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AW1488

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Posted 21 October 2019 - 07:37 PM

Hi Everyone,

 

I work for a small spice company and we have a wide variety of ingredients.  We list many sensitivities in our products.  My main concern is Sulfites since they must be declared on the label.  Should we be treating it like an allergen as far as cleaning in between products?  Would it depend on the amount of sulfite present in the finished good?  I know we must declare over 10 ppm on the label but does that mean we need to do anything in the plant?



Hank Major

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Posted 21 October 2019 - 07:46 PM

Are you adding sulfites to your products?



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Posted 21 October 2019 - 08:10 PM

Hi Everyone,

 

I work for a small spice company and we have a wide variety of ingredients.  We list many sensitivities in our products.  My main concern is Sulfites since they must be declared on the label.  Should we be treating it like an allergen as far as cleaning in between products?  Would it depend on the amount of sulfite present in the finished good?  I know we must declare over 10 ppm on the label but does that mean we need to do anything in the plant?

 

I deduce sensitivity = allergenic ?

 

(Unusual terminology for me.)


Kind Regards,

 

Charles.C


Hank Major

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Posted 21 October 2019 - 08:59 PM

I deduce sensitivity = allergenic ?

 

(Unusual terminology for me.)

 

No, people can only be allergic to large molecules, like the peanut protein Ara h1, which weighs 150 kilodaltons, not tiny molecules like sodium metabisulfite, which weighs 190 daltons. Sensitivity is the correct term.



Hank Major

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Posted 21 October 2019 - 09:01 PM

Anyway, I asked the OP if they are adding sulfites, since only added sulfites must be declared on the labels.



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Posted 22 October 2019 - 03:14 AM

No, people can only be allergic to large molecules, like the peanut protein Ara h1, which weighs 150 kilodaltons, not tiny molecules like sodium metabisulfite, which weighs 190 daltons. Sensitivity is the correct term.

 

Hi Hank,

 

Ahem - maybe it depends on the reference and perhaps also on semantics (size here = mass ?!) -

 

When it comes to allergens triggering an allergic response via the oral route, several specific characteristics have been described in the scientific literature. Only few proteins account for most food allergies and many food allergens share some common characteristics, which nevertheless are not unique to them (Bannon, 2004; Breiteneder and Mills, 2005; Vickery et al., 2011). Food allergens are usually relatively abundant in the food source, which seems to enhance their chance to interact with the immune system (Bannon, 2004). Allergenic food proteins are generally relatively small with a molecular size below 70 kDa (Vickery et al., 2011) However, a molecular size of at least 3.5 kDa is necessary to induce an antibody response, ...........
(all 1)(all2)

 

The major allergens in peanuts are generally considered Ara h 1 and Ara h 3 that are members of the cupin superfamily of proteins, and Ara h 2 and Ara h 6 that are members of the prolamin superfamily. ... Ara h 1, a member of this superfamily, is a 65-kDa, 7S globulin or vicilin seed storage protein.

(all3)

 

Regarding the OP's  "Sensitivities", perhaps i should have written "allergenic" in Post 3 since semantics may again be involved (or not), eg consider this quote -

(1)

However, even though there is significant heterogeneity amongst patients with food allergy, in practice all individuals are considered to be equally sensitive to all foods, and strict avoidance is the standard of care.
(all2)

 

Or perhaps in the context of the OP, this Canadian one -

(2)

Sulphites do not cause true allergic reactions, and are generally grouped with the priority food allergens because sulphite-sensitive individuals may react to sulphites with allergy-like symptoms.
(all4)

 

(3) Or, probably less likely, the OP was referring to one of the Famous Three - Sensitivity, Allergenicity and Intolerance, as in -

 

https://www.healthli...vity-difference

 

(4) Or perhaps most likely in view of US location,  the word "Sensitivities" was being used in a (very) general FARRP kind of way,eg -

 

https://farrp.unl.edu/resources/gi-fas

 

 

Enlightenment awaits, particularly after your Post2. :smile:

 

 

Attached File  all1 - Stability of allergens.pdf   750.49KB   10 downloads

Attached File  all2 - pathophysiology of food allergy.pdf   77.95KB   7 downloads

Attached File  all3 - molecular basis peanut allergy.pdf   1.37MB   33 downloads

Attached File  all4 - Sulphites,Canada,2017.pdf   447.99KB   10 downloads

 

PS - I note that the 2013 review by Yang Zhou gave size of Ara h1 as 150kD. Best of 3 ?

