MERCOSUR Food Packaging & Food Contact Materials - Polymers
- Working Heroes
- Feb 9
- 11 min read
Regulation of Plastics and Coatings for Food Contact in MERCOSUR
When it comes to food safety, the regulation of plastics and polymeric coatings for food contact plays a pivotal role. MERCOSUR (Mercado Comum do Sul), one of the world’s largest regional trade blocs, has established comprehensive guidelines to ensure that food packaging and related materials meet strict safety and quality standards.
In this article, we’ll explore the key aspects of these regulations, their implications for businesses, and how they contribute to consumer health across MERCOSUR’s member countries.
Check out our podcast discussing more details on Food Packaging & Food Contact Materials
Audio Overview
Why Are Food Contact Regulations So Important?
Every day, millions of people rely on food packaging to keep their meals fresh and safe. But did you know that the materials used in that packaging can impact the food itself? That’s why MERCOSUR has created stringent rules to regulate:
Permissible additives and monomers: Only approved substances can be used in plastics and coatings.
Migration limits: Ensuring harmful chemicals don’t transfer from packaging to food.
Testing conditions: Simulating real-world scenarios to validate packaging safety.
These regulations are not just about compliance—they’re about building trust in the food we eat.
What Do MERCOSUR’s Food Contact Rules Cover?
The regulations include a wide array of directives, such as:
Positive lists of materials, additives, and monomers permitted for use.
Specific migration limits (SMLs) for substances to control contamination.
Guidelines on colorants in plastics, including the maximum allowable levels of metals.
Testing protocols to simulate food contact scenarios and measure substance migration.
These rules apply to a variety of materials used in packaging, coatings, and even the inks and adhesives that come into contact with food.
Who is MERCOSUR and Why Does It Matter?
MERCOSUR, founded in 1991 through the Treaty of Asunción, unites key economies in South America under a shared goal of economic integration and trade facilitation.
Member Countries
Full Members: Argentina, Brazil, Bolivia, Paraguay, Uruguay (and Venezuela, currently suspended).
Associate Members: Chile, Colombia, Ecuador, Peru, and others.
This bloc isn’t just about trade; it’s about harmonizing standards to create safer products and seamless trade across borders.
The Bottom Line: Building a Safer Future
By regulating food contact materials, MERCOSUR ensures that businesses prioritize consumer safety. These standards protect millions of people while fostering innovation in food packaging.
For companies, staying compliant isn’t just a legal requirement—it’s an opportunity to build consumer trust and enhance brand reputation in an increasingly safety-conscious market.
Unlocking Food Safety with more details on MERCOSUR Regulations.
MERCOSUR regulations set limits for the migration of substances from plastic food packaging into food, including both overall migration and specific migration limits. These limits are in place to ensure that food contact materials do not pose a health risk by transferring undesirable substances into food.
Here's a breakdown of the migration limits:
Migration Limits: The regulations define limits for the migration of substances from packaging into food. These limits can be specific (LME - Limite de Migração Específica) for individual substances, or a total migration limit (LMT - Limite de Migração Total). Different migration limits are established for metals, monomers, additives and other substances.
Overall Migration (Total Migration):The overall migration limit for non-volatile substances is 10 mg/dm² [5]. This limit applies to the total amount of substances that migrate from the packaging material to the food simulant.
For packaging with a defined volume, the overall migration can be expressed as mg/kg, based on the real ratio between the contact surface area and the mass of food.
For elements like lids, seals, and other sealing systems, the total migration value is expressed in mg/kg, using the actual volume of the container, with a limit of 60 mg/kg, or in mg/object, if the intended use is unknown.
For coatings applied to pipes or hoses used for continuous liquid transport, migration is expressed in mg/kg using a surface area/food mass ratio of 0.1 dm²/kg, with a limit of 60 mg/kg.
For packaging and equipment with a capacity equal to or greater than 250 ml, and for sealing elements or small objects, the limit is 50 mg/kg of food simulant.
For packaging and equipment with a capacity of less than 250 ml, the limit is 8 mg/dm² of the surface area of the packaging.
