MoniQA www.moniqa.org Food Allergens and EU regulations Hamit Köksel 1 , Demet Köroğlu 1 , Bert Pöpping 2 1 Hacettepe University, Food Engineering Department, Turkey 2 Eurofins Scientific Group, UK [email protected]7th Food Engineering Congress, 24-26 November 2011, Ankara, Turkey
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Food Allergens and EU regulations · food allergens in food products. •It is important to note that, in addition to the obligatory declaration of food allergens on the label, many
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…… is an adverse immune response to a food protein orportion of a protein.
Trace amounts can cause a reaction!
Sensitivity differs between individuals and depends on type offood.
The prevalence of clinically diagnosed food allergy is estimatedto be 1-2% in adults and 5-8% in children.
There is no cure for food allergies!Avoidance of the
related food is the
only protection!!
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Symptoms of food allergy
• Gastrointestinal (vomiting, cramps, diarrhoea)
• Dermal (urticaria, itching, dermatitis)
• Respiratory (rhinitis, asthma, swelling in the oral cavity)
• Anaphylaxis (dramatic drop in blood pressure; shock;life-threatening; in rare cases, multiple organ systemsare triggered and death can occur in as little as tenminutes)
Food intolerances often induce similar clinicalsymptoms.
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Food allergies can lead to serious or even life-
threatening allergic reactions…
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Major foods associated with food allergy
• Peanuts
• Tree nuts
• Milk
• Eggs
• Soybeans
• Fish
• Crustaceans
• Molluscs
• Cereals containing gluten
• Sesame
• Celery
• Mustard
• Lupin
At the present time, the only available treatment is
removing problematic food allergens from the diet of
those experiencing allergic responses.
negative effects on the quality of life of food allergic
consumers and their families.
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EU Regulations on Food Allergens
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Codex Alimentarius Standard – basis
for food allergen regulations
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Directive 2000/13/EC – General Labelling Directive
labelling, presentation and advertising
of foodstuffs
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Deals with:
- Product name
- Ingredient list
- BBE (Best Before End)
- Irradiation
- Storage conditions etc.
….but not: allergens…
Directive 2000/13/EC – General Labelling Directive
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Amendment:Directive 2003/89/EC – Annex IIIa
incorporate labelling of food allergens
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Mandatory labelling of ingredients containing or made of allergens:
Amendment:Directive 2003/89/EC – Annex IIIa
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Directive 2003/89/EC – Annex IIIa
• The aim of the directive was to facilitate consumer identification of
food allergens in food products.
• It is important to note that, in addition to the obligatory declaration
of food allergens on the label, many food manufacturers also
provide voluntary allergen advisory statements, which provide
information about possible unintended cross-contamination
between the food product and a food allergen (precautionary
labelling).
• The purpose of the advisory statements is to alert food allergic
consumers to the possible food allergens in the food product.
However, these advisory statements may result in confusion on
the food allergic consumer!
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Final amendment:Directive 2007/68/EC including certain food ingredients
Detailed allergen list including an exemption
list – final version?
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Directive 2007/68/EC - Finalising the Allergen and
Exemptions List – updated Annex IIIa
The exemptions include e.g.
certain refined oils, glucose
syrups, polydextrins, fish gelatin
and whey for specified purposes
in Annex IIIa
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EU Allergen Labelling Directive
- overview
• Directive 2000/13/EC, as
amended by Directives
2003/89/EC and 2007/68/EC
identifies 13 foods or food
groups and sulphur dioxide
(listed in Annex IIIa) that are
found in a wide variety of
processed foods which are
considered to be important
relevant triggers of allergic
reactions and must be
indicated on food labels.
• Ingredients which are
exempted from allergen
declaration (as listed in
Annex IIIa of Directive
2007/68/EC) include certain
food substances, which
analytical and clinical
studies have shown that
they do not present a
danger for allergic
consumers.
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EU Allergen Labelling Directive -
Problems (I)
Annex IIIa - Listed 14 groups which require labelling and
include - with some listed exceptions where allergenicity is
likely to be low or non existent
Confusing for consumer as now “contains xxx” appears on label
i.e. less choice for allergic consumer and lower quality of life.
Regulation set for pre-packed food products only
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EU Allergen Labelling Directive -
Problems (II) No legal threshold levels!
• No thresholds are listed as regulations only refer to
allergens present in ingredients.
• This is not a real-life scenario as many allergens, which are
not part of the ingredient list, may be inadvertently carried
over into a product and not part of the ingredient list.
No guidance or regulation deal specifically with this
scenario – just general food safety and product liability
directives.
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EU Allergen Labelling Directive
Problems (III)No legal threshold levels!
Producers do not know how to deal with this risk and
which thresholds to work to (if any) !!
