FOOD STANDARDS AGENCY - Food Allergy Training Course

Allergen rules
Allergenic ingredients must be indicated in list of ingredients with clear reference to name of the substance or
product as listed in Annex II of the EU Food Information for Consumers Regulation No.1169/2011 and
Commission Delegated Regulation (EU) No. 78/2014 amending Annex II to Regulation (EU) No 1169/2011.
Annex II outlines the 14 allergens (and products thereof) that must be labelled or indicated as being present in
foods and are:
 Cereals containing gluten, namely: wheat (such as spelt and khorasan wheat), rye, barley, oats
 Crustaceans for example prawns, crabs, lobster, crayfish
 Eggs
 Fish
 Peanuts
 Soybeans
 Milk (including lactose)
 Nuts; namely almonds, hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts,
macadamia (or Queensland) nuts
 Celery (including celeriac)
 Mustard
 Sesame
 Sulphur dioxide/sulphites, where added and at a level above 10mg/kg or 10mg/L in the finished
product. This can be used as a preservative in dried fruit
 Lupin, which includes lupin seeds and flour and can be found in types of bread, pastries and
pasta
 Molluscs like, mussels, whelks, oysters, snails and squid
The allergenic ingredients need to be emphasised using a typeset that clearly distinguishes it from the rest of
the ingredients, for example by means of the font, style or background colour. Food businesses can choose
what method they want to use to emphasise the 14 allergens on their product label.
When a product is not required to provide an ingredients list such as a bottle of wine, any allergenic ingredients
within this product must be declared using a ‘contains’ statement followed by the name of the allergenic
substance as listed in Annex II and Commission Delegated Regulation (EU) No. 78/2014 amending Annex II to
Regulation (EU) No 1169/2011
Where several ingredients or processing aids in a food originates from a single allergenic ingredient, the
labelling should make this clear for each ingredient or processing aid concerned. For example,
skimmed milk powder, whey (milk), lactose (milk)
Where the name of the food (such as a box of eggs or bag of peanuts) clearly refers to the allergenic
ingredients concerned, there is no need for a separate declaration of the allergenic food
Where foods are offered to sale to the final consumer or to mass caterers without packaging, or where foods
are packed on the sales premises at the consumer’s request or prepacked for direct sale, information about
allergenic ingredients is mandatory and must be provided
Allergen information must be provided for non-prepacked foods in written or oral formats with clear signposting
to where consumers can obtain this information, when it is not provided upfront

Know the law

There are both criminal and civil legal regimes that are relevant to the sale of foods containing allergens and
the provision of 'allergen-free' lists. It is essential that these are given careful consideration.

The following is a brief outline of the main provisions to assist manufacturers in identifying their legal
obligations. It also suggests the appropriate courses of action in respect of good manufacturing practice and
the provision of information for consumers. Manufacturers should seek their own legal advice as appropriate.
The EU Food Information for Consumers Regulation (EU FIC) changes the way allergen information appears
on labels and on food that is prepacked, sold loose or served when eating out. The EU FIC brings general and
nutrition labelling rules together and simplifies and consolidates existing labelling legislation into a single
framework.

The regulation builds on the previous allergen labelling provisions for prepacked foods as well as extending the
provision of allergen information to foods sold non-prepacked or prepacked for direct sale.

Definitions
Mass caterer / Catering establishment
This could be a restaurant, canteen, club, public house, school, hospital or similar establishment (including a
vehicle or a fixed or mobile stall) for example where, in the course of a business, food is prepared to be ready
for consumption by the final consumer.

'Prepacked food'
'Prepacked' foods are foods, which have been put into packaging before sale (final consumer or to mass
caterers), where there is no opportunity for direct communication between producer and customer, and the
contents cannot be altered without opening or changing the packaging. For example, most pre-packed foods
sold in supermarkets will fall under this definition, such as tinned food, ready-made meals or frozen food
products.

'Prepacked for direct sale'

Generally, means those foods that have been packed on the same premises as they are being sold. In these
situations, it is thought that the customer would be able to speak to the person who made/packed the foods to
ask about ingredients and so these foods do not generally have to be labelled with ingredients by law. Foods
which could fall under this category are meat pies made on site, and sandwiches made and sold prepacked or
not pre-packed from the premises in which they were made.

'Non-prepacked'(Loose foods)
Foods which are non-prepacked can be often described as foods sold loose. In a retail environment this would
apply to any foods which are sold loose from a delicatessen counter (for example, cold meats, cheeses,
quiches, pies and dips), fresh pizza, fish, salad bars, bread sold in bakery shops etc. In a catering environment
this would apply to foods ready for consumption such as meals served in a restaurant, café or purchased from
a takeaway.

Criminal law
The Regulations implementing Directive 2003/89/EC and Directive 2007/68/EC requirements for the labelling of
allergenic foods, or their derivatives, used as ingredients in pre-packed foods were revoked on 13 December
2014.