 

PPS - If I read it correctly, this 2018 article uses a value of ca. 69kD (with xrefs) -

 

Attached File  all5 - Peanut allergens,2018.pdf   520.22KB   8 downloads

(the values given for Ara h3 are also much smaller than in the 2013 review, (57-62) cf (360-380)kD). Not my area of knowledge at all so cannot analyse further.)


Kind Regards,

 

Charles.C


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mahantesh.micro

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Posted 22 October 2019 - 07:32 AM

No, people can only be allergic to large molecules, like the peanut protein Ara h1, which weighs 150 kilodaltons, not tiny molecules like sodium metabisulfite, which weighs 190 daltons. Sensitivity is the correct term.

But sulfite (KMS & SMS) is listed as allergen in EU regulation



pHruit

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Posted 22 October 2019 - 09:09 AM

But sulfite (KMS & SMS) is listed as allergen in EU regulation

 

Doesn't mean it's a "true" allergen though, and indeed this is reflected in the full wording of the relevant regulation - the heading to Annex II of Regulation (EU) states: Substances causing allergies or intolerances ;)



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Posted 22 October 2019 - 11:31 AM

Doesn't mean it's a "true" allergen though, and indeed this is reflected in the full wording of the relevant regulation - the heading to Annex II of Regulation (EU) states: Substances causing allergies or intolerances ;)

Since it induce allergic type reaction it is listed in allergen group, whatever may be the case, we have to declare it on the labels if sulfite is involved either in the product naturally or added or used in the factory elsewhere.



AW1488

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Posted 22 October 2019 - 11:59 AM

Hey Everyone,

 

Thanks for the replies.  In the USA we use the term sensitivity for some ingredient items the could cause an allergen like reaction but they are not considered in the "big 8" allergens in the USA (examples sulfites, msg, red 7 color).  My facility is not adding sulfites but we have several ingredients that have naturally occurring sulfites.  The previous Director to me decided not to declare the naturally occurring sulfites on those product labels even though as a single ingredient we have documentation from the supplier showing it is greater then 20 ppm.  I reached out to FDA and referenced FARRP and they said we had to declare it on the labels whether it was naturally occurring or added.  So I know I need to make some updates there but as I was reviewing our blends and getting pricing for testing I had the thought that if we run multiple sulfite products in a row is there an issue of cross contamination to non-sulfite products?  I have never worked at a plant with so many products declaring sensitivities.  At a previous position we had only one item that had MSG in it but it had an allergen so we had to clean after for the allergen.  So does anyone do any type of cleans after ingredients with sensitivities?  I couldn't find anything on FDA's site but it's not the easiest place to find information.



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Posted 22 October 2019 - 12:19 PM

Hey Everyone,

 

Thanks for the replies.  In the USA we use the term sensitivity for some ingredient items the could cause an allergen like reaction but they are not considered in the "big 8" allergens in the USA (examples sulfites, msg, red 7 color).  My facility is not adding sulfites but we have several ingredients that have naturally occurring sulfites.  The previous Director to me decided not to declare the naturally occurring sulfites on those product labels even though as a single ingredient we have documentation from the supplier showing it is greater then 20 ppm.  I reached out to FDA and referenced FARRP and they said we had to declare it on the labels whether it was naturally occurring or added.  So I know I need to make some updates there but as I was reviewing our blends and getting pricing for testing I had the thought that if we run multiple sulfite products in a row is there an issue of cross contamination to non-sulfite products?  I have never worked at a plant with so many products declaring sensitivities.  At a previous position we had only one item that had MSG in it but it had an allergen so we had to clean after for the allergen.  So does anyone do any type of cleans after ingredients with sensitivities?  I couldn't find anything on FDA's site but it's not the easiest place to find information.

 

I deduce the answer to Hank's previous query (Post 2) is Yes.

Seems like you are using the FARRP "loose" terminology as I speculated (No.4) in Post 6.

afaik the labelling declaration for sulfite relates to SO2 concentration in finished product, not ingredient per se.

 

It sounds like you might need to do some urgent calculating / lab.testing for SO2 so as  to perhaps avoid breaking the law.

 

see -

 

https://farrp.unl.edu/sulfites-usa


Kind Regards,

 

Charles.C


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Posted 22 October 2019 - 01:04 PM

As a fellow QA in the spice industry I was unaware of sulfites in any ingredients. The company I work for is small and does not add any sulfites into the product. Where in the supply chain are you finding sulfites? I too would like to avoid breaking the law.



