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Allergen Management

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Training participants will gain a basic understanding of Allergen Management and its applications within food safety and quality systems. Basic knowledge competency will be verified through successful completion of the accompanying Allergen Management assessment activity. Basic skill competency can be verified through the Allergen Management competency checklist available as a resource for this training activity.

Key Definitions For Allergen Management
- Allergen: A normally harmless substance which creates a reaction in the body of a sensitive individual.
- Cross Contact: Description of the incidence of allergenic materials becoming part of a foodstuff or process not specified to contain that foodstuff as a declared ingredient.
- Cross Contamination: Description of the incidence of an unwanted material becoming part of a foodstuff or process.
- Food Intolerance: Food intolerance is an adverse food-induced reaction that does not involve the immune system.
- HACCP: Hazard Analysis Critical Control Point or HACCP is a science based risk management system, relying on identification and recognition of specific hazards, and nominates measures for their control to ensure the safety of food.
- Immunoglobulin E or IgE: A substance created by the human body after an “allergic” person has consumed a particular allergenic food, potentially resulting in anaphylaxis, hives, asthma, or other common symptoms of an allergic reaction.

Allergen Management Development
When considering the development, documentation and implementation of Allergen Management within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

About Allergen Management
Food allergens only affect a relatively small percentage of the population, but can be life threatening under certain circumstances. Allergens are contained within many different foods and food ingredients, but can also be introduced into foods through inappropriate production scheduling, raw material contamination, in-effective raw material, product and work in progress identification and traceability and in-effective cleaning and sanitation programs. Allergen management programs should be applied with the intent of controlling and managing the use of allergenic materials, production processes and pre-requisite programs within any food business.

Historical food safety and quality management systems utilised “Cross Contamination” as a term to define allergen interactions; contemporary food safety and quality management systems use the term “Cross Contact”, meaning there may be an acceptable limit of specified allergens within a particular foodstuff. The term “Cross Contamination” generally indicates the un-acceptable presence of a substance within foodstuffs.

About Allergens
An allergy is the reaction of the immune system to a normally harmless substance. This occurs when the body mistakenly believes that a food is harmful, and creates specific antibodies to attack the substance. The next time the individual eats that particular food, the immune system releases massive amounts of chemicals including histamines which are intended to protect the body against the substance. These chemicals can cause a variety of allergic symptoms that can affect the respiratory system, gastrointestinal tract, skin or cardiovascular system. Allergies are often mistaken for a food intolerance or sensitivity, which are generally of less concern than genuine allergies.

Allergenic sensitivities vary from one person to another and it is possible to be allergic to an extraordinary range of substances. A common example of a genuine allergic reaction occurs when the body creates Immunoglobulin E or IgE antibodies after the person has consumed the food. When these IgE antibodies react with the food, histamine and other chemicals called "mediators" can cause hives, asthma, or other common symptoms of an allergic reaction. This reaction is usually classed as an Anaphylaxis, which is a sudden, severe and potentially fatal allergic reaction that can involve numerous systems within and on the exterior of the body. One form of treatment for Anaphylaxis is the administration of sterile epinephrine to the person experiencing anaphylaxis, which suppresses the body's overreaction to the allergen, and allows time for the patient to be transported to a medical facility.

Food Intolerance
Food intolerance is an adverse food-induced reaction that does not involve the immune system. True food allergies include activation of the immune system. An example of food intolerance is lactose intolerance, which is usually when a person does not have any or enough of the enzyme required to digest milk or milk products. If a lactose intolerant person consumes milk or milk products, they might suffer from bloating and abdominal pain, but there is no production of any chemicals related to the immune system within the body.

Foods Commonly Associated with Allergies
A variety of foods contain ingredients that can cause adverse reactions in hypersensitive individuals. Most adverse food reactions are caused by the following foods and products made from them – Peanuts and products containing peanuts, Tree Nuts including almonds, brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts and products containing tree nuts, Sesame Seeds and products containing sesame seeds, Milk and products containing milk, Egg and products containing egg, Fish and products containing fish, Crustaceans including crab, crayfish, lobster, and prawns and products containing crustaceans, Shellfish including clams, mussels, oysters and scallops and product containing shellfish, Soy and products containing soy, Wheat Gluten and products containing wheat gluten, Sulphites and products containing sulphites. It is important that products containing even small amounts of the allergens listed above are identified with appropriate labelling to ensure allergen sufferers can avoid relevant foods.

