Customer Focused, Science Driven, Results Led

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1 Navigating allergen claims, labelling requirements and what they actually mean for manufacturers Simon Flanagan Senior Consultant Food Safety and Allergens Customer Focused, Science Driven, Results Led

2 Overview Allergen labelling requirements of FIC (1169/2011) Free-from claims what do these really mean? The thresholds dilemma & action levels Latest on precautionary labelling (may-contain) What must I, and what can I put on the label?

3 Allergen labelling requirements of FIC (UK FIR) Customer Focused, Science Driven, Results Led

4 EU Food Information for Consumers 1169/2011 Regulation 1169/2011 comes into force 13th Dec Establishes a legal framework in the European Union with regard to information related to foodstuffs provided to consumers by food business operators at all stages of the food chain Food intended for the final consumer Foods delivered by mass caterers Foods intended for supply to mass caterers Also applies to catering services provided by transport leaving from the EU Member States (airline catering) Distance selling (i.e. internet) Applicable to pre-packaged and foods sold loose Regulation covers mandatory and voluntary particulars

5 1169/2011 Mandatory Particulars Article 9.1(c): Mandatory particulars. Any ingredient or processing aid listed in Annex II, or derived from a substance or product listed in Annex II causing allergies or intolerances, used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form 13 allergens + SO2 (>10ppm) (Annex II) must be declared in the ingredient list regardless of quantity (unless exempt) if intentionally added as ingredients. Change in the way that allergen information is to be presented (emboldened, underlined, different colour).

6 Mandatory Example Labels* * BRC Guidance on Allergen Labelling & the Requirements in Regulation 1169/2011

7 1169/2011 Voluntary Particulars Article 36.3(a): Additional voluntary allergen labelling ( may contain information on the possible and unintentional presence of substances or products causing allergies or intolerances). Covers the requirements for voluntary food information and the implementing measures that the European Commission needs to take on the application of the requirements. Article 36.2 covers the general requirements that voluntary food information must meet: (a) it shall not mislead the consumer, as referred to in Article 7; (b) it shall not be ambiguous or confusing for the consumer; and (c) it shall, where appropriate, be based on the relevant scientific data. Contains / allergy advice box currently used on a voluntarily basis by manufactures & retailers will not be permitted after Dec

8 Voluntary Guidance* Replacing the Allergy Advice (Contains) Box Voluntary Voluntary * BRC Guidance on Allergen Labelling & the Requirements in Regulation 1169/2011

9 Free-From Claims Only gluten-free claims currently within the scope of FIC Only currently have legal limits for gluten-free (EC 41/2009) Patchy regulation and sparse published best practice guidance therefore manufacturers, retailers and foodservice setting own polices In absence of limits many companies relying on combination of high level allergen control & positive release (non-detectable at LOD / LOQ) Invitation to purchase by potentially most at risk consumers No such thing as zero but this is what many consumers expect! Sector key focus of Enforcement surveys

10 FSA Best Practice Guidance on Managing Allergens with Particular Reference to Avoiding Cross-Contamination (2007) Section Allergen-free foods A growing number of food manufacturers and retailers are providing ranges of substitute foods made without certain common allergenic foods, such as milk, egg or cereals containing gluten. In addition, some manufacturers choose to exclude certain allergens from a site. It should not be assumed that the lack of a need to use advisory allergen warnings entitles a product to make a Free From or made in allergen X free factory claim. Consumers are likely to actively seek such products if they need to avoid particular ingredients and it is essential that any such claims are based on specific, rigorous controls to ensure their validity..an allergen-free claim is an absolute claim, which may be interpreted by consumers to mean a complete absence, whereas the best that can be scientifically demonstrated at present is that samples of the food were shown to be below the analytical limit of detection of a testing method on one or more occasions. Expected that any claim is based on a robust risk assessment, control and can be supported with evidence

11 BRC Global Standard for Food Safety V6 Section Allergen claims It is essential that any allergen claim is based on rigorous controls to ensure its validity and continuous implementation Where a claim is made regarding the suitability of the food, full validation and verification activities will be required to ensure that the claim is consistently met. Typically this will include: Demonstration that production processes are in place to ensure that the product does not contain traces of the allergen Analysis of the final product Assessment of the adequacy of cleaning as detailed in clause (where the site also produce products containing the allergen about which the claim is being made, additional verification controls will be required). Raw material controls in addition to the normal requirements listed in clause additional validation / verification requirements are likely to be needed (for example raw material testing, additional supplier questionnaires, site audits etc.)