AW1488

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Posted 22 October 2019 - 06:33 PM

Hi SpiceyQA,

 

We also do not add any sulfites ourselve but have found a lot of both added and  naturally occurring in our ingredients.  Added items would be dried fruits, a lot of soy flours, worchestershire powder, and some other binding agents.  Naturally occurring are found in garlic, onion, tomato, leeks, and peppers.  You may want to check your ingredient specification sheets from your suppliers.  On added most of them include it as part of their allergen statement and for the naturally occurring our supplier provided a statement of the levels found in the ingredient.  



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Posted 22 October 2019 - 07:56 PM

if the concentration of the sulfite is greater than 10 ppm ,you have to declare it in your label in the allergen statement .



Hank Major

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Posted 23 October 2019 - 07:54 PM

Hi Hank,

 

Ahem - maybe it depends on the reference and perhaps also on semantics (size here = mass ?!) -

 

No, it depends on the ability of antibodies to detect and bind to the antigen.  Antibodies are themselves made of large proteins.  They can recognize as foreign molecules (or portions of molecules) that are 5-15 amino acids or 3-4 sugar residues in size.



Hank Major

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Posted 23 October 2019 - 07:56 PM

But sulfite (KMS & SMS) is listed as allergen in EU regulation

 

Government regulators being wrong, what's next?



Hank Major

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Posted 23 October 2019 - 08:06 PM

Hey Everyone,

 

Thanks for the replies.  In the USA we use the term sensitivity for some ingredient items the could cause an allergen like reaction but they are not considered in the "big 8" allergens in the USA (examples sulfites, msg, red 7 color).  My facility is not adding sulfites but we have several ingredients that have naturally occurring sulfites.  The previous Director to me decided not to declare the naturally occurring sulfites on those product labels even though as a single ingredient we have documentation from the supplier showing it is greater then 20 ppm.  I reached out to FDA and referenced FARRP and they said we had to declare it on the labels whether it was naturally occurring or added.  So I know I need to make some updates there but as I was reviewing our blends and getting pricing for testing I had the thought that if we run multiple sulfite products in a row is there an issue of cross contamination to non-sulfite products?  I have never worked at a plant with so many products declaring sensitivities.  At a previous position we had only one item that had MSG in it but it had an allergen so we had to clean after for the allergen.  So does anyone do any type of cleans after ingredients with sensitivities?  I couldn't find anything on FDA's site but it's not the easiest place to find information.

 

The FDA wants sulfites declared if they are added and are over 10 ppm. What your FDA person was saying is that in the end, in the finished product, if the naturally-occurring sulfites push your added sulfites over 10 ppm, that's tough, you have to declare.



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Posted 23 October 2019 - 08:59 PM

No, it depends on the ability of antibodies to detect and bind to the antigen.  Antibodies are themselves made of large proteins.  They can recognize as foreign molecules (or portions of molecules) that are 5-15 amino acids or 3-4 sugar residues in size.

 

Hi Hank,

 

I confess to having  zero knowledge as to the mechanistic logics involved however I stopped investigating the size issue  when the  odds reached 4 :1 against.150 kDa. For example (2018) -

 

Attached File  Peanut allergens.PNG   495.49KB   0 downloads


Kind Regards,

 

Charles.C


Hank Major

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Posted 23 October 2019 - 09:23 PM

Hi Hank,

 

I confess to having  zero knowledge as to the mechanistic logics involved however I stopped investigating the size issue  when the  odds reached 4 :1 against.150 kDa. For example (2018) -

 

attachicon.gif Peanut allergens.PNG

 

Ara h1 is a trimer. In other words, the plant assembles the protein from three subunits (which I think are identical). So if each subunit weighs 66-69 kDa, then the full protein is 198 to 207 kDa, which in biologist-speak is roughly 150 kDA (presumably they are looking at an average of partially and fully assembled proteins).

 

The business end of antibodies are only binding to a small portion of a protein this size.  Since the Ara h1 is globular, the recognized sites are undoubtedly on the outside of the glob.



Charles.C

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Posted 24 October 2019 - 07:32 AM

Ara h1 is a trimer. In other words, the plant assembles the protein from three subunits (which I think are identical). So if each subunit weighs 66-69 kDa, then the full protein is 198 to 207 kDa, which in biologist-speak is roughly 150 kDA (presumably they are looking at an average of partially and fully assembled proteins).

 

The business end of antibodies are only binding to a small portion of a protein this size.  Since the Ara h1 is globular, the recognized sites are undoubtedly on the outside of the glob.

 

Hi Hank,

 

Thanks for the biochem. assist. :thumbup:

 

I now suspect that (biochemical) semantic confusion may have been a factor in this discussion.

