PackagingLaw.com®
A resource provided by Keller and Heckman LLP
GRAS Program
Plastics and Polymers
Regulatory Interpretations
Technical Considerations
Western Pacific Rim
KH Careers
KH Law
Home Special Focus
Regulation of Food-Contact Materials in Latin America (Part 1)
The regulatory systems governing food contact materials in Latin America run the gamut of complex to minimal. Several of the principal economies in Latin America have largely harmonized their framework of laws as full members of Mercosur (Mercado Común Del Sur or the "Common Market of the South"), the largest trade bloc in South America.
Modeled fundamentally after the EU regulatory system, Mercosur's food contact legislation consists of positive lists that limit the specific materials that may be used in food contact, and their use and migration. Other Latin American countries, while members of Comunidad Andina (CAN), the second largest trade group in South America, govern food-contact materials (FCMs) with separate, non-harmonized national legislation. By contrast, other Latin American countries independently and more loosely operate under general standards of "safety."
This report on the regulation of FCMs in Latin America will be presented in two parts. The first part will provide an overview of the regulations in Mercosur and CAN countries. The second part will discuss the regulations in Chili, Mexico, El Salvador, Costa Rica, Panama, Guatemala, and Belize.
Established by the Treaty of Asuncion del Paraguay on March 26, 1991, Mercosur was formed to promote free trade among its member states. Argentina, Brazil, Paraguay, and Uruguay are the four full members, while Chile, Colombia, Ecuador, Peru, Suriname, and Guyana constitute associate members; Bolivia is currently a member of CAN but was approved to become a full member of Mercosur in July 2015. It is now in the process of accession. Venezuela, which became a full member in 2012, remains suspended due to its failure to meet key Mercosur provisions.
Generally speaking, two levels of compliance apply in the Mercosur countries with respect to FCMs. First, the regulation of FCMs is generally accomplished through Mercosur resolutions (including a general "framework" resolution and resolutions applicable to specific categories of FCMs) that are adopted and incorporated into the laws of the member countries by their individual legislative bodies. The Mercosur resolutions on specific materials contain "positive lists" of substances that are permitted for use.
Second, the individual member countries may establish separate registration requirements that apply to packaging materials/articles. (With respect to the registration requirements, with the exception of recycled materials, no such requirements have been adopted in Brazil.)
Thus, for Mercosur's four full members, FCMs are governed by "GMC Resolutions," initially developed by the Packaging Working Group, and ultimately adopted by the Common Market Group (GMC), the executive body of Mercosur. GMC Resolutions must be transposed into the national legislation of each member state pursuant to the Protocol of Ouro Preto and only have the effect of law once transposed.
All FCMs, including housewares, must comply with Mercosur's general safety standard, GMC Res. No. 03/92 (General Criteria for packaging and articles to come into contact with foodstuffs: terminology, general criteria, and classification of materials).
Res. No. 03/92 requires all FCMs to:
be manufactured under good manufacturing practices (GMPs);
be suitably pure;
not transfer harmful or toxic compounds from the packaging to the food; and
not cause an unacceptable change in food composition, taste, or odor.
Overall migration limits are also specified under this resolution. A separate regulation, GMC Resolution No. 32/99, specifies the test methods that should be used to determine overall migration values.
In addition to the general safety standard, FCMs are obligated to comply with applicable GMC resolutions addressing specific packaging categories. For example, for plastics and paper FCMs, only substances identified on the relevant positive list may be used in Mercosur to produce FCMs. The existing positive lists include:
GMC Res. No. 02/12 identifies monomers, polymers, and other starting substances that may be used in the manufacture of food-contact plastics;
GMC Res. No. 32/07 (which is in the process of being amended) lists additives that may be used in the manufacture of food-contact plastics, including antioxidants, foaming agents, lubricants, and plasticizers, surfactants, pH buffering agents, and solvents. The resolution does not apply to impurities, intermediates, and aids to polymerization, such as catalysts, initiators, and accelerators. Both GMC Res. No. 02/12 and GMC Res. No. 32/07 include limitations pertaining to the use, composition, and specific migration levels (SMLs) of listed substances;
GMC Res. No. 40/15 ("Technical regulations on cellulosic materials, containers, and equipment intended to contact food") applies to paper and paperboard FCMs, establishing a positive list of additives used in paper, paperboard, and recycled fibers, and also specifies use, migration, and compositional restrictions. The resolution does not apply to paper used for filtration, infusion, cooking, or microwave applications;
GMC Res. No. 41/15 ("Technical regulations on cellulosic materials for hot cooking and filtration") includes a positive list for cellulosic materials used to filter aqueous foods. The resolution limits the nitrogen content of total residue from hot water extraction of paper; and
GMC Res. No. 42/15 ("Technical regulations on materials, containers, and cellulose equipment intended to be in contact with food during cooking or heating in oven") contains a positive list for paper and paperboard used for cooking in the oven and microwave, as well as identifies specific conditions for extraction testing and applicable migration limits.
