Regulation of Food-Contact Materials in Latin America (Part 2)
This is the second article in a two-part series on the regulation of food-contact materials (FCMs) in Latin America. Part 1 provided an overview of the regulations in Mercado Común Del Sur (Mercosur) and Comunidad Andina (CAN), the first and second-largest trade blocs in South America.
Part II discusses regulations in Chile, Mexico, El Salvador, Costa Rica, Panama, Guatemala, and Belize. FCMs are not as extensively regulated in these countries as they are in Mercosur and CAN countries.
Chile’s Ministry of Health regulates food and food packaging under Decree No. 977, the Sanitary Regulation for Food Products. Title II (regarding food), Paragraph III (on packaging and utensils) of this regulation establishes general standards for FCMs.
Article 123 of Decree No. 977 generally provides that all utensils, vessels, containers, packaging, wrappings, and packaging apparatuses must not release substances that are toxic, or otherwise contaminate or modify the organoleptic or nutritional characteristics of the food.
Article 125 sets further limits on the content of heavy metal impurities in these articles (specifically, a combined limit of 0.1% for lead, antimony, zinc, copper, chrome, iron, or tin, and a 0.01% limit for arsenic or other contaminants composed of hazardous metals).
Similarly, Article 126 - in addition to setting residual monomer limits for styrene, vinyl chloride, and acrylonitrile - requires in general that plastics in contact with food may not contain substances that may be hazardous to health.
Food-packaging materials in Chile are also subject to official standards established by the National Institute of Standardization (Instituto Nacional de Normalización). While Chile has not adopted a positive list of monomers or additives that are permitted for use in plastic food packaging, a 1972 standard entitled, “Processed Food Containers: Terminology, Classification and General Requirements,” establishes good manufacturing practice standards for finished materials.
Likewise, in Mexico, FCMs must simply be safe for their intended use. Unlike Mercosur, Mexico does not maintain a positive list of materials that are considered acceptable for use in FCMs. And premarket clearance of packaging materials is not currently required.
Mexico’s General Health Law (the Ley General de Salud) governs, among other things, the manufacture and sale of food and beverages. In January 1988, Mexico’s Secretary of Health issued regulations under the Ley General de Salud, which are still in place today. (See Regulations of the General Health Law Concerning Sanitary Control of Activities, Establishments, Products, and Services (1988) (“Health Regulations”).)
The Health Regulations prohibit the adulteration or contamination of foods, and address specific aspects of the manufacture, production, transportation, and marketing of food, food additives, and food packaging. A “food additive” is defined narrowly as any substance that is added to food or beverages for a particular purpose, to enhance aroma, color, or flavor; thus, FCMs are not subject to the same regulatory requirements as direct food additives.
Title 24 of the Health Regulations defines primary packaging as those “containers” used in direct contact with food, and requires that such containers preserve the physical, chemical, and sanitary integrity of their contents.
The regulations state that food-packaging should be sufficient to prevent chemical and microbiological contamination of the product and should be in good, clean, and if necessary, sterilized condition. In addition, packaging for products intended for direct human consumption may not transfer its elements or substances detrimental to health to the packaged food in proportions greater than those authorized by any corresponding standard.
Mexico also has various official norms enforced by the Secretary of Health, referred to as Official Mexican Norms (or Norma Oficial Mexicanas (NOMs)) that relate to hygienic/sanitary specifications for FCMs. The only NOMs directly related to FCMs are:
- NOM-130-SSA1-1995, Bienes y Servicios. Alimentos Envasados en Recipientes de Cierre Hermético y Sometidos a Tratamiento Térmico. Disposiciones y Especificaciones Sanitarias. (Goods & Services. Food Packaged in Airtight Sealed Containers and Subjected to Heat Treatment. Dispositions and Sanitary Specifications.)
- NOM-002-SSA1-1993, Salud Ambiental. Bienes y Servicios. Envases Metálicos Para Alimentos y Bebidas. Especificaciones de la Costura. Requisitos Sanitarios. (Environmental Health. Goods & Services. Metallic Containers for Food and Beverages. Specifications for Sealing. Sanitary requirements.)
- NOM-194-SSA1-2004, Productos y servicios. Especificaciones sanitarias en los establecimientos dedicados al sacrificio y faenado de animales para abasto, almacenamiento, transporte y expendio. Especificaciones sanitarias de productos. (Products and services: Sanitary specifications in establishments dedicated to the slaughter and dressing of animals for supply, storage, transport, and sale)
The above-listed NOMs generally provide only minimum language regarding hygienic/sanitary specifications, and do not establish compositional requirements for FCMs.
Like Mexico, other Latin American countries such as El Salvador, Costa Rica, Panama, Guatemala, and Belize do not have positive lists or specific technical requirements for FCMs.
El Salvador’s Ministry of Public Health and Social Assistance regulates the safety of food and beverages, but has not passed legislation regarding food packaging specifically.
Costa Rica’s General Health Law (Ley no. 5395 of October 30, 1973) requires that materials used to manufacture food packaging do not result in any risk to human health.
Panama merely requires that food be packaged with food grade materials.
Guatemala’s Health Code (Decreto No. 90-97) requires that food packaging materials not alter their contents.
Belize’s Food and Drugs Act, Chapter 291 (2000) governs food safety and prohibits substances from being added to food if they would make such food injurious to human health or unfit for consumption.
Latin American countries that are not members of Mercosur or CAN generally have less comprehensive regulations governing FCMs than those countries that are members. These regulations range from general safety requirements specifically for food packaging to safety requirements for food that can apply to food packaging. For example, Belize’s prohibition against the addition of substances to food that make the food injurious to human health or unfit for consumption applies to FCMs that migrate from the package to the food. Thus, FCMs must merely be safe for their intended use in the Latin American countries discussed above.