CLP regulation

In the chemical safety report, the hazard assessment of a particular substance is based on the data set provided in the technical dossier. This contains substance-specific information on physicochemical properties as well as on toxicological and ecotoxicological hazards. One objective of the hazard assessment is the substance s hazard identification, which comprises the determination of its physicochemical and hazardous properties for the purpose of classification. Concerning human health hazards, both human and nonhuman information is taken into consideration and evaluated with respect to the classification criteria laid down in the Dangerous Substances Directive and in the CLP Regulation, respectively. However, in most cases human data do not exist, so the hazard identification has to be based on data from animal experiments. With respect to teratogenicity, this hazardous property may in principle be detected in the following toxicity studies ... 

But despite the stipulated duties for industrial companies, circumstances may arise in which authorities conclude that additional measures still need to be initiated in order to improve human health and environmental protection. For this purpose, different processes are laid down in REACH as well as in the CLP Regulation and reproductive toxicants often take a special position within them. This is because reproductive toxicity is considered a particularly serious health hazard. The three procedures explained below show in more detail how substances with reproductive toxic properties are taken into particular consideration. In this context, teratogenic substances are not explicifly named by the legal texts but, as they constitute as developmental toxicants a hazard differentiation of reproductive toxicity, they are implicitly always included by the provisions. 

The basic idea of the CLH process is the transfer of responsibility for classification and labeling from industrial companies to authorities on a European Community level. In case of active substances in biocidal or plant protection products, all intrinsic properties including physicochemical properties, human health hazards, and environmental hazards are subject to the harmonization. By contrast, in the case of chemicals which are used in other application fields only some specific hazard classes are considered in the CLH procedure. According to Article 36 of the CLP Regulation, these are respiratory sensitization, carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Consequently, these provisions have... 

As mentioned previously, the authorization process starts with the identification of a substance as substance of very high concern (SVHC). For this purpose, the ECHA on behalf of the European Commission or a member state competent authority prepares a dossier. It generally includes a proposal for the identification of a substance as SVHC, a justification for this proposal and information on the substance s use, exposure, and risks as well as on alternatives. The extent of the justification may differ considerably between substances and may range from a sophisticated assessment of the harmful effects caused by the substance to a simple reference to Annex VI Part 3 of the CLP Regulation if a harmonized classification... 

The proposed CLP regulations announced that based on the requirements of the proposal, the FDA would conduct a number of surveillance inspections of testing facilities during No-... 

Although there is nothing in the definitions section of the CLP regulations to rival RCRA s rewriting of the basic laws of chemistry and physics, a clear understanding of CLP definitions is essential to a proper interpretation of CLP requirements. 

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