Check out our COVID-19 dedicated page for tenders related to medical equipment needs.
231901-2021 - Belgium-Brussels: Production, Priority-purchasing Options and Supply of Covid-19 Vaccines, Including Adapted Vaccines to SARS-CoV-2 Variants and Paediatric Formulations of such Vaccines for EU Member States
Luxembourg-Luxembourg: Analysis to support implementation of Articles 5, 6, 8 and 8c of Directive 2014/87/Euratom
Section I: Contracting authority
Section II: Object
Analysis to support implementation of Articles 5, 6, 8 and 8c of Directive 2014/87/Euratom
Council Directive 2009/71/Euratom as amended by Council Directive 2014/87/Euratom, (the Nuclear Safety Directive, hereafter “the Directive”) significantly strengthens the EU legal framework on nuclear safety. The Directive formulates a common basis for the management of nuclear safety, describing the essential administrative, technical and procedural requirements.The Commission now wishes to broaden its analysis of the implementation of the Directive, focussing on several practical issues, namely; the responsibilities of the Competent Regulatory Authority (CRA) and the Licence Holder. In addition, the Transparency requirements, in which both the CRA and the Licence Holder play an important role, should also be analysed.
Implementation of requirements on the Competent Regulatory Authority (CRA) and Transparency — Article 5 and Article 8
An analysis of the provisions of Article 5 and of Article 8 of the Directive, together with those international and European level standards and guidance that are available to support the implementation of the Directive’s legal requirements. The analysis should include scope, detail, level of practicability of the provisions of the Directive and a description of possible gaps, between the Directive and the applicable standards.
A comprehensive survey of the existing legal, administrative and organisational framework for applying the requirements of Article 5 and of Article 8 in all the EU Member States, specifically examining how these systems, procedures and practices have been set up and should work in practice.
Implementation of requirements on Licence Holders for the safety demonstration and subsequent periodic safety review (PSR) — Articles 6(b), 6(c), 8c(a) and 8c(b)
The underlying principle of Article 6, where the prime responsibility for the nuclear safety of a nuclear installation rests with the licence holder remains essentially unchanged.
However, Paragraph 6(b) contains a new obligation; based on IAEA requirements, for the licence holder to submit a demonstration of safety in support of an application for the licence for a nuclear installation or an activity.
The requirement gives considerable leeway to MSs to define the requested content of the safety demonstration or information to be provided in the licencing process. However the safety demonstration must as a minimum include safety assessments with respect to the requirements of Article 8a (Nuclear safety objective), 8b (Implementation of the nuclear safety objective (defence-in-depth)), 8c (Initial assessment and periodic safety reviews) and 8d (On-site emergency preparedness and response).
The provisions of Article 6(c) were already in Directive 2009/71 and remain largely unchanged. The national framework must require the licence holders to regularly:
(ii) verify; and
(iii) continuously improve the nuclear safety of their nuclear installations in a “systematic and verifiable manner”. The licence holder should be required to perform appropriate safety assessments, providing evidence or arguments (e.g. developing a safety case).
The safety assessments should demonstrate that the nuclear safety objective and requirements (Article 8a-8c) have been met.
These activities should be carried out in a systematic manner that can be reviewed and verified by the CRA (or involving a TSO) as part of its supervisory competence. The CRA should define how these activities are to be performed.
The scope of Lot 2 is limited to those Member States with nuclear installations, as per the obligations of Articles 6 and 8a-8d of the Directive.
Section III: Legal, economic, financial and technical information
Section IV: Procedure
European Commission, DG Energy, 1, rue Henri Schnadt, Zone d'activités Cloche d'Or, L-2530 Luxembourg.
Section VI: Complementary information