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Free-from allergen claims: appropriate use of free-from claims in relation to food allergens and

overview of European regulation and future changeMay 8th 2019 Anne-Claire Thiboult

[email protected]

mailto:[email protected]


Introduction


Introduction

▪ What is a free from claim?– Communication on the absence

of some ingredients/constituents that are considered as : “bad for health” / “bad for environment” / “bad for specific groups” / “not useful”/ “controversial”…

– Part of the Clean label

Free from

claims

Free from

glutenFree from TFA

Free from

GMOsFree from E171

Free from

Palm oil

Free from

lactose

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Summary

▪ Overview of the evolution of regulations on food allergens and specific foods for people with food allergies– 2 main regulations:

• Food information to consumer• Foods for specific groups

▪ Reviewing rules for making a free-from claim– General free from claims– Particular case of gluten– Other free from allergen claims including lactose

▪ Discussion of future legislation on allergens and global overview of free-from allergen claims regulation outside Europe

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Overview of the evolution of regulations on food allergens and specific foods for people with food allergies


Changes in the legislation

▪ LABELLING : ALLERGENS

▪ The regulations regarding consumer information on food allergens have changed over the past 15 years.

▪ Since 2003 and the Directive 2003/89/EC : allergens shall be indicated on the labelling

– List of 12 allergens– Shall be indicated on the labelling : “contains”+ the name of the ingredient(s) concerned.– indication not necessary when the ingredient is already included under its specific name in the list of

ingredients or in the name under which the food is sold

▪ In 2007 Commission Directive 2007/68/EC : gives an update of the list– list of 14 allergens– and exclusions of ingredients or substances derived from those listed ingredients which are not likely

to cause adverse reactions in susceptible individuals

Enable consumers to make informed choices

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▪ LABELLING : ALLERGENS

▪ More recently, the rules regarding the labelling of substances or products causingallergies or intolerances have been strengthened by the regulation n° 1169/2011of 25 October 2011 on the provision of food information to consumers.

▪ Which ingredients are concerned?

– All the ingredients including food additives, processing aids and other substances orproducts with a scientifically proven allergenic or intolerance effect listed in Annex II orderived from a substance or product listed in Annex II used in the manufacture orpreparation of a food and still present in the finished product, even if in an altered form.

Current legislation

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▪ LABELLING : NEW PRESENTATION OF THE ALLERGENS

– They shall be indicated in the list of ingredients emphasis by font, style or background colour

– In the absence of a list of ingredients, theyshall comprise the word ‘contains’ followedby the name of the substance

– The information shall be clear for eachingredient or processing aid concerned.

– The indication (…) shall not be required incases where the name of the food clearlyrefers to the substance or productconcerned.

+ Article 44 : Mandatory allergen informationfor non-prepacked food, including in restaurantsand cafes Still 14 allergens in Annexe II 8


▪ Accidental contamination - labelling– The Commission is working on an implementing act regarding

requirements for voluntary food information on the possible and unintentional presence in food of substances or products causing allergies or intolerances according to article 36. • No delay

– Some Member States/associations already issued Guidance→In general, what is required is to avoid cross contamination by quality management (GMP + allergen management practices). Only the contamination that cannot be avoided should be mentioned in the labelling : “may contain traces of…”. The industrial shall prove that everything has been put in place to avoid the presence of the allergens. → Free from claims excluded

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▪ On 13 July 2017, the Commission adopted a Notice on the provision of information on substances or products causing allergies or intolerances– to assist consumers, businesses and national authorities in understanding the new requirements of

Regulation (EU) No 1169/2011 related to the indication of the presence of certain substances or products causing allergies or intolerances.

– This Notice was drafted in collaboration with EU countries and was subject to Public Consultation.

▪ For example: – Where gluten is added as such, as an ingredient, the type of the cereal the gluten is coming from has

to be indicated.• gluten (wheat), wheat gluten or gluten (from wheat)• dextrin (wheat) or (wheat gluten); dextrin (contains wheat) or (contains wheat gluten).

– When a product containing one of the cereals mentioned in Annex II (e.g. oats) meets the relevant requirements of Commission Implementing Regulation (EU) No 828/2014, then the statement ‘gluten-free’ or ‘very low gluten’ can be used on the product. However, the cereal mentioned in Annex II has to still be indicated and emphasised in the list of ingredients in accordance with Articles 9 and 21 of the Regulation.


