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Mars Inc., Good Manufacturing Practices, Allergen management Version 2, 2007

2
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4 Mars Inc.,
5 Good Manufacturing Practices
6

7 Specific Requirements for Allergen Management

8 in Human Foodstuffs
9
10
11Version 2, Jan 23rd, 2007
12
13

14 DRAFT
15 For input from GQC
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Published by the Global Quality & Food Safety Group

No part of this document can be used outside of Mars Inc. without prior approval from the Global Q&FS Safety Group.

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Mars Inc., Good Manufacturing Practices, Allergen management Version 2, 2007

33 MEMBERS of the STEERING TEAM

34
35 The Global Q&FS Group would like to acknowledge the following persons for their extensive
contributions to this document

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Authors
Steve Rizk
Regulatory Affairs manager MFUSA
Laurie Post
Microbiology Manager MFUSA
Timothy Ahn
Quality Manager Snackfood MFUSA
Gerardine Thornton-Taylor Head of Quality Management, GQ&FSGrp
Document Approver
Andy Bennett
Contributors
Tom Mackie
Elizabeth Donnelly
Derek Lulham
Emma Hawkins
Cathy Stannard
Rian van der Doelen
Paul Krykant

Global Q&FS Group Director

Quality & Food Safety Manager MFUSA

Quality Manager MFANZ
Quality Manager MFANZ
Food Safety Scientist Snackfood
Head of Food Safety Sciences, GQ&FS Grp
Microbiology Manager MFE Snackfood
Food Safety Chemist MFE

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Peer reviewed by endorsed by the Global Quality Community

Andy Bull
Petfood MFUSA
Tom Mackie
Snackfood and Food MFUSA
Joao Souza
South America
Andy Bye
MF Europe
Bogdan Czarnecki
MF Central Europe
Sergey Stenin
CIS
Ashraf Shehata
AIME
Karen Beyer
AIME
Rober Baker
Asia Pac
Derek Lulham
MFANZ
Peter Hall
Drinks Group
Margaret Jordan

Legal Counsel

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Mars Inc., Good Manufacturing Practices, Allergen management Version 2, 2007

73 TABLE OF CONTENTS
74

75 Section Title

Page

76

Introduction

77

Glossary

78 1

Allergen management principles

79 2

Allergen management pre-requisites

80 3

HACCP-based environmental hazard analysis

11

Allergen labelling criteria

14

When to analytically test for allergens

19

82 Figure 1 Approach to management of identified allergen risks

83 Figure 2 Environmental cross-contamination decision tree

13

81

84
85 Table 1

Global list of Top Allergens/ingredients by market

86 Table 2

Definitions for assessing significance of vectors

12

87 Table 3

Adsorpancy rate of vector Vs vector/allergen contact

12

88 Table 4

Adsorpancy rate of vector Vs vector/allergen contact x vector/product contact

13

89 Table 5

Example of how to apply labeling criteria across a brand

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90 Table 6

Mars Global allergen labeling criteria

18

91
92 References

20

93
94 __________________________________________________________________

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95 INTRODUCTION
96 This risk management standard is a part of a suite of standards developed for good manufacturing
practices, Mars Inc., GMP/GHP. The risk management strategy in this document is specific for the
prevention of cross-contamination by allergenic materials/products in to non-allergen-containing
materials/product.
97
98 Allergies are hypersensitivity reactions of the immune system to specific proteins. The most severe form
of allergy is anaphylactic shock. These type of reactions can be life threatening and require medical
attention. A food allergy is an immune system response to food proteins that the body mistakenly
identifies as harmful. Once the immune system identifies a particular food as harmful, it creates specific
antibodies for it. The next time the individual eats that food, the immune system releases large amounts
of chemicals, including histamine, in order to protect the body. These chemicals trigger a cascade of
allergic symptoms that can effect the respiratory system, gastrointestinal tract, skin, or cardiovascular
system. At the present time, there is no cure for food allergies. Avoidance is the only way to prevent an
allergic reaction.
99
100 It is intended that this document defines the minimum management requirements for preventing and/or
communicating allergen risks to consumers and are relevant for any Mars Inc., factory that is using, or
intending to use, allergen-containing ingredients as detailed in Table 1. A simple step-by-step process to
be applied in a Vendor or Mars manufacturing facility is summarised in Figure 1 and is extrapolated on in
the rest of this document.
101

102 Figure 1: Approach to manage identified allergen risks

103
104 Step 1: Identify allergens being used on site (Section 1)
105
106 Step 2: Put all mandatory GMPs in place (Section 2)
107
108 Step 3: Perform a hazard analysis to determine if extra controls are needed (section 3)
109
110 Step 4: Where a hazard can not be managed to LOW/NEGLIGIBLE, apply the labeling requirements (Section 4)
111

112 Step 5: Verify that the controls and labeling are appropriate (Section 5)
113
114
115
116

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117 GLOSSARY of TERMS

118

119

Adsorption : To hold molecules (air, gas, liquid) in a layer on its surface

120
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122
123
124
125
126
127

Compulsory ,Shall or must: is a requirement to comply with the contents of the statement
Hazard: a biological, chemical or physical agent in or condition of, product with the potential to cause an adverse health effect.
Hygiene junction: a lock between a high risk area and low risk area, enabling personnel traffic between these areas and
preventing cross-contamination from the high risk area to the low risk area.

128
129
130
131
132
133
134
135
136
137

Physical segregation: separation of items by a physical barrier such as a wall, hygiene barrier, or a separate room.

