Re: Can soy in supplements be causing some regressions?

[Guest guest]

Soy from fish oil makes my daughter agitated. In my son it makes him

sluggish.

[Guest guest]

Hi Dana,

The natural form of vitamin E is made from soybeans -while the

synthetic form of Vitamin E is made from turpentine or petroleum

products, the same source as motor oil. From my understanding -

high quality (perhaps all?) liquid Es don't contain the protein that

would be the allergen. It's sad if your child can't take vitamin E

as it's anecdotally together with fish oil like ProEFA it's shown to

quickly create moderate to dramatic surges for over 90% that have

tried it here. It may appear to those that don't read the authors

name that it works for less than 90% -but the majority it works for

don't post as often as for those who are still desperately seeking

answers to help their child. Below is both an archive on this as

well as recent research that backs up -it's probably OK to use

vitamin E or fish oil with vitamin E in almost all cases. But if you

don't want any soy at all -you could try flax seeds or an EFA formula

made primarily of flax oil -healthy but probably you won't see much

in the way of surges. As you read on you'll see why fish oil

contains vitamin E. (if you are part of this group you already know

why most of us use extra vitamin E too -some in very high dosages

like Dr. -with incredible results)

Here's an archive:

Here are two reasons why vitamin E

is added to fish oil for those of you searching for " soy free " (or

vitamin E free) fish oil.

1. " The processing and packaging of the fish oil are crucial in

determining its quality. Low quality oils may be quite unstable and

contain significant amounts of mercury, pesticides, and undesirable

oxidation products. High quality oils are stabilized with adequate

amounts of vitamin E and are packaged in individual foil pouches or

other packaging impervious to light and oxygen. "

2. " Supplementing with fish oils has been found to be entirely safe

even for periods as long as 7 years and no significant adverse

effects have been reported in hundreds of clinical trials using as

much as 18 grams/day of fish oils. Fish oil supplementation does,

however, lower blood concentrations of vitamin E so it is a good

idea to take extra vitamin E when adding fish oils to your diet. A

clinical trial carried out by the US Department of Agriculture found

that taking 200 mg/day of synthetic vitamin E (equivalent to about

100 IU of natural alpha-tocopherol) is sufficient to completely

counteract this effect of fish oil supplementation. [74, 75, 77,

78] " http://vvv.com/healthnews/fishoils.html

RE: [ ] Re: ProEFA --?SOY

I've been supplementing my soy allergic 4 year old since last August

without

problems. I guess it depends on the degree of sensitivity, and how

the oil

is processed. -

>

> Hi Colleen and ,

>

> I had just posted this in a recent message

> (quoted from the Nordic Natural's website regarding soy/allergies)

>

> " If a person is sensitive to soy, can they take fish oils that

> contain vitamin E?

>

> Vitamin E is an important addition for fish oil because it helps

> preserve fish oil freshness (along with other important

> manufacturing factors). Fish oils, like all liquid oils, are

subject

> to becoming oxidized, and vitamin E is a very effective and natural

> anti-oxidant (for fish oil and for people!). Most of the time

people

> with sensitivities to soy can consume vitamin E without worry, even

> if it's originally derived from soy. Vitamin E is an oil (a fat-

> soluble vitamin) and, for supplements, is purified to be 100% pure

> vitamin E, no protein components [note: the allergen in a food is

> usually the protein (e.g. gluten in wheat, casein in milk)]. It is

> always a good idea to consult with your healthcare practitioner

> before beginning a supplement regime.

>

>

> What if a person is allergic to fish? Can they ingest fish oil?

>

> Generally yes. Allergens (what people react to) in food are usually

> the protein component of a food (e.g. gluten in wheat, casein in

> milk). Because Nordic Naturals pure fish oils are thoughtfully and

> carefully manufactured (gentle processing, low temperature, clay

> filtered and microdistilled) they are essentially void of protein

> components. As a result, people who react to eating fish can

> generally consume fresh fish oil capsules. It is always a good idea

> to consult with your healthcare practitioner before beginning a

> supplement regime.

> http://www.nordicnaturals.com/direct/faqs.asp

And here's a recent study on natural vitamin E and soy allergies (in

conclusion -you probably can still use the vitamin E)

" In a clinical study in 32 soy allergic patients, none reacted during

skin testing to tocopherols and 31 did not reveal any adverse

allergic reaction to a maximum dose of 500 mg mixed tocopherols. One

patient reported oral allergy symptoms. The Panel considers that this

clinical study is insufficient to predict the likelihood that the

product may trigger an allergic reaction in susceptible individuals.

Considering the information provided by the applicant regarding the

starting material, thesubsequent production process, and the

demonstration of low residual protein content, the Panel considers

that it is unlikely that natural mixed tocopherol/D-alpha tocopherols

from soybean sources will trigger a severe allergic reaction in

susceptible individuals. "

The EFSA Journal (2007) 485, 1-9© European Food Safety Authority,

2007Page 1 of 9 Opinion of the Scientific Panel on Dietetic Products,

Nutrition and Allergies on a request from the Commission related to a

notification from Cognis, ADM and Cargill on natural mixed

tocopherols (E306), natural D-alpha tocopherol, natural D-alpha

tocopherol acetate and natural D-alpha tocopherol succinate from

soybean sources pursuant to Article 6, paragraph 11 of Directive

2000/13/EC(Request N° EFSA-Q-2006-151) (adopted on 3 May 2007)

SUMMARY Soy is a common dietary constituent and allergic reactions to

soy proteins are well described. Soy allergy prevalence studies are

lacking, estimated prevalences are about 0.5% in the general

population with about 3-6% of allergic children being allergic to soy

proteins. Clinical reactions are similar to those observed with other

major food allergens, such as milk, egg or peanut and include

systemic anaphylaxis. The application covers natural mixed

tocopherols (vitamin E, E306) and a range of D-alpha tocopherols

derived from vegetable oil (soybean oil). Natural mixed tocopherols

are mainly used as antioxidants in fatty foods at a concentration of

about 50 mg/kg (referring to the fat fraction of the specific food).

This corresponds to an intake of about 0.03µg soy protein assuming a

fat intake of 60-80 g/day (3-4 mg tocopherols). Natural mixed

tocopherols are also used as dietary supplements. Natural mixed

tocopherols and D-alpha tocopherols under consideration are derived

from soybean oil deodorised distillates. The applicant has conducted

analytical studies which have improved sensitivity and specificity of

protein analysis. In a clinical study in 32 soy allergic patients,

none reacted during skin testing to tocopherols and 31 did not reveal

any adverse allergic reaction to a maximum dose of 500 mg mixed

tocopherols. One patient reported oral allergy symptoms. The Panel

considers that this clinical study is insufficient to predict the

likelihood that the product may trigger an allergic reaction in

susceptible individuals. Considering the information provided by the

applicant regarding the starting material, thesubsequent production

process, and the demonstration of low residual protein content, the

Panel considers that it is unlikely that natural mixed tocopherol/D-

alpha tocopherols from soybean sources will trigger a severe allergic

reaction in susceptible individuals.

