DRAFT

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

Mars Inc.,Good Manufacturing Practices

Specific Requirements for Allergen Management in Human Foodstuffs

Version 2, Jan 23rd, 2007

DRAFTFor input from GQC

Published by the Global Quality & Food Safety GroupNo part of this document can be used outside of Mars Inc. without prior approval from the Global Q&FS Safety Group.

MEMBERS of the STEERING TEAM

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

AuthorsSteve RizkRegulatory Affairs manager MFUSALaurie Post Microbiology Manager MFUSATimothy AhnQuality Manager Snackfood MFUSAGerardine Thornton-TaylorHead of Quality Management, GQ&FSGrp

Document ApproverAndy BennettGlobal Q&FS Group Director

ContributorsTom MackieQuality & Food Safety Manager MFUSAElizabeth DonnellyQuality Manager MFANZDerek LulhamQuality Manager MFANZEmma HawkinsFood Safety Scientist SnackfoodCathy StannardHead of Food Safety Sciences, GQ&FS GrpRian van der DoelenMicrobiology Manager MFE SnackfoodPaul Krykant Food Safety Chemist MFE

Peer reviewed by endorsed by the Global Quality Community Andy BullPetfood MFUSATom Mackie Snackfood and Food MFUSAJoao SouzaSouth AmericaAndy ByeMF EuropeBogdan CzarneckiMF Central EuropeSergey SteninCISAshraf ShehataAIMEKaren BeyerAIMERober BakerAsia PacDerek LulhamMFANZPeter HallDrinks Group

Margaret JordanLegal Counsel

TABLE OF CONTENTS

SectionTitlePageIntroduction4Glossary51Allergen management principles62Allergen management pre-requisites93HACCP-based environmental hazard analysis114 Allergen labelling criteria145 When to analytically test for allergens19

Figure 1Approach to management of identified allergen risks4Figure 2Environmental cross-contamination decision tree13

Table 1Global list of Top Allergens/ingredients by market7Table 2Definitions for assessing significance of vectors12Table 3Adsorpancy rate of vector Vs vector/allergen contact12Table 4Adsorpancy rate of vector Vs vector/allergen contact x vector/product contact13Table 5Example of how to apply labeling criteria across a brand16Table 6Mars Global allergen labeling criteria18

References20

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INTRODUCTIONThis 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.

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.

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.

Figure 1: Approach to manage identified allergen risks

Step 1: Identify allergens being used on site (Section 1)

Step 2: Put all mandatory GMPs in place (Section 2)

Step 3: Perform a hazard analysis to determine if extra controls are needed (section 3)

Step 4: Where a hazard can not be managed to LOW/NEGLIGIBLE, apply the labeling requirements (Section 4)

Step 5: Verify that the controls and labeling are appropriate (Section 5)

GLOSSARY of TERMS

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

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.

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).

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

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

State of hazard: the physical form that the allergen is presented in (e.g. liquid, gas, powder, sticky, oil residue etc)

Validation: confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are achieved.

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

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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1. ALLERGEN MANAGEMENT PRINCIPLES

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

1. We will always indicate the presence of any of the major food allergens[footnoteRef:1] within the ingredient declaration of our products, whenever the ingredient is part of the recipe.[footnoteRef:2] [1: 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.] [2: For more details please refer to Chapter 4 of this document]

2. Our goal is to eliminate or minimize allergen cross contact in our products, and, therefore, allergen advisory statements[footnoteRef:3], in order to provide the food allergic consumer with more choices. [3: Refers to statements that indicate the possible presence of allergens in the products (e.g. May Contain ; Contains traces; etc. ). ]

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 measures[footnoteRef:4], Good manufacturing Practices, etc. [4: 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. ]

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.

List of Commonly Allergenic Foods 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. 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 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.

