Novel food assessments
Under the Novel Foods Regulation a novel food is defined as a food that does not have a significant history consumption within the EU prior to May 1997. Such foods are subject to a pre-market safety assessment before a decision is made on EU-wide authorisation.
Submitting an application
A novel food application is first made to a single EU Member State. Once this application has been accepted the Member State has 90 days to produce an initial opinion. This opinion is then circulated to all EU Member States, who are then given a further 60 days to comment.
The Novel Foods Regulation includes a simplified procedure where a novel food is considered substantially equivalent to a food that is already on the market. In this case, the applicant can submit a notification to the European Commission after obtaining an opinion on equivalence from an EU Member State. Guidance on the data that should be provided when a request for such an opinion is submitted in the UK can be found in the ACNFP's guidelines for the presentation of data to demonstrate substantial equivalence.
- Application lists
- Full applications submitted via the UK
- Simplified procedure
- Full applications submitted to other Member States
Application lists
List of applications made under simplified procedure
Substantial equivalence notifications submitted to the European Commission under the Novel Foods Regulation (EC) No 258/97 article 5.
List of full applications
List of full applications for the approval of novel (inc GM) foods submitted under the Novel Foods Regulation (EC) No 258/97.
Full applications submitted via the UK
Baobab dried fruit pulp
August 2006: Application from PhytoTrade Africa to approve baobab dried fruit pulp as a novel food ingredient. Authorised July 2008
Chia
June 2003: Application from R Craig & Sons [M] Ltd to approve whole and ground chia seed as a novel food ingredient. Authorised October 2009.
Clinoptilolite
January 2004: Application from Euremica Environmental to approve clinoptilolite as a food supplement. Rejected September 2008.
D-Ribose
April 2008: Application from Bioenergy, Inc., for the authorisation of D-Ribose from Bacillus subtilis under the Novel Food Regulation (EC) 258/97. Under evaluation.
D-Tagatose
March 2005: Application from Bioresco, acting on behalf of Arla Food Ingredients to approve D-Tagatose as a novel food ingredient. Authorised December 2005
DHA Gold
February 2001: Application from OmegaTech for approval of DHA Gold, a DHA-rich oil. Authorised June 2003.
DHA Rich Microalgal Oil
January 2008: Application from Martek Biosciences Corporation, for the extension of use of a DHA-rich algal oil from the microalgae Schizochytrium sp under the novel food Regulation (EC) 258/97. Authorised October 2009.
Dihydrocapsiate
August 2010: Application from Ajinomoto Co., Inc., Japan for the authorisatin of Dihydrocapsiate Under the Novel Food Regulation (EC) 258/97. Under Evaluation
Drinks consisting of fruit juice or nectars with added phytosterols
October 2004: Application from Coca-Cola Services S.A to approve fruit juices, fruit nectars and tomato juice with added plant sterols as a novel food. Under evaluation.
Echium oil
October 2000: Application from John K King & Sons to approve Echium oil as a novel food. Withdrawn March 2002.
Ferric Sodium EDTA
July 2006: Application from AKZO Nobel Functional Chemical to approve ferric sodium EDTA as a novel food ingredient. Authorised June 2010
Glucosamine hydrochloride
August 2006: Application from Cargill to approve glucosamine hydrochloride from Aspergillus niger as a novel food ingredient. Under evaluation.
Ice structuring proteins
June 2006. Application from Unilever to approve an ice structuring protein preparation as a novel food ingredient. Authorised April 2009
Isomalto-oligosaccharide
January 2009: Application from Bioneutra Inc, for the authorisation of Isomalto-oligosaccharide (IMO) under the Novel Food Regulation (EC) 258/97. Under evaluation.
Isomaltulose
October 2003: Application from Cerestar to approve isomaltulose as a novel food ingredient. Authorised April 2005.
Kiwiberry concentrate
July 2007: Application from Efficas, Inc., to approve Kiwiberry concentrate from the hardy kiwi fruit as a novel food ingredient. Under evaluation.
Lentinan-rich extract: Glycanova
July 2008. Application from Glycanova for the approval of lentinan-rich extract obtained from the mycelium of fermented-produced shiitake mushroom (Lentinus edodes). Under evaluation.
Lycopene cold water dispersible products from Blakeslea trispora
September 2007: Application from Vitatene, to approve Lycopene Cold Water Dispersible products from the fungus Blakeslea trispora. Under evaluation.
Lycopene from Blakeslea trispora
October 2003: Application from Vitatene to approve lycopene from Blakeslea trispora as a novel food ingredient. Under evaluation.
Lycopene-rich tomato extract
September 2004: Application from LycoRed to approve a lycopene rich tomato extract as a novel food ingredient. Under evaluation.
Magnolia bark extract
July 2009: Application from William Wrigley Jr. Company for the authorisation of magnolia bark extract under the Novel Food Regulation (EC) 258/97. Under evaluation.
