European Plasticisers (former ECPI) estimates confirm a positive trend in Europe for High Molecular Weight (HMW) Ortho-phthalates, cyclohexanoates, terephthalates and other plasticisers, accompanied by a progressive
decline in the use of Low Molecular Weight (LMW) Ortho-phthalates.
This trend was corroborated by a review study of phthalates exposure in Europe conducted by Holger M. Koch and published in the International Journal of Hygiene and Environmental Health in November 2016. The study showed a significant drop in exposure to key LMW phthalates in Germany from 1988 to 2015, while exposure to HMW phthalates stayed relatively steady despite increasing consumption.
Studies and Research
An epidemiology study, commissioned by European Plasticisers and carried out by Maastricht University, was published in Annals of Epidemiology in August 2016. The study examined the reliability of scientific papers that report an association between phthalate exposure and health effects such as obesity, asthma and reduced fertility.
Two scientific papers by Dr Dekant and Prof. Bridges were published in Autumn 2016 in Regulatory Toxicology and Pharmacology. The first independent study developed a Quantitative Weight of Evidence (QWoE) methodology for the assessment of reproductive and developmental toxicity and its application for the classification and labelling of chemicals. The second paper, commissioned by European Plasticisers, applied the QWoE in a case study to assess the classification and labelling of DINP, DCHP and DnHP. Key conclusions showed that, based on existing data, DINP does not warrant any classification.
ECHA's Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) expressed their support in September 2014 for authorising companies that had applied for Authorisation to continue to use DEHP in both virgin and recycled PVC and DBP in specific applications.
The European Commission in April 2016 definitively granted Authorisation for the use of DEHP in recycled soft PVC. Authorisation for the use of new DEHP in products is still pending.
The evaluation and Risk Management Option Analysis (RMOA) conducted by the French authorities on DINCH and DOTP concluded that no danger or risk is identified under REACH; therefore, no additional risk management measures are needed.
The Public Activities Coordination Tool (PACT) lists the substances for which a risk management option analysis (RMOA) is under development. The evaluation of ATBC conducted by ANSES under the PACT RMOA concluded that there is “low priority for further work”.
The evaluation of DINCH, DEHTP, ATBC and TXIB in toys and childcare articles also conducted by ANSES showed no risk for the use of these substances.
In 2014, the European Commission and Member States endorsed a four-year re-evaluation showing no risk for DINP and DIDP in consumer applications excluding toys and childcare articles that can be put in the mouth, which are restricted. In spite of this, the Danish EPA submitted a dossier to ECHA in 2016, proposing that DINP be classified as a reproductive agent under the CLP Regulation. The Danish dossier is still pending.
A proposal to restrict DEHP, BBP, DBP and DiBP was submitted to ECHA in April 2016. RAC’s and SEAC’s opinions are expected in 2017.