美国及加拿大对新食品原料的判定英文版(共2页).docx

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1、精选优质文档-倾情为你奉上Novel Food in the US and Canada. The United States DefinitionThere is no so-called Novel Food in the Unites States. The Unites States regulates the Novel Food category in the same way as managing some other normal food categories in accordance with the FDAs strategy of generally recogni

2、zed as safe (GRAS) (21 CFR 170.30 & 170.35).There is no specific definition of GRAS. It refers to the food additive defined under F&D Act under which three points are highlighted:1. The substance is safe, or it is deemed to be safe under the conditions of its intended use;2. The safety of this subst

3、ance is evaluated and approved by experts qualified by scientific training and experience; 3. The substance has been adequately shown through either scientific procedures or experience based on common use in food to be safe under the conditions of its intended use.Scientific procedures: Scientific p

4、rocedures include the application of scientific data (including, as appropriate, data from human, animal, analytical, or other scientific studies), information, and methods, whether published or unpublished, as well as the application of scientific principles, appropriate to establish the safety of

5、a substance under the conditions of its intended use (21 CFR 170.3(h).Experience based on common use in food: Common use in food means a substantial history of consumption of a substance for food use by a significant number of consumers (21 CFR 170.3(f). GRAS through experience based on common use i

6、n food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information. However, the safety of certain substance cannot be ensured with previous history of usage before January 1, 1958.

7、 It has to have been used in a wide range and no health threats shall be reported during the period mentioned previously. It is obvious that the safety of substances is of the major concern with the GRAS certification. RegulatoryIn the Unites States, under GRAS, the government regulates food busines

8、s operators applying for permission of using foods and food ingredients (including Novel Foods) in a way of self-recognition by enterprises and records by FDA.Canada Definition (B.28.001 of C.R.C., c.870) Novel Food means: (a)a substance, including a microorganism, that does not have a history of sa

9、fe use as a food; (b)a food that has been manufactured, prepared, preserved or packaged by a process thato (i)has not been previously applied to that food, ando (ii)causes the food to undergo a major change; and (c)a food that is derived from a plant, animal or microorganism that has been geneticall

10、y modified such thato (i)the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,o (ii)the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorgani

11、sm, oro (iii)one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism.(B.28.001 of C.R.C., c.870) Major changemeans, in respect of a food, a change in the food that, based on the manufacturers experience or

12、generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to (a)the composition, structure or nutritional quality of the food or its generally recognized physiological effects; (b)the manner in which th

13、e food is metabolized in the body; or (c)the microbiological safety, the chemical safety or the safe use of the food.Pre-marketing Notification:In Canada, the Novel Food is regulated under the Health Canada. The manufacturers or importers of novel foods cannot sell or advertise their products unless they have acquired a written notice of approval from the Health Canada.专心-专注-专业