Conferencias 2013

Fi & Hi South America

Fi & Hi South America

06 a 08 de Agosto de 2013
13h às 20h
Food Allergy
Regulatory Status in
Brazil and Mercosul

Georgia Fernandes

January 2013
Agenda

• International Regulation:
– Codex Alimentarius
– European Union
– Australia and New Zealand
– Canada
– United States
• Brazilian proposal for Mercosul
• Highlights
• Opportunities

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International Regulation – Overview
Codex Alimentarius (Codex Stan 1-1985)

• Codex defines only foods and ingredients known to cause

hypersensitivity and established that they shall always be
declared on the label:
– Cereals containing gluten
– Eggs and egg products
– Fish and fish products
– Peanuts, soybeans and products of these
– Milk and milk products (lactose included)
– Tree nuts and nut products
– Sulphite in concentrations of 10mg/kg or more

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International Regulation – Overview
European Union (Regulation EU 1169/2011)

• European Union regulation define a list of ingredients that cause

allergies or intolerances. These ingredients and ingredients derived
from them must be declared on the label

• Information on the possible and unintentional presence in food of

ingredients causing allergies or intolerances is voluntary

Labeling rules:
• Those ingredient shall be indicated in the list of ingredients, emphasised through a typeset
that clearly distinguishes it from the rest of the list, with a clear reference to the name of
the substance or product.

• In the absence of a list of ingredients, the indication shall comprise the word “contains”
followed by the name of the ingredient.

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International Regulation – Overview
European Union (Regulation EU 1169/2011)
• Ingredients causing allergies or intolerances:
– Cereals containing gluten, namely: wheat, rye, barley, oats, spelt,
kamut or their hybridised strains, and products thereof, except:
• Wheat based glucose syrups, including dextrose
• Wheat based matodextrins
• Glucose syrups based on barley
• Cereals used to make alcoolic distillates including ethyl alcohol of
agricultural origin
– Crustaceans and products thereof
– Eggs and products thereof
– Fish and products thereof, except:
• Fish gelatin used as carrier for vitamins and carotenoids preparations
• Fish gelatin or Isinglass used as fining agent in beer and wine

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International Regulation – Overview
European Union (Regulation EU 1169/2011)
• Ingredients causing allergies or intolerances (cont.):
– Peanuts and products thereof
– Soybeans and products thereof, except:
• Fully refined soybean oil and fat
• Natural mixed tocopherols (E306), natural D-alpha tocopherol, natural
D-alpha tocopherol acetate, and natural D-alpha tocopherol succinate
from soybean sources
• Vegetable oils derived phytosterols and phytosterol esters from soybean
sources
• Plant stanol ester produced from vegetable oil sterols from soybean
sources
– Milk and products thereof (including lactose), except:
• Whey used for making alcoholic distillates including ethyl alcohol of
agricultural origin
• Lactitol
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International Regulation – Overview
European Union (Regulation EU 1169/2011)
• Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus
avellana), walnuts (Juglans regia), cashews (Anacardium occidentale),
pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts
(Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or
Queensland nuts (Macadamia ternifolia), and products thereof, except
for nuts used for making alcoholic distillates including ethyl alcohol of
agricultural origin
• Celery and products thereof
• Mustard and products thereof
• Sesame seeds and products thereof
• Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg
or 10 mg/litre in terms of the total SO 2 which are to be calculated for
products as proposed ready for consumption or as reconstituted
according to the instructions of the manufacturers
• Lupin and products thereof
• Molluscs and products thereof TM

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International Regulation – Overview
European Union (Regulation EC 1333/2008)
• European Union establishes specific labeling rules for products using
some artificial colors

• Foods containing one or more of the following food colors shall

include on the label the warning “name or E number of the color(s):
may have an adverse effect on activity and attention in children”:
– Sunset yellow (E 110)

– Quinoline yellow (E 104)

– Carmoisine (E 122)

– Allura red (E 129)

– Tartrazine (E 102)

– Ponceau 4R (E 124)

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International Regulation – Overview
Australia and New Zealand (Food Standard Code 1.2.3)
• Australia and New Zealand regulation does not define an allergen
list, however defines a list of substances that must be declared on the
label:
– Cereals containing gluten and their products, namely, wheat, rye, barley,
oats and spelt and their hybridised strains other than where these
substances are present in beer and spirits standardised in Standards
2.7.2 and 2.7.5 respectively
– Crustacea and their products
– Egg and egg products
– Fish and fish products, except for isinglass derived from swim bladders
and used as a clarifying agent in beer and wine
– Milk and milk products
– Peanuts and soybeans, and their products
– Added Sulphites in concentrations of 10 mg/kg or more
– Tree nuts and sesame seeds and their products other than coconut from
the fruit of the palm Cocos nucifera
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International Regulation – Overview
Australia and New Zealand (Food Standard Code 1.2.3)
• The label on a package of a food listed in the table bellow must
include the advisory statement listed:

Food Product Advisory Statement

Statement to the effect that the product

Bee pollen contains bee pollen which can cause severe
allergic reactions
Statement to the effect that the product
Propolis contains propolis which can cause severe
allergic reactions
This product contains royal jelly which has
been reported to cause severe allergic
Royal jelly
reactions and in rare cases, fatalities,
especially in asthma and allergy sufferers

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 International Regulation – Overview
Canada
• Canadian regulation is based on the potentially of allergic and sensitivity
reactions to foods
• The following foods or their derivatives must be declared, in ingredient
lists:
– Peanuts
– Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts,
pecans, pine nuts, pistachios, walnuts)
– Sesame seeds
– Milk
– Eggs
– Fish, crustaceans (e.g., crab, crayfish, lobster, shrimp) and shellfish (e.g.,
clams, mussels, oysters, scallops)
– Soy
– Wheat
– Sulphites
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International Regulation – Overview
United States (Food Allergen Labeling and Consumer
Protection Act of 2004 – Public Law 108-282)
• United States regulation define a list of food allergens:
– Milk
– Eggs
– Fish
– Crustacean sellfish
– Tree nuts
– Peanuts
– Wheat
– Soybeans
• It is not considered a food allergen any highly refined oil derived from a food
specified in the list above and any ingredient derived from such highly refined
oil
Labeling rules:

• Food allergen must declare in the list of ingredients, or

• The word “Contains”, followed by the name of the food allergen, printed immediately after or
is adjacent to the list of ingredients (in a type size no smaller than the type size used in the
list of ingredients)

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Brazilian Proposal for Mercosul
• Defines a list of ingredients known to cause hypersensitivity or intolerance:
– Cereals containing gluten and products thereof
– Crustaceans and products thereof
– Eggs and products thereof
– Fish and products thereof
– Peanuts and products thereof
– Soybeans and products thereof
– Milk (including lactose) and products thereof
– Nuts and tree nuts and products thereof (almonds, Brazil nuts, cashews, pistachio nuts,
hazelnuts, pecan nuts, macadamia and others)
– Sulphites at concentrations of 0,001g/100g or g/100ml (Expressed in SO2) or more
– Tartrazine (INS 102)

• This list can be updated based on the opinion of specialists committee from
FAO/WHO or in other scientific studies.

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Brazilian Proposal for Mercosul
• Labeling rules:
– Those ingredients must be declared in the list of ingredients, in bold and in
contrast with the label, independently of the amount present in the product.
– In case of products derived from these food or ingredients, the declaration must
be followed by the name of the food source of the allergen in between brackets.
Example: casein (from milk), lactose (from milk), lecithin (from soy), albumin
(from egg).
– Food products constituted of single ingredients are exempted from declaration
above, provided that the ingredients that can cause hypersensitivity or
intolerance are in the name of the product.
– For compound ingredients that have allergens, the allergen declaration must be
done in between brackets after the compound ingredient, as follows: “contains
(name of the allergen)”. Example: butter (contains milk).
– If an ingredient known to cause hypersensitivity or intolerance is not part of the
food product, but exists the possibility incidental contamination during the
manufacturing process, must be declared on the label “May contain traces
of…(name of the ingredient that can cause hypersensitivity)”, in bold

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Brazilian Proposal for Mercosul
• Brazilian Proposal states that the following artificial colors may
aggravate attention deficit disorder / hyperactivity conditions and
other behavioral problems in sensitive children:
– sunset yellow FCF (INS 110)
– quinoline yellow (INS 104)
– azorubine (INS 122),
– allura red AC (INS 129)
– ponceau 4R (INS 124)

Labeling rules:
• These colors must be declared in the list of ingredients in bold and in contrast with the
label, independently of the amount present in the product

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Highlights
• The focus of the regulations are on labeling rules, despite the
cause of the allergenicity.

• The regulations do not have clear definitions on the cause of the

allergenicity:
Regulation In which regulation is based on
Codex Alimentarius Hypersensitivity
European Union Allergies or intolerances
Australia and New Zealand -
Canada Allergic and sensitivity reactions
United States Allergy
Brazilian proposal Hypersensitivity or intolerance

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Opportunities
• Clarify the differences between Allergies, Hypersensitivity and
Intolerance.

• Demystify safety concerns of artificial colors sunset yellow FCF

(INS 110), quinoline yellow (INS 104), azorubine (INS 122), allura
red AC (INS 129) and ponceau 4R (INS 124).

• Reinforce the importance of Thresholds levels definition;

• Discuss the best way to deal with incidental contamination;

ILSI Brazil organized a workshop due to May 09th approaching
the discussion of Food Allergens, including those topics for
clarification.

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Thank you!

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