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:
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