Regulatory information

Several European texts regulate the use of certain phthalates in consumer goods and in health products, and mainly target phthalates used as plasticizers.

REACH Regulation

Four phthalates are included in the Annex XIV of the REACH Regulation: Benzyl Butyl Phthalate (BBP), Di(2-EthylHexyl) Phthalate (DEHP), DiButyle Phthalate (DBP) and DiIsoButyle Phthalate (DIBP). This annex lists substances for which authorization is necessary in order to place them on the market of the European Union (regarding uses targeted by the REACH Regulation).

European Sector Directives

For toys and childcare articles, the Commission Decision of 7 December 1999 (1999/815/EC) and Directive 2005/84/EC prohibited the placing on the market of toys and childcare articles in PVC with DINPdi (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), di-iso-decyl phthalate (DIDP), di-n-octyl phthalate (DNOP) and butylbenzyl phthalate (BBP).

Since July 22, 2019, concentrations of DEHP, DBP, BBP and DIBP in homogeneous materials of electrical and electronic equipments (excluding medical devices and monitoring and control instruments) must be less than 0.1%. From July 22, 2021, the same applies to medical devices and monitoring and control instruments (including industrial monitoring and control instruments) (Directive (EU) 2015/863, known as RoHS Directive). However, on the 08 August 2019, the European Commission granted five-year exemption for DEHP use in some rubber components of engine systems.

Some restrictions on the use of phthalates in materials in contact with foodstuffs are defined by Directive 2007/19/EC: a ban on DIBP, specific migration limits for food for DEHP, DBP, BBP, and (together with other substances) for DIDP and DINP.

The European regulations on medical devices (regulation EC n°1272/2008) prescribe that for all phthalates classified as carcinogenic, mutagenic or toxic for reproduction, class 1A or 1B, a labeling is required. In France, the National Assembly adopted Law No.2012-1442 of 24 December 2012 prohibiting the use of tubing containing DEHP in the pediatric, neonatology and maternity activities.

Finally, the European Union has prohibited, via European regulation n°1223/2009, the placing on the market of cosmetics containing DBP, DEHP, BBP, DMEP (Bis (methyl glycol) phthalate), the mixture of phthalates in C5 [N-pentyl isopentyl phthalate, di-n-pentyl phthalate, diisopentyl phthalate] (CAS: 84777-06-0) and the mixture of C7-C11 phthalates [Di (heptyl, nonyl, undecyl) phthalate](CAS: 68515-42-4).