LegalizeRegulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance)
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*34).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 13b
Urgency procedure
Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 13a(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
2. Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (38)
In order to update Directive 2008/48/EC, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend that Directive to add additional assumptions for the calculation of the annual percentage rate of charge or to modify the existing assumptions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2008/48/EC is amended as follows:
(1) in Article 19, paragraph 5 is replaced by the following: ‘5. Where necessary, the additional assumptions set out in Annex I may be used in calculating the annual percentage rate of charge. If the assumptions set out in this Article and in Part II of Annex I do not suffice to calculate the annual percentage rate of charge in a uniform manner or are no longer adapted to the commercial situations in the market, the Commission is empowered to adopt delegated acts in accordance with Article 24a amending this Article and Part II of Annex I to add the necessary additional assumptions for the calculation of the annual percentage rate of charge or to modify the existing ones.’;
(2) the following Article is inserted: ‘Article 24a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 19(5) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 19(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*35).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 19(5) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) Article 25 is deleted.
IX. MOBILITY AND TRANSPORT
2. Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC (39)
In order to adapt Directive 2002/59/EC to the evolution of Union and international law and to the experience gained in its implementation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend:
— the references to Union and International Maritime Organisation (IMO) instruments in that Directive, in order to bring them into line with provisions of Union or international law,
— certain definitions in that Directive, in order to bring them into line with other provisions of Union or international law,
— Annexes I, III and IV to that Directive in the light of technical progress and experience gained with that Directive.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2002/59/EC is amended as follows:
(1) Article 27 is replaced by the following: ‘Article 27 Amendments
Within the scope of this Directive as defined in Article 2, the Commission is empowered to adopt delegated acts in accordance with Article 27a amending references to Union and IMO instruments in this Directive and the definitions in Article 3 and the Annexes in order to bring them into line with provisions of Union or international law which have been adopted or amended or which have entered into force.
Within the scope of this Directive as defined in Article 2, the Commission is empowered to adopt delegated acts in accordance with Article 27a amending Annexes I, III and IV in the light of technical progress and experience gained with this Directive.’;
(2) the following Article is inserted: ‘Article 27a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 27 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*36).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) Article 28 is deleted.
3. Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) and amending the Regulations on maritime safety and the prevention of pollution from ships (40)
In order to update the list of Union acts referring to the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) in Regulation (EC) No 2099/2002, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend that Regulation to include a reference to the Union acts conferring powers on the COSS that have entered into force. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 2099/2002 is amended as follows:
(1) in Article 3, paragraph 3 is deleted;
(2) Article 7 is replaced by the following: ‘Article 7 Powers of COSS and amendments COSS shall exercise the powers conferred on it by virtue of the Union maritime legislation in force. The Commission is empowered to adopt delegated acts in accordance with Article 7a amending point 2 of Article 2 in order to include a reference to the Union acts conferring powers on COSS that have entered into force following the adoption of this Regulation.’;
(3) the following Article is inserted: ‘Article 7a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 7 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 7 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*37).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 7 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
4. Directive 2003/25/EC of the European Parliament and of the Council of 14 April 2003 on specific stability requirements for ro-ro passenger ships (41)
In order to adapt Directive 2003/25/EC to technical progress, to developments at international level and to experience gained in its implementation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes to that Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2003/25/EC is amended as follows:
(1) Article 10 is replaced by the following: ‘Article 10 Amendment of Annexes The Commission is empowered to adopt delegated acts in accordance with Article 10a amending the Annexes in order to take account of developments at international level, in particular in the IMO, and to improve the effectiveness of this Directive in the light of experience and technical progress.’;
(2) the following Article is inserted: ‘Article 10a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*38).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) Article 11 is deleted.
6. Regulation (EC) No 785/2004 of the European Parliament and of the Council of 21 April 2004 on insurance requirements for air carriers and aircraft operators (42)
In order to adapt Regulation (EC) No 785/2004 to the evolution of international law, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend certain values in that Regulation in the light of amendments to international agreements. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 785/2004 is amended as follows:
(1) in Article 6, paragraph 5 is replaced by the following: ‘5. The Commission is empowered to adopt delegated acts in accordance with Article 8a amending the values referred to in paragraphs 1, 2 and 3 of this Article where amendments to the relevant international agreements make this necessary.’;
(2) in Article 7, paragraph 2 is replaced by the following: ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 8a amending the values referred to in paragraph 1 of this Article where amendments to the relevant international agreements make this necessary.’;
(3) the following Article is inserted: ‘Article 8a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 6(5) and Article 7(2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 6(5) and Article 7(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*39).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 6(5) and Article 7(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(4) in Article 9, paragraph 3 is deleted.
