Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food-A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA(2)LEN position paper

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Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food-A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA(2)LEN position paper

Zuberbier, T. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany

Dorr, T. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany

Aberer, W. (author): Med Univ Graz, Dept Dermatol, Graz, Austria

Alvaro, M. (author): Hosp St Joan de Deu, Serv Allergol Immunol Clin, Barcelona, Spain

Angier, E. (author): Univ Southampton, Fac Med, Primary Care Populat Sci & Med Educ, Southampton, Hants, England

Arasi, S. (author): Bambino Gesu Hosp IRCCS, Pediat Allergol Unit, Rome, Italy

Arshad, H. (author): Univ Hosp Southampton NHS Fdn Trust, NIHR Southampton Biomed Res Ctr, Southampton, Hants, England.;Univ Southampton, Fac Med, Clin & Expt Sci, Southampton, Hants, England.;St Marys Hosp, David Hide Asthma & Allergy Res Ctr, Newport, Wight, England

Ballmer-Weber, B. (author): Univ Hosp Zurich, Dept Dermatol, Zurich, Switzerland.;Kantonsspital St Gallen, Clin Dermatol & Allergol, St Gallen, Switzerland

Bartra, J. (author): Hosp Clin Barcelona, Serv Neumol & Allergia Resp, Unitat Allergia, Barcelona, Spain.;Inst Invest Biomed August Pi & Sunyer IDIBAPS, Barcelona, Spain

Beck, L. (author): Univ Rochester, Dept Dermatol, Med Ctr, New York, NY USA

Begin, P. (author): CHU St Justine, Montreal, PQ, Canada

Janson, Christer (author): Uppsala universitet,Lung- allergi- och sömnforskning,Klinisk fysiologi

Bislimovska, J. (author): Ss Cyril & Methodius Univ Skopje, Fac Med, WHO Collaborating Ctr, Inst Occupat Hlth RNM, Skopje, North Macedonia

Bousquet, J. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany.;Univ Hosp Montpellier, Montpellier, France.;MACVIA France, Montpellier, France

Brockow, K. (author): Tech Univ Munich, Sch Med, Dept Dermatol & Allergy Biederstein, Munich, Germany

Bush, A. (author): Imperial Coll, London, England.;Royal Brompton Hosp, London, England

Cianferoni, A. (author): Univ Penn, Dept Pediat, Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA

Cork, M. J. (author): Univ Sheffield, Sheffield, S Yorkshire, England,European Acad Allergy & Clin Immunol, Zurich, Switzerland,Helsinki Univ Hosp, Skin & Allergy Hosp, Helsinki, Finland.;Univ Helsinki, Helsinki, Finland,Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Dept Dermatol & Venereol 2, Allergy Unit, Athens, Greece,Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany,Ss Cyril & Methodius Univ Skopje, Fac Med, WHO Collaborating Ctr, Inst Occupat Hlth RNM, Skopje, North Macedonia,Univ Barcelona, Hosp Clin, ENT Dept, Rhinol Unit,CIBERES, Barcelona, Catalonia, Spain.;Univ Barcelona, CIBERES, IDIBAPS, Smell Clin,ENT Dept,Hosp Clin, Barcelona, Catalonia, Spain

Custovic, A. (author): Imperial Coll London, Natl Heart & Lung Inst, London, England

Darsow, U. (author): Tech Univ Munich, Sch Med, Dept Dermatol & Allergy Biederstein, Munich, Germany

Jong, N. (author): Erasmus MC, Sect Allergol & Clin Immunol, Dept Internal Med, Rotterdam, Netherlands

Deleanu, D. (author): Univ Med & Pharm Iuliu Hatieganu, Allergy, IRGH, Cluj Napoca, Romania

Del Giacco, S. (author): Univ Cagliari, Dept Med Sci & Publ Hlth, Cagliari, Italy,Ss Cyril & Methodius Univ Skopje, Fac Med, WHO Collaborating Ctr, Inst Occupat Hlth RNM, Skopje, North Macedonia

Deschildre, A. (author): Univ Lille, CHU Lille, Lille, France.;Hop Jeanne de Flandre, Pediat Pulmonol & Allergy Unit, Lille, France

Galvin, A. D. (author): Univ Coll Cork, Cork, Ireland.;Sechenov Univ Moscow, Moscow, Russia.;Anaphylaxis Ireland, Cork, Ireland

Ebisawa, M. (author): Natl Hosp Org Sagamihara Natl Hosp, Clin Res Ctr Allergy & Rheumatol, Sagamihara, Kanagawa, Japan

Fernandez-Rivas, M. (author): Univ Complutense UCM, Hosp Clin San Carlos, Fac Med, Allergy Dept,IdISSC, Madrid, Spain

