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ANNEX I
Annex I to Directive 2002/72/EC is amended as follows:
(1) The following points 2a and 2b are inserted:
`2a. Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF):
"Fat Reduction Factor" (FRF) is a factor between 1 and 5 by which measured migration of lipophilic substances
into a fatty food or simulant D and its substitutes shall be divided before comparison with the specific migration
limits.
General rules
Substances considered
"lipophilic" for the application of the FRF are listed in Annex IVa. The specific migration
of lipophilic substances in mg/kg (M) shall be corrected by the FRF variable between 1 and 5 (M
FRF
). The
following equations shall be applied before comparison with the legal limit:
M
FRF
= M/FRF
and
FRF = (g fat in food/kg of food)/200 = (% fat 5)/100
This 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 containing less than 20 %
fat;
(b) 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 91/321/EEC and 96/5/EC;
(c) for substances in the Community lists in Annexes II and III having a restriction in column (4) SML= ND or
non-listed substances used behind a plastic functional barrier with a migration limit of 0,01 mg/kg;
(d) 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 dm
2
/kg.
This correction by the FRF is applicable under certain conditions in the following case:
For containers and other fillable articles with a capacity of less than 500 millilitres or more than 10 litres and for
sheets and films in contact with foods containing more than 20 % fat, either the migration is calculated as
concentration in the food or food simulant (mg/kg) and corrected by the FRF, or it is re-calculated as mg/dm
2
without applying the FRF. If one of the two values is below the SML, the material or article shall be considered in
compliance.
The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.
2b. Correction of specific migration in food simulant D:
The specific migration of lipophilic substances into simulant D and its substitutes shall be corrected by the
following factors:
(a) the reduction factor referred to in point 3 of the Annex to Directive 85/572/EEC, hereinafter termed simulant
D Reduction Factor (DRF).
The DRF may not be applicable when the specific migration into simulant D is higher than 80 % of the
content of the substance in the finished material or article (for example thin films). Scientific or experimental
evidence (for example testing with the most critical foods) is required to determine whether the DRF is
applicable. It is also not applicable for substances in the Community lists having a restriction in column (4)
SML = ND or non-listed substances used behind a plastic functional barrier with a migration limit of 0,01
mg/kg.
EN
31.3.2007
Official Journal of the European Union
L 91/23