This article is written to meet the following sections of the Standards:

BRCGS Food Safety Issue 85.3 Management of allergens
BRCGS Packaging Issue 6P618: 4.9.3.3, 4.9.3.4 Management of allergens
BRCGS Agents & Brokers Issue 3Not applicable
BRCGS Storage & Distribution Issue 47.7 Management of allergens
FSSC22000 Version 5.12.5.2 Product labelling
IFS Food Version 74.19 Allergen risk mitigation
SQF Edition 92.8 Allergen management

Scope

The allergens to be controlled depend on which part of the world your material is to be used or consumed.

In the UK and EU there are 14 allergens, which are:

  • Celery.
  • Cereals containing gluten.
  • Crustacean.
  • Eggs.
  • Fish.
  • Lupin.
  • Milk.
  • Molluscs.
  • Mustard.
  • Peanuts.
  • Sesame.
  • Soy.
  • Sulphites.
  • Tree nuts.

In the U.S the FDA list of 8 allergens are:

  • Eggs.
  • Fish.
  • Milk.
  • Peanuts.
  • Shellfish.
  • Soy.
  • Tree nuts.
  • Wheat.
  • Sesame (from 1st Jan 2023).

In Australia and New Zealand there are 10 allergens, which are:

  • Eggs.
  • Fish.
  • Lupin.
  • Milk.
  • Peanuts.
  • Sesame seeds.
  • Shellfish.
  • Soy.
  • Tree nuts.
  • Wheat.

This means it’s key to understand where your product is intended to be used – as this will affect the allergens you need to have in your scope.

Allergen management

All allergens present on site, must be controlled to ensure that they don’t contaminate product, where they’re not listed on the ingredient declaration.

A risk assessment is required to identify the controls that are required to prevent cross-contamination of allergens.

Risk assessment

A risk assessment of all materials and products is required to establish:

  • The presence of allergens contained in the material.
  • The physical state of the material, as certain formats are more likely to create a high risk of contamination.
  • The presence of allergens contained in the recipe.
  • The likelihood of contamination during processing and handling.
  • The likelihood of contamination from shared equipment.

Allergen risk assessments can become complicated documents, so here are our five top tips to make sure you’ve got it all covered.

1. Cross-contamination at your supplier’s site

In order to ensure that any cross-contamination risks from your supplier manufacturing process is covered, you should find out from them what allergens they handle on site, which aren’t contained in the material you’re purchasing.

Where your supplier has other (not contained) allergens on site, then you need to understand from them if there’s a risk of cross-contamination from this allergen. Depending on their process it may not be possible for cross-contamination to be removed altogether.

Where a cross-contamination risk is possible, you must decide how you’re going to handle this in your allergen risk assessment. Depending on the likelihood of cross-contamination occurring, you may decide to include the allergen in your risk assessment.  In all cases, where there’s a risk of cross-contamination, you’ll need to discuss this with your supplier to establish the best action to take.

2. Multiple ingredient supply

Make sure that you include all of your suppliers in the assessment, as there may be different allergens in the same material – from different suppliers.  Where there’s more than one supplier for a material, you need to list the allergens in each material, from each supplier. Don’t forget to include contingency suppliers too if you have them.

Make sure you use the specifications from each supplier, when you’re carrying out the assessment – just because they’re supplying the same material, doesn’t mean that they’ll contain the same allergens.

3. Grouping can help!

If you have many products to assess, your allergen risk assessment can get really complicated.

One way of making it a little bit easier to work with, and also read once it’s finished – is to group the products by the type of allergens that they contain, before you put them through the risk assessment for the process.

To do this, list all of your products – then document the allergens in each product. If you use an excel spreadsheet to do this, rather than a word document – you can then filter the results of the allergens that each product contains, to see what allergen groups you have. For example, all products that contain wheat gluten, soya and milk. Then all products that contain wheat gluten, milk and egg, and so on.

