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While the most commonly used high phthalates, DINP and DIDP, are not classified substances, three low phthalates, DEHP, DBP and BBP are classified in the European Union as reproductive toxicants.
The Dangerous Substances Directive 67/548/EEC – currently replaced by the Regulation 1272/2008/EC on classification, labelling and packaging of substances and mixtures (CPL) – specifies the hazard classification, packaging and labelling requirements for dangerous substances based on their intrinsic properties. This can help to ensure that users and handlers take the appropriate measures.
In March 2001, the European Commission adopted a proposal for the Classification and Labelling Committee to classify DEHP as a category 2 reproductive toxicant for both fertility and developmental effects. Similarly it decided that DBP should be classified as a reproductive toxicant in category 2 for developmental effects and category 3 for fertility effects.
The necessary amendments to the Dangerous Substances Directive were agreed on 7 August 2001 and published in the Official Journal of the European Community on 21 August of that year. The Directive stated that the new labelling should be introduced no later than 30 July 2002.
BBP was classified as category 2 for developmental effects, category 3 for fertility effects and as dangerous to the environment in June 2004. These requirements under the EU Dangerous Substances Directive have now been superceded by the requirements of the Classification, Labelling and Packaging Directive (CLP; Regulation (EC) No 1272/2008). Category 2 under the EU Dangerous Substances Directive is now Category 1B under the CLP, and Category 3 under the EU Dangerous Substances Directive is now Category 2 under the CLP.
As a result of the classifications, preparations containing 0.3% or more of DBP, DEHP DIBP and BBP must now carry a label with the appropriate CLP Pictogram and Hazard and Precautionary Statements. PVC flooring and other finished products are not required to carry this label; although as noted above there are communication requirements for suppliers of articles with respect to the content of REACH Candidate List substances.