Policy: the overall intentions and direction of a Dept/division with respect to quality.
Product: any ingredient, in-process product or finished product.
Recommended: when there is not a requirement to comply with the content of the statement, but compliance is recommended
as best practice within Mars, Incorporated. New factories shall be designed based on best practice requirements.
Risk assessment: a scientifically based process consisting of the following 4 steps (i) hazard identification; (ii) evaluation of
severity of effect of hazard (hazard characterization); (iii) evaluation of the likely occurrence of the hazard in the
product/area/process (exposure assessment); (iv) an overall estimation of the risk associated with this hazard based on information
gathered in steps (i) to (iii) (risk characterization).

138

139

Separation: items are separated by space, not by a physical barrier.

140
141 Specification:any criteria with which product, process, service or other activity must conform.
142

143

State of hazard: the physical form that the allergen is presented in (e.g. liquid, gas, powder, sticky, oil residue etc)
144
145 Validation: confirmation by examination and provision of objective evidence that the particular requirements for a specific intended
use are achieved.
146

147

Vector: a 'vehicle' that transfers a hazard from one location to a product or product contact surface (e.g. air, people, boots,
clothes etc)

148
149 Verification: the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine the
compliance with established requirements.

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151 _____________________________________

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152 1. ALLERGEN MANAGEMENT PRINCIPLES

153
154 These are the 5 guiding principles, by which, all decisions shall comply:

155
156
1. We will always indicate the presence of any of the major food allergens 1 within the ingredient declaration
of our products, whenever the ingredient is part of the recipe. 2
2. Our goal is to eliminate or minimize allergen cross contact in our products, and, therefore, allergen
advisory statements3, in order to provide the food allergic consumer with more choices.
3. Allergen advisory statements will only be used on products when all reasonable means for eliminating
the allergen cross contact have first been considered, e.g., dedicated facility, dedicated lines, effective
cleaning measures4, Good manufacturing Practices, etc.
4. We will not intentionally add an allergen to the recipe for a product unless it is intended to be in the
product design.
5. We will base our Mars allergen practices on the latest and best peer-reviewed science.
157
158
159
160
161

List of Commonly Allergenic Foods

162

Over 200 foods

have been documented to cause an allergic reaction. However, in reality only a small number of them are
responsible for over 90 % of the most severe reactions. These key allergens can differ slightly by country
and may be modified over time to account for differences in sensitivity within a given population. The current
regional lists can be found in Table 1. These are the lists that should be used to determine which allergens
are of importance for a particular market. The allergens referred to must be considered in both allergen
management and for labeling purposes where cross contact exists. A manufacturing site must be aware of
the markets they are exporting to and which allergens are considered most prevalent in that region. It is the
responsibility of the importing unit to provide the proper allergen labeling (as well as other labeling matters,
see Section 4). However, the guidance provided by this document should be followed unless it is
inconsistent with requirements of the importing country.
163
164 For those markets not listed in Table 1 or that do not have a clearly established allergen list, the CODEX
list shall be the default requirements. Codex Alimentarius (under W.H.O.), or the International
Food Code was established to ensure fair trade and protect consumers around the globe.
As such they have established benchmarks against which National food standards and
regulations are evaluated within the legal parameters of the Uruguay Round Agreements. In
addition, if a Mars Inc., unit or co-manufacturer is exporting the product, it is also recommended that the
allergen ingredient listing used by the exporting unit be used by the importing country/unit. Where a new
1
2
3
4

This list of major food allergens may vary by market and are typically identified by regional scientific allergen experts and/or the
national regulatory agencies. Refer to Table 1 for further information.
For more details please refer to Chapter 4 of this document
Refers to statements that indicate the possible presence of allergens in the products (e.g. May Contain <allergen>; Contains
<allergen> traces; etc. ).
Effective cleaning measures assumes that an expert associate has conducted a risk assessment of the manufacturing procedures
and raw materials, that a plan is in place to regularly audit that the product remains below scientifically agreed-upon allergen
threshold levels and that controls and standards are in place, validated and assessed.

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allergen has been identified for a region(s) (due to increased prevalence and/or severity of reactions
and/or government declaration), then that allergen should be identified on the label. That action should
then be communicated to the Global Quality & Food Safety Group to allow the regional lists to be kept
up-to-date.
165

166

TABLE 1
167

168 Global Lists of Top Allergens/Ingredients That Cause Food Hypersensitivity (by Market)
169 Updated - Jan 2007 ('X and/or text' - indicates the allergen of concern)
170

Ingredie
nt1

171

U.S.
2

172

Canad
a3

179 Peanuts
186
Tree
Nuts7

180 x
187 x

Eggs
Cow's milk
206 Fish

194 x
200 x
207 x

195 x
201 x
208 x

215 x

217 x

213 Shellfish
214 (Crustace
an,
Molluscs)

181 x
188 x

173 Japan
182 x
189

Chestnut

174 Australia/
175
New
Zealand4
183 x
190 x
191

216

Only
crusta
cea

196
202

x
x

Specific for
abalone,
salmon,
salmon roe &
mackerel8
218 Specific for
Shrimp & Crab,
Squid 8

219 x
220

177

Codex5

178

(Mars default
list)

