Extensive experience gained during the implementation of the full declaration has shown that knowledge of the full qualitative composition of flavours and fragrances (aromatic substances) with complex compositions does not provide any clear added value for the assessment at Swissmedic.
The requirements for these types of mixtures are therefore being aligned with those in the EU and a full qualitative declaration will no longer be required. Instead, a generalised qualitative declaration will suffice in future. In addition, the primary ingredients and any excipients of particular interest according to Annex 3a TPLRO (for human medicinal products) or any safety-relevant excipients (for veterinary medicinal products) in the flavouring must be listed.
In particular, this means that flavouring manufacturers no longer need to submit confidential documents directly to Swissmedic – a complex process that was often necessary in the past for reasons of confidentiality.
Section 2 Further information of the Full declaration form has been revised accordingly; the revised form enters into force on 1 January 2025.