12 Gluten Free Labelling Regulations New EC Regulation 41/2009 into force in Jan Implemented Codex gluten-free claims <20ppm Implemented very low gluten claim of <100ppm Does not identify any specific gluten analytical method Does not override existing allergen labelling rules Applies also to food sold non-pre-packed Applies to foods as sold not consumed (e.g. dry bread mixes) GF claims moved to FIC / FIR

13 Allergen Thresholds & Action Levels Customer Focused, Science Driven, Results Led

14 How Much Is Too Much? Clinical Thresholds Knowledge base increased in last 5 years Clinical feeding studies - oral challenges (DBCPFC) EuroPrevall Project Thresholds differ between individuals Individuals thresholds can vary day-to-day (exercise, medication etc.) Not all allergens are equal - some are more potent and prevalent Differences in prevalence patterns across Europe Threshold studies being used to establish population based safe action levels

15 Peanut Thresholds

16 Action Levels Currently no internationally agreed levels Swiss legislation >1000 mg/kg for advisory labelling for cross-contact Japanese legislation 10 mg/kg Do not permit may-contain statement Can however use factual statements Action levels will change our approach from hazard to risk based zero a very difficult number to manage

17 VITAL 2.0 Action Levels Allergen VITAL Estimated Reference Dose (mg Protein) 5 g Serving Size: Action Level (ppm) [VITAL 1.0 Level] 50 g Serving Size: Action Level (ppm) 250 g Serving Size: Action Level (ppm) Peanut [2] Milk [5] Egg [2] Hazelnut [2 tree nuts] Soy [10] Wheat [20 gluten] Cashew Mustard Lupin Sesame [2] Shrimp [2 crustacea] Celery Fish Insufficient data Insufficient data

18 Latest on Precautionary Labelling (may-contain) Customer Focused, Science Driven, Results Led

19 Principles Of Risk Analysis in Pre-Packaged Foods (FSA 2006) Risk assessment - what's the risk? Risk management - what's the risk? Risk communication how to warn consumers? Risk review has the risk changed?

20 Labelling for Unintentional Allergen Presence Risk assessment is key to deciding what and when to label To quote FSA guidance Advisory labelling should only be used when, following a thorough risk assessment, there is a demonstrable and significant risk of allergen crosscontamination Not a substitute for poor GMP FIC Article voluntary food information: (a) it shall not mislead the consumer, as referred to in Article 7; (b) it shall not be ambiguous or confusing for the consumer; and (c) it shall, where appropriate, be based on the relevant scientific data.

21 .With That in Mind!

22 Risks of Over-labelling

23 UK FSA Snapshot Survey 2012/ pre-packed foods sampled in duplicate from a range of retail outlets from small to large across the UK Samples chosen across a broad range of 12 product categories Allergens chosen milk, gluten, peanut and hazelnut Analysis conducted for allergens not present as intentional ingredients Huge variety in the warning phases used no difference in risk Cross-contamination well managed

24 So to Summarise What must I, and what can I put on the label? Customer Focused, Science Driven, Results Led

25 Allergen Labelling Legislation Area Dir. 2000/13/EC Reg. 1169/2011 From 13 th Dec Foods sold loose / non pre-packed Excluded Included Allergen labelling list Contains boxes Mandatory ingredients declaration of 13 allergens and derivatives and sulphites >10mg/kg; Named specific exemptions Voluntary, permitted Mandatory ingredients declaration and highlighting of 13 allergens and derivatives and sulphites >10mg/kg; Named specific exemptions No longer permitted May-contains labelling Free-from claims Voluntary, permitted Voluntary, Restrictions on gluten free claims in Reg. EC/41/2009 Voluntary, permitted; Potential for future requirements in law Voluntary, Restrictions on gluten free claims in Reg. EC/41/2009

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