Specific Migration:Specific migration limits are set for individual substances that may migrate from plastic packaging into food. These limits are established based on toxicological concerns.
Specific migration limits are established for a variety of substances including monomers, additives, colorants, heavy metals and other elements.
For substances that confer color, heavy metals and other elements, the specific migration limits are defined in the MERCOSUR Technical Regulation for colorants in plastic packaging and equipment intended for food contact.
Specific migration limits are also defined for monomers and additives used in plastic food packaging.
Specific migration is determined using methods described in EN Series 13130 standards. When analytical methods are not described in this standard, instrumental analytical techniques with adequate sensitivity are to be used.
For substances that are unstable in food simulants or when there is no adequate analytical method for specific migration, compliance can be verified by calculating the migration by approximation.
It's important to note that the specific migration limits are often substance-specific and can vary. The regulations also specify requirements for analytical testing and the use of food simulants to assess migration. Additionally, the regulations emphasize the use of good manufacturing practices to minimize migration and ensure food safety.
Food Simulants in Migration Testing
Food simulants are used in migration tests to imitate the behavior of different types of foods. The simulants are brought into contact with plastic materials, and the amount of substances that migrate into the simulant is measured to ensure it is within established safety limits. The selection of simulants depends on the characteristics of the food the plastic is intended to contact.
Here are the food simulants used in migration tests, according to the sources:
Simulant A: Used for aqueous, non-acidic foods with a pH greater than 4.5. Simulant A is distilled or deionized water.
Simulant B: Used for aqueous, acidic foods with a pH less than 4.5. Simulant B is a 3% (m/v) solution of acetic acid in distilled or deionized water.
Simulant C: Used for alcoholic foods with an alcohol content greater than 5% (v/v). Simulant C is a 10% (v/v) solution of ethanol in distilled or deionized water. The concentration is adjusted to match the actual alcohol content of the product if it exceeds 10%.
Simulant D: Used for fatty foods. The specific simulant used depends on the type of fatty food being simulated.
For total migration tests, Simulant D or D' is used.
For specific migration tests, Simulant D or D' is used.
For migration tests of substances that impart color in plastic materials containing colorants, coconut oil is used.
For products such as whole milk, condensed milk, skim or partially skimmed milk, fermented milks like yogurt, cream, sour cream, and refrigerated dairy desserts, a 50% (v/v) ethanol solution in distilled or deionized water is used.
Simulant D': This is an alternative simulant for fatty foods. The sources do not specify the components of simulant D', but do note that it is used for total migration tests. When simulant D' is used, the test conditions differ from when simulant D is used.
Isooctane: When evaluating compliance for contact with fatty foods, isooctane is used as simulant D.
The appropriate simulant is selected based on the type of food. For instance, only one of simulants A or B is used for non-alcoholic beverages, with simulant A used for foods with a pH greater than 4.5 and simulant B used for foods with a pH of 4.5 or less.
When testing food contact materials with multiple food categories, a combination of simulants is used, such as A and D or D' for aqueous non-acidic foods containing fats and oils or B, C, and D or D' for aqueous acidic, alcoholic, and fatty foods.
It is also noted that for plastic materials intended to come into contact with foods at room temperature or below, migration tests are conducted for 10 days at 40°C.
Solvent Regulations for Food Contact Materials
The sources provide several rules and restrictions regarding the use of solvents in the production of plastic materials and coatings intended for food contact. Here's a summary of the key regulations:
Solvents must be authorized. Only substances included in the positive lists of authorized components can be used in the manufacture of plastic packaging and equipment, and these components must have a degree of purity that is compatible with their intended use. These lists may be modified to include new components if they don't pose a significant health risk and there is a technological need.
Boiling point restrictions: Solvents with a boiling point of less than 150°C, not specifically listed in the positive list of authorized additives, may be used if they are not mutagenic, carcinogenic, or toxic to reproduction, and if they do not result in migration exceeding 0.01 mg/kg. Alkanes and cycloalkanes are permitted for use as polymerization solvents if their boiling point is up to 100ºC.