Page 2

KEY WORDS Allergenicity, natural mixed tocopherols, vitamin E, D-

alpha tocopherols, protein content, neutralised, refined, bleached,

deodorised, vegetable oil (soybean oil). BACKGROUND In November 2003,

the European Parliament and the Council adopted Directive

2003/89/EC1amending Directive 2000/13/EC, as regards indication of

the ingredients present in foodstuffs. Annex IIIa of the Directive

specifies a list of food ingredients or substances that are known to

trigger allergic reactions or intolerances in sensitive individuals

for which no labellingexemptions are allowed. Whenever the listed

ingredients/substances or their derivatives are used in the

production of foodstuffs, they must be labelled. Article 1, paragraph

11, subparagraph 2 of the Directive establishes a procedure allowing

for temporary labelling exemption of derivatives from ingredients

listed in Annex IIIa for which it has been scientifically established

that it is not possible for them to cause adverse reactions. In

accordance with this provision, submissions of request for temporary

labelling exemption were notified to the Commission before 25 August

2004. The Commission, after consultation with the European Food

Safety Authority, adopted a list (Directive 2005/26/EC2) of those

ingredients which are temporarily excluded from Annex IIIa until 25

November 2007,pending the final results of the notified studies.

Consequently, applicants who submitted a dossier in 2004 on the basis

of subparagraph 2, resulting in the inclusion of a product in the

list of Directive 2005/26/EC, and who areseeking exclusion of that

product from Annex IIIa beyond 25 November 2007 will have tosubmit a

request enclosing the final results of the notified scientific

studies. Therefore in the context of the permanent labelling

exemption procedure, the European Food Safety Authority is asked to

provide scientific opinions on the submissions in accordance with the

present terms of reference. TERMS OF REFERENCE In accordance with

Article 29 (1) (a) of Regulation (EC) N° 178/2002, the European

Commission requests the European Food Safety Authority to evaluate

the scientific data submitted by Cognis Deutschland GmbH & Co KG

(Cognis), Archer Midland Corporation (ADM) and Cargill Incorporated

(Cargill) in the framework of the procedure laid down in Article 6,

paragraph 11 of Directive 2000/13/EC. On the basis of that

evaluation, EFSA is requested to issue an opinion on the information

provided, and particularly to consider the likelihood of adverse

reactions triggered in susceptible individuals by the consumption of

the following ingredients/substances used under the conditions

specified by the applicant: natural1Directive 2003/89/EC of the

European Parliament and of the Council amending Directive 2000/13/EC

as regards indication of the ingredients present in foodstuffs. OJ L

308. 25.11.2003, p. 15. 2Commission Directive 2005/26/EC of 21 March

2005 establishing a list of food ingredients or substances

provisionally excluded from Annex IIIa of Directive 2000/13/EC of the

European Parliament and of the Council.OJ L 75, 22.03.2005, p. 33-34.

© European Food Safety Authority, 2007Page 2 of 9

Page 3

mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha

tocopherol acetate, natural D-alpha tocopherol succinate.ASSESSMENT

Soy is a common dietary constituent and allergic reactions to soy

proteins are well described. Soy allergy prevalence studies are

lacking; estimated prevalences are about 0.5% in the general

population with about 3-6% of allergic children being allergic to soy

proteins. Clinical reactions are similar to those observed with other

major food allergens, such as milk, egg or peanut. Soy allergy can

affect all common allergy target organs such as the

gastrointestinaltract, respiratory tract and the skin and can also

cause systemic anaphylaxis (NDA, 2004). Natural mixed tocopherols

(vitamin E, E306) and D-alpha tocopherols (including: natural D-alpha

tocopherol, natural D-alpha tocopherol acetate, natural D-alpha

tocopherol succinate) are derived from soybeans, which are an

allergenic source material, and therefore it isappropriate that the

Panel considers the potential allergenic activity for labelling

purposes.Tocopherols derived from other sources are not considered by

the Panel. In 2005, the Panel issued an Opinion on a notification

submitted by Cognis, ADM and Cargill to the European Commission

pursuant to Article 6, paragraph 11 of Directive 2000/13/EC as

amended by Directive 2003/89/EC, for temporary exemption from

labelling (NDA, 2005). Under the framework of permanent exemption

from labelling, the present Opinion is based on assessment of an

updated dossier from Cognis, ADM and Cargill, which contains

additional information or data mainly with regard to the analytical

methodology and the clinical study. 1. Production process Natural

mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha

tocopherol acetate and natural D-alpha tocopherol acid succinate are

derived from vegetable oil deodorised distillate (VOD) from soybean

as the starting material. The production process of VOD oils involves

several steps and includes cleaning and drying, crushing and solvent

extraction of soybeans. Crude soybean oil is degummed, neutralised,

and deodorised yielding VOD. The applicant states that the protein

content of the starting material (VOD) is variable depending on the

source and is reduced to low levels during the production process and

that residual proteins were not detected at a limit of detection

(LOD) of 10µg/g. The actual level of protein content depends on the

production processes of the VOD. In view of the intended use of the

tocopherols, the applicant has to comply with purity requirements

ofEuropean Food Law. The Panel notes however that there are no

statutory levels of permittedprotein concentration in VOD oils.

Natural mixed tocopherols and D-alpha tocopherols are produced from

the deodorised distillate of vegetable oil (an intermediate product

in the neutralised, refined, bleached and deodorised (N/RBD) soybean

oil production) by further processes including solvent extraction,

distillative neutralisation and precipitation. They are further

purified and undergo separation via molecular distillation under high

temperature (>200°C) (, 2004). © European Food Safety

Authority, 2007Page 3 of 9

Page 4

The applicant states that these processes are likely to further

reduce the presence of allergenicproteins. They have submitted

additional information related to the production process andprovided

further analytical evidence related to the content of allergens in

the final product. The applicant uses an enzyme-linked immunosorbent

assay (ELISA) for soybean trypsin inhibitor (Transia GmbH) with a LOD

of 1 µg/g for batch control of natural mixed tocopherols and D-alpha

tocopherols. Using this ELISA test kit, and based on the contribution

of the soybean trypsin inhibitor to thetotal soya protein mass (2-

4%), the applicant assumes an extrapolated LOD for total soybean

protein of 25-50 mg/kg. The applicant acknowledges the limitations

and uncertainties of this approach. 2. Characterisation of the

product All natural tocopherols are isolated from the deodorised

distillate of refined vegetable oil (VOD) from soybean and other

oilseed sources, which are not under consideration in this opinion.

Natural tocopherols are further purified by various processing steps,

including solvent extraction, chemical modification and distillation.

