4 replies to this topic

[ilariadesimone]

Dear all,

 

I am working to develop an allergen control plan. The first step that I have identified to proceed is doing a risk assessment. My question is: do I have to know and score all the allergenic ingredients that are handled in the labs and in the pilot plant? how can this be done if the ingredients are too many?

 

Thank you.

[Scampi]

are the labs completely segregated?  Does the pilot plant share the foot print of the actual processing facility?

 

The lab should be designed with safety of migration in mind, not just for allergens but pathogenic bacteria movement into the processing plant, if it is constructed that way, there should be zero risk to allergens present in the lab making there way to the processing areas.

 

I think we need some more info on the pilot plant to answer that portion

[Charles.C]

Some context on the  the Standard / Product / Process might assist.

[ilariadesimone]

Hello, 

thanks for the reply. The pilot plant and the labs are not meant to be segregated, there are not separated lines for allergen containing product and allergen-free ones. 

I should have been more specific. I would like to know how I am going to perform the risk assessment, since it's the first time I am working in this field. 

I have read that to perform a risk assessment, first I have to determine which one of the raw materials and ingredients contain allergens and then score them to prioritize actions in managing them. I have found out that I should calculate the HAZARD SCORE to be = Potency Score x Allergenic Protein Concentration x Physical Form x Amount consumer may be exposed to. Can I found these information somewhere? Is it necessary to score all the possible allergens or do i have to take into account only the 14 major allergens listed in the General Food Law (EU)?

 

Thank you for your replies

[Charles.C]

Hello, 

thanks for the reply. The pilot plant and the labs are not meant to be segregated, there are not separated lines for allergen containing product and allergen-free ones. 

I should have been more specific. I would like to know how I am going to perform the risk assessment, since it's the first time I am working in this field. 

I have read that to perform a risk assessment, first I have to determine which one of the raw materials and ingredients contain allergens and then score them to prioritize actions in managing them. I have found out that I should calculate the HAZARD SCORE to be = Potency Score x Allergenic Protein Concentration x Physical Form x Amount consumer may be exposed to. Can I found these information somewhere? Is it necessary to score all the possible allergens or do i have to take into account only the 14 major allergens listed in the General Food Law (EU)?

 

Thank you for your replies

 

IMEX there is normally no score of the type you mention involved.

 

You need to know what allergens XYZ are required to be declared on the product label for Italy assuming that is the destination.

Then you need to check if any of XYZ are present in process inputs.

Then you need to risk assess if any of XYZ may enter yr product due to "process/environmental contamination".

 

IIRC Italy is in EC for which a list of the declarable allergens exists. Occasionally a Country deviates from the published details but I think unlikely for allergens. I daresay the "list" is  the 14 items you refer.

 

An allergen risk assessment for inputs, if present, typically requires a control measure to be added which is typically a label declaration / checking procedure.

A significant contamination risk assessment typically requires GMP controls such as segregation, cleaning etc and validating no cross-contamination.

 

The entire allergen control program is now often handled as a PRP in the hazard plan. Some examples of "allergen programs" are posted on this Forum.