Preventive controls for food allergens, gluten and added sulphites

Introduction

Certain foods, ingredients or their components can cause adverse or life threatening reactions in individuals with food sensitivities. Food allergens, gluten and added sulphites are considered chemical hazards that food operators should consider during their hazard analysis and when establishing control measures.

Undeclared allergens, gluten and added sulphites are a leading cause of food recalls. The presence of allergens, gluten and added sulphites cannot be eliminated by a thermal treatment or post-processing step. Preventive control measures are necessary throughout the preparation steps to prevent them from coming into contact with a food in which they are not an intended ingredient. Proper declaration of ingredients on the food label is necessary to inform consumers that may be sensitive to a food allergen, gluten or added sulphites.

Many different foods (particularly those with a high protein content) can cause allergic reactions in susceptible individuals. In Canada the common food allergies, sensitivities and intolerances are related to:

• peanuts

• tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachio nuts and walnuts)

• sesame

• milk

• eggs

• crustaceans and molluscs

• fish

• soy

• wheat and triticale

• mustard

• sulphites

• gluten

Definitions

Chemical Sensitivity

Is a type of food sensitivity cause by a reaction to chemicals that occur naturally in, or are added to, foods.

Cross-contact

Is the inadvertent, unintentional transfer of residues of an allergenic food into another food that is not intended to contain the allergen.

Food allergy

Is a type of food sensitivity caused by a reaction of the body's immune system to specific proteins in a food. In allergic individuals, a food protein is mistakenly identified by the immune system as being harmful.

Food intolerance

Is a type of food sensitivity that does not involve the immune system. A food intolerance is usually caused by an inability to digest or absorb certain foods, or components of a food. The symptoms of food intolerance vary, and may be mistaken for food allergies.

Food sensitivity

Is an adverse reaction to a food as a result of a food allergy, food intolerance or chemical sensitivity.

Gluten

Is a protein found in certain grains such as barley, oats, rye, triticale, and wheat. It can trigger an autoimmune reaction in individuals with Celiac disease.

Purpose

The Canadian Food Inspection Agency (CFIA) created this document as a guideline to help food businesses comply with the Safe Food for Canadians Regulations.

It's your choice

You may use other guidance developed by provincial governments, industry associations, international partners or academic bodies as long as they can achieve the outcomes identified in the regulations. Always ensure that the guidance you choose is relevant for your particular business, product or products, and market requirements.

What's included

The document outlines preventive controls a food operator should take to:

• prevent ingredients and food that are allergens or contain allergens, gluten or added sulphites, from contaminating a food in which they are not an intended ingredient

• ensure that ingredients that are allergens or contain allergens, gluten or added sulphites, are properly declared in the list of ingredients on the food label

What's not included

While this document provides information on control measures to prevent the cross-contact of a food with allergens, gluten or added sulphites that should not be present, it is not exhaustive – the preventive control measures needed will depend on the size and complexity of the food operation and be unique for each business.

The document does not discuss food labelling requirements. Labelling requirements can be found in the Labelling tool.

Roles and responsibilities

Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written preventive control plan (PCP) is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.

The CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

Preventive controls for allergens, gluten and added sulphites

Allergens, gluten and added sulphites can end up in a food, in which it is not an intended ingredient, as a result of:

• cross-contact points along the processing lines

• carry over from an ingredient used

• dust or aerosols that get carried throughout the processing area

• re-using an ingredient such as cooking oil

• a change, substitution or addition of an ingredient or the supplier of ingredients

• using the wrong ingredient

• using unknown ingredients

• ineffective cleaning

  • food proteins can be difficult to remove from food contact surfaces especially if the protein has been heated/denatured

  • re-using cleaning solutions

Establish an allergen prevention team

It is a good practice to have an allergen prevention team. This helps ensure proper identification of allergens and sources of gluten and added sulphites, how and where they can come into contact with a food, and the application of effective measures to prevent cross-contact.

For smaller food businesses, food allergen preventive controls can be effectively led by 1 person. Larger food businesses may require a team. The person or team could include staff responsible for the hazard analysis and preventive control plan, quality assurance, purchasing, manufacturing, engineering and food development.

