10 replies to this topic

[Wexermann]

Hello everybody



First, this is a nice Forum with much information for me.



So now to my question:

Our company has bought the Global Standards and the best practice guideline: Foreign Body Detection purchased.

I am looking for specific information:

My question is, is there a requirement similar to the FDA, at what size foreign bodies are to be detected like in the FDA requirement (must conform to FDA's Health Hazard inch evaluation board supported regulatory action against products with metal fragments 0.3 inch (7 mm) to 1 (25 mm) in length. See FDA's "Compliance Policy Guide," Sec. 555 425.)?

If there is in them such a requirement where I can find this?

Thank you a lot!!!!

[GMO]

From my extensive searches on the subject, no. The FDA is the only place I've been able to find which identifies a size. It's still a useful (and valid) reference for EU production as part of your validation but I'd also look at any customer specifications etc as you may find they're significantly tighter.

[Cranberry]

The short answer from my searches pre-BRC audit is no. I have used 7mm as a guide for risk assessment and validation.

Depending on your product you may have different customer requirements and possibly different processes impacting on forign body control for your products. For example, passing through different sized filters, metal detection etc.


All the best

[Cranberry]

The short answer from my searches pre-BRC audit is no. I have used 7mm as a guide for risk assessment and validation.

Depending on your product you may have different customer requirements and possibly different processes impacting on forign body control for your products. For example, passing through different sized filters, metal detection etc.


All the best

Look at the state of that post. You can tell I'm covering night shift as well as the moment. Sorry spelling, sorry grammar.

[Charles.C]

Dear Wexermann,

My question is, is there a requirement similar to the FDA...

Actually, from memory, there are other (more strict) numerical regulations associated (or implied) within the related USFDA document you mention. As usual, the risk analysis is relevant, eg target consumer. There are many threads here on this topic, often related to metal detectors / critical limits.

Other legislatory guidelines do exist, i can recall posting at least one link (maybe even 2) here (somewhere) for an EC country(s)(Holland maybe?). But whether the same amount of supporting detail, eg metal, glass data etc, was available as per USFDA, i don't remember checking. I think the only (presumably max.) quoted tolerance was 2mm. I predict other guidelines will also exist, probably in Germany for one.

Rgds / Charles.C

[Tony-C]

BRC lacks prescription I assume due to the range of products it covers, what it does prescribe is 'Maximum Practical Protection' and 'Industry Best Practice' which I would look to use for validation.

I am aware of the '7mm' guideline but this wouldn't wash with BRC in a liquid that could run through a 1mm sieve

[D-D]

Yes - it's the Dutch work that talks about 2mm (and references the FDA 7mm). They go down to this based on risk to small children / infants. Attached.

[D-D]

Yes - it's the Dutch work that talks about 2mm (and references the FDA 7mm). They go down to this based on risk to small children / infants. Attached.

Try again...hopefully attached this time.

Attached Files

•  Fysische_verontreiniging_van_voedsel_door_productvreemde_delen.pdf   95.3KB   194 downloads

[campbell]

The USFDA have a book - Defect Levels Handbook - which help define contanimants in food. The sizes mentioned 7mm relate to potential cocking hazards. In terms of food industry requiremenes all equipment should be optimised tosuch that they remove the smallest particle possible. For instance using metal detection of dry flour products it may be possible to detect less tham 1.0mm. However when water salt and vinegar are added to sample detection may go up ro 3-4 mm using same detector. Therefore you cannot transfer requirements from one product/system to anorher without some compromise.

[Charles.C]

Dear campbell,

Actually I don’t think the USFDA choice of 7mm is related to cooking as such, more likely a statistical heath risk assessment of consequence as related to factors such as size, shape and specific consumer.

However you are surely correct that detection ability is related at the practical control level (and risk in FMEA viewpoints). I interpret yr numbers as meaning that the detection ability of “metal” in totally dry flour can change from 1mm to 3-4mm by including some salt and vinegar. Interesting, presumably it depends on how much ? Do you have any validation for this comment ?

Rgds / Charles.C

[Charles.C]

Dear D-D,

Thanks for the very useful attachment.

After some “Google Translating” I think (cannot guarantee ) that the document’s conclusions basically reaffirm the results of USFDA and conservatively quantitate point (d) in one of the primary US documents -

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

I enclose some, very slightly smoothed, translated chunks which looked the most relevant to current thread –

[Referring to USFDA] A committee of experts (Health Hazard Evaluation Board) has 190 reported incidents on hard or sharp food items evaluated in (8)……>>

Based on these data, the FDA proposed that sharp or hard objects of 7 mm or greater a threat
for consumers in general. The U.S. Department of Agriculture (USDA) has taken over this limit ( 9,10). Smaller items (2-6 mm) are less often a danger to the consumer. For vulnerable people, whose
eating and drinking are dependent on the care and attention of others, they are however a risk
considered. One can think of small children and people in institutions.
Relatively large objects are not normally seen as an unacceptable risk, because consumers usually
see for consumption and not eat. The FDA has a cap of 25 mm.
………………….>>


Article 14 of Regulation (EC) Nr. 178/2002 (16) prohibits food in the market, which are considered
as:
(a) harmful to health.
(b). unfit for human consumption.
The VWA takes yet the conclusions of the FDA regarding the risk of product in foreign hard parts (in?) foods. The data from the mentioned literature and the findings of the evaluation committee of the FDA constitute sufficient grounds for the VWA (17).
This means that for the VWA the presence of food in hard and sharp parts of 7 mm or greater is an
unacceptably high risk to the consumer. For food that is intended for small children or other risk the VWA uses a limit of 2 mm.

Personally I would be distinctly unhappy to bite on a 6mm iron ball in my burger. As a supplier of such products, I hv never encountered a “7mm-type” specification. Perhaps such products also fall into the “small children” category ??

Rgds / Charles.C