184 x
192 x

185 x
193 x

198 x
204 x
211 x

199 x
205 x
212 x

221 x

223 x
224 Only

Excluding coconut

197 x
203 x
210 x

209

176 E.U. 6

Only crustacea

222

crustacea

11

225 Soya
232 Wheat
239 Cereals
containin
g
Gluten10
246 Sesame
seed
253 Sulfite2
260 Buckwhea
t
267 Fruit

228 Soy8

226 x
233 x
240

227 x
234 x
241

235
x
242

229 x
236 x
243 x

230 x
237
244 x

231 x
238
245 x

247

248

249

250 x

251 x

252

256
263 x

257 x
264

258 x
265

259 x
266

271

272

273

278
285

279 Celery
286

280

292

293 Mustard,

294

254

x2

255

261

262

268

269

270

274 Vegetable
281 Meal

275
282

276
283

277 Yam8

288 Other

289

290

Orange,
Peach, Apple,
kiwi8

284

Beef, pork,
chicken,
gelatin8

291 Matsutake
mushroom8

295

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296

FOOTNOTES TO TABLE 1

1
297
The bolded allergens under this column are those that may be used in allergen advisory statements. This decision will be based on risk
assessment as defined in Mars HACCP.
2
298
While the U.S. government and Food Standards Australia New Zealand (FSANZ) do not list sulfites as a top allergen they do require labeling
of sulfites in products when they exist at 10 mg/kg (similar to other countries). According to the Canadian Food Inspection Agency though
sulfites are not considered to be true allergens, they do produce an adverse reaction that can lead to anaphylactic shock and death. It is the
seriousness of these reactions that has led to the inclusion of sulfites on the priority allergen list.
3
299
Canada - Recalls will be initiated when one of the following situations exist: (I) when peanut protein is detected in a food at <1 ppm and
is not declared on the label; (ii) when tree nuts, sesame seeds, soy, cows milk, eggs, fish, crustaceans and shellfish, wheat and sulfites (> 10 ppm)
are added as ingredients/additives to a food without any declaration of their presence on the product label; and (iii) when trace quantities of tree nuts,
sesame seeds, soy, cows milk, eggs, fish, crustaceans and shellfish, and wheat are present in a food as a result of cross contamination at some
stage in the food production process (and without label warning). In the case of wheat, a variety of cereals has been implicated in IgE-mediated
allergic reactions and anaphylactic reactions to wheat have been reported in children. This has resulted in the inclusion of wheat on the priority
allergen list (May 11, 2004)
300
4
Source: Food Standards Australia New Zealand, Food Standards Code Standard 1.2.3. Mandatory Warning and Advisory Statements
And Declarations.
5
301
Codex Alimentarius Commission (CAC): Foods and ingredients that are known to cause hypersensitivity should always be declared,
including, cereals containing gluten, i.e. wheat, rye, barley, oats and spelt, their hybridized strains and products of these; crustacean and byproducts;
eggs and egg products; fish and fish products; peanuts, soybeans and products of these; milk and milk products (lactose included); tree nuts and nut
products; sulfites in concentrations 10 mg/kg. This list was adopted as a final text by the CAC in June 1999 with the understanding that future
additions and/or deletions will be considered by CCFL, taking into account advice received from the Joint FAO//WHO Expert Committee on Food
Additives (JECFA).Source: Emerging Problems With Food Allergens, Taylor SL, Food, nutrition and agriculture - 26 (2000) (Food and Agriculture
Organization of the United Nations web site)
6
Source: Annex IIIA Directive 2000/13/EC as determined by the European Food Safety Authority (EFSA) Scientific Panel on Dietetic Products,
Nutrition and Allergens
7
Tree Nuts include: Walnuts, almonds, pistachios, hazelnuts (filberts), cashews, brazil, pecan, macadamia & pine nuts. In FSANZ Food Standards
Code under Editorial Note, coconut is the fruit of the palm (Cocos nucifera) and is not generally considered to be a tree nut.
8
302
Japan: Only the 5 foods in (bold Xs) are those for which Japan have mandatory labeling requirements. Under Japans Ministry of
Health, Labor & Welfare, a new allergen labeling scheme for the other allergens listed in this column labelling is recommended, but voluntary. Foods
containing those five foods, or ingredients prepared from them, must be labeled. If a food contains an ingredient, or traces amounts as a result of
residues or processing aids, made from a designated potential allergen, the label must identify the source. For example, lysozyme extracted from
eggs needs to be labeled as "egg white lysozyme" or "lysozyme (from egg)" rather than just lysozyme". Inappropriate labeling of the 5 designated
foods is treated as a violation of the Law and could result in recalls. Source: USDA Foreign Agriculture Service report (6/20/2005)
http://www.fas.usda.gov/gainfiles/200506/146130065.pdf
303
9
FSANZ Food Standard Code requires only the declaration of crustacean and their products, not molluscs. It is important not to use the
term shellfish, as this is a generic term that can cover both molluscs and crustacean.
10
304
Such as: wheat, rye, barley, oats, spelt or other hybridized strains. Note: The Codex and E.U. lists include celiac disease as a food
allergy. Source: Food Allergy: ILSI Europe Concise Monograph Series (2003). ILSI Press. Washington, DC.

305 11 Molluscs include Bivalvia (clams, oysters, scallops, cockles,), Cephalopidia (squid, cuttlefish); Gastropodia (snail, abalone, whelk), Crustacean
include shrimp, crabs, lobster, crayfish and prawns.

