Proposal to restrict four classified phthalates under REACH not justified

Press Release
Media enquiries: ECHA Press

The Committee for Risk Assessment (RAC) has adopted by consensus its opinion concluding that the proposed restriction of four classified phthalates (DEHP, DBP, BBP, and DIBP) in articles is not justified.

Helsinki, 15 June 2012 In 2011, the Danish competent authorities made a restriction proposal with the aim of limiting exposure to humans from the four phthalates in consumer articles.

At its meeting this week, RAC concluded that the available data does not indicate that there is currently a risk from combined exposure to the four phthalates. In addition, RAC was of the opinion that the existing regulatory measures and the consequential reduction in use would further reduce exposure. On the basis of these considerations, RAC concluded that the proposed restriction is not justified.

ECHA´s Committee for Socio-economic Analysis (SEAC) noted a steady decline in the use of these phthalates over the last decade. This trend is expected to continue, and is thought to be further strengthened by the authorisation requirement for the four phthalates. Considering the uncertainties regarding the future exposure RAC recommended biomonitoring and following up of use trends for the four substances.

This was the first time since the adoption of REACH that a combined assessment approach was used.  It is important to note that RAC did not question the principle of addressing risks through combined exposure if the substances act similarly. For example, in the case of the four phthalates, they all show anti-androgenic properties.

Following the RAC conclusions that the proposed restriction was not considered justified, SEAC concluded that they would have no basis for a supportive opinion as risk was not  demonstrated. The draft opinion of SEAC will be submitted for public consultation for sixty days with their final opinion to be adopted in December 2012 at the latest. 

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