Is the Migration report valid as per (EU) 10/2011?
We just receive a new packaging from a new supplier, in their declaration of compliance they state:
The overall migration tests have been performed on representative samples of the plastic layer of extrusion coated paperboard according to EN 1186-14 and EN 1186-5 with the following results. The overall migration limit 10 mg/dm2 stipulated in the Commission Regulation (EU) 10/2011* is not exceeded.
In their migration report it says:
The concentration of breakdown product 2 was found to be above the restricted migration limit for non-listed substances (1.7µg/dm2 equivalent to 10 ppb). On basis of toxicological data provided by the ink supplier, the result of breakdown product 2 is currently assessed as uncritical value (>10ppb but <50ppb).
Can we use these boxes as they say in their DoC?
In the text 10/2011 i did't find any reference to µg/dm2 or ppb's or an "uncritical value"
In my opinion, the listed substances and required levels are based on the risk associated with food safety aspects; this is to say by the laboratory analysing non-listed substances, they did it either by them (the supplier) requesting them to do so or they have a facility to perform such analysis; the statutory requirement is the listed substances; the rest if FYI,
I suggest you go on and make use of the packaging materials,they are safe.
I think that comment in the declaration is regarding only to the ink, note that regulation 10/2011 is only regarding to plastic materials and ink aren't in its scope, see paragraph 6 in the introduction of regulation
"Therefore plastic materials and articles that are printed, coated or held together by adhesives should be allowed to contain in the printing, coating or adhesive layer other substances than those authorised at EU level for plastics. Those layers may be subject to other EU or national rules"
I think they are perfoming a risk assesment above sustances not listed in regulation 10/2011 (annex I). And it's possible it is based in some national regulation, mabye LFGB (Germany)
I agree with previous posters the material sounds ok as per 10/2011.
I would have a question back to the supplier to understand their practcial method for migration testing and also about their printing controls e.g. are they in compliance with (EC) No 2023/2006
This would help me to understand perhaps how the ink component is migrating to the product and to give confidence that the 10ppb can consitently be mainatined (for this and other substances) through good print press management and consitently effective curing / drying.
Regards,
Simon
Thank you all,
in regards to 2023/2006, they've already put this in their DoC.
The fact that the report said that 1 component was above the restricted migration limit got me a bit worried.
I didn't look forward to the part where I had to postpone/cancel the new design of the packaging.