Division 4.1 Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF)

For lipophilic substances for which F1... it is indicated in F2the authorisation for the substance concerned that the FRF is applicable the specific migration can be corrected by the FRF. The FRF is determined according to the formula FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100.

The FRF shall be applied according to the following rules.

The migration test results shall be divided by the FRF before comparing with the migration limits.

The correction by the FRF is not applicable in the following cases:

1. (a)

   when the material or article is or is intended to be brought in contact with food intended for infants and young children as defined by Directives 2006/141/EC and 2006/125/EC;

2. (b)

   for materials and articles for which it is impracticable to estimate the relationship between the surface area and the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated using the conventional surface area/volume conversion factor of 6 dm²/kg.

F3The specific migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.

F4When testing is performed in food simulant D2 or E and when the test results are corrected in application of the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.