TABLE 1

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

Ingredient1U.S. 2Canada3JapanAustralia/New Zealand4E.U. 6Codex5(Mars default list)

Peanutsxxxxxx

Tree Nuts7xxChestnut 8xExcluding coconutxx

Eggsxxxxxx

Cow's milkxxxxxx

FishxxSpecific for abalone, salmon, salmon roe & mackerel8xxx

Shellfish(Crustacean, Molluscs)11xOnly crustaceaxSpecific for Shrimp & Crab, Squid 8xOnly crustacea 9x

xOnly crustacea

SoyaxxSoy8xxx

Wheatxxxx

Cereals containing Gluten10xxx

Sesame seedxx

Sulfite2x2xxxx

Buckwheatx

FruitOrange, Peach, Apple, kiwi8

VegetableYam8Celery

MealBeef, pork, chicken, gelatin8

OtherMatsutake mushroom8Mustard, lupin

FOOTNOTES TO TABLE 11 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 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 Canada - Recalls will be initiated when one of the following situations exist: (I) when peanut protein is detected in a food at 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)4 Source: Food Standards Australia New Zealand, Food Standards Code Standard 1.2.3. Mandatory Warning and Advisory Statements And Declarations.5 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 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.pdf9 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 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. 11 Molluscs include Bivalvia (clams, oysters, scallops, cockles,), Cephalopidia (squid, cuttlefish); Gastropodia (snail, abalone, whelk), Crustacean include shrimp, crabs, lobster, crayfish and prawns.

Allergen Threshold LevelsThere 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.

2. ALLERGEN MANAGEMENT PRE-REQUISITES

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.

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.

1. Raw Materials

1.1 Raw materials must be sourced from approved suppliers and the risk of allergen cross-contamination in the raw material must be assessed as part of the Material Quality Management process.

1.2 Raw materials carrying an allergen advisory label must be treated as containing the allergen.

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.

2. Production Areas

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.

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.

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.

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.

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 allergen-containing areas.

3. Associate Movement

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.

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.

4. Waste Handling

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

1. Equipment and Tools

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.

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.

6. Non-Production Areas

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.

7. Rework

7.1 Rework usage must comply with specified product recipes. Recipes must be specified to assure like-into-like ingredient usage.

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.

8. Training

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).

9. Verification

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.

10. Labeling

10.1 Product labels will comply with the Mars Inc. Labeling requirements in Section 4 of this document.

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.

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.

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.

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.

3. HACCP - based Environmental Hazard Analysis Tool

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. 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.

The Environmental Hazard Analysis procedure can be broken down into 5 key steps.

STEP 1 Identify the exact location where the allergen may reside in the environmentBriefly describe the activities of the area including people, equipment and airflow.

STEP 2 Allergen identification: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;

STEP 3 Identify the vector which can pickup the allergen (intentionally or unintentionally):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.

STEP 4 Assessment of significance of vectorTo 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;

Table 2 Definitions for assessing significance of vector

Risk RatingAdsorption rate of vectorVector contact with hazardVector contact with product/product contact surface

High100% adsorpancy (porous, rough, absorbent surface e.g. cotton, rubber) or high air flow

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

MediumSemi- adsorpancy (e.g. smooth plastics) or moderate air flowFrequency of evidence (visual and/or analytical) that the vector is in occasional contact with the hazard (1/period)

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

LowLow adsorpancy (e.g. smooth shiny metal, glass)) or low air flowLittle evidence (low level analytical data) that the vector is in direct contact with the hazard

Infrequent and low level positive analytical result from product contact surface

NegligibleNo adsorpancyNo direct contact with the hazardNo direct contact with the product or product contact surface

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).

Table 3(adsorpancy rate of vector) x (vector/hazard contact)

Vector/hazard contact risk rating

Adsorbancy rate of vector risk ratingHighMediumLowNegligible

HighHHML

MediumHMML

LowMMLN

NegligibleLLNN

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).

