On November 23, 2021, the European Commission announced the adoption of a new regulation recognizing the endocrine disrupting properties of four phthalates within Annex XIV of the EU’s REACH Regulation, which is known as the Authorization List. The four substances bis(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7), dibutyl phthalate (DBP, CAS 84-74-2), diisobutyl phthalate (DIBP, CAS 84-69-5), and benzyl butyl phthalate (BBP, CAS 85-68-7) were initially recommended for limits on their use in 2017 (FPF reported) based on their recognized toxicity to reproduction, and the measures came into force later in July 2020 (FPF reported). The existing rule had dictated that “the four substances will be restricted to a concentration equal to or below 0.1% by weight individually or in any combination in any plasticized material in articles used by consumers or in indoor areas.” These set limits, however, did not apply to their use in food contact materials (FCMs).
In the years since, the European Chemicals Agency (ECHA) has determined that all four substances also fulfill the criteria of having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health, and for DEHP also to the environment. The most recently announced regulation officially adds these endocrine disrupting properties to the REACH entries for these chemicals. As a consequence, DEHP is no longer exempt from the authorization requirement for uses in FCMs. Companies will be required to apply before June 14, 2023 to receive permission for any uses in FCMs greater than 0.1% by weight.
European Commission (November 23, 2021). “Harmful chemicals – updated list of endocrine disrupting substances (REACH Regulation).”