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Brasil
PackTrends
2020
213
safety & regulatory issues
Simplistic or simplified
This assumes the worst case exposure of 6 dm
2
/kg food/person/day, as stated by MERCOSUR and Brazilian
law, which is based on that established by the European Union. The biggest disadvantage of this method is
that in many cases, different types of packages contain different substances and migration depends on the
type of food and processing. It is considered that this approach overestimates exposure to migrants from
packaging and applies severe limits to migrant substances that do not necessarily increase consumer safety.
On the other hand, it is also argued that such an approach underestimates children’s exposure to these con-
taminants. This is an argument already being examined by the European Commission and which has changed
limits for certain substances when used for baby food packages (also adopted by MERCOSUR and Brazil for
some plasticizers).
Deterministic
Fixed values of consumption, normally the highest, are combined with the maximum migration value found.
It is a more suitable approach for additives and other contaminants which do not originate in the package
material, since the type of food which can contain the additive and the amount consumed are known. These
data are more difficult to obtain considering the substances which migrate from the package.
Probabilistic
A statistical model is used to predict unknown parameters yielding a more refined estimate of exposure. This
tool has gained greater acceptance for allowing exposure assessment where data is lacking or not exact. Cle-
arly, not all required information is available and in many cases there is little information. Thus, assumptions
must be made and their impact on the exposure should be evaluated and the probabilistic model facilitates
this requirement.
For a more realistic estimate of exposure to a
given substance (migrant), the following data is needed:
• Weight of food consumed.
• Concentration of the migrant in the food consumed.
The weight of food consumed can be obtained
through research on the diet. However, these studies
do not always include the type of package used for a
given food. This information can be obtained through
participation in a market for a particular package for
a specific product. However, little data exists and
statistical studies should be conducted to increase
knowledge about the types of packages used for the
different food categories (DUFFY et al., 2006).
Concentration of the substance of interest in
different foods consumed is much more difficult to
obtain. The migration depends on the physicochemical
characteristics of food and contact conditions as the
ratio between the contact area of the package and, the
volume of food and temperature and contact time. It is
impossible to obtain this data through practical analysis
for different types of foods consumed. Therefore, the
concentration of these migrants can be obtained through
testing with food simulants or by means of mathematical
models established for some types of plastic materials. As
migration is a physical-chemical process, the diffusion of
the migrant in the package material (diffusion coefficient)
and the migration of the migrant to food / food simulant