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European trade organisations, aware that the current system for the safety assessment
of chemicals migrating from food contact materials overestimates the exposure to fat-
soluble migrants, requested the introduction of an additional reduction factor which
takes into account that a person cannot eat as much as 1 kg of fat/day.
The Commission services, before submitting the request to the Committee, have
instituted a task force composed of experts in migration to consider the request. The
conclusions drawn by the task force are described below.
1.1.1 In the early 1960's, it was decided that the safety assessment of chemicals used in
food contact materials would make the assumption that a person of 60 kg will eat
daily during his lifetime, up to 1 kg of foodstuffs in contact with a surface of 6 dm≤ of
the same type of plastic packaging, containing the migrant substance at the maximum
value compatible with the established specific migration limit (SML). Hence, for a
substance having a TDI
, the SML was established as follows :
£ SML (mg/kg food) = TDI (mg/kg/bw) x 60 (kg/bw) x 1 kg food
1.1.2. Another assumption was that each of this 1 kg of foodstuff could have an
"aqueous","acidic", "alcoholic" or "fatty" character and could be simulated by 1 kg of
food simulant (respectively "water", "3% acetic acid", "10% ethanol" and "olive oil
or other fat simulants") (see also 1.1.5). In this system, the total dose of migrant
absorbed per day can only be derived from 1 kg of food in contact with the plastic and
that this kg is composed either of 1 kg of fatty food or 1 kg of one of the other types
of food, but never by the sum of the various types of food.
Summarising the assumptions of the current system, they are the following:
no material use factor (plastic, paper & board, glass, metal, etc.)
same plastic packaging material type (= no plastic use factor)
100% market share for the migrants under review
life-time exposure day by day
all packaging materials release the migrants at the maximum value
1.1.3 A material is considered suitable for packaging any type of food if the migration in
each of the four simulants is below the SML. If the migration into a given food
exceeds the SML, the material is considered unsuitable for this corresponding class of
For reasons of clarity this summary uses as an example a substance for which a TDI has been established.
However, relatively few food contact substances have been assigned a full TDI. Rather, restrictions are
frequently derived from reduced toxicity dossiers, leading directly to fixed migration limits e.g. R=0.05 or
R=5mg/kg food or food simulant. The principles explained above using a substance with a TDI as an example,
apply also to substances with fixed migration restrictions.