Ferrer, M. (author): Clin Univ Navarra, Dept Allergy, Pamplona, Spain

Fiocchi, A. (author): Bambino Gesu Hosp IRCCS, Pediat Allergol Unit, Rome, Italy

van Wijk, R. G. (author): Erasmus MC, Sect Allergol & Clin Immunol, Dept Internal Med, Rotterdam, Netherlands,Univ Bologna, Dept Med & Surg Sci, Pediat Unit, Bologna, Italy,Univ Amsterdam, Acad Med Ctr, Dept Expt Immunol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, Dept Otorhinolaryngol, Amsterdam, Netherlands

Gotua, M. (author): Ctr Allergy & Immunol, Tbilisi, Georgia

Grimshaw, K. (author): Salford Royal Fdn Trust, Dietet Dept, Salford Care Org, Salford, Lancs, England

Grunhagen, J. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany

Heffler, E. (author): IRCCS Humanitas Res Hosp, Personalized Med Asthma & Allergy, Rozzano, MI, Italy.;Humanitas Univ, Dept Biomed Sci, Pieve Emanuele, MI, Italy

Hide, M. (author): Hiroshima Citizens Hosp, Dept Dermatol, Hiroshima, Japan

Hoffmann-Sommergruber, K. (author): Med Univ Vienna, Dept Pathophysiol & Allergy Res, Vienna, Austria

Incorvaia, C. (author): ASST Pini CTO, Cardiac Pulm Rehabil, Milan, Italy

Janson, C. (author)

John, S. M. (author): Univ Osnabrueck, Dept Dermatol Environm Med Hlth Theory, Osnabruck, Germany.;Univ Osnabrueck, Inst Interdisciplinary Dermatol Prevent & Rehabil, Osnabruck, Germany

Jones, C. (author)

Jutel, M. (author)

Katoh, N. (author): Kyoto Prefectural Univ Med, Dept Dermatol, Kyoto, Japan

Kendziora, B. (author): Ludwig Maximilians Univ Munchen, Dept Dermatol & Allergy, Univ Hosp, Munich, Germany

Kinaciyan, T. (author): Med Univ Vienna, Dept Dermatol, Vienna, Austria

Knol, E. (author): Univ Med Ctr Utrecht, Dept Dermatol & Allergol, Utrecht, Netherlands.;Univ Med Ctr Utrecht, Lab Translat Immunol, Utrecht, Netherlands

Kurbacheva, O. (author): NRC Inst Immunol FMBA, Moscow, Russia

Lau, S. (author): Charite Univ Med Berlin, Pediat Resp Med Immunol & Crit Care Med, Berlin, Germany

Loh, R. (author): Univ Western Australia, Perth Childrens Hosp, Dept Immunol, Perth, WA, Australia

Lombardi, C. (author): Ente Osped Fdn Poliambulanza, Unita Dipartimentale Allergol Immunol Clin & Mala, Brescia, Italy

Makela, M. (author): Asthma & Allergy Assoc, Stockholm, Sweden

Marchisotto, M. J. (author): MJM Advisory, New York, NY USA.;Univ Michigan Med, Mary H Weiser Food Allergy Ctr, Ann Arbor, MI USA

Makris, M. (author)

Maurer, M. (author)

Meyer, R. (author): Imperial Coll, Dept Paediat, London, England

Mijakoski, D. (author): Ss Cyril & Methodius Univ Skopje, Fac Med, WHO Collaborating Ctr, Inst Occupat Hlth RNM, Skopje, North Macedonia

Minov, J. (author)

Mullol, J. (author)

Nilsson, C. (author): Karolinska Institutet

Nowak-Wegrzyn, A. (author): Icahn Sch Med Mt Sinai, Div Allergy & Immunol, Dept Pediat, Jaffe Food Allergy Inst,Kravis Childrens Hosp, New York, NY 10029 USA

Nwaru, Bright I (author): Gothenburg University,Göteborgs universitet,Institutionen för medicin,Krefting Research Centre,Institute of Medicine,Univ Gothenburg, Krefting Res Ctr, Inst Med, Gothenburg, Sweden

Odemyr, M. (author)

Pajno, G. B. (author): Univ Messina, Pediat Unit, Policlin Hospitsl, Messina, Italy

Paudel, S. (author): Civil Serv Hosp, Kathmandu, Nepal

Papadopoulos, N. G. (author): Univ Athens, Allergy Dept, Pediat Clin 2, Athens, Greece

Renz, H. (author): Philipps Univ Marburg, Inst Lab Med & Pathobiochem, Univ Hosp Giessen & Marburg, Mol Diagnost, Marburg, Germany.;Sechenov Univ, Dept Clin Immunol & Allergol, Lab Immunopathol, Moscow, Russia

Ricci, G. (author)

Ring, J. (author): Tech Univ Munich, Sch Med, Dept Dermatol & Allergy Biederstein, Munich, Germany.;Christine K Hne Ctr Allergy Res & Educ CK Care, Davos, Switzerland

Rogala, B. (author): Univ Silesia, Dept Internal Dis Allergol & Clin Immunol Med, Katowice, Poland