Identify sources of food allergens, gluten and added sulphites

During the hazard analysis, it is important to identify:

• all the ingredients or food received that are allergens or contain a food allergen, gluten or added sulphites

  • prepare a list of all ingredients, raw materials and foods that are allergens or may contain an allergen, gluten or added sulphites

  • indicate the control measures applied to prevent them from coming into contact with a food in which they are not an intended ingredient

• all the processing steps where a food allergen, gluten or added sulphites can come into contact with a food in which they are not an intended ingredient

  • pay particular attention to the receiving, storing, mixing, blending/formulation and labelling steps

Implement control measures

Food related control measures

Incoming ingredients

You should provide written specifications to each supplier of ingredients you use to prepare a food. This helps ensure that the suppliers have controls to:

• prevent allergens, gluten or added sulphites from coming into contact with an ingredient, in which they should not be present, that they supply to you

• identify allergens, gluten and added sulphites when present in the ingredient

You should verify the ingredients and their labels upon their receipt at your establishment to ensure they meet your specifications. The document Supplier food safety assurance program provides additional information on measures you can take to ensure the products you receive meet your specifications. Annex A provides a checklist you can use with your suppliers as part of your controls for allergen, gluten and added sulphites.

Food formulation

The most current formula or recipe of each food should be available in writing for production staff to follow. This helps ensure that multi-ingredient foods are produced in accordance to their formula and prevents the mistaken addition of unintended ingredients that are allergens or could contain food allergens, gluten or added sulphites.

• Prepare a written formula or recipe for each food

  • identify each ingredient and component

  • define steps to be followed when modifications to existing formulations are made

  • establish procedures to dispose of obsolete formulas

  • if necessary, the product formulation can be adjusted to avoid using ingredients that are allergens or may contain allergens, gluten or added sulphites

Process related control measures

Areas where cross-contact can occur

Map out the flow of ingredients in the establishment, through the processing steps and by air movement, in order to identify areas where cross-contact with a food allergen, gluten or added sulphites can occur.

• Create a flow diagram mapping out each production line, ingredient, food and conveyance

  • identify each area where cross-contact is possible

  • identify equipment that is used for both allergenic and non-allergenic foods

  Note: multi-use equipment presents a greater potential for cross-contact between food allergens, gluten and sulphites, with a food.

• Outline the traffic pattern flow for employees and visitors to prevent them from being a source of contamination

Production scheduling

When possible, use dedicated production lines. If this is not feasible, the preparation of foods containing allergens, gluten or added sulphites should be scheduled so that the equipment can be thoroughly cleaned prior to the preparation of a food that should not contain them.

Re-use of ingredients/reworked food

When a batch of food containing an allergen, gluten or added sulphites, or an ingredient such as frying oil is used to prepare a food containing an allergen, gluten or added sulphites, the food or ingredient should only be reworked or re-used in the preparation of the same food product.

Specify when a food can be reworked, an ingredient can be re-used and in what food they can be used.

Storage and handling

Ingredients and food that contain an allergen, gluten or added sulphites should be stored and handled in a manner that will prevent them from coming into contact with other ingredients and food that do not contain them. The following practices can help prevent cross-contact.

• having a dedicated storage area for ingredients and foods with allergen, gluten or added sulphites

• storing ingredients and food with allergen, gluten or added sulphites on shelves below other ingredients and food and keeping them away from packaging materials and labels. This helps prevent cross-contact in the event spillage occurs

• clearly identifying ingredients and food with allergen, gluten or added sulphites using signs or colour codes

• keeping ingredients, food, packaging materials and labels sealed until their use

Conveyances used to transport ingredients, food, packaging and labels could be a source of cross-contact with allergens, gluten or sulphites.

• they should be maintained and cleaned to remove residues of an allergen, gluten or sulphites they may have come into contact with

• ingredients and food that contain an allergen, gluten or added sulphites should be in sealed packages during transportation. If they are not in closed packages, they should be transported separately from other ingredients and food

Packaging and labelling

Having undeclared allergens, gluten or added sulphites in a food is a serious risk for individuals that are sensitive to them. You should have control measures to ensure allergens, gluten and added sulphites are properly declared on your food label.

