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Migration testing in plastics; overall and specific migration limits


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#1 Sans

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Posted 15 October 2015 - 11:22 AM

Hi all,

 

I am new to this forum, but I already found some very interesting info and topics in here! An awesome addition to my bookmarks, that's for sure :-) 

 

I have a question regarding migration tests. I recently transferred from food industry to packaging and I found myself in a whole new world, especially since there is no technician working here and I need to find out things pretty much on my own. The company manufactures plastic containers that are mostly meant for cosmetic and industrial products, but they now are selling the products to food customers as well. These customers obviously want to have DoCs and/or the results of migrations tests, but these are hardly performed at the moment, due to the costs involved. They have 1 test performed (in 2013, by an external lab) that had an overall migration limit for a mono-layer container and 1 test (2015, also an external lab) with specific migration limits for a multi-layer container. Both containers had a printed label attached to them. 

 

I have always worked on the other end in this and didn't have to go in depth with migration tests before, so I'm kinda struggling here. My questions are (or at least for the moment ;-)): 

 

- when do you need to have a lab test for the specific migration limits and when do overall specific limits suffice? I did check EC 10/2011, but I'm still not sure. 

- our containers vary in size, but come from the same material (LDPE/HDPE); can the one container that was tested, represent our other containers as well? 

- labels and prints vary of course, as these are specified by the customers. Do I need to take something about this into account as well?

- are ther any other subjects I might look into before compiling a DoC? 

 

Thanks beforehand for your help and advice! 



#2 Sans

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Posted 15 October 2015 - 11:29 AM

Argh, I meant GLOBAL migration limits, not overall!  



#3 Simon

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Posted 15 October 2015 - 12:49 PM

Hi Sans,

 

Overall migration tests are carried out to monitor the overall migration limit (OML) have no toxicological meaning, but they give a good indication about the stability of the food contact material towards the filled product. Specific migration tests are performed to check the migration limits. Those SMLs are based on toxicological data, and compliance with those SML values is crucial for the intended conditions of use.

 

Does this make sense?

Regards,
Simon

 

I edited my original post as I think I was talking rubbish. :ejut:


Edited by Simon, 15 October 2015 - 02:03 PM.

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#4 John Moreton

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Posted 15 October 2015 - 02:44 PM

Hi Sans

 

I have just this month done the same thing,  Left food to go in to Plastics...although we are food contact Plastic Film.

 

So far as far as I been informed, is that we only have to produce a DoC to EC 10/2011, we don't have to or neither would we produce our results ( something about Confidential, we don't want our competitors knowing our results ) as long as we can prove due diligence and that our blends/finished product conform then we are fine, however we are looking now at doing more migration tests on finished products and keeping them as a template. 

 

I will try to find more about limits

 

http://ec.europa.eu/...pec_dirs_en.htm

 

John



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#5 Sans

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Posted 16 October 2015 - 12:13 PM

Hi Sans,

 

Overall migration tests are carried out to monitor the overall migration limit (OML) have no toxicological meaning, but they give a good indication about the stability of the food contact material towards the filled product. Specific migration tests are performed to check the migration limits. Those SMLs are based on toxicological data, and compliance with those SML values is crucial for the intended conditions of use.

 

Does this make sense?

Regards,
Simon

 

I edited my original post as I think I was talking rubbish. :ejut:

 

Well yes, it does make sense. So in order to comply with EC 10/2011 the SML are not always needed and the OML could suffice as well? 



#6 Sans

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Posted 16 October 2015 - 12:16 PM

Hi Sans

 

I have just this month done the same thing,  Left food to go in to Plastics...although we are food contact Plastic Film.

 

So far as far as I been informed, is that we only have to produce a DoC to EC 10/2011, we don't have to or neither would we produce our results ( something about Confidential, we don't want our competitors knowing our results ) as long as we can prove due diligence and that our blends/finished product conform then we are fine, however we are looking now at doing more migration tests on finished products and keeping them as a template. 

 

I will try to find more about limits

 

http://ec.europa.eu/...pec_dirs_en.htm

 

John

Ah, a fellow plastics newbie! :-) At least I noticed that it doesn't matter whether you're in plastics or in food: as long as you're in QA, you'll get shit dropped on your desk ;-) 



#7 Simon

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Posted 16 October 2015 - 01:12 PM

Well yes, it does make sense. So in order to comply with EC 10/2011 the SML are not always needed and the OML could suffice as well? 

 

I believe so, your chosen accredited lab will be able to confirm.

 

Regards,

Simon


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#8 Sans

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Posted 22 October 2015 - 07:47 AM

Thanks, Simon. I will do so case by case. 






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