Polymeric coatings applied to the interior food-contact side of metal cans, paper, and other substrates must comply with the positive lists and other requirements provided in GMC Res. No. 02/12 and GMC Res. No. 32/07. However, coatings applied to the exterior of metal cans are not yet regulated under Mercosur, as the can itself is considered a functional barrier to migration from exterior coating substances.
While not discussed in detail here, other GMC resolutions (other than positive lists), also govern the use of metals, colorants, glass and ceramics, adhesives, paper and paperboard, elastomers, and regenerated cellulose.
The Mercosur petition process
As noted, Mercosur employs a positive list approach to regulate FCMs, and in the case where an individual substance is not listed on an applicable resolution covering a harmonized food-contact sector, the compound may not be used. For substances not currently listed or listed for a more limited use than is of interest, the only avenue to obtain a clearance is to submit a petition for the resolution to be updated to include the substance(s). To obtain a clearance for a new food contact substance, a petition should be submitted to either Brazil's National Health Surveillance Agency (Anvisa) or Argentina's National Food Commission (Conal) for potential inclusion in an update to the applicable Mercosur resolution.
Anvisa reviews individual petitions for advancing to the Mercosur Packaging Group to obtain a listing. A division within Anvisa, the Gerência de Avaliação de Riscos e Eficácia or "Division for Risk and Effectiveness Evaluation" (GEARE), evaluates and prepares opinions on the safety and risks associated with materials in contact with food. Once satisfied with the petition and the data contained therein, Anvisa will advance the petition to the Mercosur Packaging Group for its review.
Likewise, within Argentina, Conal reviews individual petitions and, via consensus, will approve them for sending to the Mercosur Packaging Group for further consideration. Notably, to be considered for clearance in Mercosur, the substance must already be cleared in the U.S. or EU.
Mercosur currently will only consider petitions and updates to its legislation as part of a larger modification or update to a Resolution and does not have a mechanism for adding individual substances to the resolutions on an ongoing basis. While the Mercosur Packaging Group delegates have suggested that updates can and should occur every five years, the timeline for amending a resolution in practice is far longer.
National Registration Requirements
Each member state may also have its own additional registration requirements for FCMs. For example, member states, with the exception of Brazil, also require finished food packaging to be registered before being sold. In Argentina, final (primary) food-contact packaging articles must be registered and approved by one of three national sanitary authorities:
the National Wine Institute (INV),
the National Service of Agricultural Food Health and Quality (Senasa), or
the National Food Institute (INAL) (responsible for imported food contact articles and those domestically produced food-contact articles used by food and beverage companies not registered with Senasa or INV).
To obtain an approval of the final article, a sample of the container must be submitted to the appropriate authority listed above, along with information on the composition of all of the components of the constituent materials. The authority will:
verify that all the components of the constituent materials declared in the application are present in the positive lists of the Argentine legislation (CAA); and
arrange for migration tests on the sample according to the requirements set forth in the CAA and the declared composition.
In Paraguay, the National Institute of Food and Nutrition (INAN) is responsible for enforcing food and food-contact legislation, including the registration requirements that apply to final food contact articles.
As for Uruguay, the Ministry of Public Health oversees the registration of food and FCMs. The Uruguay Technological Laboratory (Latu) performs evaluations of FCMs.
Again, Brazil only requires registration of food packaging produced from recycled materials.
