ECHA recommends endocrine disrupting properties be added to four phthalates on REACH Authorisation List

The European Chemicals Agency (ECHA) has announced that endocrine disrupting properties will be added to four phthalates currently on the EU Authorisation List (Annex XIV of REACH). Once the European Commission (EC) decides on the amendment, some previously exempted uses will require authorisation.

The four phthalates identified are:

• bis(2-ethylhexyl) phthalate (DEHP) (EC 204-211-0, CAS 117-81-7)
• benzyl butyl phthalate (BBP) (EC 201-622-7, CAS 85-68-7)
• dibutyl phthalate (DBP) (EC 201-557-4, CAS 84-74-2)
• diisobutyl phthalate (DIBP) (EC 201-553-2, CAS 84-69-5)

Previously identified as substances of very high concern (SVHC), the four phthalates were added to the Authorisation List in 2011 and 2012 due to their classification as toxic for reproduction. Now, they have also been identified as having endocrine disrupting properties with effects on human health. DEHP was also identified for its effects on the environment.

These phthalates are commonly used as plasticisers to provide flexibility and longevity to plastic articles and there are many different applications. Some end-uses include adhesives, agricultural adjuvants, personal-care products, medical devices, detergents and surfactants, printing inks and coatings, pharmaceuticals, food products and textiles. While many of these applications previously required authorisation, some medical devices and food products were exempt. ECHA’s announcement could mean that previously exempt uses, such as DEHP in blood bags, may require authorisation.

A public consultation on the draft amendment recommendation was held between December 2018 and March 2019. A previous consultation on behalf of the EC on the same issue was held between June and August 2018. The Member State Committee considered the comments received and adopted its opinion on 26 June 2019.

The actual amendment of the entries, including the final decision on the dates by which companies will need to apply for authorisation to ECHA and on exemptions of uses, will be made by the European Commission in collaboration with the Member States and the European Parliament.

Follow the link to view the full ECHA press release, published on 10 July 2019.

Next steps

TSG recommends that manufacturers start to take action now to identify which products the amends will affect, evaluate the options available and decide the best way forward. TSG’s experienced regulatory consultants can help provide strategic advice throughout this process as well as guide companies through the authorisation process should a company decide to take this route.