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The Advisory list for self-classification of dangerous substances 1 Introduction to the amendment
1.1 BackgroundWhen chemical substances are classified in terms of the danger they represent, their inherent properties are assessed on the basis of the knowledge and information available /2, 7, 8/. Such assessments are often carried out on the basis of laboratory test results because the hazard classification criteria to a large extent refer to such results. Assessment must be carried out individually for each property, which means that often extensive animal testing may be required for a single substance. Thus, complete identification of all the properties for which hazard classification criteria exist, at present requires results from many animal studies for just one substance. According to the legislation, it is the duty of the companies to self-classify the chemicals they import or produce. Lack of data on hazardous properties of chemicals however, makes it difficult for companies to fulfil this duty. As an aid The Danish Environmental Protection Agency (DK-EPA) published a substance list - "The advisory list for self classification of chemical substances" – with advisory classifications for a number of endpoints of more than 30,000 substances /11/. The list has been published in three previous versions /3, 10, 11/. In all three versions, the classification proposals were made according to the Dangerous Substances Directive 67/548/EEC (DSD) /2/. The lists were prepared using mathematical modelling, so-called (Quantitative) Structure-Activity Relationships, (Q)SARs, for prediction of properties of chemicals. Classifications based on (Q)SAR predicted dangerous properties can save time and money if used as an alternative to animal testing, as well as increase the level of information for chemicals that will not undergo testing. By January 2009 the new CLP regulation on classification, labelling and packaging of substances and mixtures has had legal effect in the EU /5/. This regulation will gradually replace the present regulation for classification and labelling. The new regulation will come into force for single substances December 1st 2010 and for mixtures June 1st 2015 /5/. The current report presents a new version of the advisory list for self classification of chemical substances which is adjusted according to the CLP-regulation. 1.2 The CLP regulation for Classification and labellingCriteria for classification, packaging and labelling of dangerous substances and preparations are harmonised in order to protect public health and the environment and ensure the free movement of such products /4, 5, 8/. Hazard labelling allows consumers to recognize dangerous substances and preparations easily and to take adequate measures as regards risk avoidance and safe handling and disposal. New regulation The CLP regulation is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS, UN 2007) /8/. The GHS classification criteria are in certain cases slightly different to those of the previous EU legislation on hazard classification, labelling and packaging of chemical substances /2, 4/. In comparison with the previous EU-regulation /2, 4/, new hazard statements and pictograms are introduced. For some of the endpoints, slightly revised classification criteria have also been introduced. Certain provisions under EU Community legislation (REACH and other regulation for chemicals) may be triggered by the CLP-classification of a substance or a mixture. The CLP-regulation came into force on 20 January 2009 and substances and mixtures could be classified according to the CLP-regulation from that date. By 1 December 2010 substances must be classified, labelled and packaged according to CLP /5/. However, until 1 June 2015 a substance must also be classified according to the DSD /2, 4/ to allow for mixtures to be classified either according to CLP or the DPD until 1 June 2015. 1.3 (Q)SARs in chemical regulationStructure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs), collectively referred to as (Q)SARs, are theoretical models that can be used to predict the physico-chemical, biological (e.g. toxicological) and environmental fate properties of molecules based on the chemical structure. (Q)SARs tools are used more and more by authorities e.g. in the US and the EU, as well as by industry, to assess physico-chemical, (eco-)toxicological, and fate properties of substances. REACH and CLP In the new EU chemicals legislation, REACH, all other options, including use of (Q)SARs, should be considered before performing (or requiring) vertebrate testing /1/. With the implementation of REACH-it is expected that (Q)SARs will be used increasingly for the direct replacement of test data as their use, when available and adequate, is in fact an obligation /6/. The goal of assessing many thousands of chemicals under REACH may not be achievable without the use of (Q)SARs and other non-test methods. Especially for low tonnage chemicals, (Q)SARs and other non-test methods may also give further information beyond the standard information requirements of regulations such as REACH. Similarly for CLP, (Q)SARs and other non-test methods may be used on a case-by-case basis to assess how chemicals should be classified.
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