The applicant states that natural source vitamin E products consist

of natural mixed tocopherols, alpha-tocopherol, alpha-tocopherol

acetate, and alpha-tocopherol succinate. The most biologically active

antioxidant is D-alpha-tocopherol. Vitamin E activity is expressed as

D-alpha-tocopherol equivalents. Where activity is given as

International Units (IU), one IU of D-alpha-tocopherol is equivalent

to 0.67 mg (EGVM, 2003). 2.1 Exposure estimationPlant oils are the

main dietary sources of vitamin E (560-1600 mg/kg in soybean oil, 530-

1620 mg/kg in corn oil and 50-150 mg/kg in olive oil), with meat (0.5-

1.6 mg/kg), poultry (1.6-4.0 mg/kg) and dairy products (0.4-10.0

mg/kg) providing only moderate amounts. The amount of vitamin E in

foods at the point of consumption is difficult to assess as it

depends upon the effects of processing, storage and preparation. In

the UK, vitamin E is present in a variety of dietary supplements at

doses of up to 268 mg/day in multi-constituent products and670 mg/day

in single constituent products. Vitamin E is also present in licensed

medicinal products; the highest doses authorised in the UK are 20-100

mg (EGVM, 2003).The applicant states dietary supplements found on the

European market limit the maximum recommended additional daily intake

to 830 mg (ERNA, 2003). This would result in 41 µg soy protein when

taking into account 50 mg/kg residual protein in the tocopherol

fraction. The applicant states that mixed tocopherols are used as a

food antioxidant in concentrations of about 50 mg/kg (referring to

the fat fraction of the specific food). Assuming a fat intake of 60 -

80g/day, this could result in a dose of 3 (- 4 mg) tocopherols per

day, which corresponds to 0.03 µg of protein (based on 10 µg/g

residual protein in tocopherol). This amount of protein, likely to be

spread over three meals a day, is considerably below levels at which

clinical allergic reactions have been reported (NDA, 2004). The

applicant also states that D-alpha tocopherol-succinates are used as

food supplements, Assuming additional daily doses of up to 830 mg/day

as recommended by food supplement producers would result in a dose of

8.3 µg protein (based on the 10mg/kg residual protein in the

tocopherol fraction as a worst case assumption). © European Food

Safety Authority, 2007Page 4 of 9

Page 5

Natural mixed tocopherols are almost exclusively used as antioxidants

in fatty foods (E306) and as dietary supplements at a dose of around

100 mg/day. However, consumption of tocopherols from multiple sources

may result in a higher intake. 3. Evidence of non-allergenicity The

applicant has performed a literature search with the help of standard

and several additional databases and fails to find any report

relating to allergic reactions to tocopherols and vitamin E. However,

due to the lack of clear labelling of soybean derived mixed

tocopherols/D-alpha tocopherols, under-reporting of allergic

reactions may have occurred.3.1 Laboratory-based tests3.1.1 Sample

selectionThe in vitro investigations to ascertain residual protein

were conducted on both the starting material i.e. vegetable oil

deodorised distillate (VOD) as well as on the finished tocopherol

product. Nine VOD and nine commercial mixed tocopherol samples were

provided by the joint notification partner companies (manufacturers).

Each manufacturer provided three different batches of VOD and

tocopherol samples for analysis. All VOD batches were mainly of

soybean origin. Additionally, one batch of tocopherols from each

manufacturer was chosen randomly to prepare a blend with equal batch

distribution. This blended sample was used in the in vitro

investigations as well as the clinical study (section 3.3). 3.1.2

Analytical approach The following analytical methods were applied for

detection of both hydrophilic and lipophilic peptides, and denatured

peptides thereof. Two strategies were followed by theapplicant for

the analysis of the presence of residual soybean proteins: a)

Extraction of hydrophilic proteins for analysis in an enzyme-linked

immunosorbent assay (ELISA) that detects hydrophilic proteins, and

for analysis in immunoblotting that detects hydrophilic, lipophilic,

and denatured proteins. The soybean specific ELISA allowed a

detection of hydrophilic soybean proteins at or above 0.5-2 ng/ml in

diluted extract. Extraction of lipophilic and denatured proteins

for immunoblotting analysis. The immunoblotting method allowed the

detection of 50 ng of internal reference soybean (IRS) extract and

100 ng of oleosin, respectively. Each VOD and tocopherol sample

extract was analyzed for total protein, soy protein and IgE-reactive

(soy) protein in a primary screening. 3.1.2.1 Detection of

hydrophilic soy proteins in VOD samples A VOD sample spiked with IRS

protein extract prior to extraction was used for investigation of IRS

protein recovery. Following SDS-PAGE analysis and application of the

Sypro®Ruby stain lipophilic proteins such as oleosins were not

detectable at a level of 1µg/g and hydrophilic proteins were not

detectable at a level of 10µg/g in any of the VOD or tocopherol

samples © European Food Safety Authority, 2007Page 5 of 9

Page 6

There was no detectable hydrophilic protein in any of the nine VOD

samples at or above 10µg/g. 3.1.2.2 Detection of lipophilic and

denatured soy proteins in VOD samples A VOD sample was spiked with

the oleosin fraction from soybean prior to extraction for

investigation of lipophilic protein recovery. All protein extracts of

VOD samples were analyzed in SDS-PAGE/Sypro®Ruby. There was no

detectable lipophilic protein in any of the nine VOD samples at or

above 1µg/g. 3.1.2.3 Detection of hydrophilic soy proteins in

tocopherol samples Selected tocopherol samples as well as the

tocopherol blend used in the clinical study wereanalyzed for residual

soybean protein.Additionally a tocopherol (blend) sample was spiked

with IRS protein extract prior toextraction for investigation of IRS

protein recovery. Using ELISA, soy protein was not detectable at or

above 10µg/g in extracts of all investigated tocopherol samples

including the blend sample. 3.1.2.4 Detection of lipophilic and

denatured soy proteins in tocopherol samples The tocopherol blend was

additionally spiked with the oleosin fraction from soybean prior to

extraction for investigation of lipophilic protein recovery (oil

bodies in seeds contain a unique protein known as oleosin associated

with the oil body surface. Oleosins are unique in thatthey have a

high affinity for lipids). In none of the investigated samples

including the tocopherol blend was soy protein detectable at or above

1 µg/g.The applicant developed an ELISA inhibition assay for soybean

specific IgE. The range ofvitamin E derivatives mentioned above were

analysed and none of the samples produced inhibition. 3.2

Immunochemical methodologiesThe applicant has analysed published IgE

binding studies to N/RBD and other purity gradesof soybean oils and

discusses possible limitations in detail. A small number of studies

describe the immunochemical characterisation of non-refined

(Awazuhara et al., 1998; Paschke et al., 2001) and N/RBD oils

(Zitouni et al, 2001; Errahali et al, 2002; Montagnon et al, 2003).

