Implemented and functioning allergen management program is a required element of well designed good manufacturing practices system. It is a requirement of the GMP system, any GFSI (Global Food Safety Initiative) standard such as SQF, BRC and others and any private standard used by most customers. Allergen management system is required to ensure that your customers are informed about allergens that may be present in your products or introduced during processing.
According to the FDA, there are 8 distinct allergen groups in the US:
- Crustacean shellfish
- Tree nuts (almonds, walnuts, pecans)
If you are manufacturing in Canada or export your products there, must also declare two additional allergens and include them into your allergen assessment:
- Sesame seeds
If you need to build or improve your current allergen management system, I have outlined some common steps to get you started:.
Allergen Identification- Evaluating your formulas, recipes or products.
When working with my customers I always begin by analyzing formulation of their products or their recipes. Are nuts present in the facility or used in the product? Do you use soy lecithin as an emulsifier? Do you use dry milk or egg whites? Is your packing facility handles and stores nut or milk containing products such as chocolates? Take a close look at the ingredients and processing aids to make a thorough assessment of the allergens that you will need to control for in your operation.
Processing aids often have hidden allergens such as wheat (especially in the confectionary manufacturing) nut shells (for some baking processes). Any processing aid that originates from an allergen is considered an allergen and must be included in your allergen management program.
NOTE: an allergen warning on the label is NOT an acceptable way to control for allergens and is in no way a substitute for your allergen management program.
Create a list of all allergens present in the facility along with the ingredients contain them. Request allergen statements from your suppliers to be aware of the ingredients that were processed on common equipment and therefore may contain traces of allergens. Here is an example of an allergen master list:
Table 1: Master allergen list, Company A
In order to manage allergens appropriately it is required that they are color coded for easy identification. Here are some examples of the color coding:
- Peanuts: orange
- Milk- white
- Egg: yellow
- Wheat: dark blue
- Tree nuts: green
- Soybeans and their derivatives: purple
- Fish- light blue
- Shellfish- grey
Ingredient segregation and handling
All allergen containing ingredients must be stored and segregated from non allergen containing ingredients and from each other. You must separate all allergens from each other (simply calling an area or a utensil “for allergen handling” is not acceptable) There are individuals who may have severe allergic reaction to one type of allergen (i.e. peanut) but none it all to egg or milk or other type of allergen.
The main principle for the practices described below is to ensure that non-allergens are separated from the allergens and cross-contact (i.e. the possibility of contact or contamination between allergens and non-allergens) your facility is minimized.
Consider the following principles:
- Receiving- all allergen-containing ingredients must be inspected upon receiving for punctures, tears of leaks. Ensure that allergen clean up SOP is available for your shipping/receiving staff to refer to in case of accidents or spills.
- Storage- all ingredients must be labeled and color-coded according to their allergen profile (see examples above). Its best to dedicate a certain area of your storage space to allergens. If that is not possible due to the space constraints, I recommend dedicating a space in the existing shelving to the allergen storage. At no time allergen containing ingredients shall be stored over allergen free ingredients. It’s best to store the same ingredients in the same space for ease of identification and to prevent confusion.
- Identification- all allergens must be color coded and display their lot traceability information.
- Care shall be taken to collect ingredients for production to prevent accidental spilling or breaking which may result in contaminating a larger storage area. Again, make sure that your warehouse employees are trained spill clean up SOP.
- When storing pre-printed packaging used for final product, take care to adequately separate labels for allergen- containing products to prevent mislabeling.
Pre Process Handling:
- Always make sure that your staff verifies formulas and batch sheets while preparing the batch for processing. All allergen containing ingredients must be listed on the batch sheet and verified by the handlers.
- When preparing allergen containing ingredients for production, you must ensure that dedicated scoops and small utensils are used for the allergen containing ingredients. One of the best practices I have seen is to store scoops and other small utensils used for each separate allergens in an allergen-dedicated bin (i.e. one bin per allergen type). Those bins and utensils must be cleaned and sanitized regularly and included on your sanitation schedule.
- At minimum, your staff must change gloves and wash hands when switching between allergens and non-allergens. If disposable gowns are used, gowns must be changed along with gloves.
- Another best practice is to notate allergens on your process control sheets.
- Production sequencing must be utilized to minimize cross-contact. Below is an example of the principles of production sequencing that is based on a weekly production schedule:
Make sure that your equipment is easily cleanable and follow SOPs for cleaning of the equipment during clean up and change over.
Note: even if ONLY allergen containing ingredients are produced on Thursday and Friday, regular change over and allergen cleanliness validation testing must be performed to validate cleanliness.
You and you staff must take protective measures to avoid cross- contact during production.
Do not stage exposed allergens or allergen containing products next to the production line.
Ensure that staff follows proper allergen handling practices such as glove and smock changing as well as hand washing procedures.
If at all possible avoid having non-allergen product manufactured next to the allergen containing product. Use production sequencing or physically separate two lines.
Ensure that air handling is minimizing the possibility of cross-contact. Maintain positive air pressure between the manufacturing areas. Ensure that all areas are regularly cleaned to prevent dust accumulation.
Rework and Work- in- Progress (WIP)
If used, all rework must be labeled according to their allergen content and segregated according to the program until it’s used or disposed of. Its best to have a process for rework reconciliation and ensure that your staff understands how to handle rework. Work in Progress (WIP) is used commonly and should also be labeled and stored according to it’s allergen content.
New Product development
When developing new products you must evaluate ingredients new to your manufacturing facility for a potential allergen content. If new allergens are introduced, I recommend completing the following steps
- Revise allergen management program to include the new allergen that facility controls for
- Review and revise visual aids and color coding to include new allergen.
- Dedicate appropriate storage space for the new allergen.
- Create new set of dedicated small utensils and bin for ingredient handling.
- Include new allergen in the allergen section of your GMP training for your staff and train the staff immediately to identify the allergen and understand its handling and storage practices.
As with every program, there is no “one size fits all” approach for developing allergen management program that is right for your operation. Work with your QA department or a qualified consultant to develop the program that is right for your facility. I am here to answer any questions regarding developing allergen management program that is right for you.