SCF Releases Opinion Regarding Fatty Food Consumption Correction Factors
An opinion that introduces a fatty food "consumption" factor into the evaluation of migration test results was released Dec. 12, 2002, by the European Community's Scientific Committee on Food (SCF). The opinion, "Fat (Consumption) Reduction Factor (FRF) in the estimation of the exposure to a migrant from food contact materials," was offered in response to an industry initiative. It is available on SCF's Web site, at http://europa.eu.int/comm/food/fs/sc/scf/out149_en.pdf.
As discussed more fully below, the SCF agreed with industry data indicating that a realistic estimate of the maximum intake of fat is 200 grams of fat per person per day instead of the traditional value of 1 kg per person per day. Also, the SCF agreed that a reduction factor can be applied to the migration when measured in a fatty food in some conditions. It appears from the opinion, however, that the committee was more reluctant to apply an automatic five-fold reduction to the migration level when measured in a fatty food simulant. The committee was concerned that, without more restrictions on the use of such a factor, consumers could be exposed to potential migrants at levels above their predetermined specific migration limits (SMLs).
Background
When determining the compliance of a particular food packaging material, the European Union has not traditionally taken into account factors associated with either the type of food stored in the package, or the percentage of the daily diet that is stored in the particular type of package being evaluated. Rather, the EU assumes that the 1 kg of food consumed in the daily diet of an individual can consist entirely of a single type of food, packaged in the same packaging material, and compares the migration of a component to the predetermined SMLs. If the migration to a given food simulant among representative time/temperature conditions exceeds the specified limit, the material is considered unsuitable in the intended application for that corresponding type of food.
In actuality, of course, the daily diet is composed of a mixture of all types of food. Accordingly, a group of industry representatives from the European Chemical Industry Council (CEFIC) developed a proposal that would account for daily fat consumption, with the long-term goal of implementing a system in the EU that more realistically accounts for exposure in the risk assessment and risk management procedures when establishing a clearance for packaging materials for fatty foods. In its proposal, CEFIC provided data demonstrating that the realistic maximum exposure to fat in the daily diet does not exceed 200 grams of fat per person per day.1
The SCF reviewed the data provided by the industry group and agreed that 200 grams of fat is a realistic estimate of the maximum expected daily consumption of fat. The industry proposal also recommended that the Commission allow for consideration of fatty food consumption when determining compliance of a food-contact material with the estimated SML. The proposal recommended two different approaches, depending on whether migration was measured in actual foodstuffs, or in a fatty food simulant.
Correction of Migration to Foodstuffs
The SCF reviewed the industry proposal with respect to the correction of specific migration when measured in actual foodstuffs. The industry recommended that an FRF be applied to specific migration results from testing of foodstuff packaged in the packaging material of interest. The industry proposal defined the FRF as follows:
FRF = [Mass fraction fat in food (g-fat/kg of food)] ÷ 200
We point out that the mass fraction of fat in this expression is calculated on a grams fat per kilogram food basis. A more simplified expression of the FRF is simply the grams of fat per gram of food multiplied by 5.
To determine if the resulting migration complies with the SML, the proposal recommends that the experimental migration value obtained in food (Mexp) be corrected by dividing the Mexp by the FRF. This results in the migration value (Mcorr) that can be compared to the SML.
The industry proposal recommended several limitations on the application of the FRF correction factor. First, the correction would not be applied to foodstuffs with less than 20 percent fat (i.e., FRF=1). Also, the FRF would not be applied in situations in which the SCF listing for a substance is SCF List 4 (substances for which there should be no detectable migration into food). Finally, the application of the FRF should not result in any specific migration exceeding the overall migration limit.
The SCF supported the use of the proposed FRF when applied to specific migration results in actual foodstuffs. However, in reviewing this proposal, the SCF was concerned that the industry proposal did not account for situations in which the substance of interest migrates into non-fatty foodstuffs and therefore also seem to support the limitations proposed by the Commission task force that another restriction be placed on the use of the FRF, namely, that migration into non- fatty food simulants should not exceed 10 percent of the SML.
Correction of Migration to Fatty Food Simulants
Although receptive to the industry proposal on the fatty food consumption estimate and the use of the FRF for correcting migration into actual foodstuffs, the SCF was more concerned with the industry proposal regarding the correction of migration into fatty food simulants.
Based on an assumption that migration to fatty food is proportional to the percentage of fat in the food, and because fatty food makes up no more than one-fifth of the daily diet, the industry group concluded that it was appropriate to reduce migration in fatty food simulants by a factor of five. Accordingly, the group recommended that this factor replace the factors set forth in the EU Testing Directive 85/572/EEC, which provides reduction factors to account for differences in the expected migration from actual fatty food and data from testing with Simulant D (olive oil or its equivalent). This proposal would greatly simplify testing, and would allow a supplier to make representations regarding the use of its product in all types of food.
Because the corrected fatty food simulant migration level does not account for contribution to exposure from non-fatty food simulants, the industry proposal recommended adding the highest migration level found in the three other simulants (Simulants A, B, and C). This sum of the corrected fatty food migration with the highest migration from the non-fatty food simulants would then be compared to the SML to determine if the proposed use complies with the prescribed limit.
The SCF expressed concern that limitations recommended by the industry group did not go far enough to ensure that the exposure to the migrant was a conservative estimate of the actual migration. The SCF was concerned that certain situations could exist (such as contact with food at high temperatures, or thin film applications) in which migration of the material into fatty food simulants is not, in fact, proportional to the percentage of fat in the food. In such circumstances, one of the basic assumptions of the industry proposal would not be true, and as such, a reduction factor of five would not be supportable.
To take these concerns into account, the SCF recommended that additional conditions be placed on the use of this factor. For example, the committee recommended that the factor not be used in situations in which the specific migration of the material exceeded 80 percent of the initial content of the substance in the plastic article. It is not clear whether the SCF would apply the same limitations that were recommended for factoring down the migration testing determined in actual food stuffs (i.e., only SCF List 4 materials, specific migration (before application of correction factor) cannot exceed OML, etc.).
Conclusion
Although this opinion suggests a slight movement toward taking actual food exposure into account when conducting risk assessment and risk management of food-contact substances, it remains to be seen whether, and to what extent, the Commission will implement this opinion into actual legislation. We will continue to monitor and report on how this opinion will be incorporated into amendments to the Plastics Directive and the various testing directives.
FOOTNOTES
1When establishing clearances for food-contact materials in the EU, the SCF assumes that a 60-kg person consumes as much as 1 kilogram of food per day. Therefore, the 200 grams of fat is 20 percent, or one-fifth, of the total daily diet.