Allergen management

The requirements

Procedure

All allergens present on site must be controlled to ensure that they do not contaminate product, where they are not listed on the ingredient declaration.

Allergens should not be seen as a whole, i.e. the prevention of cross contamination from allergen containing products from non-allergen containing products.  But also for example, that a milk containing product must be prevented from contaminating a nut containing product and vice versa.

Where materials are unpackaged, a full risk assessment is required to identify the controls. Where products are packaged, a reduced risk assessment can be completed, which focuses on the risks of damage and cross-contamination due to spills.

Where risks are identified, controls appropriate to the level of risk must be determined, documented and implemented.

The risk of cross contamination can be reduced through the use of the following techniques:

• Physical segregation of allergenic containing materials.
• Systems to restrict the movement of airborne dust containing allergenic material.
• The use of separate or additional protective overclothing when handling allergenic materials.
• Cleaning.
• Segregation of allergen containing materials through time through the scheduling of production.
• Waste handling.
• Spillage controls.
• Restrictions on food brought onto site by personnel.

Even where on-pack warning labels are used, the above controls must be applied where they physically can be as they are minimum good manufacturing practices.

 

Establish the risks

A risk assessment of all raw materials, including additives and processing aids to establish:

• The presence of allergens contained in the material.
• The likelihood of contamination by allergens prior to delivery.

This shall include the review of raw material specifications and, where required, the receipt of additional information from suppliers, through questionnaires for example.

The risk assessment must then assess the risks of allergens in work in progress materials, rework and finished products, to determine:

• The presence of allergens contained in the product.
• The likelihood of contamination by allergens during processing and handling.
• The alibi labelling of each product.

 

Assess the risks and identify the controls

The risk assessment must also look at the risk of cross contamination:

• Through each equipment step in the process.
• From the use of shared equipment.

The risk assessment must assess the physical state of the allergenic material, as certain materials are more likely to create a high risk of contamination:

• Powders for example are more likely to be airborne.
• Sticky or fatty ingredients are more likely to adhere to surfaces if cleaning is not effective.
• Materials made up of particulates such as nibbed nuts, as they can easily get lodged in equipment.

Where allergens are handled in the form of fine powders, the movement of airborne dust should be minimised by:

• Using physical barriers to separate areas.
• Dedicated areas.
• Closed containers.
• Extraction.

The location of air-conditioning or fans should be positioned to ensure these do not distribute airborne allergens.

Allergenic ingredients and products must be physically segregated from non-allergenic ingredients and products, through the application of:

• Dedicated storage areas or dedicated areas within a store area.
• Dedicated equipment, tools and utensils where possible.

Where products must be processed in the areas or on the same processing lines, the production runs must be scheduled based on the allergen risk.

All non-allergenic products should be produced before allergenic products, and then allergens introduced to the schedule, in such as way that it minimises the risk of allergen cross contamination.

Production scheduling should be used to minimise the occurrence of changeovers between allergen containing and non-allergen containing products.

Where possible it’s good practice to limit the use of allergens to the end of a shift or production week, followed by a deep clean.

Allergenic materials must be listed on an approved allergen tracker, that is used at material intake, to ensure that materials are handled correctly.

Ideally, allergenic materials will be segregated during storage. However, as a minimum the materials must be segregated where required by customers or where there is a risk of cross-contamination from spillage.

Where materials are not segregated and are stored in packaging which is prone to breakage (such as paper sacks), these materials must be stored at ground level to reduce the risk of contamination if they are to get damaged.

The risk assessment must consider errors made due to accidental use or mix up of ingredients, components or equipment.

Waste which contains allergens should be removed so that the removal process does not become the source of allergen contamination in other areas of the factory.

 

Verify the risk assessment

Check that the risk assessment is accurate, by physically walking the process to ensure all risks have been considered and accurately scored.

 

Create an improvement plan

An allergen improvement plan is required, which addresses any risks, with clear actions, timescales, and responsibilities.

 

Validation

Cleaning validation must be carried out to prove that the cleaning instructions (CICs) work.

The cleaning procedures must be revalidated where there is a change to the procedure, the materials used or the equipment being cleaned.  The cleaning procedure must also be considered when specifying and purchasing new equipment.

 

Determine the remaining risk

Where all possible controls have been implemented and a documented risk assessment demonstrates that there is still a risk of cross contamination, a warning should be included on the label or in the specification.

The use of a warning label isn’t a substitute for good manufacturing practices.

National guidelines or customer codes of practice shall be used when making such a warning statement and where these are used, they must be referenced in the documentation.

Where there is no legislation or customer codes of practice to comply with the following should be considered, to ensure that the warning is clearly displayed on consumer labels:

• The location of the warning should be in close proximity to the ingredients list.
• Colour, highlighting and font size should be used to aid visibility of the statement to consumers.
• The choice of the warning phrase used should be clearly understood by consumers.

 

Change control

The allergen risk assessment must be reviewed annually and following:

• Any changes to product, materials.
• If there’s an allergen related complaint.
• An allergen related incident.
• A change to allergen labelling requirements.