306 Allergen Threshold Levels

307 There is currently no globally accepted allergen threshold level for most of the top allergens.
Regulatory authorities in some markets have used 5-10 ppm of allergenic protein as an action level for
enforcement of recalls for a few of the allergens (e.g., peanuts, egg). Some top scientists have also
selected 10 ppm as a level below which it is highly unlikely that one would have an adverse reaction.
Until additional data becomes available we will use the more conservative level of 5 ppm of allergenic
protein as our own insignificant level and threshold level for internal action. Five ppm is equivalent to
250 micrograms allergenic protein per 50 gram unit/serving.

308

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309 2. ALLERGEN MANAGEMENT PRE-REQUISITES

310
311 Once it has been identified that allergens are present in the manufacturing facility it is imperative that all
possible routes of cross-contamination onto non-allergen containing products (and associated
equipment) are prevented or at least minimized. The most effective means of prevention is to segregate
allergen and non-allergen-containing manufacturing (& storage) areas. Where segregation is not
feasible, Allergen Management Pre-requisites (outlined below) must be applied.
312

313

The following list of Allergen Management Pre-requisites must be used in conjunction with the Mars

Good Manufacturing Practices/Good Hygiene Practices General Principles of Food Hygiene

(GMP/GHP). These combined, form the basis for the development of site-specific HACCP prerequisite
programs. The effectiveness of these controls will determine the risk of cross-contamination and this will
further inform whether labelling is required or not.

314
315 1. Raw Materials
316 1.1 Raw materials must be sourced from approved suppliers and the risk of allergen crosscontamination in the raw material must be assessed as part of the Material Quality Management
process.
317 1.2 Raw materials carrying an allergen advisory label must be treated as containing the allergen.
318 1.3 Where separation is necessary to avoid allergen cross-contact to non-allergen containing product,
commingled storage of allergenic and non-allergenic raw materials is not permitted. Allergenic raw
materials must be stored in clearly identifiable areas. Storage must provide sufficient separation and
isolation from non-allergen containing materials, to prevent cross-contact due to material spillage,
personnel and equipment movement. Spill control requirements must be specified in a documented
procedure. Any restrictions on Personnel or equipment movement in this area must be clearly
communicated.

319
320 2. Production Areas
321 2.1 The Site Quality Function must approve all decisions to produce non-allergen containing products
on shared equipment with allergen-containing products and must ensure that the Mars Labeling policy
is being applied correctly.
322 2.2 Where an allergen is a significant cross-contamination risk (e.g. shared line), validated cleaning
procedures must be applied between changeovers from allergen-containing to non-allergen-containing
products. Should the cleaning procedure not be completely effective at reducing the allergen risk to
below the threshold level, consistently, allergen advisory statements must be applied on the product at
risk.
323 2.4 Processes that inherently contain, or generate, significant levels of visible allergenic material, such
as dust and particulate matter (peanut processing, milk powder processing, etc) must be physically
segregated from non-allergen processing areas. In addition, airflow must be controlled to assure that
such material does not create a cross-contact hazard.
324 2.5 Sanitation and housekeeping of production environment must be maintained to achieve a standard
of no visible presence of allergenic material in the areas where the allergen is not intended for use as
an ingredient.
325 2.6 HACCP Factory layout plan must clearly indicate allergen exclusion/inclusion areas. Appropriate
communications must be in place to inform visitors, contractors and associates of the allergencontaining areas.

326
327

3. Associate Movement

328 3.1 For plants where allergens and non-allergenic foods are manufactured, operations associates
must be assigned to a specified allergen or non-allergen production line. This includes associates that
are responsible for the storage and transport of materials around the site, operation and maintenance
of processing and packaging equipment and the dispatch of raw and packaging materials to such
equipment. Where cross-contact presents a risk, work must be designed and managed to restrict
movement between allergen and non-allergen production areas. Exceptions to this requirement must
be risk assessed and approved by the Site Quality Function.
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329 3.2 In circumstances where an exception to 3.1 has been approved, associates must, as a minimum,
wash hands (using a validated procedure), clean soiled shoes and change work uniforms when
moving between allergen and non-allergen production areas.

330
331

4. Waste Handling

332 4.1 The storage and handling of allergen-containing waste containers must be managed to prevent
allergen cross-contact via spillage or mishandling.

333
334

Equipment and Tools

335 5.1 Where allergen cross-contact presents a risk due to process tools, cleaning implements and
utensils (scoops, spoons, cutlery, buckets etc) , such items must be clearly identified as to belonging
to an allergen specific area. Process tools, cleaning implements and utensils shared from allergen to
non-allergen areas must be cleaned using validated procedures.
336 5.2 Maintenance activities must be managed to assure product integrity and safety. GMPs must be
followed to avoid allergen cross-contact. The site Quality and Food Safety function is responsible for
assessing allergen cross-contact risks associated with specific maintenance activities and defining
necessary measures to effectively control them.

337
338

6. Non-Production Areas

339 6.1 Non-production areas of factories (product development kitchens, process development pilot
plants, laboratories, canteens and offices) must be assessed (using the HACCP - Environmental
Hazard Analysis Tool) for cross-contact hazards. Where necessary, appropriate control measures
must be implemented to address identified hazards.

340
341

7. Rework

342 7.1 Rework usage must comply with specified product recipes. Recipes must be specified to assure
like-into-like ingredient usage.
343 7.2 Rework containers must be clearly labeled to identify product contained. Rework containers must
be dedicated to specified product, or cleaned between use according to a validated cleaning
procedure.

344
345

8. Training

346 8.1 All factory-based associates, temporary employees, contractors, and service providers must be
trained on the risks posed by allergens, and measures necessary to effectively control them.
Refresher training must be completed at least every 2 years for all such personnel (as part of the
refresher hygiene training).

