Regulatory Overview on Food Contact Materials
- 13 Mins to read
- DarkLight
Regulatory Overview on Food Contact Materials
- 13 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
Food Contact Materials (FCM)
Brazil
The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.
| Version Number | Content Creation Date | Publishing Date | Section(s) Updated & Reason(s) for Update |
|---|---|---|---|
| V0 | 26 April 2023 | 17 January 2024 | N/A (new report) |
Disclaimer
At RegASK, we are committed to providing our clients with the most up-to-date and accurate information on regulatory requirements and compliance. To ensure the highest level of accuracy and relevance, we regularly review and update our e-guidebooks at least twice per year to reflect the latest regulatory developments in the market. (Please contact us if you wish to activate this feature.) In the meantime, our RegAlerts service is designed to keep our clients notified of any regulatory updates that may impact their business.
Overview of Relevant Regulatory Standards
In Brazil, the National Health Surveillance Agency (ANVISA), according to Article 8 of Law N° 9782/1999 [1] is the health authority in charge of regulating, controlling, and supervising products and services that involve risk to public health, including food packaging, and also the physical facilities and technologies involved in the production process.
In this sense, ANVISA issued Resolution RDC N° 91/2001 [2] that establishes the Technical Regulation on general criteria for packaging and equipment in contact with food. This regulation is an adoption of the MERCOSUR (i.e. Southern Common Market comprising of Argentina, Brazil, Paraguay, and Uruguay) Resolution N° 46/06 approving the harmonized regulation on the matter within the trade bloc. This piece of regulation establishes the general criteria and classifies the materials for packaging and equipment in contact with food. This standard also brings the regulation for adhesives for food contact.
It is worth mentioning that all packaging-related regulations in Brazil are harmonized within the MERCOSUR trade bloc and therefore any changes to these regulations will require discussion and consensus at this level.
Regulatory Requirements on Food Contact Materials
1. General requirements
Article 3 of the Technical Regulation [2] on food contact materials lays down the general requirements that all food packaging must comply with. These general requirements are the following:
- Packaging in direct contact with food must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not produce migration to the product of undesirable, toxic, or contaminant components in quantities exceeding the established maximum total or specific migration limits that:
- May represent a risk to human health;
- Give rise to an unacceptable change in the composition of the food or in its sensory characteristics.
- The components used in food contact materials shall be governed by the following principles:
- They must be included in positive lists which are the exhaustive lists of substances that have been proven to be physiologically harmless in animal tests and whose use has been authorized for the manufacture of food contact materials. These lists may be modified according to the criteria described in Annex I of this Regulation.
- In some cases, for specific foods, restrictions of use may be established. Note: It is worth mentioning that after checking all the packaging regulations only canned hearts of palm have restrictions related to the packaging material described in the corresponding regulation for metallic food contact materials.
- Food additives that are allowed in foods are also allowed in packaging materials, according to the restriction/conditions of use per the specified product categories foreseen in the food additive regulation powered by the advisory panel for food additives [3].
- They must follow purity criteria compatible with their use.
- They must comply with the established total migration limit and with the specific migration limits established for certain components.
- Packages shall be fitted with seals or fastenings to prevent unintentional opening. Systems or devices that render them tamper-proof or show evidence of intentional opening shall not be required, except as specifically provided for.
In addition, ANVISA does not certify materials for food contact. It is important to mention that Annex I of Resolution RDC N° 27/2010 [4] establishes that packages in general are exempted from the obligation to register. For products exempted from the registration, communication of the beginning of manufacture must be made, according to the procedures defined in Item 5.1 of Resolution N° 23/2000 [5].
However, packaging made from post-consumer recycled PET (PCR) food grade is subject to mandatory registration, as determined by annex II of Resolution RDC N° 27/2010 [3]. In this case, the registration procedure for registration must follow the procedure described in Item 5.2 of Resolution N° 23/2000 [5] and for the specific case of recycled packaging (only the final packaging is registered, not raw materials), the company must submit a proposal for technical regulation, containing the following information:
- International reference, in order of priority: Codex Alimentarius. European Community (EC) and Code of Federal Regulations (CFR)
- FDA-USA or meet the requirements of the risk and safety assessment guidelines established in a specific technical regulation;
- Studies on the toxicity of the packaging material;
- Methodology for determining migration (total and specific) into the food;
- List of foods in which it will be used and technological justification;
- Analytical methodology for the identification and verification of the purity degree of the packaging material.
2. Specific requirements per type of food contact materials
In Brazil, packing-related regulation is organized by type of material, i.e. plastic, cellulosic material, metallic material, glass, porcelain, ceramic, and elastomer, based on the classification provided by Resolution RDC N° 91/2001 [2]. The corresponding piece of regulations for the specific type of packaging materials is the following:
Cellulosic materials:
- Resolution RDC N° 88/2016 [6], Technical Regulation on cellulosic materials, packaging, and equipment intended to come into contact with food. This regulation foresees composition requirements, Maximum residue limit (MRL) for contaminants, and the positive list of substances authorized in cellulosic food contact materials (see Item 3). It also establishes the migration limits and the specific test methods for its determination (total and specific migration).
