Manufacturers and suppliers of food contact packaging, utensils, lids and metallic equipment are advised of Brazil’s amendments to its Technical Regulation.
Brazil’s Ministry of Health and National Health Surveillance Agency (ANVISA) published Resolution of the Collegiate Board of Directors (RDC) No. 498 of May 20, 2021, on May 26, 2021. This amends RDC No. 20/2007 and transposes Mercosur’s GMC Resolution No. 16 of December 17, 2020, into Brazilian national law.
Among the changes brought in by the Resolution are:
- Laser welding is now allowed in the manufacture of side seams in metal packaging
- Section 3 ‘Positive List of Raw Materials for Packaging and Metallic Equipment’ updated with editorial and technical changes. These include:
- ‘Polymeric coatings’
- ‘Sealings or sealants’
- ‘Surface lubricants’
- ‘Restrictions’
- Emphasizes that overall (total) and specific migrations for coated materials are to be carried out on the finished goods
- Allows specimens of metallic substrates that are manufactured using identical conditions as the finished product for overall and specific migration
- Clarifies that the overall migration limits are those that are established in the technical regulation corresponding to the type of coating used
- ‘Determination of the specific migration of metals in tinplating packaging’ replaced with ‘Determination of the specific migration of metals in packaging, lids, utensils and metallic equipment not covered by Clause 4.1’
Finally, there are also new requirements on the use of simulants and sample preparation. These include:
- Use of 0.5% (w/v) citric acid as simulant for the specific migration of metals from uncoated metallic materials that are intended for acidic foods (pH no greater than 4.5)
- Use of artificial water as simulant for the specific migration of metals from uncoated metallic materials that are intended for non-acidic, alcoholic and fatty foods (0.5% (w/v) citric acid may also be used but subject to results meeting limits, otherwise artificial water)
- Details the procedure from EN 16889:2016 for the preparation of artificial water
- Indicates uncoated materials to be evaluated under the actual conditions of use where applicable, otherwise the following conditions are to be used:
- 40 °C, 10 days for storage at room temperature
- 70 °C, 2 h followed by 40 °C, 24 h for hot-fill and short-term storage (less than 24 h) at room temperature.
- 70 °C, 2 h followed by 40 °C, 10 days for hot-fill and long-term storage (more than 24 h) at room temperature.
- Boiling temperature of simulant, 2 h for boiling conditions
Resolution No. 498 of May 20, 2021, came into force on June 1, 2021. Stakeholders have until November 27, 2021, to comply with its provisions.
SGS Food Contact Material Services
SGS’s technical experts have extensive experience of testing materials and articles in contact with food. They can ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. SGS offers the full range of testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Learn more about SGS’s Food Contact Material Services.
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