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