The observed binding pattern in non-refined oils (Paschke, 2001) was

similar to that of N/RBD oils with 2 binding activities at 28 kDa and

56 kDa described by the French authors (Zitouni et al, 2001; Errahali

et al, 2002; Montagnon et al, 2003).3.3 Clinical studies The

applicant reports the results of a European two centre clinical

study, in 32 patients from Germany (Berlin) and Switzerland (Zurich).

A total of 32 patients (17 males, age range 6 © European Food Safety

Authority, 2007Page 6 of 9

Page 7

months to 65 years) with confirmed clinical food allergy to soy

(clinician-confirmed positive history of soy allergy and confirmed

double-blind placebo-controlled food challenge (DBPCFC) reaction to

soy), were skin prick tested and underwent open and DBPCFC with up to

500 mg natural mixed tocopherols in different food matrices. Natural

mixed tocopherols were chosen by the applicant since these represent

the least refined tocopherols available tothe consumer. All 32

individuals failed to react to the skin prick test with the test

substance. Twenty-twosubjects had a positive skin reaction (>3mm) to

a commercial soy extract, soy isolate or soymilk. Thirty-one out of

thirty-two subjects consumed the test article in an open food

challenge without allergic reaction. One patient with a positive skin

prick test to soy protein and soy protein-specific serum IgE reported

mild oral allergy symptoms and nausea, which were confirmed in a

DBPCFC. Immunoblotting analysis of this patient's serum failed to

show IgE binding to samples of mixed tocopherols and the

investigators attribute these symptoms to a non- IgE based reaction,

although further evidence for this assumption is lacking. This

individual is also a participant of the FAREDAT study investigating

threshold levels for soy allergy where he reacted with oral allergy

symptoms only after a cumulative dose of 4 g soy protein without

developing systemic symptoms after being challenged with higher doses

(Ballmer-Weber et al, 2007). The Panel considers that this clinical

study is insufficient to predict the likelihood that the product may

trigger an allergic reaction in susceptible individuals. CONCLUSIONS

Considering the information provided by the applicant regarding the

starting material, thesubsequent production process, and the

demonstration of low residual protein content, the Panel considers

that it is unlikely that natural mixed tocopherol/D-alpha tocopherols

from soybean sources will trigger a severe allergic reaction in

susceptible individuals. DOCUMENTATION PROVIDED TO EFSADossier

submitted by Cognis Deutschland GmbH & Co KG (Cognis), Archer

MidlandCorporation (ADM) and Cargill Incorporated (Cargill) to the

European Commission pursuant to Article 6 paragraph 11 of Directive

2000/13/EC as amended by Directive 2003/89/EC on 15 September 2006.

REFERENCES Awazuhara H, Kawai H, Baba M, Matsui T, Komiyama A (1998).

Antigenicity of theproteins in soy lecithin and soy oil in soybean

allergy. Clinical and Experimental Allergy 28: 1559-1564. Ballmer-

Weber BK, Holzhauser T, Scibilia J, Mittag D, Zisa G, Ortolani C,

Oesterballe M, Poulsen LK, Vieths S, Bindslev-Jensen C (2007).

Clinical characteristics of soybean allergy in Europe: A double-

blind, placebo-controlled food challenge study. J Allergy Clin

Immunol20, [Epub ahead of print]. © European Food Safety Authority,

2007Page 7 of 9

Page 8

Bindslev-Jensen C, Briggs D, Osterballe M (2002). Can we determine a

threshold level for allergenic foods by statistical analysis of

published data in the literature? Allergy 57: 741-746. ERNA (European

Responsible Nutrition Alliance) (2003). Vitamin and Mineral Fact

Sheets, Vitamin E, Brussels. Errahali Y, Morisset M, Moneret-Vautrin

DA, Kanny G, Metche M, Nicolas JP, Frémont S (2002). Allergen in soy

oils. Allergy 57: 648–649. Expert Group on Vitamins and Minerals:

Safe upper levels for vitamins and minerals: report of the expert

group on vitamins and minerals ISBN 1-904026-11-7.

http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdfHourihane JO'B,

Bedwani SJ, Dean TP, Warner JO (1997). Randomised double blind

crossover challenge study of allergenicity of peanut oils in subjects

allergic to peanuts. BritishMedical Journal 314: 1094-1087. Montagnon

I, Errahali Y, Metche M, Nicolas JP, Frémont S (2003). Allergenicity

of soya oils. Food Allergy and Intolerance 4: 153-163. NDA

(Scientific Panel on Dietetic Products, Nutrition and Allergies)

(2004). Opinion of the Scientific Panel on Dietetic Products,

Nutrition and Allergies on a request from the Commission relating to

the evaluation of allergenic foods for labelling purposes. The EFSA

Journal 32, 1-197.

http://www.efsa.europa.eu/en/science/nda/nda_opinions/food_allergy/341.html. NDA

(Scientific Panel on Dietetic Products, Nutrition and

Allergies) (2005). Opinion of the Scientific Panel on Dietetic

Products, Nutrition and Allergies related to a notification

fromCognis, ADM and Cargill on natural mixed tocopherols (E306),

natural D-alpha tocopherol, natural D-alpha tocopherol acetate and

natural D-alpha tocopherol succinate from soybean sources pursuant to

Article 6 paragraph 11 of Directive 2000/13/EC. The EFSA Journal 189,

1-7.

http://www.efsa.europa.eu/en/science/nda/nda_opinions/food_allergy/846.html.

Paschke A, Zunker K, Wigotzki M, Steinhart H (2001).

Determination of the IgE-binding activity of soy lecithin and refined

and non-refined soybean oils. J Chromatogr B, 756: 249–254. A

(2004). Fats and Fatty Oils. Ullmann's Encyclopedia of Industrial

Chemistry. Release, 7th Edition, Wiley & Sons, New York. Zitouni N,

Errahali Y, Metche M, Moutete F, Kanny G, Moneret-Vautrin DA, Nicolas

JP, Fremont S (2001). Soy allergens are detected in some edible soy

oils. Abstract 623. J Allergy Clin Immunol 107:188. PANEL MEMBERS

Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof,

Hannu Korhonen, Pagona Lagiou, us Løvik, ngela Marchelli,

Ambroise , Bevan Moseley,© European Food Safety Authority,

2007Page 8 of 9

Page 9

Andreu Palou, Hildegard Przyrembel, Seppo Salminen, () J

Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van

Loveren and Hans Verhagen. ACKNOWLEDGEMENT The Scientific Panel on

Dietetic Products, Nutrition and Allergies wishes to thank Taraneh

Dean, Stern and Jean-Michel Wal for their contributions to the

draft opinion. © European Food Safety Authority, 2007Page 9 of 9

http://www.efsa.europa.eu/EFSA/Scientific_Opinion/nda_op_ej485_tocopherols_adm_c\

ognis_cargill_en.pdf,0.pdf

I know nothing about yeast or soy creating regressions -and don't

know if you are saying that you believe soy is yeast? and if so don't

know if that is true -but do know that regressions can come from a

number of reasons -and one that may shock the newbies is that

regressions come when there is growth in one area (such as a child

with apraxia learning to read can start to stutter again etc.) It's

temporary. A true regression isn't.

