# Calculations on Specific Migration Limits in multilayer material

Migration Tests Simulants 10/2011 packaging testing

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### #1 Jurate

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Posted 20 August 2015 - 09:33 AM

Hi All,

I have read the 10-2011 legislation several times, the legislation is clear with regard to food safety, the supply chain has to prove the product is safe and this might be done by testing the film or having a modelling tool with supporting information.

We are manufactures of packaging materials and we buy the materials from our Suppliers and we laminate them together. We have hundreds of different combinations and say about 40 suppliers with 10 different types of materials (Nylon, Poly, Polyester etc., they all fdifferent microns, different substances used etc.)

Does anyone have an excel sheet how would you  calculate the values of Specific limits given by the Suppliers? Could you please explain how would you calculate? If material A has been tested for the SML and the result is 0.1 mg/kg and material B is 4mg/kg will I just add them togetther (which would be 4.1mg/kg or is that 4.1mg per 2kg now???? ) and if I am not exceeding the limit as per 10/2011 does that mean we ok ? Is there other formula on how to calculate, do I need to look at microns or other things? Would such an excel sheet cover the requirements and is that what we need to do to be in compliance?

I actually looking for the headings on the excel sheet so I could have a look what other companies do. We have an auditor comming in and we have to do some work.

Does anyone outsource people to do this job, I mean to do calculations and excell sheet etc? Could you share contacts please?

Thank you very much.

Jurate

### #2 Snookie

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Posted 24 August 2015 - 04:41 PM

We have our plastics tested through a third party lab.  This validates our material meets standards and is conclusive.  The lab does all of our calculations.  One of the challenges with modeling is that is just a model and a bad calculation, could  cause a lot of problems.

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### #3 Simon

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Posted 25 August 2015 - 07:16 AM

Hi Jurate, if you process the materials such as laminating, converting printing etc. you need to test the finished products after they have been through your process. Ultimately this is what’s important. Certainly you need the input of migration data from your raw material suppliers to ensure they are fit for purpose, but they just feed into your test plan. I agree with Snookie it is best to outsource to a qualified lab, they will work with you to develop a testing plan that is holistic enough and complies with 10/2011.

Regards,
Simon

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### #4 Charles.C

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Posted 25 August 2015 - 02:50 PM

Hi Jurate,

These documents may illustrate one reason to prefer outsourcing -

Kind Regards,

Charles.C

### #5 djammur

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Posted 26 August 2015 - 01:38 PM

Won't the spec sheets from the supplier indicate this?

### #6 garyjgatf

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Posted 26 August 2015 - 04:15 PM

What would the migration modelling math be for a paper based substrate?

### #7 CMHeywood

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Posted 26 August 2015 - 04:26 PM

Worst case - you assume that all the SML components would migrate out of all the layers.  You would than add all the SML numbers to see if you exceed the OML.

If you are going to assume that there is a functional barrier that would prevent anything from migrating from certain layers, you would need good test data to support that assumption.

### #8 garyjgatf

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Posted 26 August 2015 - 05:34 PM

What would the test method be for determining migration from a paper based package into food?

### #9 Jurate

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Posted 31 August 2015 - 03:26 PM

Thank you all for your replies.

We have the external Lab but we have only done the Global Migration Tests yet. I am lost in regards SML.

We have Declarations for food use from all of the Suppliers, but I am strugling who has to analyse their DoC. Is that Quality Department Job or Technical Department Job or is that for the External Lab???

If you've done your all Tests on SML throught the external Lab - do you ask them to check for number 235 and 962 for example or do you just handle the Suppliers DoS's and they do all the bits?

The other thing - who compiles the list of what substances are in each material? I would imagine there must be a software or extremely big axcel sheet with all the details, monomers, additives, etc.

### #10 Jurate

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Posted 31 August 2015 - 03:33 PM

Hi Jurate,

These documents may illustrate one reason to prefer outsourcing -

Hi Charles,

Thank you for your reply. I see you have posted the AKTS presentation. I was actually thinking about the AKTS-SML software. Is this any good? Looks good to me but not too sure is this not too complicated. It also stated those calculations are accepted instead of actual Migration Tests. Is that right? I was also wondering just in case if you know - is this easy to use, I mean is that only a few minutes per day work or is that something huge where would we need a full timer on this software?

Thank you.

