you are here: Home: Food Industry: Information for the food industry
 
Printer friendly version
 
Information
Food Alerts
Guidance for schools and pre-schools
Info for Young Adults
Health Professionals
Food Industry
New EC allergen labelling regulations
Information for the food industry
Key messages for caterers
Join Us
Products
Events
Donate
Contact Us

 


The new EC allergen labelling regulations:
what the food industry needs to know

Introduction

Under new EU labelling regulations, food manufacturers are compelled to declare, in terms that are clear to consumers, the presence of 12 major allergenic ingredients in pre-packed food products.

This new legislation comes from three EU Directives (2003/89/EC, 2005/26/EC and 2005/63/EC). It amends the UK’s Food Labelling Regulations 1996.

The Anaphylaxis Campaign believes this is a welcome step forward in protecting people with food allergy.

The regulations remove the 25 per cent rule governing compound ingredients. This rule allowed any compound ingredient making up less than 25 per cent of a final product (such as jam in a sponge or sausage on a pizza) not to declare its component ingredients, with the exception of additives.

The deadline

Products manufactured and labelled after November 25th 2005 must be in line with the new requirements. Products manufactured and labelled before that date may continue to be sold while stocks last.

Many manufacturers already give full ingredient declarations and have already brought in the new allergen labelling requirements. Indeed, for about a decade many food companies have been ignoring the 25 per cent rule in respect of nuts (and sometimes other allergens) and ensured that these ingredients are fully labelled.

Back to Top

The allergens that must always be labelled

Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains).

Crustaceans (e.g. crab, lobster, crayfish, shrimp, prawn).

Eggs.

Milk (including lactose).

Fish.

Peanuts.

Soybeans.

Tree nuts (almonds, hazelnuts, walnuts, cashews, pecans, Brazils, pistachios, and macadamia/Queensland nuts).

Celery and celeriac.

Mustard.

Sesame seeds.

Sulphites at concentrations of over ten parts per million.

Products containing any of these allergens must always be labelled unless an exemption has been granted by the European Commission based on scientific evidence that processing has largely removed their allergenicity (see “Allergen derivatives”, below).

Labelling must be in clear terms

The new regulations state that the presence of the allergen must be clear to the consumer. Examples:

The label must make it clear that caseins/caseinates and whey products are derived from milk.
Lecithin must declare its source, e.g. lecithin (from soya).
Flavourings must include source ingredients, e.g. flavouring (contains almond).

What the legislation doesn’t cover

The legislation covers only ingredients added intentionally and not traces that may be present due to cross-contamination. “May contain” labelling is not specifically covered by legislation – although high levels of unlabelled allergens can be controlled under general food quality law.

The Anaphylaxis Campaign accepts that “may contain” labelling is necessary in many instances to protect allergic consumers. However, it urges food companies to apply such labelling only as a last resort, after a thorough risk assessment has concluded that cross-contamination is potentially hazardous and unavoidable. The Food Standards Agency (FSA) has launched a consultation exercise on this issue.

The new EU legislation applies only to packaged food, so freshly prepared foods and loose foods from bakeries, delicatessens and catering establishments (such as restaurants, takeaways, hotels) are not covered. However Regulation 79/112/EEC Article 12 requires EU member states to ensure that consumers buying foods in these places should be able to obtain sufficient information. The FSA is currently leading an initiative with stakeholders to find out the best way to do this, particularly for the benefit of people with food allergies and intolerances.

Back to Top

Other allergens

The new rules require fuller ingredient labelling in general, so that other food allergens not appearing on the EC list will have to be labelled, although not in every single case. Minor exceptions mainly involve products defined in EU legislation, e.g. fruit jams, jellies, fruit juices, cocoa and chocolate products, spreadable fats and sweetened chestnut puree. If a pre-packed product – for example, a dessert – contains one of those ingredients at a level of less than two per cent, then any sub-components of that ingredient will not have to be declared. As a hypothetical example, a tiny quantity of kiwi fruit would not have to be listed if it was part of a jam that made up less than two per cent of the finished product.

But the major 12 allergens will always have to be labelled no matter how small the amount in the food. But see “Allergen derivatives”, below.

Is the list final?

The European Commission has made it clear that new allergens can be added to the list in the future if there is clear evidence that they cause problems. A few that may be discussed are molluscs, kiwi fruit, chestnuts, lupin and pine nuts. Theoretically allergens can also be taken off the list, but this seems highly unlikely.

