Migration testing requirements virgin polymer unprinted bags?

Due to EU regulations, more and more of our customers are now expecting migration (overall migration not specific migration) test results from us. Our bags are made from virgin polymer, no printing.  I understand the concept however I have some questions that go unanswered.

1. Does 'overall' migration testing cover the full range of simulants?

2. We make hundreds of different sizes and thicknesses of bags for different products, if customer A uses our bags for fish, customer B uses our bags for fruit, customer C uses our bags for ice, do I need a separate result for customer A, another for customer B and so on?

3. It is a very expensive exercise. How do I go about this intelligently?

4. What am I not asking? 

I want the answer to be 1 bag + 1 test = all the customers are happy.

Please help

It is a minefield; these days every packaging company needs to employ a scientist.  In reality that’s not going to happen, so you have to muddle your way through.

The regulation that applies is Commission Regulation 10/2011/EC.  In the Annex to the regulation is a list of substances that have been approved for food contact. First check your product specification formulation against this list.

Some of the substances in the lists can be used without specific restrictions. If a product only contains substances without specific restrictions, it only needs to be tested for overall migration to determine how much product migrates into the food. It is not intended to show which substances migrate, but the total quantity that migrates.  All food contact materials must not exceed an overall migration limit of 10 mg/dm2.

In the list there are also a number of substances that are subject to specific migration limits in which case specific migration testing will be required. Again check your product specification formulation against this list to see if anything listed.

Seems simple, but this is where it gets a little complicated.  Depending on what food product is going in the bag then different migration tests may be required with different food simulants at different temperatures etc. 

Ultimately you cannot do this on your own and you need to contact a professional lab that can do this for you.

They should come in and look at your product portfolio, manufacturing process, supplier specifications, customer products, end user locations and develop a testing plan that is comprehensive enough to cover all intended uses.

It may well be that only overall migration is required, which will be cheaper, but even so multiple tests may still be required with different simulants under different conditions.

If it is all the same substrate I really don’t think thickness and size of bag will make a difference to the amount of testing required.

I’m no expert, but that’s as much as I know from what I’ve picked up over the years.

Thank you Simon.

I will carefully read through your reply till I understand it fully. We have to send our samples to Europe for testing. There is no approved lab in South Africa (or so I am told).This is what makes it very expensive. I want to understand (as much as I need to) before I start making decisions. It will be interesting to hear from suppliers of food what they want from their packaging suppliers. Let me put it this way, what do they need and what do they want from us.

Thanks again

I will keep you up to date as I am sure there are many packaging suppliers who need answers too.

I recently transitioned from food to packaging and just completed my first round of EU testing.  After all was said and done it was not as bad as I thought, but initially it was very confusing.  A really good lab will help through it.  While many of the recognized labs have offices and testing facilities in China which are usually cheaper I found language a huge barrier and I struggled to get good answers.  I recently found Bureau Veritas in Germany and really like them.  I sent them samples asked them what I needed done to be in EU compliance and got a quote back very quickly.  Once we okayed the quote the work was done very quickly.  While I found a little language difficulties with Germany overall there grasp was much better than what I experienced with the Chinese. 

Surely the responsibility rests with the packer filler to ensure that the pack is fit for purpose?

Surely the responsibility rests with the packer filler to ensure that the pack is fit for purpose?

If you mean the company purchasing the material to pack their food in.  That would be a bad idea.  As someone who came from food while I had some idea of what needed to be done, I did not have the full scope.  This testing is very expensive and it would greatly raise the price on the packaging if each food manufacturing company did it.  It is much more cost effective for the manufacturer of the product to do this testing and they are the most knowledgeable of the process and materials. 

the responsibility lies with the packaging manufacturer to prove it is fit. 

the responsibility lies with the packaging manufacturer to prove it is fit. 

Yep I agree. 

Hi

we are a user of packaging.

a) our requirement is to receive from the supplier "worst case" test results with simulants (acc. 10/2011/EC) - OM, SM etc

b) we do our own risk assessment i.e. we have to do in some cases analytics on our own (acc. 1935/2004/EC)

Rgds

moskito

I love this subject! Thanks for all the comments.

We manufacture direct food contact cartons. The situation maybe different for plastics?

In the EU there is no legislation directly applicable to paper and board packaging as there is with plastics.

(Obviously 1935/2004 and 2023/2006 apply to all food contact packaging.)

The packaging converter has a responsibility to ensure that the pack conforms to legislation 1935/2004, 2023/2006 as it leaves their factory but they cannot have the detailed knowledge of how the particular food will react with the pack. This responsibility lies with the packer filler to ensure that when the pack is packed with their particular food, under their particular packing conditions, with their particular storage conditions and shelf life it is fit for purpose and conforms to legislation.

Snookie: regarding your comment about cost to the food manufacturer and it raising the price of the final product, if the converter has to pay it will go on the cost of the pack and be passed on to the packer filler and ultimately the consumer. In the UK the supermarkets are constantly driving down prices from suppliers (as we all know) but food packaging should not be regarded as 'cheap' or 'low cost'. If it is going to comply with legislation there is going to be additional costs.

Hello, 

As far as I know, there is not yet a global food contact legislative approach, so, an important issue will be where is located the user of your products and of course the legislation applicable in the country where the packaging materials are produced. At this moment, I believe that there are two major regulatory systems for control of food contact materials which should be take into consideration: those of the EU and US (FDA).

BR, 

Costi