These low phthalates are already on the REACH Candidate and Authorisation Lists on the basis of adverse reproductive effects observed in laboratory animal studies with specific thresholds derived by ECHA’s Risk Assessment Committee (RAC) based on their toxicity to reproduction. These include adverse endocrine-related effects and therefore, ECPI considers that there is no need for additional endocrine-disrupting SVHC dossiers.
“These substances are already undergoing the REACH Authorisation process,” explained Content. “This means that after 21 February 2015, these four substances will be placed on the EU market only for those uses for which an authorisation has been granted or for exempted uses.”
Seven applications covering uses of DEHP and DBP have been submitted. Since no applications for BBP and DIBP have been submitted, their use in the EU will be phased out by February 2015.
The producers of DEHP and DBP have invested major resources in the preparation of the Authorisation dossiers, which are thoroughly assessed by The Committee for Risk Assessment (RAC) and The Committee for Socio-economic Analysis (SEAC).
The European Court of Justice’s so-called Lapin ruling – which lead Denmark to drop the proposed ban – sets an important precedent within the EU legal system. As such, it clearly defines the prevalence of European regulations over particular initiatives of Member States especially when they may be harmful to industry, retailers and consumers or when they are politically driven rather than based on the scientific data analysed as part of the evaluation processes carried out at European level.
“Any additional proposals by national authorities are likely to create more confusion and inefficiencies resulting into increased uncertainty for such an important sector which is already under significant stress,” said Content. “We ask the Danish EPA to take a proportionate approach based on solid scientific evidence and to withdraw their proposal to duplicate the SVHC dossiers for these four classified phthalates. EU national authorities should let the Authorisation process continue its course.”
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