“Allergen boxes”

In addition to the requirements under legislation, some manufacturers and retailers choose voluntarily to highlight the presence of allergens in designated allergen boxes/panels. Many consumers welcome these because they speed up the shopping process. But there are pitfalls. “Allergen boxes” may encourage the consumer to take short cuts, i.e. look at the allergen box and skip the ingredient list. If a food company omits an allergen from the “allergen box” by mistake – which occasionally happens – this may prove hazardous for the allergic consumer.

It is recommended that allergen boxes are printed in the same field of vision as the ingredients panel.

Alcoholic drinks

Under the new regulations, alcoholic beverages that contain more than 1.2 per cent alcohol will have to be clear about whether any of the 12 listed allergens are present. Allergens not on the list would not have to be labelled. One possible example of an allergen not on the list that could slip through the net might be mango in a fruity alcoholic drink. However, as there is currently no requirement to list any ingredients in alcoholic drinks, the legislation is a welcome improvement.

Alcoholic drinks containing less than 1.2% alcohol and soft drinks are subject to general food labelling provisions relating to ingredients listing.

Back to Top

“Policing” the regulations

The regulations will be "policed" by local authority enforcement bodies such as environmental health officers and trading standards officers, in conjunction with public analysts, as part of their normal duties.

It will be for each local authority enforcement office to decide whether to mount any special exercises to check the labels on pre-packed foods produced after November 25. Enforcement officers are currently working with manufacturers to help them prepare for the change in the law.

Local enforcement officers will decide on a case-by-case assessment whether to prosecute manufacturers not complying with the new legislation once it comes into force. Historically enforcement officials have preferred to work hand in hand with companies to ensure that standards are improved. Given the impending legislation and forthcoming FSA guidelines on allergen control, the bar has certainly been raised on the standard of “due diligence” required by food companies.

Product alerts

The process under which food companies notify the regulators of any product alerts will not change.

Allergen derivatives

The new improved food labelling is intended to cover not only the allergens mentioned in the EC list, but also “products thereof” – in other words, ingredients derived from those allergens. Examples would be peanut oil, wheat-based glucose syrups, and gelatine derived from fish.

While the regulations were being debated, it was pointed out that some highly-processed derivatives are no longer allergenic and therefore cause no problems for people with allergies. The question was asked: Would compulsory labelling be necessary in those cases?

In response, the European Commission decided that manufacturers and trade associations should be invited to provide scientific evidence stating why any ingredient should be exempt from compulsory allergen labelling. A number of submissions were put forward by industry for consideration by the European Food Safety Authority (EFSA). Based on EFSA’s opinion on each one, the Commission made a preliminary decision on what derivatives will have to be labelled and which will be exempt.

Refined peanut oil

Refined peanut oil will now have to be labelled to indicate its peanut origin. EFSA said there was too little scientific information available to give it a clean bill of health.

This has come as a surprise to leading scientists. In 1997, researchers based in Southampton undertook tests and concluded that refined peanut oil would not cause reactions for the overwhelming majority of peanut allergic individuals, and if any reaction did occur it would almost certainly be mild.

In the Anaphylaxis Campaign’s eleven-year history, reports of allergic reactions allegedly caused by refined peanut oil have been few and far between – in fact our helpline staff cannot recall a single confirmed case. Many of the medical experts we consult agree that refined peanut oil is unlikely to present a problem. But EFSA decided that there was a chance that refined peanut oil could still contain significant amounts of allergenic protein and the resulting Commission decision is clear: refined peanut oil will have to be allergen labelled (e.g. it cannot be included in a blend of vegetable oils without stating “peanut”).

The temporary exemption list

The list below shows which derived ingredients are exempt from compulsory labelling, based on EFSA’s consideration of scientific evidence. This labelling exemption is temporary and will have to be reviewed in November 2007 on the basis of further studies, so other derivatives may be included at a later date.

Wheat-based glucose syrups including dextrose
Wheat-based maltodextrins
Glucose syrups produced from barley starch
Distillates made from cereals e.g. whisky, gin, vodka
Fully refined soybean oil and fat
Lactitol (a product of milk)
Fish gelatine when used as a carrier for vitamins, carotenoids and flavours.
Fish gelatine as a carrier for flavour
Mustard and celery seed oils
Isinglass (derived from fish) for clarifying beer.
Nuts (almonds, walnuts) extracts used as flavour in distillates, e.g. brandy
Milk, egg and fish products used in the manufacture of wine
Milk, egg and fish products used as fining agents in cider
Distillates made from whey, e.g. gin, ouzo, aquavit
Tocopherols

Further guidance

Guidance Notes on the Food Labelling (Amendment) (No 2) Regulations 2004

Draft guidance on allergen control and consumer information

Guidance on clear labelling

Enforcement

Information on exempt ingredient derivatives

 

Back to Top