APRIL 2014

AUTHOR

Dr Evangelia Komitopoulou Global Technical Manager for Food, SGS

ALLERGEN MANAGEMENT AS A PART OF A SAFE GLOBAL FOOD SUPPLY CHAIN

DISCUSSION ON THE MAIN CHALLENGES AND TRENDS IN ALLERGEN MANAGEMENT WITH A FOCUS ON THE KEY ELEMENTS OF AN EFFECTIVE ALLERGEN CONTROL PLAN

1CONTENTS

ABSTRACTThe purpose of this white paper is to provide an overview on current thinking within the food industry for how best to manage allergen risk in the supply chain. The aim is to promote an understanding of the key principles of allergen risk management and best practice allergen management guidelines. This paper is aimed equally at those organisations with established allergen control and management plans as well as those considering development and implementation of allergen risk protocols.

I. EXECUTIVE SUMMARY 2

II. SCOPE OF THE STUDY 3

III. FOOD ALLERGIES AND ALLERGEN-RELATED PRODUCT RECALLS 3

IV. KEY PRINCIPLES OF ALLERGEN RISK MANAGEMENT 5

V. MAIN FINDINGS 7

VI. CONCLUSIONS 15

VII. REFERENCES 16

2An industry-wide survey on current allergen management practices conducted by SGS confirmed industrys need to harmonise its approaches on allergen management. Lack of consensus on allergen threshold levels is widely identified as the top gap in knowledge and number one priority towards achieving consistency in allergen risk interpretation and management as well as minimising the unnecessary use of precautionary labelling.

More and more companies require their suppliers to be GFSI certified to be included in their list of approved suppliers. A number of manufacturers operate additional allergen control practices and require their suppliers to comply and demonstrate their own management and control plans are equally effective. Internal label review, equipment/tool and people traffic within the operation, appropriately validated and verified cleaning protocols as well as systems that manage information of incoming raw ingredients are examples of such control practices that are part of all available best practice guidelines. Despite industrys awareness and application of such practices (to varying degrees) the increasing number of product recalls related to raw ingredient supplier issues, extending beyond allergens, indicates that supplier management is a weak link in the overall allergen management process. A deeper look into the current practices of qualifying and approving suppliers is therefore required.

Effective allergen management is a shared responsibility that requires consistency across the supply chain. Building awareness, identifying, sharing and promoting best practices can help align the supply chain towards a consistent and effective implementation of best practices.

I. EXECUTIVE SUMMARY

LACK OF CONSENSUS ON ALLERGEN THRESHOLD LEVELS IS AFFECTING CONSISTENCY IN ALLERGEN RISK INTERPRETATION AND MANAGEMENT.

3SCOPE AND PARAMETERS

The survey aimed to identify current industry practices on allergen management and examine the practical challenges industry is facing in the implementation of effective control measures.

During a period of 3 months, 230 individual responses were received which represented a range of companies from 46 countries across a number of different sectors (e.g. finished products, ingredient manufacturers, etc.).

A total of 27 questions investigated industry thinking on a number of key principles of allergen management such as allergen risk assessment, supplier management, staff training, approaches used to minimise/prevent allergen cross-contamination, and others.

II. SCOPE OF THE STUDY

III. FOOD ALLERGIES AND ALLERGEN-RELATED PRODUCT RECALLS Recently published data by Food Allergy Research & Education (FARE) indicate that up to 15 million Americans suffer from food allergies, affecting 1 in every 13 children under the age of 18 and bringing the economic cost of childrens food allergies alone to an estimated USD 25 billion per year. Food allergies among children increased approximately 50% between 1997 and 2011 while hospital admissions for severe reactions in children in Europe have risen seven-fold over the past decade. Every 3 minutes, a food allergy reaction sends someone to the emergency department accounting for more than 200,000 emergency department visits per year.

Allergen-related product recalls are mainly a result of some simple operational errors:

Failure in the review and approval of product labels

Failure to load and/or change to the correct product packaging

Failure to ensure separate tools are used to handle specific allergenic ingredients

Failure to notice the presence of allergens on a supplier certificate of analysis

However, no matter how simple and easy it would seem to fix these errors, the reality is that allergen-related product recalls in the EU continue to rise. In the US, undeclared allergens were the single largest cause of food recalls, representing approximately 40% of recalls reported in the third quarter of 2013 (ExpertRecall, 2013). The majority of those recalls are a result of the operational errors mentioned previously, namely mislabelling and mispackaging, but unintentional cross-contamination remains an important cause of allergen-related product withdrawals.

ALLERGEN MANAGEMENT: CHALLENGE, CONFUSION AND UNCERTAINTY

Food companies continue to face the challenge of ensuring consistency in controlling allergens across the food chain. Inconsistent use of allergen risk communication, such as the clear declaration of the presence of allergens on product labels, contributes to consumer confusion on what is safe to consume. This uncertainty forces consumers to largely ignore labels, potentially exposing them to greater risk.

The absence of universally agreed acceptable levels for allergens has led to the over-use of the fail-safe warning or precautionary labelling (e.g. may contain) on packs. In the absence of a consistent and harmonised approach towards allergen risk assessment and management, there is still a lot of uncertainty on how best to control allergen risk.

Different manufacturers have different approaches to identify and interpret allergen-related risk, and allergen-labelling regulations vary widely around the world. This lack of consistency increases operational complexity and leads to more labelling errors and associated product recalls.

THERE IS A NEED FOR HARMONISATION AROUND ALLERGEN TESTING PERFORMANCE CRITERIA AND STANDARDS.

4The hazard of hidden allergens occurring in the food chain has further generated a high demand for the implementation of sensitive methods able to trace allergens in different food commodities. There is a need for harmonisation around allergen testing performance criteria and standards in order to assure the reliability, accuracy and comparability of results. Harmonisation can also ensure that applied methods are fit for purpose. However, the absence of safe allergen threshold levels in itself questions the necessity to pursue the development of highly sensitive allergen testing technologies. It is argued that until such thresholds are agreed and adopted, the development of super sensitive methodologies would simply increase the incidents of allergen traces detected in foods, which could possibly counter allergen-free claims and limit consumer choice by depriving consumers of products that could otherwise be safe to consume.

AVAILABLE ALLERGEN MANAGEMENT GUIDELINES

Food and Drug Administration (FDA)

In the US, the Food and Drug Administration (FDA) is required to develop a voluntary allergen management program. Under the Food Safety Modernisation Act (FSMA) rules (FSMA Section 103), FDA registered facilities will be required to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards (i.e. biological, chemical, physical and radiological covering natural toxins, pesticides, drug residues, parasites, allergens, etc.) and hazards that occur naturally or those that may be unintentionally introduced.

Under FSMA rules, facilities will be required to implement appropriate preventive controls for the identified hazards, including at critical control points, to ensure that the hazards are

significantly minimised or prevented and in this case, the food will not be adulterated with undeclared allergens. The appropriate preventive controls will include the following:

Sanitation procedures for food- contact surfaces, including utensils and equipment

Staff training to cover supervisor, manager and employee hygiene training

Environmental monitoring and control programme to verify the effectiveness of process control against pathogens in cases where food is exposed to potential environmental contamination

Food allergen control programme

Recall contingency plan

Good Manufacturing Practices (GMP)

Supplier verification activities relevant to food safety

Facilities will be required to monitor the performance of the above preventive controls and establish corrective action procedures to cover their potential improper implementation, including adequate record keeping (i.e. written plan and documentation) covering monitoring of preventive controls, instances of non-conformance, instances when corrective actions were implemented, results of testing and/or other verification activities, and efficacy of preventive controls and corrective actions.

Foods Standards Agency (FSA)

At a European level, the need for consistency around allergen management principles and strategies led to the development of guideline documents on recommended practices. In 2006, the Foods Standards Agency (FSA) in the UK published the first guidance document on allergen management and consumer information with a particular reference to minimising allergen cross-contamination, as well as the use of precautionary labelling.

FoodDrinkEurope (FDE)

In January 2013, FoodDrinkEurope (FDE) published a guidance document on allergen management practices for food manufacturers. The document provides an overview of key elements in allergen risk management, including:

Staff training

Supplier management

Raw material handling

Equipment and factory design

Documentation and record keeping

Manufacturing processes

Product development/reformulation

Consumer information

FDE guidelines also include some practical implementation tips, an allergen risk assessment model, and an overview of the latest European legislation on allergen labelling.

British Retail Consortium (BRC)

A new best practice guideline document on allergen management in food manufacturing sites published in March 2014 by the British Retail Consortium (BRC) aims to provide additional explanation of the allergen management requirements of the BRC Global Standard for Food Safety. It has been designed to assist individuals and companies towards the development of robust allergen management systems and procedures that would meet the requirements of the standard.

IV. KEY PRINCIPLES OF ALLERGEN RISK MANAGEMENT

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RISK ASSESSMENT

The first step in allergen risk management is allergen risk assessment. This covers the identification of the hazard and those activities able to increase the probability of that hazard occurring, referred to as risk factors. The latter may be of particular importance considering that in a lot of operations the same manufacturing facilities are used to manufacture food for both allergen-containing and allergen-free products (or those not intentionally containing allergens). In these instances the possibility for cross-contamination does exist.

Identification and assessment of risk factors need to cover the entire manufacturing operation to identify at what point and how allergens may enter and transfer while onsite. Some considerations would be:

Where are allergens stored?

How are allergens stored?

How are allergens handled?

Who is responsible for executing these activities?

Who is responsible for monitoring these activities?

The results of an allergen risk assessment can identify and optimise the appropriate prerequisite programmes as part of the allergen risk management process, with the aim being to minimise the likelihood of cross-contamination.

The need to effectively manage the potential risks from allergenic foods in a food production environment is widely acknowledged, as is the fact that allergen management needs to be integrated within existing food safety management systems. It needs to take into account all different operations (i.e. sourcing of raw materials, manufacturing, processing, packaging of the end product, new product development) rather than being a completely separate system. To be effective, the process

must be carried out by appropriately trained staff and be facilitated by well documented, visible and readily available procedures that cover the control and prevention of allergen contamination.

A detailed account of recommended activities under each key element of allergen risk management is included within FDE guidance and within the framework document for food processors published by the Food Allergy Research and Resource Program (FARRP) on the components of an effective allergen control plan. Highlights from FDE and FARRP guidance are compared with the relevant key findings from this industry survey on current allergen management practices in the next section.

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7V. MAIN FINDINGSPRECAUTIONARY LABELLING

Precautionary labelling claims on products were used as follows by respondents:

64.3% may contain

33.5% allergen-free

22.5% gluten-free

10.6% nut-free

9.7% lactose-free

Other claims included contains sulphites and/or other allergens

PEOPLE TRAINING AND EDUCATION

Anyone involved in the commercialisation, production and distribution of foods should be fully aware of the presence of food allergens, and know the measures to minimise the risk of allergen cross-contamination, and what immediate action to take in the case of suspected risk of contamination. However, this means permanent, temporary and contract employees must go through training specific to their job responsibilities.

Training programme procedures

There are certain procedures that would ideally be included in a training programme (FDE, 2013), some of which are listed here:

General awareness of allergens, their impact to consumers and the business

Awareness of allergen presence in raw materials and ingredients linked to requesting, accessing, and reviewing relevant supplier information (e.g. supplier specifications, supplier audit reports)

Procedures for storage of raw materials and finished products, verified and validated cleaning regimes, handling rework, managing label controls, and waste management

People and equipment movement around the site, including visitors, use/traffic of maintenance tools, food trays, plus others across the site

Managing the risk of potential exposure of allergic employees/visitors to allergenic ingredients

Human resources procedures and housekeeping rules

QUESTION: PLEASE INDICATE THE ALLERGEN-RELATED CLAIMS YOU MAKE ON YOUR PRODUCT LABELLING?

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May contain

Allergen free

Gluten free

Nut free

Lactose free

65.8% OF RESPONDENTS STATE AN ALLERGEN-FREE PRODUCT RANGE IS PART OF THEIR 5-YEAR PRODUCT DEVELOPMENT STRATEGY.

NB: The list changes based on the type of the operation and its specific requirements identified.

Independent of the requirements identified per site, training should be repeated on a regular basis and its content regularly reviewed and updated as conditions change within the site.

Survey results

Along with the development of a training programme, the delivery channels are equally important to ensure it achieves maximum effect:

79.6% of respondents rely on electronic communications (e.g. e-mails, e-news, etc.) to ensure personnel are updated on key allergen issues and regulations

44.3% ensure personnel attend regular training courses

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8For companies that offer inhouse training for employees:

66.5% include HACCP/GMP training

63.6% include general awareness on allergen risks and consequences

54.5% include hygiene training

40% include allergen labelling and regulatory updates

38.6% include raw ingredients risk assessment, handling and specifications review

31.3% include record keeping and incidence reporting

30.7% include people and equipment traffic within the site

25.6% include recall procedures

Given that the vast majority of allergen-related product recalls are due to operational errors, it is clear that relying on electronic communications may not be sufficient to provide the required

level of staff training and education which should cover the what and how, and most importantly, the why for specific actions needing to be taken. The value of hands-on training should be reinstated to cover troubleshooting through real-time practical scenarios, and ensure theory coverts to practice.

SUPPLIER MANAGEMENT

The commitment to produce safe products should be extended to include the whole supply chain. Such commitment needs to be clearly demonstrated through setting up specific responsibilities and expectations at all levels. This ensures food operators at any point in the supply chain are able to receive the correct information on the allergen status of incoming raw ingredients that they will be eventually handling within their facility.

Suppliers

Suppliers should be expected to have a documented allergen control plan and a procedure in place to review its effectiveness on a regular basis. They should also have the appropriate procedures to communicate any changes in their ingredients that may affect allergenic status, and therefore, the status of the ingredients end application. Suppliers should be expected to train their own personnel in all the important aspects of allergen management previously mentioned, and maintain accurate records of such training. For allergen cleaning programmes and protocols, suppliers should have in place regularly validated and reviewed processes, which are made readily available for external review and audit.

QUESTION: PLEASE INDICATE THE AREAS COVERED WITHIN YOUR INHOUSE ALLERGEN TRAINING COURSES?

HACCP & GMP

General awareness

Hygiene training

Labelling & updates

Raw ingredients

Records & reporting

People & equipment

Recall procedures

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9Food operators

Food operators should not just rely on information provided by their suppliers. They need to ensure that the allergen status of incoming ingredients is fully described in the suppliers packaging, labelling and specification declarations. In addition, the ability to review the specifications and documents is

essential. For some food operators, reviewing supplier specifications is a desktop exercise, however, assessing supplier allergen management practices should involve an onsite audit, with the findings of any audit documented. Procedures should be in place to describe how supplier documentation and information is handled, stored and communicated through the site.

Food operators need to be able to inspect the supplier change notification process to ensure its effectiveness. They also need to have systems in place to benchmark the potential risk imposed by alternative ingredients/suppliers that may have to be used in the event of substitution; with the results accurately recorded and documented.

Survey results

When verifying suppliers:

25.5% of respondents take supplier information at face value without including any additional verification procedures

For companies that do include additional verification procedures:

55.9% rely on reviewing certificates of analysis

41.9% use vendor questionnaires and surveys

41.3% conduct testing (i.e. inhouse or third party) of the end product

23.5% ensure random sampling of incoming raw ingredients

Packaging risk is considered as follows:

40.8% verify the allergenic status of the packaging material in contact with the raw ingredients

29.5% identify packaging itself as a potential source of allergens and include that risk in allergen management plans

Asked to select the statement that best describes their supplier approval process:

55.1% review their approved supplier list once a year

QUESTION: SELECT THE INTERNAL PROCEDURES USED TO VERIFY AND VALIDATE SUPPLIER CLAIMS?

Review certificates of analysis

Vendor questionnaires

and surveys

Testing of the end product

Random sampling of raw ingredients

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20.7% OF RESPONDENTS INCLUDE ALL ADDITIONAL VERIFICATION PROCEDURES.

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47.2% of respondents supplier audits involve both a document review and in-factory audits

26.1% of in-factory audits are unannounced

42% of respondents include sampling and testing as part of their supplier approval process

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RAW MATERIAL HANDLING AND THE MANUFACTURING PROCESS

Clear identification of incoming raw materials and ingredients as well as accurate labelling and segregation are the main important steps against cross-contamination. Recommended practices include appropriate manage-ment (mainly through segregation) of allergenic materials at all stages of the manufacturing process, including picking and transfer. Where sufficient segrega-tion is not possible or where allergenic materials are stored in non-segregated areas then other practical approaches should be used to prevent cross-con-tamination (e.g. use of bottom-level rack-ing or storing like allergens together, etc.)

Sampling

On delivery, sampling of allergenic ingredients should ideally be carried out using disposable sampling kits. Where this is not practically possible, separate and easily distinguishable tools should be used instead. All containers of allergenic ingredients should be inspected at delivery, prior to unloading. Any damaged containers should be isolated and handled at receipt ideally using allergen spillage procedures that should already be in place.

Recipe verification

It is important during the manufacturing process to ensure that the right materials are used in the recipe. Recipe verification can be facilitated by the use of technology in the form of barcode cross-checking. This would check the barcodes in the recipe against those of the ingredients when these are weighed out, prior to mixing. This ensures the operator can only proceed provided a complete match is achieved.

Planning/scheduling

The appropriate production planning/scheduling should also be in place. It should include the order in which different products are manufactured and packaged to prevent cross-contam-ination. This is of particular importance in cases where the same manufacturing facility is used to process allergen- containing and allergen-free products.

Post-production

Post-production controls would involve procedures used to ensure that the correct labels are uploaded and applied to products, and regularly audited to ensure their effectiveness. Where recipe changes affect product labelling and render existing packaging inappropriate to use, product labels should not only be withdrawn from use but be physically destroyed to prevent any potential reuse.

Zoning

The recommended approaches that can be followed to ensure production of allergen-containing products is separated from that of allergen-free products, or products that contain different allergens are as follows:

Dedicated areas or zones within the production facility

Physical barriers between production lines

Implementation of an appropriately designed production scheduling (e.g. after the last full cleaning, products containing no allergenic material are manufactured first)

Rework

Rework should be treated as an ingredient and the responsibility for its appropriate storage, labelling, handling and overall use needs to be defined and assigned to ensure that rework handling is appropriately managed and documented. Implementation of the principle of identical-into-identical is recommended for rework use. It is critical that rework should only be used in another batch or run of the same product or a product containing the same allergen.

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EQUIPMENT AND FACTORY DESIGN

Critical allergen-related risks linked to equipment and factory design come from the selection of incorrect or inappropriate equipment, and the potential for cross-contamination between materials and/or products manufactured on the same line.

Good Manufacturing Practices (GMP)

Application of GMP is thought to be the basis for minimising critical allergen-related risks from the above. Recommended approaches are mainly based on:

Separation and segregation

Managing and limiting people and equipment traffic across the site

Dedicated and easily distinguishable equipment

Appropriately validated cleaning regimes

Sufficient space around equipment and between production lines to ensure cleaning is effective and to facilitate adequate inspection and maintenance

Prevention and/or mitigation of the potential for airborne impacts

DOCUMENTATION AND RECORD KEEPING

For the application of effective allergen management there is a need for efficient and accurate record keeping which covers all the different aspects of an operation (e.g. training, manufacturing, cleaning, supplier management, etc.). Ideally, this should be integrated to already existing operations. A record keeping system needs to be simple to follow, maintain and communicate in order to ensure maximum uptake by employees.

QUESTION: SELECT THE APPROACHES IMPLEMENTED TO MINIMISE ALLERGEN CROSS-CONTACT AND UNINTENTIONAL CONTAMINATION?

Proper labelling

Appropriate segregation

Production scheduling

Rework & WIP

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Survey results

The results confirm that respondents are aware of and already implementing some, if not all, of the recommended practices to minimise allergen cross-contamination, including:

54.5% ensure proper labelling for all allergenic ingredients

52.3% apply appropriate segregation of allergenic ingredients and finished products

42.6% operate appropriate production scheduling

36.9% verify incoming ingredients do not contain undeclared allergens

34.1% control rework and work in progress (WIP)

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27.8% OF RESPONDENTS INCLUDE ALL RECOMMENDED PRACTICES TO MINIMISE ALLERGEN CROSS-CONTAMINATION.

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Allergen control and management plan

The allergen control and management plan needs to be a written document that:

Adequately describes the process of allergen risk assessment that has been used to identify the appropriate allergen management approaches taken, as part of due diligence

Includes details of how the programme is validated, and its ongoing verification

Clearly defines the allergen control team and their individual responsibilities and roles in the operation

Includes an allergen flow diagram or allergen map that illustrates the presence and traffic of allergenic ingredients throughout the operation

Is specific to the processing facility and is regularly reviewed and updated, as necessary

QUESTION: IN THE CORPORATE ALLERGEN CONTROL/MANAGEMENT SYSTEM, SELECT THE AREAS COVERED WITHIN INHOUSE PROGRAMMES?

Raw ingredients

Monitor labelling

Manufacturing processes

Track facilities & equipment

Supplier management

Conduct staff training

Recall procedures

Product development

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Survey results

The development and maintenance of an allergen control and management plan is one of the fundamentals of effective allergen management, and our survey shows:

28.6% of respondents state their companies do not operate within a corporate allergen management plan

Even though companies may operate on some other localised food safety management systems instead, the absence of a systematic and corporate-level process is a concern.

For respondents that do operate within a corporate allergen management plan, the following areas have been considered:

76.5% manage raw ingredients handling

66.9% control manufacturing processes

59.6% monitor labelling

56% track facilities and equipment use

50% conduct staff training

49.4% include supplier approval processes

46.4% apply product development and reformulation

37.3% have recall procedures

28.9% OF RESPONDENTS INCLUDE ALL AREAS IN THEIR INHOUSE CORPORATE ALLERGEN MANAGEMENT PLAN.

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Related to inhouse allergen management plans:

43.5% of inhouse plans have been developed based on the contribution of an inhouse allergen control team

41.7% of inhouse plans have been developed based on a combination of inhouse expertise and third-party input (e.g. external consultants)

Across the disciplines and different groups within an organisation involved in the development of allergen management plans:

84.6% manage food safety

79.7% focus on quality

69.2% cover production/manufacturing

39.6% consider regulatory processes

38.3% monitor procurement

37.9% deliver research and development

HACCP was the top approach used in allergen management, selected by 73.1% of respondents, used in combination in some cases with:

57.2% risk assessment

55.8% traceability

41.8% supplier audits and supplier approval processes

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RISK COMMUNICATION AND LABELLING

Labelling is an important risk management and communication tool. Allergen risk communication must adhere to existing legislation to declare to consumers any foods known to cause significant allergies when intentionally used as ingredients in products as part of the recipe. However, currently there is no legislation for the unintentional presence of allergens in a product due to cross-contamination. For this reason, precautionary labelling has been extensively adopted by the food industry.

Regulation (EU) 1169/2011

From 13 December 2014, Regulation (EU) 1169/2011 on the provision of food information to consumers will considerably change existing legislation on food labelling, including information and requirements on allergens. It outlines requirements relating to allergens such as mandatory particulars, the labelling of certain substances or products causing allergies and intolerances, additional voluntary information, and allergen labelling of non-prepacked foods.

The allergen-relevant articles within Regulation (EU) 1169/2011 are as follows:

Article 9.1(c): Mandatory particulars

Article 21: Labelling of certain substances of products causing allergies or intolerances

Article 36.3(a): Additional voluntary allergen labelling (may contain)

Article 44.1(a) and 44.2: Allergen labelling of non-prepacked foods

Annex II: List of substances or products causing allergies or intolerances

A supplementary guidance document on Regulation (EU) 1169/2011 has been published by FDE in collaboration with EuroCommerce to assist in the effective implementation of the rules (FDE, September 2013).

