The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) published, on 3/27/21, the first revision of the guidance on ‘assessment on safety of nutrient sources and bioavailability of nutrients from sources‘. (1)
The guidelines note for food fortification, the making of so-called diet therapy products, the authorization of Novel Food, nutritional labeling and the use of Nutrition & Health Claims.
The update also considers new features introduced in reg. EC 178/02, with objectives of transparency and sustainability of risk assessment in the food chain (EU reg. 2019/1381).
EFSA guidelines, objectives
The primary objective of the EFSA guidelines is to clarify what scientific data should be submitted to support applications to verify the safety of nutrient sources. Having regard to both risk analysis and bioavailability of nutrients. Excluded from these guidelines, however, is the evaluation of the nutritional, physiological and safety aspects of individual nutrients considered as they are.
Risk assessment is carried out by EFSA, at the request of the European Commission, in the case of proposals to use new substances in foods that may be sources of nutrients such as vitamins, minerals and other substances. With particular regard to:
– dir. 2002/46/EC on food supplements, (2)
– reg. EC 1925/06 on food fortification, (3)
– reg. EU 609/2013 on foods for infants and young children, foods for special medical purposes and substitutes for the whole daily food ration for weight control, (4)
– reg. EU 2015/2283, on so-called novel foods. (5)
Safety assessment of new nutrient sources
EFSA reserves the right to take several considerations into account when evaluating safety in the proposed new nutrient sources. These considerations, in order of priority, include:
1) Dissociation in the lumen of the gastrointestinal tract. The starting point of the assessment is to understand whether and at what level dissociation can occur here. Evaluation may come based on existing data obtained from previous evaluations (e.g., use as a food additive), in case of extensive and immediate dissociation in dietary and/or human body constituents.
Dissociation may not be immediate and occur in the gastrointestinal wall or liver, as long as it occurs before reaching the circulatory system. Further evaluations, including toxicological ones, may be required in the absence of these dissociations or in the case of the formation of non-nutrient type substances (so-called antinutrients).
2) bioavailability. In the face of the impossibility of consistent evaluation of this parameter, the use of surrogate tests is permissible. By comparison with other already approved sources of the same nutrient. If there are similarities between the two sources, no further testing is necessary. Otherwise, more complex studies such as dissociation studies (e.g., artificial digestion), in vitro and/or in vivo studies are appropriate.
Novel food
Vitamins, minerals and other substances may fall under reg. EU 2015/2283(novel foods, novel foods), if obtained by production processes not used in the EU before 15.5.97 that may result in a change in nutritional value and/or metabolism and/or presence of undesirable substances, if they contain or consist of engineered nanomaterials. (5) In such cases, in addition to this guideline, reference is made to the guidelines for novel food applications. (6)
Transparency and sustainability of food risk assessment, reg. EU 2019/1381
The guidelines under consideration recall the reform of the General Food Law (GFL, reg. EC 178/02), aimed at increasing transparency and sustainability of risk assessment in the food supply chain (reg. EU 2019/1381, effective 3/27/21. The main new features include:
– submission of applications electronically, including through the websites of the European Commission or EFSA,
– possibility for the potential applicant or notifier to request from EFSA ‘guidance on the applicable standards and prescribed content of the application or notification prior to its submission‘ (GFL, Article 32-bis(1)),
– EFSA ‘shall establish and maintain a database of studies commissioned or carried out by economic operators in support of an application or notification in relation to which Union law contains provisions on the provision of scientific output, including scientific opinion, by the Authority‘ (GFL, Article 32b),
– Publication of non-confidential versions of all information submitted in support of the request and the related confidentiality decision-making process (GFL, Articles 38-39-octies),
– public consultation on submitted applications (GFL, Article 32-quater. See notes 7,8,9).
Dario Dongo and Andrea Adelmo Della Penna
Notes
(1) European Food Safety Authority (2021). Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources (Revision 1). EFSA Journal 19(3):e06552, https://doi.org/10.2903/j.efsa.2021.6552
(2) Dir. 2002/46/EC, on the approximation of the laws of the member states relating to food supplements. EUR-Lex, https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02002L0046-20210320 (last updated on 03/20/2021)
(3) Reg. EC 1925/06, on the addition of vitamins and minerals and of certain other substances to foods. https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02006R1925-20190515
(4) Reg. EU 609/2013 on food intended for infants and young children, food for special medical purposes and substitutes for the whole daily ration for weight control. https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02013R0609-20170711
(5) Reg. EU 2015/2283, on novel foods. https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02015R2283-20210327
(6) EFSA (2016). Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. EFSA Journal 14(11):e04594, https://doi.org/10.2903/j.efsa.2016.4594
(7) Reg. EC 178/02, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in the field of food safety. EUR-Lex, https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02002R0178-20210327 (last updated on 03/27/2021)
(8) Reg. EU 2019/1381, on the transparency and sustainability of Union risk analysis in the food supply chain. EUR-Lex, https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A32019R1381
(9) Dario Dongo, Fabrizio Adorni. Glyphosate damages the microbiome even at doses allowed in the EU. Scientific study and permit renewal application. GIFT (Great Italian Food Trade). 12/15/19, https://www.greatitalianfoodtrade.it/sicurezza/il-glifosato-danneggia-il-microbioma-anche-alle-dosi-ammesse-in-ue-studio-scientifico-e-domanda-di-rinnovo-autorizzazione
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
