CEC05-03 EU Legislations where Regulatory Toxicology is applied: The CLP Example (Theoretical lecture)

The Classification, Labelling and Packaging (CLP) Regulation is based on the United Nations’ Globally Harmonised System (GHS). CLP ensures that the hazards of chemicals, recognised via the classification process, are clearly communicated, once placed on the market, to workers and consumers throughout the supply chain in the European Union, regardless their quantity. Manufacturers, importers or downstream users have to (self)classify and label hazardous substances and mixtures based on the identified hazards thereof. Hazards are identified by comparing all available data on hazard information with the explicit criteria laid down in CLP. If no data are available, tests should be performed according the REACH Regulation, the OECD principles and any internationally recognised and validated methods. Any new animal tests required, should comply with the provisions for the protection of laboratory animals (Directive 2010/63/EU). Alternative methods are being developed to replace the use of animals, reduce the number of animals in a test, or refine the procedures to make them less painful or stressful to the animals under study (3Rs principle). The classification is based on the hazardous properties of a substance or mixture and not on the likelihood of exposure and risk considerations. Self-classification describes the toxicological evaluation of a chemical substance or mixture regarding physical, health and/or environmental hazards made by manufacturers, importers or downstream users. Hazard classes and categories are described in the CLP and in 2023 new hazard classes were identified on endocrine disrupting properties and persistent, bioaccumulative, toxic and mobile properties for the environment. Especially for hazards of highest concern [carcinogenicity, mutagenicity, reproductive toxicity (CMR) and respiratory sensitisers], classification and labelling should be harmonised throughout the EU to ensure adequate risk management. This is done via inclusion of a substance classification in Annex VI of the CLP Regulation and it is mandatory for all. Once the hazardous properties of a substance or mixture have been identified and classification is assigned, this information must be communicated to the other actors in the supply chain. The labeling requirements set by CLP ensure the safe use and supply of hazardous substances and mixtures. Labeling elements include among others, pictograms, signal words and standard statements for hazard, prevention, response, storage and disposal, for every hazard class and category, along with specific general packaging standards. In 2017, a new Annex VIII was added to the CLP Regulation, implementing harmonised information requirements for notifications used for emergency health response (Poison Centres). Enforcement of CLP Regulation, which is a national responsibility in EU, entails a range of actions that national authorities initiate to verify the compliance of the duty holders with the legislation.