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Migration data for food contact liners: obligation of the manufacturer


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#1 Konstantinos

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Posted 12 March 2014 - 09:09 AM

Can you anyone help on whether a manufacturer is obliged to do migration tests for the product which have direct contact with food, please?

If the manufacturer has to provide data, then under which legislation umbrella, UK or European, please?

What is the ''obligation'' due diligence of the user under the BRC standards?

 

I am looking forward to all your replies.

 

Thank  you


Edited by Charles.C, 13 March 2014 - 02:23 AM.
topic moved to food packaging

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#2 teody

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Posted 13 March 2014 - 01:32 AM

Im also interested with the replies. We are BRC, the supplier (packaging) analyses are sufficient. 

 

we try to address the impact of packaging (Even if results of supplier are okay) with our end-product testing with is part of our shelf life monitoring. 

 

any ideas? 


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#3 moskito

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Posted 15 March 2014 - 03:20 PM

Hi,

 

in the EC this ist covered by the regulations

1935/2004

2023/2006

10/2011 ("PIM") for plastics

etc.

 

Packaging supplier has to provide a declaration of conformity (where required by regulation e.g. plastics) or declaration of ...(similar for other materials) acc the test requirements. The customer should inform the supplier about the application/conditions (composition of the product, temperature, time etc)

For the effect of the packaging material on the final product the manufacture of the product is responsible (-> end of shelf life)

 

Rgds

moskito


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#4 Caglar

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Posted 25 March 2014 - 11:40 AM

I assume you mean the food manufacturer by "manufacturer"... 

 

Packaging supplier has to provide "Declaration of Conformity" according to EU legislation 10/2011 Annex IV. In this document you should find what types of food can be packed (for how long at what temperature) with that packaging. Packaging supplier declares what types of food can be packed based on the migration test results which are carried out according to Annex III of the same legislation. This should cover the due diligence of packaging supplier. 

 

On your side, packaging should be covered under HACCP study, so you should assess the potential risk that can come from packaging.  I work in packaging manufacturing therefore I do not know exactly how it works for you, but as far as I can imagine, if you meet the conditions in the "Declaration of Conformity" you are doing your due diligence. 

 

For example you bought vacuum bags from me for your frozen fish fillets and I supplied DoC stating that this vacuum bag is OK to use all types of food for 10 days @40°C. I can only declare that based on my migration tests. If your conditions are within 10 days @40°C I don't see why you have to do migration test. But if your shelf life is 14 days, I (packagin supplier) cannot guarantee that packaging is safe in terms of migration. In that case you can cover the risk by testing my packaging in accredited lab  for 14 days. Or you can ask me to do it for you which I will reflect on the price of the packaging.

 

So you see, for the whole system to work, first you have to tell me what you are packing unless all my packaging is OK for all types of food. Then I supply the correct packaging with DoC. Then you assess the risk of packaging in your HACCP study based on my DoC.

 

I hope this was clear.  


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#5 Bean Queen

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Posted 26 March 2014 - 11:09 PM

I have not been able to get migration data from packaging suppliers. I think it may be because packaging manufacturers  purchase/utilize materials and inks already approved for use in food.


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#6 Charles.C

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Posted 26 March 2014 - 11:25 PM

Dear All,

 

All input is welcome but please note the OP is apparently specifically interested in UK scenario.

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#7 paulo tavares

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Posted 26 March 2014 - 11:26 PM

Good evening,

 

Reg.CE 1935/2004

Reg.CE 10/2011

 

And you can also use the recomendations from BfR, which gives you other relevant information for the food safety of the packaging. But it is a recomendation (ver usefull)

 

For inks, you can look for some guidance in the Swiss Ordinance on the annex VI.

 

BfR and Swiss ordinance on inks, are excellent support documents, together with the EU regulation, to build a good support for the BRC..

 

Hope it can help.

 

Paulo


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#8 Charles.C

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Posted 26 March 2014 - 11:33 PM

Good evening,

 

Reg.CE 1935/2004

Reg.CE 10/2011

 

And you can also use the recomendations from BfR, which gives you other relevant information for the food safety of the packaging. But it is a recomendation (ver usefull)

 

For inks, you can look for some guidance in the Swiss Ordinance on the annex VI.

 

BfR and Swiss ordinance on inks, are excellent support documents, together with the EU regulation, to build a good support for the BRC..

 

Hope it can help.

 

Paulo

Dear Paulo Tavares,

 

thks for input.

 

I think I recall posting material here on the BfR organisation you mention a few years ago but probably now out of date.

