Brasil
PackTrends
2020
221
safety & regulatory issues
The packaging manufacturer needs to provide the correct
control of the produced package, a traceability system,
quality assurance and good manufacturing practices. Food
producers, if they are using packaging containing recycled
material, can only use approved / authorized packages
registered by the Competent National Health Authority.
The package must be labeled “PET-PCR” (PADULA,
2010).
The use of recycled materials for food contact is
growing , including new materials and development of
new technologies for decontamination and new processes.
The law will be updated and will incorporate the new
processes as they are deemed safe for the production of
materials for food packages, although it is expected that
the individual approval process will remain.
Biopolymers
Biopolymers like all food contact materials must meet
the requirements set out in current legislation on packages in
contact with food. The polymers and additives that are part of
the material must be included in the positive lists and must
meet the established restrictions and limits.
PLA - poli(lactic acid), the most widely used
biopolymer in food packages, is approved as long as
the additives added in its formulation are listed in the
positive lists and meet the limits set by law.
The copolymer of 3 - hydroxypentanoic and
3-hydroxybutanoic acids (PHB / PHV) is also listed in
Regulation 10/2011 of the European Union (COMISSÃO
DAS COMUNIDADES EUROPEIAS (COMMISSION OF
THE EUROPEAN COMMUNITIES), 2011) and in RDC
Resolution 56/2012 of Brazil (BRASIL, 2012). In the
two laws, this copolymer is in the Appendix with a very
specific definition related to the type of microorganism
used for the production thereof.
It is important to stress that new biopolymers must
be subjected to toxicological studies and risk assessment to
establish the safety of their use for food contact and approval.
8.3 CERTIFICATION AND PROCESS SAFETY MANAGEMENT SYSTEMS
Good Manufacturing Practices
One of the basic requirements for the safety of
package materials for food contact is the application of
good manufacturing practices (GMP) in its production
process. This requirement is described in the legislation
for food contact materials in the European Union,
United States, Brazil and MERCOSUR.
GMPs are designed to ensure the safety of food
and its consumers through prevention and control of
contaminants (chemical, physical and / or biological)
following rules and procedures ranging from raw
materials to the finished product. GMP procedures are
needed to ensure sanitary quality and compliance of
packages and equipment with the law, with the aim of
contributing to the safety of the food or beverage.
According to Ordinance No. 1428 of ANVISA
(1993), GMPs are defined as rules of procedure to achieve
a certain standard of identity and quality of a product or a
service in the area of food, whose efficacy and effectiveness
should be evaluated by inspection and / or research.
In thecaseofpackages,GMPbeginwiththeselection
of suitable raw materials for which specifications should
be established, including the purity of the chemical used
and compliance with current legislation for food contact
materials, to ensure the production of a safe package. The
fabrication of the material must be monitored to avoid
the formation of products of degradation or undesired
reaction, to avoid the presence of not intentionally
added substances (NIAS) in the final package. A quality
assurance system involving the facilities, equipment and
qualified personnel should be established to ensure that
the prerequisites of safety and control are met. All aspects
and documents related to GMP must be registered and
available to the health authority.
Codes, Procedures and Manuals for Good
Manufacturing Practices should be developed and
describe the operations performed by the establishment,




