Europe – List of botanicals at risk of being banned
Alpha Lipoic Acid (ALA) Discussions between the European Commission (EC) and Member States about Alpha Lipoic Acid (ALA) have concluded. EC has confirmed that it has presented a proposal to ban ALA in foods, including Food Supplements. The industry and various trade associations proposed managing the risk of ALA consumption through labelling requirements, as […]
Brazil: New normative of specifications for ingredients (new ingredients and novel foods)
Last week, Brazil approved a new Normative Instruction that will regulate petitions in the food sector based on approvals already granted by Equivalent Authorities from Foreign Countries (known as Autoridades Reguladores Estrangeiras Equivalentes – AREEs – in Portuguese). This new norm is a significant step toward streamlining Brazil’s approval system, as it will allow petitions submitted to ANVISA to reference […]
Novel Food Europe Updates: Summary from February 2025
Novel Food Status Catalogue Updates Below are the updates related to the new entries for the Novel Food Status Catalogue. These updates refer to the month of February 2025 and have impact on Food Supplements. Diosmectite: Substance: Unauthorised Novel Food (includes Food Supplements) Update: New entry DMAE (dimethylaminoethanol) and its salts: Substance: Unauthorised Novel Food […]
Belgium and France: Updates on Belgian Decrees and French Pharmacopoeia
Belgium: Royal Decrees on Nutrients, Substances, and Plants In January 2025, the Belgian authorities published a Royal Decree amending three existing decrees related to nutrients, non-nutrient substances, and plant preparations. This update refines the general provisions and notification procedures. While the lists of authorised or prohibited ingredients remain unchanged, key procedural updates were introduced. The […]
Brazil: Petitions submitted to ANVISA can refer to pre-approvals from FDA, EFSA and Codex
Last week, Brazil approved a new Normative Instruction that will regulate petitions in the food sector based on approvals already granted by Equivalent Authorities from Foreign Countries (known as Autoridades Reguladores Estrangeiras Equivalentes – AREEs – in Portuguese). This new norm is a significant step toward streamlining Brazil’s approval system, as it will allow petitions submitted to ANVISA to reference […]
MAJOR UPDATE – European Court of Justice annuls prohibition for HADs in Aloe spp
The European Commission has appealed all General Court rulings concerning HADs in Aloe spp., suspending the November 2024 decisions. This keeps the listings in Annex III of Regulation 1925/2006 in effect until the appeal is resolved. Aloe-based preparations containing HADs should be avoided.
USA: Regulatory Freeze on Pending Rules for Food Supplements
The White House issued a regulatory freeze on January 20, suspending rulemaking activities for review by the new administration. This impacts FDA regulations on food supplements, including additive bans, nutrition labeling, and supplement access laws. The review does not guarantee rule rejection.
Brazil: Novel Foods and Novel Ingredients Update
ANVISA is set to publish specifications for Novel Foods and Ingredients in three phases, classifying them as compendial, public, or proprietary. Additionally, an optional consultation process allows manufacturers to determine their product classification before regulatory submission.
Vietnam – Changes in Quality Control for Health Supplements
Vietnam’s new Circular 12, effective August 1, 2025, sets stricter quality control standards for health supplements, aligning with ASEAN guidelines. It introduces limits on contaminants, new testing methods, and updated product management requirements.