EU Food Information for Consumers Regulation No. 1169/2011 (EU FIC) repeals Directive 2000/13/EC as
amended by Directives 2003/89/EC 2007/68/EC. The EU FIC is enforced in England, Scotland, Wales and
Northern Ireland by the Food Information Regulations 2014 (each country has its own version which is the
same in most respects). These provide for the declaration of the specified allergenic foods when they are used
as ingredients in prepacked, non-prepacked and prepacked for direct sale. The Food Information Regulation
(FIR) 2014 revoked regulations implementing the Food Labelling (Declaration of Allergens) Regulations 2008
and provides the powers to requirements contained in the EU Food Information for Consumers Regulation. It is
the duty of each food authority within its area and each port health authority within its district to enforce the
regulation.
Article 14 of EC Regulation 178/2002 (General Food Law Regulation)

This provision applied from 1/1/2005. Paragraph (1) prohibits unsafe food from being placed on the market. For
the purposes of the Regulation, placing on the market means the holding of food for the purpose of sale,
including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution,
and other forms of transfer themselves. Food is deemed to be unsafe if it is injurious to health or unfit for
human consumption, and Article 14 contains provisions for determining whether food falls within this
prohibition.
Paragraphs (3) and (4) of this article are particularly relevant:
"(3). In determining whether any food is unsafe, regard shall be had:
a)to the normal conditions of use of the food by the consumer and at each stage of production, processing and
distribution, and
b)to the information provided to the consumer, including information on the label, or other information generally
available to the consumer concerning the avoidance of specific adverse health effects from a particular food or
category of foods."
"(4) In determining whether any food is injurious to health, regard shall be had:
a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a
person consuming it, but also on subsequent generations;
b) to the probable cumulative toxic effects;
c) to the particular health sensitivities of a specific category of consumers where the food is intended for that
category of consumers."

Various criteria, have to be considered, including information provided to the consumer concerning the
avoidance of specific adverse health effects from a particular food or category of foods (see Article 14(3)(b));
and also the particular health sensitivities of a specific category of consumers where the food is specifically
intended for that category of persons (see Article 14(4)(c)). In the context of allergy, this refers particularly to
foods sold as free from certain allergens or suitable for people with particular health needs (for example, those
people who have coeliac disease). (See section 3.3.2)

Article 16 of EC Regulation 178/2002 (General Food Law Regulation)

This article requires that the labelling, advertising and presentation of food, including the information made
available, should not mislead consumers.

These articles are enforced in Great Britain by means of the General Food Regulations No 3279/2004.
Equivalent regulations apply in Northern Ireland1.
Section 14 of the Food Safety Act 1990 (Article 13 of the Food Safety (Northern Ireland) Order 1991)

This provision makes it an offence for anyone to sell to the purchasers prejudice, any food which is not of the
nature, substance or quality demanded by the purchaser.
Section 15 of the Food Safety Act 1990 (Article 14 of the Food Safety (Northern Ireland) Order 1991)

This provision makes it an offence to falsely describe or present food. More particularly, it is an offence for food
labelling to be false or likely to mislead as to the nature, substance or quality of the food. The section also
applies in relation to the advertising and presentation of food.
It remains widely accepted that individuals who have allergic reactions to certain foods should take care to
scrutinise food labels more closely than an average consumer does.

Enforcement

It should be noted that criminal legislation is enforced through local enforcement authorities. It would be
prudent for manufacturers to advise their local officers of the management measures they have adopted, to
obtain advice on the adequacy of the measures, and to increase the likelihood of the acceptability of such
measures as constituting a defence of due diligence, should the need arise. Ultimately, however, in the event of
a prosecution the adequacy of a manufacturer's due diligence procedures would be a matter for the Courts.

Civil law
In addition to the criminal regime, liability can also arise at civil law under the product liability provisions of the
Consumer Protection Act 1987 or under the common law of negligence.
Consumer Protection Act 1987
Under the Consumer Protection Act 1987 (CPA), a manufacturer can be held liable to consumers for injury,
loss or damage suffered as a result of them supplying a defective product 2, whether or not they are negligent.
Negligence

In negligence, it is well established that manufacturers owe a duty of care to their consumers to supply safe
products. In order to discharge their duty satisfactorily they are required to take all the steps a reasonable
manufacturer in the same circumstances would have taken to ensure the safety of his products.

Labelling implications

A manufacturer's position under the Consumer Protection Act 1987 for supplying a defective product and under
the rules of negligence will vary in different circumstances and may or may not be affected by advisory notices.

Unintentional presence

Allergens that are, or may be, unintentionally present in products will not, of course, be labelled as ingredients.
Under the Consumer Protection Act 1987, a product unintentionally cross-contaminated with an allergen may
be defective especially when the presence is outside the specification. The question then arises as to whether
or not advice about the possible presence of the allergen will effectively cure such a defect. The ability of such
advice to cure such a defect may depend on a number of factors (for example the size and prominence of the
advisory statement and consumer expectation as to the nature of the product) and would be decided on a case
by case basis.

A manufacturer may be deemed to be negligent either in the manufacture of the product or in its presentation.
Where good manufacturing practices or other due diligence measures are in place, they will go a long way to
rebutting negligence in manufacture. Nonetheless, a manufacturer could be negligent in respect of their
labelling if they fail to give advice in a situation where, despite the operation of good manufacturing practices
(GMP), the manufacturer should have been aware of a significant likelihood of product contamination.
In practice, it will become more difficult for a manufacturer who does not provide the relevant advice to
establish that their product is not defective under the Consumer Protection Act 1987, or that they are not
negligent in the labelling of their product where a significant number of other suppliers are providing advice on
the potential presence of allergens in their products.

Consumer redress

In civil law, individual consumers have the right to bring actions against manufacturers directly for
compensation in respect of any loss, damage or injury they have suffered.
Manufacturers who employ good manufacturing practices reduce the risk of cross-contamination of their food
products by any allergens, and should therefore minimise their legal liability in respect of on-pack claims or
other indications of freedom from specified allergens. However, the provision of an incorrect list could bring
such manufacturers within the food safety and consumer protection controls detailed above, and it is thus a
matter for individual companies' commercial judgement to decide whether or not such claims should be made
or lists compiled. Such advice should not be provided unless supported by an appropriately documented quality
system.

1
 General Food Regulations (Northern Ireland) 2004 SR. No. 505/2004
2
 A defective product is defined as one where the safety of the product is not such as persons generally are
entitled to expect. Criteria include any instructions or warnings given with the product and what might
reasonably be expected to be done with it.