1. Innovation | Nutrition | Regulatory | Safety | Sensory An update on the legislative requirements for allergen labelling in the EU, including may-contain and free-from labelling Devina Sankhla, Senior Regulatory Advisor 4 June 2013

2. www.leatherheadfood.com 2 © Leatherhead Food Research EU Allergen Labelling Legislation Amendments: Directive 2003/89/EC Directive 2006/142/EC Directive 2007/68/EC Regulation (EU) No. 579/2012 Regulation (EU) No. 1169/2011 14 allergenic ingredients Exemptions Wine exemption ended

3. www.leatherheadfood.com 3 © Leatherhead Food Research Cereals containing gluten (specified) Crustaceans Eggs Fish Peanuts Soybeans Milk (including lactose) Nuts (specified) Celery Mustard Sesame seeds Sulphur dioxide and sulphites >10 mg/kg or 10 mg/l... and products thereof 14 Allergenic Ingredients Directives 2003/89/EC and 2006/142/EC Lupin Molluscs

4. www.leatherheadfood.com 4 © Leatherhead Food Research Specific Allergens CEREALS CONTAINING GLUTEN almond, hazelnut, walnut, cashew, pecan, brazil, pistachio, macadamia, Queensland nuts NUTS Wheat, rye, barley, oats, spelt, kamut or their hybrids

5. www.leatherheadfood.com 5 © Leatherhead Food Research Exemptions Directive 2005/26/EC (amended by Directive 2005/63/EC) provided temporary exemptions from allergen labelling requirements for certain derived ingredients originating from listed allergens. Expired on 26 November 2007. Directive 2007/68/EC provides permanent exemptions from allergen labelling requirements for certain derived ingredients shown to no longer be allergenic.

6. www.leatherheadfood.com 6 © Leatherhead Food Research List of Exempt Derivatives Allergenic Ingredients ‘Products thereof’ excluded Cereals containing gluten Wheat based glucose syrups including dextrose (+ products of) Wheat based maltodextrins (+ products of) Glucose syrups from barley Cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages Fish Fish gelatine as carrier for vitamin or carotenoid preparations Fish gelatine or isinglass as fining agent in beer & wine Nuts Nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages

7. www.leatherheadfood.com 7 © Leatherhead Food Research Allergenic Ingredients ‘Products thereof’ excluded Soybean Fully refined soybean oil and fat (+ products of) Natural mixed tocopherols (E 306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources Vegetable oils derived from phytosterols and phytosterol esters from soybean sources Plant stanol ester produced from vegetable oil sterols from soybean sources Milk Whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages Lactitol List of Exempt Derivatives (2)

8. www.leatherheadfood.com 8 © Leatherhead Food Research Temporary Exemption Ended for Wine Regulation (EU) No. 579/2012 Use of lysozyme and albumin from eggs, casein from milk, as fining agents in wine without allergen labelling was extended until 30 June 2012. Must now be labelled for new products place on market - Unusual in that wording prescribed ‘egg’, ‘egg protein’, ‘egg product’, ‘egg lysozyme’ or ‘egg albumin’ Also optional logos

9. www.leatherheadfood.com 9 © Leatherhead Food Research Indication of Allergenic Ingredients The ingredients list of a foodstuff containing an allergenic ingredient or its derivative must be labelled accordingly to make clear reference to the allergenic ingredient present in the foodstuff.

10. www.leatherheadfood.com 10 © Leatherhead Food Research Allergen Considerations The following would not normally require indication in an ingredients list: Processing aids Solvents or media for additives or flavourings Ingredients of defined ‘compound ingredients’ at <2% (e.g. spices – celery, mustard) Ingredients within ‘generic name categories’ (e.g. ‘flour’) If they originate from allergenic ingredients and are present in the final product, even in altered form, the allergenic ingredients must always be declared.

11. www.leatherheadfood.com 11 © Leatherhead Food Research Format Examples If allergenic ingredient not in the product name, must give ‘clear reference’ e.g. …, flavouring (contains milk), … …, colour: beta-carotene (contains soya), … …, whey powder (from milk) …, sesame-tahini …, semolina (wheat)

12. www.leatherheadfood.com 12 © Leatherhead Food Research Format – Future Requirements in FICR FICR – Regulation (EU) No. 1169/2011 (Article 21) Allergenic ingredient shall be emphasised through a typeset that clearly distinguishes it from the rest of the list of ingredients, for example, by means of the font, style or background colour E.g. tofu as “tofu (soya)” The labelling shall make it clear for each ingredient or processing aid concerned Ingredients: Cultured skimmed milk (58%), Buttermilk, Plant stanol ester (plant stanol 4%), Vegetable oil (5%), Butter, Cream powder....

13. www.leatherheadfood.com 13 © Leatherhead Food Research Alcoholic drinks above 1.2% abv: “contains …” Unless the allergenic ingredient is already in name of the drink or any list of ingredients “CONTAINS BARLEY” Format Examples – Alcoholic Drinks

14. www.leatherheadfood.com 14 © Leatherhead Food Research Allergen box? Repetition - Allergen Boxes/Statements?

15. www.leatherheadfood.com 15 © Leatherhead Food Research ‘May Contain’ Labelling No specific provisions for advisory statements such as ‘may contain x’. General food law under Regulation (EU) No. 178/2002 (as amended). “when determining if a food is injurious to health one must take into consideration health sensitivities, along side with any immediate or long-term effects” Use of statements must be clear and in close proximity to the ingredients list.

16. www.leatherheadfood.com 16 © Leatherhead Food Research EU-Vital/Vital? (European) Voluntary Incidental Trace Allergen Labelling [(EU)VITAL] A risk management tool developed by the food industry to better manage incidental presence of trace amounts of allergens. Three/two level action grid to determine whether precautionary labelling statements are required.

17. www.leatherheadfood.com 17 © Leatherhead Food Research Future - ‘May contain’ Labelling in FICR FICR – Regulation (EU) No. 1169/2011 (Article 36.3(a)) Information provided on a voluntary basis must meet the following requirements: (a)it shall not mislead the consumer (b)it shall not be ambiguous or confusing for the consumer (c)it shall, where appropriate, be based on the relevant scientific data The European Commission must adopt implementing measures detailing the application of the requirements related to voluntary information on “may contain” labelling. Development of European guidance related to “may contain” labelling.

18. www.leatherheadfood.com 18 © Leatherhead Food Research TRACE Peanut Study in UK 3 year study aims to find out the amount of peanut required for an allergic reaction to occur in those with a peanut allergy. Following publication of final results (summer 2016), the FSA aims to improve the clarity of ‘may-contain’ allergen labelling for peanut- allergic consumers in the UK.

19. www.leatherheadfood.com 19 © Leatherhead Food Research ‘Free From’ Labelling ‘X free’ claims not defined in general EU law with the exception of: Lactose free in PARNUTS (infant formula) legislation - max 2.5mg/100kJ (10mg/100kcal). Gluten free in PARNUTS legislation... Member States national legislation/guidance…

20. www.leatherheadfood.com 20 © Leatherhead Food Research Regulation (EC) No. 41/2009 - Maximum limits for foodstuffs specifically formulated for gluten intolerant people (PARNUTs): ‘Very Low Gluten’ for foodstuffs of grain origin specifically processed to reduce gluten (& blends with substitutes) < 100 ppm ‘Gluten Free’ for foodstuffs of grain origin specifically processed to reduce gluten (& blends with substitutes) < 20 ppm ‘Gluten Free’ for substitute products <20 ppm Gluten Free

21. www.leatherheadfood.com 21 © Leatherhead Food Research Maximum limit for ‘normal’ and other PARNUT foodstuffs – ‘Gluten Free’ for foodstuffs not exceeding 20 ppm [‘Very Low Gluten’ not permitted on these products] Applied from 1 Jan 2012 Gluten Free (2)

22. www.leatherheadfood.com 22 © Leatherhead Food Research Lactose Free – Examples of Rules in EU Member States Denmark/Sweden/Finland/Czech Republic Limit of detection 0.01% per 100 g/ml. Low-lactose claim – 1g per 100g/ml. In both cases the authorities must be informed. Levels to be given. UK - Guidance Limit of detection 0.03% per 100g/ml. Levels recommended to be given.

23. www.leatherheadfood.com 23 © Leatherhead Food Research Lactose Free – Rules in EU Member States (2) Germany - Guidance ≤ 10 mg/100 g resp. ml ready to consume foodstuff Low lactose claim - ≤ 1g/ 100 g resp. ml Very low lactose claim - ≤ 100 mg/ 100 g resp. ml

24. www.leatherheadfood.com 24 © Leatherhead Food Research Other ‘X Free’ Claims E.g. ‘Egg Free’, ‘Free from Soya’, ‘Made in a Nut Free Factory’ Shall be used in line with general food law. Sufficient sampling and regular review.

25. www.leatherheadfood.com 25 © Leatherhead Food Research Allergens – Non-Prepacked Foods Format may be decided at National level… Germany - Allergens must be highlighted via a board close to the product. “Where foods are offered for sale to the final consumer or to mass caterers without pre-packaging, or where foods are packed on the sales premises at the consumer's request or prepacked for direct sale the provision of information on allergenic ingredients or processing aids is mandatory.”

26. Innovation | Nutrition | Regulatory | Safety | Sensory Thank you for your time Devina Sankhla dsankhla@leatherheadfood.com