A substance/product type combination listed in Annex II that fulfils the following conditions: 1- it has not been the subject of any of the following acts: - a directive relating to inclusion in Annex I or IA of Directive 98/8/EC; - a regulation establishing that it has been approved under Article 89(1), third subparagraph, of Regulation (EU) No 528/2012; 2- it has not been the subject of any non-approval decision or the last non-approval decision concerning it was repealed