KEY KNOWLEDGE GAPS AND INDUSTRY NEEDS

The survey asked respondents to identify what they perceive the knowledge gaps are in allergen management and effective implementation, and select areas where they require more support.

Survey results

When identifying key knowledge gaps:

67.1% state a lack of consensus on internationally harmonised safe threshold levels

58.2% state a lack of development and validation of allergen testing methodologies

46.6% state a lack of allergen cross-contamination labelling rules

41.8% state a lack of effective cleaning methodologies

Additional responses note a lack of awareness on the best methodology to use for the detection and targeting of allergens and allergen levels following cleaning.73.1% OF RESPONDENTS

USE HACCP IN ALLERGEN MANAGEMENT.

21.6% OF RESPONDENTS USE HACCP, RISK ASSESSMENT, TRACEABILITY, AND SUPPLIER AUDITS IN PARALLEL WITHIN THEIR ALLERGEN MANAGEMENT PLANS.

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The survey highlighted which areas of support from a third party can add value to respondents businesses, including:

45.9% for allergen risk assessment

36.3% for labelling and regulatory advice

32.2% for analytical testing

31.5% for HACCP/GMP

31.5% for supply chain management

27.4% for support on cleaning and validation

26% for traceability

19.9% for hygiene

Other allergen research

Extensive reviews of the current clinical and other research related to food allergen thresholds have been carried out by reputable organisations such as The Allergen Bureau in Australia and New Zealand, Food Allergy Research and Resource Program (FARRP), TNO, and the International Life Sciences Institute (ILSI) in an effort to propose safe allergen reference doses that could be used by the food industry, regulators and others. It is expected that it will be some time before a multistakeholder consensus is reached, and before endorsement by regulatory agencies is achieved.

QUESTION: INDICATE IN WHICH AREAS A THIRD PARTY CAN ADD VALUE TO YOUR BUSINESS?

Allergen risk assessment

Analytical testing

Labelling & regulatory advice

HACCP & GMP

Cleaning & validation

Supply chain management

HygieneTraceability

88.3% OF RESPONDENTS ARE NOT FAMILIAR/AWARE OF THE VOLUNTARY INCIDENTAL TRACE ALLERGEN LABELLING (VITAL) CALCULATOR, CLOSELY MATCHING THE 88.9% OF RESPONDENTS NOT CURRENTLY USING VITAL.

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VI. CONCLUSIONSGiven that each operation is different, allergen management approaches should be designed against individual specifications, needs and requirements. Applying a one-size-fits-all solution would not be effective and would therefore not be recommended.

Allergen tools

Originally developed by The Australian Allergen Bureau as a risk assessment and labelling tool, the Voluntary Incidental Trace Allergen Labelling (VITAL) calculator is not being used by 88.9% of survey respondents, largely due to 88.3% of those respondents being unaware/unfamiliar with the tool. Along the same lines, 88.2% of participants are unaware of the allergen management guidance document

published by FDE (FDE, January 2013). The FDE guidance was primarily developed in order to harmonise allergen management at EU level, however its recommended practices are generic enough to be widely applied.

Staying up-to-date

Due to the complexity and impact to consumers, and operational impact, it is imperative that everyone involved in allergen management is continuously

In most, if not all cases, effective allergen management relies on three main constituents:

1. Top management commitment to approve necessary reforms

2. Staff training designed around specific operations, job responsibilities, roles, and individual involvement in the allergen management process; with regular reviews and updates to ensure continuous compliance

3. Consistent implementation of standard operating procedures (SOPs) that need to be in place to cover key elements of the operation (e.g. cleaning and training)

Operational consistency across the supply chain is a major challenge for industry and requires a wider consensus on key elements of allergen risk management, a review of the existing training curriculum based on identified gaps in knowledge and needs, and regular calibration of all implicated parties to ensure continuous alignment.

