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Brasil
PackTrends
2020
217
safety & regulatory issues
Packages and materials approved as prescribed by the
FDA for sale and use in Brazil must be approved according
to MERCOSUR / Brazil legislation as the two countries have
differences in procedures for approval of a package material.
The harmonization of laws is not a simple
issue. As described above, the differences begin in
the establishment of acceptable limits of substances,
where, although, the toxicological issue is the main
aspect, the interpretation of consumer exposure differs
by country. Undoubtedly, the harmonization of existing
laws, including those of Japan and one that is being
established by China, is the desire of the professionals
involved to guarantee the compliance of a material with
the various laws currently enforced. It is difficult, time
consuming and expensive work. Harmonization greatly
facilitates international trade in this era of globalization
and would undoubtedly be an important factor for Brazil.
Efforts and studies have been conducted aimed
at harmonization of laws in the future, as is the case
for studies developed in the European Union. However,
we must remember that harmonization should start
with studies to establish acceptable limits for various
substances and that exposure to contaminants depends
on the characteristics of each country.
Harmonization
can also be generally included in the legal exemptions
such as Substances Generally Recognized as Safe (GRAS)
or those sanctioned or approved before the enactment
of the Food Additives Amendment of 1958 or even be
considered exempt from regulation by the principle of
Threshold of Regulation. Upon proving that the substance
will not migrate to food under the conditions of use, it is
not considered a food additive and therefore does not
require FDA approval. The substance for applying this
principle cannot be carcinogenic or contain carcinogenic
contaminants. (BAUGHAN; ATTWOOD, 2010).
The FCN program was initiated in 2000 and,
although it requires the same documentation required
for the petition process it has the advantage of approval
time, when the notice can become effective in up to
120 days. The process of petition application in some
cases can take four years. Another difference is that
in the case of FCN the identified manufacturer is the
owner and only he can market the substance.
Active and smart packages
According to the principles that guide legislation,
packaging must be inert, not release substances to the
food which could endanger human health and not change
the odor and taste of the product and its composition.
However, with recent technological developments it has
been possible to attribute new functions to packaging: to
inform consumers about the condition of the packaged
food and interact with the food product by releasing or
absorbing substances (SCHAFER, 2010) . Because of this
fact, new concepts had to be introduced in the legislation:
active packages and intelligent packages. The European
Union revised the legislation and in 2004 published the
Regulation 1935/2004 introducing these new concepts.
In 2009, they published Regulation (EC) 450/2009 with
additional rules for these materials (COMMISSION OF
THE EUROPEAN COMMUNITIES, 2009). These new
concepts have not yet been introduced in MERCOSUR
legislation, while U.S. law assumes that these concepts
are already covered by their current legislation.
In accordance with European regulation, the concept
of being inert as well as control of migration is applicable
for smart packages. However, due to the extra function
of monitoring the packaged food, it is essential that the
information provided by the package does not confuse or
mislead the consumer.
Legislation for New Technologies and New Materials