=====

[Guest guest]

>

Dr. Ron's Unique E is a soy free alpha and gamma tocopherol. I have

no idea what the source of the vit E is...but it is not soy. I don't

think it is as effective as soy-based vit E...and have heard that

from others on the site too. But it is another option if soy allergy

is truly a problem. -

[Guest guest]

While we are figuring out our E dilemma Sunbutter has been helpful.

> >

> > Hi Colleen and ,

> >

> > I had just posted this in a recent message

> > (quoted from the Nordic Natural's website regarding soy/allergies)

> >

> > " If a person is sensitive to soy, can they take fish oils that

> > contain vitamin E?

> >

> > Vitamin E is an important addition for fish oil because it helps

> > preserve fish oil freshness (along with other important

> > manufacturing factors). Fish oils, like all liquid oils, are

> subject

> > to becoming oxidized, and vitamin E is a very effective and

natural

> > anti-oxidant (for fish oil and for people!). Most of the time

> people

> > with sensitivities to soy can consume vitamin E without worry,

even

> > if it's originally derived from soy. Vitamin E is an oil (a fat-

> > soluble vitamin) and, for supplements, is purified to be 100% pure

> > vitamin E, no protein components [note: the allergen in a food is

> > usually the protein (e.g. gluten in wheat, casein in milk)]. It is

> > always a good idea to consult with your healthcare practitioner

> > before beginning a supplement regime.

> >

> >

> > What if a person is allergic to fish? Can they ingest fish oil?

> >

> > Generally yes. Allergens (what people react to) in food are

usually

> > the protein component of a food (e.g. gluten in wheat, casein in

> > milk). Because Nordic Naturals pure fish oils are thoughtfully and

> > carefully manufactured (gentle processing, low temperature, clay

> > filtered and microdistilled) they are essentially void of protein

> > components. As a result, people who react to eating fish can

> > generally consume fresh fish oil capsules. It is always a good

idea

> > to consult with your healthcare practitioner before beginning a

> > supplement regime.

> > http://www.nordicnaturals.com/direct/faqs.asp

>

> And here's a recent study on natural vitamin E and soy allergies (in

> conclusion -you probably can still use the vitamin E)

>

> " In a clinical study in 32 soy allergic patients, none reacted

during

> skin testing to tocopherols and 31 did not reveal any adverse

> allergic reaction to a maximum dose of 500 mg mixed tocopherols. One

> patient reported oral allergy symptoms. The Panel considers that

this

> clinical study is insufficient to predict the likelihood that the

> product may trigger an allergic reaction in susceptible individuals.

> Considering the information provided by the applicant regarding the

> starting material, thesubsequent production process, and the

> demonstration of low residual protein content, the Panel considers

> that it is unlikely that natural mixed tocopherol/D-alpha

tocopherols

> from soybean sources will trigger a severe allergic reaction in

> susceptible individuals. "

>

> The EFSA Journal (2007) 485, 1-9© European Food Safety Authority,

> 2007Page 1 of 9 Opinion of the Scientific Panel on Dietetic

Products,

> Nutrition and Allergies on a request from the Commission related to

a

> notification from Cognis, ADM and Cargill on natural mixed

> tocopherols (E306), natural D-alpha tocopherol, natural D-alpha

> tocopherol acetate and natural D-alpha tocopherol succinate from

> soybean sources pursuant to Article 6, paragraph 11 of Directive

> 2000/13/EC(Request N° EFSA-Q-2006-151) (adopted on 3 May 2007)

> SUMMARY Soy is a common dietary constituent and allergic reactions

to

> soy proteins are well described. Soy allergy prevalence studies are

> lacking, estimated prevalences are about 0.5% in the general

> population with about 3-6% of allergic children being allergic to

soy

> proteins. Clinical reactions are similar to those observed with

other

> major food allergens, such as milk, egg or peanut and include

> systemic anaphylaxis. The application covers natural mixed

> tocopherols (vitamin E, E306) and a range of D-alpha tocopherols

> derived from vegetable oil (soybean oil). Natural mixed tocopherols

> are mainly used as antioxidants in fatty foods at a concentration of

> about 50 mg/kg (referring to the fat fraction of the specific food).

> This corresponds to an intake of about 0.03µg soy protein assuming a

> fat intake of 60-80 g/day (3-4 mg tocopherols). Natural mixed

> tocopherols are also used as dietary supplements. Natural mixed

> tocopherols and D-alpha tocopherols under consideration are derived

> from soybean oil deodorised distillates. The applicant has conducted

> analytical studies which have improved sensitivity and specificity

of

> protein analysis. In a clinical study in 32 soy allergic patients,

> none reacted during skin testing to tocopherols and 31 did not

reveal

> any adverse allergic reaction to a maximum dose of 500 mg mixed

> tocopherols. One patient reported oral allergy symptoms. The Panel

> considers that this clinical study is insufficient to predict the

> likelihood that the product may trigger an allergic reaction in

> susceptible individuals. Considering the information provided by the

> applicant regarding the starting material, thesubsequent production

> process, and the demonstration of low residual protein content, the

> Panel considers that it is unlikely that natural mixed tocopherol/D-

> alpha tocopherols from soybean sources will trigger a severe

allergic

> reaction in susceptible individuals.

>

> Page 2

> KEY WORDS Allergenicity, natural mixed tocopherols, vitamin E, D-

> alpha tocopherols, protein content, neutralised, refined, bleached,

> deodorised, vegetable oil (soybean oil). BACKGROUND In November

2003,

> the European Parliament and the Council adopted Directive

> 2003/89/EC1amending Directive 2000/13/EC, as regards indication of

> the ingredients present in foodstuffs. Annex IIIa of the Directive

> specifies a list of food ingredients or substances that are known to

> trigger allergic reactions or intolerances in sensitive individuals

> for which no labellingexemptions are allowed. Whenever the listed

> ingredients/substances or their derivatives are used in the

> production of foodstuffs, they must be labelled. Article 1,

paragraph

> 11, subparagraph 2 of the Directive establishes a procedure allowing

> for temporary labelling exemption of derivatives from ingredients

> listed in Annex IIIa for which it has been scientifically

established

> that it is not possible for them to cause adverse reactions. In

> accordance with this provision, submissions of request for temporary

> labelling exemption were notified to the Commission before 25 August

> 2004. The Commission, after consultation with the European Food

> Safety Authority, adopted a list (Directive 2005/26/EC2) of those

> ingredients which are temporarily excluded from Annex IIIa until 25

> November 2007,pending the final results of the notified studies.

