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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,