Department of Food and Nutritional Sciences, The University of Reading

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Novel foods

Note: The requirements specified here are contained in EU Regulation 2015/2283 (as amended) and not EU Regulation 1169/2011

The controls apply to the placing of novel foods on the market in the United Kingdom It does not apply to foods or food ingredients which, at the date the original controls entered into force (15 May 1997),which had been 'used for human consumption to a significant degree within the EU or the United Kingdom'.

A 'Novel Food' is defined in Regulation 2015/2283 and involves a number of categories:

novel food’ means any food that was not used for human consumption to a significant degree within the EU or the United Kingdom before 15 May 1997, irrespective of the dates of accession of member States, and that falls under at least one of the following categories:

(i) food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the EU or the United Kingdom before 15 May 1997;

(ii) food consisting of, isolated from or produced from microorganisms, fungi or algae;

(iii) food consisting of, isolated from or produced from material of mineral origin;

(iv) food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the EU or the United Kingdom and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:

  • traditional propagating practices which have been used for food production within the EU or the United Kingdom before 15 May 1997; or
  • non-traditional propagating practices which have not been used for food production within the EU or the United Kingdom before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;

(v) food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the EU or the United Kingdom before 15 May 1997 and the food from those animals has a history of safe food use within the EU or the United Kingdom;

(vi) food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;

(vii) food resulting from a production process not used for food production within the EU or the United Kingdom before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;

(viii) food consisting of engineered nanomaterials as defined in point (f) of this paragraph;

(ix) vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where:

  • a production process not used for food production within the EU or the United Kingdom before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; or
  • they contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;

(x) food used exclusively in food supplements within the EU or the United Kingdom before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC;

Article 3(2)(a) (as amended for the UK)

Note that 'novel foods' do not include genetically modified foods as these are now covered by separate legislation (see GM food page).

Novel foods are approved under a system of controls involving a safety assessment by the Food Standards Agency or, for Scotland, Food Standards Scotland. Once approved, a novel food is added to an official List of novel foods. The granting of approval may include specific labelling requirements to ensure that consumers are appropriately informed. If a novel food is used as an ingredient then any specific labelling requirements will need to be applied to the label.

Approved novel foods are included in the List. The original list was published in the Annex to EU Regulation 2017/2470. This is retained legislation for the UK and this can be viewed on the main UK legislation website - see: Commission Implementing Regulation 2017/2470 establishing the Union list of novel foods. Specific additional labelling requirements are usually included and should be consulted.

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