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Guidance for Use of Food-Grade Shell-Egg Sanitizers

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Directions for Use of Food-Grade Shell-Egg Sanitizers 

  • All formulations must be cleared under 21 CFR 178.1010 as sanitizing solutions for food contact surfaces or have a tolerance or exemption from the requirement of a tolerance in 40 CFR Part 180 that covers use as a sanitizing solution for food contact surfaces.
  • Any reference/directions for use for eggs intended for use as hatchlings is a drug claim and is regulated only by FDA. This type of claim is not allowed on FIFRA labels.
  • Only clean, whole eggs can be used for sanitizing. Dirty, cracked or punctured eggs cannot be sanitized.
  • If the product is intended for use as both a cleaner and a sanitizer, separate directions for use as a cleaner must be provided and followed by a potable water rinse, preceding the directions for use as a sanitizer with a fresh solution.

The directions for use in sanitizing eggs must be similar to the following:

[x] = company to provide amount/rate based on efficacy data.

To sanitize clean shell eggs intended for food or food products, spray with a solution of [x] ounces of product in [x] gallons of water (providing [x] ppm active). The solution must be equal to or warmer than the eggs, but not to exceed 130o F. Wet eggs thoroughly and allow to drain. (**Insert the applicable statement below, as appropriate). Eggs must be reasonably dry before casing or breaking. The solution must not be reused for sanitizing eggs.

  1. Eggs that have been sanitized with this quaternary ammonium compound shall be subjected to a thorough potable water rinse only if they are to be immediately broken for use in the manufacture of egg products.
  2. Eggs that have been sanitized with this chlorine compound may be broken for use in the manufacture of egg products without a prior potable water rinse.
  3. Eggs that have been freshly washed may be sanitized with this iodine compound only if the eggs are rinsed prior to application of the compound. A subsequent potable water rinse is not required.

Prior authorization from USDA is no longer required in order for a product to be intended or recommended for use in plants operating under the USDA egg grading and egg products inspection programs. However, in order for a product label to infer/recommend that it can be used in federally inspected egg plant there must be a complete set of use directions similar to the ones described above.

Directions for Sanitization Use in Federally Inspected Meat and Poultry Facilities

  • Prior authorization from USDA is no longer required in order for a company to add a claim that their product can be used in federally inspected meat and poultry facilities.
  • All formulations must be cleared under 21 CFR 178.1010 as sanitizing solutions for food contact surfaces or have a tolerance or exemption from the requirement of a tolerance in 40 CFR Part 180 that covers use as a sanitizing solution for food contact surfaces. Otherwise a claim for use in federally inspected meat and poultry factilites is not acceptable.
  • The product label must contain directions for use on hard non-porous food contact surfaces and must also contain use sites that would allow the product to be used in federally inspected meat and poultry facilities.
  • If the product is intended for use as both a cleaner and a sanitizer, separate directions for use as a cleaner must be provided and followed by a potable water rinse, preceding the directions for use as a sanitizer with a fresh solution.
  • The addition of a claim for use in federally inspected meat and poultry facilities to a registered product must be made via an amendment.
  • Label language allowed would be "This product can be used in Federally Inspected Meat and Poultry Facilities as a sanitizer."

This information was first published March 31, 1999.

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