### #11 Jurate

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Posted 31 August 2015 - 03:39 PM

We have our plastics tested through a third party lab.  This validates our material meets standards and is conclusive.  The lab does all of our calculations.  One of the challenges with modeling is that is just a model and a bad calculation, could  cause a lot of problems.

Just wondering do you give your Suppliers Declarations for Food Use to the Lab and they read them and analyse and decide on what has to be tested? Are you a member of any organisation with their Lab? Do they consult and come in regularly on to your site?

The reason why I am asking that we dont have anyone assigned for this job in our company and everything fauls to me. I think I know a lot in this area and legislation but I can't immagine how can I do calculations on my own (this is how the management expects me to do).

### #12 Jurate

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Posted 31 August 2015 - 03:46 PM

Won't the spec sheets from the supplier indicate this?

The Declarations from the Suppliers are done very smart. They only overwrites the 10/2011 requirements and states at the end that it is our responsibility to test the finished product. Of course they are right in this case. But some of them don't even bother to give us a list of substances used in the material, but they still states they are in compliance with 10/2011 and states that they do have a "worst case" calculations and they are in compliance.

To the question- can you please supply the test results or your calculations - they reply - it is confidential.

Does anyone have the same issues ? :)

### #13 Snookie

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Posted 31 August 2015 - 04:00 PM

Just wondering do you give your Suppliers Declarations for Food Use to the Lab and they read them and analyse and decide on what has to be tested? Are you a member of any organisation with their Lab? Do they consult and come in regularly on to your site?

The reason why I am asking that we dont have anyone assigned for this job in our company and everything fauls to me. I think I know a lot in this area and legislation but I can't immagine how can I do calculations on my own (this is how the management expects me to do).

The Declarations from the Suppliers are done very smart. They only overwrites the 10/2011 requirements and states at the end that it is our responsibility to test the finished product. Of course they are right in this case. But some of them don't even bother to give us a list of substances used in the material, but they still states they are in compliance with 10/2011 and states that they do have a "worst case" calculations and they are in compliance.

To the question- can you please supply the test results or your calculations - they reply - it is confidential.

Does anyone have the same issues ? :)

Asking for a plastic formulation is like asking Coke for their recipe, it is usually proprietary.  That is why modeling can be difficult and inconclusive.  Most suppliers are going to tell you whether its homo or heterogeneous material and the main component such as polypropylene or polystyrene.  Since you are doing something else to the materials, they can't validate what your process is doing to the migration limits.  We use a reputable lab and ask to perform all applicable tests to ensure food safety in the EU.  While you have individual countries who may want some additional testing other than the normal EU criteria, thus far the it has not been an issue.  Thus far its worked.

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### #14 Charles.C

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Posted 01 September 2015 - 06:09 AM

Hi Charles,

Thank you for your reply. I see you have posted the AKTS presentation. I was actually thinking about the AKTS-SML software. Is this any good? Looks good to me but not too sure is this not too complicated. It also stated those calculations are accepted instead of actual Migration Tests. Is that right? I was also wondering just in case if you know - is this easy to use, I mean is that only a few minutes per day work or is that something huge where would we need a full timer on this software?

Thank you.

Fortunately, IMEX outsourcing has been the normal route.

Even then, arguments over specific procedures for migration testing for different countries are not unknown but usually end up in a compromise of mutual incomprehension.

There is another older forum thread on this topic with, from memory, some worked examples but unfortunately i could not find it so far.

My guess is that in practice some proprietary rules-of-thumb are in use analogous to Post 7.

Kind Regards,

Charles.C

### #15 Jurate

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Posted 04 September 2015 - 08:39 AM

Can anyone help me please to understand -  if I have a specific Migration Tests done on the material, do I still need to carry out the Overall Migration Test for the same material or does this cover both?

Thank you.

### #16 CMHeywood

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Posted 04 September 2015 - 03:09 PM

This is how I understand SML vs OML:

SML = is a particular raw material clean enough?  Similar to meeting FDA 21 CFR codes for raw materials

OML = is the final product clean enough so there is not too much material migrating into the food.  In the USA, the FDA does not approve finished products.  You must determine if your packaging product is FDA compliant for the intended use (per customer product type and packing/storing conditions), even if you are using raw materials that are all "OK" for food packaging.

Example - adhesives:  FDA requires that you have an adequate functional barrier.  Thus the adhesive is OK to use (meets SML) but you need to determine that migration from the adhesive is within limits (meets OML).