Other foods such as Pumpkin, Celery, Celeriac, Corn, Maize, Legumes are also often found to be food allergens.

Common hidden sources of allergens in foods include:

- Peanut oil is sometimes used as an ingredient or a processing aid;
- Asian foods may contain peanuts in the form of oil, pastes, sauces or garnish;
- Crushed Nuts which are commonly used within baked goods and desserts may contain peanuts;
- Producers, processors and packers of other nuts may use the same equipment for peanuts;
- Some breakfast cereals may contain peanuts.

Tree Nuts
- Some manufactured meat products may contain tree nuts, for example, pistachio nuts in Mortadella;
- Dessert items may contain tree nuts, or traces of tree nuts;
- Baked goods such as crackers and cereals may contain tree nuts;
- Some breakfast cereals may contain tree nuts.

Sesame Seeds
- Some Asian and Middle Eastern foods may contain sesame seeds in the form of oil, pastes, sauces or garnish;
- Sesame is often used within sauces such as Tahini and Hommous.

- Casein, a milk protein is often used in processed fish, meat and non-dairy products;
- Butter and cream are often found within ready-to-eat prepared foods from restaurants and cafes;
- Meat slicing equipment is often used to slice meats, dairy products and other items.

- Egg albumen protein may be used as a processing aid, in both dried and wet forms;
- Egg lecithin emulsifier may be used an agent in processed items;
- Whole or parts of eggs may be used in dressings such as mayonnaise;
- Some pastas and pasta products may contain egg, both within the pasta, and fillings.
- The equipment used to make egg-free pasta may also be used to produce pasta that contains egg.

Fish, Crustaceans and Shellfish
- Ethnic dishes from regions such as the Mediterranean, Northern Africa and Asia often contain fish, crustaceans and shellfish. This includes fish content within sauces and ingredients such as fish sauce, oyster sauce, dried anchovies, whole anchovies and other dried fish, crustaceans and shellfish varieties;
- Fish, crustacean or shellfish stock may be used in prepared foods, both within foods and sauces;
- Traditional Worcestershire sauce contains anchovies;
- Omega 3 is commonly sourced from fish.

- Soy and soy products are often used as processing additives within fish, meat, dairy and non-dairy products;
- Soy oil is sometimes used as an ingredient, processing aid or lubricant;
- Asian foods may contain soy and soy products in the form of oil, pastes, sauces or garnish;
- Soy products such as tofu in fresh, fried, paste, dried or marinated forms may be used in some Asian foods;
- Derivatives of Soy are often used in food processing for their functional effects on processed or manufactured foods.

Wheat Gluten
- Wheat products are often used as functional additives within fish, meat, dairy and other products;
- Wheat Glucose may contain traces of Gluten.

- Sulphites are given many different names including Sulphur Dioxide, Sodium Sulphite, Sodium Bisulphite, Sodium Meta-bisulphite, Potassium Bi-sulphite and Potassium Meta-bisulphite;
- Sulphites are commonly used as a preservative in many food products and beverages.

Allergen Sufferers
Consumers with food allergies are generally advised to contact the manufacturer of a particular product, and in the case of restaurant meals, to enquire about the ingredients used prior to consumption. If allergen suffers are in doubt about a certain food, it is best to avoid it totally, rather than risking an allergic reaction.

Oral Allergy Syndrome
ral allergy syndrome is an allergic reaction to certain proteins in a variety of fruits, vegetables and nuts, which develops in some people with pollen allergies. It is referred to as an oral allergy syndrome because it usually affects the mouth and throat. These reactions are generally not related to pesticides or metals.

Oral allergy syndrome is nearly always preceded by hay fever and tends to occur most often in older children and adults. It is usually associated with pollen allergies but it can also affect people with allergies to the pollens of grass, and other plants. These reactions can occur at any time of year, but are often worse during the pollen season.