347
348

9. Verification

349 9.1 The effectiveness of the site allergen management programme must be audited and reviewed
regularly. The review shall include, as a minimum, a review of audit findings, consumer feedback,
incident reports and analytical data.

350
351

10. Labeling

352 10.1 Product labels will comply with the Mars Inc. Labeling requirements in Section 4 of this
document.
353 10.2 The adherence to Good Manufacturing Practices (Mars General Principles of Food Hygiene and
Mars Allergen Compulsory GMPs) is necessary to reduce the risk of allergen cross-contact. Labeling
is not a substitution for poor GMP compliance.
354 10.3 Risk assessments, conducted as part of the site HACCP process, will determine the control
measures necessary to address site-specific allergen cross-contact hazards. Allergen Advisory
labeling decisions will be made by the Site Quality Function, using outcomes from the site risk
assessment process and market brand labeling rules.
355 10.4 Finished product conformance assessment must include the verification that product packaging is
correctly labeled as to ingredient contents. In addition, controls must be established to verify graphics
for ingredient and allergen advisory statements, and for the management of obsolete packaging.
356 10.5 R&D test products will be labeled to identify food allergens included in the product recipe, as well
as those that may be present as a result of manufacturing cross-contact.

357

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358 3. HACCP - based Environmental Hazard Analysis Tool

359
360 In conjunction with pre-requisites, a manufacturing facility producing allergen and non-allergen
containing products must perform a hazard analysis of the process and the environment. For details on
how to perform a HACCP on the process see Mars Inc. A HACCP-based food safety management
standard.
361 The Environmental Hazard Analysis must be performed on the whole environment surrounding the
production facility as outlined in the Factory Layout Plan (see Mars Inc. A HACCP-based food safety
management standard). The rest of this section describes how to assess the risk of cross-contamination
in the environment surrounding the product and processes.
362
363 The Environmental Hazard Analysis procedure can be broken down into 5 key steps.
364
365 STEP 1 Identify the exact location where the allergen may reside in the environment
366 Briefly describe the activities of the area including people, equipment and airflow.
367
368 STEP 2 Allergen identification:
369 For each location identify the hazard and the state the hazard is presented. The HACCP team must
brainstorm, identify and document all potential allergens that may reside in the environment (either as a
cross-contaminant or as a material itself) that can have an adverse effect on the safety of the products.
The team should ensure the state of the hazard (liquid, aerosol, solid, sticky, oil residue etc) is clearly
identified. The hazard identification must include contamination sources such as:

raw materials (dust on external packaging, spillages, allergen next to nonallergen raw material etc)

location of rooms, routing, storage and separation of raw materials, interim products, end products, ventilation, etc.;

associate practices and customs around equipment and procedures;

370
371 STEP 3 Identify the vector which can pickup the allergen (intentionally or unintentionally):
372 List the source/cause of each allergen identified. There may be more than one cause/source of the
allergen or there may be several allergens arising from one cause/source. It is important to document all
sources as different measures may be required for control.

373
374 STEP 4 Assessment of significance of vector
375 To determine whether or not a vector is significant (i.e. reasonably be expected to occur) it is necessary
to perform an analysis using the definitions in Table 2. There are three parameters to assess:

what is the adsorption rate of the vector;

how frequently is the vector in direct contact with the allergen;

how frequently is the vector in contact with a non-allergen containing product or product contact surface;

376

377
378

379
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380
381

382
384 Risk
Rating
388 High

Table 2 Definitions for assessing significance of vector

383

385 Adsorption rate

of vector

386 Vector contact

with hazard

389 100% adsorpancy

(porous, rough,
absorbent surface
e.g. cotton, rubber)
or high air flow
390

391 Frequency of evidence

(visual and/or
analytical) such that
the vector is in
frequent contact with
the hazard (several
times a shift)

394 Mediu
m

395 Semi- adsorpancy

(e.g. smooth
plastics) or moderate
air flow

399 Low

400 Low adsorpancy

(e.g. smooth shiny
metal, glass)) or low
air flow

404 Negligi
ble

405 No adsorpancy

396 Frequency of evidence

(visual and/or
analytical) that the
vector is in occasional
contact with the
hazard (1/period)
397
401 Little evidence (low
level analytical data)
that the vector is in
direct contact with the
hazard
402
406 No direct contact with
the hazard

387 Vector contact with

product/product contact surface
392 Frequency of visual or analytical
evidence (e.g. product positive) such
that the hazard is in the product or
product contact surface despite the
current controls that are in place. Or
there is an obvious opportunity for the
contact to take place.
393
398 Occasional visual and/or analytical
evidence (e.g. positive swab result
from a product contact surface) that
the hazard is present despite the
current controls which are in place
403 Infrequent and low level positive
analytical result from product contact
surface

407 No direct contact with the product or

product contact surface

408
409 To determine how likely it is for a vector to 'pick-up' the identified allergen, multiply the adsorbancy rate of
the vector by the likelihood of cross contact occurring between the vector and the allergen (Table 3).
410

411 Table 3
412
413
415 Adsorbancy
rate of vector
risk rating

(adsorpancy rate of vector) x (vector/hazard contact)

416
422 High
428 Mediu
m
434 Low
440 Negli

414 Vector/hazard contact risk rating

417 High
418 Medium
419 Low

420 Negligible

423 H
429 H

424 H
430 M

425 M
431 M

426 L
432 L

435 M
441 L

436 M
442 L

437 L
443 N

438 N
444 N

gible

445
446 The significance of the vector then cross-contaminating a non-allergen containing product is derived by
multiplying the is calculated as [(adsorpancy rate of vector) x (vector/hazard contact)] (as derived in
Table 3) by the likelihood of the vector coming in contact with nonallergen containing product or product
contact surface (Table 4).

