Consumer understanding of allergen risk: an update on Food Information for Consumers (FIC) and thresholds

An Anaphylaxis Campaign Corporate conference, hosted by the Food Standard Agency – 12th November 2013

Another excellent Anaphylaxis Campaign conference was introduced and chaired by the campaign's immediate past chair of trustees, Tony Hines who is also head of Food Security and Crisis Management at Leatherhead Food International – well versed therefore in food-related risk situations.

(For a report on the campaign's October conference for health care professionals, Managing allergies in children and young people, see here.)

Perspectives on the thresholds: where are we now? Dr Rachel Ward

Consumer perception of thresholds. Lynne Regent

Understanding food allergy: it's not always straightforward. Dr Michael Radcliffe

How testing can help support allergen thresholds. Pauline Titchener

Update on the FIC guidelines produced in 2013. Sue Hattersley

Consumer information at Debenhams. John Baker

Perspectives on the thresholds: where are we now? Dr Rachel Ward, independent risk management consultant.

It is widely recognised that the provision of food for allergic people and the whole 'freefrom food' market is being seriously held back by the ongoing lack of 'thresholds'– an agreed level of the allergen in the food which will not cause an allergic reaction in any but the most super-sensitive allergic people. (This has been in place for gluten – 20 parts per million – for the last couple of years and it could be argued that the surge in gluten-free products on the shelves can at least be partly attributed to the fact that there is now an agreed threshold for gluten.)

Dr Ward led us through the thinking behind allergen thresholds and how they could and will be applied. Some notes on her presentation:

• There are 160 foods known to cause allergic reactions
• An allergic reaction differs from a toxic reaction in that each person has their own personal threshold, which can be very low and can have a very severe outcome.
• Allergens need to be avoided by those who are allergic to them, but that avoidance must be appropriate.
• A common approach to the problem across all brands and all countries is essential.

1995. Food allergy was first recognised as a public health issue with the 'big eight' allergens being recognised across Europe and in Codex Alimentarius.

2000. It was agreed to develop national requirements for allergen control according to population prevalence – eg thresholds. This work is on-going and is hoped to be completed by 2015-ish.

As of now:

• All intentionally added foods or ingredients must be declared.
• All unintentional contamination must be controlled through the transport, manufacture and storage of the food, all of which is possible, although cleaning of machinery remains a problem. (We need machinery specifically designed for total cleaning.)
• There remain few areas which cannot be controlled such as seed contamination. With crop rotation some seeds from the previous crop (wheat in a field of oats; soya in a field of wheat) will always remain and would be impossible to trace/remove.
• Since there are no 'thresholds' (apart from gluten) for what level of allergen is acceptable/safe/allowed there are no 'standards' – and a lot of confusion!
• However, the mechanisms are all in place and once the standards arrive the system will be effective.


In toxicology the dose is very relevant. It had been thought that dose was not relevant in allergy but it is now accepted that there is a dose below which an allergic person will not react – and that the level of the dose will affect the severity of the reaction.

Policy decisions

It is not possible to protect everyone against every possible reaction so a policy decision needs to be made about what is an acceptable level of residual risk. The principles of risk analysis apply to food as much and to anything else:

Assessing the hazard – the inherent potential of the food to cause a specific (harmful) effect.
Assessing the risk – the probability of an adverse reaction if the hazard is not properly managed.

Hazard identification (in terms of allergens) started in the 1990s. Since then ongoing research funded largely by the Food Standards Agency and other similar agencies across Europe, have pulled together a great deal of excellent data – especially good because it is all human, rather than animal data – which has been subjected to some sophisticated statistical analyses.

Their aim was to establish, in terms of allergic reactions, a 'point of departure' from 'normal' health, population wide, through monitoring reactions.

However their task was complicated by the fact that, when tested, only 44-69% of those tested actually reacted to the test – which indicates that over 30% of the reactions were subjective, rather than objective. This does not invalidate those reactions but could confuse the picture in terms of levels.

Reaction levels (the amount to which they reacted) also differed – although the differing levels were all in the low microgram range so might not be that relevant for policy decisions. The severity of reactions was also affected by extrinsic factors (health of the sufferer at that point, exercise, in what sort of the food the allergen was found etc) which cannot be built into any risk assessment.

Also to be taken into account is that in terms of allergens, only one exposure is needed to cause a reaction whereas in almost all other hazards, the effect is cumulative over several days/weeks/months.

Using these criteria it is likely that there will eventually be four categories of risk that will need to be declared:

1. Totally 'freefrom' foods which would be safe for anyone to eat no matter how severe their allergy.
2. 'Mainstream freefrom' foods which are below the safety level (whatever that is set at) so will be safe for most allergic people but not for the super sensitive.
3. 'May contain' foods where there is a genuine risk of contamination.
4. 'Contains the allergen' foods.

Consumer perception of thresholds. Lynne Regent, CEO of the Anaphylaxis Campaign.

While welcoming all of this excellent work, Lynne pointed out that while it would be wonderful to have thresholds for allergens, they would be of limited use unless the allergic population, and the GPs and dietitians who look after them, understood what they meant.

The campaign's own experience suggests that there is currently a great deal of confusion among all three groups about thresholds, labelling and allergen warnings. To attempt to define exactly what this public perception is, the campaign, along with allergy groups in Canada, the US, Australia, Belgium and Italy, have just combined on a consumer survey, the results of which they hope to make available over the next few months.

Understanding food allergy : it's not always straightforward. Dr Michael Radcliffe, Consultant in Allergy Medicine, University College Hospital.

Dr Radcliffe described allergy as an inappropriate reaction of the immune system which had been very useful in dealing with parasitic infections, but was not at all useful now!