Specific solvents are permitted for specific uses, such as in adhesives or polymeric coatings.
Methanol is allowed for use only in adhesives and polymeric and resinous coatings.
n-Propanol is allowed for use only in adhesives and polymeric and resinous coatings.
Isobutanol is allowed for use only in adhesives.
Isoforone is allowed for use only in adhesives.
Acetone is allowed for use only in adhesives.
Isopropyl acetate is allowed for use only in adhesives.
n-Hexane is allowed for use in adhesives, polymeric and resinous coatings for polyolefin films, and as a polymerization solvent.
2-Methylpentane is allowed for use as a polymerization solvent.
Cyclohexane is allowed for use in adhesives and as a polymerization solvent.
Diacetone alcohol is allowed for use only in adhesives.
Dipentene is allowed for use only in adhesives.
Heptane is allowed for use only in adhesives.
Monometil ether of propylene glycol is allowed for use only in adhesives.
Pinene oil is allowed for use only in adhesives.
Tall oil fatty acids are allowed for use only in adhesives.
Migration limits:
Solvents must not migrate into food in quantities that represent a risk to human health.
For some solvents, there are specific migration limits. Toluene, for example, has a specific migration limit of 1.2 mg/kg. Methyl ethyl ketone (2-butanone) has a migration limit of 5 mg/kg, and methyl isobutyl ketone also has a migration limit of 5 mg/kg.
Tetrahydrofuran has a specific migration limit of 0.6 mg/kg, and is allowed for use in adhesives, polymeric coatings for polyolefin films, and in PVC, PVDC and PVA resins.
Cyclohexane has a migration limit of 1 mg/kg and must have a benzene content of less than 0.1% m/m. It is allowed for use in adhesives and as a polymerization solvent.
For some solvents that are ethers of ethylene glycol, there is a combined migration limit. Monoethyl ether of ethylene glycol, monobutyl ether of ethylene glycol, monoethyl ether of diethylene glycol, and their acetates each have a combined migration limit of 3 mg/kg, which applies to the sum of these substances.
Purity standards: Substances used in the manufacture of plastic materials must comply with purity criteria that are compatible with their intended use.
Restrictions on use:
Some solvents are restricted to specific applications, such as use only in adhesives or coatings.
Some solvents, like alcohols, may only be used in polymeric and resinous coatings.
Some solvents, like hydrocarbons, are restricted to use as polymerization solvents.
Good Manufacturing Practices: The regulations emphasize the use of good manufacturing practices to minimize migration and ensure food safety.
Communication: Manufacturers and importers of materials intended for food contact must have information about the composition of their products available for access by the competent health authority or other responsible body when requested.
These regulations aim to control the use of solvents in food contact materials to prevent the transfer of potentially harmful substances into food, thereby protecting consumer health.
Colored plastic materials and printing inks
MERCOSUR has specific regulations for colored plastic materials and printing inks that come into contact with food. These regulations aim to control the migration of substances from colored materials and inks into food, thereby protecting consumer health.
Here are the key rules:
Scope: These rules apply to plastic packaging and equipment that contain colorants in their formulation and are intended to come into contact with food, as well as to the colorants used to color them. This includes both colorants and organic and inorganic pigments used as additives in plastic materials. The regulations also apply to printed plastic packaging.
Colorant Requirements: The verification of the regulations is carried out on the colorants in the form of active ingredients and not on the same included in a polymer ("masterbatch").
Migration Limits:General: The regulations require that colorants do not migrate into food.
Specific Migration of Metals: There are specific limits for the migration of heavy metals from colorants. These limits are expressed as percentages by mass (m/m) of the colorant.
