New allergen labelling legislation

Those in the medical profession should be up-to-date and aware of the situation to be able to advise accordingly. By having a thorough understanding of these changes, it means it will be possible to highlight key aspects of ingredient labelling to patients, to inform them of the changes to expect and when to expect them. Advice on `label checking` is a key role of the dietitian in the education of people with food allergy. An explanation of these changes, and typical ingredients affected, is given here.

What will change?
Currently, ingredients in all foodstuffs are listed in the ingredients list in descending order by weight. However, some legal exemptions exist which mean that it has often been difficult to identify all allergens in a food. In November 2003 new EU legislation¹ established an agreed list of common food allergens, which will always have to be labelled wherever used. All processed foods made after 25 November 2005 must carry allergen information.

What does the list include?
From November 2005 statutory rules will require the mandatory declaration of 12 allergenic foods i.e. those foods considered to be the major triggers of allergic or hypersensitivity reactions, and their derivatives (`products thereof`), listed in Table 1. Some of the substances are not true allergens in immunological terms (e.g. sulphites and gluten) but can still cause adverse reactions in some people. Cereals containing gluten are listed for the benefit of people with gluten sensitive enteropathies e.g. coeliac disease and dermatitis herpetiformis.

Table 1

Allergenic foods	Some derivatives and foods made from the allergen that may trigger an allergic reaction
Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains)	•flours •starches •breads •semolina •cous cous
Crustaceans	•shrimp paste
Eggs	•egg powder/dried egg •mayonnaise •albumin •lecithin (E322) if made from egg
Fish	•fish extracts •fish sauces •Worcester sauce (some brands) •omega-3 rich oils derived from fish
Peanuts (also known as ground nut or monkey nuts)	•unrefined, cold-pressed peanut oil (also known as arachis oil) •satay sauce •refined peanut oil *
Soy(a) beans	•soya infant formula •soya flour •tofu •soya protein isolates •textured soya protein •lecithin (E322) if made from soya •soy sauce
Milk and milk products thereof (including lactose)	•whey •caseinates •lactose •butter, cheese, cream, yoghurt, ghee
Nuts i.e. Almond, Hazelnut, Walnut, Cashew, Pecan nut, Brazil nut, Pistachio nut, Macadamia nut and Queensland nut	•nut butters •praline (Hazelnut) •marzipan (almond) •nut oils e.g. walnut oil used in salad dressings
Celery**	•celery powder; seeds •celeriac powder
Mustard**	•mustard paste, seeds, powder
Sesame seeds	•sesame seeds, oil, paste •tahini •houmous
Sulphur dioxide and sulphites at concentrations of more than 10mg/kg or 10mg/litre expressed as SO2	Preservatives from sulphur dioxide and sulphites found in many foods such as dried fruits and vegetables, soft drinks, fruit juices, fermented drinks (wine, beer and cider), sausages and burgers e.g. additives E220 - E 228

* according to the Anaphylaxis Campaign most peanut allergic consumers do not react to this
** Celery and mustard have been included as these foods pose an allergenic threat to a significant number of people in other EU countries.

What type of food products does this new legislation apply to?
It applies to all food and drink products, including infant formula, weaning foods, sip feeds and other medical foods, and gluten free foods. Alcoholic drinks currently do not carry an ingredient list but now, at least, they will have to declare any allergens used. The implicated food ingredients, and some examples of derivatives of these, are seen in Table 1.

What changes are expected in ingredient lists on food products?
Ingredient lists are likely to appear longer as all allergens in the product must be declared. The key changes being:

• The presence of an allergen or the ingredient derived from an allergen e.g. soya lecithin rather than lecithin or E322 as currently permitted.
• Previous exemptions to ingredient listing of compound ingredients have largely been abolished. For example, all the ingredients in a pepperoni sausage in a pizza topping need to be declared whereas before, only any additives present needed to be declared.
• Labelling requirements now extend to processing aids, carriers and carry over additives which have not previously needed to be declared in the ingredients list e.g. soya oil, often a carrier for Vitamin E in formulations, must now be declared.

Some companies plan to place an additional `Contains` or `Allergy Advice` box on pack to group all allergens in one place to help the consumer find the information quickly and easily. For example, all Cow & Gate foods and milks will feature this additional information box if there is an allergen in the product, even though it will also be listed in the ingredients list, to make it easier for the consumers to spot.

What other changes does the legislation include?

• An effect of the legislation is that a few products may have declarations that do not seem logical. For instance, Cow & Gate Pepti Junior is formulated specifically for the management of babies and children with severe cows` milk protein allergy and lactose intolerance. It is made with extensively hydrolysed cows` milk to remove the allergenicity of the protein and is lactose free. However, the law now specifies that even extensively hydrolysed milk protein must have the allergen `milk` indicated on the label.
• As new evidence and research becomes available the list of 12 allergens will be changed to accommodate the addition or removal of allergens.
• It is accepted that highly refined ingredients derived from allergens may not be harmful to people with food allergy or other conditions such as coeliac disease e.g. soya bean oil; wheat maltodextrin. Labelling of all such non-allergenic derivatives would cause even further but unnecessary dietary restriction and may lead people to believe that having eaten a highly refined ingredient, there is no danger from eating the unrefined allergen. The new legislation allows the European Food Safety Authority (EFSA) to establish a list of derived ingredients, based on scientific evidence, which will ultimately not need to be labelled.
• Until EFSA has had the opportunity to consider all relevant scientific studies, an interim list of ingredients has been published showing ingredients which are provisionally exempted from the requirement to be labelled. Table 2 provides some examples. These ingredients, derived from the source allergenic foods, are considered to be sufficiently processed so as to remove the protein and are thus unlikely to trigger allergic reactions in sensitive individuals. By November 2007 the European Commission must publish a final list of permanently exempted ingredients; any derived ingredient, not approved by EFSA, will have to be labelled.