Symptoms may include itching and burning of the lips, mouth and throat, watery itchy eyes, runny nose and sneezing. Some individuals report that peeling or touching the offending foods may result in a rash, itching or swelling where the juice touches the skin. More serious reactions can include hives and swelling of the mouth, pharynx and windpipe. In rare cases, severe allergic reactions have been reported such as vomiting and diarrhoea, bronchial asthma, generalised hives and anaphylactic shock. Symptoms usually develop within minutes of consuming or touching the food, but occasionally occur more than an hour later. A variety of fruits, vegetables and their juices, including orange, tomato, apple and grape, sometimes cause skin rashes and diarrhoea, especially in young children. Strawberries and pineapple can occasionally cause hives.

Most oral allergy reactions are caused by raw foods, since allergenic proteins are usually destroyed by cooking. The main exceptions to this are celery and nuts which may cause reactions even after being cooked. Some plant parts, such as the skin, may be more allergenic than others; however the allergic characteristics of some fruits appear to decrease during storage. Foods associated with the oral allergy syndrome, which has occasionally been reported to cause anaphylactic reactions, include: kiwifruit, hazelnut, white potato, celery, parsley, beans and cumin.

Individuals who are hypersensitive to specific foods usually find that they can consume these foods if they are well cooked, canned or microwaved. People who develop a rash, itching or swelling when touching or peeling these foods may prevent this by wearing gloves. Consultation with a qualified allergen specialist is recommended to determine the cause of reactions to plant foods, and whether any special precautions are advisable.

Control of Allergens Within a Food Business
Various processes and controls may be put in place to manage allergens on site and prevent food which should not contain certain allergens from containing them.

These may include:
- Control of allergens on site through purchasing. This may include obtaining raw material specifications prior to purchasing products in order to assess, and restrict if necessary, the allergens within each required raw material;
- Control of processes such as re-working, which may potentially contaminate non-allergen products with allergenic ingredients. It is common for policies and procedures to be developed, documented and implemented to ensure that only “like for like” products are reworked into each other, or alternately, for a matrix of reworkable products to be made available for production scheduling and operational teams;
- Giving consideration to the purchase of synthetic flavorings and functional raw materials if the requirement is to restrict or eliminate certain allergens from the food business site. For example, synthetic peanut flavoring that does not contain peanuts or glazing for baked products that does not contain egg may be used;
- Identification and storage of allergens in designated areas, including grouping similar allergens where possible;
- Storage of allergenic material on lower shelving / racking to prevent spills onto non-allergenic materials;
- Where possible, segregating preparation and processing areas, manufacturing or packaging lines for allergenic and non-allergenic foods;
- If the same preparation and processing areas, manufacturing or packaging lines have to be used for processing, consider scheduling of non-allergenic products prior to processing allergenic products. Allergen scheduling is one of the most prominent methods for controlling allergen cross contacts within food businesses that produce both allergen containing and non-allergen products;
- Specified allergen cleans between batches of allergenic and non-allergenic products. The verification of “allergen” cleaning activities between batches of products is commonly verified through the use of rapid testing methods that detect the presence of proteins on the surfaces cleaned;
- Training of staff in basic allergen management and ensuring all possible measures are taken to prevent allergen cross contact. For example glove changing, hand washing, uniform control, utensil washing and staff site movements should be considered within targeted Allergen Management training.

Allergen Labelling
Undeclared ingredients on food labels may occur because of production and packaging instances such as “carry-over” or “hang ups” of product or work in progress within production and packaging systems. This may occur due to incomplete cleaning of surfaces and utensils, incorrect or incomplete listing of ingredients, or unknown ingredients in raw materials. Precautionary allergen labelling must be accurate and adequate, and must not take the place of good manufacturing practices.

In instances where precautionary or advisory allergen labelling is applied, it is important to consider that sales of product may be affected by “over declaring” the potential for a product to contain an allergen that is not actually an ingredient. A structured risk-based methodology should be applied and documented to display the outcomes of such risk assessments.

