EC: Draft Delegated Directive To Restrict Phthalates Under RoHS

The European Commission (EC) has prepared a Draft Delegated Directive to restrict four phthalates (DEHP, BBP, DBP and DIBP) under Directive 2011/65/EU (RoHS). The restriction limit will be set to 0.1 % for each substance and the directive shall come into force on 22 July 2019 (22 July 2021 for medical devices as well as monitoring and control instruments).


Directive 2011/65/EU (RoHS) entered into force on 21 July 2011. Under Annex II the Directive restricts substances lead, mercury, cadmium, hexavalent chrom, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) in electrical and electronic equipment. According to article 6 (1) of the RoHS Directive Annex II shall periodically be thoroughly assessed and amended if necessary. Therefore, substances Bis (2 ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Hexabromocyclododecane (HBCDD) were assessed and restrictions for four phthalates are suggested.

Important innovation through Draft Delegated Directive:

• DEHP, BBP and DBP (reprotoxic plasticizer): due to possible alternatives these phthalates shall integrate to Annex II with a maximum tolerated concentration value of 0.1 weight % per substance per homogeneous material

• HBCDD (a persistent, reprotoxic, brominated flame retardant): shall not integrate to Annex II due to the fact that HBCDD is already restricted under Regulation (EC) No 850/2004 on Persistent Organic Pollutants (POP)

• DIBP (reprotoxic plasticizer): the assessment of DIBP would be the same as for DBP because of their similar properties, so that DIBP shall also be integrate to Annex II with the same limit (0.1 weight %) as the above mentioned phthalates

• No conflict between Annex XIV to REACH (authorization list incl. DEHP, BBP, DBP and DIBP which will be prohibit during manufacturing in the EU from 21 February 2015 on) and Annex II to RoHS (list of restricted substances with the proposed phthalates DEHP, BBP, DBP and DIBP which will be restricted in the finished product) was observed

• Toys with electrical and electronic equipment (EEE toys): DEHP, BBP and DBP will furthermore regulated under Annex XVII (entry 51) of REACH due to the stricter limits (REACH: maximum tolerated concentration for the sum of these three phthalates were set to 0.1 % by weight of the plasticized material)

• Proposed Transition period: 22 July 2019 (22 July 2021 for medical devices as well as monitoring and control instruments)


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