Vitamins/Minerals, Botanicals, Bioactives, Additives…
Numerous legislations concerning food ingredients have to be taken into account for product formulation, particularly:
- Regulation (EC) N° 1333/2008 on food additives
- Regulation (EC) N° 1334/2008 on food flavourings
- Regulation (EC) N° 1332/2008 on food enzymes
- Positive lists of vitamins and minerals from Directive 2002/46/EC, Regulation (EU) N° 609/2013 and Regulation (EC) N° 1925/2006
- Regulation (EU) 2015/2283 on novel foods which have not been used for human consumption to a significant degree within Europe prior to 15 May 1997, for which an authorization is needed to place the product on the market
Some specific domestic rules may exist for substances with a nutritional or physiological effect and botanicals, the use of which is not currently harmonized across Europe. Each European Member State may have its own positive and/or negative list, with possible specific conditions of use (parts of plants, warnings, maximum doses, etc).
Communication on those ingredients is regulated by Regulation (EC) N° 1924/2006 on nutrition and health claims.
Food supplements, considered foodstuffs, are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are marketed in dosage forms designed to be taken in measured small unit quantities.
Directive 2002/46/EC establishes the specific provisions on the labeling of food supplements and lists vitamins and minerals (and their forms) authorized in food supplements. However, maximum amounts of those vitamins and minerals and the use of substances with a nutritional or physiological effect of which botanicals are not harmonized at European level. For formulation of a food supplement, the national specific legislations as amended on authorized ingredients and possible maximal daily doses have to be checked.
General food law (food safety, information to consumers, novel foods, nutrition and health claims, etc) also applies to food supplements.
Each Member State has established its own notification or registration procedure which is mandatory before placing a food supplement on the market no matter what is your channel of distribution (pharmacy, online, etc).
According to Regulation (EU) N° 609/2013 concerning the revision of PARNUTS legislation, sports foods are now classified on a case-by-case basis as fortified foods or food supplements, with possible nutrition and health claims. Composition and notification processes for food supplements and/or fortified foods should be checked against domestic specifications.
General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to sport foods.
Foods for special medical purposes (FSMP) are intended for the dietary management of patients and may be used only under medical supervision. They are regulated for composition and labeling by Regulation (EU) N° 609/2013 and Regulation (EU) 2016/128 as regards the specific compositional and information requirements for Food for Special Medical Purposes. This Regulation applies instead of Directive 1999/21/EC since 22 February 2019 for FSMP developed to satisfy the nutritional requirements of people other than infants and since 22 February 2020 for FSMP developed to satisfy the nutritional requirements of infants as the delegated Regulation (EU) 2016/127 concerning infant formula and follow-up formula).
These products must be notified at national level and competent Authorities may request a bibliographic dossier justifying that the product meets the specific requirements of the target population.
General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to FSMP.
Intended for children under three years old who have specific nutrition requirements, infant formulas, follow-on formulas and other foods intended for infants and young children (meals, desserts, processed cereal-based foods,…) are specifically regulated at European level concerning composition, labelling and communication by Regulation (EU) N° 609/2013 and specific delegated acts by category.
For infant formula and follow-on formula, Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding applies instead of Directive 2006/141/EC since 22 February 2020 (excepted infant formula and follow-on formula manufactured from protein hydrolysates, to which it shall apply from 22 February 2021).
Infant formula and some follow-on formula (depending on the composition) must be notified at the national level.
For processed cereal-based foods and baby foods, Directive 2006/125/EC continue to apply, pending the publication of a new delegated act.
General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to foods for infants and young children without prejudice to their specific provisions.
Foods for weight control are regulated by specific provisions on composition and labeling according to Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. Regulation (EU) N° 609/2013 provides that the current directive will be replaced by a new delegated act: Regulation (EU) 2017/1798 will apply instead of Directive 96/8/EC from 27 October 2022.
From July 2016, according to Regulation (EU) N° 609/2013 concerning the revision of PARNUTS legislation, meal replacements for weight control are ordinary foods or fortified foods: the two authorized health claims on meal replacements may continue to be used, the conditions of use of those claims are amended by Regulation (EU) 2016/1413.
General food law (food safety, information to consumers, novel foods, nutrition and health claims…) also applies to foods for weight control.
Fortified foods are ordinary foodstuffs to which vitamins, minerals or other substances with a nutritional or physiological effect have been added. They are regulated by Regulation (EC) N° 1925/2006 establishing the list of authorized vitamins and minerals (and their forms) and the procedures to create a negative list of substances. Some countries have established a notification procedure for those products.
General food law (food safety, information to consumers, novel foods, nutrition and health claims, etc) applies to fortified foods.