It is important to consider any legislative requirements for the labelling of allergens within any food product. This is particularly important where foods contain ingredients which are pre-formulated, and are added.

Additional Relevant Information 
The following information is provided from other foodindustrycompliance.com Training Activities as the content is relevant to Allergen Management:

General Product Labelling
Depending on the type of food your customers are buying and the intended usage of the food, it may or may not require labelling. There is generally no requirement for items produced for consumption within a premise to be labelled with details of ingredients and usage details. Labelling requirements for specific products or product groups are defined with the applicable food standards legislation.

General labelling requirements for products for retail sale include:
- Product name;
- Manufacturer address and contact details;
- Manufactured on, Use By, Best Before Date. These dates must be objective regarding the type food being packaged, and its intended use;
- Ingredients, usually in descending order from most proportionate to least proportionate;
- Allergy concerns, for example, contains or may contain “specified allergen”;
- Specific usage instructions, for example “Keep refrigerated and use within 24 hours”;
- Nutritional Information Panel or NIP The documented content of the labelling NIP must be verified to ensure the information displayed is appropriate;
- Country of origin declaration;
- Net Weight and Gross Weight.

The aim of labelling is to provide consumers with information that will ensure they can make an informed decision regarding their choice of food, and to ensure its safety at the time of consumption providing it has been handled and used according to the nominated requirements.

It is important to ensure that labelling review activities are scheduled, conducted and recorded on an ongoing basis to ensure labels are accurate, and meet customer and regulatory requirements. The frequency for labelling review activities is often nominated to meet customer requirements, though annually is a common minimum frequency.

HACCP Purpose
The Purpose of the HACCP Plan should define the intent of the HACCP Plan regarding the identification and control of hazards. In the context of contemporary food safety management systems, it is quite common to see quality and regulatory aspects included within the Purpose of the HACCP Plan. Some HACCP Purposes may require a mention of specified hazards or hazard types, especially where high risk products are concerned.

An example of a HACCP Purpose which is generally suitable for most HACCP Programs is as follows:
- The purpose of the HACCP Plan is to identify and control all relevant Microbiological, Chemical, Physical, Allergen, Quality and Regulatory hazards.

Product Description – HACCP Step 2
The second step in HACCP implementation involves assessment of the food products that are being produced or handled by the food business. Where a service is being provided rather than a product, a similar method can be applied. The information gathered will assist in the identification of hazards that may be present in either ingredients or materials used in the processing of food. The use of comprehensive standard recipe forms can simplify this task, allowing all input materials and ingredients, as well as processing, storage and treatment methods to be plainly viewed. This step should also include references to appropriate legislative and industry guidelines, or scientific validations regarding the documented Product Description and Intended Use. Generic Product Descriptions may be developed for product groups rather than each individual line where applicable.

When compiling a Product Description, the following should be addressed as a minimum:
- Product name: Including its menu name or other names that are used to describe it within the workplace or by consumers;
- Product composition: A comprehensive listing of all ingredients and materials for the product including ingredient specification, packaging, supplier listings and relevant ingredient substitutes;
- Compositional information: It is often helpful to include compositional information such as physical or chemical structure, as well as treatments undertaken during processing. It may include preservation methods;
- Packaging type: The variety of packaging that is used to contain the product, including both primary and secondary packaging;
- Storage and Handling conditions: The conditions under which the product is stored and handled, which may include several process steps;
- Distribution method: Distribution procedures and documentation;
- Anticipated shelf life: The maximum shelf life under optimal storage conditions;
- Labelling requirements: Includes relevant information for consumers required by legislation and industry guidelines. This must include information for at risk consumers;
- Specific requirements: Any extra information that may affect the safety of the product;
- Intended consumers: A nominated scope of consumers for which the product is intended for, or not intended for. Allergens or targeted suitability should be included as specific nominations.

HACCP: Chemical Hazards Management
When considering the hazards associated with the process steps in the HACCP plans, the three traditional groupings of hazards to consider include biological, chemical and physical hazards. As HACCP plans evolve and customer standards and regulatory requirements become more stringent, often allergens, regulatory hazards, quality hazards and engineering hazards are also commonly considered in HACCP Plans.