447
448
449
450
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451
452
453 Table 4
454

[(adsorpancy rate of vector) x (vector/hazard contact)] x (vector/product

contact)
456 Vector/product contact risk rating

455

457 (Adsorbancy
rate of vector)
x
(vector/hazard
contact risk

458
464 High
470 Mediu

459 High
465 Significant
471 Significant

460 Medium
466 Significant
472 Significant

461 Low
467 Significant
473 Significant

462 Negligible
468 Not significant
474 Not significant

m
476 Low
482 Negligi

477 Significant
483 Not

478 Significant
484 Not

479 Not significant

485 Not significant

480 Not significant

486 Not significant

significant

significant

ble

rating)
487
488 Where the [(adsorpancy rate of vector) x (vector/hazard contact)] x (vector/product contact) rate is
calculated to be significant, extra control measures need to put in place to prevent either the vector
coming in contact with the allergen in the first place or to vector/hazard contact and/or the vector/product
contact or by eliminating the vector itself. Figure 2 illustrates the decision making process. The HACCP
team must identify and document the control measure (consult the appropriate compulsory GMPs for the
identified hazard and well as the GMP/GHP General Principles of hygiene) that is to be applied or
implemented for all significant vectors. Where control may not be absolute, control may be applied to
reduce the risk of occurrence to an acceptable level. Where the control measure is part of a Pre-requisite
Programme, this must be indicated.
489
490 Whenever the food business operation changes in a manner that could adversely affect food safety all
relevant elements of the Hazard Analysis must be up-dated.

491
1 Figure 2 Environmental Cross-contamination Decision Tree
2
3 Q1. Is there a significant Vector identified in the environment?
4

NO No extra controls required

5
YES Q2
6
7 Q2. Are all mandatory GMPs in place?
8
NO Implement mandatory GMPs and redo the Hazard Analysis to determine if the
vector is still significant. If implementation is not immediate refer to the labelling guidelines
9
YES Identify and validate additional preventative actions and document in local
GMP programme Q3
10

11 Q3. Is there still a significant Vector?

12

13

NO No extra controls required

YES Consult Mars Allergen Labelling Policy (Section 4)

14

492
493
494
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495
496
497
498
499

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500 4 Mars Allergen Labeling Policy

501

Food-allergic

consumers must rely upon food labels for the effective implementation of their avoidance diets. These
consumers are avid label readers. The ingredient statements on food labels must be accurate to meet the
needs of this special segment of the consuming public. It is the intent of this document to provide clear
guidance on when and how to provide allergen labeling. These guidelines should be followed unless they
are inconsistent with local/country labeling regulations.
502
503 Ingredient Labeling
Whenever an allergen, from Table 1, is present as an ingredient in the recipe 5 always indicate its

504

presence by using the common name of the allergenic source. For example, hydrolyzed soy protein, not
hydrolyzed proteins; soy Lecithin, not Lecithin, wheat starch , not wheat Starch; soybean oil, not vegetable
oil, Whey (milk), not whey.
505
506

Always declare the presence of a commonly allergic food/ingredient even where collective terms are

permitted (e.g., flavorings, seasonings, colors, etc.) or where the allergenic food/ingredient is considered to
be an incidental additive, carry-over ingredient, or other minor component exempt from label declaration, for
example: natural flavor (milk), not natural flavor.
507
508

There are two exceptions to sections regarding declaring the allergenic source.

509

(i) First, if it

can be demonstrated that there is an insignificant level present (see document Introduction) and if
declaration by source is not required by local regulation. For example, wheat glucose syrup contains no
measurable wheat protein. Therefore, it could be labeled as glucose syrup.

510

(ii) Second, if

we have evidence that it is commonly understood by the consumer that the food contains the allergenic
ingredient and this is permitted by local legislation (for example, in Europe, cheese does not need to be
identified as derived from milk).

511
512

Mars should not use Contains <allergen> statements, on the retail or primary selling unit, unless

they are required by legislation in the market where the product is being sold (see Table 1).
The reasons for this are as follows:

Such statements discourage consumers from reading the ingredient list, which should always be the
primary source of allergen information;

If used such statements must refer to all key allergens in the product (as defined by your regional list);

513

Making reference to only some of the allergens present can be an opportunity for costly mistakes.

(For example , a number of recalls have been required in the UK where manufacturers have accidentally left
an allergen out of the Contains box even though it was listed in the ingredient list.)
514

5
17

The specific type of tree nut, crustacean, molluscs, fish or cereal source should be used in the label declaration.
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515

An exception to this guideline is that a Contains statement may be appropriate on packages where

ingredient listing is not required (e.g., Miniatures, Fun Size) if it is felt it will provide essential assistance to
the food allergic consumer. Such a statement would, however, have to refer to all key allergens in the
product (as described in your regional allergen list).
516
Allergen Advisory Statements
517

It

is

the

intention of Mars Inc. to minimise the requirement to label products by applying the following criteria:

Market brand policy does not require it;

Product is manufactured on shared equipment with allergen-containing product, and cleaning between
runs is validated to remove all traces of allergen and signed off by Site Quality Function;

518

OR

519 Product is manufactured on separate equipment to allergen- exposed equipment and the HACCP
hazard analysis has determined that there is no significant vector (negligible or low) to transfer the
allergen to the product or product contact surface;

HACCP & environmental hazard analysis has indicated that all necessary control measures have been
identified and validated appropriately;

Raw material do not have any traces of allergen declared;

Verification programme is in place and the findings demonstrate that all allergen cross-contact control
measures taken are effective.