Refer to the List of ingredients and allergens requirements for more information.

Any protein-containing ingredient has the potential to trigger an allergic reaction, particularly where the protein is similar to one of the common food allergens (known as "cross-reactive" proteins). It is therefore important to ensure all ingredients are declared on the food label. Health Canada has published guidance on some specific known cross-reactive proteins, for example canola protein and mustard allergy, pea protein and peanut allergy, edible insects and crustacean allergy, and lupin and peanut allergy.

The following are measures you can take to ensure that the proper label is applied to your food:

• include a break in production when there`s a change in the type of food prepared

• use marked containers to ensure different foods are not intermixed prior to labelling

• verify labels prior to their application to ensure the right label is applied to the right food

• verify that packaging and labelling for the inner and outer packaging are for the same food

• include a label review and update whenever there is a substitution of ingredients and a change in formulation, especially if a substitution will introduce an allergen that is not already declared on the label

• dispose of incorrect or outdated labels

Establishment related control measures

Equipment maintenance

Equipment is designed, installed and maintained in a manner that prevents cross- contact of allergens, gluten or sulphites with food in which they are not an intended ingredient.

When setting up or renovating a processing line:

• identify the lines used to prepare food that are allergenic or contain gluten or added sulphites

• consider the proximity of pieces of equipment to each other and the potential for cross-contact of the food prepared

• avoid line cross-over

• allow sufficient space to perform cleaning, sanitation and inspection

• reduce the creation and spread of dust

• use dedicated lines for foods that are allergenic or contain gluten or added sulphites

• isolate the ingredient addition steps and add ingredients that are allergenic, or contain gluten or added sulphites, near the end of the process (when possible). This helps minimize the amount of equipment that comes into contact with these ingredients

• dedicate hard to clean equipment to the preparation of foods that contain allergens, gluten or added sulphites and

• separate or dedicate, colour code, or use another means to identify tools and equipment used for preparing and handling ingredients or foods that are allergenic or contain gluten or added sulphites

Sanitation controls

Effective cleaning is 1 of the most important strategies for preventing cross-contact of a food with an ingredient that can cause food sensitivities. Validation of cleaning methods is important for ensuring its effectiveness.

Factors to consider that can affect the cleanup of allergens, gluten or added sulphites:

• its form: paste, particulate, powder, liquid

• its solubility – water or lipid-based

• its concentration – high or low

• the application of heat during processing

• the type of food contact surface

• the length of processing run and the biofilm/build-up of food material

• the type of cleaning method

A sanitation program should address the:

• cleaning up of spills as they occur and the cleaning of all equipment and utensils once the manufacturing cycle is complete

• cleaning of equipment, food contact surfaces and other areas during operations (where dedicated lines, equipment or areas for preparing foods that are allergenic, or contain gluten or added sulphites, are not available)

• disassembly and manual cleaning of equipment to remove trace amounts of allergens, gluten and sulphites

Wet cleaning methods

Wet cleaning is recommended to eliminate doughy or sticky residues that can contain allergens, gluten or sulphites.

Wet cleaning methods:

• should only be used in areas and with equipment designed to accommodate water

  • some equipment may need to be disassembled and hand cleaned

• should make use of detergents and sanitizers

  • rinsing with water alone, is insufficient

  • chlorinated alkaline detergents are the most effective for removing proteins. Alkaline/Caustics with hydrogen peroxide and enzymes are also effective

• can be automated Clean-in-place (CIP), semi-automated Cleaning out of place (COP), or manual

  • when using a CIP system, processing equipment should be examined for evidence of pitting or rough welds that cannot be adequately cleaned and may trap residues

Dry cleaning

Dry cleaning (cleaning without water) is mostly used in areas and with equipment not designed to accommodate water (in the preparation of low water activity foods). It is not recommended when the food being prepared can result in wet, sticky, or gummy residues.

