Specific Migration testing and the alternative - screening method

Hi,

I have been trying to understand specific migration testing.  In Regulation (EU) No 10/2011, Annex V chapter 2, there is mention of screening approaches (paragraph 2.2).  It says specific migration can be replaced with overall migration. The approach is to test at conditions as severe as specific migration testing.  I have a couple of questions:

1. How is screening done?  Since it sounds like it is not analysis of the compounds?

2. On some migration certificates,  I see Overall migration where there is some migration detected but less than the overall migration limit, but there is no specific migration looking at the specific compounds since some of them have very low SMLs.  Is this acceptable?

2. For my packaging of interest, it is used for oil for instance.  The packaging manufacturer does overall migration with the right simulant (D2, Isooctane, Ethanol 95%).  When it comes to specific migration, they only test with acetic acid.  I am concerned because they don't have specific migration using D2 or equivalent.  

I have looked at Regulation 10/2011 and I still don't have clarity on specific migration testing requirements for simulants and when screening is permitted and how is screening done.

Thanks,

Purity

Greetings Purity,

As per the regulation (Annex III) concerning specific migration, your supplier should test with D2. In the same Annex, just above Table 2 and elsewhere in the regulation you can find exception cases (omitting the analysis for specific migration) if certain conditions are met, so maybe that is why you may see in some certificates only overall.

Screening is used when the composition of the material or sample is unknown. The screening analysis gives information about the migrating components. It is also a good tool for detection of non-intentionally added substances.

Regards!

 Hi ;)

I found this document quite useful. 

See attachment