Posted by Regulation (European Commission) No. 470/2009 lays down Community procedures for the establishment of residue limits of pharmaceutical active substances, excipients or degradation products and their metabolites which remain in food obtained from animals.
Committee for Veterinary Medicinal Products (CVMP), at European Medicines Agency (EMA) has deliberated on many substances (including excipients, adjuvants and preservatives) to be used in veterinary medicinal products intended for food producing species, and regularly receives requests (either scientific advice or ad hoc requests) to consider whether such substances fall within the scope of the maximum residue level (MRL) regulation.
The substances for which the CVMP has concluded that no MRL evaluation is required are listed in the
CVMP publication “Substances considered as not falling within the scope of Regulation (EEC) No.
2377/90” (EMEA/CVMP/046-00), also often referred to as the ‘out of scope list’.
On 14 November 2025, the CVMP updated the ‘out of scope list’ with betadex sulfobutylether sodium (Sulfobutyl ether beta-cyclodextrin sodium (SBECD), CAS No: 182410-00-0), characterized that 1,4-butane sultone impurity present at levels not more than specified in the Ph. Eur.) with the restriction for oral use only. The meeting minutes are not public yet, however, it may be anticipated that the low oral absorption of SBECD and the safety of this exipient both contributed to the justification of above CVMP decision.