Table 2

Ingredient	Examples: Products thereof provisionally excluded from labelling requirements
Cereals containing gluten	•glucose syrup from wheat inc. dextrose* •maltodextrins from wheat* •glucose syrups from barley •cereals used in distillates for spirits
Eggs	•lysozym from egg used in wine •albumin from egg used in wine and cider
Fish	•fish gelatine •used as a carrier •used as a fining agent in beer, wine, cider
Soy(a) bean	•fully refined soybean oil and fat* •plant stanol ester from vegetable oil sterols from soybean sources
Milk	•whey used in distillates for spirits •lactitol •milk (casein) products used as fining agents in cider and wines
Nuts	•nuts used in distillates for spirits •nuts (almonds, walnuts) used (as flavours) in spirits

* and derivatives of these ingredients

When will changes in ingredient lists be seen?
From 25th November 2005 all new food labels used in Europe must comply. Labels on products which were on the market before this date may be sold until product stocks are used up. This means that there will be a mixture of old and new labels on the shop shelves for at least the next year, as foods with long best before dates are sold through.

What does the legislation NOT cover?
The new changes only cover the deliberate addition of allergenic ingredients. There are currently no statutory controls governing the labelling of possible cross-contamination in the food chain resulting from the presence of an allergen e.g. milk powder dust particles entering a product claiming to be `milk-free`. The UK Food Standards Agency (FSA) is currently consulting on Best Practice Guidance on controlling food allergens, in particular on efforts to avoid cross-contamination during the manufacture and transportation of food. The FSA aims to protect consumers by improving food safety and by ensuring honest, clear information is available to enable consumers to make informed choices and thus is also considering the use of appropriate advisory labelling and warnings commonly seen on labels e.g. may contain traces of nuts; produced in a factory that handles nuts.

Will labels still carry statements such as `May contain traces of nuts`?
The new legislation will not change the use of `may contain` statements. For those consumers with food allergies and intolerances, it is vital they are fully informed about the nature and contents of the foods they are buying. Food companies have, for many years, been discouraged from using such statements in place of adequate safety controls and due diligence. `May contain` statements will continue to be seen on labels. It is hoped that the Best Practice Guidance, when finalised, will encourage risk-based judgements to be made by food manufacturers, regarding allergens, which will lead to a decision on whether allergen advisory labelling is really necessary. Each manufacturer will need to make their own assessment of the particular risks associated with the products they supply.

What is the position of `allergen-free` claims?
The allergen labelling legislation will not change the use of `allergen-free` claims on food products e.g. soya free. Any such claim, or food lists of such claims, should be clearly dated and limited in time and/or scope to ensure they remain valid. Any manufacturer who demonstrates good manufacturing practices should be able to substantiate the use of such on-pack claims or other indications. Any erroneous claims could result in criminal prosecution or product liability cases under food safety and consumer protection controls. Individual companies need to decide whether such claims can be justified; they should not be made unless they can be supported by an appropriately documented quality system

Written by Ruth Birt BSc (Hons) LLM FIFST CSi. Advisor-Regulatory Affairs, Regulatory Solutions (Scotland) Ltd.

1. Directive 2003/89/EC of the European Parliament and of the Council amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs

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The Anaphylaxis Campaign, a national patient support organisation, welcomes the new regulations.

David Reading, the charity`s director and co-founder, said: "We know of many cases where people with food allergy have reacted to allergens that were quite legally undeclared. In one case, a teenage boy suffered severe symptoms to an apple pie that contained only 0.006 per cent milk protein. This kind of thing should not happen once all food labelling complies with the new rules."However, there are still many allergy-related issues to be addressed. One example is allergy awareness in schools. We are about to launch a major programme of training for school nurses which, we hope, will improve the lives of the many thousands of children across the UK who have food allergy."

"Another burning issue is the rise in the number of warning labels that state that a product `may contain` an allergen such as nuts. People with food allergy have become more and more frustrated and angry as they see their food choices being eroded. Many of them believe that food companies are adopting these labels simply to `cover their backs` and therefore they ignore them. But we always urge people to heed these warning labels. Nine out of ten times a product may be free of allergen traces, but the next time there may be serious cross-contamination. This is a very real risk. People can be assured that we are working behind the scenes to limit the growth in these warning labels and reverse the trend."

It is also important to remember that the new labelling regulations cover pre-packed food and not food sold loose (at instore bakeries, for example) and not food sold in catering establishments, such as restaurants, cafes, hotels and takeaways. A large proportion of the serious reactions occur in these circumstances. Allergic customers must be very direct with staff and, if they are not reassured, eat elsewhere. Much of our work is spent educating the catering sector so that people with food allergies can eat out safely."

Contact details: Anaphylaxis Campaign, PO Box 275, Farnborough, Hampshire GU14 6SX. Helpline: 01252 542029.

Websites: www.anaphylaxis.org.uk and www.allergyinschools.org.uk.