7. Regulation (EC) No 789/2004 of the European Parliament and of the Council of 21 April 2004 on the transfer of cargo and passenger ships between registers within the Community and repealing Council Regulation (EEC) No 613/91 (43)
In order to adapt Regulation (EC) No 789/2004 to developments at international level, in particular in the International Maritime Organisation, and to improve the effectiveness of that Regulation in the light of experience and technical progress, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend certain definitions in that Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 789/2004 is amended as follows:
(1) in Article 7, paragraph 3 is deleted;
(2) in Article 9, paragraph 1 is replaced by the following: ‘1. Within the scope of this Regulation as defined in Article 3, the Commission is empowered to adopt delegated acts in accordance with Article 9a amending the definitions in Article 2 in order to take account of developments at international level, in particular in the IMO, and to improve the effectiveness of this Regulation in the light of experience and technical progress.’;
(3) the following Article is inserted: ‘Article 9a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 9(1) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 9(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*40).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Articles 9(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
8. Directive 2005/44/EC of the European Parliament and of the Council of 7 September 2005 on harmonised river information services (RIS) on inland waterways in the Community (44)
In order to adapt Directive 2005/44/EC to technical progress and to take into account experience gained from its application, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes I and II to that Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2005/44/EC is amended as follows:
(1) Article 10 is replaced by the following: ‘Article 10 Amendments to Annexes I and II The Commission is empowered to adopt delegated acts in accordance with Article 10a amending Annexes I and II in the light of the experience gained from the application of this Directive and in order to adapt those Annexes to technical progress.’;
(2) the following Article is inserted: ‘Article 10a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*41).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) in Article 11, paragraph 4 is deleted.
9. Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing port security (45)
In order to update the technical measures necessary to ensure port security on a regular basis, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes I to IV to Directive 2005/65/EC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2005/65/EC is amended as follows:
(1) Article 14 is replaced by the following: ‘Article 14 Amendments to Annexes I to IV The Commission is empowered to adopt delegated acts in accordance with Article 14a amending Annexes I to IV in order to adapt them to the experience gained in their implementation without broadening the scope of this Directive. Where, in the case of amendments required to adapt Annexes I to IV, imperative grounds of urgency so require, the procedure provided for in Article 14b shall apply to delegated acts adopted pursuant to this Article.’;
(2) the following Articles are inserted: ‘Article 14a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 14 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 14 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*42).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 14 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 14b
Urgency procedure
Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 14a(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
(3) Article 15 is deleted.
10. Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating air carrier, and repealing Article 9 of Directive 2004/36/EC (46)
In order to adapt Regulation (EC) No 2111/2005 to scientific and technical progress and to specify further the applicable procedures, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annex to that Regulation and to supplement that Regulation with detailed rules in respect of certain procedures. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 2111/2005 is amended as follows:
(1) in Article 3, paragraph 2 is replaced by the following: ‘2. The common criteria for imposing an operating ban on an air carrier, which shall be based on the relevant safety standards, are set out in the Annex and are hereafter referred to as “common criteria”. The Commission is empowered to adopt delegated acts in accordance with Article 14a amending the Annex in order to modify the common criteria to take account of scientific and technical developments.’;
(2) Article 8 is replaced by the following: ‘Article 8 Detailed rules The Commission is empowered to adopt delegated acts in accordance with Article 14a in order to supplement this Regulation by laying down detailed rules in respect of the procedures referred to in this Chapter taking due account of the need for decisions to be taken swiftly on updating the Community list. Where, in the case of measures referred to in the first paragraph, imperative grounds of urgency so require, the procedure provided for in Article 14b shall apply to delegated acts adopted pursuant to this Article.’;
(3) the following Articles are inserted: ‘Article 14a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 3(2) and Article 8 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 3(2) and Article 8 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*43).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 3(2) and Article 8 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of one month of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by one month at the initiative of the European Parliament or of the Council.
