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Brasil
PackTrends
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safety & regulatory issues
required to produce plastic, cellulosic and metallic
packages coated and uncoated in addition to
adhesives, print inks and so on. It is also known
that components of the package, when in contact
with food can migrate to the product, in a process of
mass transfer known as migration. In order to avoid
chemical contamination of food products, laws based
on the principle that the packages should be inert
were conceived. Positive lists of substances which
can be used in the composition of materials for food
contact have been established.
The authorization for these substances to
become part of the Positive Lists is based on risk
assessment and management. The risk, irrespective
of its origin, is the combination of the toxicity of the
substance (hazard) and how much of the substance
is consumed (exposure). Therefore, to ensure the
safety of package materials, it is not only necessary to
consider the toxicity of any migrant (risk assessment),
but also how much of this substance is found in foods,
present in the basic diet of the population (estimated
consumption).
Likewise, changing a migration limit or restriction
of a substance already listed or approved or approval of a
new substance (polymer or additive), new materials and
new technologies, risk assessment should be performed.
The legislation for food contact in the European
Union is based on the hazard of the chemical substance
and a very conservative estimate of exposure in order
to establish the Positive Lists. When the substance
is known it is submitted to toxicological tests in
accordance with protocols of traditional assessment
of toxicity, where ADI (acceptable daily intake) or TDI
(tolerable daily intake) are determined. The requirement
for toxicological studies is linked to the amount of the
substance that may ultimately migrate to the food
product; the higher the migration, the more rigorous
and greater number of toxicological tests should be
carried out (BARLOW, 2008). The consumers’ exposure
to these substances is established assuming that 1 kg
of food; packed in a container of 6 dm
2
is eaten every
day during their lifetime and that food will always be
packaged in the same package type and that migration
of the substance of interest is always at the maximum
concentration allowed. Based on these parameters,
restrictions on the use and limits of composition and,
especially, the specific migration limits (SML) for many
of the substances on the Positive Lists are established.
The legislation in force in the United States
differs from the European principally in relation to
toxicological tests required to establish the safety of
the substance for food contact. Whereas the European
Union considers that the level of migration determines
the toxicological tests that should be conducted,
in the United States, the level of exposure to the
substance will dictate the tests to be performed. The
Food and Drug Administration (FDA) estimates the
likely exposure to the substance by combining the
migration data with information relating to typical
uses of the package containing the substance of
interest. As such, the lower the consumer exposure
to the substance the fewer toxicological tests are
required and it can be more easily included on the list
of permitted substances for food contact (OLDRING,
2010).
The MERCOSUR legislation, and hence the
Brazilian legislation, is based on the harmonized
European legislation and therefore the limits in force
are also conservative. The MERCOSUR legislation also
includes some substances approved by the United
States, and in such cases, includes limits set by the
Food and Drug Administration (FDA).
Exposure assessment is the key part of risk
assessment of a substance and is defined by the Codex
Alimentarius (CODEX. .., 1969) as a “qualitative and
/ or quantitative evaluation of the intake of physical,
chemical or biological agents by means of food or other
sources if relevant”.
Currently there is no universally recognized
approach to estimate the exposure of consumers to
migrants from packaging material. Exposure is the sum
of the concentrations of migrants in food versus the
weight of food consumed. The exposure can be estimated
in various ways and can be summarized as described
in the document published by the International Life
Sciences Institute,( 2007):