 

here is an extract from article previously mentioned in PS/post6 (see all-6 attached) -

 

To date, 13 peanut allergens (Ara h 1 through h 13) have been recognized by the Allergen Nomenclature Sub-Committee of the International Union of Immunological Societies. These allergens come from 7 protein families. Except for Ara h 1 (150 kD) and Ara h 3 (360–380 kD), the molecular weight of the other allergens ranges from 5 to 17 kD [13].

 

 

Here "MW" clearly refers to the native existing form of the allergen, eg a trimer as in case of Ara h1 and a hexamer for Ara h3

 

There is a discrepancy as compared to the "MW"s quoted in my extract of Post 18. I deduce that those tabulated values refer to the so-called "monomer" forms.

 

Unfortunately it is unclear which interpretation is being (generally) employed in the other references I quoted. My second quote in Post 6 is clearly in disagreement with the quotation above.

------------------------------------------------------------------------

 

No, people can only be allergic to large molecules, like the peanut protein Ara h1, which weighs 150 kilodaltons

 

Offhand, the data in file all-6 suggests that allergenicity for peanuts exists from "low" to "high" combined molecular weights.  Also notable that Ara h2 (16kDa)  has been found more potent than Ara h1(150kDa). However this presumably does not exclude other factors also being involved (assuming "allergenicity" may be multi-factor.)

 

Attached File  all-6 - Peanut allergy, allergen composition.pdf   2.17MB   3 downloads

 

This is truly a highly complex subject.!


Kind Regards,

 

Charles.C


Hank Major

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Posted 25 October 2019 - 07:17 PM

Hi Hank,

 

Thanks for the biochem. assist. :thumbup:

 

This is truly a highly complex subject.!

 

And the lay media are no help, consistently publishing confusing material. Probably there are people out there who think that they are allergic to small molecules such as ethanol or cholesterol.


Edited by Hank Major, 25 October 2019 - 07:20 PM.


Charles.C

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Posted 26 October 2019 - 12:08 AM

Hey Everyone,

 

Thanks for the replies.  In the USA we use the term sensitivity for some ingredient items the could cause an allergen like reaction but they are not considered in the "big 8" allergens in the USA (examples sulfites, msg, red 7 color).  My facility is not adding sulfites but we have several ingredients that have naturally occurring sulfites.

 

  The previous Director to me decided not to declare the naturally occurring sulfites on those product labels even though as a single ingredient we have documentation from the supplier showing it is greater then 20 ppm.  I reached out to FDA and referenced FARRP and they said we had to declare it on the labels whether it was naturally occurring or added.

 

  So I know I need to make some updates there but as I was reviewing our blends and getting pricing for testing I had the thought that if we run multiple sulfite products in a row is there an issue of cross contamination to non-sulfite products?  I have never worked at a plant with so many products declaring sensitivities.

 

  At a previous position we had only one item that had MSG in it but it had an allergen so we had to clean after for the allergen.  So does anyone do any type of cleans after ingredients with sensitivities?  I couldn't find anything on FDA's site but it's not the easiest place to find information.

 

Hi AW,

 

Yr query got sort of side-tracked.

 

The answer is presumably Yes. For example see this short thread -

 

https://www.ifsqn.co...-or-not-in-usa/

 

PS - JFI, in passing I noticed this Canadian interpretation of "Sensitivity" -

 

Food sensitivity Is an adverse reaction to a food as a result of a food allergy, food intolerance or chemical sensitivity.

http://www.inspectio...3/1528203218321

 

Each to their own.


Kind Regards,

 

Charles.C


Leila Burin

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Posted 01 November 2019 - 02:20 PM

Hello AW1488, sorry to add more fog on the arena, but if your product is going to be sold on Australia and New Zealand, pls rememeber their laws:

 

"Sulphites are substances used as a food additive that generally perform a preservative function. The term ‘sulphites’ includes sulphur dioxide and sodium and potassium sulphites [International Numbering System (INS) or Food Additive Code numbers 220, 221, 222, 223, 224, 225, 228].

Labelling requirements for food additives are set out in Standard 1.2.4 Information requirements – statement of ingredients, and Schedules 7 and 8 of the Code. In addition to meeting the labelling requirements for food additives, added sulphites must be declared when present in foods in concentrations of 10mg/kg or more [Standard 1.2.3]. This should apply even when sulphite additives are not required to be declared in an ingredient list, such as when they are present as a processing aid or are an ingredient within a compound ingredient comprising less than 5% of the food for sale [Standard 1.2.4]. 
 
best regards,
Leila





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