The following limits apply to metals soluble in hydrochloric acid (HCl) or sodium hydroxide (NaOH):
Arsenic (As) (soluble in HCl 0.1N) 0.005% m/m; Barium (Ba) (soluble in HCl 0.1N) 0.01% m/m; Cadmium (Cd) (soluble in HCl 0.1N) 0.01% m/m; Chromium (Cr) (soluble in HCl 0.1 N) 0.10% m/m; Lead (Pb) (soluble in HCl 0.1N) 0.01% m/m; Mercury (Hg) (soluble in HCl 0.1N) 0.005% m/m; Selenium (Se) (soluble in HCl 0.1N) 0.01% m/m; Zinc (Zn) (soluble in HCl 0.1N) 0.20% m/m.
For printed packaging, the specific migration limits for metals and other elements apply, unless there is a barrier that prevents the ink from contacting the inner surface of the material.
The specific migration of metals and other elements is determined in extracts, and techniques such as spectrometry should be used to ensure the established limits are met. The limits are: Antimony (Sb) 0.04 mg/kg, Arsenic (As) 0.01 mg/kg, Barium (Ba) 1 mg/kg, Boron (B) 0.5 mg/kg, Cadmium (Cd) 0.005 mg/kg, Zinc (Zn) 25 mg/kg, Copper (Cu) 5 mg/kg, Chromium (Cr) 0.05 mg/kg, Tin (Sn) 1.2 mg/kg and Fluorine (F) 0.5 mg/kg.
Specific SubstancesAromatic Amines: The content of primary aromatic amines not sulfonated, soluble in 1 M hydrochloric acid solution, expressed as aniline, should not exceed 500 ppm (mg/kg) of the dye (0.05% m/m). The content of benzidine, β-naphthylamine, and 4-aminobiphenyl, individually or combined, should not exceed 10 ppm (mg/kg).
Sulfonated Aromatic Amines and Benzidine: There are also requirements for the content of sulfonated aromatic amines and benzidine, beta-naphthylamine, and 4-aminobiphenyl in the colorants.
Carbon Black Pigment: For carbon black pigment, there are additional requirements such as limits on toluene extractables (max 0.1% m/m), cyclohexane extractables (absorbance at 386 nm <0.02 AU for a 1cm cuvette or <0.1 AU for a 5 cm cuvette), benzo(a)pyrene content (max 0.25 mg/kg), and the maximum level of carbon black in the polymer (2.5% m/m).
Analytical Methods:The analytical methods for determining metals in colorants and pigments are described in the relevant MERCOSUR regulations.
For extraction of metals and metalloids, the analytical methods from the Council of Europe, Committee of Ministers, Resolution AP (89) 1 (section III, paragraph 2) should be followed. For filtration procedures, the standard DIN 53770-1 should be used.
The determination of the content of metals and metalloids in extracts should be performed using spectrometric techniques with adequate sensitivity to verify compliance with the established limits.
For toluene extractables in carbon black, ISO 6209:1988 is the reference standard. For cyclohexane extractables in carbon black, the German BfR method is used.
Migration Testing:Migration tests for plastic packaging and equipment containing colorants are performed with food simulants at specified temperatures and contact times. The extracts obtained in the total migration test must be visually compared against a white background with their respective blanks, and there should be no visually appreciable differences.
Specific migration of metals and other elements is determined in extracts obtained as described in the total migration tests, using a 3% acetic acid solution in distilled water as a simulant.
Aromatic Amines: Colored, printed plastic materials or those with polyurethane adhesives should not migrate primary aromatic amines into food or the simulant B, except for those listed in the regulations, at detectable levels. The detection limit is 0.01 mg/kg of food or food simulant. This limit applies to the total of primary aromatic amines that migrate.
Compliance: Packaging must comply with the limits established in these regulations. If the packaging is for food with established contaminant limits, the packaged food must not exceed those limits for that specific food product.
These rules are in place to ensure that colored plastic materials and printing inks do not transfer harmful substances into food, thereby protecting consumer health.
Conclusion
These regulations provide a framework for ensuring the safety of food packaging and coatings by setting limits on the migration of potentially harmful substances. The use of positive lists, specific and total migration limits, and defined testing conditions aim to protect consumers from exposure to unwanted chemicals from food contact materials. These rules reflect a detailed approach towards food safety and represent the extensive considerations when using plastics and polymers for food contact.
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