Classification & Labelling

In Europe, chemical substances are regulated under REACH. To date, eleven low molecular weight phthalates have been classified as Category 1B reproductive agents and hence have been listed as Substances of Very High Concern (SVHC) and placed on the REACH Candidate List. Four of them, DEHP, DBP, BBP and DIBP, are on the Authorisation List. This means that after February 2015, these four substances can be placed on the EU market only for those uses for which an Authorisation has been granted to specific applicants. Only seven applications covering uses of DEHP and DBP have been submitted. Since no applications for BBP and DIBP have been submitted, their use in the EU was phased out by February 21, 2015.

The old requirements under the EU Dangerous Substances Directive have been superseded by those of the Classification, Labelling and Packaging Directive (CLP; Regulation (EC) No 1272/2008). It is important to note that 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.

In Europe, preparations containing 0.3% or more of DBP, DEHP DIBP and BBP must carry a label with the appropriate CLP Pictogram and Hazard and Precautionary Statements.  Preparations containing these four substances can be placed on the market only for professional uses and after February 21, 2015 only for Authorised uses. Articles containing these phthalates such PVC flooring and other finished products are not required to carry this label. Use in such articles is subject to the Authorisation requirements of REACH. There are specific communication requirements for suppliers of mixtures and articles with respect to the content of REACH Candidate List substances. The content of any SVHC in a mixture or an article is required to be communicated down the supply chain and any consumer can request the SVHC content of any article from a retailer, with a response being required within 45 days. In addition any importer of an article containing an SVHC has to notify ECHA prior to import unless another company in any supply chain has already registered that use as part of a REACH registration. Import of all substances including SVHCs is of course subject to full REACH registration requirements.