 

Do you have any links ? (too lazy to start IT searching :smile: )

 

I also suspect Simon previously in another thread here answered the (UK) legislatory question in the OP.

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#9 Caglar

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Posted 27 March 2014 - 11:37 AM

1. Packaging manufacturer is obliged to make the migration tests according to EU regulations mentioned above (10/2011 and 1935/2004). Same goes for UK since it is in EU.

 

2. Packagin manufacturer is obliged to declare these results (along with other mandatory data) in Declaration of Conformity according to EU 10/2011. Same goes for UK since it is in EU. If you are buying packing for your food without these declarations in place, you are risking your product's safety.

 

3. Food manufacturer has to assess himself whether it is enough to rely on the DoC from packaging supplier or he should make further migration test. (Criteria for this assessment are explained above, in my previous post)


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#10 paulo tavares

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Posted 27 March 2014 - 07:42 PM

Dear Paulo Tavares,

 

thks for input.

 

I think I recall posting material here on the BfR organisation you mention a few years ago but probably now out of date.

 

Do you have any links ? (too lazy to start IT searching :smile: )

 

I also suspect Simon previously in another thread here answered the (UK) legislatory question in the OP.

 

Rgds / Charles.C

Hello Charles.C,

 

Here it is what I found:

 

Swiss ordinance (check the bottom of the page) - http://www.blv.admin...ex.html?lang=en

 

BfR - http://bfr.zadi.de/k...360-english.pdf

 

Hope this helps!

 

Paulo


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#11 Peter Snopko

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Posted 27 March 2014 - 09:45 PM

The food manufacturer is responsible for making sure their food product is safe.

The packaging manufacturer is responsible for making sure the packaging material / structure they supply to you is safe, so need to supply all the compliance information and chemical migration
tests and heavy metal test results to you.

Migration tests can be carried out by a number of special labs around the world, but make sure these labs are qualified to do the testing.

Raw material vendors need to supply information showing their materials comply with the specific regulations of where the food is packed and sold.

The biggest problem is the raw materials suppliers as many do not understand their responsibilities when materials go into markets they have not supplied before, or where regulations have recently changed.
Make sure you know which country regulations you need to be compliant with, then work backwards to your packaging vendor.

Remember that Organoleptic testing needs to carried out by the food manufacturer.

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Peter Snopko
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Ph: +64 21 813259

#12 Charles.C

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Posted 28 March 2014 - 01:29 AM

Hello Charles.C,

 

Here it is what I found:

 

Swiss ordinance (check the bottom of the page) - http://www.blv.admin...ex.html?lang=en

 

BfR - http://bfr.zadi.de/k...360-english.pdf

 

Hope this helps!

 

Paulo

Dear paulo tavares,

 

Thks for the very useful links.

 

I extracted one of  the links for convenient usage, and in case the webpage changes in the future. :smile:

 

Attached File  packaging inks, accepted materials, Switzerland, 2012.pdf   1.64MB   48 downloads


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Kind Regards,

 

Charles.C


#13 maddox

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Posted 02 April 2014 - 03:24 AM

Hi Everyone,

 

Does this include the BPA-free test?


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#14 Jurate

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Posted 23 September 2015 - 09:30 AM

The food manufacturer is responsible for making sure their food product is safe.

The packaging manufacturer is responsible for making sure the packaging material / structure they supply to you is safe, so need to supply all the compliance information and chemical migration
tests and heavy metal test results to you.

Migration tests can be carried out by a number of special labs around the world, but make sure these labs are qualified to do the testing.

Raw material vendors need to supply information showing their materials comply with the specific regulations of where the food is packed and sold.

The biggest problem is the raw materials suppliers as many do not understand their responsibilities when materials go into markets they have not supplied before, or where regulations have recently changed.
Make sure you know which country regulations you need to be compliant with, then work backwards to your packaging vendor.

Remember that Organoleptic testing needs to carried out by the food manufacturer.

 

Hi ,

 

I have the problem with our Suppliers. They dont do the Migration Tests or if they do - they won't give us the results. Can you tell me which clause of 10/2011 obliged the suppliers to pass the results to next business operator. In my case we laminate different types of the plastic films in the final material. Most of the suppliers states it is not their responsibility to carry out the Migration Tests. I disagree.

 

Jurate


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#15 Caglar

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Posted 23 September 2015 - 10:09 AM

Hi ,

 

I have the problem with our Suppliers. They dont do the Migration Tests or if they do - they won't give us the results. Can you tell me which clause of 10/2011 obliged the suppliers to pass the results to next business operator. In my case we laminate different types of the plastic films in the final material. Most of the suppliers states it is not their responsibility to carry out the Migration Tests. I disagree.