Chemical hazards are quite often viewed by the consumer as posing a significant food safety risk, where as in reality, they more often pose a very low immediate health risk at levels likely to be found in food. Some chemicals are harmful to health and others simply affect the quality of food as judged by consumers. It is possible for chemical contamination of foodstuffs to occur at any stage of their production, from the growing and cultivation of raw materials, through to the consumption of the finished product. The effect of chemical contamination on the consumer can be long term chronic effects that are extremely damaging to the body, such as for carcinogenic or accumulative chemicals including heavy metals, which can build up for many years, or it can be short term acute, such as the effect of allergenic foods. Improper use, storage, location, display, and labelling of poisonous and toxic materials, first aid supplies, medicines and cosmetics presents a public health risk due to food and food contact surface contamination.

Cleaning Procedures
The goals of Cleaning and Sanitation are to:
- Remove micro-organisms;
- Remove food and other residues that provide the nutrition for microbiological growth;
- Remove food residues that could be classed as a hazard for food safety or quality. Remove foreign matter, if introduced to another food product, including allergens where applicable;
- Pursue the abovementioned goals while not permitting the contamination (For example cleaning chemical contamination) of food through cleaning and sanitizing applications.

Cross Contamination
Cross contamination can occur when pathogenic micro-organisms are transferred from one food of food contact surface to another, carried by utensils, hands or other foods. Another form of cross contamination involves allergens, and usually occurs due to improper cleaning between production runs; this is more commonly known as “Cross Contact” for Allergens. Cross contamination can be controlled within the food processing environment through effective and adequate cleaning and sanitising procedures, along with staff participation in procedures implemented to reduce its occurrence. Controlling cross contamination is critical where raw and ready to eat products are being prepared, and certain activities can minimise and eliminate its potential.

Glove Usage
The use of gloves within any food business should be defined within procedures to ensure their use does not compromise food safety. It must be considered here that the use of gloves does not exclude the risk of contamination, indeed many food manufacturers are moving away from using gloves for food handlers because of the common (and unfounded) perception that if gloves are worn then hands are clean.

If gloves are to be worn in a facility, a policy should be developed to include:
- When gloves are to be used, for example:
- Disposable gloves are to be used when handling ready-to-eat foods or foods that require no further processing or cooking;
- Disposable gloves must be worn by any staff member, regardless of the task being completed, if any part of the hand has a cut covered by a medical plaster or band aid;
- Gloves are not required when handling raw food that will be cooked, and when cleaning or handling garbage;
- Gloves must be worn, regardless of task, by any staff member known to have a high natural flora of specific food borne illness bacteria;
- Gloves used should be of a colour which is contrasting to the products and processes facilitated to ensure the risk of contamination are minimized.

How gloves are to be used, for example:
- Hands are washed and sanitised before putting on gloves, and the external surface of the gloves is to be sanitised after they are put on and every 30 minutes thereafter;
- Used gloves must be disposed of immediately and appropriately - not placed momentarily onto food contact surfaces.

When gloves are to be changed, for example:
- Gloves are to be removed and discarded when leaving the work area, going to the toilet and going on a break;
- Gloves are always changed when switching from raw food to ready-to-eat food;
- Gloves are to be changed before starting another job and when they are torn, dirty or contaminated.

Where gloves are to be sourced, for example:
- Disposable vinyl, latex, nitrile or polyethylene gloves need to be purchased from an approved supplier. Worthy of note is that latex is considered an emerging allergen within the food industry and usage of latex gloves is being seen less and less;
- Gloves must be food grade quality;
- No other gloves are approved for food handling purposes;
- Employees allergic to latex can wear vinyl or polyethylene food grade quality gloves where appropriate.

Microbiological and Chemical Assessment and Testing
Microbiological and Chemical criteria for foods are commonly defined within both regulatory and customer standards. It is important that food businesses conduct validation and verification testing on an ongoing scheduled basis to provide evidence that such Microbiological and Chemical limits are being met.

