WORKING DOCUMENT - Contact alimentaire

2.4 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 relevant food contact sources ofexposure 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 monomers and other starting substances currently used have notbeen fully assessed by SCF/EFSA, mainly because they are specifically used forcoatings. In order that they can continue to be used, they must have authorisation byat least one member state or be listed by the FDA. It is intended that the substances,which are used and are not on SCF Lists 0-4, will be subjected to toxicological testingor exposure assessments as described above.3. In addition to those substances in the list in Annex II, any substances which havean SCF or EFSA opinion (list SCF 0-4) may be used for the manufacture of thecoatings for direct food contact, subject to any restrictions applicable to them.EXPLANATORY NOTEThe current list of monomers and other starting substances reflects those currentlyused to manufacture coatings, which are in contact with food. Industry reserves theright to use any fully evaluated (SCF 0-4) substance, but not-listed in Annex II, infuture developments, as an SCF/EFSA opinion exists. As this list is regularly updatedthese substances, will eventually appear on a future revision.11Europäische 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/