 

Jurate

 

Hello,

 

Are you buying "ready films to laminate" or are you buying "plastic pellets to make films and laminate" ?

Because there is a difference there.

 

If you are buying plastic pellets you will not get migration data from the supplier. Migration of chemicals depends on many factors. Some of these factors such as thickness controlled by film maker (converter). Therefore it will be meaningless to get migration data from pellet supplier. Pellet supplier can mention in ther DoC that "they do not incorporate restricted chemicals in the pellets" and "they put material A, Material B etc. in the pellets which are regulated by EU regulation". That's it. You as a converter have to determine that your final packaging complies with migration restrictions. Based on the DoC from pellet supplier you will know what restricted chemicals will be present in the film you make. Therefore you will know which migration tests has to be carried out. And you also have to declare these results to your customer according to EU regulation.

 

However if you are buying ready films and laminating them, then you are in the position of "customer" in above paragraph. So the film maker (converter) has to declare the migration. This is very clearly stated in 1935/2004 article 16/1; also 10/2011 article 15.  

 

I hope this helps.

 

Caglar


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#16 Jurate

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Posted 23 September 2015 - 10:32 AM

Hello,

 

Are you buying "ready films to laminate" or are you buying "plastic pellets to make films and laminate" ?

Because there is a difference there.

 

If you are buying plastic pellets you will not get migration data from the supplier. Migration of chemicals depends on many factors. Some of these factors such as thickness controlled by film maker (converter). Therefore it will be meaningless to get migration data from pellet supplier. Pellet supplier can mention in ther DoC that "they do not incorporate restricted chemicals in the pellets" and "they put material A, Material B etc. in the pellets which are regulated by EU regulation". That's it. You as a converter have to determine that your final packaging complies with migration restrictions. Based on the DoC from pellet supplier you will know what restricted chemicals will be present in the film you make. Therefore you will know which migration tests has to be carried out. And you also have to declare these results to your customer according to EU regulation.

 

However if you are buying ready films and laminating them, then you are in the position of "customer" in above paragraph. So the film maker (converter) has to declare the migration. This is very clearly stated in 1935/2004 article 16/1; also 10/2011 article 15.  

 

I hope this helps.

 

Caglar

 

Hi ,

 

Thank you for your reply. We buy Nylon, Polyethylene, Polyester, Polypropylene. Some of them are multi layer materials. I mean made of 20% of LDPE and 80% of something else etc but the material we buy is plastic materials wounded on the reels and our processes is printing inks, laminating a few layers together. 

Our Technical director's opinion is that the Regulation 10/2011 does not obliged our Suppliers to give us their Test Results. I have a different opinion.

 

Kind Regards,

Jurate


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#17 Caglar

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Posted 23 September 2015 - 10:43 AM

Hi ,

 

Thank you for your reply. We buy Nylon, Polyethylene, Polyester, Polypropylene. Some of them are multi layer materials. I mean made of 20% of LDPE and 80% of something else etc but the material we buy is plastic materials wounded on the reels and our processes is printing inks, laminating a few layers together. 

Our Technical director's opinion is that the Regulation 10/2011 does not obliged our Suppliers to give us their Test Results. I have a different opinion.

 

Kind Regards,

Jurate

 

I don't think this is a matter of opinion. I would advise you to discuss this with your technical director. Your supplier (who is a converter) has to give you the information that the films comply with migration limits.

 

Let me paste the text here from 10/2011:

 

Article 15
Declaration of compliance
1.
At the marketing stages other than at the retail stage, a written declaration in accordance with Article 16 of Regulation (EC)No 1935/2004 shall be available for plastic materials and articles,products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles.
2.
The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV.
 
 
And if we look at Annex IV;
(6)
adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions;
(7)
adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;
 
 
English is not my native language but I think it is perfectly clear that information on restricted materials (migration of these materials) has to flow downstream. 

 

By the way since you modify the films you buy, you also have to make your own migration tests and declare them in DoC to the next in line (which is the food manufacturer). Your company is subject to same rules as your supplier. 


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#18 Jurate

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Posted 23 September 2015 - 10:55 AM

I don't think this is a matter of opinion. I would advise you to discuss this with your technical director. Your supplier (who is a converter) has to give you the information that the films comply with migration limits.