- Resolution RDC N° 89/2016 [7], Technical Regulation on cellulosic materials for hot cooking and filtration. This regulation foresees composition requirements, the positive list of substances authorized with their corresponding migration limits. Note: This applies to coffee filters and tea/coffee sachets.
- Resolution RDC N° 90/2016 [8], Technical Regulation on cellulosic materials, packaging, and equipment intended to come into contact with food during cooking or oven heating. This provides the list of the substances allowed and their migration limits, among other provisions.
Elastomers:
- Resolution RDC N° 123/2001 [9], Technical Regulation on elastomeric packaging and equipment in contact with food. This foresees the general provisions and requirements for the elastomeric food contact materials, the positive list of substances authorized (see Annex 1), and migration limits (total and specific).
Metallic materials:
- Law N° 9832/1999 [10]. This Law prohibits the industrial use of metal packaging soldered with lead and tin alloys for packaging foodstuffs, except for dry or dehydrated products.
- Resolution RDC N° 20/2007 [11], Technical Regulation for packages, coatings, utensils, lids, and metallic equipment in contact with food. This provides the corresponding rules for metallic materials, their alloys, restrictions, provisions on substances allowed to be used coating, and migration limits, among other provisions.
Glass, porcelain, ceramic and enameled implements:
- Ordinance N° 27/1996 [12], Technical Regulations for glass or ceramic (enameled or vitrified) containers and equipment that come into direct contact with food during its production, preparation, fractionation, storage, distribution, commercialization, and consumption. This regulation establishes the classification and specific definition of these materials, restrictions, specific migration of heavy metals, as well as test methods of determination and calculation.
Plastic:
- Resolution RDC N° 105/1999 [13], Technical Regulation on general provisions for plastic packaging and equipment in contact with food. This regulation has been amended by several resolutions so, currently, the following items are effective:
- General Provisions
- Annex VI - General Criteria for Fixed Equipment for the Provision, Storage, and Distribution of Drinking Water
- Annex VIII - Fluorinated Polyethylene Packaging and Equipment in Contact with Food
- Annex IX - Returnable Plastic Packaging for Non-Alcoholic Carbonated Beverages
As the above-mentioned Resolution RDC N° 105/99 has been amended several times, the following complementary resolutions must be also observed:
- Resolution RDC N° 56/2012 [14], Positive list of monomers, other starting substances, and polymers authorized for the manufacture of plastic food contact packaging and equipment. This provides for the use of monomers including their migration limits.
- Resolution RDC N° 326/2019 [15], Positive list of additives for use in the manufacture of plastic materials and polymeric food contact coatings. This provides for the use of additives including their migration limits.
- Resolution RDC N° 51/2010 [16], Technical Regulation on migration criteria for plastic materials, packaging, and equipment intended to come into contact with food. This establishes the general criteria for the determination of total and specific migrations and applies to the following plastic materials, packaging, and equipment intended to come into contact with different food simulants:
- Composed exclusively of plastics.
- Composed of two or more layers of materials, each one made exclusively of plastic.
- Composed of two or more layers of materials, one or more of which may not be exclusively plastic, where the layer in contact with the food is made of plastic or polymeric coating. In this case, all the plastic or polymeric coating layers shall comply with the Common Market Group Resolutions related to plastic materials, packaging, and equipment, with regards to migrations and inclusion of components in positive lists.
- Resolution RDC N° 52/2010 [17], Technical Regulation on colorants in plastic packaging and equipment intended to come into contact with food. It applies to plastic packaging and equipment containing colorants in its formula, intended to come into contact with food, as well as the dyes used to color them, establishing the requirements they must meet as well as the analytical reference methodology for its control. It establishes requirements for specific migration of metals and other elements.
In addition, there are other regulations related to plastic materials such as:
- Ordinance N° 987/1998 [18], Technical Regulation for disposable packaging made of polyethylene terephthalate - PET - multilayer intended for packaging non-alcoholic carbonated drinks. This foresees the general conditions and assessment criteria for packaging made of polyethylene terephthalate - PET – multilayer. Requirements on composition, hygiene control, and labeling are provided.
- Resolution RDC N° 146/2001 [19], Approves the process of deposition of amorphous carbon inner layer in virgin polyethylene terephthalate (PET) bottles via plasma, intended to come into contact with food under different conditions from types I to VI, from freezing temperature to room temperature for extended time, and maximum food processing temperature of 121ºC.
- Resolution RDC N° 20/2008 [20], Technical Regulation for post-consumer recycled polyethylene terephthalate (PET) food grade packaging (PET-PCR food grade) intended to come into contact with food. This establishes the general requirements and criteria for the assessment, approval/authorization, and registration of PET packaging made with varying proportions of virgin (food-grade) PET and decontaminated post-consumer recycled (food-grade) PET intended to come into contact with food.