Furthering excellence in allergen management can only be achieved through effective communication, sharing of knowledge and experience, and implementing proven best practices.

kept up-to-date in a number of key areas, including:

Status of allergen threshold levels

Use of allergen threshold levels in allergen risk management

New initiatives in the form of guidelines and/or recommended best practices that may be occasionally published by different industry or other research bodies around the world

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VII. REFERENCESCampden BRI

Food Allergens: Practical Risk Analysis, Testing and Action Levels

(2013: Guideline No. 71. Campden BRI, UK)

ExpertRecall

Quarterly Recall Index

(Last accessed: 6 March 2014)

http://recall.stericycleexpertsolutions.com/index/

Regulation (EU) 1169/2011

On the Provision of Food Information to Consumers

(Last accessed: 8 March 2014)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:EN:PDF

Food Allergy Research & Education (FARE)

Food Allergy Facts & Statistics

(Last accessed: 6 March 2014)

http://www.foodallergy.org/facts-and-stats

Food Allergy Research and Resource Program (FARRP)

Components of an Effective Allergen Control Plan

(Last accessed: 6 March 2014)

http://farrp.unl.edu/wat/allergen- control-plans

FoodDrinkEurope (FDE)

Guidance on Food Allergen Management for Food Manufacturers

(Last accessed: 6 March 2014)

http://www.fooddrinkeurope.eu/publication/fooddrinkeurope-launches-guidance-on-food-allergen-management

FoodDrinkEurope (FDE)

Guidance on the Provision of Food Information to Consumers

(Last accessed: 6 March 2014)

http://www.fooddrinkeurope.eu/S=0/publication/guidance-on-the-provision-of-food-information-to-consumers/

Food Standards Agency (FSA)

Guidance on Allergen Management and Consumer Information

(Last accessed: 6 March 2014)

http://www.food.gov.uk/businessindustry/guidancenotes/labelregsguidance/maycontainguide

Gendel, M

Comparison of International Food Allergen Labelling Regulations

(2012: Regulatory Toxicology and Pharmacology, 63, 279-285)

Food and Drug Administration (FDA)

Food Safety Modernization: Title I General Food Provisions, Section 103 Hazard Analysis and Risk-Based Preventive

Ward, R, Crevel, R, Bell, I, Khandke, N, Ramsay, C, and Paine, S

A Vision for Allergen Management Best Practice in the Food Industry

(2010: Trends in food science and technology, 21, 619-625)

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ABOUT THE AUTHOR

Dr Evangelia Komitopoulou Global Technical Manager for Food, SGS

Dr Evangelia Komitopoulou is the Global Technical Manager for Food at SGS. She is responsible for providing technical support to the global network of certification and auditor teams and is the Product Manager for SGS Gluten-Free Certification Services. Evangelia is an expert food microbiologist with specific areas of experience in microbiological risk assessment and specifications, food processing and preservation. Evangelia is recognised for her involvement in the development and validation of microbial detection and antimicrobial assay methodologies as well as the identification and evaluation of novel and natural antimicrobial systems in food preservation. With a career which includes over 10 years spent in food technical consultancy, troubleshooting and contract applied research and development, Evangelia is also the author and editor of many technical reports and articles.

ABOUT SGS

SGS is a leading independent third-party service provider offering efficient solutions to help safeguard quality, safety and sustainability throughout all stages of the global food supply chain. SGS can fulfil all your testing, certification, technical assistance, audit, inspection and verification needs.

SGS is the worlds leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.

Enhancing processes, systems and skills is fundamental to your ongoing success and sustained growth. We enable you to continuously improve, transforming your services and value chain by increasing performance, managing risks, better meeting stakeholder requirements and managing sustainability.

With a global presence, we have a history of successfully executing large-scale, complex international projects. Our people speak the language, understand the culture of the local market and operate globally in a consistent, reliable and effective manner. We have a harmonised approach to delivering services to our customers, leveraging the largest independent network of consumer product experts in the world.

FOR MORE INFORMATION ON SGS SERVICES AND SOLUTIONS FOR ALLERGEN MANAGEMENT IN FOOD SUPPLY CHAINS VISIT WWW.SGS.COM OR CONTACT FOODSAFETY@SGS.COM

PLEASE VISIT WWW.SGS.COM/WHITEPAPERS TO REVIEW OUR OTHER WHITE PAPERS ABOUT FOOD QUALITY, SAFETY AND SUSTAINABILITY

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