Table 4[(adsorpancy rate of vector) x (vector/hazard contact)] x (vector/product contact)

Vector/product contact risk rating

(Adsorbancy rate of vector) x (vector/hazard contact risk rating)HighMediumLowNegligible

HighSignificantSignificantSignificantNot significant

MediumSignificantSignificantSignificantNot significant

LowSignificantSignificantNot significantNot significant

NegligibleNot significantNot significantNot significantNot significant

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.

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.Figure 2 Environmental Cross-contamination Decision Tree

Q1. Is there a significant Vector identified in the environment?NO No extra controls requiredYES Q2

Q2. Are all mandatory GMPs in place?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 guidelinesYES Identify and validate additional preventative actions and document in local GMP programme Q3

Q3. Is there still a significant Vector?NO No extra controls requiredYES Consult Mars Allergen Labelling Policy (Section 4)

4 Mars Allergen Labeling PolicyFood-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.

Ingredient LabelingWhenever an allergen, from Table 1, is present as an ingredient in the recipe[footnoteRef:5] always indicate its 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. [5: The specific type of tree nut, crustacean, molluscs, fish or cereal source should be used in the label declaration.]

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.

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

Mars should not use Contains 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);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.)

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).

Allergen Advisory StatementsIt 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; ORProduct 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.

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 level7 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. Advice on Position and Phrasing of Allergen Advisory Labelling Statements: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.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)

Wording of Allergen Advisory Statements:The preferred statement for Mars, Incorporated is: May Contain (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. Note: the words Allergy Information: may preceed the May Contain statement.

Guideline for Labeling across Packs/BrandsAs 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.

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.

Table 5Example of how to apply Labeling criteria across a Brand

Umbrella BrandBrand NameVariety SizeFormatX-contamination riskAllergen advisory statement required

BountyBountyMilkStandardSingleYesYes

BountyBountyMilkFun/MinsBagNoYes

BountyBountyDarkStandardSingleNoNo

BountyBountyDarkFun/MinsBagNoNo

BountyCalupuno-PralineSingleNoNo

BountyBounty Ice CreamMilkStandardSingleNoNo

Bounty Ice CreamMilkStandardGrocery packNoNo

BountyBounty Ice CreamDarkStandardSingleNoNo

Bounty Ice CreamDarkStandardGrocery packNoNo

Labeling on Smaller Packages Not Intended for individual Retail SalesFood 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 wrap[footnoteRef:6], e.g., the individual Fun Size/Miniatures package. [6: For example, a Contains and/or May contain 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.]

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 concernedThe 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).

Labeling In order to label a product as 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. 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.

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

Table 6Mars Global Allergen Labeling Criteria

Label ClaimPre-conditions

No Allergen Advisory Statement requiredEach 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; OR 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.

Allergen Advisory Statement Required When the output of the HACCP-based environmental analysis indicates that despite all controls implemented, there is still a risk of cross-contamination 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

'Allergen-free' Statement allowed Dedicated facility (refers to production equipment, people, practices, etc.) Dedicated facilities at supplier and/or assurances that the supply chain has negligible allergen risk

5 When to analytically test for allergensThere are 4 scenarios for when allergen testing has been seen to add value.

1) Validating control measures (manufacturing or environmental)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.

2) Troubleshooting 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).

3) VerificationOngoing 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)

4) Labelling a product as 'Allergen-free' A comprehensive sampling programme across the supply chain on all product types shall be an element of the verification activities to support the claim.

REFERENCESThe following documents and organizations have been consulted to put this document together (other specific references are cited and indicated throughout the document)

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

Food & Drug Administration (FDA), for regulatory requirements in the USA

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

Food Allergy Issues Alliance Group and Food Allergy Anaphylaxis Network (FAAN), USA, for consumer inputs to aid the allergen labeling guidelines

UK Food Standards Agency 2006, Guidance on Allergen Management and Consumer Information, for benchmarking the general risk management approach for allergens

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