6 replies to this topic

[Dawny P]

Help!,

my work collegues and I have been discussing Allergens in the office today but no one can give me a definitive answer as to how food is finally declared as an allergen in UK legislation.
What are the parameters? Does it have to be a killer? Does it just have to cause shock?

Does it have to effect a certain percentage of the population before it is legally classed as an allergen? Why celery?

Pleeeze put me outa my misery.....

Regards to all,
Dawny B.

[Simon]

Anybody in the know on how they detemine what a food allergen is?

Can you help Dawny?

Regards,
Simon

[FSSM]

Well, I know the question is explicitly formulated in the context of UK, but maybe this information could be useful:
"Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food"

http://www.fda.gov/F...n/ucm106108.htm

I also want to know why Celery!

Regards,

FSSM

[Charles.C]

Dear Dawny,

This is not an easily answered query in a limited space. If you are not too knowledgeable on immune systems, some heavy going is likely. It was for me anyway.

The wiki general definition of an allergen is –

An allergen is a nonparasitic antigen capable of stimulating a type-I hypersensitivity reaction in atopic individuals.[1]

(!!!!)

Details in http://en.wikipedia.org/wiki/Allergen

Above also contains a link to a nice (illustrated) discussion of the celery case.

More specifically on the food case, the Wiki definition is simplified somewhat (fortunately) -

A food allergy is an adverse immune response to a food protein.

http://en.wikipedia....ki/Food_allergy
(I guess the latter diagnostic part of above is part answer to yr main question [added - see my footnote below])

If you are really interested in the meaning of “immune response”, this one is fairly understandable –

http://www.aolhealth...lergic-reaction
(esp pg2)

I noticed simpler and harder versions of the above. It is possible that versions in more layman-language exist which retain adequate scientific rigor and are more readable but I didn’t see any. Maybe on the FSA website. Any offers ?

Rgds / Charles.C

PS beautiful moggie

added - I hadn't studied FSSM's link before i added above post (looked alarmingly long ) and having gone back to it, does contain some good, readable, stuff also IMO. I noticed the choice of "big 8" was from 160 possibilities (!) and covered 90% of reported cases but the exact selection procedure does not seem to be given as far as I could see, presumably a haccp type risk analysis of some sort, ie frequency / severity, maybe weighted on frequency.

[FSSM]

I´m almost sure the document (from UK FSA) attached to this post was downloaded from this forum, but I could not find exactly were.

Guidance on Allergen Management and Consumer Information
 Allergen_management.pdf   672.19KB   85 downloads
It states this on page 32:

"At present there is a lack of scientific and clinical evidence on which tobase firm conclusions regarding the minimum amounts of some allergens needed to trigger adverse reactions in sensitive individuals. The available evidence was evaluated by the European Food Safety Authority in 2004 and by the US Food and Drug Administration in 2005. Collaborative work to establish agreed management action levels for the most significant food allergens is currently underway (6).

In the absence of thresholds, a qualitative approach to managing allergens should be applied and a number of factors considered. These factors are outlined in section 3.2. The following table should be used to feed into the risk assessment process.

(6) For example, the US Food and Drug Administration draft report on ‘Approaches to establish Thresholds for Major Food Allergens and for Gluten in Food’, that was issued for consultation in June 2005 and the Food Allergy Research and Resource Programme Scientific Roundtable on Thresholds in October 2004. ILSI Europe Newsletter, June 2005, pg.10-12."

Maybe there is a newer document about this somewere in the web.

Help!,
What are the parameters? Does it have to be a killer? Does it just have to cause shock?

Going back to the FDA document, on section C

"C. Range of Adverse Effects
The clinical manifestations of food allergic reactions range from mild irritation to severe, life-threatening respiratory distress and shock. Specific signs and symptoms may involve the skin (e.g., pruritis, erythema, urticaria, angiodemia, eczema), eyes (e.g., conjunctivitis, periorbital swelling), nose (e.g., rhinitis, sneezing), oral cavity (e.g., swelling and itching of lips, tongue, or palate), or gastrointestinal tract (e.g., reflux, colic, abdominal pain, nausea, vomiting, diarrhea). In more severe reactions, involvement of the respiratory tract (e.g., cough, asthma, difficulty breathing, swelling around the larynx and vocal cords) and cardiovascular system (e.g., faintness, hypotension) can lead to loss of consciousness, asphyxiation, shock, or death. The term "anaphylaxis" is used to describe multisystemic severe reactions to an allergen requiring immediate medical intervention (Jackson, 2003)."

So I would take the least unwated adverse reaction, "mild irritation", maybe some images from a classic mild irritation would help.

Does it have to effect a certain percentage of the population before it is legally classed as an allergen?

Regards to all,
Dawny B.

On section "D. Prevalence" you can find this table:

Allergy Prevalence in the United States
 Table_II.doc   26KB   54 downloads
So it is based on clinical data, but I haven´t found yet what number of reports would be needed to consider a product or ingredient as a food safety risk for consumers.

Look for reference also in this other document:

The application of statistical approaches and the use of clinical data
 Hazard_characterisation_in_food_allergen_risk_assesment.pdf   214.94KB   67 downloads

Regards,
FSSM

Edited by Simon, 31 July 2009 - 06:05 PM.
Tidy up formatting of broken fonts and sizes :-)

[Charles.C]

Dear All,

As far as the original question goes, the basic designation of an “allergenic substance” is made on visual / medical / genetic / biochemical / immunological data (and probably others).

Any generalised ranking of allergenic activity (eg via threshholds) is obviously diagnostically extremely difficult. The procedure which nominated the “big 8” was apparently as quoted in the attachment below (2006) and its geographical, etc limitations are well detailed in the full article ( book - food allergy, Maleki et al). The same reference also details the biochemical complexities involved (if you hv the background to follow it).

 the_big_8.jpg   59.88KB   31 downloads

FSSM’s last pdf makes fascinating reading. Just illustrates how difficult the risk management is. And as concisely put in the conclusions section, the current result is typically, and not too surprisingly, defensive (precautionary) labelling.

Rgds / Charles.C

[Dawny P]

Dear all,
Teabag (Moggy) & I would like to thank all of you for your contributions to my question.
There has been lots of very useful and interesting bedtime reading (nerd alert!!) from a lot of very knowledgeable people. Thank you very much.
Just thought I'd pass on part of a response I received from the FSA.

"The initial list of 12 and now increased to 14 allergens was selected following scientific assessment by European Food Safety Authority (EFSA). The list takes account of the difference in geographical distribution of food allergies across the EU, so for example the list included mustard and celery, which are not major issues in the UK, but which are important allergens on the continent.
However, the Directive (Directive 2003/89/EC) has a provision for further allergens to be added for the list following evaluation by EFSA of scientific data, showing a public health risk in the EU."