In order to demonstrate compliance with article 3 of the Framework Regulation (EC)No 1935/2004, the following must be considered:- By defining the end use application(s) of the coating, it may be possible toestimate a limit of migration equating to an exposure of < 1.5 µg/person/day. Inthis case, the reaction product does not deserve any further toxicologicalevaluation 1 . This process may utilise probabilistic modelling for exposureassessments 2 .- If the level of 1.5 µg/person/day is exceeded, then it is necessary to apply otherconsiderations using universally recognised techniques, such as SAR(Structural Activity Alerts) and Kramer classes for toxicological thresholds whereif the structure of a substance is broadly known, higher levels of migration maynot require toxicological testing of that substance.12See ILSI Monographs, ‘Threshold of Toxicological concern for chemical substances present in thediet, report of a workshop held in October 1999’ Anon August 2000 and ‘Threshold of toxicologicalconcern (TTC) – a tool for assessing substances of unknown toxicity present at low levels in thediet’ S. Barlow July 2005.Further information is contained in I. C. Munro, J. J. Hlywka, E. M. Kennepohl - Risk assessmentof packaging materials, Food Additives and Contaminants 19, Proceedings Supplement 3-12,2002.Industry has asked the Commission for an opinion on the suitability of probabilistic modelling forassessing exposure to migrants from food packaging materials. Examples of the use ofprobabilistic modelling for assessing exposure to migrants from food packaging may be obtainedfrom the following:ILSI Monograph ‘Exposure from food contact materials. Summary report of a workshop held inOctober 2001’. K. Svennson 2002.M.J. Holmes, A. Hart, P. Northing, P.K.T. Oldring, L. Castle, D. Stott, J. Smith, O. Wardman‘Dietary exposure to chemical migrants from food contact materials: a probabilistic approach Foodadditives and contaminants Oct 2005, 22, pp 907 - 919L. Castle, A. Hart, M. Holmes, P.K.T. Oldring ‘Stochastic modelling of consumer exposure for anysubstance from canned foods using simulant migration data’ Food additives and contaminantsmay2006, 23, pp 528 - 538 P.K.T. Oldring, L. Castle, A. Hart, M.J. Holmes ‘Migrants from foodcans revisited – application of a stochastic model for a more realistic assessment of exposure toBADGE’ Packaging technology and science 2006, 19, pp 121 - 137.Duffy, E., Gibney, M. J. ‘Use of a food-consumption database with packaging information toestimate exposure to food-packaging migrants: expoxidized soybean oil and styrene monomer;food additives and contaminants, FEB 2007, 24, pp 216 - 225Duffy, E., Hearty, A. P., McCarthy, S., Gibney, M. J. ‘Estimation of exposure to food packagingmaterials. 3: Development of consumption factors and food-type distribution factors from datacollected on Irish children’; food additives and contaminants, JAN 2007, 24, pp 63 – 74Duffy, E, Hearty, AP, Gilsenan, MB, Gibney, MJ; ‘Estimation of exposure to food packagingmaterials. 1: Development of a food-packaging database’, food additives and contaminants, JUN2006, 23, pp 623 - 633Duffy, E, Hearty, AP, Flynn, A, McCarthy, S, Gibney, MJ; ‘Estimation of exposure to foodpackagingmaterials. 2: Patterns of intakes of packaged foods in Irish Children aged 5-12 years’,food additives and contaminants JUL 2006, 23, pp 715 - 72548Europäische 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/
For risk assessments made for foodstuffs stored in large containers, the size of thecontainers (volume ratio to contact area) should be taken into account.49Europäische 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/
Change language