Mercosur developments
GMC Res. No. 32/07 may be nearing the end of a years-long revision process to align it more closely with the EU's Plastics Resolution No. 10/2011. The revised version of the resolution has been designated as Proposed Res. No. 05/18 (Mercosur Technical Regulation on the positive list of additives for the preparation of plastic materials and polymeric coating in contact with foodstuffs) and updates the list of permitted additives. Notably, solvents are excluded from the scope of the draft resolution, provided they meet certain restrictions:
a boiling point less than 150°C;
must not be mutagenic, carcinogenic, or reproductive toxicants (CMRs); and
must not migrate at levels greater than 0.01 mg/kg.
All member states have completed the required internal consultation period and gathered comments on the draft resolution. Paraguay and Uruguay presented the results of their internal consultation periods in the April 8-12, 2019 meeting of Mercosur's SGT No. 3 committee (i.e., the technical subgroup to which the Mercosur Food Commission belongs).
Argentina and Brazil are expected to present the results of their internal consultation at the next SGT No. 3 meeting. If further changes are recommended to the draft based on the comments received, then the Mercosur Food Commission may of course revise the draft, subject to another round of public consultation. However, if further changes are not needed, it will be sanctioned as an official GMC Resolution. Transposition into member state national legislation is expected to occur over a period of six months to a year.
GMC Res. No. 02/12 is only in the early stages of potential revision. Brazil has proposed adding new substances to the monomers resolution, as well as reducing the SML for bisphenol A (BPA). Further, a report presented by Argentina during the April 8-12, 2019 SGT No. 3 meeting requested the inclusion of new substances that were recently added to the EU Plastics Regulation. Nevertheless, given that the Proposed GMC Res. No. 05/18 has been years in the making and has still not been finalized, it may be some time before any update to GMC Res. No. 02/12 can be expected.
Formed in 1969 by the Cartagena Agreement, Comunidad Andina (CAN)'s members are Bolivia, Colombia, Ecuador, and Peru. Bolivia, as noted above, is in the process of integrating into Mercosur.
The regulation of FCMs among CAN member states is not harmonized. Thus, companies should look to the national law of each member state for guidance. Notable legislation in each of these countries pertaining to FCMs are summarized below.
Bolivia – The Bolivian National Service of Livestock Health and Food Safety is responsible for food safety in Bolivia. Administrative Resolution No. 019/2003 sets forth sanitary requirements for foods and beverages and requires that packaging materials for foods and beverages provide adequate protection to foods so that they do not become contaminated or damaged. Further, packaging materials must be non-toxic. The Bolivian Institute for Standardization and Quality has issued standards pertaining to FCMs (including plastic containers), but does not define the methods of assessment.
Colombia – Resolution No. 683 (2012) provides a general safety framework for FCMs and requires that all FCMs be cleared in the U.S., EU, or Mercosur; otherwise, a petition may be submitted to obtain formal clearance.
Ecuador – Executive Decree 4114 (1988) establishes general requirements for food packaging, including that they must be safe.
Peru – Ministerial Decree N. 007/1998, Regulation on the Sanitary Surveillance and Control of Foods and Beverages, requires that packaging not transfer substances to food and must not contain impurities such as heavy metals and metalloids that can cause damage to consumers' health. The decree also prohibits certain residual monomers and limits any other residual monomers that would damage consumers' health.
While many Latin American countries simply mandate that FCMs be safe for their intended use, Mercosur and CAN member states have specific requirements pertaining to FCMs that should be carefully followed. Companies seeking to market FCMs in Mercosur member countries should be mindful of the legal requirements at both the Mercosur level and the individual member state level, as they may well differ in scope and depth.
Copyright 2019: This article was re-published with the permission of Chemical Watch www.chemicalwatch.com. The original article in Chemical Watch can be viewed here.
Catherine R. Nielsen
Related By Topic
Brazil Adopts Updated Positive List for Plastic FCMs
FDA Adds Seven New Substances to its Inventory of Effective FCS Notifications
Related By Region
Mercosur's Updated Additives Positive List Discussed at KH Seminar
Regulation of Food-Contact Materials in Latin America (Part II)
© 2020 Keller and Heckman LLP