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«Questions and Answers on the EU Food Information for Consumers Regulation allergen provisions These questions and answers (Q&As) have been compiled ...»

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Questions and Answers on the EU Food Information

for Consumers Regulation allergen provisions

These questions and answers (Q&As) have been compiled to help food businesses

understand the new allergen rules and how to reach compliance.

It supplements the Food Standard Agency’s technical guidance on the allergen

provisions within the EU Food Information for Consumers Regulation

(No.1169/2011) (EU FIC) and Food Information Regulations 2014 (FIR).

You can find the technical guidance here: www.food.gov.uk/allergen-resources Background From 13 December 2014, all food businesses will need to provide information about allergenic ingredients used in food sold or provided by them. There are 14 major allergens

which need to be declared*. These are:

 Cereals containing gluten (you need to declare the presence of wheat (such as spelt and Khorasan), rye, barley, oats and their hybridised strains  Crustaceans  Eggs which includes hen, duck, goose and ostrich etc.

 Fish  Peanuts  Soybeans  Milk which includes cows, goats, sheep etc.

 Nuts (you need to declare the presence of almond, hazelnut, walnut, cashew, pecan nut, Brazil nut, pistachio nut and macadamia nut (also known as Queensland nut))  Celery (including celery leaves, seeds and celeriac)  Mustard  Sesame  Sulphur dioxide or sulphites (where added and is above 10mg/kg in the finished product. Often found in dried fruit and wine)  Lupin  Molluscs EU FIC outlines the new requirements for businesses which provide food prepacked and non-prepacked (loose) in a range of settings. In the UK, the FIR also gives powers to authorised food officers in enforcing these rules.

*Some food ingredients derived from these foods are exempt from allergen declaration.

Further details can be found in this Q&A.

Introduction These Q&As will be useful to any food business operator supplying food to the public, mass caterers, or intended to be sold to the public and mass caterers. This

includes:

 producers, manufacturers, packers, distributors, wholesalers, retailers and caterers involved in prepacked and non-prepacked foods  food businesses providing non-prepacked foods (including prepacked foods for direct sale) such as restaurants, cafés, fast food outlets, delicatessens, butchers, bakeries, online food delivery aggregators and institutional caterers (eg. in schools, hospitals and prisons) and other caterers (including childminders who provide food)  catering services provided on transport (eg. airplanes, trains and ships) leaving from any EU Member State.

They are also relevant to local authority enforcement officers who are responsible for enforcing the allergen rules.

It will cover:

 allergen provisions, national provisions and enforcement details found within EU FIC and FIR  related areas outside the scope of the allergen provisions (e.g. cross contamination)  general scientific detail on food allergies and intolerances (see Annex of this document) The new allergen requirements EU FIC and the allergen provisions in general Does EU FIC only cover allergens?

No. The legislation covers a number of areas in food labelling such as nutrition information, quantity labelling, country of origin labelling, and the labelling of vegetable oil, nanomaterials (tiny food components with at least one measurement below 100 nano metres) and alcoholic drinks.

Does EU FIC apply to food only?

No, the legal definition of food according to EU legislation includes drink which is also covered.

Is the FSA responsible for all areas of EU FIC in the UK?

In England, policy responsibility for EU FIC is split across three Government departments:

Defra is responsible for general labelling, Department of Health for nutrition and FSA for food allergens.

In Wales, policy responsibility for general labelling and food safety labelling such as food allergens lies with the FSA Wales.

In Scotland and Northern Ireland, policy responsibility for general labelling, nutrition and allergens lies with FSA Scotland and FSA Northern Ireland respectively.

Local authorities have responsibility in the UK for the enforcement of this legislation, including the allergen rules.

Are the new allergen rules different to those covered in the EU General Food Labelling Regulation and other legislation?

Yes, it introduces a new requirement for food business operators providing or selling nonprepacked foods (including prepacked foods for direct sale) to provide information about the allergenic ingredients used in these foods. This includes restaurants, cafés, bars, school meals and foods from bakeries and delicatessen counters for example.

For prepacked foods, EU FIC retains existing allergen labelling rules, and introduces a new requirement for allergens to be emphasised within the ingredients list.

How is the Food Information Regulations 2014 different to EU FIC?

The Food Information Regulations 2014 (FIR), in England, Wales, Scotland and Northern Ireland, is UK legislation which enables enforcement officers to take action against businesses who fail to comply with the allergen rules. It includes details on national provisions, how local authorities enforce the rules and what steps they can take to help business comply when they fail to follow these rules.





Explaining the changes Why are the allergen rules changing?

The rules are changing to provide greater consumer protection. Food allergies and

intolerance affect many people across Europe. In the UK alone:

 around 10 people die from allergic reactions to food every year due to undeclared allergenic ingredients  an estimated 1-2% of adults and 5-8% of children have a food allergy (around 2 million people within the population)  in addition to those with allergies, there are many people with food intolerances (eg.

1 in 100 people who suffer from coeliac disease) There is also no cure for food allergies which means that the only way to manage the condition is to avoid the foods that make you ill. EU FIC’s allergen provisions require food businesses to provide accessible, clear and accurate information about allergenic ingredients in prepacked and non-prepacked foods to enable consumers to make safe and informed food choices.

How will the rules make a positive difference to consumers?

The introduction of the wider new rules will enable safer food choices being made for a greater variety of foods, which consumers buy or eat, across the UK and Europe. It will raise the importance of food allergies and intolerances with food businesses.

Have costs to food manufacturers resulting from the change been considered?

We appreciate that there will be some additional costs to food manufacturers. These include familiarisation and transition outlays associated with the way allergen information should be displayed on food labels. The three-year transition period allowed food businesses to make changes during the natural cycle of updating and modifying packaging to help keep costs down.

What about the cost to food businesses (especially small and medium ones) which are providing non-prepacked foods?

There will undoubtedly be an initial investment of time to collect and record the allergen information, for food business. Once that is done, we expect that maintenance of this information to ensure its accuracy would be straightforward and less time intensive. We have created a bank of resources to help food businesses comply. These include an allergen menu matrix, recipe cards, signage, Think Allergy posters in various languages among other products. You can find these at: www.food.gov.uk/allergen-resources In order to familiarise themselves with the new requirements, we suggest food businesses read our technical guidance on the new allergy provisions. As part of our public consultation on the guidance, there was general consensus that it would take food business operators about two hours to read and familiarise with the requirements as covered by the guidance.

The FSA’s technical guidance on the allergens provision is available at:

www.food.gov.uk/sites/default/files/food-allergen-labelling-technical-guidance.pdf The FSA have also produced an advisory leaflet for small and medium businesses on the

non-prepacked (loose) food allergen rules, available at:

www.food.gov.uk/sites/default/files/multimedia/pdfs/publication/loosefoodsleaflet.pdf In addition, the FSA offers free online training to help food businesses learn about the

allergen rules, available at:

http://allergytraining.food.gov.uk/english/ Scope of EU FIC Are there any food businesses, providing non-prepacked food, exempt from the rules?

No. The rules cover all businesses providing non-prepacked foods (including foods prepacked for direct sale). This also includes contract caterers, schools, hospitals and childminders who provide food.

What are ‘foods prepacked for direct sale’ that the regulation refers to?

These are foods packed on the same premises from which they are being sold. For such

products, one or both of the following can apply:

 the food is made on site (eg. meat pies and sandwiches) and are sold from the premises where they are made  the customer is able to speak with the person who packed the product to ask about allergenic ingredients This does not include food products made at a central site for sale at retail outlets in other geographical locations for example.

Do the rules apply to private individuals selling or offering food at local community/ charity events?

No, they don’t. Private individuals who occasionally provide food at community/ charity events are exempt from the allergen information requirements. However, if the individual is providing food as a food business operator at such events, the necessary allergen information should be provided.

What about situations where private individuals bring food to share in places like schools and hospitals?

Institutions such as schools and hospitals, which provide meals, fall within the scope of the regulation. However, the rules do not apply where food is brought in by friends and family.

Where many businesses are involved in a supply food chain, who has overall responsibility for the allergen information?

The food business operator (FBO), whose name the food is marketed under, is responsible for ensuring that the allergen information is compliant with EU FIC. However, Article 1 of EU FIC also explains that food businesses which are not directly supplying products to the final consumer / user need to ensure that their customers have sufficient information to enable them to comply with the rules.

Where business to business transactions are involved, all food businesses in the chain have a responsibility to communicate the presence and accuracy of allergen information on the food they provide. If products are sourced from suppliers, the food business should ensure they are aware of any allergens that are present in these products.

For prepacked food, the allergen information should already be provided on the labelling. For non-prepacked food, food suppliers should provide the necessary information to enable the mandatory allergen information being supplied to the final consumer. This requires all FBOs in the food chain to work closely together to achieve this.

Are precautionary allergen warning statements (eg. ‘May Contain Nuts’) covered by the rules?

No. Precautionary allergen statements or ‘May Contain’ type statements, which food manufacturers voluntarily use to communicate allergen cross-contamination risks, do not fall within the scope of EU FIC.

Precautionary allergen labelling is voluntary and used to communicate the real risk of any allergens present due to cross contamination. ‘May Contain’ type statements are still permitted and its use and basis for application has not been affected.

Why does EU FIC not cover precautionary allergen labelling and allergen cross-contamination?

EU FIC covers the intentional or deliberate presence of any one of the 14 allergens when added in foods. Nevertheless, Article 36 provides scope for introducing specific rules to inform the application of precautionary allergen labelling in future.

Declaration of the 14 allergens Why are there 14 allergens?

The 14 allergens are recognised as the most common and potent causes of food allergies and intolerances across Europe. This follows detailed EU level discussions and scientific evidence presented by the European Food Safety Authority (EFSA). For more information

about EFSA’s work in this area please see:

www.efsa.europa.eu/en/panels/nda.htm?wtrl=01 What are the 14 allergens which should be declared?

The allergens, as listed in EU FIC’s Annex II, are:

 Cereals containing gluten: namely wheat (including specific varieties like spelt and Khorasan), rye, barley, oats and their hybridised strains) and products thereof  Crustaceans and products thereof (for example prawns, lobster, crabs and crayfish)  Egg and products thereof  Fish and products thereof  Peanut and products thereof  Soybeans and products thereof  Milk and products thereof (including lactose)  Nuts: namely almond, hazelnut, walnut, cashew, pecan nut, Brazil nut, pistachio nut and Macadamia nut (Queensland nut) and products thereof  Celery and products thereof  Mustard and products thereof  Sesame seeds and products thereof  Sulphur dioxide and sulphites (at concentrations of more than 10mg/kg or 10mg/L in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers)  Lupin and products thereof  Molluscs and products thereof (for example clams, oysters, scallops, snails and squid) When should the 14 allergens be declared?

If there is a food product which contains or uses an ingredient or processing aid (such as enzymes added to make cheese or wheat flour used to roll out dough made from rye flour) derived from one of the substances or products listed in the Annex II, it will need to be declared by the food business.

This means that if a food business provides:



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