> Consequently, applicants who submitted a dossier in 2004 on the

basis

> of subparagraph 2, resulting in the inclusion of a product in the

> list of Directive 2005/26/EC, and who areseeking exclusion of that

> product from Annex IIIa beyond 25 November 2007 will have tosubmit a

> request enclosing the final results of the notified scientific

> studies. Therefore in the context of the permanent labelling

> exemption procedure, the European Food Safety Authority is asked to

> provide scientific opinions on the submissions in accordance with

the

> present terms of reference. TERMS OF REFERENCE In accordance with

> Article 29 (1) (a) of Regulation (EC) N° 178/2002, the European

> Commission requests the European Food Safety Authority to evaluate

> the scientific data submitted by Cognis Deutschland GmbH & Co KG

> (Cognis), Archer Midland Corporation (ADM) and Cargill Incorporated

> (Cargill) in the framework of the procedure laid down in Article 6,

> paragraph 11 of Directive 2000/13/EC. On the basis of that

> evaluation, EFSA is requested to issue an opinion on the information

> provided, and particularly to consider the likelihood of adverse

> reactions triggered in susceptible individuals by the consumption of

> the following ingredients/substances used under the conditions

> specified by the applicant: natural1Directive 2003/89/EC of the

> European Parliament and of the Council amending Directive 2000/13/EC

> as regards indication of the ingredients present in foodstuffs. OJ L

> 308. 25.11.2003, p. 15. 2Commission Directive 2005/26/EC of 21 March

> 2005 establishing a list of food ingredients or substances

> provisionally excluded from Annex IIIa of Directive 2000/13/EC of

the

> European Parliament and of the Council.OJ L 75, 22.03.2005, p. 33-

34.

> © European Food Safety Authority, 2007Page 2 of 9

>

> Page 3

> mixed tocopherols (E306), natural D-alpha tocopherol, natural D-

alpha

> tocopherol acetate, natural D-alpha tocopherol succinate.ASSESSMENT

> Soy is a common dietary constituent and allergic reactions to soy

> proteins are well described. Soy allergy prevalence studies are

> lacking; estimated prevalences are about 0.5% in the general

> population with about 3-6% of allergic children being allergic to

soy

> proteins. Clinical reactions are similar to those observed with

other

> major food allergens, such as milk, egg or peanut. Soy allergy can

> affect all common allergy target organs such as the

> gastrointestinaltract, respiratory tract and the skin and can also

> cause systemic anaphylaxis (NDA, 2004). Natural mixed tocopherols

> (vitamin E, E306) and D-alpha tocopherols (including: natural D-

alpha

> tocopherol, natural D-alpha tocopherol acetate, natural D-alpha

> tocopherol succinate) are derived from soybeans, which are an

> allergenic source material, and therefore it isappropriate that the

> Panel considers the potential allergenic activity for labelling

> purposes.Tocopherols derived from other sources are not considered

by

> the Panel. In 2005, the Panel issued an Opinion on a notification

> submitted by Cognis, ADM and Cargill to the European Commission

> pursuant to Article 6, paragraph 11 of Directive 2000/13/EC as

> amended by Directive 2003/89/EC, for temporary exemption from

> labelling (NDA, 2005). Under the framework of permanent exemption

> from labelling, the present Opinion is based on assessment of an

> updated dossier from Cognis, ADM and Cargill, which contains

> additional information or data mainly with regard to the analytical

> methodology and the clinical study. 1. Production process Natural

> mixed tocopherols (E306), natural D-alpha tocopherol, natural D-

alpha

> tocopherol acetate and natural D-alpha tocopherol acid succinate are

> derived from vegetable oil deodorised distillate (VOD) from soybean

> as the starting material. The production process of VOD oils

involves

> several steps and includes cleaning and drying, crushing and solvent

> extraction of soybeans. Crude soybean oil is degummed, neutralised,

> and deodorised yielding VOD. The applicant states that the protein

> content of the starting material (VOD) is variable depending on the

> source and is reduced to low levels during the production process

and

> that residual proteins were not detected at a limit of detection

> (LOD) of 10µg/g. The actual level of protein content depends on the

> production processes of the VOD. In view of the intended use of the

> tocopherols, the applicant has to comply with purity requirements

> ofEuropean Food Law. The Panel notes however that there are no

> statutory levels of permittedprotein concentration in VOD oils.

> Natural mixed tocopherols and D-alpha tocopherols are produced from

> the deodorised distillate of vegetable oil (an intermediate product

> in the neutralised, refined, bleached and deodorised (N/RBD) soybean

> oil production) by further processes including solvent extraction,

> distillative neutralisation and precipitation. They are further

> purified and undergo separation via molecular distillation under

high

> temperature (>200°C) (, 2004). © European Food Safety

> Authority, 2007Page 3 of 9

>

> Page 4

> The applicant states that these processes are likely to further

> reduce the presence of allergenicproteins. They have submitted

> additional information related to the production process andprovided

> further analytical evidence related to the content of allergens in

> the final product. The applicant uses an enzyme-linked immunosorbent

> assay (ELISA) for soybean trypsin inhibitor (Transia GmbH) with a

LOD

> of 1 µg/g for batch control of natural mixed tocopherols and D-alpha

> tocopherols. Using this ELISA test kit, and based on the

contribution

> of the soybean trypsin inhibitor to thetotal soya protein mass (2-

> 4%), the applicant assumes an extrapolated LOD for total soybean

> protein of 25-50 mg/kg. The applicant acknowledges the limitations

> and uncertainties of this approach. 2. Characterisation of the

> product All natural tocopherols are isolated from the deodorised

> distillate of refined vegetable oil (VOD) from soybean and other

> oilseed sources, which are not under consideration in this opinion.

> Natural tocopherols are further purified by various processing

steps,

> including solvent extraction, chemical modification and

distillation.

