(1)

Regulation (EC) No 1333/2008 of the European Parliament and of the Council (1) lays down the provisions for monitoring food additive intake. In accordance with Article 27 of that Regulation, Member States are to maintain systems to monitor the consumption and use of food additives listed in Annex II, Part B to that Regulation (EC) No 1333/2008 following a risk-based approach and to report their findings with appropriate frequency to the Commission and the European Food Safety Authority (‘the Authority’). To this end, the Commission was to adopt a common methodology for the gathering of information by the Member States on dietary intake of food additives in the Union.

(2)

Regulation (EC) No 1334/2008 of the European Parliament and of the Council (2) lays down the provisions for monitoring food flavourings intake. In accordance with Article 20 of that Regulation, Member States are to establish systems to monitor, by using a risk-based approach, the consumption and use of flavourings set out in the Union list and the consumption of the substances listed in Annex III to that Regulation (EC) No 1334/2008, and to report their findings with appropriate frequency to the Commission and to the Authority. To this end, the Commission was to adopt a common methodology for the gathering of information by the Member States on dietary intake of food flavouring in the Union.

(3)

While a common methodology is necessary to ensure that the intake of food additives and food flavourings calculated by different Member States may be compared and that the collected data may be used to calculate the intake at Union level, the elaboration of that common methodology is hampered by the limited availability of methods of analysis, analytical standards and the lack of information on the use of food flavourings.

(4)

However, on 23 June 2010 (3) and 23 December 2022 (4), the Authority provided guidance for estimating the dietary intake of food flavourings. For food additives, the Authority provided on 18 July 2012 guidance on estimating dietary intake (5) and launched at the same time an exposure assessment tool for food additives namely the Food Additive Intake Model (FAIM). On 17 October 2017, the Authority published a statement on the approach followed for the refined exposure assessment as part of the safety assessment of food additives under re-evaluation (6). On the basis of that guidance and in order to gain experience, tackle some of the difficulties encountered and facilitate the adoption of a common methodology in the future, the Commission recommends Member States to apply the methodology provided in this Recommendation.

(5)

Considering the high number of food additives and food flavourings that may be present in different foodstuffs on the market and consequently the high number of potential combinations of food additives and food flavourings with food categories, it is appropriate that Member States categorise and prioritise food additives and food flavourings based on the risk associated to them. In order to ensure an objective prioritisation, the risk should be assessed mainly on the basis of the outcome of the most recent risk assessment by the Authority or the Scientific Committee on Food, of other indications that a food additive or food flavouring needs to be kept under closer surveillance, such as the presence of impurities in case of food additives, or of indications that the dietary intake used for the safety assessment is outdated or underestimated. However, Member States should not categorise and prioritise food flavourings for which the Commission intends to request information from producers and users and those for which monitoring does not appear necessary based on the outcome of the last assessment made by the Authority. Furthermore, in order to ensure flexibility, Member States may adjust the priorities by taking other factors into account.

(6)

In order to ensure the information is available among the Member States, the Commission and the Authority, Member States should reflect the outcome of the prioritisation carried out in a multi-annual monitoring plan and keep the multi-annual monitoring plan updated.

(7)

Since the collected data should allow for the calculation of the food additive and food flavouring intake, the collection of presence data only is not sufficient and Member States should collect at least one type of occurrence data. However, presence data may also be collected since they allow to identify whether a food additive or food flavouring is used or not used in a particular foodstuff.

(8)

In order to ensure that the collected data is representative for the use of the food additive or food flavouring in foods on the market within the Member State and for estimating the intake of those food additives and food flavourings, Member States should decide on the foodstuffs where the presence or occurrence of food additives and food flavourings is to be monitored in accordance with criteria that take into account the relative contribution of foods or brands to the dietary intake. Furthermore, since certain substances, such as ascorbic acid, can occur in food due to natural presence, due to their addition as a nutrient source, or due to their addition as a food additive or food flavouring, Member States should also take into account foods that contribute to the dietary intake of a substance from sources other than its use as food additive or food flavouring, in order to allow for the calculation of the dietary intake from sources other than food additive or food flavouring use and for the calculation of the overall exposure to the concerned substance.

(9)

To obtain a more complete view of the situation, Member States may complement monitoring data with data originating from official control tasks in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (7) that are representative for the use of food additives or food flavourings in food available on the market.

(10)

In order to obtain reliable results, Member States should use methods of analysis referred to in Article 34 of Regulation (EU) 2017/625, which contains a list of methods used for laboratory analyses.

(11)

Given the diversity of food additives and food flavourings, of the foods in which they are used and of their conditions of use, experience and knowledge gained by Member States may only be compared and assessed if they have been obtained on the same food additives and food flavourings. Therefore, Member States should not only proceed to the prioritisation of food additives and food flavourings and inform the other Member States, the Commission and the Authority, but, as a first stage, they should also agree to monitor at least a common, limited, list of foods additives and flavourings,