Microbiological and Chemical assessment and testing is commonly conducted either in-house, within the food business, or by a contracted external service provider. Regardless of whether in-house or external laboratories are used for Microbiological and Chemical assessment and testing, it is important to ensure that the testing methods and results reporting formats meet regulatory and customer requirements.

In-house assessment and testing may include the use of rapid indicator tests, or standardised laboratory techniques. Where in-house Microbiological and Chemical assessment and testing is conducted, it is important to ensure that the methods used and outcomes applied meet the expectations of regulatory and customer standards. It is important to ensure that Microbiological and Chemical assessment and testing activities are conducted in a manner that meets the prescribed requirements of Good Laboratory Practices, so as to achieve appropriate outcomes whilst not providing any risk of product contamination.

Contracted external laboratory service providers are often utilised where required Microbiological and Chemical testing can’t be conducted onsite, usually due to the availability of suitable resources. Where an external laboratory service provider is required, the nominated laboratory should be managed through the Approved Supplier Program to ensure appropriate outcomes. The generally accepted minimum requirement for contracted external laboratory service providers is for them to be accredited to the ISO17025 standard, which provides confidence in the testing methods and results issued by the business. ISO17025 is a global standard, established by the International Organization for Standardization, for the technical competence of calibration and testing laboratories.

The methods used for testing and reporting are often based upon published and accepted national or international standards. These are commonly given codes to differentiate a specific assessment or testing method from another. In some cases, where a specified testing method code is nominated against Microbiological and Chemical criteria, it is important to ensure that the results show some correlation between the required testing method, and the actual testing method employed. This is particularly important where external laboratories are used; these laboratories may have their own testing code linked to a national or international standard. In such cases, it is common for testing results to reference both internal and external testing method codes, or for the contracted laboratory to provide an equivalence statement, which provides a link between the accepted national or international standards and their internal testing codes.

Examples of Microbiological and Chemical Assessment and Testing include, but are not limited to:
- Bacteria and pathogen screening;
- Bacterial toxin screening;
- Food additive chemical screening;
- Agricultural chemical screening;
- Cleaning and sanitation chemical screening;
- Naturally occurring chemical screening;
- Heavy metals screening;
- pH assessment;
- Allergen screening;
- Species testing;
- Identity preserved status testing.

About Product Identification and Traceability
When considering the development, documentation and implementation of Product Identification and Traceability within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

The primary reason for having a functional traceability system in place is to ensure safe food and to aid in the removal of unsafe food from the market place. A logical and systematic form of product identification is integral in such a system. Such a program must allow trace back and trace forward of all finished products, ingredients and other raw materials. This system must be validated, and verified, to ensure it is effective.

All raw materials and finished products must be identifiable and traceable at all stages of the process from receipt to finished products, including process steps where process deviations such as work in progress and re-working occur.

A food business should have documented policies and procedures that details how products are identified at all stages of the process including the following aspects:
- All foods and ingredients should be labelled at the end of production and prior to storage. Items must also be re-labelled where they have been removed from their previous container. As a minimum, the product label should include the product name and a best before or use by date;
- All foods should be covered before labelling, and must not be compromised by the action of covering or labelling;
- A physical description of how waste, rework, raw materials, work in progress and, where applicable, allergenic materials should be defined;
- A first in first out policy should be applied to all products in storage;
- Raw ingredients are to be stored in original packaging or in sealed containers to prevent the risk of allergen cross contact or foreign body cross-contamination;-
Pre-existing labels should be removed to reduce confusion and to allow sufficient cleaning and sanitizing of the container they were adhered to;
- If day type labels of differing colours are used, dates and descriptions should also be used to provide sufficient information about the item;
- If an item is to be frozen, it should contain sufficient details including the date of freezing and any special instructions;
- If coloured utensils, containers, cleaning equipment or chopping boards are used for specific product types or tasks, this should also be outlined in the policy;
- A description of how raw materials and finished products are batch and date coded;
- Frozen items should also be dated when they are removed from frozen storage for defrost;
- The shelf life of perishable products invariably alters from the manufacturers original Use By or Best Before date once the original container or pack has been opened. Appropriate labelling will be used to indicate the new Use By or Best Before date.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Development requirements in relation to their items.

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