Vietnam Sanitary and Phytosanitary Notification Authority and Enquiry Point

Regulation (EC) No 429/2008 provides for the detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications, the assessment and the authorisation of feed additives.

It lays down in Article 2(1) that an application shall be submitted using the form set out in Annex I. This Annex I is currently unnecessarily detailed. In addition, it duplicates information that applicants are required to provide anyway in the electronic submission system provided by the Commission (E-SUBMISSION Food Chain platform). This initiative therefore proposes to simplify and shorten Annex I, and to allow for the system to have an automatically generated application form by extracting the necessary information from the electronic submission, thus reducing administrative burden.

Experience shows that there is a real need to propose a comprehensive list of target animal species and categories that can be used consistently by applicants and EFSA throughout the application and assessment process, in order to avoid uncertainties or misunderstandings which complexify and sometimes even delay the outcome of the authorisation process. This comprehensive list of animal species with appropriate definitions to ensure common understanding is to be laid down in a new Annex V to Regulation (EC) No 429/2008, while Annex IV thereto is expanded to provide a comprehensive list of animal categories.

Additional adjustments are proposed in other parts of Regulation (EC) No 429/2008, such as the addition of a new definition of major species, or to ensure wording consistency.

Furthermore, a concordance table is provided, in Annex III to this draft Implementing Regulation, offering a correspondence between the terms commonly used for the designation of animal species and categories in the current authorisations of feed additives and the new terminology, with a view to help applicants prepare applications for the renewal of existing authorisations.

Finally, in order to enable business operators to adapt to the new requirements set by this draft Implementing Regulation, it is proposed that it starts applying six months after its date of entry into force.