Public consultation on the future update of Annex XIV entries of 4 LMW phthalates

The European plasticiser market has already adapted to the regulatory and market pressures with an important major shift from the use of these classified LMW phthalates to the use of non-classified HMW phthalates and other plasticisers. Nevertheless, given that the four LMW phthalates are already regulated and Authorisation as well as Restriction procedures are ongoing, we believe that their double listing for the same adverse health effects in animals and inclusion in the Authorisation List for their ED properties is extensive regulation whose efficiency can be questioned, as it increases pressure on the industry, weakens policy predictability, and hence hinders the European industry from investing and staying competitive in a global market. Due to the fact that some uses of DEHP (e.g. in food contact materials or medical devices) will as a result no longer fall under the generic exemptions from the authorisation requirement, the update of the annex XIV list will oblige DEHP producers, medical devices producers and recyclers of flexible PVC to face a new challenge regarding the Authorisation process.


Background information on the current regulatory status:

  • DIBP and BBP are no longer used in Europe as there was no Authorisation dossier submitted for these substances by the sunset date of February 2015.
  • DBP is authorised in very limited specific industrial applications.
  • DEHP : Authorisation for use in producing original PVC compounds and articles has been recommended by ECHA and while official confirmation by the European Commission is still pending – the substances can currently be safely used in those applications for which an Authorisation request was submitted.The recycling of flexible vinyl containing DEHP has also been Authorised for several companies and recently ECHA has recommended re-Authorisation of such recycling.