You can then put groups of products that contain the same allergens through the assessment, meaning there’s less to assess. Just make sure you list all the products in each group, and also still show which products go through with process steps.

4. Reverse thinking

When carrying out your allergen risk assessment, you must reverse your thinking. The aim of this is to protect the products that don’t contain the allergen. It’s easy to get distracted with the products that contain the allergen – but those are the ones that aren’t at risk.

5. Prove it! Before and after

Once you’ve carried out your risk assessment, you should be able to determine where the cross-contamination risks occur and also set your production scheduling to minimise these risks.

You then need to validate the controls. To do this, make sure that you prove that the allergen is there before you apply the control. For example, when swabbing – make sure that you swab equipment prior to cleaning as well as after. If you don’t do it before, you can’t show that the allergen was there and therefore, you can’t prove that the cleaning method that you’ve put in place removed it.

It’s also a good idea to send off the first products produced on that piece of equipment for testing, to show that the cleaning method covered all the parts of the equipment and that there are no trap points that haven’t been controlled.

Controls

Where risks are identified through the assessment, controls appropriate to the level of risk must be determined, documented and implemented. This may include application of controls such as:

  • Physical segregation of allergenic containing materials.
  • Dust controls.
  • Protective overclothing.
  • Cleaning.
  • Scheduling.
  • Waste handling.
  • Spillage controls.
  • Personnel food.

Even where on-pack warning labels are used, good allergen practice must be applied.

Validation

Validation must be carried out to prove that allergen cleaning procedures work, and this must include:

  • Identification of worst-case cleaning variables.
  • Swabbing after cleaning, to prove cleaning was effective – after an allergen run.
  • First-off product sampling.
  • Sampling and testing following accredited laboratory methods, which are suitably sensitive.

Rapid tests, ATP and lateral flow devices are acceptable for verification activities but aren’t suitable for validation. Where they’re used for verification, they must be validated against the lab swabs.

The cleaning procedures must be revalidated where there’s a change to the procedure, the materials used or the equipment being cleaned.

Where a ‘free from’ claim is made regarding the suitability of a food for allergy, intolerant or sensitivity sufferers – all aspects of the process must be fully validated. This is to prove that the stated claim can be achieved consistently. A routine material verification programme must also be in place.

Where in-house testing is carried out for allergens, positive control testing must be carried out routinely, to confirm that it’ll detect the allergen if it’s present in a real sample.

On-pack warning labels

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

The use of a warning label is not a substitute for good allergen practices. The use of warnings on labels as an alternative to applying the right controls is known as alibi labelling.

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.

As a minimum the consumer labels must comply with the following:

  • 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 warning.
  • The warning phrase must be easily understandable.
Contamination Control eDocs

Have your say…

6 thoughts on “Allergen management

  1. Hi all, great job, you could mention that sesame is being added as the 9th major food allergen in USA – effective January 1, 2023

  2. Sesame Seed will be included in the list of allergens for the US beginning January 1, 2023. This is an important item of note, because manufacturers using sesame seed or its’ byproducts will need time to implement allergen controls and put warning language in place for any products placed for sale on or after January 1, 2023.

  3. I believe there is also a confusing issue in the USA that FDA guidance currently lists coconut as a tree nut

  4. Very well documented and written, well done!
    At some point in my tenure, I had to support a process where up to seven allergens (Milk, Wheat, Soy, Fish, Eggs, Peanuts and Almonds) and three sensitizers, at the time, (Sesame, Sulfites and Celery) were present and used in the process. What our team decided to do, was verify risk at every step of the process, From Supplier to Finished product) and if we had appropriate tools (SOP, SSOP, etc.) to deal with potential deviations. After concluding HAZARD ANALYSIS, We also decided to identify accurate Allergen labeling as a CCP, in process HACCP Plan, to bring awareness to fact allergen accuracy declaration and control was imperative.

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