‘May Contain & Free From’
Navigating Allergen Label
Claims
Simon Flanagan
Senior Consultant Food Safety and Allergens
Customer Focused, Science Driven, Results Led
Overview
• Allergen labelling requirements of FIC (1169/2011)
• ‘Free-from’ claims – what do these really mean?
• The thresholds dilemma & action levels
• Latest on precautionary labelling (may-contain)
• What must I, and what can I put on the label?
Allergen labelling
requirements of FIC
Customer Focused, Science Driven, Results Led
EU Food Information for
Consumers 1169/2011
• Regulation 1169/2011 comes into force 13th Dec. 2014
• Establishes a legal framework in the European Union with
regard to information related to foodstuffs provided to
consumers by food business operators at all stages of the
food chain
Food intended for the final consumer
Foods delivered by mass caterers
Foods intended for supply to mass caterers
Also applies to catering services provided by transport leaving from
the EU Member States (airline catering)
– Distance selling (i.e. internet)
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• Applicable to pre-packaged and foods sold loose
• Regulation covers ‘mandatory’ and ‘voluntary’ particulars
1169/2011 Mandatory
Particulars
Article 9.1(c): Mandatory particulars.
• Any ingredient or processing aid listed in Annex II,
or derived from a substance or product listed in Annex
II causing allergies or intolerances, used in the
manufacture or preparation of a food and still present in
the finished product, even if in an altered form
• 13 allergens + SO2 (>10ppm) (Annex II) must be
declared in the ingredient list regardless of quantity
(unless exempt) if intentionally added as ingredients.
• Change in the way that allergen information is to be
presented (emboldened, underlined, different colour).
Non-Prepacked Foods
Article 44(1) – national measures for nonprepacked foods
• Where foods are offered to sale to the final
consumer or to mass caterers without prepackaging, or where foods are packed on the sales
premises at the consumer’s request or pre-packed
for direct sale, the provision of the information
about allergenic ingredients is mandatory
What does this mean for the food
service sector in UK?
• Businesses must provide information on Annex II
allergens used as ingredients in dishes
– saying that you do not know if an allergenic food
ingredient is present, will no longer be allowed
– nor can you say that all the foods could contain certain
allergenic ingredients
• Information has to be placed in a conspicuous
place, be easily visible, clear and legible
• Oral provision will also be permitted, but needs to
be consistent and verifiable, if challenged.
• Signposting to oral information is required
• FSA guidance being updated
BRC / FDF Guidance –
Interpretation of 1169/2011
• Name of allergen suffixed i.e. anchovy (fish) unless
allergen included in name of ingredient; i.e. skimmed
milk powder
• Milk will be declared after cream, butter and cheese
despite consumer understanding
• The named nuts in Annex II of the Regulation will be
listed by their specific name and not suffixed by (nut)*
• Cereals containing gluten will be declared in the
ingredients list using the specific name of the cereal,
i.e. wheat, rye, barley, oats, spelt or kamut
* Exemption: pecans and macadamias will be declared as pecan nuts and macadamia nuts. For these nuts, both words ‘pecan’
and ‘nuts’ should be in bold, for consistency with nuts such as hazelnuts.
Mandatory – Example Labels*
* BRC Guidance on Allergen Labelling & the Requirements in Regulation 1169/2011
1169/2011 Voluntary
Particulars
• Article 36.3(a): Additional voluntary allergen labelling
(“may contain” – information on the possible and
unintentional presence of substances or products
causing allergies or intolerances)
• Article 36.2 covers the general requirements that voluntary
food information must meet:
– (a) it shall not mislead the consumer, as referred to in Article 7;
– (b) it shall not be ambiguous or confusing for the consumer; and
– (c) it shall, where appropriate, be based on the relevant scientific data.
• Article sets out implementing acts at member state level
• Contains / allergy advice box used in current format on a
voluntarily basis by manufactures & retailers will not be
permitted after Dec. 2014.
Voluntary Guidance* – Replacing the
Allergy Advice (Contains) Box
Voluntary
Voluntary
* BRC Guidance on Allergen Labelling & the Requirements in Regulation 1169/2011
Free-From Claims
Customer Focused, Science Driven, Results Led
Free-From Claims
• Claims not currently within the scope of FIC
• Only currently have legal limits for ‘gluten-free’ & ‘very low
gluten’ (EC 41/2009)
• Patchy regulation and sparse published best practice guidance
therefore manufacturers, retailers and foodservice setting own
polices
• In absence of limits many companies relying on combination of
high level allergen control & positive release (non-detectable at
LOD / LOQ)
• Invitation to purchase by potentially most at risk consumers
• No such thing as zero but this is what many consumers expect!
