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GUIDANCE DOCUMENT

CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives November 2002

Final
Docket Number:
FDA-1994-D-0007
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Feeds can be maintained Salmonella-negative in several ways, including the addition of chemical substances to the feeds.  Such chemical substances are deemed to be food additives under section 201(s) (21 USC 321(s)) of the Federal Food, Drug, and Cosmetic Act (the Act) unless they are generally recognized as safe (GRAS) for use against Salmonella in feed (Ref. 6).  According to section 409(a) (21 USC 348(a)) of the Act, a food additive is deemed to be unsafe, unless it and its intended use conform to the terms of an exemption or existing regulation and/or (for food contact substances) an effective notification prescribing the conditions under which such additive may be safely used.

Companies or individuals (sponsors) intending to market a food additive for use against Salmonella in feeds may file, under section 409(b) of the Act, a food additive petition to establish the safety and utility of the food additive for such use.  Details of the regulations governing the filing of food additive petitions and the data they must include can be found in 21 CFR 571.1 (Ref. 4).  Briefly, a food additive petition must contain data establishing that the food additive is safe and will have the intended effect.  The amount of food additive necessary to accomplish this effect must also be identified.  21 CFR 570.17 specifies the conditions under which a food additive or food containing a food additive intended for investigational use shall be deemed to be exempt from the requirements of section 409 of the Act.  

Our experience with food additive petitions indicates a need for consistency in evaluating the ability of anti-Salmonella food additives to achieve their intended effect of maintaining feeds Salmonella-negative.  Thus, the objective of this guidance is to help assure that appropriate studies are conducted by sponsors to evaluate the utility of anti-Salmonella food additives, and that uniform review and decision-making are accomplished by CVM.  This should facilitate the approval process for such food additives.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1994-D-0007.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002