ECPI statement on the ECHA draft Substance Evaluation List

On 21 October 2011, the European Chemicals Agency (ECHA) submitted the first draft Community Rolling Action Plan (CoRAP) of Substance Evaluation to the EU Member States. It listed 91 substances, amongst which were a number of phthalate plasticisers, including four high phthalates (see Attachment I). The Member States Committee will prepare an opinion on the draft CoRAP in February 2012, and – on the basis of the Committee’s opinion – ECHA will then adopt the final plan for substance evaluation by 28 February 2012.

The European Council for Plasticisers and Intermediates (ECPI) would like to provide some background information on these four substances. The four high phthalates are relatively low volume plasticisers, being used in specialty applications such as roofing membranes, high temperature cables and automotive upholstery. The use of these four high phthalates is not increasing as they do not have the technical properties and economics for use as general purpose plasticisers.

In October 2004, the Organization for Economic Cooperation and Development (OECD) completed an evaluation of high phthalate plasticisers (C9 – C13 alkyl phthalates), including the four high phthalates proposed in the draft Substances Evaluation List, under the Existing Chemicals Assessment Program, with the following conclusions at the SIAM in Berlin:

• “The chemicals in this category are currently of low priority for further work because of their low hazard profile.” Link

• With regard to potential for exposure the following was noted: “Therefore, minimal consumer exposure is foreseen, since the consumer is only indirectly exposed through the use of products, which may contain HMWPEs* and uptake is expected to be low.” Link
  

*High Molecular Weight Phthalate Esters
ECPI is not aware of any new data which would invalidate the OECD conclusions. Furthermore, ECPI would add that these HMW phthalate plasticisers bind tightly within the PVC matrix during the high temperature fusion process for the manufacture of articles and as a result do not meet the definition of “wide dispersive use”.

ECPI and its members are committed to product safety, and will continue to support the use of sound science and risk assessment when analysing and assessing phthalate plasticisers.

For further information on the high phthalates present on the draft CoRAP, ECPI would advise to contact the individual producers.

 

HMW phthalates included in the draft Substance Evaluation List

 

YEAR
EC NUMBER
CAS NUMBER
SUBSTANCE NAME

2014
271-085-1
68515-43-5
1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters

2014
271-089-3
68515-47-9
1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

2014
287-401-6
85507-79-5
diundecyl phthalate, branched and linear

2014
222-884-9
3648-20-2
diundecyl phthalate