- Resolution RDC N° 122/2001 [21], Technical Regulation on waxes and paraffins in contact with food. It foresees, among other provisions, the positive list of those waxes and paraffin authorized and their migration limits (see Item 3).
- Resolution N° 124/2001 [22], Technical Regulation on film-formed preparations based on polymers and/or resins intended for food coating. It foresees, among other provisions, the positive list of substances authorized and their migration limits (see Item 3).
3. Other rules
Companies that manufacture packaging must also follow the general criteria defined by Portaria SVS/MS 326/1997 [23] which provides for the Technical Regulation on hygienic-sanitary conditions and good manufacturing practices for food-producing/industrializing establishments.
4. Summary table
Food contact materials | General legislation applicable | Specific legislation applicable |
|---|---|---|
Cellulosic materials |
|
|
Elastomers | Resolution RDC N° 123/2001. Technical Regulation on elastomeric packaging and equipment in contact with food. | |
Metallic materials |
| |
Ordinance N° 27/1996. Technical Regulations for glass or ceramic and porcelain containers and equipment for direct contact with food. | ||
Plastics |
| |
PET |
| |
Wax and paraffin | Resolution RDC N° 122/2001. Technical Regulation on waxes and paraffins in contact with food. | |
Film-formed/Coatings | Resolution N° 124/2001. Technical Regulation on film-formed preparations based on polymers and/or resins intended for food coating. |
References
1. Law N° 9782/1999 that creates the National Sanitary Surveillance System, creates the National Sanitary Surveillance Agency, and makes other provisions
2. Resolution RDC N° 91/2001. Technical Regulation on general criteria for packaging and equipment in contact with food
3. Advisory Panel for Food Additives
4. Resolution RDC N° 27/2010. Establishes the categories of foods and packaging exempted from sanitary registration
http://antigo.anvisa.gov.br/documents/10181/2718376/%283%29RDC_27_2010_COMP.pdf
5. Resolution N° 23/2000. Provides on the Manual of Basic Procedures for Registration and Exemption from Mandatory Registration of Products Pertaining to the Food Area
https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2000/rdc0023_15_03_2000.html
6. Resolution RDC N° 88/2016. Technical Regulation on cellulosic materials, packaging and equipment intended to come into contact with food http://antigo.anvisa.gov.br/documents/10181/2883670/RDC_88_2016_COMP.pdf/3ef890f1-2ca8-4eae-aba7-04d35f25fa65
7. Resolution RDC N° 89/2016. Technical Regulation on cellulosic materials for hot cooking and filtration
8. Resolution RDC N° 90/2016. Technical Regulation on cellulosic materials, packaging and equipment intended to come into contact with food during cooking or oven heating
9. Resolution RDC N° 123/2001. Technical Regulation on elastomeric packaging and equipment in contact with food
10. Law N° 9832/1999. Prohibits the industrial use of metal packaging welded with lead and tin alloy for packaged foodstuffs
https://www.planalto.gov.br/ccivil_03/leis/l9832.htm
11. Resolution RDC N° 20/2007. Technical Regulation for packages, coatings, utensils, lids and metallic equipment in contact with food
12. Ordinance N° 27/1996. Technical Regulations for glass or ceramic and porcelain containers and equipment for direct contact with food
https://bvsms.saude.gov.br/bvs/saudelegis/svs1/1996/prt0027_18_03_1996.html
13. Resolution RDC N° 105/1999. Technical Regulation on general provisions for plastic packaging and equipment in contact with food
14. Resolution RDC N° 56/2012. Positive list of monomers, other starting substances and polymers authorised for the manufacture of plastic food contact packaging and equipment
15. Resolution RDC N° 326/2019. Positive list of additives for use in the manufacture of plastic materials and polymeric food contact coatings
16. Resolution RDC N° 51/2010. Technical Regulation on migration criteria for plastic materials, packaging and equipment intended to come into contact with food
17. Resolution RDC N° 52/2010. Technical Regulation on colorants in plastic packaging and equipment intended to come into contact with food
18. Ordinance N° 987/1998. Technical Regulation for disposable packaging made of polyethylene terephthalate - PET - multilayer intended for packaging non-alcoholic carbonated drinks
19. Resolution RDC N° 146/2001. Approves the process of deposition of amorphous carbon inner layer in virgin polyethylene terephthalate (PET) bottles
20. Resolution RDC N° 20/2008. Technical Regulation for post-consumer recycled polyethylene terephthalate (PET) food grade packaging (PET-PCR food grade)
21. Resolution RDC N° 122/2001. Technical Regulation on waxes and paraffins in contact with food
22. Resolution N° 124/2001. Technical Regulation on film-formed preparations based on polymers and/or resins intended for food coating
23. Portaria SVS/MS 326/1997. Technical Regulation on hygienic-sanitary conditions and good manufacturing practices for food producing/industrializing establishments
Was this article helpful?