Brazil – Anvisa approves Regulatory Agenda 2024-2025

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The Collegiate Board of Directors (DICOL in Portuguese) of the National Health Surveillance Agency (ANVISA in Portuguese) approved through the Deliberative Circuit (CD 1.312, of December 15, 2023), the Regulatory Agenda (RA) for the 2024-2025 cycle.

The document, published in Ordinance 1.409/2023, is composed of 172 regulatory topics distributed in 16 macro-themes. According to the Normative Agenda Manual, the themes are aligned with the strategic objectives of the 2024-2027 Strategic Plan and are feasible to advance during the Agenda’s term.

The construction of the RA 2024-2025 was initiated through a consultation directed to society and entities of the National Health Surveillance System (SNVS) on the regulatory topics that should be addressed by Anvisa in the next biennium. On July 21, 2023, Public Notice 9 was published to receive comments from any interested party regarding the preliminary list of 102 regulatory proposals for the Agency’s AR 2024-2025, as well as suggestions for the inclusion of other regulatory topics.

For further information, you can access the original source in Portuguese

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Brazil – ANVISA updates its library of food regulatory documents

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The National Health Surveillance Agency (ANVISA in Portuguese) has published the update of the updated library of food regulations in December 2023.

For further information, you can access the original source in Portuguese

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Brazil – Anvisa updates standards to demonstrate safety of novel foods and ingredients

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The National Health Surveillance Agency (ANVISA in Portuguese) has published Resolution RDC 839/2023, which updates the rules and procedures for testing the safety and authorizing the use of novel foods and novel ingredients.

The new resolution comes into force on March 16, 2024, with the exception of Articles 7, 8 and 9, which deal with the requirements and flows for making available the public version of the opinions and the authorization for the use of novel foods and novel ingredients. The effectiveness of these articles will begin on December 26.

Changes:

  • Improvement of the definition of novel foods and ingredients, reinforcing that they are those that have no history of safe consumption in Brazil and including a list of different sources of procurement and situations in which they can be classified.
  • Inclusion of other conceptual bases relevant to the application of the legal concept of novel foods and novel ingredients, with emphasis on safe food consumption history, purpose of the food, selective extraction or concentration, significant modification and nanomaterial.
  • Creates an administrative procedure that allows companies to consult the classification of a given food or ingredient as novel, with confirmed responses being published on the Anvisa portal.
  • Details the safety assessment requirements, according to the nature and complexity of novel foods and novel ingredients.
  • Incorporates optimized analysis procedures, with relaxation of regulatory requirements for novel foods and novel ingredients that meet characteristics that increase the certainty of safety of use or reduce existing uncertainties.
  • Incorporates forecasting procedures for the preparation and updating of regulatory lists of novel foods and novel ingredients.
  • Defines criteria for the publication of non-confidential information from Anvisa’s opinions on novel foods and novel ingredients.
  • Description of a general list of novel foods and novel ingredients, their specifications, limits and conditions of use.

For further information, you can access the original source in Portuguese

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Mexico – In amendment to the General Education Law to regulate the sale of processed foods in schools

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The Ministry of Public Education (SEP in Spanish) published today in the Official Gazette of the Federation (DOF in Spanish) the decree which amends, adds and repeals various provisions of the General Law of Education, regarding food health in schools.

The document specifies that the federal education agency will have a term of no more than 180 days to update the general guidelines for the sale and distribution of prepared and processed foods and beverages in the schools of the national education system, in order to avoid the advertising and consumption of ultra-processed products in these educational spaces.

For further information, you can access the original source in Spanish

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Brazil – Amendment to the Regulatory Instruction – IN nº 211/2023 on the technological functions, maximum limits and conditions of use of food additives and technological aids authorized for use in foods

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The National Health Surveillance Agency (ANVISA in Portuguese) has published an amendment to the Normative Instruction – IN nº 211/2023 on the technological functions, maximum limits and conditions of use of food additives and technological aids authorized for use in foods.

Art. 2 Annex III of the Normative Instruction – IN No. 211, of 2023, enters into force with the exclusions contained in Annex I of this Normative Instruction.

Art. 3 Annex III of the Normative Instruction – IN nº 211, of 2023, enters into force with the modifications contained in Annex II of this Normative Instruction.

Art. 4 Annex III of the Normative Instruction – IN No. 211, of 2023, enters into force in addition to the food additives, their respective technological functions, maximum limits and conditions of use that appear in Annex III of this Normative Instruction.

Art. 5 Annex IV of the Normative Instruction – IN No. 211, of 2023, enters into force with the modifications contained in Annex IV of this Normative Instruction.

Art. 6 Annex IV of Normative Instruction – IN No. 211, of 2023, comes into force with the addition of the technological aids, their respective technological functions, maximum limits and conditions of use established in Annex V of this Normative Instruction.

For further information, you can access the original source in Portuguese

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