New Requirements for Food Contact Materials and Articles in Brazil

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’

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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

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Resolution No. 498 of May 20, 2021, came into force on
June 1, 2021. Stakeholders have until November 27, 2021, to comply with its

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


keep you up to date with the latest news and developments in the consumer goods
industry. Read the full Brazil Revises
Requirements for Food Contact Materials and Articles

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further information contact:

Dr HingWo Tsang

Global Information and Innovation Manager

(+852) 2774 7420

Alessandra Shimizu
Technical Manager
Tel: (+55) 11 3883-8880 Ext. 8785





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