5.11. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components OJ L 33, 8.2.2003, p. 30.

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four · European Union

As regards Directive 2002/98/EC, the Commission should be empowered in particular to adapt the technical requirements set out in Annexes I to IV to technical and scientific progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2002/98/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. In the event that scientific and technical developments indicate that additional information should be provided to or obtained from donors, in order, for instance, to exclude donors presenting a health risk to others, an adaptation should be made without delay. Similarly, if scientific progress suggests new eligibility criteria concerning the suitability of blood and plasma donors, new deferral criteria should be added to the list immediately. When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adaptation to scientific and technical progress of the technical requirements concerning information to be provided to or obtained from donors, as well as requirements related to the suitability of blood and plasma donors, set out in Annexes I to IV. Accordingly, Directive 2002/98/EC is hereby amended as follows: Article 28 shall be replaced by the following: ‘Article 28 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’; Article 29 shall be amended as follows: the first paragraph shall be replaced by the following: ‘The adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 28(4) as regards technical requirements set out in Annexes III and IV.’; the introductory wording in the second paragraph shall be replaced by the following: ‘The following technical requirements and their adaptation to technical and scientific progress shall be decided by the Commission:’; the following paragraphs are added: ‘Technical requirements referred to in points (a) to (i) of the second paragraph, being measures designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3). On imperative grounds of urgency the Commission may have recourse to the urgency procedure referred to in Article 28(4) as regards technical requirements referred to in points (b), (c),(d), (e), (f) and (g) of the second paragraph.’.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.