Professional Documents
Culture Documents
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4 Mars Inc.,
5 Good Manufacturing Practices
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8 in Human Foodstuffs
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11Version 2, Jan 23rd, 2007
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14 DRAFT
15 For input from GQC
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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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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
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Legal Counsel
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73 TABLE OF CONTENTS
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75 Section Title
Page
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Introduction
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Glossary
78 1
79 2
80 3
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85 Table 1
86 Table 2
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87 Table 3
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88 Table 4
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89 Table 5
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90 Table 6
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92 References
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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.
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112 Step 5: Verify that the controls and labeling are appropriate (Section 5)
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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.
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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).
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State of hazard: the physical form that the allergen is presented in (e.g. liquid, gas, powder, sticky, oil residue etc)
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145 Validation: confirmation by examination and provision of objective evidence that the particular requirements for a specific intended
use are achieved.
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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)
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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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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.
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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.
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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
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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.
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166
TABLE 1
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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
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(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
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271
272
273
278
285
279 Celery
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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
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290
Orange,
Peach, Apple,
kiwi8
284
Beef, pork,
chicken,
gelatin8
291 Matsutake
mushroom8
295
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lupin
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FOOTNOTES TO TABLE 1
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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.
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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.
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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)
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4
Source: Food Standards Australia New Zealand, Food Standards Code Standard 1.2.3. Mandatory Warning and Advisory Statements
And Declarations.
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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)
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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.
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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
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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.
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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.
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.
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313
The following list of Allergen Management Pre-requisites must be used in conjunction with the Mars
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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.
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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.
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334
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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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.;
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:
how frequently is the vector in contact with a non-allergen containing product or product contact surface;
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377
378
379
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380
381
382
384 Risk
Rating
388 High
394 Mediu
m
399 Low
404 Negligi
ble
405 No adsorpancy
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
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
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
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
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
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493
494
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495
496
497
498
499
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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
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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:
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;
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
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
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.
526
527
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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
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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592 Groce
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Yes
15
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
Custom and practice with similar products on sale in the market concerned
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
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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618
Please refer to Table 6 for an overview of the Criteria for Allergen-Free Labeling; when an allergen
619
620
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
640 'Allergen-free'
Statement allowed
Dedicated facilities at supplier and/or assurances that the supply chain has
negligible allergen risk
641
642
643
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Pre-conditions
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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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