Phosphated distarch phosphate
August 2005: Application from National Starch Food Innovation to approve phosphated distarch phosphate as a novel food ingredient. Under evaluation.
Phosphated distarch phosphate: MGP Ingredients
November 2009: Application from MGP Ingredients to approve two phosphated distarch products (Fibersym® RW and FiberRite® RW) as novel food ingredients. Under evaluation.
Phytosterol-esters in 'milk' and 'yogurt' type products
August 2002: Application from Unilever for approval of phytosterol-esters to be included as a cholesterol-lowering ingredient in 'milk' and 'yogurt' type products. Authorised March 2004.
Refined Echium Oil
August 2006: Application from Croda Chemicals Europe Ltd to approve refined echium oil as a novel food ingredient. Authorised July 2008.
Taxifolin
August 2010: Application from Ametis JSG, Russia for the authorisation of Taxifolin under the Novel Food Regulation (EC) 258/97. Under evaluation.
Touchi (fermented black bean) extract
July 2008: Application from CBC Co. Ltd., for the authorisation of Touchi extract under the Novel Food Regulation (EC) 258/97. Under evaluation.
Trehalose
May 2000: Application from Bioresco for approval of Trehalose as a novel food ingredient. Authorised September 2001.
Venom from Honeybee (Apis mellifera)
July 2009: Application from Nelson Honey and Marketing (New Zealand) Ltd., to approve venom from the honeybee (Apis mellifera) as a novel food ingredient. Under evaluation.
Simplified procedure
Applications made under Article 5 of Regulation (EC) 258/97
Article 5 of the Novel Food Regulation (EC) 258/97, allows the company concerned to notify the European Commission of their intention to market a novel food, which is substantially equivalent to an existing food in terms of nutritional value, metabolism, intended use and level of undesirable substances.
Astaxanthin extract
March 2004: Application from US Nutra for an opinion on the equivalence of astaxanthin-rich carotenoid oleoresin extracted from the algae Haematococcus pluvialis using super critical carbon dioxide extraction. Authorised June 2004.
Astaxanthin extract: Algatechnologies (1998) Ltd.
July 2007. Application from Algatechnologies (1998) Ltd. for an opinion on the equivalence of astaxanthin-rich extract obtained from Haematococcus pluvialis, using supercritical carbon dioxide. Authorised April 2008.
Astaxanthin extract: Cyanotech Corporation
June 2006. Application from Cyanotech Corporation for an opinion on the equivalence of astaxanthin-rich extract obtained from the dried algae biomass of Haematococcus pluvialis, using supercritical carbon dioxide. Authorised February 2007.
Astaxanthin extract: Parry Nutraceuticals
February 2009. Application from Parry Nutraceuticals for an opinion on the equivalence of astaxanthin-rich extract obtained from the dried algae biomass of Haematococcus pluvialis, using solvent extraction. Under evaluation.
Chia seed: The Chia Company
February 2010. Application from The Chia Company for an opinion on the equivalence of chia seed grown in Australia, compared with the Columbus Paradigm chia seed which is grown in South America. Under evaluation
Forbes Cholesterol-lowering Phytosterol Esters
FCP-3P7 is the product code for a cholesterol-lowering food ingredient containing esters of plant sterols and plant stanols produced by Forbes Medi-Tech.
Glucosamine hydrochloride
February 2004: Application from Cargill for an opinion on the equivalence of glucosamine HCL derived from Aspergillus niger compared with the existing glucosamine HCL derived from shellfish. Authorised August 2004.
Lentinan-rich extract: MediMush
September 2006. Application from MediMush for an opinion on the equivalence of lentinan-rich extract obtained from the mycelium of fermented-produced shiitake mushroom (Lentinus edodes). Under evaluation.
Noni juice: Agrolabs Inc.
December 2004: Application from Agrolabs Inc for an opinion on the equivalence of noni juice (from the fruit of Morinda citrifolia L). UK opinion finalised. Awaiting notification from the Commission.
Noni juice: Hawaiian Noni LLC
October 2005: Application from Hawaiian Noni LLC for an opinion on the equivalence of noni fruit (from the fruit of Morinda citrifolia L). Awaiting notification.
Noni juice: Leap of Faith Farms
January 2006: Application from Leap of Faith Farms for an opinion on the equivalence of noni juice (from the fruit of Morinda citrifolia L). Authorised September 2006.
Noni juice: Mi GmbH
March 2005: Application from Mi GmbH for an opinion on the equivalence of noni juice (from the fruit of Morinda citrifolia L). Authorised June 2005.
Noni juice: Natures Products Ltd
September 2004: Application from Natures Products Ltd for an opinion on the equivalence of noni juice (from the fruit of Morinda citrifolia L). Authorised November 2004.
Noni juice: Neways Inc.
July 2003: Application from Neways Inc. for an opinion on the equivalence of noni juice (from the fruit of Morinda citrifolia L), grown in Hawaii. Awaiting notification.
