Advice for SMEs on prepacked food

What does 'prepacked' mean?
'Prepacked' refers to any food put into packaging before being placed on sale, when all the following things apply:
●● the food is either fully or partly enclosed by the packaging
●● the food cannot be altered without opening or changing the packaging
●● the product is ready for sale to the public or to a catering establishment

What foods should I consider?
Although people can be allergic to a wide variety of foods and ingredients, there are certain ones which are particularly important when labelling products.

The allergen rules within the EU Food Information for Consumers Regulation (EU FIC) will change how allergens are labelled on prepacked foods sold in the UK. The new rules will apply on 13 December 2014 and will be enforced in the four UK nations (England, Scotland, Wales and Northern Ireland) by the Food Information Regulations 2014.

The EU FIC lists fourteen major allergens (see list below) which will need to be emphasised within the ingredients list.

These allergens are:
●● cereals containing gluten (such as wheat, (including spelt and khorasan), rye, barley and oats and their hybridised strains)
●● crustaceans (for example prawns, crab and lobster)
●● eggs
●● fish
●● peanuts
●● soybeans
●● milk
●● nuts (namely almonds, hazelnuts, walnuts, pecan nuts, Brazil nuts, pistachio nuts, cashew, macadamia nuts or Queensland nuts)
●● celery (including celeriac)
●● mustard
●● sesame
●● sulphur dioxide/sulphites (preservatives used in some foods and drinks) at levels above 10mg per kg or per litre
●● lupin
●● molluscs (for example clams, mussels, whelks, oysters, snails and squid)

Clear reference to the allergen
Allergens should be declared with clear reference to name of the allergenic ingredient as listed in the EU FIC Annex II. for example 'tofu (soya)' or 'tahini paste (sesame)'. If there are several ingredients or processing aids in a food which come from a single allergen, then the labelling should clearly emphasise each ingredient or processing aid concerned – for example 'skimmed milk powder, whey (milk)”¦'

The use of 'contains' type statements
The voluntary use of allergen statements such as 'Contains: milk and nuts' to repeat allergen ingredient information already given in the ingredients list will no longer be allowed. All information about allergenic ingredients must be in a single place and that is within the ingredients list.

Distance selling
The EU FIC rules on distance selling concern businesses which sell foods online and/ or by telephone/ catalogue order. If you sell prepacked foods in these ways you will need to provide the same level of information on allergens, on your website or catalogue for instance, as when food is bought from a retail environment. This is so allergen information is made available to the consumer before they decide whether or not to buy the product. The allergen information needs to be made available at the point of purchase and upon delivery.

The distance selling rules do not apply to prepacked foods sold through vending machines. Nevertheless, prepacked food manufacturers should ensure that correct allergen information appears on the food labels regardless of the method by which it is sold.

Cross-contamination
Sometimes traces of allergens can get into products unintentionally during the manufacturing process or during transport or storage. This is called 'cross-contamination'.

Ideally, you should prevent this from happening (see the
section 'How can allergen cross contamination be avoided?'). but in some circumstances this may not be possible. Some manufacturers choose to say on the label that a certain food could have got into the product unintentionally and this is called precautionary allergen labelling, for example 'may contain' type statements. This type of labelling is voluntary and is not covered by the provisions set out in the EU FIC.

Precautionary allergen labelling
If you think there is a real risk of a food product being affected by cross-contamination with an allergen you may choose to say so on the label using one of these phrases:
●● 'may contain X',
●● 'not suitable for someone with X allergy'

IMPORTANT
Precautionary allergen labelling should only be used following a thorough risk assessment when you think there is a real risk of allergen cross-contamination that cannot be eliminated.

How can allergen cross-contamination be avoided?
There are several ways cross-contamination can occur, but with careful management many of these risks can be avoided or reduced. Some of the areas to think about are described below:

Staff awareness
All staff involved in handling ingredients, equipment, utensils, packaging and final food products should be aware of the situations in which foods can be cross-contaminated by an allergenic food.

Design
The ideal approach to avoiding cross-contamination with allergenic foods is to have separate production facilities for specific products. Alternatively, you may be able to make the food containing the allergenic food on a separate day, or at the end of the day, and then thoroughly clean the production area. However, food manufacturing premises and product ranges vary greatly and these approaches are not always an option.

Storage
Where possible, allergenic raw materials should be stored away from other ingredients. One way of doing this would be to keep them in sealed plastic bins that are clearly marked or colour-coded.

Sourcing your ingredients
You should find out about the allergens present in the ingredients you use and of those used by your suppliers. Any change in supplier should be accompanied by the appropriate checks. It may be possible to manage the risk of cross-contamination by changing a particular ingredient that contains it, or by changing the supplier.

Cleaning
Very small amounts of some allergens, such as nuts, can cause severe allergic reactions in sensitive people. That is why it is so important to clean thoroughly in a way that reduces the risk of cross-contamination. Cleaning practices that are satisfactory for hygiene purposes may not be adequate for removing some allergens.

There may be times when equipment may need to be dismantled and cleaned by hand to make sure that 'hard-to clean' areas are free from allergen residues. Even dust contamination by some allergens can cause an adverse reaction. By developing and following a suitable cleaning regime, you can help minimise allergen crosscontamination and reduce the likelihood of product recalls.

Packaging
Incorrect packaging and/or labelling is often the cause of allergy-related product withdrawals or recalls. It is vital to ensure that the correct labels are applied to products and any outer packaging. This should be checked regularly, so that accurate information is provided to allergic consumers.

Packaging should be removed and/or destroyed at the end of a production run, including any packaging that may be within the wrapping machine. This is to avoid packaging mix-ups when the product is changed.

Developing new products or changing existing products
If you start making a new product, or change an existing product, this might mean you could be handling an allergenic ingredient you have not used before. This could lead to cross-contamination of other products produced in the same premises. You will need to assess the risk and decide whether precautionary allergen labelling is appropriate for both the new and existing products.

Free – from labelled foods
Some food manufacturers and retailers provide special ranges of foods made without certain common allergenic foods, such as milk, egg or cereals containing gluten.
Some manufacturers choose to exclude certain allergens from their premises. If you are going to print a claim on a label such as 'free from milk' or, 'made in peanut free
factory', it is essential that the claim is based on specific and rigorous controls.

This includes checking that all ingredients, and anything else that comes into contact with the food (such as packaging materials), do not contain the particular allergen.

There is specific legislation setting out compositional and labelling requirements for foods making a 'gluten-free' claim. See separate guidance under Food Safety.