Brazil and New Normative of Specifications for Ingredients

    From May 2nd until June 16th, a public consultation is being held regarding ANVISA’s proposal for a new norm that outlines the specifications for ingredients. This proposal is structured into 4 annexes:

        • Annex 1 – New Ingredients with Specifications Approved by Anvisa

        • Annex 2 – New ingredients with Compendial Specifications.

        • Annex 3 – New Ingredients with Proprietary Specifications.

        • Annex 4 – New Ingredients with Specifications Approved in Specific Standards.

Prohibition of Food Supplements containing ora-pro-nóbis (Pereskia aculeata)

    ANVISA has prohibited the sale of all Food Supplements containing ora-pro-nóbis in Brazil, as the plant is not been authorised as a safe constituent for Food Supplements.

    Effective April 3rd, the marketing, distribution, manufacture, advertising and sale of Food Supplements containing Pereskia aculeata is banned.

    However, this measure does not affect the consumption or sale of the fresh plant. Ora-pro-nóbis has a long-standing tradition of use in the daily diet, particularly in the states of Goiás and Minas Gerais.

ANVISA and the Safe Use of the Dye Erythrosine

    Due to the ban on the dye Erythrosine (INS 127) by the FDA earlier this year, ANVISA has reaffirmed its stance on the safe use of this dye in Brazil. According to ANVISA, Erythrosine is considered safe for use in food and medicines.

    Internationally, the safe use of Erythrosine in food is recognised by JECFA and the Codex Alimentarius, which establishes an Acceptable Daily Intake (ADI) of up to 0.1 mg/kg body weight per day.

This is a developing narrative; we will update it as new information emerges.