• Sector key focus of Enforcement surveys
FSA “Best Practice Guidance on Managing
Allergens with Particular Reference to Avoiding
Cross-Contamination” (2007)
Section 3.3.2 Allergen-free foods
A growing number of food manufacturers and retailers are providing ranges of
substitute foods made without certain common allergenic foods, such as milk, egg
or cereals containing gluten. In addition, some manufacturers choose to exclude
certain allergens from a site. It should not be assumed that the lack of a need
to use advisory allergen warnings entitles a product to make a ‘Free From’
or claim.
Consumers are likely to actively seek such products if they need to avoid particular
ingredients and it is essential that any such claims are based on specific, rigorous
controls to ensure their validity. …….An ‘allergen-free’ claim is an absolute
claim, which may be interpreted by consumers to mean a complete
absence, whereas the best that can be scientifically demonstrated at
present is that samples of the food were shown to be below the analytical
limit of detection of a testing method on one or more occasions.
Expected that any claim is based on a robust risk
assessment, control and can be supported with
evidence
BRC Global Standard for Food Safety V6
• Section 5.2.7 Allergen claims
• It is essential that any allergen claim is based on rigorous
controls to ensure its validity and continuous implementation
• Where a claim is made regarding the suitability of the food, full
validation and verification activities will be required to ensure
that the claim is consistently met. Typically this will include:”
– Demonstration that production processes are in place to ensure that the
product does not contain traces of the allergen
– Analysis of the final product
– Assessment of the adequacy of cleaning as detailed in clause 5.2.8
(where the site also produce products containing the allergen about which
the claim is being made, additional verification controls will be required).
– Raw material controls – in addition to the normal requirements listed in
clause 5.2.1 additional validation / verification requirements are likely to
be needed (for example raw material testing, additional supplier
questionnaires, site audits etc.)
Gluten Free Labelling
Regulations EC 41/2009
• 1983 Codex Standard (guidelines) products labelled “gluten
free” if <200 ppm gluten in finished product
• 2007 Updated Codex Standard
– Reduced the limit to <20 ppm gluten (gluten-free)
– Introduced new claim of ‘very-low gluten’ for products especially
processed to remove gluten <100 ppm
• EC Regulation 41/2009 into force in Jan. 2012
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Implemented Codex gluten-free claims <20ppm
Implemented very low gluten claim of <100ppm
Does not identify any specific gluten analytical method
Does not override existing allergen labelling rules
Applies also to food sold non-pre-packed
Applies to foods as sold not consumed (e.g. dry bread mixes)
GF claims set to move to FIR
From Allergen Thresholds
& Action Levels
Customer Focused, Science Driven, Results Led
How Much Is Too Much?
Clinical Thresholds
• Knowledge base increased in last 5 years
– Clinical feeding studies - oral challenges (DBPCFC)
– EuroPrevall Project
• Thresholds differ between individuals
• Individuals thresholds & speed of onset of
symptoms can vary day-to-day
– exercise medication
• Not all allergens are equal - some are more potent
and prevalent
• Differences in prevalence patterns across Europe
• Threshold studies being used to establish
‘population based’ safe action levels
Peanut Thresholds
Action Levels
• Currently no internationally agreed levels
• Swiss legislation
– >1000 mg/kg for advisory labelling for cross-contact
• Japanese legislation
– 10 mg/kg
– Do not permit advisory labelling
• Action levels will change our approach from
‘hazard’ to ‘risk’ based – zero a very difficult
number to manage
Action Levels
VITAL 2.0 Toolkit
• Voluntary Incidental Trace Allergen Labelling (VITAL) is
an initiative of the Allergen Bureau, (developed by the
Australian Food & Grocery Council industry body’s
Allergen Forum)
• VITAL is a risk-based methodology to guide food
manufacturers on use of allergen precautionary labelling
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Heterogeneous contamination would always warrant a may-contain
• Standardised allergen risk assessment tool based upon
modelling of clinical food allergy thresholds data
• Web based downloadable resource pack
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Decision trees
Background resource materials
Allergen levels calculator
Labelling thresholds!!!!!
