European Commission Issues Proposal on Methodology for Monitoring Intake of Food Additives and Food Flavourings

May 19, 2023

On 16 May 2023, according to the Official Journal of the European Union (OJEU), the European Commission issued Proposal (EU) 2023/965 on a methodology for monitoring the intake of food additives and food flavourings. The main elements of the proposal include:

　　(1) Definitions of key words related to monitoring the intake and actual use of food additives and food flavourings. For example: "intake monitoring of food additives and food flavourings" means the collection of data on the presence and occurrence of food additives and flavourings in foods to assess national intakes of food additives and flavourings and to verify the occurrence data and estimated dietary intakes used by EFSA or the Scientific Committee on Food (SCF) in the most recent exposure assessment; analytical data means data on occurrence and estimated dietary intakes used by EFSA or SCF in the most recent exposure assessment; analytical data means data on actual use; analytical data means data on actual use. intake; analytical data means the concentration of the food additive or food flavouring measured in the food; acceptable daily intake (ADI) means the estimated maximum amount of an agent, expressed on the basis of body mass, to which an individual in a (sub)population is likely to be exposed on a daily basis over the course of a lifetime and to which there is no appreciable health risk.

　　(2) Member States shall classify food additives and food flavourings in accordance with parts A and C of the Annex respectively. However, food additives undergoing re-evaluation or undergoing re-evaluation follow-up are not monitored.

　　(3) Member States shall assign a priority to each food additive and food flavouring in accordance with parts B and D of the Annex. Member States may take into account other legitimate factors such as dual use as food additives and food flavourings, availability of methods of analysis and standards, public concern, exceptionally high or low use of a particular food additive or food flavouring in their territory, frequent consumption by specific groups of people, or lack of information on food products in which a particular flavouring may have been used.

　　(4) Member States shall, by 30 September 2025, classify and prioritise food additives; food flavourings belonging to Groups 1, 2 and 4 as defined in Part C of Annex C and substances belonging to Group 3 as defined in Part C of Annex C for which a reference point has been established and an intake assessment is available shall be classified and prioritised. From 2026 onwards, Member States shall update the categorisation and prioritisation on an annual basis, taking into account the results of the previous year's monitoring and new risk assessments published by EFSA.

　　(5) Member States shall prepare a multi-annual monitoring plan reflecting the results of the prioritisation. This multi-annual monitoring plan should cover at least three years and should list the food additives and food flavourings to be monitored each year. The plan should be updated annually, taking into account the latest classification and prioritisation.

　　(6) Decide on the prerequisites and requirements for foods to be monitored for the presence of food additives or food flavourings.

　　(7) Member States shall carry out monitoring activities for food additives and food flavourings using appropriate methods of analysis which have been shown to produce reliable results. Methods used for laboratory analysis shall comply with Article 34 of Regulation (EU) 2017/625. As a minimum requirement for the monitoring of intake of food additives and food flavourings, Member States should consider the use of methods for which inter- or intra-laboratory method validation studies have been carried out in accordance with internationally recognised scientific protocols.

　　(8) Annex. Grouping and Priority Level Provisions for Food Additives and Food Flavourings in the Risk-Based Categorisation and Prioritisation Monitoring Programme for Food Additives and Food Flavourings.

　　(9) Member States shall organise a pilot phase and, to that end: propose a list of five food additives and five food flavourings to the other Member States and to the European Commission by April 2023; agree on a list of five food additives and five food flavourings; collect data on three food additives and two food flavourings from the agreed list during the course of 2024 and submit them to EFSA by 2025 30 June; collect data on two food additives and three food flavourings in the agreed list during 2025 and report the collected data to EFSA by June 2026

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