Forum. Those campaigns are projects adopted for execution by the Forum. There are 3 types of projects: REF-projects, BEF-projects and pilot projects. The main difference between the two types is that in principle all countries of the European Economic Area participate in REF-projects while this is not necessarily the case for pilot projects. An enforcement campaign is to be understood as inspecting duty holders to investigate if they comply with selected legal provisions and enforce compliance where necessary.