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safety & regulatory issues
the decontamination process and to approve processes,
protocols have been established by the FDA - Guidance
for Industry: Use of Recycled Plastics in Food Packaging:
Chemistry Considerations (U.S. DEPARTMENT..., 2006)
and by the EFSA - Guidelines on submission of the
dossier for safety evaluation by the EFSA of a recycling
process to produce recycled plastics intended to be used
for manufacture of materials and articles in contact with
food (GUIDELINES..., 2008). The protocols require
that the material must be contaminated with model
contaminants, representative of substances that may be
present in the material after use, and then must undergo
a cleaning process (Challenge test). By the end, the
contaminants should be quantified in the material, and
migration testing or estimations of migration should be
performed. No migration may be detected, i.e. it must be
below the detection limit of the method. The Challenge
test is the first step toward approving a process for
recycling post-consumer plastics for food contact. To
regulate all the requirements for this type of material,
specific legislation for recycled materials for food contact
were established by the European Union, United States
and MERCOSUR / Brazil.
The European Union established Regulation (EC)
N° 282/2008 (COMMISSION OF THE EUROPEAN
COMMUNITIES, 2008). This regulationprovides individual
authorization for processes within the Community after
the safety assessment of the recycling process conducted
by EFSA (SCHAFER, 2010). The source of material to
be recycled and the ability of the process to reduce the
contamination are considered critical. Only plastics which
meet the composition requirements established by the
regulations can be used as feedstock for the recycling
process. All recycling processes should have a system of
quality assurance and should be audited by the member
states, and processes as well as packages containing
recycled material must be accompanied by a declaration of
compliance. The final product must meet the requirements
of the regulations on plastics and Regulation 1935/2004
(PARLAMENTO EUROPEU, 2004).
The United States does not have specific legislation
for post-consumption recycled materials. For the process to
be approved, the protocol Use of Recycled Plastics in Food
Packaging: Chemistry Consideration (U.S. DEPARTMENT...,
2006) must be considered. The results are submitted to the
FDA that issues a No Objection Letter (NOL) that contains the
name of the company responsible for the process, the type of
material, the date of the letter, the type of process (chemical or
mechanical), the permitted use and limitations (food, contact
temperature and rawmaterial) (U.S. DEPARTMENT..., 2013).
PET, for its extensive use in soft drink bottles and also for its
characteristics, is the most studied material and has the most
recycling processes approved.
In 1999 MERCOSUR adopted Resolution GMC
25/99 - Disposable multilayer PET packages intended
for the packaging of non-alcoholic carbonated beverage
- which allows use of the middle layer of recycled post-
consumer PET (published in Brazil as Ordinance No.
987, of December 8, 1998). This resolution states that
the layer which comes into contact with the beverage
is virgin PET with a minimum thickness of 25 μm and
control analysis should be performed on the bottles to
guarantee its quality. The company must be authorized
by the competent authority (PADULA, 2010).
The use of post-consumer recycled PET for direct
food contact was approved in MERCOSUR as Resolution
GMC 30/07, in December 2007, and published in Brazil
as RDC 20, of March 26, 2008 – Technical Regulation
on food grade post-consumer polyethylene terephthalate
packages (PET) (food grade PET-PCR), intended to come
into contact with food (BRAZIL, 2008). While the laws of
the European Union and the United States apply to plastics
in general, this MERCOSUR resolution is only for PET. To
assess the efficiency of the process, protocols established
and authorization given by the FDA and EFSA are accepted
and packages must alsomeet the requirements established
in MERCOSUR legislation on plastic containers. The
responsibility for the quality of PET-PCR is divided among
the producer of PET-PCR resin, the producer of PET-PCR
packaging and the food producer. It is important in this
resolution that the packages and/or precursor articles of
food grade PET-PCR must be approved/authorized and
registered with the Competent National Health Authority,
following established procedures. Controls of the source
of raw material, and of the process and quality of the
resin obtained are required of the resin manufacturer.