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EFSA, guidelines on safety and bioavailability of new nutrient sources

Il panel EFSA on Food Additives and Nutrient Sources added to Food (ANS) published, on 27.3.21, the first revision of the guidelines on 'assessment of the safety of nutrient sources and the bioavailability of nutrients from the sources'. (1)

The guidelines are relevant for the fortification of food, the creation of so-called diet therapy products, the authorization of novel food, nutrition labeling and the use of Nutrition & Health Claims.

The update also considers the changes introduced in the reg. CE 178/02, with the objectives of transparency and sustainability of risk assessment in the food supply chain (EU regulation 2019/1381).

EFSA guidelines, objectives

Primary goal of the EFSA guidelines is to clarify which scientific data should be submitted to support requests for verification of the safety of nutrient sources. With regard to both the risk analysis and the bioavailability of nutrients. On the other hand, the evaluation of the nutritional, physiological and safety aspects of the individual nutrients considered as such does not fall within these guidelines.

The evaluation risk is carried out by EFSA, at the request of the European Commission, in the case of proposals for the use in food of new substances that may constitute sources of nutrients such as vitamins, minerals and other substances. With particular regard to:

- dir. 2002/46 / EC on food supplements, (2)

- reg. CE 1925/06 on the fortification of foods, (3)

- reg. EU 609/2013 on foods for infants and young children, foods for special medical purposes and substitutes for the entire daily diet for weight control, (4)

- reg. EU 2015/2283, relating to the so-called novel foods. (5)

Safety assessment of new nutrient sources

EFSA reserves the right to take into account various considerations in order to evaluate the safety of the new nutrient sources proposed. These considerations, in order of priority, concern:

1) dissociation in the lumen of the gastrointestinal tract. The starting point of the evaluation is to understand if and at what level a dissociation can occur here. The evaluation can be based on existing data obtained from previous evaluations (eg use as a food additive), in case of extensive and immediate dissociation into the constituents of the diet and / or the human body.
Dissociation may not be immediate and may occur in the gastrointestinal wall or liver, as long as it occurs before it reaches the circulatory system. Further evaluations, even of a toxicological nature, may be required in the absence of these dissociations or in the event of the formation of non-nutritious substances (so-called antinutrients).

2) bioavailability. Given the impossibility of a constant evaluation of this parameter, the use of surrogate tests is allowed. By comparison with other already authorized sources of the same nutrient. In case of similarities between the two sources it is not necessary to carry out further tests. Otherwise, it is appropriate to perform more complex studies such as dissociation studies (e.g. artificial digestion), studies vitro and / or in vivo.

novel food

Vitamins, minerals and other substances may fall within the scope of reg. EU 2015/2283 (novel foods, novel foods), if obtained from production processes not used in the EU before 15.5.97 which may lead to a change in nutritional value and / or metabolism and / or the presence of unwanted 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 the request for authorization of novel foods. (6)

Transparency and sustainability of food risk assessment, reg. EU 2019/1381

The guidelines under examination refer to the reform of General Food Law (GFL, reg. CE 178/02), aimed at increasing transparency and sustainability of risk assessment in the food supply chain (reg. UE 2019/1381, in force since 27.3.21. The main changes concern:

- submission of applications electronically, including through the websites websites the European Commission or EFSA,

- possibility, for the potential applicant or notifier, to request EFSA 'guidance on the applicable rules and the required content of the application or notification prior to its submission'(GFL, article 32-bis, paragraph 1),

- EFSA 'establishes and manages 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 a scientific output, including a scientific opinion, by the Authority'(GFL, article 32-ter),

- publication of non-confidential versions of all information submitted in support of the request and the related decision-making process regarding confidentiality (GFL, articles 38-39-octies),

- public consultation on the applications submitted (GFL, article 32-quater. See notes 7,8,9).

Dario Dongo and Andrea Adelmo Della Penna


(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, for 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 update on 20.03.2021)

(3) EC Reg. 1925/06, on the addition of vitamins and minerals and of certain other substances to foodshttps://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02006R1925-20190515

(4) EU Reg. 609/2013, on foods intended for infants and young children, foods for special medical purposes and substitutes for the entire daily diet for weight control. https://eur-lex.europa.eu/legal-content/IT-EN/TXT/?from=EN&uri=CELEX%3A02013R0609-20170711

(5) EU Reg. 2015/2283, related to 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 authorization 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) EC Reg. 178/02, establishing the general principles and requirements of food law, establishing the European Food Safety Authority and establishing 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 update on 27.03.2021)

(8) EU Reg. 2019/1381, on the transparency and sustainability of the 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 the doses allowed in the EU. Scientific study and application for renewal of authorization. GIFTS (Great Italian Food Trade). 15.12.19/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/sicurezza/il-glifosato-danneggia-il-microbioma-anche-alle-dosi-ammesse-in-ue-studio-scientifico-e-domanda-di-rinnovo-autorizzazione

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

Andrea Adelmo Della Penna
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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.

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