Food allergen preventive controls: explained!

In this post we’re going to cover the FDA’s requirements for food allergen preventive controls and how they may differ from those required in the BRC Food Safety standard. This is one of a series of posts on preventive controls – if you would like to read the rest, you can find them here:

FSMA Companion Articles Link

Food Allergen Preventive Controls

The first important point to clarify here, is that the requirements set out in the Preventive Control Rule for Human Food, under the §117.135 Preventive Controls section are brief to say the least.  There are some specifics in the GMP’s, which I’ll go over, but the actual preventive control requirements are not detailed.  What this means, is that they do not specify how you should comply.  The level to which you apply controls is up to you and the FDA would expect you to base this on risk. To explain what I mean, I’ve copied the food allergen preventive control requirements below, so you can see what the rule actually says:

Ҥ117.135 Preventive Controls

(2) Food allergen controls. Food allergen controls include procedures, practices, and processes to control food allergens. Food allergen controls must include those procedures, practices, and processes employed for:

(i) Ensuring protection of food from allergen cross‐contact, including during storage, handling, and use; and
(ii) Labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.”

So, basically, the FDA have said you must ensure that:
  • The product is not contaminated with allergens that are not on the label
  • the allergen information on the label must correct
  • the product must have the correct label.
How you actually achieve this is up to you.  Below is a list of all the allergen requirements, which are detailed in the GMPs. Then I’m going to explain what we were taught on the PCQI training, so you know what level of detail the FDA are implying you should adhere to.

GMP Requirements

§117.10 Personnel
  • Personnel must wear garments that prevent allergen cross-contact
  • Personnel must ‘take any other necessary precautions’ to prevent allergen cross-contact
§117.20 Plant and grounds
  • The plant must allow the application of precautions to prevent allergen cross-contact
  • Where required, allergenic practices should be segregated to prevent allergen cross-contact
  • Ventilation and dust controls should be in place to prevent the spread of allergenic materials
§117.35 Sanitary operations
  • Cleaning practices should not spread allergenic contamination
  • Food contact surfaces should be sufficiently cleaned to prevent allergen cross-contact
  • Disposable items such as paper towels must be disposed of carefully so not to cause spread of allergenic contamination
  • Cleaned portable equipment must be stored in a manner so it does not pose a risk of allergen cross-contact
§117.40 Equipment and utensils
  • Equipment and utensils must be designed so that they can be cleaned effectively
  • Seams on food contact surfaces and equipment must be smooth so they do not trap allergenic materials
§117.80 Processes and controls
  • Production processes must not create allergen contamination issues (I would imagine this includes scheduling of production to minimise the risk of cross-contact as well)
  • Chemical, micro or foreign body testing may be used to identify issues with cleaning practices (this is a strange one because the FDA have specifically said that testing is not required to prove that allergen cleans are sufficient – a visual inspection is enough)
  • Allergenic raw materials must be segregated (this includes bulk)
  • Water can only be reused from washing of ingredients, where this does not pose an allergenic risk
  • Rework and work in progress material controls must prevent allergen contamination
  • Allergenic materials including rework and work in progress material must be labelled to identify them
  • Product on open conveyor belts must be protected from allergen contamination

PCQI Training of Allergen Preventive Controls

The first thing that is required is hazard analysis of the allergen risks, this would be carried out in three parts:

  1. Raw material risk assessment
  2. Finished product risk assessment
  3. Process risk assessment

Raw material risk assessment
You need to complete an assessment of all the ingredients used on site, from each supplier.  This should take what allergens each of the ingredients contain.

An ingredient specification of each ingredient is required, which states what allergens are contained in the ingredient and if the ingredient also ‘may contain’ any allergens due to the processing method.  Where the ingredient specification does not provide this level of detail, a written guarantee from the supplier is required.

Finished product risk assessment
Once the list of ingredients is complete, this information should then be used to create a finished product risk assessment. This should detail which ingredients are in which finished product and therefore what overall allergens are in the total product.

Process risk assessment
For the manufacture of each product, the allergen cross-contact risks should be assessed for each step in the process. This should determine:

  • The allergen preventive controls required to prevent cross-contact
  • The required schedule of production, to:
    • Understand the order to which product should be produced to reduce the risks
    • Understand when an allergen clean is required, when changing from one product to another
Comparison to BRC

The requirements taught during PCQI training are in line with those required by the BRC in section 5.3, with one exception.  The BRC would require validation of allergen cleans and were the risk is on-going, they would require further verification of the allergen cleans as well.  The FDA only require a visual inspection for allergen cleans, which would not be acceptable to BRC.  The only watch out I would also add to this is, not all sites have a robust allergen hazard analysis – which goes through the risk assessment of the raw materials, finished product and the process, even though it is a requirement of the BRC standard. If you are a BRC site, just make sure that your allergen risk assessment is really robust and that the preventive controls that it has identified are being effectively managed.

Have your say…

2 thoughts on “Food Allergen Preventive Controls

  1. Hi we have been audited earlier this year by BRC version 7 food safety and achieved AA accreditation.
    During this audit we were told that we must train the staff in allergen awareness.
    We don’t have any allergens on site, there are no allergens associated with raw fresh meat, we have good hygiene practices in place and packaging suppliers have completed our allergen declaration that confirms all packaging will be free from allergens.
    The canteens are situated well away from production areas and staff put clean garments on after each break.
    We have notices and company allergen policy displayed in staff areas, SO HOW DO I TRAIN THE STAFF?

    1. Hi,
      I can understand your frustration with this. Unfortunately the auditors audit against the clauses of the standard and do not always take into consideration the application, or the risks involved with different businesses.
      There are a couple of things that your personnel would benefit from, under the header of allergen training. I would recommend you put together some training which explains to your staff what the 14 EU allergens are, the consequences of allergens (i.e. intolerance, allergies and anaphylactic shock) and then the key controls for your site for allergens – which would be centred around the canteen, PPE changing and hand washing.
      I hope that helps 🙂

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