Article 14b
Urgency procedure
Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 14a(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
(4) in Article 15, paragraph 4 is deleted.
11. Regulation (EC) No 336/2006 of the European Parliament and of the Council of 15 February 2006 on the implementation of the International Safety Management Code within the Community and repealing Council Regulation (EC) No 3051/95 (47)
In order to update the provisions concerning the implementation of the International Safety Management Code, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex II to Regulation (EC) No 336/2006. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 336/2006 is amended as follows:
(1) in Article 11, paragraph 2 is replaced by the following: ‘2. Within the scope of this Regulation as defined in Article 3, the Commission is empowered to adopt delegated acts in accordance with Article 11a amending Annex II in order to take account of developments at international level and in particular in the IMO, or to improve the effectiveness of this Regulation in the light of the experience gained in its implementation.’;
(2) the following Article is inserted: ‘Article 11a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 11(2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 11(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*44).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 11(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) in Article 12, paragraph 3 is deleted.
12. Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (48)
In order to adapt Directive 2008/68/EC to technical and scientific progress, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes to that Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2008/68/EC is amended as follows:
(1) in Article 8, paragraph 1 is replaced by the following: ‘1. The Commission is empowered to adopt delegated acts in accordance with Article 8a amending the Annexes in order to take account of amendments to the ADR, RID and ADN, in particular those relating to scientific and technical progress, including the use of technologies for tracking and tracing.’;
(2) the following Article is inserted: ‘Article 8a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 8(1) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 8(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*45).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 8(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) in Article 9, paragraph 3 is deleted.
13. Directive 2009/15/EC of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations (49)
In order to adapt Directive 2009/15/EC to the evolution of relevant international instruments and to modify the maximum amounts payable to compensate the injured parties, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend that Directive so as to:
— incorporate subsequent amendments to certain international conventions, protocols, codes and resolutions related thereto, which have entered into force,
— alter certain amounts specified therein.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2009/15/EC is amended as follows:
(1) the following Article is inserted: ‘Article 5a
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 7(1) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 7(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*46).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 7(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(2) in Article 6, paragraph 3 is deleted;
(3) in Article 7, paragraph 1 is replaced by the following: ‘1. The Commission is empowered to adopt delegated acts in accordance with Article 5a amending this Directive, without broadening its scope, in order to: (a) incorporate, for the purposes of this Directive, subsequent amendments to the international conventions, protocols, codes and resolutions related thereto referred to in point (d) of Article 2, Article 3(1) and Article 5(2), which have entered into force; (b) alter the amounts specified in point (b)(ii) and (iii) of Article 5(2).’.
14. Regulation (EC) No 391/2009 of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (50)
In order to complete Regulation (EC) No 391/2009 and to adapt it to the evolution of international rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission:
— to amend the minimum criteria set out in Annex I to that Regulation taking into account, in particular, the relevant decisions of the IMO,
— to supplement that Regulation with criteria for the measurement of the effectiveness of the rules and procedures as well as the performance of the recognised organisations as regards the safety of, and the prevention of pollution from, their classed ships, having particular regard to the data produced by the Paris Memorandum of Understanding on Port State Control or by other similar schemes,
— to supplement that Regulation with criteria for determining when such performance is to be considered an unacceptable threat to safety or the environment, which may take into account specific circumstances affecting smaller-sized or highly specialised organisations,
— to supplement that Regulation with detailed rules concerning fines and periodic penalty payments and the withdrawal of recognition of ship inspection and survey organisations.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 391/2009 is amended as follows:
(1) in Article 12, paragraph 4 is deleted;
(2) in Article 13, paragraph 1 is replaced by the following: ‘1. The Commission is empowered to adopt delegated acts in accordance with Article 14a amending Annex I, without broadening its scope, in order to update the minimum criteria set out therein, taking into account, in particular, the relevant decisions of the IMO.’;
(3) in Article 14, paragraphs 1 and 2 are replaced by the following: ‘1. The Commission is empowered to adopt delegated acts in accordance with Article 14a in order to supplement this Regulation by establishing the following: (a) criteria to measure the effectiveness of the rules and procedures as well as the performance of the recognised organisations as regards the safety of, and the prevention of pollution from, their classed ships, having particular regard to the data produced by the Paris Memorandum of Understanding on Port State Control or by other similar schemes; (b) criteria to determine when such performance is to be considered an unacceptable threat to safety or the environment, which may take into account specific circumstances affecting smaller-sized or highly specialised organisations.