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https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52017XC1213(01)


▪ DIETETIC FOODS

In Europe, the status of food products specifically processed for consumers suffering from a food allergy orintolerance has never been clearly defined :

▪ At the beginning, these products have been considered as dietetic foodstuffs because the populationconsuming these products was considered as a “specific” population – Directive 2009/39/EC

▪ But, a specific European Directive has only been published in 2009 for consumers intolerant to gluten(Regulation 41/2009/EC)

▪ For other allergens, no specific European regulation, the products could either be considered as “othercategories” dietetic foodstuffs or as common foodstuffs by the member states.

With the new European Regulation n°609/2013 of 12 June 2013 on dietetic foodstuffs, the status of thefood products for intolerant people has changed. This population is no longer considered as a specificgroup according to this regulation. All the new legislations on allergens will be part of the FIC regulation(1169/2011) including “free from claims”.


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Reviewing rules for making a free-from claim


Free from claims – several legislations

▪ Regulation shall be checked before making a free from claim

– Lots of different legislations depending on the type of claim that is made

•Authorized under condition

•Regulations 1829/2003 and 1830/2003 for GMOs

•National laws for the use of free from claims (ie.: French decree n° 2012-128)

Free from GMO

•No EU regulation

•In general: Not authorized if it is considered as denigrating or refers to non-authorized additives (Ex: free from aspartame) / Authorized if it concerns the absence of a category of additives (“Free from colors”) except if this category is forbidden in the application (fruit juices)

Free from additives

•Depends if it is considered as a nutrition claim (Reg 1924/2006 : exhaustive positive list of claim including claims on FA → forbidden) or as an environmental claim (ok if you can prove the change has been done to answer sustainability issues)

Free from palm oil

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“Free from allergens” claims

▪ “Free-from allergens” foods:– There is a trend toward special ranges of foods made without common

allergenic foods

– Is there a specific legislation applicable for this communication today?

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Current legislation : Gluten

▪ European legislation– Only one regulation for “free from allergens” claims : Case of gluten

• Harmonised thresholds in the COMMISSION IMPLEMENTING REGULATION (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food : applicable from 20 July 2016

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Current legislation : Gluten

▪ With the new regulation on gluten free products (Regulation n°828/2014), informationmay be accompanied by the statements :

✓ ‘suitable for people intolerant to gluten’ or ‘suitable for coeliacs’.

✓ ‘specifically formulated for people intolerant to gluten’ or ‘specifically formulatedfor coeliacs’ if the food is specially manufactured to:✓ reduce the gluten content of one or more gluten-containing ingredients;✓ substitute the gluten-containing ingredients with other ingredients naturally

free of gluten.

▪ It is misleading to suggest that a food possesses special characteristics when in fact all similar foods possess such characteristics. Therefore you should not claim “gluten-free” on water and similar products.

The new regulation aims to ensure that people who are intolerant to gluten areadequately informed of the difference between a food that is specially manufactured inorder to reduce the gluten content of the food and other food that is made exclusively

from ingredients naturally free of gluten.

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Current legislation : other allergens

▪ European legislation– Other allergens do not have specific harmonised rules for “free from allergens”

claims• General food law applies (Regulation 178/2002)

– You shall ensure the safety of your product• Regulation on FIC applies (Regulation 1169/2011)

– You shall not mislead the consumer by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics

– In case of new regulation for products for intolerant people (new free from claims), it should be included to the Regulation FIC 1169/2011 (FSG regulation 609/2013 does not include this category anymore)

• Specific guidelines are set for some allergens (lactose free)• Case by case assessment is done by the authorities• Quality management is under industrial responsibility (GMP / allergen management

practices (eventually including tests according to recognized methods)

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▪ Specific case of lactose– Labelling and compositional rules indicating the absence or reduced presence of lactose

in food will be determined through the Regulation (EC) 1169/2011 (amending act) (recital 42 and article 36 of the Regulation (UE) N°609/2013) → NO DELAY

– EFSA Scientific opinion on lactose thresholds 2010 concludes that no general thresholds can be set for general population.