Allergens are peptide fractions of proteins not amino acids, the building blocks of proteins to which the immune system does not react.

Mast cells in tissues, and basophils in blood, both store histamine which is released when the cell or basophil comes into contact with the allergen. The histamine causes mucus production (itching), blood vessel dilation leakage (angiodaema or swelling) affecting airways and throat, and a drop in blood pressure.

Both skin prick and blood tests can be used to diagnose and, although neither are totally reliable, they are an easy and cheap guide to allergic sensitivity. However, they should only ever be used in conjunction with the patient's history which, for an allergist, is the key to making an accurate diagnosis.

Dr Radcliffe then described several cases to illustrate the importance of a detailed understanding of the patient's circumstances and history if an accurate diagnosis was to be reached:

1. A lady suffered severe reactions to eating figs. She had no previous history of fig sensitivity but had suffered from breathing problems for a few years. In depth questioning discovered that she had two ornamental non-fruit-bearing fig trees, Ficus Benjamina, in her house. She removed the trees, did not eat figs, had no further reactions and no further breathing problems.

2. A patient collapsed after eating spaghetti Bolognese in a restaurant but had no known allergies to any of the ingredients of the dish. However, he did have a severe reaction each autumn to the mould/fungus, altenaria. On further investigation it was found that it had been a vegetarian spaghetti Bolognese and that the meat alternative had been Quorn – a fungus which cross reacts with altenaria.

3. Another patient with a history of eczema and hay fever had several episodes of idiopathic anaphylaxis (no known cause). The episodes all appeared to have occurred after she had eaten sesame seeds or oil, but her skin prick and blood tests to sesame were all negative. Even so she was told to avoid sesame seeds – only to have another reaction when she ate a vegetable curry made with sesame oil. A provocation test showed that she was allergic both to sesame seeds and oil. (Sesame oil is normally cold pressed so, unlike sunflower and soya oil whose allergenicity is all but destroyed by processing, it retains the full allergenicity of the seeds.) Sesame allergy often does not test positive in blood or skinprick tests, probably because both tests are done in an aqueous environment and cannot therefore access the sesame protein, oleosin, which is masked by the oil/fat. This can sometimes also apply to peanut protein.

4. A patient suffered from hives and a tight throat afer exercise when he had recently eaten a wide range of foods whose only common ingredient was wheat. However, while he tested positive to wholewheat flour, he could normally eat wheat without a problem. The reaction was only triggered by a combination of exercise and wheat consumption and its seriousness depended on how much wheat he had eaten and how soon before the exercise. He also suffered a reaction when he took aspirin prior to eating wheat – which could have implications for the large number of people who take regular aspirin as a prophylactic.

All of which go to prove that both clinical assessment and history are VITAL in diagnosing allergy!

How testing can help support allergen thresholds. Pauline Titchener, Business Development Executive, Allergens and Speciation at Neogen Europe.

Pauline pointed out that allergen testing was only one part of food allergen management although testing was also very useful in validating cleaning methods and testing efficacy.

In testing, several things needed to be borne in mind:
1. The physical nature of the allergen and whether it is dispersible.
2. The protein content – this can vary hugely.
3. The protein versus food residue conversion.
4. The nature of the sample to be analysed: raw material, environmental swabs, finished products, rework etc.
5. The effect of food processing on the allergen. For example, processed soya lecithin would not show up as soya on an ELISA test.
6. Portion size. This is very important when assessing testing methods.

Pauline also pointed out that the proposed action levels referred to a single portion of the food in which the allergen would be found. What happens if the consumer were to eat, for example, all of the packs in a multipack in one sitting (not unknown...) or over a relatively short period of time?

Update on the FIC (Food Information for Consumers) guidelines produced in 2013. Sue Hattersley, Head of Food Allergy at the Food Standards Agency.

Brief notes on Sue's presentation:

1. Provisional information for consumers covers mass caterers and all transport (trains, planes etc) within Europe.
2. Existing exemptions for highly processed ingredients (such as glucose syrup) remain.
3. All ingredients and processing aids, listed in Annex II (the 14 major allergens), or derived from those allergens, must be declared in words and/or numbers, not in symbols.
4. Allergens have to be conspicuous among the ingredients; they must use a minimum font size and clear colours.
5. The regulations also cover 'distance selling' – mail order, internet etc.
6. The information must be on the food or on a website.

Food sold loose.

The regulations do not mandate on how the information is to be delivered. Some countries are going for a full ingredients listing for each dish, others (UK) will deliver it orally although they must have clear signage indicating that the information will be delivered orally.

If it is delivered orally, then the information needs to be consistent and verifiable. Each establishment must have one person on site who is fully informed about all allergens that they use. It is hoped that if the customer asks about allergens that will also alert the establishment to the fact that they have an allergy.

The FSA will be providing technical guidance for food service on their website – especially important as the research they have carried among caterers suggests that many of them think they understand a great deal more about allergy than they actually do!

Enforcement will be carried out by Environmental Health Officers (EHOs); training for food service will differ little from training to monitor allergens in prepacked foods.

The government wants to move to purely civil law enforcement for allergen control but the FSA is anxious to retain criminal sanctions for allergen breaches of the regulations.

Consumer information at Debenhams. John Baker, Director of Food Services at Debenhams.

To finish the day, John gave a quick run down of the Debenhams operation:

• 165 stores, 3,000 staff and 17 million customers a year being served over 600 products from multiple suppliers many of whom are small artisan producers with very little understanding of allergy.

• Detailed, relevant staff training materials – but the high turnover of staff is challenging...

• Allergen information.
   1. Allergy advices file on display with allergen highlights.
   2. Product knowledge manual with all details of all products available on request.

First published November 2013.

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