Noni juice: Noni de Tahiti Ltd
May 2007: Application from Noni De Tahiti Ltd for an opinion on the equivalence of noni fruit (from the fruit of Morinda citrifolia L). Authorised in June 2007. Awaiting notification from the Commission.
Noni juice: PINA
7 May 2004: Application from Pacific Islands Noni Association (PINA) for an opinion on the equivalence of noni juice (from the fruits of Morinda citrifolia L), grown in various Pacific Islands. Awaiting notification.
Oils derived from two GM cottonseed lines
The Committee on Novel Foods and Processes has considered these applications under Articles 3(4) and 5 of the Novel Food Regulation, (EC) 258/97, on the substantial equivalence of oil derived from two distinct genetically modified cotton lines, Insect Protected line 531 and Roundup Ready line 1445.
Phytosterol application: Cognis
May 2004: Application from Cognis GmbH & Co requesting an opinion on the equivalence of phytosterols to be used in milk and yoghurt-type products, and yellow fat spreads. Authorised July 2004.
Phytosterol application: DDO Processing
November 2005: Application from DDO Processing for an opinion on the equivalence of phytosterols for use as an ingredient in various food categories. Awaiting notification.
Phytosterol application: DRT
August 2006: Application from DRT for an opinion on the substantial equivalence of phytosterols as an ingredient in various food categories. Under evaluation
Phytosterol application: Prima Pharm
September 2005: Application from Prima Pharm requesting an opinion on the equivalence of phytosterols to be used in yellow fat spreads, milk based fruit drinks, yoghurt type products, cheese type products, soya drinks, milk and fermented milk type products. Awaiting notification.
Phytosterol application: Triple Crown
May 2004: Application from Triple Crown AB requesting an opinion on the equivalence of phytosterols to be used in milk-type and yoghurt-type products. Authorised November 2005.
Phytosterols: Lipofoods
August 2006: Application from Lipofoods for an opinion on the equivalence of phytosterols as an ingredient in various food categories. Authorised February 2007.
Phytosterols: Naturis (ACI Group Ltd)
December 2007: Application from Naturis for an opinion on the substantial equivalence of phytosterols as an ingredient in various food categories. Under evaluation.
Saskatoon berries
May 2004: Application from Prairie Lane Ltd for an opinion on the equivalence of saskatoon berries to blueberries. Rejected June 2004.
Full applications submitted to other Member States
Application by Laboratoires Pharmascience to place the ingredient maize-germ oil high in unsaponifiable matter on the market
The Food Assessment Body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the French Competent Authority for the placing on the market of Maize germ oil High in Unsaponifiable matter. The UK Competent Authority wishes to make the following comments:
Application under EC Regulation 258/97 - Coagulated Potato Proteins and Hydrolysates thereof
The Competent Food Assessment Body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial assessment report produced by the Netherlands Competent Authority on the marketing of Coagulated potato protein and hydrolysates thereof.
GM maize line MON863 and MON863 X MON810 hybrids
The Competent Food Assessment body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial assessment report from the German Competent Authority for the authorisation of foods derived from insect-resistant GM maize MON863 and MON863 X MON810 hybrids.
Information paper: Fruitim - fat replacer - Proposed secretariat action
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Iodine in Eggs
The Competent Food Assessment body for the UK Competent Authority (CA), the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the Belgian CA for the placing on the market of iodine-enriched wild-type eggs.
Multibene Phytosterol Products
The Competent Food Assessment Body for the UK Competent Authority (CA), the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the Finnish CA for the placing on the market of Multibene® Phytosterol products.
Noni Juice: Morinda Inc
April 2000: Application from Morinda Inc to the Belgium Competent Authority to approve noni juice (juice of the fruit of Morinda citrifolia) as a novel food. Authorised June 2003.
Phospholipids from egg yolk
The Competent Food Assessment Body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the Belgium Competent Authority for the placing on the market of Phospholipids from egg yolk. The UK Competent Authority wishes to raise the following objections to the marketing of this product:
Placing on the market of transgenic radicchio rosso and green hearted chicory
The Competent Food Assessment Body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the Dutch Competent Authority for the placing on the market of transgenic Radicchio rosso and green hearted chicory.
Plant Sterols and Sterol Esters
The Competent Food Assessment Body for the UK Competent Authority (CA), the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the Dutch CA for the placing on the market of products containing plant sterols and sterol esters derived from oil seed processing.
Plantsterol enriched bakery products, grain-based snacks and gum arabic pastilles
The Advisory Committee for Novel Foods and Processes (ACNFP) considered the above application from Oy Karl Fazer by post as no meeting was scheduled within the designated 60 day period. The Committee broadly agreed with the initial opinion of the Finnish Competent Authority, however there were several concerns raised by members.
Rapeseed oil high in unsaponifiable matter
The Food Assessment Body for the UK Competent Authority, the Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report from the French Competent Authority for the placing on the market of Rapeseed oil High in Unsaponifiable matter. The UK Competent Authority wishes to make the following comments:
http://www.acnfp.gov.uk/assess/