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Certificates of Conformance 2.3.2.5 SQF Ed. 8


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dayclear

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Posted 11 April 2018 - 08:32 PM

Could you please help solve a debate over what is necessary for us to have on file for our food contact packaging. We are a dry blend manufacturer of breading mixed with spices sold to distributors. No retail. 

 

My coworker's statement: "The FDA frowns upon a company's use of a Certificates of Compliance unless the company requesting such is able to make an independent verification that the specifications are correct.  We are not such a company.  Requesting such certificates to rely on could create a real problem for our company in an FDA or third-party audit." 

 

This statement seems the opposite of what the SQF rule says. Is the FDA requirement different?

 

If this is true what else can we request to be compliant? Is it better to have a letter of guarantee or COA? Thanks for any input.

 



Tony-C

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Posted 12 April 2018 - 04:59 AM

Hi dayclear,
 
The degree of verification/validation should be based on risk. I would not normally consider food contact packaging low risk and therefore believe that a certificate of conformity is insufficient in this case.
 
SQF Code Edition 8 2.3.2.5 Verification of packaging materials shall include:
i. Certification that all packaging that comes into direct contact with food meets either regulatory acceptance or approval criteria. 
Documentation shall either be in the form of a declaration of continued guarantee of compliance, a certificate of conformance, or a certificate from the applicable regulatory agency.
ii. In the absence of a certificate of conformance, certificate of analysis, or letter of guarantee, tests and analyses to confirm the absence of potential chemical migration from the packaging to the food contents shall be conducted and records maintained.
 
SQF Guidance
All raw and packaging materials must be validated to ensure hazards and risks to finished product safety are identified and controlled. 
Raw and packaging materials should be included in the HACCP Food Safety Plan (refer to 2.4.3) to ensure that controls are in place to eliminate hazards or reduce them to an acceptable level.  
Validation is testing over and above daily monitoring to ensure that established food safety limits are effective, i.e., they achieve the desired results, so that the supplier can have confidence that the product and process are safe. 
Validation methods will vary depending on the risk to finished product safety. 
Validation for low risk materials may include certificates of analysis or certificates of conformance, provided by a trusted vendor. 
For high risk materials, testing and analysis is required for validation, and must be carried out annually (refer to 2.5.2). 
For food-contact packaging material, this may include testing or assurances for potential chemical migration to the food product.  
 
Kind regards,
 
Tony


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Posted 12 April 2018 - 01:18 PM

You could also request the composition of the packaging and do your own research on each component. A good supplier should be able to get you everything you need up to and including the scientific data to support the safety of that product.

 

I sent a request (we're also organic) to a company that would be providing detergent, I received back 20 documents including the research paper that proved their position. That is the kind of support you should be getting.

 

From the FDA

"You may ask the manufacturer for a letter of guaranty to customers (Section 303©(2) of the act) certifying that a particular product is acceptable for the intended food-contact use." Which is not a letter of comformance

www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/default.htm

 

FSAN/Office of Food Additive Safety
December 2007

Section 303 of the Federal Food, Drug, and Cosmetic Act

Section 303 of the Federal Food, Drug, and Cosmetic Act (the Act) provides penalties for persons who violate certain provisions of the Act. Section 303, paragraph © of the Act states that no person shall be subject to the penalties of subsection (a)(1) for having received, or proffered delivery of, adulterated or misbranded food additives if he has established a good faith guarantee from whom he received the articles. This paragraph was included in the 1958 amendments to the Federal Food, Drug and Cosmetic Act and remains the legal basis for the "letter of guaranty" supplied by many manufacturers to their clients. Title 21 CFR 7.12 Guaranty and Title 21 CFR 7.13Suggested forms of guaranty, provide example language for such a letter of guarantee.


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