Brasil Pack Trends 2020

Brasil

PackTrends

2020

219

safety & regulatory issues

and a decision tree for toxicological testing. This guide

has been the basis for studies related to nanoparticles

embedded in package materials.

The European Union, in 2011, published Regulation

10/2011 (European Commission, 2011) which stipulates

in Article 9 section 2 that the substances in nano form can

only be used if they have been expressly authorized, i.e., the

authorization of use of nano substances must be carried out

on a case by case basis. It also establishes in Article 14 that

the functional barrier concept does not apply to nanoscale

substances. Currently this Regulation has approved only

three nanometric substances: SiO

(with size specification

included), carbon black (with size specification included)

and TiN (with size specification included).

In 2012, the FDA published a Draft Guidance for

Industry:Assessing

theeffectsofSignificantManufacturing

Process Changes, including Emerging Technologies, on

the Safety and Regulatory Status of Food Ingredients

and Food Contact Substances, including ingredients that

are color additives (U.S. DEPARTMENT... 2012) which

includes in item III-E issues related to nanotechnology.

This document states that safety assessments of nanoscale

substances should be based on relevant data related to the

chemical and physical properties of the substance. It also

considers that the extrapolation of results is not possible

and that the assessment should be conducted on a case

by case basis.

Amajor focus for the characterization of nanoparticles

is its definition. The FDA, in the above cited document,

has not yet established an official definition of a regulatory

standpoint. The European Union published this definition

in Recommendation 2011/696/EU of 18 October 2011:

“Nanomaterial means as a natural, incidental

or manufactured material, containing particles in an

unbound state or as an aggregate or as an agglomerate

and where, for 50% or more of the particles in the

number of particles distribution, one or more external

dimensions are in the size range of 1nm - 100nm.

In specific cases where warranted by concern for the

environmental, health, safety or competitiveness

threshold of 50%may be replace by a threshold between

1 and 50%”.

This document also provides definitions

for particles, agglomerations and aggregates.

Other documents related to risk assessment and

risk management of nanotechnology were published by

FAO (LUETZOW, 2012) and ILSI Europe (COCKBURN;

BRADFORD, 2012).

Studies related to the characterization of

nanomaterial, nanoparticle migration and risk

assessment have been conducted, and some results

related to the migration of silver nanoparticles were

published by Bott et al. (2012 a, b) and Noonan et

al. (2012) and TiN nanoparticles (BOTT; STORMER;

WOLZ; FRANZ, 2012c).

In Brazil and MERCOSUR there is still no specific

legislation on the use of nanomaterial for food contact.

Recycled Materials

With increasing environmental awareness and issues

related to sustainable development, recycling of package

materials for food contact has become very important.

Plasticmaterials, which have their origin in oil, have become

the main focus of discussion and since the nineties many

plastics recycling processes have been developed.

Plastics for food contact are regulated by various

laws and must comply with positive lists and migration

tests and should not transmit toxic substances to foods

and / or change the odor / taste of the food. Recycled

materials must also comply with these regulations.

However, due to the chemical nature of the plastics,

it is possible that contaminants resulting from the

first use of the package or container misuse by the

consumer can remain in the material and migrate to

the food product. Thus, processes that ensure the

cleanliness of the material for potential contaminants

have been developed, allowing post-consumer recycled

materials to be used again for food contact. There are

two different processes for recycling, chemical and

mechanical recycling. In chemical recycling, the plastic

is depolymerized to monomers or oligomers, which are

purified, isolated and used in the polymerization of new

materials. For this process, if the monomers meet the

purity criteria set out in the legislation, they are approved

for food contact. In mechanical recycling, post-consumer

material is melted again and subjected to steps of

washing and decontamination. To prove the efficiency of