 

Let me paste the text here from 10/2011:

 

Article 15
Declaration of compliance
1.
At the marketing stages other than at the retail stage, a written declaration in accordance with Article 16 of Regulation (EC)No 1935/2004 shall be available for plastic materials and articles,products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles.
2.
The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV.
 
 
And if we look at Annex IV;
(6)
adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions;
(7)
adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;
 
 
English is not my native language but I think it is perfectly clear that information on restricted materials (migration of these materials) has to flow downstream. 

 

By the way since you modify the films you buy, you also have to make your own migration tests and declare them in DoC to the next in line (which is the food manufacturer). Your company is subject to same rules as your supplier. 

 

I agree with you. My English is not native as well, but I would understand that the adequate info is not only list of substances but the test results as well.

It also clarifies on Guidance "Relevant information is the amount of substance present or adequate information". See page 20-21 of the Guidance. I think our Suppliers are the Manufacturers of Intermediate Materials See clause 4.3.1 and my company would be Plastic Final Material as per clause 4.4? Would you agree with me?

 

See the link to Guidance.

 

http://ec.europa.eu/...-10-2011_en.pdf

 

Thank you,

Jurate


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#19 Simon

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Posted 23 September 2015 - 11:00 AM

Just to add to Caglar's fine information.

 

Jurate, you are required to conduct migration testing on the range of your end products.  This can be done without supplier migration data, but it will make it more difficult for the lab to interpret results and pinpoint which material component may be causing out of specification results (if there are any).

 

Regards,

Simon


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#20 Caglar

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Posted 23 September 2015 - 11:04 AM

I agree with you. My English is not native as well, but I would understand that the adequate info is not only list of substances but the test results as well.

It also clarifies on Guidance "Relevant information is the amount of substance present or adequate information". See page 20-21 of the Guidance. I think our Suppliers are the Manufacturers of Intermediate Materials See clause 4.3.1 and my company would be Plastic Final Material as per clause 4.4? Would you agree with me?

 

See the link to Guidance.

 

http://ec.europa.eu/...-10-2011_en.pdf

 

Thank you,

Jurate

 

Yes completely agreed.

 

Caglar


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#21 Jurate

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Posted 23 September 2015 - 01:17 PM

Just to add to Caglar's fine information.

 

Jurate, you are required to conduct migration testing on the range of your end products.  This can be done without supplier migration data, but it will make it more difficult for the lab to interpret results and pinpoint which material component may be causing out of specification results (if there are any).

 

Regards,

Simon

 

Thank you Simon. I know all that. And we do our own Testing as well. In this case I just want to make sure our Suppliers do their bits whatever they are obliged to do as per Regulation. Also if we get their test results - it becomes much easier to us as we can compare and add together the substances in all layers and see do we need additional tests. In some cases if they use different substances it woudnt be neccesary to carry out the Migration Tests for the particular specific substances. 

 

Would you agree with Calgar in regards the Regulation that the raw material suppliers must pass the Test results and not only the names of the substances?

 

Kind Regards,

Jurate


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#22 purg

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Posted 12 January 2016 - 02:33 PM

Hi All

 

Im new to the community. As this topic is my major and Im working for a food packaging plastic converter, I decided to give you my comments as well.

 

Accoriding to 10/2011 plastic converter doesnt have to disclose any migration data to anyone apart of authorities. Plastic converter is obliged to confirm compliance with regulation. THis can be done by migration testing but is not limited to. Compliance can be also proved by migration calculations or any other scientific proof. Imagine that you have a SM limited compound which even if migrating 100% out of the package wont exeed the limit. In such case migration testing doesnt have to be done in order to prove compliance.

 

So to conclude: plastic converter has to prove compliance and he has to have data for proving compliance available for authorities but not for its customers. Converter needs to provide declaration of compliance to their customers where it states: product suitability, testing conditions and testing methods, simulants used and adequate information on results. "Adequate" is a key word in this case. For a food packer who is not doing any postprocess conversion of plastic package adequate means: information on that it was tested OM (passed the test) and that there were specific migration limited substances tested and they are within the limit. Food packer doesnt have to have data on migration as he is not obligated to test those products. It is enough to prove due dilligence when you have a written confirmation that package is compliant with certain regulations. In this case: 1935/2004, 10/2011, 2023/2006, package waste regulation. Plastic converter is a different story, they need to test it as they convert resins and mix them with masterbatches and such process can modify migration patterns. Both of substances separately might pass migration but when combined they fail.

 

Of course there is a common practice to give food fillers results of migration testing but this is a comercial decision of each plastic converter rather than a law requirement.

 

Michal


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