Declaration of Compliance - EU 10/2011; migrations

Hi, I hope I posted this in correct section.

I would appreciate if someone can please explain sections (6) and (7) from 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;

 

 

If I understand correctly - the section (6) refers to SML and (7) for dual additives and such.

But I'm not sure, how do I know for which SML I need testing? Do I take that data from the DoC of the raw material supplier?

Thank you.

There are 1000+ substances listed in the Annexes so it is unreasonable to test for all of them all 'just to be safe' - You would very quickly go out of business.

The way that I have approached it is to ask the supplier precisely for confirmation if any of the listed substances are used and if so which and how much. I have found that suppliers give out a general D of C if you don't push them. I don't know what sort of products you make but remember to look at all of the materials - base polymer, masterbatches and additives which make up the finished product.Dual Use substances are reasonably common in masterbatches. (eg Titanium Dioxide)

Then if they are known to be present or have these tested specifically.

In addition, have the lab carry out a Non Intentionally Added Substance (NIAS) analysis. This will tell you about the breakdown products which you also need to include in the Declaration.

Remember to review the results, particularly the NIAS. If a substance is there you need to be able to state whether it is safe for food contact or not. This normally means heavy reliance on google.

Thank you very much for your answer!

I understand now - if I have BOPP and CPP combination packaging I have to take the data from supplier which substances are used/detected and give it to the lab.

I have found that suppliers give out a general D of C if you don't push them. 

Ha, same here. 

One more question - if I use external laboratory service for testing OML and SML - do I have to give our customers official report from the lab or is it sufficient to show the results in our DoC?

The lab report and D of C are separate items.

In Europe, the D of C is a document required by legislation, in this case EU10/2011 and the content is defined in the legislation (Annex IV)

The lab report is something that you have purchased and will have used in preparing your D of C. It is your property and there is nothing in the legislation which says that you have to give the lab report to a customer, although an enforcement agency can request it to confirm the content of the D of C.

However, we live in a commercial world and large customers frequently ask for a lab report as well as the D of C. (Many of them have no idea what it means, it is just in their procedure!)

It depends therefore upon your relationship with your customer.

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However, we live in a commercial world and large customers frequently ask for a lab report as well as the D of C. (Many of them have no idea what it means, it is just in their procedure!)

 

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Understandable. They are mostly foodmakers and don't have expertise in packaging (even not mind to employ an expert either).

Btw, my company has some customers in UK. Could you advise me what/how to make a British equivalence of EU10/2011 DoC? (resulting by brexit from 2021, IIRC)

At the moment the UK has passed  European Union Withdrawal legislation which amongst other things essentially transposes existing EU laws into UK laws until such time as they are changed.

I haven't seen anything about the UK changing food contact legislation so would assume that existing D of C formats will be required at least for a while. I don't know how it will work with amendments to existing legislation which is a problem, as EU10/2011 is amended nearly every year, sometimes more.

I would guess that in the absence of anything else UK food manufacturers will just use the EU amendments. They will still want to export their products to the EU and so will need EU compliance.

At the moment the UK has passed  European Union Withdrawal legislation which amongst other things essentially transposes existing EU laws into UK laws until such time as they are changed.

 

I haven't seen anything about the UK changing food contact legislation so would assume that existing D of C formats will be required at least for a while. I don't know how it will work with amendments to existing legislation which is a problem, as EU10/2011 is amended nearly every year, sometimes more.

 

I would guess that in the absence of anything else UK food manufacturers will just use the EU amendments. They will still want to export their products to the EU and so will need EU compliance.

Exactly this, for now at least - the UK regulations are transposed directly from the EU equivalents, with the only real changes largely being to replace references to EU bodies with equivalent UK ones. I'd continue to send your declaration making reference to 10/2011 for the time being.

Handling of amendments is anybody's guess at present. Historically been happy with the science/risk basis behind them and will want definitely want to continue trading with the EU, so arguably irrespective of what happens here locally we'll all want to continue using packaging that keeps pace with EU requirements. Common sense says we'd therefore mirror these in UK law too, but I'm a little wary of relying on common sense in the context of the "B word" :helpplease:

Thank you, Foodworker and pHruit. Your comments are very helpful.

Understandable. They are normally foodmakers and do not have expertise in packaging (even now not thoughts to rent an expert either). to find the List of Best Blender for Iced Coffee 2020 online, You can see the link.

pHruit, you said The UK regulations are transposed directly from the EU equivalents, with the only real changes largely being to replace references to EU bodies with equivalent UK ones thus continue to send your declaration making reference to 10/2011 for the time being.

Should I have in place 2 DoC's when I send produts to EU and within UK?

pHruit, you said The UK regulations are transposed directly from the EU equivalents, with the only real changes largely being to replace references to EU bodies with equivalent UK ones thus continue to send your declaration making reference to 10/2011 for the time being.

Should I have in place 2 DoC's when I send produts to EU and within UK?

I suspect that for the time being, one declaration giving a general confirmation ref. UK and EU law, but making specific reference to the EU regulations, will continue to suffice for the time being. How long that remains viable rather depends on whether there is some sort of crazy divergence of UK law away from EU on food-related matters, and right now that is anybody's guess :helpplease:

My feeling is that a lot of this is going to be tied into trade agreements, and since they're arguably as much about silly political posturing as they are about making it easy for food (and other goods) to flow between the UK and the EU, I'm watching somewhat nervously at present. Nonetheless I suspect we've got at least a few years of vaguely sensible equivalence to look forward to first.