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GRAS notifications and novel food applications same process, different name?

New foods and food ingredients are the lifeblood of the functional food and nutraceutical industry. Innovation and the 'right' product can yield big dividends for food manufacturers. The EU and the US both have large consumer bases that makes them attractive for any food business, but what regulatory difficulties face a new food product in these regions? And is it possible to gain approval in the EU and the US without paying twice?

The Legal Definition of GRAS

GRAS or Generally Recognized As Safe first appeared in the Food Additives Amendment (1958) to the Food, Drug and Cosmetics Act. Under this amendment, a distinction was made between food additives that were subject to premarket approval before they could be used in food products and those substances that were considered to be "generally recognized as safe." In 1997, the US Food and Drug Administration (FDA) proposed a new system known as GRAS notification. This process allows a food manufacturer to submit a dossier to the FDA, who would then determine whether this information supported the GRAS determination. (1) It is important to note that a food manufacturer is not obliged to notify the FDA. An alternative route, known as "self-affirmed GRAS," allows the GRAS determination to be made by the food manufacturer. However, the FDA can request access to the information that supports the "self-affirmed GRAS" determination at any time. The definition of a GRAS substance as determined by the FDA is as follows: "A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts. In addition, a substance that is used in accordance with a sanction granted prior to 6 September 1958 is not subject to premarket approvl (2)

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One of the key elements in this definition is the word "safe." The FDA has clarified the meaning of this word in the context of GRAS: "A reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use." (3) The definitions highlighted above clearly distinguish a food additive from a GRAS substance. Although both of these substances are intended to be added to food, a food additive can only be used once a premarket approval has been granted by the FDA. (4) Dietary supplements are not approved by the GRAS notification scheme. The FDA regulates these products under the Dietary Supplement Health and Education Act (1994). If the food manufacturer intends to market a dietary supplement with a new ingredient, then they are obliged to obtain premarket approval under the New Dietary Ingredient Notification scheme.

The Legal Definition of Novel Food

In the EU, new foods are regulated according to (EC) No. 258/97, which concerns the placing on the market of novel foods and novel foods ingredients. Article 1(2) provides this definition for a novel food: "This Regulation shall apply to the placing on the market within the Community of foods and food ingredients that have not hitherto been used for human consumption to a significant degree within the Community. (5) Since this regulation came into force on 15 May 1997, any food product that cannot demonstrate a significant history of consumption in the EU prior to this date has to be authorized prior to marketing.

The novel food legislation does not provide any definitions relating to the word "significant" when referring to "a significant history of consumption." However, the European Commission is currently debating new legislation to supersede the current novel food regulation. One of the new aspects being considered would allow a simplified application for foods with a long history of traditional use outside of the EU. According to the current version of the EC consultation document, these traditional foods would need to meet the following definition: "Traditional food from a third country means novel food with a history of food use in a third country, meaning that the food in question has been and continues to be part of the normal diet for at least one generation in a large part of the population of the country. (6) Therefore, using the above definition, any food that cannot meet this standard for traditional use in the EU is likely to fall under the scope of the Novel Food regulations. Unlike the situation in the US, dietary supplements fall under the scope of the novel food legislation if the ingredient has no significant history use prior to May 1997. Food additives do not fall under the scope of the Novel Food legislation. These ingredients must be authorized according to separate legislation, depending on whether they are intended to be used as food colourings, sweeteners or additives other than colourings or sweeteners. (7)

Application Process for GRAS Notification and Novel Food Applications

The GRAS notification process offers food manufacturers two potential routes for demonstrating the safety of their food or food ingredient. The first route is the general recognition of safety through experience based on the common use in food prior to 1 January 1958. (3) The second route is the general recognition of safety through scientific procedures. (3) This route is applicable to all GRAS notifications when the first route, general recognition of safety through experience, is not applicable. In both cases, the food manufacturer can only demonstrate GRAS by using data and information that is generally available in the public domain (the FDA has published guidance to support GRAS determinations). (8-10) For foods or food ingredients that require authorization under the Novel Food regulations, there are also two potential routes of approval. The simplified application process uses the principle of substantial equivalence. (5) In this instance, the food manufacturer demonstrates the safety of the novel food by using a counterpart food under the same conditions of use and level of intake. (11) The second route for approval requires a full application. (5) This means that the food manufacturer must provide data that demonstrates the safety of their own product. (12)

Unlike the GRAS notification process, the information used to support the safety of a novel food can come from publicly available data and/or unpublished data. A GRAS determination seeks to demonstrate that the intended use for a food or food ingredient is expected to be safe in US consumers. (3) This means that a food or food ingredient could be GRAS for one food use but not GRAS for another intended use. By contrast, novel food authorizations seek to demonstrate the safety of the food or food ingredient. Here, the intended use of the food or food ingredient is just one part of the overall review process used to assess the safety of a novel food. (12)

Review Process for GRAS Notifications and Novel Food Applications

For GRAS determinations, the FDA aims to respond to each notification within 180 days. (13) Once the FDA has made its determination, the food manufacturer will receive one of two responses: "Notice does not provide a basis for a GRAS determination" or "FDA has no questions." There is an appeals procedure if the food manufacturer disagrees with the FDA review. (14) This process is normally done by a supervisor or higher official within the FDA, but there is no formal time limit for this process. For novel food applications, the review process is more complicated. A simplified application is only assessed by one EU member state. (5) On average, this review process takes around 30 days, but in reality there is no formal time limit.

