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

Fourteen phthalates are included in the Annex XIV of the REACH Regulation: Benzyl Butyl Phthalate (BBP), Di(2-EthylHexyl) Phthalate (DEHP), DiButyle Phthalate (DBP), DiIsoButyle Phthalate (DIBP), Diisopentyl phthalate, 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich, 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, 1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear, Bis(2-methoxyethyl) phthalate, Dipentyl phthalate (DPP), n-pentyl-isopentylphthalate, 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear, dihexyl phthalate (DnHP) and 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters or mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate. 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, Annex XVII of the REACH Regulation restricts the use of Di-Isononyl Phthalate (DINP), Di-Isodecyl Phthalate (DIDP) and Di-n-Octyl Phthalate (DNOP): toys or childcare articles which can be placed in the mouth by children may not contain more than 0.1% by mass of plasticised material of any of these phthalates as a substance or in mixtures. Furthermore DEHP, BBP, DBP and DIBP may not be used in toys and childcare articles as substances or in mixtures (individually or in combination) in a concentration equal to or greater than 0.1% by weight of the plasticised material (Annex XVII of the REACH Regulation).

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 for DEHP, DBP, BBP, and for DIDP and DINP (together with phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 and phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10).

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.

In France, construction and decoration products (including wall, floor and ceiling coatings) may only be placed on the market if their emissions are less than 1 µg/m³ of DEHP and DBP (Arrêté du 30 avril 2009 relatif aux conditions de mise sur le marché des produits de construction et de décoration contenant des substances cancérigènes, mutagènes ou reprotoxiques de catégorie 1 ou 2).

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).

As from November 1st, 2020, bis(2-methoxyethyl) phthalate, DiPP, DPP, DnHP and 1,2-benzenedicarboxylic acid di-C6-8-branched alkylesters, C7-rich may not be present in textiles, clothing, related accessories and footwear at concentrations higher than 1000 mg/kg (individually or in combination with other phthalates listed in Annex XVII of REACH).

For more information: https://echa.europa.eu/fr/substances-restricted-under-reach/-/dislist/details/0b0236e182ed1fc0