Changes in production flow (one product is produced
after the next, often on a contract basis with changing
products and small quantities) make it difficult to make
a good risk assessment and therefore good risk
management
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EU Allergen Labelling Directive -
Problems (IV)Mis/overuse of precautionary statements
• Producers do not want to carry this unknown risk and
choose the common “may contain xxx” label.
Consumers have different perception of risk coming from
products labelled with “may contain”, e.g. „may contain
hazelnuts‟
“may contain” label also sometimes abused by producers
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Precautionary labelling
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EU Allergen Labelling Directive -
Problems - overview
Currently;
• This Directive does not include foods sold loose or allergens
that enter foods unintentionally (cross-contamination).
• “may contain” only means the manufacturer can not be sure the
product is allergen-free.
• Shopping and eating out can be time-consuming, costly, and
full of unexpected risks for allergic individuals with a
significant negative impact on their quality of life.
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Gluten – Regulation 41/2009/EC
Separate Regulation with Thresholds
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Gluten – Regulation 41/2009/ECSeparate Regulation with Thresholds
• What is so special?
The only regulation with thresholds:
- 20mg/kg gluten-free (optional)
- 100mg/kg very low gluten (mandatory)
• Refers to Codex Alimentarius Document CODEX STAN 118-
19791: “CODEX STANDARD FOR FOODS FOR SPECIAL
DIETARY USE FOR PERSONS INTOLERANT TO GLUTEN”
1Adopted in 1979; amended 1983; revised 2008
Gluten – Regulation 41/2009/EC
Includes:
• Wheat (i.e. all Triticum species, such as
durum wheat, spelt, and kamut),
• Rye and barley
have been identified as grains that are
scientifically reported to contain gluten.
The gluten present in those grains can cause adverse health
effects to persons intolerant to gluten and therefore should be
avoided by them.
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Gluten – Regulation 41/2009/EC
Excludes:
• „Pure oats‟ from these grains, given that current
evidence indicates most people with Celiac disease
are able to tolerate oats.
However, the regulation still defines Gluten as;
“a protein fraction from wheat, rye, barley, oats or their crossbred
varieties and derivatives thereof, to which some persons are intolerant
and which is insoluble in water and 0.5 M sodium chloride solution.”
Oats contained in foodstuffs for people intolerant to gluten must have
been specially produced, prepared and/or processed in a way to
avoid contamination by wheat, rye, barley, or their crossbred varieties
and the gluten content of such oats must not exceed 20 mg/kg.
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Allergen Labelling Requirements
in Turkey
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Allergen labelling requirements in Turkey
Communiqué on Rules for General Labelling and
Nutritional Labelling of Foodstuffs - 2002/58 - the rules
for general labelling and nutrition specific labelling of
foodstuffs (complies with Directives 2000/13/EC and
80/232/EEC)
•Amendment - Communiqué 2006/34, establishing the
list of allergenic ingredients (Annex-8), which must
clearly be indicated on the label even if they are present in
the finished product in an altered form.
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Amendment - Communiqué 2006/34 (Annex-8)Bileşenler Hariç tutulan ürünler
Gluten içeren tahıl çeşitleri (buğday, çavdar, arpa, yulaf, kılçıksız buğday, kamut
veya hibrit türleri) ve ürünleri
- Dekstroz dahil buğday bazlı glukoz şurupları
- Buğday bazlı maltodekstrinler
- Arpa bazlı glukoz şurupları
-Distile alkollü içkilerin distilatında kullanılan tahıl çeşitleri
Kabuklular ve ürünleri
Yumurta ve ürünleri
- Şarapta kullanılan yumurtadan üretilen lizozim
- Şarap ve elma şarabında inceltici madde olarak kullanılan yumurtadan üretilen
albumin
Balık ve ürünleri
- Vitamin ve aroma taşıyıcısı olarak kullanılan balık jelatini
- Bira, şarap ve elma şarabında inceltici madde olarak kullanılan balık jelatini veya
Isinglass
Yerfıstığı ve ürünleri
Soya fasulyesi ve ürünleri
- Rafine soya fasulyesi yağı
- Soya fasulyesinden elde edilen tokoferollerin (E306) doğal karışımları, doğal D-
alfa tokoferol, doğal D-alfa tokoferol asetat, doğal D-alfa tokoferol suksinat
- Soya fasulyesinin fitosterol ve fitosterol esterlerinden elde edilmiş bitkisel yağlar
- Soya fasulyesi sterollerinden üretilen bitkisel stanol esteri
Süt ve süt ürünleri (laktoz dahil)
- Distile alkollü içkilerde distilat olarak kullanılan peynir altı suyu
- Laktitol
- Şarap ve elma şarabında inceltici madde olarak kullanılan süt (kazein) ürünleri
Yerfıstığı, fındık ve fıstık gibi sert kabuklu meyveler; badem (Amygdalus
communis L.), fındık (Corylus avellana), ceviz (Juglans regia), cashew fıstığı