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safety & regulatory issues
(partition coefficient) can be predicted and therefore
described by mathematical equations.
Studies to establish the parameters for
estimating the migration of substances from packages
to food using mathematical models as an extension of
existing models for food simulants have already begun
for monolayer materials and should be extended to
multilayer structures (FRANZ; SIMONEAU, 2008).
The consensus is that mathematical modeling is the
only practical way to combine the relevant parameters,
including variable composition of foods, the package’s
processing conditions and time and temperature of
storage in order to get data on the concentration of
migrants in foods and obtain with more precision
exposure to the consumer.
As described, there is no simple method for
determining consumer exposure to contaminants from
packages. The availability of data needed to estimate this
will define the methods that can be used. It is expected
that in the near future modifications in the assessment
of consumer exposure to contaminants from packages
will occur in the European Union. The completion of
the projects listed below will help to provide tools for
more realistically assessing and managing the risk of
substances from packages (OLDRING; CASTLE; FRANZ,
2009).
• Creation of databases on the usage pattern of food
packaging and on the chemical substances used in
different types of packaging materials.
• Development of a new classification of food based on
the migration behavior for a more realistic estimate
of consumer exposure.
• Determination of diffusion and partition coefficients,
fundamental to describe the process of migration in
packaged foods.
• Development of mathematical models to estimate
the migration of package components to food
under actual conditions of use and application of
deterministic and probabilistic models to estimate
consumer exposure.
• Development and validation of the QSAR approach
(Quantitative Structure Activity Relationship) acting
as a tool for estimating the toxicity of substances
based solely on their molecular structure for
application mainly on NIAS (Not Intentionally Added
Substances) in the package material.
The laws of Brazil and MERCOSUR are based
on European regulations and, therefore, changes in
European regulations may also lead to changes in these
laws. However, it should be emphasized that studies of
Brazilian consumer exposure to contaminants from the
package must be made, as a European study may not
necessarily represent what happens in Brazil.
8.2 LEGISLATION AND COMPLIANCE
The legislation on materials and packages for food
contact in force in Brazil, MERCOSUR, the European
Union and the United States states that packaging
materials
“shall not transfer, under foreseeable
conditions of use, undesirable substances, or toxic
contaminants that pose a risk to consumer health or
which may change the composition of the food or its
sensorial characteristics“
(BRAZIL, 2001; EUROPEAN
PARLIAMENT, 2004). So, based on the principles
that the package should be safe and inert, laws have
established criteria to be followed concerning materials
in contact with food. It is essential that all materials
in direct food contact must demonstrate compliance
with the requirements of these laws. Declarations of
Compliance assuring that materials and packages are
in accordance with the laws are essential in providing
material and for trade negotiations.
Currently, two regulations for food contact at a
global level are references for all others: harmonized
EU legislation and U.S. law. MERCOSUR and Brazil are
not exceptions.