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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
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:
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, ineffective 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 utilized “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 unacceptable presence of a substance (allergens) within foodstuffs.
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.
An allergy is the reaction of the immune system to a normally harmless substance. This occurs when the body mistakenly believes that consumed/ingested 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.
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.
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. Products containing even small amounts of the allergens listed above must be identified with appropriate labeling 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:
Mustard
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 before consumption. If allergen sufferers are in doubt about a certain food, it is best to avoid it totally, rather than risking an allergic reaction.
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, maybe more allergenic than others; 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.
Oral 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 diarrhea, bronchial asthma, generalized 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 diarrhea, especially in young children. Strawberries and pineapple can occasionally cause hives.
Various processes and controls may be put in place to manage allergens on-site and prevent food that should not contain certain allergens from containing them.
These may include:
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.
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, an incorrect or incomplete listing of ingredients, or unknown ingredients in raw materials. Precautionary allergen labeling must be accurate and adequate, and must not take the place of good manufacturing practices.
In instances where precautionary or advisory allergen labeling is applied, it is important to consider that sales of the product may be affected by “over declaring” the potential for a product to contain an allergen that is not 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 labeling of allergens within any food product. This is particularly important where foods contain ingredients that are pre-formulated and are added.
Document: A document provides guidance and or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Allergen Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Documentation requirements in relation to their items.
You may wish to visit the Allergen Management Templates section of haccp.com for examples of Allergen Management documentation, record, and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Allergen Management within any food business requires genuine commitment from senior management, staff, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcomes of Allergen Management do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Allergen Management must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing Allergen Management within food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are – self-monitored and/or self-adjusted when variances are identified. Regardless of the system used – The goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Common Allergen Management monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
The following examples of monitoring activities and record formats may be applicable to Allergen Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Monitoring requirements in relation to their items.
You may wish to visit the Allergen Management Templates section of foodindustrycompliance.com for examples of Allergen Management documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation to the Quality System occurs, particularly in relation to a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure identified non-conformances are documented, investigated, and rectified within appropriate timeframes.
Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability.
Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Allergen Management related non-conformances: – Review of the Allergen Management policy;
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans, and operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformances are identified and rectified within an appropriate timeframe. When non-conformances are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may be applicable to Allergen Management: – Review of the Allergen Management policy;
To verify that the systems implemented for Allergen Management are effective, allergen-specific analysis can be carried out by a laboratory. This may be relevant to the product, process, or a combination of both. Product allergen testing is commonly scheduled, conducted, and recorded to confirm the inclusion or exclusion of specified allergens. Process allergen testing is commonly scheduled, conducted, and recorded to confirm the effectiveness of cleaning and sanitation in removing allergens. A variety of “rapid” test kits are available to assist with process verification for Allergen Management. Whilst the testing applied for allergen testing whether as “rapid” test kits or substantial analytical methods are commonly assessed to confirm proficiency of outcomes, it is important to ensure the application of allergen testing is appropriate for the outcomes anticipated. In this regard, it is often recommended that technical specialists are consulted regarding the confirmation of allergen testing methods employed.
Where Allergen “Free” Claims are made within product specifications or packaging, it is important that scheduled testing be conducted and recorded to verify such claims. It is generally considered best practice for Allergen-Free Claims to be confirmed on an ongoing basis against recognized testing methods, to ensure regulatory and consumer confidence.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any inappropriate limits of control or acceptability are identified and rectified within an appropriate timeframe. When non-conformances are identified through the validation process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to the validation of the limits of control or acceptability for Allergen Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of fhaccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specified job-related task.
Training and competency requirements for Allergen Management must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Allergen Management should have knowledge including: – Basic Allergen Management requirements;
Team members who have defined responsibilities regarding Allergen Management should have skills including:
Team members who have defined responsibilities regarding Allergen Management should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Allergen Management Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.