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ECHA’s recent announcement followed a proposal by Denmark in February 2015 to reexamine DINP.

WASHINGTON (July 9, 2018) – The European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) recently published its full opinion, confirming the conclusion from its March 2018 meeting that di-isononyl phthalate (DINP) does not warrant classification for reproductive and developmental toxicity effects under the European Union’s Classification, Labelling and Packaging regulation. The CLP regulation is the EU implementation of the UN Globally Harmonized System (GHS).

The RAC opinion rejected by consensus the proposed classification of DINP as a reproductive toxicant category 1B (Development) and Category 2 (Fertility) and concluded “no classification for DINP for either effects on sexual function and fertility, or for developmental toxicity is warranted.” The ruling followed an extensive evaluation of existing toxicity data on DINP, including two reproductive (fertility) toxicity studies, 13 developmental toxicity studies, 15 repeat-dose toxicity studies – all in animals – and eight epidemiological studies in humans. The American Chemistry Council’s (ACC) High Phthalates Panel issued the following statement about ECHA’s conclusion:

“The panel fully supports thorough scientific examination of chemicals to help ensure they are used safely. ECHA’s conclusion that DINP warrants no classification for reproductive and developmental toxicity provides additional support for the safety of DINP in current applications.

“The conclusion brings to a close a regulatory process that lasted more than three years from the original registry of intent from Denmark and included public consultation and a year-long assessment of the proposal by a RAC rapporteur and co-rapporteur, culminating in a conclusion by the full RAC in March 2018 and publication of the full opinion in June 2018.

“High molecular weight (HMW) phthalates such as DINP have been used safely in consumer and commercial products for more than 50 years to enhance durability, flexibility and performance. Phthalates are primarily used to make polyvinyl chloride (PVC or vinyl) flexible and are used in hundreds of products in our homes, hospitals, cars and businesses. DINP is one of the most tested substances in commerce and multiple government agencies in North America, Europe and Australia have extensively reviewed the scientific data about its safety and have concluded DINP is safe for use in current applications.”

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