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Commission Regulation (EU) No 10/2011Show full title
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)
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CHAPTER 4Correction factors applied when comparing migration test results with migration limits
4.1.Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF)
For lipophilic substances for which in Annex I it is indicated in column 7 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:
(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;
(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.
The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.
4.2.Correction of migration into food simulant D2
For the food categories where in sub-column D2 of column 3 of Table 2 of Annex III the cross is followed by a figure the migration test result into food simulant D2 shall be divided by this figure.
The migration test results shall be divided by the correction factor before comparing with the migration limits.
The correction is not applicable to the specific migration for substances in the Union list in Annex I for which the specific migration limit in column 8 is ‘not detectable’ and for non-listed substances used behind a plastic functional barrier covered by the rules of Article 13(2)(b) which should not migrate in detectable amounts.
4.3.Combination of correction factors 4.1 and 4.2.
The correction factors described in 4.1 and 4.2 can be combined for migration of substances for which the FRF is applicable when testing is performed in food simulant D2 by multiplying both factors. The applied maximum factor shall not exceed 5.
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