Dry cleaning methods include:

• compressed air

  • its use should be controlled to prevent airborne particles that could be a source of cross-contact

• grit/CO

  2

  blasting

• pre-moistened (alcohol) wipes

• vacuum

• dry steam

• brushing

• purge/push-through with ingredients or some of the food prepared next

Personnel hygiene and training

In addition to the measures you have in place for personnel hygiene to prevent contamination of the food you prepare, you should also consider the risks of cross-contact of a food with residues of allergens, gluten or added sulphites that can cling to clothing worn by the personnel.

Disposable plastic aprons, gloves, or other impermeable clothing should be used by personnel.

You should provide training to your personnel on allergens, gluten and sulphites to ensure that they understand and are aware of:

• the priority allergens and gluten and sulphite sensitivities

• sources of allergens, gluten and added sulphites and the areas of cross-contact with the foods you prepare

• the control measures used to prevent cross contact and remove residues of allergens, gluten and added sulphites

• the importance of proper labelling

Verifying the effectiveness of the control measures

The effectiveness of the control measures applied can be verified by determining whether residues of ingredients that can cause food sensitivities remain in the processing environment – or end up in foods that should not contain them.

The most frequently used methods to detect for the presence of food allergens and gluten can be classified into protein-based and DNA-based methods.

Note: the analytical methods used should be capable of detecting the ingredient under consideration in the low mg/kg range.

• Protein-based methods: Enzyme-linked immunosorbent assays (ELISAs)

  • Detect the allergenic protein or a marker protein using an antibody such as:

    • well and lateral flow devices (LFDs)/dipsticks

    • sandwich and competitive

    • multiplex LFDs

  • Can be used on:

    • push through materials after cleaning (for example, salt, sugar or the next product prepared)

    • the first product prepared after cleaning (prepared off line or finished products)

    • Clean In Place (CIP) rinse-water

    • food-contact surfaces after cleaning

• DNA-based methods: Polymerase chain reaction (PCR)

  • Targets specific DNA sequences

    • offers the best option for the sensitive detection of food allergens

    • is negatively affected by thermal treatments (with the effect being most pronounced under acidic conditions)

• Non-specific methods

  • Adenosine Triphosphate (ATP) Swabs: measures the ATP residues present from biological sources
    

    Note:

    • ATP residues may not come from an allergen

    • total protein measures the protein residues present (the protein measured may not come from an allergen)

Tell me more! Further reading

The following references contain information that helps explain food safety controls, demonstrates how to develop them, and provides examples. The CFIA is not responsible for the content of documents that are created by other government agencies or international sources.

CFIA references

• Preventing cross-contamination

• List of ingredients and allergens

• Food allergen precautionary statements

• Reference database for hazard identification

• Food allergen labelling

Other references

• Codex Alimentarius Commission, General standards for the labelling of prepackaged foods,

  CXS 1-1985, 2018

• Codex Alimentarius Commission, Code of Practice on Food Allergen Management for Food Business Operators,

  CXC 80-2020, 2020

• Health Canada, Common food allergens

• Health Canada, Compendium of food allergen methodologies

• Health Canada, Food allergen labelling

• Health Canada, The use of food allergen precautionary statements on prepackaged foods

Annex A

The following is an example checklist that can be used to obtain information from your suppliers. It includes the priority allergens which are known to cause life threatening reactions in individuals that are sensitive to them.

Having your suppliers complete such a checklist, provides you with the necessary information to use during your hazard analysis – and can trigger the need to revise a label and the addition of a precautionary statement on the label.

Food suppliers allergen, gluten and added sulphites checklist

Product name: Universal product code number

Fill out the following table for each food or ingredient product supplied. Fill each cell with a Yes or No. Where applicable include the name of the ingredient.

• Column I – indicate the priority allergens, gluten or added sulphites that may be found in the food or ingredient, from addition or cross-contact.
• Column II – indicate the priority allergens, gluten or added sulphites present in other food or ingredients that are prepared on the same equipment but at a different time.
• Column III – indicate whether any priority allergens, gluten or added sulphites are present in your establishment.