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Difficulties in Declaring "Free From" Allergens


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#1 bnue

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Posted 20 August 2012 - 02:21 PM

There is a new label regulation that went into effect on August 4 , 2012. This guideline states that products cannot claim to any of the top 9 allergens as free from if there is any trace as a zero tolerence is now in place in Canada. So even if there are ' traces of, ' based on these new guidelines for Canada a precautionary statement needs to be applied.

Industries which have a 'free from' claim will have to include an exhaustive allergen control and analytical program in place

The testing for allergens should be at the lowest level of analyte in a sample that can be reasonably quantified. Total milk LOQ1ppm, Peanut LOQ 1 ppm, Almonds LOQ 0.3 - 2 ppm, Eggs 0.3 ppm, & Soy 2ppm.

No safe levels have been established for soy and like Gluten and Sulfites there is no 'soy free' definition available. The safe levels for Gluten will be <20ppm and Sulfites at 10ppm.

It is difficult to gather data as to what typical levels of soy could be present in ingredients as it depends on how the cultivars are grown, what kind of quality assurance is applied to the process - the process has to be controlled from field, transportation, storage, and processing - in the end what goes out of the door is what counts.

http://www.inspection.gc.ca/english/fssa/labeti/allerg/queste.shtml



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#2 Simon

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Posted 16 September 2012 - 01:51 PM

Thanks for this infomation Bnue I'm sure it will be useful to members.
This regulation is Canada - other members do the rules/limits compare with your country?

Regards,
Simon


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#3 Charles.C

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Posted 17 September 2012 - 12:42 AM

Dear bnue,

Thks for the interesting link.

As an elaboration of yr post, I noted this rather curious piece of text via yr sub-links -

Threshold levels for food allergens and action levels for enforcement purposes

Industry expressed concerns related to the lack of threshold levels for food allergens (i.e. a level below which there will not be clinical manifestations of an allergic response in sensitive individuals). This lack of thresholds would necessitate the declaration of allergenic proteins present at very low levels.

Health Canada recognizes that the absence of threshold levels for food allergens is a challenge for regulatory agencies, industry and sensitive consumers. In the absence of established threshold levels, the proposed regulatory amendments would require the declaration of a food allergen when it is present in the prepackaged product as determined by the best available analytical methods. The current proposal specifically excludes the requirement to declare food allergens that would be present in the prepackaged product as a result of cross-contamination. Based on knowledge of the ingredients and components that are used in the manufacture of the prepackaged product and the food allergen control programs implemented by the manufacturer and ingredient suppliers, the manufacturer would be able to determine if the proposed requirements would apply to its product.

http://www.gazette.gc.ca/rp-pr/p1/2008/2008-07-26/html/reg1-eng.html

I deduce that the specific detection levels you mention in yr post are actually US "interpreted" limits rather than Canadian.? Is a link to their origin available ?.

Rgds / Charles.C

Kind Regards,

 

Charles.C


#4 cosmo

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Posted 13 February 2013 - 07:57 PM

Hi bnue
The statement that the lack of thresholds would necessitate the declaration of allergenic proteins present at very low levels is correct. In these instances the acceptable level is the LOD of the most sensitive test kit available. This is an absolute claim with no tolerance, (This is yes/no)
The Gluten free standard in Australia is worded "no detectable gluten" where as Canada has qualified the same statement with a reference to the codex standard of 20ppm. This is a claim with an accepted level of contamination, (up to 19ppm)
Where this becomes interesting is when you manufacture allergen free products in one country and export it to others. The differences in standards really becomes apparent especially when you compare them all in a matrix. There are a lot of commonalities but also a lot minor differences that will permit a claim in one jurisdiction and negate it in another.

Cosmo



#5 DRL

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Posted 27 November 2014 - 03:09 AM

Clarification on the levels mentioned earlier. Gluten used to have a tolerance level of <20 ppm and sulphite <10 ppm.

 

http://www.inspectio...341?chap=2#s7c2

Scroll down to:

Food Allergens, Gluten & Added Sulphites

Clearly states that the respective allergen be declared if >10 ppm is present by cross contamination.

 

If either allergen is present as an ingredient regardless of the generation of that ingredient the label must list the allergen only once in the declaration of ingredients regardless of its level.

 

Charles C. The Regulatory Impact Analysis Statement quote you included was archived and so its discussion provided options to move forward. The option chosen is reflected in the current requirements listed in the link above. I did not read the entire 32 page document but suspect that pressure from celiac organizations in Canada and other groups interested in having clearer labeling for celiacs sought out the stricter labeling requirements. If you look at the food and drugs regulation Canada you will see this change in the recent amendment and revisions.

 

Hope this helps. This is a great forum to participate in!!!

 

Daryl



#6 Charles.C

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Posted 27 November 2014 - 03:40 PM

Dear Daryl,

 

Must confess that after 2 years I don't recall too much about my post. :smile:

 

The Canadian Rules and Regs are laid out like a Dewey Nightmare.

 

But thanks anyway for the 2014 update and Welcome to the Forum.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#7 Snookie

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Posted 28 November 2014 - 04:50 PM

DRL  :welcome: .  Good information. 


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#8 DRL

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Posted 10 December 2014 - 12:19 AM

Hi Charles, I am embarrassed! I did not even look at the date on the post until today when I saw your comment. Many apologies to you!

 

The reg review has happened in 2013 and the changes in 2014 October.

 

I will keep in mind I should check the dates on the posts. Hey we all got what we needed so a win win!!!

 

Cheers Daryl



#9 RG3

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Posted 10 December 2014 - 01:03 AM

:welcome: DRL






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