Example - EVA plastic resin:  Will meet FDA requirements for EVA (clean enough to meet SML).  However, if high alcohol content in customer's product, then FDA requires that you do extraction tests (thus similar to meeting OML) to determine how much may migrate into the food.

Many raw material suppliers may make a generic statement that they pass SML, meet EC 10/2011, etc. but won't give you exact information on what is migrating and at what level.  Without that information, you cannot do modeling calculations.

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### #17 Jurate

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Posted 23 September 2015 - 09:02 AM

This is how I understand SML vs OML:

SML = is a particular raw material clean enough?  Similar to meeting FDA 21 CFR codes for raw materials

OML = is the final product clean enough so there is not too much material migrating into the food.  In the USA, the FDA does not approve finished products.  You must determine if your packaging product is FDA compliant for the intended use (per customer product type and packing/storing conditions), even if you are using raw materials that are all "OK" for food packaging.

Example - adhesives:  FDA requires that you have an adequate functional barrier.  Thus the adhesive is OK to use (meets SML) but you need to determine that migration from the adhesive is within limits (meets OML).

Example - EVA plastic resin:  Will meet FDA requirements for EVA (clean enough to meet SML).  However, if high alcohol content in customer's product, then FDA requires that you do extraction tests (thus similar to meeting OML) to determine how much may migrate into the food.

Many raw material suppliers may make a generic statement that they pass SML, meet EC 10/2011, etc. but won't give you exact information on what is migrating and at what level.  Without that information, you cannot do modeling calculations.

Hi,

Thank you for your reply. I have a major issue now on how to be in comliance as most of our Suppliers won't give us their results. From reading the Guidance on DOC I would understand that they have to give as the "adequate and relevant information" which would be the amounts of substances in the material. But the Regulation 10/2011 doesn't say they oblige to pass this info to the final business operator. It only says it has to be tested (or calculated). Therefore we are confused are they obliged to pass the test results or not?

If they dont give us their test results - we have to test each supplier film and then the final laminated film which will cost us 10 grands to test one finished product. The Regulation 10/2011 says the Tests must be done in a previous stages, I mean as sooner as possible in the supplier chain and the duplication of the same work must be avoided.

I am sure none of the Suppliers want extra costs but this is the Law...

We were audited by the Governmental Institution and they gave us NC for not having the copies of Migration Test Reports from our Suppliers. Are they obliged to give this to us by EU Law?

Any thoughts is welcomme.

Thank you.

Jurate

### #18 CMHeywood

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Posted 24 September 2015 - 03:06 PM

You may be able to do this:

(1)  Obtain statement from all the suppliers about their compliance to European food contact regulations.

(2)  If they state "does not exceed SML" then assume worse case - they are at the maximum SML.

(3)  Do a worst case calculation for each raw material:

Material A    No SML            0.0

Material B    SML 1               3.0

SML 2               5.0

Material C    SML 3               0.8

Total = 8.8 (determine if less than OML)

Also need to check if 2 or more materials have SML for the same chemical, and then determine if worst case (100% migration) the combined amount would exceed SML.

You could tell your current suppliers you are considering alternate suppliers if they don't provide exact numbers (hard data).

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### #19 Jurate

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Posted 25 September 2015 - 02:40 PM

You may be able to do this:

(1)  Obtain statement from all the suppliers about their compliance to European food contact regulations.

(2)  If they state "does not exceed SML" then assume worse case - they are at the maximum SML.

(3)  Do a worst case calculation for each raw material:

Material A    No SML            0.0

Material B    SML 1               3.0

SML 2               5.0

Material C    SML 3               0.8

Total = 8.8 (determine if less than OML)

Also need to check if 2 or more materials have SML for the same chemical, and then determine if worst case (100% migration) the combined amount would exceed SML.

You could tell your current suppliers you are considering alternate suppliers if they don't provide exact numbers (hard data).

Hi,

Thank you for your reply. What happens in a worst case calculation if I have 2 materials with the same substance? Failure?

I have spoken with a Consultant and he suggested me to work on excell sheet and to work out the amount of substance in a dm2. Just not too sure how will I work this out and what will I get from that infor then?

Do you have any ideas?

Thank you,

Jurate

### #20 Jurate

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Posted 25 September 2015 - 02:55 PM

This is what I have at the moment and not too sure can I move further with this info?

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