Module 1 – Introduction
This training tool has been developed by Food Standards Scotland to help bring greater awareness about allergens in manufacturing and catering settings. The training is primarily intended for use by food business operators and local authority enforcement officers, but may also be of interest to anyone wanting to learn more about food allergies.
Successful completion of the training carries a maximum value of 3 hours (core activity) for the REHIS Continuing Professional Development (CPD) Scheme.
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
- Milk (including lactose)
- Nuts; namely almonds, hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts, macadamia (or Queensland) nuts
- Celery (including celeriac)
- 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, information about allergenic ingredients is mandatory and must be provided in written or oral formats with clear signposting to where consumers can obtain this information, when it is not provided upfront.
From the 1 October 2021 food sold prepacked for direct sale (PPDS) must include the name of the food and the ingredients list with any of the 14 allergens required to be declared by law emphasised within it, if they are ingredients of the food. These need to be in line with the legal requirements that apply to naming the food and listing ingredients. Examples of PPDS foods include sandwiches placed into packaging by the food business and sold from the same premises, wrapped deli counter goods such as cheese and meats, and boxed salads placed on a refrigerated shelf prior to sale.
Know the law
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 Retained EU Food Information for Consumers Regulation (FIC) determines the way allergen information appears on labels and on food that is prepacked, sold loose or served when eating out. The FIC sets out requirements for general food labelling and nutrition information in one piece of legislation.
Specifically for allergen requirements, the FIC applies to prepacked foods and foods sold non- prepacked, including prepacked for direct sale (PPDS). In addition, the Food Information (Scotland) Regulations 2014 provides flexibility for businesses on how they provide allergen information, in respect of non-prepacked foods, to the consumer, this information can be provided in a written format or orally as long as consumers are signposted to where they can find the information. Following amendment, the 2014 Regulations apply new labelling requirements to food sold PPDS.
To understand allergen laws, you need first to know the difference between criminal and civil law. Each of these two branches of law has its roots in ‘statute law’ which for allergens is found within Acts and Regulations, made by the government. This is also shaped and influenced by ‘common law’ that is based on the decisions of the courts in actual cases. Therefore, we can apply the following definitions:
Criminal Law is concerned with offences against the public, and those who break the criminal law are likely to be prosecuted by the state on behalf of the public.
Civil Law is concerned with rights and duties between individuals. Some of the rules apply only if one of the parties is a food business operator; this can apply to purchases from private sellers. If you suffer a loss because someone else breaks the rules, you can take that person to court.
Nowhere is consumer protection stricter than it is for food. Our present laws state food information should be such that consumers can make informed choices and make safe use of food, especially with regard to allergen information. The legislation most likely to be offended against is :
- The Food Information (Scotland) Regulations 2014
- The Food Safety Act 1990
- The Food Hygiene (Scotland) Regulations 2006
- Food (Scotland) Act 2015
You cannot automatically get compensation by reporting a criminal offence, but the law says that court can order criminals to compensate victims. The problem is that can work only if the offending business is prosecuted and found guilty, and only then if the court is prepared to use these powers.
Consumers may make claims under contributory negligence, as well as a contractual claim, where appropriate. It is also possible that a compensation order could be made where criminal proceedings are brought for the supply of unsafe goods.
However, no-one is entitled to be compensated twice for the same loss and the courts will have regard to this principle when making a decision about the total amount of compensation payable.
Nevertheless, criminal law can help you, indirectly by registering an allergen complaint. If you suspect a breach of allergen law, you should report it to your local authority, which may trigger a visit by the enforcement authorities (Environmental Health in Scotland). For allergen matters (lack of labelling/warnings and any anaphylactic reactions) you should contact your local authority and explain your concerns. It is vital this information is immediately reported as other members of the public could be at risk, even if the allergen breach is a genuine mistake by the food business.
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' foods are foods, which have been put into packaging before sale (to 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
Prepacked for direct sale (PPDS) food is any single food item for presentation to final consumers and to mass caterers, which consists of the food item and packaging which may enclose the food item completely or partially but in such a way that the contents of the food item cannot be altered and where the food item is put into packaging before being offered for sale to the customer by the same food business:
- on the same premises, or
- on the same site, or
- on other premises if the food is offered for sale from a moveable and/or temporary premises (such as marquees, market stalls, mobile sales vehicles) and the food is offered for sale by the same food business who packed it.
In this instance ‘site’ refers to a building complex such as a shopping centre or airport terminal in which the same food business operates from more than one unit within the building complex.
From 1st of October 2021 PPDS food must be labelled with the name of the food, and an ingredients list, with any allergens intentionally included in the product emphasised within the ingredients list.
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.
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 (Scotland) Regulations (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)
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.
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.
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.
In addition to the criminal regime, product liability provisions of the Consumer Protection Act 1987 create a strict liability for damage caused by defective products. This liability for defective product damage can be applied to food and drink causing allergies or intolerances.
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 product2, whether or not they are negligent.
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 their products.
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.
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.
Any person who suffers damage caused by a defective product can make a claim under the Act even if they were not the person who originally bought the product.
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.
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.
For example, food and drink without allergen information that could cause injury or harm to health will fall within this definition.
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