Last month, a meeting was held to discuss and review ANVISA’s new Normative Instruction for Novel Foods and Novel Ingredients.

 

    Novel Foods and Novel Ingredients already approved in Brazil will have their specifications published in 3 steps:

        1. The first step will involve publishing specifications for Novel Ingredients and ingredients permitted in Food Supplements.

        2. The second step will include the publication of specifications for Novel Ingredients and ingredients permitted for Infant Formulas, Formulas for Enteral Nutrition, and Dietary Formulas for inborn errors of metabolism.

        3. Finally, at the third step will be published the missing specifications for Novel Foods and Novel Ingredients approved for other categories of conventional foods.

 

    Additionally, the specifications will be classified as follows:

        – Compendial specification: specifications already published by internationally recognized compendiums.

        – Public specification: standard specification approved by ANVISA  to meet all the parameters defined by manufacturers, who have obtained approval for their Novel Ingredient based on studies conducted with products of different specifications, but similar or equivalent to its own ingredient.

        – Proprietary specification: unique specification approved by ANVISA for a specific manufacturer, based on studies developed with its proprietary product, without considering evidence from other ingredients with similar or equivalent specifications. This specification will not be made public – only the name of the company that owns the Novel Ingredient will be disclosed.

 

    Reminder: in December 2023, ANVISA made available an optional procedure for consultation the classification of Novel Foods and Novel Ingredients.

    Manufacturers can apply for a consultation to determine how their product will be classified by ANVISA. The process will require the submission of detailed information; the result of the consultation will be communicated directly to the company and published on the ANVISA portal, along with relevant information about the classification.

    The consultations submitted are available on ANVISA’s website, under the Consultation Panel on the Classification of Novel Foods and Ingredients.

 

 

We will keep you briefed as new information becomes available.

 

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