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4
1.
BACKGROUND
I
NTRODUCTION
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.
C
URRENT
S
YSTEM
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
(1)
, the SML was established as follows :
migration
£ 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
food.
1
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.