Addition of substances for specific nutritional purposes

Addition of substances for specific nutritional purposes

A number of nutritional substances such as vitamins, minerals, amino acids and others may be added to foods for specific groups in order to ensure that the nutritional requirements of the persons for whom those foods are intended are fulfilled and/or in order to satisfy legal requirements laid down in the legislation.

The provisions concerning the list of the nutritional substances that may be used in the manufacture of infant formulae and follow-on formulae and of processed cereal-based foods and baby foods for infants and young children are currently laid down respectively in Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC, and Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children. Both measures were adopted under the old legislative framework of Directive 2009/39/EC.

The provisions concerning the list of the nutritional substances that may be used in the manufacture of the other foods for specific groups (foods for special medical purposes and total diet replacement products for weight control) are currently laid down in Commission Regulation (EC) No 953/2009 of 13 October 2009, also adopted under the old legislative framework of Directive 2009/39/EC.

Additional substances may be considered for authorisation based on the evaluation of appropriate scientific dossiers. The document "Administrative guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of foods" provides detailed information on the procedure that should be followed for the submission of requests for new substances to be considered for authorisation.

What will the new Regulation on Food for Specific Groups do?

The new Regulation (EU) No 609/2013 includes an Annex which consolidates the current three lists into a single Union list of substances that can be added to foods for specific groups. The Union list will start to apply when the corresponding provisions in the delegated acts foreseen by the Regulation become applicable.

Scientific advice on the addition of substances to foods for specific groups

  • Scientific Opinion on Calcium phosphoryl oligosaccharides (POs-Ca®) as a source of calcium (2016)
  • Scientific Opinion on the safety of chromium picolinate as a source of chromium (2010)
  • Scientific Opinion on the safety of ferrous ammonium phosphate as a source of iron (2010)
  • Scientific Opinion on the use of ferric sodium EDTA as a source of iron (2009)
  • Scientific Opinion (statement) on inability to assess the safety of iron-enriched yeast as a source of iron (2009)
  • Scientific Opinion (statement) on inability to assess the safety of zinc-enriched yeast as a source of zinc (2009)
  • Scientific Opinion on a mixture of chromium di- and tri-nicotinate as a source of chromium - (2008)
  • Scientific Opinion on vitamin K2 added for nutritional purposes and vitamin K2 as a source of vitamin K (2008)
  • Scientific Opinion on selenium-enriched yeast as source for selenium (2008)
  • Scientific Opinion on certain bisglycinates as sources of copper, zinc, calcium, magnesium and glycinate nicotinate as source of chromium - (2008)
  • Scientific Opinion on vanadium citrate, bismaltolato oxo vanadium and bisglycinato oxo vanadium - (2008)
  • Scientific Opinion on calcium citrate malate as source for calcium - (2007)
  • Scientific Opinion on calcium, iron, magnesium, potassium and zinc L-pidolate as sources for calcium, iron, magnesium, potassium and zinc (2007)
  • Scientific Opinion on D-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS) (2007)
  • Scientific Opinion on calcium, magnesium and zinc malate as sources for calcium, magnesium and zinc and to on calcium malate as source for calcium (2006)
  • Scientific Opinion on magnesium potassium citrate as a source of magnesium and potassium (2006)
  • Statement on the addition of DHA-rich oil from micro algae (2006)
  • Scientific Opinion on D-α-tocopheryl acid succinate as a source of vitamin E (2005)
  • Scientific Opinion on magnesium aspartate as a mineral substance when used as a source of magnesium (2005)
  • Scientific Opinion on calcium sulphate (2003)
  • Scientific Opinion on N-acetyl-L-cysteine (2003)
  • Statement on the D-alpha-tocopheryl acid succinate (2003)
  • Statement on L-serine and some amino acid- amino acid salts (2003)
  • Scientific Opinion on the safety of use of beta carotene from all dietary sources (2000)
  • Scientific Opinion on substances for nutritional purposes which have been proposed for use in the manufacture of foods for particular nutritional purposes ('Parnuts') (1999)
  • Report on foods for particular nutritional uses whose sodium content has been modified – Low sodium foods and salt substitutes (1991)