Food Contact Materials: The Basics You Need to Know to Comply with Regulations in Latin America

Positive Lists

Genetically Modified Organisms (GMOs)

Allergens

Good Manufacturing Practices (GMP)

The regulation of food contact materials (FCMs) in Latin America follows two main approaches: alignment with MERCOSUR resolutions and the implementation of specific national requirements. This framework ensures that these materials are safe, suitable for use, and do not pose risks to human health or the environment.

MERCOSUR: Harmonization and Safety

MERCOSUR member countries adopt a harmonized approach through resolutions issued by the Common Market Group (GMC). These resolutions include positive lists of approved substances, manufacturing criteria, and migration standards. Noteworthy examples include:

• GMC Res. No. 03/92: Establishes general criteria for FCMs, requiring good manufacturing practices (GMP), adequate purity, and the absence of toxic compound transfer to food.

• GMC Res. No. 39/19: Updates permissible additives for plastics in contact with food and enforces stricter limits for substances like BPA.

• GMC Res. Nos. 40/15 and 41/15: Regulate cellulose-based materials, such as paper and cardboard, used for food packaging or filtration.

The current full members of MERCOSUR are Argentina, Brazil, Paraguay, and Uruguay, with Bolivia in the process of accession, while Venezuela remains suspended from all rights and obligations as a member state.

FCMs are governed by GMC Resolutions, developed initially by the MERCOSUR Packaging Working Group, part of Subgroup 3 (SGT-3). Once approved by the GMC, MERCOSUR’s executive body, these resolutions must be transposed into national legislation by each member state under the Ouro Preto Protocol and only take effect once adopted domestically.

Subgroup 3 (SGT-3) of MERCOSUR is responsible for establishing harmonized parameters for technical regulations and conformity assessment procedures within the bloc.

All FCMs, including household utensils, must comply with MERCOSUR’s general safety standard, GMC Res. No. 03/92. This resolution requires that all FCMs:

• Be manufactured under Good Manufacturing Practices (GMP);

• Maintain adequate purity;

• Avoid the transfer of harmful or toxic compounds from materials to food; and

• Prevent unacceptable alterations to the composition, taste, or odor of food.

General migration limits are also specified in this resolution. Separate regulations, such as GMC Res. No. 32/99, outline the testing methods required to determine overall migration values.

Beyond general safety standards, FCMs must meet specific resolutions for their material categories. For example, for plastic and paper FCMs, only substances listed in the relevant positive lists may be used to produce materials suitable for food contact.

Petition Process for Including New Materials

To include new substances in the positive list, a rigorous safety analysis is required. This process is often conducted by ANVISA (Brazil) or CONAL (Argentina) before being submitted to the MERCOSUR technical group.

National Regulations

While MERCOSUR resolutions serve as a foundation, each member country may impose additional requirements:

• Brazil: Previously required registration only for packaging made from recycled materials, such as PET-PCR. Under RDC No. 843 and Instruction No. 281/2024, only notification is now required for food-grade PET-PCR resins and precursor articles or final packaging containing PET-PCR.

• Argentina: Mandates the registration of primary packaging with specific health authorities like INV and INAL.

• Uruguay and Paraguay: Implement their own registration processes for FCMs.

Other countries in the region, such as Mexico, Chile, and Colombia, base their regulations on international standards, while nations like Peru and Bolivia are developing more restrictive approaches, including bans on substances such as BPA.

Conclusion

The regulation of FCMs in Latin America reflects a complex interaction between international standards, regional resolutions, and national legislation. For companies and consumers, the harmonization of these standards represents an opportunity to promote food safety, innovation, and sustainability throughout the region.

In addition to FCM regulations, other topics directly impact packaging and materials used in food contact, such as labeling for Genetically Modified Organisms (GMOs) and major food allergens, as well as compliance with Good Manufacturing Practices (GMP).

• GMO Labeling: Aims to inform consumers about the presence of genetically modified ingredients in food, enabling informed choices.

• Allergen Labeling: Essential for protecting individuals with food allergies by clearly identifying allergens on labels.

• GMP Compliance: Establishes guidelines for the safe and hygienic production of food, preventing contamination and ensuring product quality across the entire production chain.

These practices are critical for meeting regulatory requirements, mitigating risks, and fostering consumer trust.

Stay tuned for more publications on this topic!