No Allergens SOP

Hello, under new FSMA regulations we have to address allergens even though our company does not handle any allergens. Is anyone else in the same situation? We have to create an "allergen awareness program," any examples, any comments?

Thanks a lot! 

It is important to realize that you need to evaluate allergens as potential hazards that need preventive controls, but it is OK to find that you do not need to have allergen preventive controls.  If you don't use any of the regulated allergens, be sure that your suppliers don't have any cross-contact issues. Supply chain issues could be important if you make any sort of "free from" claim.

 If all that checks out, your employee awareness program could be part of your GMP training.  

Hello kglara,

You must also include a certification from your supplier like food additives, food grade greases and oils that it does not contain any allergenic materials and it is being produced in an allergen free environment.

regards,

redfox

Hello kglara,

correction: it should be "it does not contain allergenic materials"

redfox

Example text from my allergen SOP. We have an allergen-free facility.

I.                   SCOPE

a.       All manufacturing and label design activities that could be exposed/affected by the FDA “big 8” allergens:

i.Milk

ii.Eggs

iii.Fish

iv.Crustacean Shellfish

v.Tree Nuts

vi.Peanuts

vii.Wheat

viii.Soybeans

b.      Allergens currently present in facility: no ingredients including allergens are utilized at company at this time.

c.       Company currently does not perform rework that would create a risk of cross-contamination or labeling error.

II.                 RESPONSIBILITY

a.       Employees responsible for all activities which involve the declaration or handling of ingredients containing allergens are responsible for carrying out those tasks within the guidelines recorded in this document.

III.              POLICY

a.       This SOP shall be revised if/when company begins utilizing ingredients that contain any of the allergens listed above.

b.      Company is committed to ensuring label accuracy by following all requirements of the food allergen labeling and consumer protection act of 2004.

c.       Label accuracy shall be ensured through initial label development review, and correct assignment of labels shall be verified by operators at time of packaging.

d.      Employee GMP and Food safety training will include allergen awareness and cross contamination principals.

e.      Ongoing verification of allergen status of ingredients will be completed using the vendor approval process.

                                                               i.      Suppliers will identify if any “big 8” allergens are present in products purchased by Company.

f.        While there are no ingredients with “big 8” allergens in the facility, there is no applicable procedure for the validation of allergen removal with analytical testing.

For a facility that does not use any allergen ingredients, the SOP that you have is more than enough.

My only suggestion would be to be sure that your supplier program considers cross-contact as well as the use of allergen ingredients.  This is especially important if you market your products as being allergen free.  

Not only suppliers and potential allergen cross-contact, but your employees.  Employees can cross-contact from their eating.  Consider, if you have vending machines as well that have products containing allergens. 

You should address this in your GMP's with your personal practices.

Great input from everyone.  Consider training allergen awareness (as part of your food safety training) on an annual basis - making sure employees are familiar with the big 8 allergens.  In your HACCP/HARPC master plan, you can demonstrate the absence of a hazard through risk assessment. 

Suzie B.