The Commission is empowered to adopt delegated acts in accordance with Article 14a in order to supplement this Regulation by establishing detailed rules on the imposition of fines and periodic penalty payments pursuant to Article 6, and, if necessary, regarding the withdrawal of recognition of ship inspection and survey organisations pursuant to Article 7.’;
(4) the following Article is inserted: ‘Article 14a
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 13(1) and Article 14(1) and (2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 13(1) and Article 14(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*47).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 13(1) and Article 14(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
15. Regulation (EC) No 392/2009 of the European Parliament and of the Council of 23 April 2009 on the liability of carriers of passengers by sea in the event of accidents (51)
In order to adapt Regulation (EC) No 392/2009 to other Union and international rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission:
— to amend Annex I to that Regulation so as to incorporate amendments to the provisions of the Athens Convention relating to the Carriage of Passengers and their Luggage by Sea, 1974, as amended by the Protocol of 2002,
— to amend the limits set out in Annex I to that Regulation for ships of Class B under Article 4 of Directive 2009/45/EC of the European Parliament and of the Council (52),
— to amend Annex II to that Regulation so as to incorporate amendments to the provisions of the IMO Guidelines.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 392/2009 is amended as follows:
(1) Article 9 is replaced by the following: ‘Article 9 Amendment of the Annexes
The Commission is empowered to adopt delegated acts in accordance with Article 9a amending Annex I to this Regulation in order to incorporate the amendments to the limits set out in Article 3(1), Article 4bis(1), Article 7(1) and Article 8 of the Athens Convention to take account of decisions taken pursuant to Article 23 of that Convention.
The Commission is empowered to adopt, by 31 December 2016, on the basis of a suitable impact assessment, delegated acts in accordance with Article 9a amending the limits set out in Annex I to this Regulation for ships of Class B under Article 4 of Directive 2009/45/EC of the European Parliament and of the Council (*48), taking into consideration the consequences for fares and the ability of the market to obtain affordable insurance coverage at the level required against the policy background of strengthening passengers’ rights, as well as the seasonal nature of some of the traffic.
The Commission is empowered to adopt delegated acts in accordance with Article 9a amending Annex II in order to incorporate amendments to the provisions of the IMO Guidelines.
(2) the following Article is inserted: ‘Article 9a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 9(1) and (2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 9(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*49).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 9(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(3) Article 10 is deleted.
X. HEALTH AND FOOD SAFETY
1. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (53)
In order to achieve the objectives of Regulation (EC) No 141/2000, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to supplement that Regulation with definitions of ‘similar medicinal product’ and ‘clinical superiority’. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Regulation (EC) No 141/2000 is amended as follows:
(1) in Article 8, paragraph 4 is replaced by the following: ‘4. The Commission is empowered to adopt delegated acts in accordance with Article 10b in order to supplement this Regulation by adopting the definitions of “similar medicinal product” and “clinical superiority”.’;
(2) in Article 10a, paragraph 3 is deleted;
(3) the following Article is inserted: ‘Article 10b Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 8(4) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 8(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*50).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 8(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
2. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (54)
In order to achieve the objectives of Directive 2001/18/EC, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes to that Directive and to supplement that Directive with:
— derogatory criteria and information requirements for the notification for the placing on the market of certain types of genetically modified organisms (GMOs),
— minimum thresholds below which products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded do not have to be labelled as GMOs,
— lower thresholds than 0,9 %, below which the labelling requirements set out in the Directive do not apply to traces of GMOs in products intended for direct processing,
— specific labelling requirements for GMOs that are not placed on the market within the meaning of this Directive.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2001/18/EC is amended as follows:
(1) Article 16 is amended as follows: (a) in paragraph 2, the first subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 29a in order to supplement this Directive by establishing the criteria and information requirements referred to in paragraph 1, as well as any appropriate requirements for a summary of the dossier, after consultation of the relevant Scientific Committee. The criteria and information requirements shall be such as to ensure a high level of safety of human health and the environment and shall be based on the available scientific evidence concerning such safety and on experience gained from the release of comparable GMOs.’; (b) paragraph 3 is replaced by the following: ‘3. Before adopting delegated acts pursuant to paragraph 2, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days. The Commission shall forward any such comments, together with an analysis, to the experts referred to in Article 29a(4).’;
