Brazil has amended its Resolution approving the Technical Regulation on provisions for packaging, coatings, utensils, lids and metallic equipment in contact with food. The new law will become effective on November 27, 2021.

SAFEGUARDS | Consumer ProductsNO. 075/21

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On May 26, 2021, Brazil’s Ministry of Health/National Health Surveillance Agency (Ministério da Saúde/ Agência Nacional de Vigilância Sanitária (ANVISA)) published Resolution of the Collegiate Board of Directors No. 498 of May 20, 2021 (Resolução de Diretoria Colegiada RDC No. 498, de 20 de Maio de 2021, 498/2021) to amend RDC No. 20/2007 in relation to the nation’s Technical Regulation on packaging, utensils, lids and metallic equipment in contact with food (the Resolution).

The Resolution transposes GMC Resolution No. 16 of December 17, 2020 (MERCOSUR/GMC/RES. No. 16/20) into Brazil’s national law. 

According to the Resolution, there are two important dates:

  • June 1, 2021, for date of entry into force
  • November 27, 2021, for compliance with the provisions in the Resolution (180 days from the date of entry into force)

Highlights of several important changes in the Resolution are summarized in Table 1. 

Ministry of Health/National Health Surveillance Agency
Resolution of Collegiate Board of Directors – RDC No. 498 of May 20, 2021

Clause

Highlight of Change

2.5.5

  • Allows laser welding as one of the techniques in the manufacture of side seams in metal packaging

Section 3

  • Editorial and/or technical changes as well as new structure to Section 3 ‘Positive List of Raw Materials for Packaging and Metallic Equipment’, including requirements for ‘Polymeric coatings’, ‘Sealings or sealants’, ‘Surface lubricants’ and ‘Restrictions’

4.1.1

  • Emphasizes that overall (total) and specific migrations for coated materials are to be carried out on the finished goods

4.1.2

  • Allows specimens of metallic substrates that are manufactured using identical conditions as the finished product for overall and specific migration

4.1.4

  • Clarifies that the overall migration limits are those that are established in the technical regulation corresponding to the type of coating used

4.4

  • Replaces ‘Determination of the specific migration of metals in tinplating packaging’ with ‘Determination of the specific migration of metals in packaging, lids, utensils and metallic equipment not covered by Clause 4.1’

4.4.1

New requirements on the use of simulants and sample preparation:

  • 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 ≤ 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:

  1. 40 °C, 10 days for storage at room temperature

  2. 70 °C, 2 h followed by 40 °C, 24 h for hot-fill and short-term storage (less than 24 h) at room temperature.

  3. 70 °C, 2 h followed by 40 °C, 10 days for hot-fill and long-term storage (more than 24 h) at room temperature.

  4. Boiling temperature of simulant, 2 h for boiling conditions 

Table 1

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. In the end, it’s only trusted because it’s tested. Discover more on our website and read our brochure.   

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Hingwo Tsang
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t: (+852) 2774 7420

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