Precautionary allergen labelling Are we ready to quantify risk? Dr. Chun-Han Chan Anaphylaxis Campaign Corporate Conference 2016

Transcription

1 Precautionary allergen labelling Are we ready to quantify risk? Dr. Chun-Han Chan Anaphylaxis Campaign Corporate Conference 2016

2 What information needs to be provided Mandatory Declare deliberate use of allergenic ingredients or processing aids (regardless of level of inclusion) Voluntary Unintentional presence of allergen in food (precautionary allergen labelling) Declare absence of an allergen in food (free from)

3 Precautionary allergen labelling No specific / defined requirement in legislation General Food Law Regulation No.178/2002 Article 14 (2), (3b) Food must not be unsafe injurious to health information provided to avoid adverse health effect Risk communication for unintentional presence of allergens may contain' type statements

4 Guidance prepacked foods Food Standards Agency (2006) Food Drink Europe (2013)

5 FSA s Safer food, better business loose foods Allergy safe method Reviewed to strengthen allergen control throughout document To encourage caterers to weave allergens into their hygiene controls

6 DEFINING RISK How are we doing this now?

7 Article 14 (2), (3b) Food must not be unsafe Injurious to health information provided to avoid adverse health effect. With regard to an adverse health effect, what is considered unsafe or injurious to health? What kind of adverse health effect is unacceptable? How do we communicate this risk?

8 What is the current situation with PAL (1) Cross contamination can be intermittent and amounts can vary Proliferation of precautionary allergen warnings FSA study (2014) diverse wording May contain traces May contain Not suitable food Made on a line which handles Made on a site which handles Packed on a site which handles

9 What is the current situation with PAL (2) Subjective risk assessment = risk taking behaviour Different statement different risk to the individual May contain traces vs May contain what is a trace? Consumers ignoring PAL

10 What is the current situation with PAL (3) Current guidance is qualitative not quantitative No international agreement on use of reference doses Inconsistent approaches by Regulators and Industry Need to agree on how much is too much. What is considered unsafe for the purpose of risk assessment and management on a public health level

11 FSA approach to risk assessment Decision based on available information, for example: Amount of allergen reported (protein, total protein, DNA) Portion size and/ or consumption data Ascertain the risk to the consumer = calculate likely dose exposure Use clinical threshold data (NOAEL / LOAELs), reference doses Homogenous or heterogeneous contamination

12 GETTING THE EVIDENCE TO UNDERPIN POLICY Steps to harmonise approaches to PAL

13 Clinical data Acceptable risk Methods Initiatives Europrevall FSA studies IFAAM FARRP (US)- TNO (NL) risk modelling EFSA Opinion 2014 ILSI EG Commission TF on PAL EuroPrevall IFAAM FARRP (US)- TNO (NL) risk modelling ILSI Europe EG Commission TF on PAL IFAAM MoniQA EFSA Opinion 2014 FEPAS data CEN MCR allergy network ILSI Europe EG Commission TF on PAL

14 Quantifying risk What is allergen free? is it defined by the ability of the method used? Zero risk hard to attain i.e. gluten-free (<20mg/kg not 0mg/kg gluten) Work to inform may contain statements not make free from different levels of risk and management required

15 Managing risk a public health approach Risk management for public health purpose is managed on a population level Population data used to derive allergen reference doses ED01 where 1% of population may react ED05 where 5% of population may react Where we see a reaction we do not expect severe reactions

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17 Applying reference doses to manage allergens ED01 data for peanut, milk, egg, hazelnut Most common causes of allergy incident 2014 were : Sulphites, Milk, Cereals including gluten, Peanuts, Soya, Tree Nuts Should we start here?

18 Allergy detection methods Helps inform and underpin decisions on: Allergen management protocols Risk communication/ labelling decisions Regulatory / enforcement action What defines an allergenic food? e.g. DNA sequence, specific protein(s) Problem: cross reactivity similar looking proteins

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20 When is an almond not an almond? When it is a mahaleb

21 Prunus dulcis vs Prunus mahaleb

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23 ADDRESSING THE ISSUE Agree on what we can do and what we need to do

24 Initiatives for allergen detection methods Harmonise approaches to PAL Review whether they can detect allergens at set allergen management thresholds (action levels) Have relevant quality control materials and/or reference materials Explore new technologies orthogonal methods Establish performance criteria? use any method but need to perform to set criteria

25 Next steps What is unsafe use some /all reference doses now? Consistent and defined approach to risk assessment and risk management Consistent wording for PAL

26 THANK YOU FOR LISTENING