The substances bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) have been listed in entries 4 to 7 of Annex XIV to Regulation (EC) No 1907/2006 because they meet the criteria set out in point (c) of Article 57 of that Regulation. The Commission had already classified them as reprotoxic substances in Category 1B.

Subsequently, for all the four substances have further been found properties which lead to their inclusion to Annex XIV according to art. 57, point f). Especially:  

• Only DEHP has been identified as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment.
• All the four substances have further been identified as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health.

Thanks to this latest information, the Commission amended entries 4 to 7 of REACH Annex XIV with new hazards besides reprotoxicity.

But this change gives rise to others, some explicit and others less so.

Authorised substances can have generic and specific exemptions. In fact, there was a specific exemption for DEHP, BBP and DBP in medicinal product. The Commission has removed this exemption because it was not by art. 58, paragraph 2.

There are also indirect effects, less clear than the Annex XIV amendments:

• Article 60 paragraph 2 of Reg. REACH provides that when granting authorisation, the Commission does not consider the risks to human health posed using a substance in medical devices. Due to endocrine disrupting properties hazardous for the environment, using DEHP in medical devices is therefore subject to authorisation;
• Article 56 (6) of the REACH Regulation provides that substances listed in Annex XIV only for CMR hazards or as endocrine disruptors for human health do not need authorisation when used in food contact materials. Due to DEHP endocrine disrupting hazard for environment, this exemption is no longer applicable;
• Article 56(6) of REACH provides that authorisation requirements do not apply to substances (in mixtures) less than certain concentration. Before the inclusion of the endocrine disruption hazard for the four phthalates, the concentration limit was guided only by the reprotoxicity hazard, i.e., 0.3%. Now the concentration limit is 0.1%.

For every use of the four phthalates that are no longer exempted from authorization obligation, the Commission has defined new dates for the submission of applications (Last Application Date) and new expiry dates (definitive applicability of the obligation of authorization, “Sunset Date”). Here are the new dates: