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Guidance on

“Free-From”

Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

In partnership with:

Guidance to manufacturers and caterers

on the appropriate use of “free-from”

claims in relation to food allergens.

1 2 3 4 5 6 7

Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 2

1 2 3 4 5 6 7

A growing number of food business operators, including manufacturers, retailers and caterers are making

“free-from” allergen or “allergen-free” claims for their food products. This document provides guidance to

food business operators on the appropriate use of “free-from” claims in relation to food allergens. Terms

such as “free-from artiﬁcial colours/preservatives” and “meat-free” are outside the scope of this guidance.

With the exception of “gluten-free”, there is no

speciﬁc UK or EU legislation covering “free-from”

claims. “Free-from” claims are therefore regulated

in accordance with the provisions of General Food

Law (Regulation (EC) No 178/2002), as amended.

A “free-from” allergen claim is an absolute claim

unless a regulatory threshold has been set

and should only be used following a rigorous

assessment of the ingredients, process and

environment.

“ The Food Standards Agency

welcomes the BRC and

FDF’s efforts to achieve

greater consistency in “free-

from” allergen claims. This

consistent approach will

make it easier for consumers

with food allergies and

intolerances to ﬁnd and

understand “free-from”

allergen information to

help them make safer food

choices.”

EXECUTIVE SUMMARYFOREWORD

To make a “free-from” claim the following principles should be followed:

The product recipe does

not use any ingredients

or compound ingredients

(including additives and

processing aids) containing

the speciﬁed “free-from”

allergen. (See sections 3 and

6 for exceptions)

The product is made in an

environment (e.g. a factory

or catering facility) strictly

following good manufacturing

practices (GMP) and allergen

management practices. (See

sections 4 and 5)

A robust sampling and

testing programme (using

a fully validated analytical

method) suitable for the

speciﬁed allergen must be in

place. (See sections 4 and 5)

The communication of

a “free-from” claim to

consumers, including

labelling, of the product must

comply with the relevant legal

requirements. For catering

in particular, since foods

will be provided in a non-

prepacked format, effective

communication practices

(between customer, front

and back of house) are

imperative.

Executive

Summary

Food Standards Agency

Chief Executive

Catherine Brown

Foreword

Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 3

1 2 3 4 5 6 7

A growing number of food business operators, including

manufacturers, retailers and caterers are making “free-

from” or “allergen-free” claims for their food products.

The food industry is committed to providing accurate

and consistent food labelling and communication.

Consumers likely to purchase “free-from” food products

fall into two groups. The ﬁrst group of consumers are

those suffering from, or caring for someone with, an

intolerance or allergy to a particular food ingredient. For

these people, the presence of even very small amounts

of the allergen can be detrimental or, in the case of food

allergy, possibly fatal. The second group comprises those

for whom the avoidance of a particular ingredient is a

lifestyle choice. Regardless of the reason for purchase

the standard of a “free-from” food must be the same.

This industry guidance provides information to food

business operators on the appropriate use of “free-from”

food allergens claims. Relevant to both prepacked and

non-prepacked foods, it provides useful guidance for

food manufacturers and caterers, particularly smaller

enterprises considering making “free-from” claims. This

guidance should not be used as an enforcement tool but

will nevertheless be helpful for enforcement bodies, who

advise food businesses on best practice.

The guidance is an overview of the key considerations

for making accurate and reliable “free-from” claims, and

the preparatory work needed to substantiate them. This

aims to ensure “free-from” is applied both accurately

and consistently across the whole food industry. Some

food companies may have additional requirements that

go beyond legal compliance.

This guidance is not an exhaustive allergen

management guide. It does not address the use of ‘may

contain’ advisory statements, or alternative statements to

“free-from” or “allergen-free”. Terms such as “free-from

artiﬁcial colours/preservatives” and “meat-free” are out

of the scope of this guidance.

From a consumer perspective “free-from” means

a complete absence of the speciﬁed allergen in

the product. However, in practice it is the scientiﬁc

demonstration on an ongoing basis that the speciﬁed

allergen in the food product is at a level that ensures

safety and takes into account the analytical limit

of detection (LoD) for a recognised and accepted

laboratory test method. Scientiﬁc research is beginning

to point towards levels of allergens (thresholds) below

which adverse reactions are improbable. However, only

those for gluten, sulphur dioxide and/ or sulphites (and

lactose for infant formula only in the United Kingdom

and European Union) have been transferred into

regulatory limits. For true allergens, the focus is on limits

for precautionary allergen labelling, rather than “free-

from”.

A “free-from” claim stating the absence of a speciﬁc

food allergen in any food, including prepacked and non-

prepacked food (e.g. food sold loose or a menu item),

must be relevant and based on a comprehensive risk

assessment accompanied by rigorous controls (which

may include analytical testing) to ensure that the claim

is valid and not misleading. It is important that good

manufacturing and/or handling practices are observed

at all times with regard to the production and serving of

these specialised foods.

1) INTRODUCTION

A “free-from” allergen claim is an

absolute claim unless a regulatory

threshold has been set.

The claim “free-from”’ should

only be used following a rigorous

assessment of the ingredients,

process and environment.

Introduction

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Does the product contain the speciﬁed allergen as a deliberate ingredient or as part of a compound ingredient?

Ingredients that are ofﬁcially exempt by EU legislation are acceptable (See section 3).

“free-from”

claim

Can make a

“free-from”

claim

Can you or your suppliers substantiate the “free-from” status of your raw materials, ingredients

(including additives and processing aids) and ﬁnished products? (See sections 4 & 5)

Is the speciﬁed allergen used in the manufacturing/catering environment

(e.g. elsewhere in a factory, or handling areas within a kitchen)?

Is the risk of cross-contamination of the speciﬁed allergen strictly controlled? (See sections 4 & 5)

Have you considered the role of a robust sampling & testing programme as part

of verifying your allergen controls? (See sections 4 & 5)

Where testing has been carried out, is the speciﬁed

allergen undetectable (or the test result below 20 ppm

if the allergen is gluten)? (See sections 4 & 5)

Yes, testing would not be

appropriate for my product

Yes, testing would be

appropriate for my product

YES

Further consideration

should be given to the

consumer information

requirement (see

section 3).

* For some gluten-containing ingredients e.g. barley malt extract, they can be used so

long as the ﬁnal product contains no more than 20 ppm gluten

For allergen management information see:

FSA Guidance on

Allergen Management

and Consumer

Information

BRC Global Standard

Food Safety Issue 7

FDE Guidance

on Food Allergen

Management for

Food Manufacturers

2) CONSIDERATIONS FOR MAKING A ‘FREE- FROM’ CLAIM?

Considerations

for making a

“free-from” claim

1 2 3 4 5 6 7

Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 5

1 2 3 4 5 6 7

Overarching legislation

With the exception of gluten, there is no speciﬁc UK or EU legislation covering “free-from” claims. “Free-from” claims are regulated in accordance with

the provisions of General Food Law, to make sure the food is safe for consumption; and the regulations on food information, to make sure product

information is not misleading and is accurately communicated.

3) LEGISLATION

General Food Law, Regulation (EC) No 178/2002,

Article 14 on Food Safety Requirements establishes that:

1. Food shall not be placed on the market if it is unsafe.

2. Food shall be deemed to be unsafe if it is considered to

be:

(a) injurious to health;

(b) unﬁt for human consumption.

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.

Food Information to Consumers, Regulation (EU) No 1169/2011,

Article 7 on Fair Information Practices establishes that:

Food information shall not be misleading, particularly:

(a) as to the characteristics of the food and, in particular, as to its nature, identity, properties,

composition…

(b) by attributing to the food effects or properties which it does not possess;

foods possess such characteristics.

Points (a) and (b) mean:

If your product is not produced to the principles laid down in this guidance and to the speciﬁed criteria,

your product is unlikely to be free from the speciﬁed allergen and therefore you should be careful not

to present it in such a way that may mislead the consumer into believing the product is free from the

speciﬁed allergen and therefore suitable for them. In this case, phrases that could have a similar meaning

to “free-from” or pictorials that can give the impression that the product is suitable for those allergic to an

allergen, should be avoided.

Point (c) means:

You cannot claim “free-from” on a product when all similar products would be “free-from”

Legislation

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Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 6

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3) LEGISLATION

contd

Speciﬁc allergen legislation

For the purpose of this guidance, gluten and, sulphur

dioxide have speciﬁc rules pertaining to them. Only

infant formula has thresholds for lactose in the United

Kingdom and European Union.

Gluten

Currently in the EU the only “free-from” claim which

is covered by speciﬁc legislation relates to gluten i.e.

“gluten-free”, “suitable for people intolerant to gluten”

or “suitable for coeliacs”. In addition to gluten, there are

other proteins within gluten-containing cereals that are

allergenic. Consequently a wheat, barley or rye allergy

should be considered differently to coeliac disease.

Since there is a legislative limit for claiming “gluten-free”,

there are exceptional circumstances where some gluten-

containing ingredients may be added to “gluten-free”

products providing the ﬁnal product has a level of gluten

below the threshold of 20 ppm. Barley malt extract is an

example of this exception.

Commission Regulation (EC) No 41/2009 established

the rules for the use of terms concerning the absence

of gluten. From this date, rules relating to gluten will be

governed by Regulation (EU) No 1169/2011 and set

out in Commission implementing Regulation (EU) No

828/2014.

This regulation is explicit in permitting only these

statements to be used to provide information

to consumers on the absence of gluten in food.

Furthermore, if you are using the statements, the

conditions and compositional requirements laid out in

the regulation must be complied with.

It is misleading to suggest that a food possesses special

characteristics when in fact all similar foods possess

such characteristics, therefore you cannot claim “gluten-

free” on water and similar products.

For more information on gluten see FDF Gluten

Labelling Guidance

For more information about claiming gluten-free

in a catering environment see Coeliac UK

Sulphur dioxide and sulphites

There is no speciﬁc legislation for “free-from” sulphur

dioxide/sulphites claims; however the Food Information

to Consumers Regulation states that the allergen must

be listed in the ingredients list and emphasised when

the total SO

for sulphur dioxide and sulphites is above

10ppm.

For more information on sulphites see BRC Allergen

Labelling Guidance (2013) Section 7

Lactose

In EU legislation, thresholds for making a “lactose-free”

claim have only been deﬁned for infant and follow-

on formula, which prescribes that the lactose content

should be ≤ 10 mg/100 kcal (2.5 mg/100 kJ). A

number of European countries have speciﬁc guidance

thresholds for lactose however a level has not been

adopted in general EU legislation.

Exempt ingredients derived from

allergenic foodstuffs

Some speciﬁc ingredients derived from allergenic

foodstuffs are not allergenic themselves and have

been ofﬁcially exempted in legislation from mandatory

labelling (See section 6 glossary under ‘EU Regulated

Allergens’ for these exemptions).

The statement “gluten-free” may only

be made where the food as sold to

the ﬁnal consumer contains no more

than 20 mg/kg of gluten

Legislation

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Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 7

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4) RISK ASSESSMENT FOR PREPACKED FOODSTUFFS

A rigorous, stringent and comprehensive risk assessment of the product, its ingredients and production is an

essential pre-requisite for proposing to apply a “free-from” label to any product. It should cover all elements from

raw materials to packing, assessing the probability of contamination by the allergen from various sources. It must be

proportionate to the increased probability of harming consumers, at whom those products are speciﬁcally targeted.

If an allergenic ingredient is present (e.g. used in other product lines), then the risk of cross-contamination from the

speciﬁed allergen must be strictly controlled with GMP or as part of the site’s HACCP system.

The scope of the risk assessment should consider the

following factors for prepacked foods:

1. Supplier quality assurance, raw material

approval controls & supply agreements

a. Can the supplier consistently demonstrate that

all raw materials are “free-from” the speciﬁed

allergen and is this covered in the terms of supply

agreement?

b. Has the raw material supplier been initially

approved and regularly audited to assess their

ability to reliably maintain the “free-from” status of

the supplied raw materials?

2. Facility design

a. Is the production facility dedicated to exclude the

allergen for which the “free-from” claim is made?

b. If the production facility is not wholly dedicated,

is it sufﬁciently physically or time segregated to

eliminate the risk of cross-contamination (change

of work clothing, storage, production scheduling,

warehousing, material ﬂows etc.)?

3. Production controls

a. Are deﬁned control measures in place at the

manufacturing facility and have these controls been

validated?

b. Are these controls periodically veriﬁed and

continuously monitored?

c. If those controls include cleaning and sanitation,

have these been demonstrated reliably to remove

the allergen(s) of concern to the required extent?

4. Product testing

a. Testing for the speciﬁed allergen in the product can

be an effective way to verify allergen management

controls. It is never a substitute for good allergen

management. The necessity to test and how to

implement a robust programme depends on a

number of considerations. These include the way

the product is produced, the type of product and

the type and form of the allergen being tested

for. Have you considered the role and purpose

of testing and whether it would effectively verify

allergen management controls?

b. Where testing is considered appropriate and

necessary, have you considered:

1. What will be tested?

2. Where in the production process will the

samples be taken?

3. What test method is most appropriate?

4. Based on risk, how frequently should samples

be tested?

5. How much a sample should be and whether

this is representative?

6. What action will be taken following results?

Have you considered positive release

procedures to assure the “free-from” status of

the product?

5. Distribution & transport practices

a. Have distribution and transport practices been

assessed in the risk assessment (considering off-site

storage or third party hauliers)?

Risk assessment

for prepacked

foodstuffs

For information on allergen management see FSA

Guidance on Allergen Management and

Consumer Information, BRC Global Standard

Food Safety Issue 7 and FDE Guidance on Food

Allergen Management for Food Manufacturers.

Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 8

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5) RISK ASSESSMENT FOR NON-PREPACKED

FOODSTUFFS AND CATERING

Special attention needs to be given to the following activities:

1. Catering environment

a. Are there segregated areas in the kitchen/

preparation environment or scheduled production

times where allergens can be controlled or absent?

b. Can key equipment be segregated or made bespoke

for making allergen-free recipes (e.g. colour coding)?

c. Consider separate equipment such as mixers or

toasters.

d. Consider storage environment of ingredients and

ﬁnished dishes.

e. Is there an effective cleaning regime in place that

is validated and veriﬁed to consistently remove the

speciﬁed allergen?

f. Consider change of work clothing and hygiene

practices.

2. Ingredients

a. Have you considered the allergen status of all

ingredients in your recipe?

b. Ingredient suppliers may only tell you what allergens

are in a product. Note this is NOT the same as an

ingredient being “free-from” a speciﬁc allergen.

“Free-from” status needs to be assured by you or

your supplier.

c. Ideally, select products which are already

manufactured to meet “free-from” criteria.

3. Staff training

a. Have all staff had suitable allergen training and

do they understand the importance of cross

contamination controls and their relevance to

allergenic consumers?

b. Do you have a member of staff with sufﬁcient

knowledge to validate and audit the controls?

c. Is there effective communication between the

customer and relevant staff?

a) The incoming goods are already marketed by a manufacturer

as “free-from” and are sold in their original packaging or;

b) A full risk assessment has been completed for the

production of a “free-from” meal, speciﬁc to their kitchen,

that demonstrates they are capable of assuring “free-from”

status for the speciﬁed allergen.

Caterers should only make a “free-from” claim if:

For more information about claiming gluten-free in a catering environment see

Coeliac UK accreditation and training resources.

The risk assessment for non-prepacked food should generally consider the same factors for prepacked

(section 4). For catering and in-store production there needs to be speciﬁc considerations for the kitchen

and preparation environment and staff communication. Foods provided in a non-prepacked format will

require effective communication practices between the staff (preparation and sales or front and back of

house) and customers.

If in doubt these products should not make a “free-from” claim or any claim consumers would understand

as “free-from”.

Risk assessment for

non-prepacked food-

stuffs and catering

Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 9

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6) GLOSSARY

Glossary

Compound ingredient

An ingredient that is itself the product of

more than one ingredient.

(Regulation (EU) No 1169/2011)

Cross-contamination

The unintentional presence of another

substance in the ﬁnal product. In the

context of allergens, it usually refers to

trace amounts of allergenic foods which,

whilst not of themselves unwholesome,

may be problematic for those suffering

from particular allergies. (FSA Guidance

on Allergen Management, 2006)

EU regulated allergens

The 14 substances listed in Annex II

of the Food Information to Consumers

Regulation (EU) No 1169/2011 (as

amended by Commission Delegated

Regulation No 78/2014) recognised

across Europe as the most common

ingredients or processing aids causing

food allergies and intolerances:

1. Cereals containing gluten namely wheat

(such as spelt and Khorasan wheat), rye,

barley, oats and their hybridised strains and

products thereof, except:

a) wheat based glucose syrups

including dextrose

b) wheat based maltodextrins

c) glucose syrups based on barley

d) cereals used for making alcoholic

distillates including ethyl alcohol of

agricultural origin

2. Crustaceans and products thereof

3. Egg and products thereof

4. Fish and products thereof, except:

a) ﬁsh gelatine used as carrier for

vitamin or carotenoid preparations

b) ﬁsh gelatine or Isinglass used as a

ﬁning agent in beer and wine

5. Peanuts and products thereof

6. Soybeans and products thereof, except:

a) fully reﬁned soybean oil and fat

b) natural mixed tocopherols (E306),

natural D-alphatocopherols, natural

D-alpha tocopherol acetate and

natural D-alpha tocopherol succinate

from soybean sources

c) vegetable oils derived phytosterols

and phytosterol esters from soybean

sources

d) plant stanol ester produced from

vegetable oil sterols from soybean

sources

7. Milk and products thereof (including

lactose), except:

a) whey used for making alcoholic

distillates including ethyl alcohol of

agricultural origin

b) lactitol

8. Nuts (namely almond, hazelnut, walnut,

cashew, pecan nut, Brazil nut, pistachio nut

and Macadamia nut (Queensland nut)) and

products thereof, except for nuts used for

making alcoholic distillates including ethyl

alcohol of agricultural origin

9. Celery and products thereof

10. Mustard and products thereof

11. Sesame seeds and products thereof

12. Sulphur dioxide and/ or sulphites at

concentrations of more than 10mg/kg

or 10mg/litre in terms of the total SO

which are to be calculated for products

as proposed ready for consumption or as

reconstituted according to the instructions

of the manufacturers

13. Lupin and products thereof

14. Molluscs and products thereof

Food allergen

This is the substance in a food that can

cause an allergic reaction. Allergens are

normally proteins and in some people,

the immune system thinks allergens

are foreign or dangerous. The immune

response to these allergenic proteins is

what leads to allergic reactions. The EU

states 14 speciﬁc foods which are of

public health importance (most potent and

prevalent food allergens in Europe) which

are listed in Annex II to the EU FIC. (FSA

Allergens Technical Guidance, 2015)

Food allergy

An adverse reaction to a food that

involves the immune system and can be

a potentially life threatening condition.

Symptoms can appear within minutes, or

up to several hours after a person has

eaten a food they are allergic to. There

is no cure for food allergy. An allergic

individual must avoid the food which

makes them ill. (FSA Allergens Technical

Guidance, 2015)

Food intolerance

Most food intolerances do not involve the

immune system and are generally not

life-threatening. However, they can make

someone feel very ill or affect their long-

term health. Examples of food intolerance

include lactose and gluten intolerance.

(FSA Allergens Technical Guidance,

2015)

glossary contd...

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Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 10

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6) GLOSSARY

Glossary

Free-from

Foods made without certain common

allergenic ingredients, such as milk,

egg or cereals containing gluten in a

controlled environment which have been

scientiﬁcally demonstrated to be below

the analytical limit of detection of a testing

method. (FSA Allergy: What to consider

when labelling food, 2015)

Gluten

A protein fraction from wheat, rye, barley,

oats or their crossbred varieties and

derivatives thereof, to which some persons

are intolerant and which is insoluble in

water and 0,5 M sodium chloride solution.

(Regulation (EU) No 828/2014)

Gluten-free

The statement “gluten-free” may only

be made where the food as sold to the

ﬁnal consumer contains no more than 20

mg/kg of gluten. (Regulation (EU) No

828/2014)

Good manufacturing practices

(GMP)

Implemented procedures and practices

undertaken using best practice principles.

(BRC Global Standard Food Safety

Issue 7)

Hazard analysis and critical

control points (HACCP)

A system that identiﬁes, evaluates and

controls hazards which are signiﬁcant for

food safety. (BRC Global Standard Food

Safety Issue 7)

Lactose

A disaccharide of glucose and galactose

and the primary sugar of mammalian milk.

Lactose intolerance is not to be confused

with intolerance or allergy to (cow’s) milk

proteins. (EFSA Lactose Opinion, 2010)

Limit of detection

The smallest measure that can be

detected with reasonable certainty for

a given analytical procedure. (IUPAC

Goldbook online)

Positive release

Ensuring a product or material is of an

acceptable standard prior to release for

use. (BRC Global Standard Food Safety

Issue 7)

ppm

Parts per million

Physical segregation

To keep one food or food ingredient

separate from another through managing

space. The segregated area should be

designed to a high standard of hygiene,

where practices relating to personnel,

ingredients, equipment, packaging and

environment aim to prevent product

contamination. (BRC Global Standard

Food Safety Issue 7)

Precautionary allergen

labelling

Voluntary advisory labelling on possible

cross-contamination with allergens. (FSA

Guidance on Allergen Management,

2006)

Prerequisite

The basic environmental and operational

conditions in a food business that are

necessary for the production of safe food.

These control generic hazards covering

good manufacturing practice and good

hygienic practice and shall be considered

within the HACCP study. (BRC Global

Standard Food Safety Issue 7)

Risk assessment

The identiﬁcation, evaluation and

estimation of the levels of risk involved

in a process to determine an appropriate

control process. (BRC Global Standard

Food Safety Issue 7)

Threshold

The term refers to the amount needed

to elicit an allergic reaction in a sensitive

individual within a given population. (FSA

Guidance on Allergen Management,

2006)

Validation

Obtaining evidence to demonstrate the

effectiveness that a control or measure,

if properly implemented, is capable of

delivering the speciﬁed outcome. (BRC

Global Standard Food Safety Issue 7)

Veriﬁcation

The application of methods, procedures,

tests and other evaluations, in addition to

monitoring, to determine whether a control

or measure is or has been operating as

intended. (BRC Global Standard Food

Safety Issue 7)

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Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 11

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7) REFERENCES

Regulation (EC) No 178/2002 of

the European Parliament and of

the Council of 28 January 2002

laying down the general principles

and requirements of food law,

establishing the European Food

Safety Authority and laying down

procedures in matters of food safety,

as amended, applied from 21 February

2002.

Commission Directive 2006/141/

EC of 22 December 2006 on infant

formulae and follow-on formulae

and amending Directive 1999/21/EC,

repealed from end of 2015 by Regulation

(EU) No 609/2013 of the European

Parliament and of the Council of 12 June

2013 on food intended for infants and

young children.

Commission Regulation (EC)

No 41/2009 of 20 January 2009

concerning the composition and

labelling of foodstuffs suitable for

people intolerant to gluten, repealed

from 20 July 2016.

Regulation (EU) No 1169/2011 of the

European Parliament and of the

Council of 25 October 2011 on the

provision of food information to

consumers, as amended, applied from

13 December 2014.

Commission Implementing

Regulation (EU) No 828/2014 of

30 July 2014 on the requirements

for the provision of information

to consumers on the absence or

reduced presence of gluten in food,

applies from 20 July 2016.

Commission Delegated Regulation

(EU) No 78/2014 of 22 November

2013 amending Annexes II and III

to Regulation (EU) No 1169/2011

of the European Parliament and

of the Council on the provision of

food information to consumers,

as regards certain cereals causing

allergies or intolerances, applied from

19 February 2014.

EFSA Scientiﬁc Opinion on lactose

thresholds in lactose intolerance

and galactosaemia. (EFSA Journal

2010;8(9):1777)

Opinion

BRC Guidance on Allergen Labelling

and the Requirements in Regulation

1169/2011 (in partnership with FDF)

(March 2013)

Guidance Addendum

FDE Guidance on Food

Allergen Management for Food

Manufacturers (January 2013)

Guidance

FDF Gluten Labelling Best Practice:

How to Label Pre-Packed Foods

Which Include Cereals Containing

Gluten (in partnership with BRC,

Anaphylaxis Campaign and Coeliac

UK (June 2015)

Guidance

FSA Technical Guidance Food

Allergen Labelling and Information

Requirements under the EU

Food Information for Consumers

Regulation No. 1169/2011 (April

2015)

Guidance

FSA Guidance on Allergen

Management and Consumer

Information (2006)

Guidance

FSA Guidance on Composition and

Labelling of Foodstuffs Suitable for

People Intolerant to Gluten (January

2012)

Guidance

FSA Allergy: What to consider when

labelling food (2015)

Guidance

FSA The impact of Food Allergy

Training

International Union of Pure and

Applied Chemistry (IUPAC)

Goldbook Online

BRC Global Standard Food Safety

Issue 7 and Understanding Allergen

Management (2015)

Standard

Coeliac UK

Accreditation Training

References

Guidance on “free-from” Allergen Claims

Risk assessment for

non-prepacked food-

stuffs and cateringForeword

Executive

Summary Introduction

Considerations

for making a

“free-from” claim Legislation

Risk assessment

for prepacked

foodstuffs Glossary References

Page 12

1 2 3 4 5 6 7

The Food and Drink Federation is the voice of the UK food and drink industry, the

largest manufacturing sector in the country. Our sector directly employs around

400,000 people and accounts for almost 16% of the UK’s total manufacturing

sector by value. We are an essential partner to UK farmers, buying the bulk of

what they produce.

Our membership comprises manufacturers of all sizes as well as trade

associations dealing with speciﬁc sectors of the industry. In representing the

interests of our members, we focus on the following core priorities:

• Food Safety and Science

• Health and Wellbeing

• Sustainability

• Competitiveness

Retail is an exciting, diverse and dynamic industry undergoing

transformational change. The BRC is at the forefront – enhancing,

assisting, informing and shaping. Our mission is to make a positive

difference to the industry and to the customers it serves. Our broad

range of stakeholders demonstrates how retailing touches almost every

aspect of our culture.

The BRC leads the industry and works with our members to shape

debates and inﬂuence issues and opportunities that will help make that

positive difference. We care about the careers of people who work in

our industry, the communities retail touches and competitiveness as a

fundamental principle of the industry’s success – our 3Cs.

Food and Drink Federation

6 Catherine Street

London

WC2B 5JJ

Tel: 020 7836 2460

Email: generalenquiries@fdf.org.uk

Twitter: @Foodanddrinkfed

www.fdf.org.uk

British Retail Consortium

21 Dartmouth Street

London

SW1H 9BP

Tel: 020 7854 8900

Email: info@brc.org.uk

Twitter: @the_brc

www.brc.org.uk

ABOUT FDF ABOUT BRC

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