520
521 Where one or more of the above criteria is not satisfied, an Allergen Advisory Statement will be
necessary to apply to the label. Use an allergen advisory statement judiciously and only in situations
where the allergen cross contact is documented and a risk assessment shows that there is a risk of
cross contamination at a level likely to be above an agreed upon threshold level 7 of clinical significance.
As a general rule, if the manufacturing/exporting unit has determined that an allergen advisory statement
is appropriate for that product in the domestic market then the same/similar statement should be used on
that product in the importing market.

522
523

Advice on Position and Phrasing of Allergen Advisory Labelling Statements:

524

The primary source of information for consumers about the allergen status of our products is the

wrapper in which the product is sold, i.e., the label that the consumer reads when he/she purchases the
product.
525

Any allergen advisory statement:

Must appear adjacent to the ingredient declaration

Must be readily visible and obvious to the consumer (for example, the allergen statement could be
bolded)

Must Not be obscured by the package, e.g., folds, label overlap, crimps, etc.

Must be legible (a minimum font size of 7)

526
527

Wording of Allergen Advisory Statements:

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528

The preferred statement for Mars, Incorporated is: May Contain <allergen(s)> (reference?). This

is based on research that allergic consumers typically avoid products with this statement. However, there
may be situations where this statement is either not legally permitted or may not be the most effective
statement for a given market. In those rare cases, an alternative statement is allowed. Any alternative
statement used should be chosen with approval of the Global Q&FS Director, R&D Head and Regional
General Counsel. In order to minimize confusion, all statements in a given market should be identical.
529

Note: the words Allergy Information: may preceed the May Contain<allergen> statement.

530
531 Guideline for Labeling across Packs/Brands
532 As a general rule therefore Mars will endeavour to ensure that, within a market, the same allergen
advisory statement will be used for each variety of a brand sold there, regardless of where it was
manufactured and regardless of the format or size in which the product is produced. There may be
circumstances when it will be impossible to follow this guideline. In this event, Global Q&FS Director,
R&D Head and Regional General Counsel shall be consulted.
533
534 For example, if the Standard size of Milk Bounty bar produced at one site had a risk of cross
contamination that could not be eliminated, but no other product under the Bounty umbrella brand
carried the same risk, the guidelines would result in a statement being applied to miniature and fun size
Milk Bounty bar products even though they carried no risk of cross contamination. No other Bounty
products would however be affected, Table 5 illustrates how labelling criteria is applied across a brand.

535

536 Table 5
537
538 Umbr
ella

Example of how to apply Labeling criteria across a Brand

539 Brand
Name

540 Vari

541 Size

542 Form

ety

at

Bran

543 X-

545 Allergen

contaminatio

advisory

statement

d
546 Bount

547 Bounty

548 Milk

549 Stand

550 Singl

544 risk
551 Yes

required
552 Yes

y
553 Bount

554 Bounty

555 Milk

ard
556 Fun/

e
557 Bag

558 No

559

y
560 Bount

561 Bounty

562 Dar

Mins
563 Stand

564 Singl

565 No

566 No

y
567 Bount

568 Bounty

k
569 Dar

ard
570 Fun/

e
571 Bag

572 No

573 No

y
574 Bount

575 Calupu

k
576 -

Mins
577 Pralin

578 Singl

579 No

580 No

y
581 Bount

no
582 Bounty

583 Milk

e
584 Stand

e
585 Singl

586 No

587 No

Ice

593 No

594 No

Cream
589 Bounty
Ice

ard
590 Milk

591 Stand
ard

ry

Cream

pack
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595 Bount

596 Bounty

Ice
Cream
603 Bounty
Ice

597 Dar
k
604 Dar
k

598 Stand
ard

599 Singl

600 No

601 No

607 No

608 No

605 Stand
ard

606 Groce
ry

Cream

pack

609

610
611 Labeling on Smaller Packages Not Intended for individual Retail Sales
612

Food allergic

consumers are taught to look for allergen information within the ingredient declaration.

All allergen

ingredients and allergen advisory statements should be on the selling unit/package where full ingredient
declarations are required. For smaller package sizes not intended for individual retail sale (e.g., Fun Size
and Miniatures) it is recommended (and in some cases it may be legally required by local legislation) that,
where possible, a listing of allergenic ingredients and allergen advisory statements should also be included
on primary wrap6, e.g., the individual Fun Size/Miniatures package.
613
614

In making the decision as to whether or not to label these packages with allergen information the

following criteria should be considered:

Custom and practice with similar products on sale in the market concerned

Expectations of regulators and allergen consumer groups

The space available on the component wrapper, taking into account the use of multi-language labelling
in some markets.

The implications for supply complexity and flexibility in the market concerned

615

The decision to go above and beyond the legal allergen labelling requirements for smaller pack

sizes within a given market will be done on a case by case basis by the appropriate company associates
(site Quality Function and Scientific and Regulatory Affairs).

616
617

<Allergen-Free> Labeling

In order to label a product as <Allergen-Free> the following conditions:

Have a dedicated facility (refers to production equipment, people, practices, etc. will be further
defined in a separate document) which does not allow that allergen.