Some MS defined maximum levels :

Belgium follows the maximum limits for infant formula: Max 2,5 mg of lactose per 100 kJ (or 10 mg/100 kcal).CASE BY CASE ASSESSMENT

HAS TO BE DONE 18



▪ Common position for other allergens: – “Free from” labelling should only be used where an absolute

guarantee of the absence of allergens can be given with theexception of allergens where limits are set by legislation (ex :sulfites). It means:• Absence in the formula (via RM / Technological aids)

• No cross-contamination or unintentionally presence

• HACCP and quality control of products

– Regulation 852/2004 + specific guidances for allergens

– EFSA Scientific Opinion on the evaluation of allergenic foods andfood ingredients for labelling purposes (2014) includes methods forthe detection of allergens and allergenic foods

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▪ Considerations for making a free from claim (BRC and FDF guidance : decision tree) Guidance to manufacturers and caterers on the appropriate use of “free-from” claims in relation to food allergens. November 2015.

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Discussion of future legislation on allergens and global overview of free-from allergen claims regulation outside Europe


What about future?

▪ At the european level, – We are still waiting for…

European level

Lactose free

regulation

Common position on “free from

allergen claims”

Update of the list of

allergens

Regulation for cross-

contamination

No timeline

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What about future?

▪ At the national level– Researches on the list of allergens for an eventual update of the European

list• France :

– Réseau d’Allergo Vigilance® (RAV) emerging allergens: buckwheat, milk of small ruminants (goat and sheep), kiwi, pine nut, α-galactose (present in mammalian meat), peas and lentils.

– These allergens present a risk of anaphylaxis, that is to say serious allergic reactions, sometimes higher than certain allergens of mandatory mention, listed in Appendix II of the European regulation n ° 1169/2011.

– Update of the thresholds for some « free from claims » waiting for an harmonized legislation.

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What about future?

▪ At the international level– Codex is working on a code of practice on food allergen management

for food business operators (to avoid cross-contamination)

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What about other countries outside EU?

▪ Some examples of other legislations for allergens are summarized below

▪ Important: – Always check if the list of ingredients considered as allergens is the same in the country of origin and in the country of

destination for the labelling– Check the way you should mention them in the labelling– Search for specific rules to communicate on “free from allergens” claims

Switzerland USA Brasil

Ordinance 817.022.16• Allergens shall be put in relief • Specific thresholds for each allergen in

case of cross-contamination (Per kg or l of ready to eat food):

✓ Sulfites: <10 mg SO2 ✓ Gluten: <200mg✓ Peanut oil: <10g✓ Lactose: <1g✓ Other: <1g

✓ Gluten free: equivalent definition as in EU✓ « lactose free » (<0,1g/100g or 100ml) ✓ « low in lactose » (-50% similar products +

max 2g per 100g dried matter

FALCPA: • Different list: milk, eggs, fish (e.g., bass, flounder, cod), Crustacean

shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

• List by the common or usual name in the ingredients list OR in a “contains” statement immediately after or adjacent to the ingredients list

• Font size must be no smaller than the font size used for the ingredients listFDA gluten-free labeling rule :the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain 2) derived from a gluten-containing grain that has not been processed to remove gluten or 3) derived from a gluten-containing grain that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm. Can be used for all the ingredients respecting this rule (including water)

Lei nº 10.674 du 16 Mai 2003• Allergens shall be put

in relief • Mandatory to specify

the presence or absence of gluten in the label : ("contémGlúten" or "nãocontém Glúten“)

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Conclusion


Conclusion

▪ Gluten-free– Well regulated in Europe – Specific thresholds

▪ Free from other allergens– Advice: proof the absence in the product

• From the formula including all the raw materials, solvents and technological aids• From the manufacturing facility (accidental contamination)• By accepted methods of control

▪ Main challenges:– Every EU MS can set up his own rules for “free from claims” waiting for an harmonized legislation– At the international level, it is necessary to adapt the labelling to be compliant with the local legislation

(other allergens / other rules for the labelling of allergens - for free from claims)– Update in the future:

• List of allergens should change in the future based on new scientific researches • New thresholds could be set up

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Produits de Nutrition

& de Santé

Expertise scientifique,

médicale et toxicologique

Expertise

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Stratégie

Règlementaire

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Free-from allergen claims: appropriate use of free- from ... › content › dam › Informa › ... · small ruminants (goat and sheep), kiwi, pine nut, α-galactose (present in