New Commission working methods and secondary legislation

21.5.2015

Question for written answer P-008190-15
to the Commission
Rule 130
Béla Kovács (NI)

In keeping with the Commission’s new working methods, there will be more systematic internal planning and screening of initiatives to ensure that all proposals are in line with the President’s political priorities.

In particular, the Commission’s Agenda Planning system has been reinforced for secondary legislation. Commission services are now required to enter delegated and implementing acts having ‘significant impacts’ into the system at least 12 months before expected adoption. As for delegated and implementing acts ‘not having significant impacts’, entry into Agenda Planning must take place a minimum of 3 months before the expected adoption.

This improved planning should be welcomed, especially considering that the Commission is in the process of preparing secondary legislation implementing a number of important EC laws with great implications for relevant stakeholders. This includes, most notably, the Clinical Trials Regulation, the regulation on food for infants and special medical purposes, the Tobacco Products Directive and the Falsified Medicines Directive.

However, there is uncertainty about the meaning of the term ‘significant impacts’. Can the Commission please clarify the definition of this term and specify who, in practice, determines whether a given measure will have a ‘significant impact’? How does the Commission determine whether or not a delegated or implementing act entails ‘significant impacts’? Does it follow objective criteria in making this determination?