The future of simulants in compliance testing regarding the migration from food contact materials into food

Testing migration from food contact materials (FCMs) by the official simulation system is an approximation. Increasing measurements in food render discrepancies apparent and call for a clarification of the significance of simulating migration testing. Since the specific migration limits (SMLs) are risk-related, they refer to food, i.e., migration into food prevails over measurement in simulants. For overall migration, it is basically open as to which medium to prefer, since the limit above which a food should be considered contaminated is somewhat arbitrary; the Framework Regulation 1935/2004 defines the overall migration limit for foods. For the majority of products, overall migration cannot be determined in food, but the sum of individually determined migrants may be an approximation, enabling to check the result obtained by simulation. The European legislation should be amended: (i) SMLs refer to foods and, consequently, also the fat consumption reduction factor (FRF) should refer to foods exclusively (4th amendment of Directive 2002/72). (ii) The overall migration limit applies to foods (not to food or simulants, as stated in the 4th amendment of 2002/72). (iii) Simulation remains an important tool, but its relevancy must be defined more correctly. The legally specified conditions only apply if the determination in food is impossible; adjustment of simulation to migration into food has first priority, overruling the legally specified conditions in case of conflict (Directive 82/711/EEC as well as amendments 93/8/EEC and 97/48/EC). (iv) The continuous adjustment of the official testing method for simulation should be transferred to an analytically-oriented body. In conclusion, the official simulation system remains an important tool, but its legal relevance decreases with the increasing capabilities of measuring migrants in food. (c) 2007 Elsevier Ltd. All rights reserved.