Ensure that the raw material supply is free of that allergen. This can be accomplished by supplier
guarantees and must be properly validated and continuously monitored by the Mars Vendor
Assurance Team.

In addition, an Allergen-free status could also be verified where governments have developed
regulations/criteria to define this claim.

For example, a Contains <allergen> and/or May contain <allergen> statement would also be acceptable options for
communicating allergens on these smaller packages provided that such a statement referred to all of the key allergens (see
regional allergen lists) in the product for that particular market (as explained above). Alternatively labelling could include a
statement such as See outer pack for full ingredients list and allergy information.

8
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Mars Inc., Good Manufacturing Practices, Allergen management Version 2, 2007

Please refer to Table 6 for an overview of the Criteria for Allergen-Free Labeling; when an allergen

advisory statement is needed, and when it is not required.

619
620

Principles for Allergen Communication (e.g., Free-From product lists, etc.)

621 Mars and the Global Consumer Food Allergy communities discourage the use of these types of lists.
Mars acknowledges that consumers desire to have these lists but Mars fears that consumers misuse
them as they do not represent the latest allergen information. It is the intention to continue to encourage
consumers to read the labels for the latest allergen information and not rely on these lists.
622
623
624
625
626
627
628

629 Table 6
630

Mars Global Allergen Labeling Criteria

632

631 Label Claim

633 No Allergen
Advisory
Statement required

638 Allergen Advisory

Statement
Required

640 'Allergen-free'
Statement allowed

634 Each of the following criteria must be met:

Market brand policy does not require it;
Product is manufactured on shared equipment with allergen-containing
product, and cleaning between runs is validated to remove all traces of
allergen and signed off by Site Quality Function;
635
OR
636 Product is manufactured on separate equipment to allergen- exposed
equipment and the HACCP hazard analysis has determined that there is no
significant vector (negligible or low) to transfer the allergen to the product or
product contact surface;
HACCP-based environmental hazard analysis has indicated that all
necessary control measures have been identified and validated
appropriately;
Raw material does not have any traces of allergen declared
Verification programme is in place and the findings demonstrate that all
allergen cross-contact control measures taken are effective.
637
When the output of the HACCP-based environmental analysis indicates
that despite all controls implemented, there is still a risk of crosscontamination to the non-allergen containing product or product contact
surface.
Brand labeling policy (Table 5) indicates that a statement is required
Verification data demonstrates that the specified controls are not effective
Raw material arrives at the Mars site with an allergen advisory statement
on it
639

Dedicated facility (refers to production equipment, people, practices, etc.)

Dedicated facilities at supplier and/or assurances that the supply chain has
negligible allergen risk
641
642

643

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644 5 When to analytically test for allergens

645 There are 4 scenarios for when allergen testing has been seen to add value.
646
1) Validating control measures (manufacturing or environmental)
647 Validation is the process of obtaining objective evidence (in advance of implementation) that the
identified control measures of the control plan are effective. An independent team of appropriately
qualified personnel shall review validation data. Allergen control measures, which require validation,
include cleaning procedures (equipment, tools & personnel), flushing methods between product
changeovers and associate movement restrictions. In each of these scenarios the objective of validation
is to understand the extent of reduction of cross-contamination risk (if any) and to determine whether this
is sufficient. Allergen testing is essential to developing these operating parameters in terms of the
cleaning protocol details or the number of flushes required. Some of the data gathered during validation
will include quantitative measurement of the presence of allergen.
648
2) Troubleshooting
649 Where a cross-contamination event has occurred (can be triggered by consumer complaint, or associate
visibility of cross-contamination), testing of product for levels of a specific allergen may be appropriate to
support the incident risk assessment. In this instance, an appropriate sampling plan (as agreed with Site
Quality Function) shall be used and the samples can be qualitatively (presence/absence of protein) or
quantitatively assayed for, depending on what the data will subsequently be used for (again consult with
the Incident owner prior to performing the analysis).
650
3) Verification
651 Ongoing verification programs provide evidence that preventative control programs are effective.
Qualitative analyses of environmental surfaces in direct contact with the process line, clean production
surfaces, and CIP rinses are examples of verification points. The finding of allergen levels over the
threshold for detection would trigger the PRIMP (Product retrieval incident management process)
652
4) Labelling a product as 'Allergen-free'
653 A comprehensive sampling programme across the supply chain on all product types shall be an element
of the verification activities to support the claim.
654
655
656
657

658
659
660
661
662
663
664
665
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666 REFERENCES
667 The following documents and organizations have been consulted to put this document together (other
specific references are cited and indicated throughout the document)
668
669 Steve Taylor, Food Allergy Research and Resource Programme (FARRP) at the University of Nebraska,
for input on threshold levels, validation of cleaning procedures and allergen management pre-requisites
670
671 Food & Drug Administration (FDA), for regulatory requirements in the USA
672
673 Annex IIIA Directive 2000/13/EC as determined by the European Food Safety Authority (EFSA)
Scientific Panel on Dietetic Products, Nutrition and Allergens for regulatory requirements in Europe
674
675 Food Allergy Issues Alliance Group and Food Allergy Anaphylaxis Network (FAAN), USA, for
consumer inputs to aid the allergen labeling guidelines
676
677 UK Food Standards Agency 2006, Guidance on Allergen Management and Consumer Information, for
benchmarking the general risk management approach for allergens
678
679
680
681
682
683
684

685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
700
701
702
703
704
705
706
707
708
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