VITAL 2.0 Action Levels
Allergen
VITAL Estimated
Reference Dose
(mg Protein)
5 g Serving Size:
Action Level (ppm)
[VITAL 1.0 Level]
50 g Serving Size:
Action Level (ppm)
250 g Serving Size:
Action Level (ppm)
Peanut
0.20
40
[2]
4.0
0.80
Milk
0.10
20
[5]
2.0
0.40
Egg
0.03
6
[2]
0.6
0.12
Hazelnut
0.10
20
[2 – tree nuts]
2.0
0.40
Soy
1.00
200
[10]
20.0
4.00
Wheat
1.00
200
[20 – gluten]
20.0
4.00
Cashew
2.00
400
40.0
8.00
Mustard
0.05
10
1.0
0.20
Lupin
4.00
800
80.0
16.00
Sesame
0.20
40
[2]
4.0
0.80
Shrimp
10.00
2000
[2 – crustacea]
200.0
40.00
Celery
Insufficient data
Fish
Insufficient data
New Developments
• EFSA currently re-examining the EU mandatory
allergen labelling list:
– Are all 14 allergens still relevant? Can any come off the list
or should any new ones go on the list
– Can they agree action levels?
– Expect EFSA opinions by end 2014 / 2015
• ILSI Europe developing framework for adoption of
levels
Latest on Precautionary
Labelling (may-contain)
Customer Focused, Science Driven, Results Led
Labelling for Unintentional
Allergen Presence
• Risk assessment is key to deciding what and when to label
• To quote FSA guidance “Advisory labelling should only be
used when, following a thorough risk assessment, there is a
demonstrable and significant risk of allergen crosscontamination”
• Not a substitute for poor GMP
• FIC Article 36.2 - voluntary food information:
– (a) it shall not mislead the consumer, as referred to in Article 7;
– (b) it shall not be ambiguous or confusing for the consumer; and
– (c) it shall, where appropriate, be based on the relevant scientific
data.
….With That in Mind!
Risks of Over-labelling
UK FSA Snapshot Survey
2012/13
• 500 pre-packed foods sampled in duplicate from a range of retail
outlets from small to large across the UK
• Samples chosen across a broad range of 12 product categories
• Allergens chosen – milk, gluten, peanut and hazelnut
• Analysis conducted for allergens not present as intentional
ingredients
• Comparable products chosen that do and do not have a
precautionary label for these allergens
• Report due for publication 2014
Precautionary Labelling Variations on the Theme!
What must I, and what can
I put on the label?
Customer Focused, Science Driven, Results Led
Allergen Labelling Legislation
Area
Dir. 2000/13/EC
Reg. 1169/2011
From 13th Dec. 2014
Foods sold loose /
non pre-packed
Excluded
Included
Allergen
labelling list
Mandatory ingredients
declaration of 13 allergens and
derivatives and sulphites
>10mg/kg;
Named specific exemptions
Mandatory ingredients declaration
and highlighting of 13 allergens and
derivatives and sulphites >10mg/kg;
Named specific exemptions
‘Contains’
boxes
Voluntary, permitted
No longer permitted
‘May-contains’
labelling
Voluntary, permitted
Voluntary, permitted;
Potential for future requirements in
law
‘Free-from’
claims
Voluntary,
Restrictions on “gluten free”
claims in Reg. EC/41/2009
Voluntary,
Restrictions on “gluten free” claims in
Reg. EC/41/2009
Published Guidance (free!)
• Food & Drink Federation & British Retail
Consortium
• Food Drink Europe
• Food Standards Agency
Useful Links
• Food Drink Europe Guidance on Food Allergen Management for Food
Manufacturers
http://www.fooddrinkeurope.eu/uploads/publications_documents/FINAL_Allergen_A4_web
.pdf
• BRC & FDF Guidance Allergen Labeling & 1169/2011
http://www.brc.org.uk/downloads/Guidance%20on%20Allergen%20Labelling.pdf
• FSA Best practice guidance on managing food allergens with
particular reference to avoiding cross-contamination and using
appropriate advisory labelling (e.g. 'May contain' labelling).
http://food.gov.uk/business-industry/guidancenotes/labelregsguidance/maycontainguide
Thanks For Your Attention