> The applicant states that natural source vitamin E products consist

> of natural mixed tocopherols, alpha-tocopherol, alpha-tocopherol

> acetate, and alpha-tocopherol succinate. The most biologically

active

> antioxidant is D-alpha-tocopherol. Vitamin E activity is expressed

as

> D-alpha-tocopherol equivalents. Where activity is given as

> International Units (IU), one IU of D-alpha-tocopherol is equivalent

> to 0.67 mg (EGVM, 2003). 2.1 Exposure estimationPlant oils are the

> main dietary sources of vitamin E (560-1600 mg/kg in soybean oil,

530-

> 1620 mg/kg in corn oil and 50-150 mg/kg in olive oil), with meat

(0.5-

> 1.6 mg/kg), poultry (1.6-4.0 mg/kg) and dairy products (0.4-10.0

> mg/kg) providing only moderate amounts. The amount of vitamin E in

> foods at the point of consumption is difficult to assess as it

> depends upon the effects of processing, storage and preparation. In

> the UK, vitamin E is present in a variety of dietary supplements at

> doses of up to 268 mg/day in multi-constituent products and670

mg/day

> in single constituent products. Vitamin E is also present in

licensed

> medicinal products; the highest doses authorised in the UK are 20-

100

> mg (EGVM, 2003).The applicant states dietary supplements found on

the

> European market limit the maximum recommended additional daily

intake

> to 830 mg (ERNA, 2003). This would result in 41 µg soy protein when

> taking into account 50 mg/kg residual protein in the tocopherol

> fraction. The applicant states that mixed tocopherols are used as a

> food antioxidant in concentrations of about 50 mg/kg (referring to

> the fat fraction of the specific food). Assuming a fat intake of

60 -

> 80g/day, this could result in a dose of 3 (- 4 mg) tocopherols per

> day, which corresponds to 0.03 µg of protein (based on 10 µg/g

> residual protein in tocopherol). This amount of protein, likely to

be

> spread over three meals a day, is considerably below levels at which

> clinical allergic reactions have been reported (NDA, 2004). The

> applicant also states that D-alpha tocopherol-succinates are used as

> food supplements, Assuming additional daily doses of up to 830

mg/day

> as recommended by food supplement producers would result in a dose

of

> 8.3 µg protein (based on the 10mg/kg residual protein in the

> tocopherol fraction as a worst case assumption). © European Food

> Safety Authority, 2007Page 4 of 9

>

> Page 5

> Natural mixed tocopherols are almost exclusively used as

antioxidants

> in fatty foods (E306) and as dietary supplements at a dose of around

> 100 mg/day. However, consumption of tocopherols from multiple

sources

> may result in a higher intake. 3. Evidence of non-allergenicity The

> applicant has performed a literature search with the help of

standard

> and several additional databases and fails to find any report

> relating to allergic reactions to tocopherols and vitamin E.

However,

> due to the lack of clear labelling of soybean derived mixed

> tocopherols/D-alpha tocopherols, under-reporting of allergic

> reactions may have occurred.3.1 Laboratory-based tests3.1.1 Sample

> selectionThe in vitro investigations to ascertain residual protein

> were conducted on both the starting material i.e. vegetable oil

> deodorised distillate (VOD) as well as on the finished tocopherol

> product. Nine VOD and nine commercial mixed tocopherol samples were

> provided by the joint notification partner companies

(manufacturers).

> Each manufacturer provided three different batches of VOD and

> tocopherol samples for analysis. All VOD batches were mainly of

> soybean origin. Additionally, one batch of tocopherols from each

> manufacturer was chosen randomly to prepare a blend with equal batch

> distribution. This blended sample was used in the in vitro

> investigations as well as the clinical study (section 3.3). 3.1.2

> Analytical approach The following analytical methods were applied

for

> detection of both hydrophilic and lipophilic peptides, and denatured

> peptides thereof. Two strategies were followed by theapplicant for

> the analysis of the presence of residual soybean proteins: a)

> Extraction of hydrophilic proteins for analysis in an enzyme-linked

> immunosorbent assay (ELISA) that detects hydrophilic proteins, and

> for analysis in immunoblotting that detects hydrophilic, lipophilic,

> and denatured proteins. The soybean specific ELISA allowed a

> detection of hydrophilic soybean proteins at or above 0.5-2 ng/ml in

> diluted extract. Extraction of lipophilic and denatured proteins

> for immunoblotting analysis. The immunoblotting method allowed the

> detection of 50 ng of internal reference soybean (IRS) extract and

> 100 ng of oleosin, respectively. Each VOD and tocopherol sample

> extract was analyzed for total protein, soy protein and IgE-reactive

> (soy) protein in a primary screening. 3.1.2.1 Detection of

> hydrophilic soy proteins in VOD samples A VOD sample spiked with IRS

> protein extract prior to extraction was used for investigation of

IRS

> protein recovery. Following SDS-PAGE analysis and application of the

> Sypro®Ruby stain lipophilic proteins such as oleosins were not

> detectable at a level of 1µg/g and hydrophilic proteins were not

> detectable at a level of 10µg/g in any of the VOD or tocopherol

> samples © European Food Safety Authority, 2007Page 5 of 9

>

> Page 6

> There was no detectable hydrophilic protein in any of the nine VOD

> samples at or above 10µg/g. 3.1.2.2 Detection of lipophilic and

> denatured soy proteins in VOD samples A VOD sample was spiked with

> the oleosin fraction from soybean prior to extraction for

> investigation of lipophilic protein recovery. All protein extracts

of

> VOD samples were analyzed in SDS-PAGE/Sypro®Ruby. There was no

> detectable lipophilic protein in any of the nine VOD samples at or

> above 1µg/g. 3.1.2.3 Detection of hydrophilic soy proteins in

> tocopherol samples Selected tocopherol samples as well as the

> tocopherol blend used in the clinical study wereanalyzed for

residual

> soybean protein.Additionally a tocopherol (blend) sample was spiked

> with IRS protein extract prior toextraction for investigation of IRS

> protein recovery. Using ELISA, soy protein was not detectable at or

> above 10µg/g in extracts of all investigated tocopherol samples

> including the blend sample. 3.1.2.4 Detection of lipophilic and

> denatured soy proteins in tocopherol samples The tocopherol blend

was

> additionally spiked with the oleosin fraction from soybean prior to

> extraction for investigation of lipophilic protein recovery (oil

> bodies in seeds contain a unique protein known as oleosin associated

> with the oil body surface. Oleosins are unique in thatthey have a

> high affinity for lipids). In none of the investigated samples

> including the tocopherol blend was soy protein detectable at or

above

> 1 µg/g.The applicant developed an ELISA inhibition assay for soybean

> specific IgE. The range ofvitamin E derivatives mentioned above were

> analysed and none of the samples produced inhibition. 3.2

> Immunochemical methodologiesThe applicant has analysed published IgE

> binding studies to N/RBD and other purity gradesof soybean oils and

> discusses possible limitations in detail. A small number of studies

> describe the immunochemical characterisation of non-refined

> (Awazuhara et al., 1998; Paschke et al., 2001) and N/RBD oils

> (Zitouni et al, 2001; Errahali et al, 2002; Montagnon et al, 2003).

> The observed binding pattern in non-refined oils (Paschke, 2001) was

> similar to that of N/RBD oils with 2 binding activities at 28 kDa

and

> 56 kDa described by the French authors (Zitouni et al, 2001;

Errahali

> et al, 2002; Montagnon et al, 2003).3.3 Clinical studies The

> applicant reports the results of a European two centre clinical

> study, in 32 patients from Germany (Berlin) and Switzerland

(Zurich).