For a full novel food application, the assessment involves all of the EU member states in two distinct phases. An initial review by one EU member state is obliged to be completed within 90 days, followed by a second review by the remaining 26 EU member states, which should be completed within 60 days. (5) Provided that all of the issues raised during these two review steps are addressed, the average time for approval is around 3 years. However, there is no formal time limit for approval and the review process continues until the majority of the EU member states are satisfied that the novel food is safe for consumers. In a few cases, the majority of EU member states may feel that there are still outstanding issues that need to be addressed. The European Commission will then consult with the Standing Committee on the Food Chain and Animal Health before making a decision about the novel food. (5) There is no formal time limit for this process.

Conclusions

Both the GRAS notification and the Novel Food application involve a safety assessment with similar data requirements. This means that data from an EU submission could be used to support a GRAS determination, and vice versa. However, there are a number of key differences that should be remembered:

* The GRAS notification scheme is voluntary, whereas the Novel Food legislation requires premarket approval.

* A GRAS notification must be based on publicly available information, whereas a Novel Food application can use public or confidential information.

* Dietary supplements are subject to the Novel Food legislation; but, in the US, dietary supplements are regulated under DSHEA and not the GRAS notification programme.

* The GRAS notification review process normally takes 180 days to complete. Novel food authorization ranges from around 30 days for a simplified application to around 3 years for a full application.

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References

(1.) CFSAN/Office of Food Additive Safety, "How US FDA's GRAS Notification Program Works," December 2005/January 2006 (www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/ucm083022.htm).

(2.) CFSAN/Office of Food Additive Safety, "About the GRAS Notification Program," March 2009 (www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASNotificationProgram/default.htm).

(3.) US FDA, "21 CFR 170.3(i)--Definitions. Code of Federal Regulations--Title 21: Food and Drugs, Part 170 Food Additives," http://edocket.access.gpo.gov/cfr_2004/aprqtr/pdf/21cfr170.3.pdf.

(4.) CFSAN/Office of Food Additive Safety, "How Are Additives Approved for Use in Foods? Food Ingredients and Colors," November 2004 (www.fda.gov/Food/FoodIngredientsPackaging/ucm094211.htm).

(5.) European Commission Food and Feed Safety, Novel Food, Legislation: Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (http://ec.europa.eu/food/food/biotechnology/novelfood/legisl_en.htm).

(6.) Commission of the European Communities, "Proposal for a Regulation of the European Parliament and of the Council on Novel Foods and Amending Regulation (EC) No. xxx/xxxx [common procedure]," http://ec.europa.eu/food/food/biotechnology/novelfood/COM872_novel_food_proposal_en.pdf.

(7.) European Commission Food and Feed Safety, Current Community Legislation: Food additives (http://ec.europa.eu/food/food/chemicalsafety/additives/comm_legisl_en.htm).

(8.) CFSAN/Office of Food Additive Safety, "Estimating Dietary Intake of Substances in Food," August 2006 (www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm074725.htm).

(9.) CFSAN/Office of Food Additive Safety, "Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions," March 2009 (www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm124917.htm).

(10.) FSAN/Office of Food Additive Safety, "Summary Table of Recommended Toxicological Testing for Additives Used in Food," June 2006 (www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm054658.htm).

(11.) The Advisory Committee for Novel Foods and Processes, Novel Food Assessments, "ACNFP Guidelines for the Presentation of Data to Demonstrate Substantial Equivalence Between a Novel Food or Food Ingredient and an Existing Counterpart (www.food.gov.uk/multimedia/pdfs/seguidelines.pdf).

(12.) European Commission Food and Feed Safety, Novel Food, Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No. 258/97 of the European Parliament and of the Council (97/618/EEC) pp 10-16 (http://europa.eu/smartapi/cgi/sga_doc?smartapi!celexapiprodCELEXnumdoc&lg=EN&numdoc=31997H0618&model=guichett).

(13.) CFSAN/Office of Food Additive Safety, "Guidance for Industry: Frequently Asked Questions About GRAS," December 2004 (www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm061846.htm).

(14.) CFSAN/Office of Food Additive Safety, "Federal Register Notice: The GRAS Proposal, Supplementary Information, VI Proposed Establishment of a Notification Procedure, (D) Appeals," April 1997 (www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/ucm083058.htm).

For more information

Dr John Wilkinson and Dr Matt Hall

Herbal Sciences International Limited

The Seedbed Centre

Langston Road, Loughton IG10 3TQ, UK.

Tel. +44 1376 320 354

info@herbalsciencesinternational.com

www.herbalsciencesinternational.com
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Title Annotation:regulatory attairs; Generally Recognized As Safe
Publication:Nutraceutical Business & Technology
Geographic Code:1USA
Date:Mar 1, 2010
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