Language selection

Search

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:

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:

Refer to the Tell me more! section for other useful references related to allergens, gluten and added sulphites.

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:

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:

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:

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.

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.

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.

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

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:

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:

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:

A sanitation program should address the:

Wet cleaning methods

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

Wet cleaning methods:

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:

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:

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.

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

Other references

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: space Universal product code numberspace

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.

Priority allergens, gluten and added sulphites Column I
present in the ingredient or food
Column II
present in other ingredients or foods prepared on the same line
Column III
present in the establishment
Eggs or its derivatives:
  • frozen yolk, egg white powder and egg protein isolates
Fish or its derivatives:
  • fish protein and extracts
Milk or its derivatives:
  • milk caseinate, whey and yogurt powder
Mustard or mustard seeds
Peanut or its derivatives:
  • peanut pieces, protein, oil, butter, flour, and mandelona nuts (an almond flavoured peanut product). Peanut may also be known as ground nut
Shellfish:
  • crab, crayfish, lobster, prawn and shrimp
Mollusks:
  • snails, clams, mussels, oysters, cockle and scallops
or their derivatives:
  • extracts
Sesame or its derivatives:
  • paste and oil
Soy or its derivatives:
  • lecithin, oil, tofu and protein isolates
Tree nuts – almonds, Brazil nuts, cashews, hazelnuts (filberts), macadamia nuts, pecans, pine nuts (pinyon, pinon), pistachios and walnuts or their derivatives:
  • nut butters and oils
Wheat or its derivatives:
  • flour, starches and brans
Gluten
  • barley, oats, rye, triticale, or wheat
Sulphites:
  • sulphur dioxide and sodium metabisulphites
Others (as considered necessary)

Do you have procedures to avoid cross-contact of the food allergens, gluten, or added sulphites noted in columns II and III, with a food in which they are not an ingredient? Yes No

Attach a label to this form for each food.

Note: if, for any reason, there are changes made to this product, you are responsible for updating your records, including labels and specifications, and notifying the person responsible for purchases.

Supplier's address: space

Supplier contact: space

Signature: space Date: space

Date modified: