50 NOVEL FOODS AND PROCESSES – Food and Drink – Good Manufacturing Practice, 7th Edition



Novel food is defined by the European Union (EU) as food that has not been consumed to a significant degree by humans in the EU prior to 1997, when the first Regulation on novel food came into force. Further novel food can be described as newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU.1 However, novel foods must be safe for consumption and labelled according to legislation in the countries in which they are produced and the countries to which they may be exported.


50.1 Care should be taken in the use of novel food or food ingredients produced from raw material that has not hitherto been used (or has been used only to a small extent) for human consumption in the area of the world in question, or that is produced by a new or extensively modified process not previously used in the production of food (and would thus include genetically modified materials). This must include attention to food safety considerations, compliance with the relevant regulations of the country for which the food is intended, and provision of label information to enable the purchaser or consumer to make an informed choice.

50.2 Novel foods and processes, including especially genetic modification (GM), have the potential to offer very significant improvements in the quantity, quality and acceptability of the world’s food supply. Food scientists and technologists can support the responsible introduction of such foods and processes provided that issues of product safety, environmental concerns, information and ethics are satisfactorily addressed.

50.3 In the EU, the principal legislation is EU Regulation No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L43, 14.2.97, pp. 1–7). Proposals for amendment were tabled in 2008, 2011 and 2013, and agreement was reached on new legislation which was adopted on 25 November 2015.2 The 2015 legislation states that ‘food intended to be used for technological purposes and genetically modified food which is already covered by other Union acts should not fall within the scope of this Regulation. Therefore, genetically modified food falling within the scope of Regulation (EC) No. 1829/2003 of the European Parliament and of the Council,3 food enzymes falling within the scope of Regulation (EC) No. 1332/2008 of the European Parliament and of the Council,4 food used solely as additives falling within the scope of Regulation (EC) No. 1333/2008 of the European Parliament and of the Council,5 food flavourings falling within the scope of Regulation (EC) No. 1334/2008 of the European Parliament and of the Council6 and extraction solvents falling within the scope of Directive 2009/32/EC of the European Parliament and of the Council7 should be excluded from the scope of this Regulation.’ The legislation gives further definitions on nanomaterials, requirements for vitamins, minerals and other food supplements and food from animal clones which is regulated under Regulation (EC) No 258/97.8

50.4 Any release of genetically modified organisms (GMOs) into the environment is governed by national regulations implementing EU Directive 2001/18/EC [in the UK by the Genetically Modified Organisms (Deliberate Release) Regulations 2002], subject to amendments to the directive consequent on Regulation (EC) 1829/2003 on Genetically Modified (GM) Food and Feed, Regulation (EC) 1981/2006 and Regulation (EC) 298/2008. This has been further amended by Directive (EU) 2015/12 amending Directive 2001/18/EC, and Directive 2009/41/EC on contained use of genetically modified micro‐organisms and Regulation (EC) 1946/2003 on transboundary movement of GMOs. For more information on current EU Legislation see https://ec.europa.eu/food/plant/gmo/legislation_en. The European Food Safety Authority (EFSA) is the central body controlling the assessment of novel foods and novel food ingredients. Applications can be made to a national authority [in the UK, the Advisory Committee on Novel Foods and Processes (ACNFP)]. Any person or company contemplating marketing in the UK a novel food or one containing a novel ingredient that has not already been the subject of official evaluation and approval must make a prior submission to the ACNFP.

50.5 Enforcement and execution of certain provisions of the EU Regulation and set fees for assessment procedures in the UK are provided by the Novel Foods and Novel Food Ingredients Regulations 1997 (SI 1997/1335) and the Novel Foods and Novel Food Ingredients (Fees) Regulations 1997 (SI 1997/1336). The Novel Foods and Novel Food Ingredients Regulations (1997) apply to the placing on the market within the EU of foods and food ingredients that have not previously been used for human consumption to a significant degree and that fall into the following categories:

  • foods and food ingredients containing or consisting of GMOs within the meaning of Directive 90/220/EEC, now superseded;
  • foods and food ingredients produced from, but not containing, GMOs, foods and food ingredients with a new or intentionally modified primary molecular structure, now superseded as above;
  • foods and food ingredients consisting of or isolated from microorganisms, fungi or algae;
  • foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use; and
  • foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients that affect their nutritional value, metabolism or level of undesirable substances.

The novel foods and food ingredients must not present a danger for the consumer, mislead the consumer or differ from the foods or food ingredients that they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer. Derogations are available for foods and food ingredients that, according to expert scientific opinion, are substantially equivalent to existing foods in respect of their composition, nutritional value, metabolism, intended use and level of undesirable substances contained therein. There are proposed Novel Foods Regulations planned to be implemented as legislation in 2018 that will repeal the Novel Foods and Novel Food Ingredients (Fees) Regulations SI No. 1997/1336. The proposed Regulations will enable the execution and enforcement in the UK of the Novel Food Regulation (EU) 2015/2283 (which amends Regulation (EU) No. 1169/2011 and repeals Regulation (EC) No. 258/97 and Commission Regulation (EC) No. 1852/2001).

50.6 The EU legislation also specifies the assessment procedures that must be carried out before a novel food can be placed on the market and makes provision for objections to be raised by interested parties. The manufacturer should consult the relevant legislation in force at the time.