Overview

The deadline for sending contributions began on May 3rd.

Public Consultation (CP) 1158/2023 of Anvisa for those interested in making their contributions started on Wednesday, May 3rd, and will continue until July 31st of this year.

Key Regulations

The text submitted to public consultation introduces a series of new regulations, which include:

• Improving the definition of new foods and ingredients, emphasizing that these are those without a history of safe consumption in Brazil and providing a list of different sources and situations for classification.
• Inclusion of additional relevant conceptual bases for applying the legal concept of new foods and new ingredients. This includes considerations of the history of safe food consumption, food purpose, therapeutic purpose, extraction or selective concentration, significant modification, and nano-materials.
• Creation of an administrative procedure that allows companies to consult the classification of specific foods or ingredients as new, with confirmed responses published on the Anvisa website.
• Detailed safety evaluation requirements tailored to the nature and complexity of novel foods and new ingredients.
• Incorporation of optimized analysis procedures into the regulation, offering flexibility in the regulatory requirements for new foods and new ingredients that enhance the certainty of safe use or reduce existing uncertainties.
• Provision of procedures for preparing and updating regulatory lists of new foods and new ingredients.
• Definition of criteria for publishing non-confidential information based on Anvisa's opinions on new foods and new ingredients.
• Construction of a comprehensive list of new foods and new ingredients, including their specifications, limits, conditions of use, and relevant recommendations, warnings, and restrictions.

Methodology

The analysis and comparison of alternatives were conducted using the multi-criteria analysis (ACM) methodology, which is a mathematical model that assesses the performance of different regulatory options based on impacts to affected stakeholders, including Anvisa, SNVS entities, other public sector agencies, productive sector agents, and consumers.

Additional Information

For more detailed information, visit the following link: Anvisa Document - http://antigo.anvisa.gov.br/documents/10181/6582266/SEI_ANVISA+-+2336314+-+Voto+Diretor_CP1158.pdf/b717c0e5-7083-4ecd-9998-b8289b4452dc