Sampson, H. (author): Elliot & Roslyn Jaffe Food Allergy Inst, New York, NY USA.;Kravis Childrens Hosp, Div Allergy & Immunol, New York, NY USA.;Icahn Sch Med Mt Sinai, Dept Pediat, New York, NY 10029 USA

Senna, G. (author): Verona Univ & Gen Hosp, Asthma Ctr & Allergy Unit, Verona, Italy

Sitkauskiene, B. (author): Lithuanian Univ Hlth Sci, Dept Immunol & Allergol, Kaunas, Lithuania

Smith, P. K. (author): Griffith Univ, Southport, Qld, Australia

Stevanovic, K. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany

Stoleski, S. (author)

Szajewska, H. (author): Med Univ Warsaw, Dept Paediat, Warsaw, Poland

Tanaka, A. (author): Hiroshima Univ, Grad Sch Biomed & Hlth Sci, Dept Dermatol, Hiroshima, Japan

Todo-Bom, A. (author): Ctr Hosp & Univ Coimbra, Allergy & Clin Immunol Unit, Coimbra, Portugal

Topal, F. A. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany

Valovirta, E. (author): Univ Turku, Dept Lung Dis & Clin Allergol, Turku, Finland.;Terveystalo Turku, Allergy Clin, Turku, Finland

Van Ree, R. (author)

Venter, C. (author): Univ Colorado Denver, Sch Med, Aurora, CO USA.;Childrens Hosp Colorado, Aurora, CO USA

Wohrl, S. (author): Floridsdorf Allergy Ctr FAZ, Vienna, Austria

Wong, G. W. K. (author): Chinese Univ Hong Kong, Dept Paediat, Hong Kong, Peoples R China

Zhao, Z. T. (author): Peking Univ, Hosp 1, Dept Dermatol, Beijing, Peoples R China

Worm, M. (author): Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany.;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany

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Charite Univ Med Berlin, Dept Dermatol & Allergy, Berlin, Germany;Humboldt Univ, Berlin, Germany.;Berlin Inst Hlth, Comprehens Allergy Ctr, Berlin, Germany Med Univ Graz, Dept Dermatol, Graz, Austria (creator_code:org_t)

2021-11-24
2022
English.
In: Allergy. - : Wiley. - 0105-4538 .- 1398-9995. ; 77:6, s. 1736-1750

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Journal article (peer-reviewed)

Abstract Subject headings

Background Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as "may contain traces of" is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. Methods MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. Results In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement "this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product" for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)

Keyword

anaphylaxis
food allergy
nutrition
exercise-induced anaphylaxis
cows milk
oral immunotherapy
peanut
allergy
challenge
children
diagnosis
adolescents
sesame
tests
Allergy
Immunology
anaphylaxis

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ref (subject category)
art (subject category)

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By the author/editor: Zuberbier, T.; Dorr, T.; Aberer, W.; Alvaro, M.; Angier, E.; Arasi, S.; show more...; Arshad, H.; Ballmer-Weber, B ...; Bartra, J.; Beck, L.; Begin, P.; Janson, Christer; Bislimovska, J.; Bousquet, J.; Brockow, K.; Bush, A.; Cianferoni, A.; Cork, M. J.; Custovic, A.; Darsow, U.; Jong, N.; Deleanu, D.; Del Giacco, S.; Deschildre, A.; Galvin, A. D.; Ebisawa, M.; Fernandez-Rivas, ...; Ferrer, M.; Fiocchi, A.; van Wijk, R. G.; Gotua, M.; Grimshaw, K.; Grunhagen, J.; Heffler, E.; Hide, M.; Hoffmann-Sommerg ...; Incorvaia, C.; Janson, C.; John, S. M.; Jones, C.; Jutel, M.; Katoh, N.; Kendziora, B.; Kinaciyan, T.; Knol, E.; Kurbacheva, O.; Lau, S.; Loh, R.; Lombardi, C.; Makela, M.; Marchisotto, M. ...; Makris, M.; Maurer, M.; Meyer, R.; Mijakoski, D.; Minov, J.; Mullol, J.; Nilsson, C.; Nowak-Wegrzyn, A ...; Nwaru, Bright I; Odemyr, M.; Pajno, G. B.; Paudel, S.; Papadopoulos, N. ...; Renz, H.; Ricci, G.; Ring, J.; Rogala, B.; Sampson, H.; Senna, G.; Sitkauskiene, B.; Smith, P. K.; Stevanovic, K.; Stoleski, S.; Szajewska, H.; Tanaka, A.; Todo-Bom, A.; Topal, F. A.; Valovirta, E.; Van Ree, R.; Venter, C.; Wohrl, S.; Wong, G. W. K.; Zhao, Z. T.; Worm, M.; show less...

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Basic Medicine; and Immunology in th ...

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Respiratory Medi ...

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