WORKING DOCUMENT - Contact alimentaire

EXPLANATORY NOTEIn the case of polymeric additives made from complex raw materials, such aspetroleum distillates, HARRPA has discussed this issue with the Commissionand a distinction between polymers which can form articles and those whichcannot was agreed. A similar debate will be needed to resolve this issue forcoatings.List D: temporary appendix to List C (incomplete list of additives assessed).3.4 Substances approved by EU Member states or by FDA, not meeting thecriteria of 3.3.3.5 The substances on the temporary appendix should be subjected toadditional toxicological information depending on their migration intofoodstuffs or the level of exposure to those substances. Exposureassessments may only be used when all of the potential food contactapplications are identified.a. migration below 10 ppb - substances do not need further testingb. migration below 50 ppb – these substances should have themutagenicity tests according to REACH timeframesc. migration above 50 ppb – the supply chain needs to set up commoninterest groups in order to submit a dossier to EFSA.d. Whilst the migration may exceed 10ppb, if it can be demonstrated thatthe exposure is below 10 µg/person/day, then no further testing isrequired.e. It may also be possible to revise the requirements for cases b and c bythe use of exposure assesments.EXPLANATORY NOTEA number of the additives currently used have not been fully assessed bySCF/EFSA, mainly because they are specifically used for coatings. In order that theycan continue to be used, they must have authorisation by at least one member stateor be listed by the FDA. It is intended that the substances, which are used and arenot on SCF Lists 0-4, will be subjected to additional toxicological testing or exposureassessment as described above.13Europäische Vereinigung der Lack-, Druckfarben- und KünstlerfarbenindustrieEuropean Council of Paint, Printing Inks and Artists' Colours IndustryAvenue E. Van Nieuwenhuyse 4 - BE-1160 BrusselsTel:+32 (0)2 676 7480 - Fax: + 32 (0)2 676 7490 - E-mail: secretariat@cepe.org -Internet: http://www.cepe.org/