5 replies to this topic

[nateolson1981]

I work for a small confectionery repackaging company. We do not process any raw product but just put bulk candy into bags for distribution to stores. I was wondering if we have a product that comes in a sealed individual packages but the product in the sealed individual packages is an allergen. Do we have to do a full clean out of the packaging machine and food contact surfaces after that run and before a non-allergen run? I am wondering specifically what the FDA would say on this matter. Thanks in advance for the help!

[haikader]

Hi Nateolson,

 

Basically you are running a packaging firm, you are not producing it. still you carefully look for allergen product, run all non allergen product first, second choice for allergen product.

I would recommend complete sanitize take a allergen test on the environment keep a record, will help you in an audit.

 

Best Regards,

Abdul
 

[Charles.C]

I work for a small confectionery repackaging company. We do not process any raw product but just put bulk candy into bags for distribution to stores. I was wondering if we have a product that comes in a sealed individual packages but the product in the sealed individual packages is an allergen. Do we have to do a full clean out of the packaging machine and food contact surfaces after that run and before a non-allergen run? I am wondering specifically what the FDA would say on this matter. Thanks in advance for the help!

 

Hi nateolson,

 

Welcome to the Forum !

I'm not in the USA but i presume the basic FDA consumer safety "concern" is the presence of an undeclared allergen in a given product.

 

I assume there are both legal/non-legal aspects. This usually involves "advisory" labeling.

 

Presumably, from a purely safety POV, if there is a risk of cross-contamination, you should attempt to "minimise" it. The degree of minimisation required depends presumably on risk assessment / Regulatory issues.

 

From a legal POV, I anticipate the FDA interest will depend on the labelling and possibly the "minimisation", per se, also.

 

Whether compliance with legal labelling requirements (FALCPA?) allows you to ignore measures to minimise cross-contamination  from a FDA POV is less obvious to me. I doubt it but no local knowledge. Previous threads here have demonstrated that the issue of advisory labeling in USA is a "grey" area.

 

May I ask -

 

(1) What is the specific allergen involved in the allergen "containing" product ?

 

(2) What do you state on the labels regarding allergens for (a) the allergen "containing", (b) the (nominally) allergen "non-containing" products respectively ?

 

You may be interested in this  FDA-related survey of labelling consequences for related products.

 

 Food allergen labeling,2006.pdf   1.72MB   22 downloads

 

I note that candy is a significant recall product due allergen-related violations (the latter itself being a major recall factor in USA statistics) -

 

http://www.foodsafet...portable-foods/

(2014)

[nateolson1981]

Thanks for your help everyone! What I have suggested to our team is that we treat all these wrapped products just like we would unwrapped but I don't know that I will get management buy in as we are a small company and cleaning takes time and eats up profits. The FDA grey areas really make it hard to find the definite answer on things like this and I want to keep our company and customers safe. I will continue to test our machines to find the best answer to this question for our business. 

 

Charles.C, the specific allergen in question is peanut. Our current labeling states Contains Peanut. For our non-allergen products we have Produced in a facility that handles milk, soy, egg....

[Charles.C]

Thanks for your help everyone! What I have suggested to our team is that we treat all these wrapped products just like we would unwrapped but I don't know that I will get management buy in as we are a small company and cleaning takes time and eats up profits. The FDA grey areas really make it hard to find the definite answer on things like this and I want to keep our company and customers safe. I will continue to test our machines to find the best answer to this question for our business. 

 

Charles.C, the specific allergen in question is peanut. Our current labeling states Contains Peanut. For our non-allergen products we have Produced in a facility that handles milk, soy, egg....

 

Hi nateolson,

 

Apologies that I missed the fact in yr OP that all yr individual items are received wrapped and presumably stay that way through the repackaging ( ie there is no exposed product involved).

Assuming the “non-allergen product”  is not contaminated as received and the environment/handling is "sanitary", I would have thought that the wrapped status  would effectively minimize the risk of allergenic cross-contamination unless accidents happen during repackaging (?). Basically it is necessary to do a risk assessment based on yr actual process.

 

I note that yr “non-allergen” containing product is labeled such that a zero cross-contamination is implied.

I presume you are aware that peanut is highly potent allergen.

Presumably the logical action would be to verify that there is no cross-contamination. I suspect some operators would simply add “peanut” to the allergen list on principle since, afaik, this is legal/routine in USA advisory labelling practice.

 

I noticed this older thread here which has a similar process but slightly different problems. Maybe of some interest. Particularly note Post 6.

http://www.ifsqn.com...ibution-center/

 

I also noticed this IT document which describes an interesting allergen problem encountered by a customer of repackaged candy but with a twist to your own situation.

 toots2.pdf   1.09MB   16 downloads

 

My own products fortunately do not have such complicated allergenic features so other poster’s comments may offer better related experiences

 

PS - JFI here is another repackaging candy thread on this forum but not oriented to yr current area of interest -

http://www.ifsqn.com...d-traceability/

[nateolson1981]

Charles C. i abbreviated the statement that is on all our packaging. The full wording is "Produced in a facility that handles egg, milk, soy, peanut, wheat, and treenut."

 

We will be treating it as an allergen as in some instances the individual wrapping can come lose and exposed the inside peanut candy to the packaging machine. 

 

Thank you for all your help!