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

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EU Allergen Labelling Legislation

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Amendments: • Directive 2003/89/EC • Directive 2006/142/EC

14 allergenic ingredients

• Directive 2007/68/EC

Exemptions

• Regulation (EU) No. 579/2012

Wine exemption ended

• Regulation (EU) No. 1169/2011 © Leatherhead Food Research 2

14 Allergenic Ingredients

Directives 2003/89/EC and 2006/142/EC www.leatherheadfood.com

Cereals containing gluten (specified) Crustaceans Eggs Fish Peanuts Soybeans Milk (including lactose) Nuts (specified) • • Lupin Molluscs Celery Mustard Sesame seeds Sulphur dioxide and sulphites >10 mg/kg or 10 mg/l ...

and products thereof

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Specific Allergens

CEREALS CONTAINING GLUTEN Wheat, rye, barley, oats, spelt, kamut or their hybrids NUTS almond, hazelnut, walnut, cashew, pecan, brazil, pistachio, macadamia, Queensland nuts

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Exemptions

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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.

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List of Exempt Derivatives

Allergenic Ingredients Cereals containing gluten Fish Nuts

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‘Products thereof’ excluded

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• 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 gelatine as carrier for vitamin or carotenoid preparations • Fish gelatine or isinglass as fining agent in beer & wine • Nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages 6

List of Exempt Derivatives (2)

Allergenic Ingredients Soybean Milk

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‘Products thereof’ excluded

• 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 • Whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages • Lactitol © Leatherhead Food Research 7

Temporary Exemption Ended for Wine

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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 © Leatherhead Food Research 8

Indication of Allergenic Ingredients

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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.

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Allergen Considerations

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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.

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Format Examples

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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) © Leatherhead Food Research 11

Format – Future Requirements in FICR

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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....

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Format Examples – Alcoholic Drinks

Alcoholic drinks above 1.2% abv: www.leatherheadfood.com

“

contains …

” Unless the allergenic ingredient is already in name of the drink or any list of ingredients

“CONTAINS BARLEY”

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Repetition - Allergen Boxes/Statements?

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Allergen box?

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‘May Contain’ Labelling

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• 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.

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EU-Vital/Vital?

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(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.

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Future ‘May contain’ Labelling in FICR

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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.

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TRACE Peanut Study in UK

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• 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.

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‘Free From’ Labelling

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‘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… © Leatherhead Food Research 19

Gluten Free

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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

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Gluten Free (2)

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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

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Lactose Free – Examples of Rules in EU Member States

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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.

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Lactose Free – Rules in EU Member States (2)

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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 © Leatherhead Food Research 23

Other ‘X Free’ Claims

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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.

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Allergens – Non-Prepacked Foods

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“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.” • Format may be decided at National level… • Germany - Allergens must be highlighted via a board close to the product.

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Thank you for your time Devina Sankhla [email protected]

Innovation | Nutrition | Regulatory | Safety | Sensory