According to the procedure under Article 8 of Regulation (EC) 1925/2006, EFSA has assessed the relationship between alpha-lipoic acid (ALA) and the risk of insulin autoimmune syndrome (IAS).

The Panel concludes that the consumption of ALA added to foods, including food supplements, is likely to increase the risk of developing IAS in individuals with certain genetic polymorphisms, who cannot be readily identified without genetic testing. Considering the limited data available, the risk associated with the development of IAS following ALA consumption cannot be quantified precisely and an ALA dose below which IAS is not expected to occur cannot be determined.

On the basis of this scientific opinion, the Member States and the European Commission will have to assess the need or not to establish legal restrictions for alpha-lipoic acid in Regulation (EC) 1925/2006.