![](media/image1.png){width="0.8013888888888889in" height="0.8in"}

**DEPARTMENT OF HEALTH & HUMAN SERVICES** kifxmh1 Public Health Service

Food and Drug Administration

College Park, MD 20740

> August 26, 2002
>
> Mr. Ing. Angeles Fuentes Vargas
>
> J.B. PROVEEDORES, S.A. DE C.V.
>
> Calzada Coltongo No. 292-B
>
> Col. Industrial Vallejo
>
> Delgacion Azcapotzalco
>
> 02300 MEXICO
>
> Dear Mr. Vargas;
>
> This responds to your inquiry of July 10, 2002, requesting information
> on the procedures for registering your products with the FDA. You
> provide a list of your products for use as cleaners, sanitizers, and
> antimicrobial formulations.
>
> FDA does not register or issue certificates of authorization, or
> approvals of any kind, for specific products intended to be marketed
> as food additives in the U.S. Our role in the regulatory process is to
> review the safety and issue regulations stipulating conditions of safe
> use for chemicals intended to become components food. FDA is also
> responsible for enforcing these regulations. The authority for this
> responsibility is derived from the Federal Food, Drug and Cosmetic Act
> (the FFDCA). It is the manufacturer's responsibility to ensure that
> their products comply with all appropriate regulations.
>
> FDA evaluates petitions and writes food additive regulations for
> substances that meet the statutory definition of a food additive in
> the Federal Food, Drug and Cosmetic Act. Substances meeting that
> definition are generally expected to become components of food as a
> result of their intended use. Cleaning solutions are usually solutions
> of surfactants that must be rinsed off the food processing equipment
> before contact with food. Because cleaning solutions are rinsed off
> before the equipment contacts food, they are not reasonably expected
> to become a component of food. If your cleaning solutions are of the
> type that are rinsed off with potable water, then a food additive
> petition would not be required for their use. If they are expected to
> become a component of food as a result of their intended use, you will
> need to submit a food contact notification (FCN). The data required to
> demonstrate safety in a food contact notification is described in
> detail in our guidance documents available at our website listing for
> food contact notifications. The website listing is :
>
> http://vm.cfsan.fda.gov/\~dms/opa-noti.html
>
> Your list of chemical cleaning products cover four types of sanitizer
> usage. First, sanitizing solutions that are *not* intended to be
> rinsed from the equipment before it contacts food, are expected to
> become a component of food. In the past, FDA has regulated, as food
> additives, these sanitizing solutions for use on food processing
> equipment. These regulations are listed in title 21 Code of Federal
> Regulations (CFR) section 178.1010 *Sanitizing solutions*. However, on
> August 3, 1996, the Food Quality Protection Act (FQPA) became law.
> FQPA altered the jurisdiction over certain antimicrobial substances,
> including hard-surface sanitizers. Today sanitizing solutions used on
> food processing equipment and utensils are regulated by the
> Environmental Protection Agency (EPA) under the Federal Insecticide,
> Fungicide and Rodenticide Act (FIFRA) and section 408 of the FFDCA.
> For more information regarding EPA's requirements for sanitizing
> solutions, you are encouraged to contact Dennis Edwards, a Branch
> Chief in the Antimicrobials Division of EPA's Office of Pesticide
> Programs, US Environmental Protection Agency, 401 M St., SW,
> Washington, DC 20460 (Telephone: 703 308‑8087).
>
> Second, sanitizing solutions or hard surface sanitizers used on food
> packaging materials (i.e. milk bottles) remain under FDA's regulation
> authorization, although they are also subject to registration by EPA
> under FIFRA. Third, hand soaps with antimicrobial effect are under
> FDA's Center for Drug Evaluation and Research (CDER) regulation
> authorization as an over the counter (OTC) drug. For federal
> requirements regarding such uses of your product, I suggest that you
> contact Kevin Budich, in FDA's Center for Drug Evaluation and Research
> (CDER), OTC Drug Compliance Branch, HFD-312, 5600 Fishers Lane,
> Rockville, MD 20857, (Telephone: 301 594-1065). Fourth, hand
> sanitizers are under FDA's regulation authorization in the Office of
> Food Additive Safety as a food additive and under CDER as an OTC drug.
>
> Finally, your letter was submitted under 21 CFR 10.35 as a petition
> requesting FDA to stay the effective date in regard to chemical
> cleaning products for industrial food. This action was responded to
> with an acceptance letter from the Dockets Management Branch. We
> believe that this petition was filed in error and should be closed
> out. I have contacted Mr. Lyle Jaffe in Dockets Management Branch to
> relate to you that we are handling this matter. He recommends that we
> send a letter indicating the action taken by our Office and close out
> this submission.
>
> If you have any further questions concerning this matter, please do
> not hesitate to contact us.
>
> Sincerely,
>
> Vivian Gilliam
>
> Division of Food contact Substance
>
> Notification Review, HFS-275
>
> Office of Food Additive Safety
>
> Center for Food Safety
>
> and Applied Nutrition

cc: HFA-224 HFS-200 HFS-275 HFS-246 02P-0360/PSA 1

Letter No. 81574

R/D:HFS-275:VGilliam:08/23/02

HFS-275:MHepp:08/26/02

HFS-275:ALipman:09/05/02

F/T:HFS-275:VGilliam