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CCP Metal Detector

Metal Detector

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#1 Piero Panizzon

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Posted 13 June 2016 - 09:51 AM

Good morning,
 
during an audit of the inspector you asked me what are the limits of our CCP for the management of physical danger.
He said the suffocation due to a foreign body, the limits are defined by the food and drugs administration.
Can anyone help me find the references on which to base my control?
 
Thank you very much
Piero from Italy

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#2 Charles.C

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Posted 13 June 2016 - 02:39 PM

 

Good morning,
 
during an audit of the inspector you asked me what are the limits of our CCP for the management of physical danger.
He said the suffocation due to a foreign body, the limits are defined by the food and drugs administration.
Can anyone help me find the references on which to base my control?
 
Thank you very much
Piero from Italy

 

 

Hi Piero,

 

The interpretation of what represents a hazardous extraneous/foreign material is usually focused on hard or sharp objects, typically  brittle plastic or metal.

 

The opinion of what dimension defines "hazardous" varies with location. It also may relate to the intended consumer of the food.

 

Unfortunately i have no idea as to the situation in Italy, or did you mean the "food and drug" in USA ?

 

Some examples -

 

in Canada hazardous is, from memory >2mm

in Holland/Belgium also >2mm

In UK afaik, no limit exists.

In USA, in theory, I believe it can be anything > 0 "depending" on "XYZ" in reference below

http://www.fda.gov/I...l/ucm074554.htm

 

For metal, some locations consider the hazard to be characterised by the sensitivity of the metal detector. Or "best practice" in the relevant industry.

 

References to all the above exist on this forum at various locations. Do you have any preference or must be an Italian Regulatory value ?


Edited by Charles.C, 14 June 2016 - 04:26 AM.
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Charles.C


#3 QAGB

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Posted 13 June 2016 - 02:44 PM

 

Good morning,
 
during an audit of the inspector you asked me what are the limits of our CCP for the management of physical danger.
He said the suffocation due to a foreign body, the limits are defined by the food and drugs administration.
Can anyone help me find the references on which to base my control?
 
Thank you very much
Piero from Italy

 

 

 

Hi Piero,

 

Here's a link to an article below that discusses foreign material hazards. There's information on US and Canada, but it doesn't have too much information regarding global regulations. The FDA in the US basically states that variants of "ready-to-eat" products are adulterated if they contain foreign materials between 7mm and 25mm in length.

 

http://www.foodsafet...ood-production/

 

 

Here's a link to the US FDA's compliance manual in regard to foreign material. I don't know what the specific limits are in Italy, however. If you can, you'd be pretty safe to stay <2mm.

 

http://www.fda.gov/I...l/ucm074554.htm

 

 

QAGB


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#4 Charles.C

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Posted 13 June 2016 - 03:00 PM

Hi QAGB,

 

Yr first para. is seemingly "legally" common practice in USA but not matched to the scope of the Compliance Guide.

 

The conclusion may well depend on whether Italy has "adulteration".  A deluge of 1mm particles is unlikely to be infant acceptable IMO.


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Charles.C


#5 QAGB

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Posted 13 June 2016 - 03:19 PM

Hi QAGB,

 

Yr first para. is seemingly "legally" common practice in USA but not matched to the scope of the Compliance Guide.

 

The conclusion may well depend on whether Italy has "adulteration".  A deluge of 1mm particles is unlikely to be infant acceptable IMO.

 

 

Not sure what you mean there, as it is matched to the scope.

 

Directly quoted from the compliance guide:

 

 

"REGULATORY ACTION GUIDANCE:
The following represent the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and direct reference import detention to the districts.

The product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length."

 

There are other instances of foreign material hazards to be considered, in which case you mention a deluge of 1mm particles. I agree that a deluge of 1mm particles would not be acceptable for infants (or any one from other special-risk groups) to consume.

 

Both the article and the compliance guide address that issue. I didn't go in depth because the OP didn't really go in depth. In some instances where you are working with large granules in products, you may not be able to have critical limits that low (1mm) especially if relying on sieves/filters/screens for CCPs. However, most infants aren't going to be eating those granulated products, and the elderly (if health compromised) probably won't be eating those granulated products if they are restricted to a diet. It depends on the product characteristics as to what your critical limits would be. I didn't want to make assumptions, so I provided links to pretty well matched information.

 

 

QAGB


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#6 Charles.C

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Posted 13 June 2016 - 03:28 PM

Hi QAGB,

 

By scope i meant - 

 

A sample found to contain a foreign object that meets criterion c., d., or e., above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1) if a health hazard is established by CFSAN review. The CFSAN health hazard review in this case will consider various factors including the intended use of the product, subsequent processing steps, official guidance and requirements concerning unavoidable natural defects, and other mitigating factors that could eliminate, invalidate or neutralize the hazard prior to consumption of the food product.

 

 

Regardless, since Italy is in EC, i anticipate that European Standards are more likely applicable unless item X is for export to USA.

