DEHP, BBP, DBP and DIBP to be regulated under RoHS

Pursuant to Article 6(1) of RoHS 2, the first review of Annex II was due July 2014. The Commission published an open call and launched a preparatory study in November 2012. The consultants (Environmental Agency Vienna, UBA) developed a methodology for the identification, pre-assessment and assessment of substances that is EEE-specific and does not contradict REACH knowledge and provisions. As suggested by Article 6 of RoHS 2, DEHP, BBP, DBP (three common phthalate plasticisers) and HBCDD (a brominated flame retardant) were recommended as additional substances for restriction under RoHS II Directive. An additional result of the pre-assessment was a list of 24 priority substances for future reviews.

Annex II to the Draft Commission Delegated Directive amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as Regards the List of Restricted Substances Restricted substances would set maximum concentration values tolerated by weight in homogeneous materials for the following substances:
– Lead (0,1 %)
– Mercury (0,1 %)
– Cadmium (0,01 %)
– Hexavalent chromium (0,1 %)
– Polybrominated biphenyls (PBB) (0,1 %)
– Polybrominated diphenyl ethers (PBDE) (0,1 %)
– Bis (2-ethylhexyl) phthalate (DEHP) (0,1 %)
– Butyl benzyl phthalate (BBP) (0,1 %)
– Dibutyl phthalate (DBP) (0,1 %)
– Diisobutyl phthalate (DIBP) (0,1 %)

The restriction of DEHP, BBP, DBP and DIBP would apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.

The restriction of DEHP, BBP and DBP would not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 (RoHS 2) entered into force on 21 July 2011. RoHS 2 restricts the use of certain hazardous substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) in electrical and electronic equipment (EEE). The restricted substances are listed in Annex II to RoHS 2.

Article 6(1) of RoHS 2 establishes a procedure for a periodic review of Annex II and sets the date for the first review: “With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restricted substances in Annex II shall be considered by the Commission before 22 July 2014, and periodically thereafter. Pursuant to Article 6(3) of RoHS 2, the measures are adopted by the Commission by means of delegated acts.

For further review, five other groups of substances are also listed in descending priority order, bringing a total of 24 substances identified and recommended. The priority substances in their groups are:
– Group I: Di-(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP), Butyl benzyl phthalate (BBP), Diisobutyl phthalate (DiBP), tris(2-chloroethyl)phosphate, Hexabromocyclododecane (HBCDD), 2,3-dibromo-1-propanol, Dibromoneopentyl-glycol
– Group II: antimony trioxide, diethyl phthalate (DEP), Tetrabromobisphenol A (TBBPA), medium-chain chlorinated paraffins
– Group III: PVC
– Group IV: beryllium metal, beryllium oxide, nickel sulphate, nickel sulfamate, indium phosphide
– Group V: di-arsenic pentoxide, di-arsenic trioxide, cobalt dichloride, cobalt sulphate
– Group VI: cobalt metal, nonylphenol.