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Brasil
PackTrends
2020
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safety & regulatory issues
With the creation of the Southern Common Market
(MERCOSUR) consisting of Brazil, Argentina, Paraguay
and Uruguay there was the need to harmonize national
laws including those related to package materials
for food contact. The process of harmonization was
initiated in March 1992, coordinated by the Common
Market Group (GMC), the executive body of MERCOSUR
which has among its functions the approval of the GMC
Resolutions, which are harmonized Supranational
Laws for the countries involved. The harmonization
of legislation on package materials for food contact
is discussed in the Working Subgroup 3 (SGT-3) -
Technical Regulations and Conformity Assessment of
MERCOSUR within the Food Commission.
At the time of the formation of the common
market, Brazil and Argentina already had laws regarding
food contact materials based on the Positive List, total
migration tests and composition limits. In 1992 at the
beginning of the harmonization process, it was agreed that
the law common to all four countries should also follow
this model. The first MERCOSUR Resolution concerning
package materials comes from this time; Resolution GMC
03/92 - “General Criteria and Classification of Package
Materials and Equipment in Contact with Food in Annex
to this Resolution,” It is still in effect and published
in Brazil as Resolution RDC No. 91, May 11, 2001
(BRAZIL, 2001). This resolution applies to all packages
and equipment that come into direct contact with food
during its production, processing, fractionation, storage,
distribution, marketing and consumption and defines the
criteria for a food contact material: in compliance with
Positive Lists, total migration limits, specific migration
limits, when established, and composition limits. It is
required that the components used in the package should
have purity suitable for the intended purpose (BRAZIL,
2001).
Among the general criteria it is established that
packages must be manufactured in accordance with Good
Manufacturing Practices, should not cause unacceptable
changes in food composition or in sensory characteristics
and should not pose risks to human health. Annexed to
this resolution is the classification of package materials,
which are regulated by specific resolutions.
Legislation for plastics, cellulose, metal, glass,
regenerated cellulose, elastomers, adhesives and film-
forming polymers are in force in Brazil and MERCOSUR.
These laws follow the principle of the Positive List and
migration tests and are based on international legislation
for these materials (PADULA, 2010).
To be valid in the member states of MERCOSUR,
resolutions must be incorporated into national
legislation. In Brazil, the National Agency of Sanitary
Surveillance (ANVISA) of the Ministry of Health is
responsible for the internalization of GMC Resolutions,
which is done through the publication of Ordinances
and Resolutions for each type of package material. In
Argentina, the GMC Resolutions become Resolutions
of the Ministry of Health and are incorporated into the
Argentinian Food Code. In Uruguay and Paraguay, GMC
Resolutions were published by the Ministry of Public
Health and the Ministry of Public Health and Social
Welfare, respectively (PADULA; CUERVO, 2004).
The criteria for inclusion of new substances in the
Positive Lists involves justification of the technological
need for their use, and approval according to policies
or regulations of the European Union and/or the U.S.
Code of Federal Regulations. Exceptionally, other
internationally recognized laws can be accepted, as is
the case with German Recommendations for cellulosic
materials. The exclusion of substances or modifications
of specific migration limits or composition limits are
based on new scientific and technological knowledge.
The legislation also establishes the criteria and
procedures to be followed for the total and specific
migration tests to check they meet the limits set in
the Positive List and total migration limits (BRAZIL,
2010a). Purity criteria are also established for pigments
and colorants (BRAZIL, 2010b).
New packaging systems or new technologies must
also be approved by the competent authority, submitting
the completed studies for review and approval within
MERCOSUR.
MERCOSUR and Brazil