Early months of the updated framework for novel foods and ingredients: proactive transparency – progress and challenges

Anderson Ribeiro

Souto Correa, São Paulo

anderson.ribeiro@soutocorrea.com.br

Gabriela Melani

Souto Correa, São Paulo

gabriela.melani@soutocorrea.com.br

Background

In April 2023, the Brazilian health regulatory agency Anvisa disclosed a proposal to revise its regulation on novel foods and novel ingredients. It was a modernisation of obsolete regulation (Anvisa’s RDC 16/1999), especially in pre-market regulation, which was not treated through a health risk analysis of the products in question.

The initial modernisation proposal was inspired by the European approach provided by Regulation (EU) 2015/2283. The new paradigm intended to rely on a novel ingredient approval to enable general market entry for all entrants. This shift would be based on the disclosure of specifications and other general information from the first applicant, which would result in a generic approval.

During the Resolution proposal draft, the industry illustrated the potential illegalities and impacts of the proposal, exposing the shortcomings of the European framework and proposing modifications.

The approval of Anvisa’s RDC 839/2023

On 18 December 2023, Anvisa published RDC 839/2023, providing the regulatory pathway to prove the safety of novel foods and ingredients and the steps for their authorisation. The final version of the regulation led to the protection of trade secrets and the possible exclusivity for cases in which trade secrets are key for approval.

RDC 839/2023 came into force on 16 March 2024, and sets forth:

• general approvals, which due to manufacturing characteristics, studies and approval, allows different companies to market that ingredient; and
• specific approvals for an applicant when the essential information for the assessment is confidential, granting exclusivity to the company responsible for the ingredient.

Anvisa eventually acknowledged that transparency is essential to maintaining consumer trust; however, it is equally important that companies protect their innovations and exclusive production, which result from significant investments in research and development (R&D).

Thus, Anvisa’s RDC 839/2023 tried to strike a balance, allowing the disclosure of essential information while protecting sensitive data that could compromise companies’ competitiveness.

The first months of the new framework

Since its implementation, all applicants of novel ingredients have worked continuously to closely observe the practical effects.

As a practical example, the Resolution requires confidentiality to be indicated when submitting the new dossier. At the end of the safety evaluation, Anvisa notifies the petitioner with a draft of a summarised public version with the main information related to the approval conditions and a brief description of the approved ingredient.

The applicant has 60 days to agree or disagree with the proposed public opinion if it is approved. In the case of non-approval, companies have 30 days (Article 7, paragraph 3) to indicate confidential information in the negative opinion.

With this change, the food industry is closely monitoring the submission of confidentiality petitions seeking to protect trade secrets contained in dossiers and Anvisa’s drafts of public opinion.

Additionally, the technical area often proposes specifications of novel ingredients approved without reliance on trade secrets, so applicants can agree or indicate any discrepancies within 30 days. In cases of discrepancies, Anvisa responds and justifies its position on the specifications, granting a new period of 30 days for the company to reply.

Tracking changes, insights and implementation

While a significant progress has been made so far, some challenges and gaps have been evident during implementation:

• the lack of response from companies to Anvisa’s Official Letters with suggested specifications for several reasons (failure to keep track of the mailbox in the system; changes in corporate ownership of the previous petitioner/manufacturer, among others);
• the divergence between Anvisa’s interpretation of proprietary studies and specifications made available and those of manufacturers and companies;
• the pending draft of a new normative ruling containing those specifications, which will be open for comments in the first quarter of 2025 through a public consultation which will establish the specifications of identity, purity and composition of novel foods, ingredients and other authorised constituents.

Final considerations

Companies need to be alert and seek legal and regulatory support, especially since if there is no response to those Official Letters, the specification or the draft public opinion is deemed to be accepted, and Anvisa will disclose the documents as suggested.

It is also important that the food industry is aware of the deadlines set out in the regulation and in the Official Letters, and actively participate in the 2025 public consultation, to ensure their information and trade secrets are protected and that their confidentiality and exclusivity are preserved.