 

But, TBH, I'm not even sure if Europe has a "Food and Drug".  :smile:


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Charles.C


#7 redfox

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Posted 14 June 2016 - 03:42 AM

Hello Everyone,

 

Critical limit for our HACCP Plan for our MD step are two:

 

CL1: No detectable metal in the product

CL2: All product must pass through metal detector

 

Specimen:

Ferrous : 1.5mm

non-Ferrous: 2.0mm

SUS : 2.5mm

 

FDA standard: 7-25mm metal inclusion is hazardous

 

Accepted by auditor when we were audited last week.

 

regards,

redfox


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#8 Charles.C

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Posted 14 June 2016 - 04:13 AM

Hello Everyone,

 

Critical limit for our HACCP Plan for our MD step are two:

 

CL1: No detectable metal in the product

CL2: All product must pass through metal detector

 

Specimen:

Ferrous : 1.5mm

non-Ferrous: 2.0mm

SUS : 2.5mm

 

FDA standard: 7-25mm metal inclusion is hazardous

 

Accepted by auditor when we were audited last week.

 

regards,

redfox

 

Hi redfox,

 

Thks for above.

 

Are you saying that the Philippines regulatory simply quotes USFDA ?

 

eg Would pieces of sharp SS (SUS), 2mm in length, in a RTE food be cause for rejection due "adulteration" ?


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Charles.C


#9 redfox

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Posted 14 June 2016 - 06:25 AM

Hello Charles,

 

Yes we follow USFDA because we are exporting to US. Though we capture smaller than 7mm, of which if we based on FDA regulation still acceptable, we opt to reject the product as a precaution and also a sign of not functioning GMP rawmat supplier/supply chain level. Recall and withdrawal information from FDA and other food safety magazine, did not specify the size of the metal inclusion. Which we presumed it is smaller that 7mm.

 

Just a "Better safe than sorry" motto Charles. 

 

regards,

redfox


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#10 Charles.C

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Posted 14 June 2016 - 02:54 PM

Hello Charles,

 

Yes we follow USFDA because we are exporting to US. Though we capture smaller than 7mm, of which if we based on FDA regulation still acceptable, we opt to reject the product as a precaution and also a sign of not functioning GMP rawmat supplier/supply chain level. Recall and withdrawal information from FDA and other food safety magazine, did not specify the size of the metal inclusion. Which we presumed it is smaller that 7mm.

 

Just a "Better safe than sorry" motto Charles. 

 

regards,

redfox

                                                 Bit  :off_topic:

Hi redfox,

 

Indeed, "safe" has merit. Yr recall "reservation" is confirmed below [see(3)].

 

Might add that if  local regulatory requirements actually exist (?), the latter should anyway take precedence if more demanding than USFDA.

 

In truth, in respect to FDA guidelines, the topic is complicated in respect to the designated consumer which clearly may supercede any 7-25 mm interpretation (hence my previous 2mm query).

 

The following 2 threads (2013) from one of yr countryfolk contain substantial discussion on the (FDA) topic  and are sort of expansions of my 2mm query  –

(1)

http://www.ifsqn.com...nished-product/

(2)

http://www.ifsqn.com...-less-than-7mm/

 

Literature wise, the next link (3) (2014) seemed IMO to offer a realistic assessment of the USA recall situation although it avoids discussing motivations for "voluntary" recalls , eg  -

 

One point that needs to be made before moving forward is that foreign material in foods will render the food adulterated. It doesn’t matter if the item is very, very small; the food is now adulterated, and distributing a food that is known to be adulterated is a violation of the Federal Food, Drug and Cosmetic Act (see “Definitions of Adulteration”[4]). Food safety and quality professionals should follow the recall notices posted on the FDA, U.S. Department of Agriculture and the Canadian Food Inspection Agency websites. There are many examples of recalls for incidents where the material in question is tiny. The food may be safe using the criteria that FDA have established in its Compliance Policy Guide[5] for hard and sharp objects, but it is adulterated

 

.(3)

http://www.foodsafet...safety-or-both/

 

The consumer/size relationship is further illustrated in the FDA-extract quoted in post 5 of the IFSQN thread  linked in (1) above.

 

An even  wider generalisation of the above (ie zero tolerance for metal contaminants) is in this FDA letter (2002) to a processsor  –

Attached File  FDA Supplier Food Safety Requirements.pdf   222.42KB   24 downloads

 

JFI here is a slightly innovative approach. This CFIA current document  grades the risk (HML) based on product type / contaminant  dimensions / consumer  –

Attached File  CFIA - Reference Database for Hazard Identification - Physical Hazards.pdf   26.36KB   28 downloads

(contaminants < 2mm are low risk other than for “infant foods”)

 

and a few recent UK/USA examples of  voluntary(2)/(prob.)involuntary(1) recalls  –

 

http://www.foodmanuf...l-contamination

http://www.foodmanuf...ts-sushi-recall

http://www.foodengin...l-contamination


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Charles.C


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#11 redfox

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Posted 15 June 2016 - 09:42 AM

Hello Charles,

 

Thank you for this info.

 

regards,

redfox


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#12 Meat Hook

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Posted 15 June 2016 - 04:14 PM

USA 7mm


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#13 Charles.C

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Posted 15 June 2016 - 04:32 PM

USA 7mm

 

Please refer to the OP.


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Charles.C






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