(2) Article 21 is amended as follows: (a) paragraph 2 is replaced by the following: ‘2. For products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded, the Commission is empowered to adopt delegated acts in accordance with Article 29a in order to supplement this Directive by establishing minimum thresholds below which these products shall not have to be labelled in accordance with paragraph 1 of this Article. Threshold levels shall be established according to the product concerned.’; (b) in paragraph 3, the second subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 29a in order to supplement this Directive by establishing the thresholds referred to in the first subparagraph of this paragraph.’;
(3) in Article 26, paragraph 2 is replaced by the following: ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 29a amending Annex IV by establishing specific labelling requirements referred to in paragraph 1, without duplicating or creating inconsistencies with labelling provisions laid down in existing Union legislation. In so doing, account should be taken, as appropriate, of labelling provisions established by Member States in accordance with Union legislation.’;
(4) Article 27 is replaced by the following: ‘Article 27 Adaptation of the Annexes to technical progress The Commission is empowered to adopt delegated acts in accordance with Article 29a amending Sections C and D of Annex II, Annexes III to VI, and Section C of Annex VII, in order to adapt them to technical progress.’;
(5) the following Article is inserted: ‘Article 29a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 16(2), Article 21(2) and (3), Article 26(2) and Article 27 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegations of power referred to in Article 16(2), Article 21(2) and (3), Article 26(2) and Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*51).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 16(2), Article 21(2) and (3), Article 26(2) and Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
(6) in Article 30, paragraph 3 is deleted.
3. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (55)
In order to achieve the objectives of Directive 2001/83/EC, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission:
— to amend that Directive in respect of one of the conditions that homeopathic medicinal products must satisfy in order to benefit from a special, simplified registration procedure if new scientific evidence so warrants,
— to amend that Directive in respect of the types of operations that are considered to constitute manufacture of active substances used as starting materials, to take account of scientific and technical progress,
— to amend Annex I to that Directive to take account of technical and scientific progress,
— to supplement that Directive by specifying the principles and guidelines of good manufacturing practices for medicinal products.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2001/83/EC is amended as follows:
(1) in Article 14(1), the second subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 121a amending the third indent of the first subparagraph if new scientific evidence so warrants.’;
(2) in Article 46a, paragraph 2 is replaced by the following: ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 121a to amend paragraph 1 to take account of scientific and technical progress.’;
(3) in Article 47, the first paragraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 121a in order to supplement this Directive by specifying the principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f).’;
(4) Article 120 is replaced by the following: ‘Article 120 The Commission is empowered to adopt delegated acts in accordance with Article 121a amending Annex I to take account of scientific and technical progress.’;
(5) in Article 121, paragraph 2a is deleted;
(6) Article 121a is replaced by the following: ‘Article 121a
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 14(1), Article 22b, Article 23b, Article 46a, Article 47, Article 52b, Article 54a and Article 120 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The delegation of power referred to in Article 14(1), Article 22b, Article 23b, Article 46a, Article 47, Article 52b, Article 54a and Article 120 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*52).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 14(1), Article 22b, Article 23b, Article 46a, Article 47, Article 52b, Article 54a and Article 120 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
4. Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (56)
In order to achieve the objectives of Directive 2002/32/EC, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes I and II to that Directive to adapt them to technical progress and to supplement that Directive with acceptability criteria for detoxification processes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Accordingly, Directive 2002/32/EC is amended as follows:
(1) in Article 7(2), the first and second subparagraphs are replaced by the following: ‘2. An immediate decision shall be taken as to whether Annexes I and II should be amended. The Commission is empowered to adopt delegated acts in accordance with Article 10a amending those Annexes. Where, in the case of those amendments, imperative grounds of urgency so require, the procedure provided for in Article 10b shall apply to delegated acts adopted pursuant to this Article. The Member State may maintain the measures it has implemented as long as the Commission has not taken any decision.’;
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