On 31 January 2014, the European Commission has published its conclusions regarding the re-evaluation of the restrictions on DINP and DIDP in toys and childcare articles which can be placed in the mouth. The Commission is fully aligned with the main conclusions presented in August last year by the European Chemicals Agency (ECHA), which in September 2009 was asked to review any newly available scientific information on these two high phthalates.
Based on ECHA’s assessment, the Commission has concluded that “no unacceptable risk has been characterised for the uses of DINP and DIDP in articles other than toys and childcare articles which can be placed in the mouth”. The Commission therefore concluded that the existing restriction of DINP and DIDP in toys and childcare articles which can be placed in the mouth should be maintained (the precautionary restriction has been in place since 2005). The Commission further concluded that “in the light of the absence of any further risks from the uses of DINP and DIDP, the evaluation of potential substitutes has been less pertinent". DINP and DIDP are therefore safe for use in all current consumer applications.
“The safety and optimal performance of plasticisers is essential for the numerous durable flexible PVC articles being used by millions of Europeans every day. The European Council for Plasticisers and Intermediates (ECPI) is confident the Commission’s communication will provide reassurance to consumers as well as a stable regulatory environment for companies to continue using these two high phthalates” stated ECPI’s manager, Dr Stéphane Content. “Furthermore, DINP and DIDP have proved to be reliable substitutes for the classified low phthalates which are currently undergoing REACH Authorisation” he added.
Regarding children, ECHA concluded that “no further risk management measures are needed to reduce the exposure of children to DINP and DIDP”. In the case of adults, the biomonitoring data reviewed by ECHA confirmed that “exposure from food and the indoor environment are not very significant” and, in the case of dermal exposure to DINP and DIDP is “not expected to result in a risk for adults or the developing foetus in pregnant women”. ECHA also indicated that using sex toys containing DINP and DIDP “would not result in any risk”. Overall, the European Chemicals Agency concluded that “no further risk management measures are needed to reduce the exposure of adults to DINP and DIDP.”
This re-evaluation of the restrictions on non-classified high phthalates was required by entry 52 of Annex XVII of REACH, which incorporated the original restrictions in Directive 2005/84/EC. This four-year scientific review process included a public consultation and an independent opinion by ECHA's Risk Assessment Committee (RAC) which brings together experts from all 28 Member States. The ECHA report covered an assessment of potential exposure to DINP and DIDP from all sources, including indoor air and dust, food, clothing, vinyl flooring, and vehicle interiors amongst others.
ECHA’s final report (August 2013)