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Brasil

PackTrends

2020

218

safety & regulatory issues

For active packages that interact with the

foodstuff or the atmosphere around the product two

situations can occur: the absorption of substances

released by food (such as ethylene absorbers) or the

emission of substances (such as antioxidants) that act

on food improving its quality or condition. In this case,

these substances are added to packaging to intentionally

migrate into the food. However, the release of these

substances into the food should be performed under

certain conditions. The substance emitted must be

authorized by food legislation and used in accordance

with the requirements, i.e., the limits established

must be observed independently of the origin of the

substance in food (directly added or via the package)

and be used only for permitted foods. The declaration of

compliance of the packaging is essential in this case to

ensure that consumers are properly informed by the food

manufacturer, and also because this substance should

be declared among the food ingredients on the label.

For substances which have an active or intelligent

function in the package, but should not intentionally

migrate to food and have no function on the food,

safety evaluation studies should be performed and then

submitted to the opinion of the European Food Safety

Authority (EFSA). When authorized these substances

will be listed on a specific Positive List of active and

intelligent packages and their identity, function and

conditions and / or restrictions of use will be described.

It is also important to remember that the materials in

which the active ingredients are incorporated must comply

with specific legislation for that material, for example,

plastic material must meet the regulations for plastics.

In Brazil, nowadays, the use of active and

intelligent packages is restricted to substances described

in the Positive List of packaging materials legislation,

which are restricted to those that should not intentionally

migrate to food and to those substances related in food

laws that will be released and be part of the food. There

is no current requirement to declare the ingredient on

the food label and also no requirement of declaration of

compliance issued by the package manufacturer. It is

expected that in the near future these materials will be

regulated in Brazil and MERCOSUR.

Nanotechnology

The safety of nanomaterial for food contact raises

many questions:

• Does the nanoparticle have potential for migration?

• If so, what is the potential for ingestion of toxic,

carcinogenic or teratogenic substances?

• What are the biological interactions associated with

the presence of the nanoparticle? What is important?

Surface area? Mass? Surface modification with

fillers, for instance?

• What is the biological response to the presence of

nanoscale materials ?

• Do “traditional” toxicology risk studies apply to

nanomaterial?

• How is the consumers exposure to nanoscale

materials characterized?

• How are hazards identified and risks evaluated?

• Are analytical techniques available to detect these

materials effective?

• How are materials with nanometer dimensions

characterized? What equipment should be used?

• How are environmental and occupational questions

relating to nanomaterial answered?

Currently not all questions have answers and there

is still no specific packaging legislation for these materials.

However, in recent years many advances have been observed

in studies on the use of nanoparticles in package materials.

In 2011, the European Food Safety Authority

(EFSA) published a guide containing procedures for

risk assessment of nanomaterial - Guidance on the

risk assessment of the application of nanoscience

and nanotechnologies in the food and feed chain

(GUIDANCE..., 2011). This guide covers the requirements

for physicochemical characterization of nanomaterial

and tests to identify and characterize hazards (in vitro

genotoxicity, absorption, distribution, metabolism and

excretion (elimination) - ADME and oral toxicity studies),

which have their origin in nanoparticle properties such as

size, surface area, reactivity, ability to ‘permeate’ through

biological membranes and so on . The guide also presents

schemes for risk assessment, toxicological evaluation