> A total of 32 patients (17 males, age range 6 © European Food Safety

> Authority, 2007Page 6 of 9

>

> Page 7

> months to 65 years) with confirmed clinical food allergy to soy

> (clinician-confirmed positive history of soy allergy and confirmed

> double-blind placebo-controlled food challenge (DBPCFC) reaction to

> soy), were skin prick tested and underwent open and DBPCFC with up

to

> 500 mg natural mixed tocopherols in different food matrices. Natural

> mixed tocopherols were chosen by the applicant since these represent

> the least refined tocopherols available tothe consumer. All 32

> individuals failed to react to the skin prick test with the test

> substance. Twenty-twosubjects had a positive skin reaction (>3mm) to

> a commercial soy extract, soy isolate or soymilk. Thirty-one out of

> thirty-two subjects consumed the test article in an open food

> challenge without allergic reaction. One patient with a positive

skin

> prick test to soy protein and soy protein-specific serum IgE

reported

> mild oral allergy symptoms and nausea, which were confirmed in a

> DBPCFC. Immunoblotting analysis of this patient's serum failed to

> show IgE binding to samples of mixed tocopherols and the

> investigators attribute these symptoms to a non- IgE based reaction,

> although further evidence for this assumption is lacking. This

> individual is also a participant of the FAREDAT study investigating

> threshold levels for soy allergy where he reacted with oral allergy

> symptoms only after a cumulative dose of 4 g soy protein without

> developing systemic symptoms after being challenged with higher

doses

> (Ballmer-Weber et al, 2007). The Panel considers that this clinical

> study is insufficient to predict the likelihood that the product may

> trigger an allergic reaction in susceptible individuals. CONCLUSIONS

> Considering the information provided by the applicant regarding the

> starting material, thesubsequent production process, and the

> demonstration of low residual protein content, the Panel considers

> that it is unlikely that natural mixed tocopherol/D-alpha

tocopherols

> from soybean sources will trigger a severe allergic reaction in

> susceptible individuals. DOCUMENTATION PROVIDED TO EFSADossier

> submitted by Cognis Deutschland GmbH & Co KG (Cognis), Archer

> MidlandCorporation (ADM) and Cargill Incorporated (Cargill) to the

> European Commission pursuant to Article 6 paragraph 11 of Directive

> 2000/13/EC as amended by Directive 2003/89/EC on 15 September 2006.

> REFERENCES Awazuhara H, Kawai H, Baba M, Matsui T, Komiyama A

(1998).

> Antigenicity of theproteins in soy lecithin and soy oil in soybean

> allergy. Clinical and Experimental Allergy 28: 1559-1564. Ballmer-

> Weber BK, Holzhauser T, Scibilia J, Mittag D, Zisa G, Ortolani C,

> Oesterballe M, Poulsen LK, Vieths S, Bindslev-Jensen C (2007).

> Clinical characteristics of soybean allergy in Europe: A double-

> blind, placebo-controlled food challenge study. J Allergy Clin

> Immunol20, [Epub ahead of print]. © European Food Safety Authority,

> 2007Page 7 of 9

>

> Page 8

> Bindslev-Jensen C, Briggs D, Osterballe M (2002). Can we determine a

> threshold level for allergenic foods by statistical analysis of

> published data in the literature? Allergy 57: 741-746. ERNA

(European

> Responsible Nutrition Alliance) (2003). Vitamin and Mineral Fact

> Sheets, Vitamin E, Brussels. Errahali Y, Morisset M, Moneret-Vautrin

> DA, Kanny G, Metche M, Nicolas JP, Frémont S (2002). Allergen in soy

> oils. Allergy 57: 648–649. Expert Group on Vitamins and Minerals:

> Safe upper levels for vitamins and minerals: report of the expert

> group on vitamins and minerals ISBN 1-904026-11-7.

> http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdfHourihane JO'B,

> Bedwani SJ, Dean TP, Warner JO (1997). Randomised double blind

> crossover challenge study of allergenicity of peanut oils in

subjects

> allergic to peanuts. BritishMedical Journal 314: 1094-1087.

Montagnon

> I, Errahali Y, Metche M, Nicolas JP, Frémont S (2003). Allergenicity

> of soya oils. Food Allergy and Intolerance 4: 153-163. NDA

> (Scientific Panel on Dietetic Products, Nutrition and Allergies)

> (2004). Opinion of the Scientific Panel on Dietetic Products,

> Nutrition and Allergies on a request from the Commission relating to

> the evaluation of allergenic foods for labelling purposes. The EFSA

> Journal 32, 1-197.

>

http://www.efsa.europa.eu/en/science/nda/nda_opinions/food_allergy/341

..html. NDA (Scientific Panel on Dietetic Products, Nutrition and

> Allergies) (2005). Opinion of the Scientific Panel on Dietetic

> Products, Nutrition and Allergies related to a notification

> fromCognis, ADM and Cargill on natural mixed tocopherols (E306),

> natural D-alpha tocopherol, natural D-alpha tocopherol acetate and

> natural D-alpha tocopherol succinate from soybean sources pursuant

to

> Article 6 paragraph 11 of Directive 2000/13/EC. The EFSA Journal

189,

> 1-7.

>

http://www.efsa.europa.eu/en/science/nda/nda_opinions/food_allergy/846

..html. Paschke A, Zunker K, Wigotzki M, Steinhart H (2001).

> Determination of the IgE-binding activity of soy lecithin and

refined

> and non-refined soybean oils. J Chromatogr B, 756: 249–254. A

> (2004). Fats and Fatty Oils. Ullmann's Encyclopedia of Industrial

> Chemistry. Release, 7th Edition, Wiley & Sons, New York. Zitouni N,

> Errahali Y, Metche M, Moutete F, Kanny G, Moneret-Vautrin DA,

Nicolas

> JP, Fremont S (2001). Soy allergens are detected in some edible soy

> oils. Abstract 623. J Allergy Clin Immunol 107:188. PANEL MEMBERS

> Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof,

> Hannu Korhonen, Pagona Lagiou, us Løvik, ngela Marchelli,

> Ambroise , Bevan Moseley,© European Food Safety Authority,

> 2007Page 8 of 9

>

> Page 9

> Andreu Palou, Hildegard Przyrembel, Seppo Salminen, () J

> Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van

> Loveren and Hans Verhagen. ACKNOWLEDGEMENT The Scientific Panel on

> Dietetic Products, Nutrition and Allergies wishes to thank Taraneh

> Dean, Stern and Jean-Michel Wal for their contributions to

the

> draft opinion. © European Food Safety Authority, 2007Page 9 of 9

>

http://www.efsa.europa.eu/EFSA/Scientific_Opinion/nda_op_ej485_tocophe

rols_adm_cognis_cargill_en.pdf,0.pdf

>

>

> I know nothing about yeast or soy creating regressions -and don't

> know if you are saying that you believe soy is yeast? and if so

don't

> know if that is true -but do know that regressions can come from a

> number of reasons -and one that may shock the newbies is that

> regressions come when there is growth in one area (such as a child

> with apraxia learning to read can start to stutter again etc.) It's

> temporary. A true regression isn't.

>

> =====

>