Regulation (EU) 2019/1243 of the European Parliament and of the CouncilShow full title

X. HEALTH AND FOOD SAFETY U.K.

1. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products(1) U.K.

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

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. 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.

3. 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.

4. 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(2).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. 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(3) U.K.

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

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. 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.

3. 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.

4. 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(4).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. 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(5) U.K.

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

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. 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.

3. 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.

4. 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(6).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. 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(7) U.K.

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.’;

(2)

Article 8 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘1. The Commission is empowered to adopt delegated acts in accordance with Article 10a amending Annexes I and II to adapt them to the scientific and technical developments.

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.’;

(b)

in paragraph 2, the second indent is replaced by the following

• ‘is empowered to adopt delegated acts in accordance with Article 10a in order to supplement this Directive by defining acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes.’;

(3)

the following Articles are inserted:

‘Article 10a

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 7(2) and Article 8(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.

3. The delegation of power referred to in Article 7(2) and Article 8(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.

4. 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(8).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 7(2) and Article 8(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 from the 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 10b

1. 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.

2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 10a(6). In such 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 11, paragraphs 3 and 4 are deleted.

5. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(9) U.K.

In order to achieve the objectives of Regulation (EC) No 178/2002, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend that Regulation as regards the number and names of the Scientific Panels, and to supplement that Regulation with the procedure to be applied by the Authority to the requests for a scientific opinion, with the criteria for inclusion of an institute on the list of competent organisations designated by the Member States, and with the arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. 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 178/2002 is amended as follows:

(1)

in Article 28(4), the second subparagraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 57a amending the first subparagraph as regards the number and names of the Scientific Panels, in the light of technical and scientific development, at the Authority’s request.’;

(2)

Article 29(6) is replaced by the following:

‘6. In order to apply this Article, the Commission after consulting the Authority shall adopt:

(a) delegated acts in accordance with Article 57a in order to supplement this Regulation by establishing the procedure to be applied by the Authority to the requests for a scientific opinion;

(b) implementing acts laying down the guidelines governing the scientific evaluation of substances, products or processes which are subject, under Union legislation, to a system of prior authorisation or entry on a positive list, in particular where Union legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2).’;

(3)

in Article 36(3), the first subparagraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 57a in order to supplement this Regulation by establishing the criteria for the inclusion of an institute on the list of competent organisations designated by the Member States, the arrangements for setting out harmonised quality requirements and the financial rules governing any financial support.’;

(4)

in Chapter V, the title of Section 1 is replaced by the following:

‘SECTION 1 U.K. EXERCISE OF THE DELEGATION, COMMITTEE AND MEDIATION PROCEDURES’;

(5)

the following Article is inserted after the title of Section 1:

‘Article 57a Exercise of the delegation

1. The power to adopt delegated acts is conferred upon the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 28(4), Article 29(6) and Article 36(3) 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.

3. The delegation of power referred to in Article 28(4), Article 29(6) and Article 36(3) 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 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.

4. 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(10).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 28(4), Article 29(6) and Article 36(3) 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 58, paragraph 3 is deleted.

6. Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC(11) U.K.

In order to achieve the objectives of Regulation (EC) No 1830/2003, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to supplement that Regulation by establishing a system for the development and assignment of unique identifiers to genetically modified organisms. 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 1830/2003 is amended as follows:

(1)

Article 8 is replaced by the following:

‘Article 8 Unique identifiers

The Commission is empowered to adopt delegated acts in accordance with Article 9a in order to supplement this Regulation by establishing and adapting a system for the development and assignment of unique identifiers to GMOs taking account of developments in international fora.’;

(2)

the following Article is inserted:

‘Article 9a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in 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.

3. The delegation of power referred to in 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.

4. 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(12).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to 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 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 10, paragraph 2 is deleted;

(4)

in Article 13, paragraph 2 is deleted.

7. Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(13) U.K.

In order to achieve the objectives of Regulation (EC) No 1831/2003, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes I to IV to that Regulation in order to adapt them to technical progress and to supplement that Regulation with rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food. 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 1831/2003 is amended as follows:

(1)

in Article 3, paragraph 5 is replaced by the following:

‘5. The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex IV in order to adapt the general conditions set out therein to technological progress or scientific development.’;

(2)

in Article 6, paragraph 3 is replaced by the following:

‘3. The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex I in order to adapt feed additive categories and functional groups as a result of technological progress or scientific development.’;

(3)

in Article 7(5), the third subparagraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food.’;

(4)

in Article 16, paragraph 6 is replaced by the following:

‘6. The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex III to take technological progress and scientific development into account.’;

(5)

in Article 21, the fourth paragraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex II.’;

(6)

the following Article is inserted:

‘Article 21a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 3(5), Article 6(3), Article 7(5), Article 16(6) and Article 21 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.

3. The delegation of power referred to in Article 3(5), Article 6(3), Article 7(5), Article 16(6) and Article 21 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.

4. 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(14).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 3(5), Article 6(3), Article 7(5), Article 16(6) and Article 21 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.’;

(7)

in Article 22, paragraph 3 is deleted.

8. Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods(15) U.K.

In order to achieve the objectives of Regulation (EC) No 2065/2003, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes to that Regulation following a request to the Authority for scientific and/or technical assistance and to supplement that Regulation with quality criteria for validated analytical methods. 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 2065/2003 is amended as follows:

(1)

in Article 17, paragraph 3 is replaced by the following:

‘3. The Commission is empowered to adopt delegated acts in accordance with Article 18a in order to supplement this Regulation by establishing quality criteria for validated analytical methods referred to in point 4 of Annex II, including substances to be measured. Those delegated acts shall take into account available scientific evidence.’;

(2)

in Article 18, paragraph 1 is replaced by the following:

‘1. The Commission is empowered to adopt delegated acts in accordance with Article 18a amending the Annexes following a request to the Authority for scientific and/or technical assistance.’;

(3)

the following Article is inserted:

‘Article 18a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 17(3) and Article 18(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.

3. The delegation of power referred to in Article 17(3) and Article 18(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.

4. 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(16).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 17(3) and Article 18(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.’;

(4)

in Article 19, paragraph 3 is deleted.

9. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(17) U.K.

In order to achieve the objectives of Regulation (EC) No 853/2004, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes II and III to that Regulation and to supplement that Regulation in respect of the use of substances other than potable water to remove surface contamination from products of animal origin, in respect of amendments of the special guarantees relating to the placing of certain food of animal origin on the market in Sweden or Finland and in respect of derogations from Annexes II and III to 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 853/2004 is amended as follows:

(1)

in Article 3, paragraph 2 is replaced by the following:

‘2. Food business operators shall not use any substance other than potable water or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water, to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission. For that purpose the Commission is empowered to adopt delegated acts in accordance with Article 11a supplementing this Regulation. Food business operators shall also comply with any conditions for use that may be adopted under the same procedure. The use of an approved substance shall not affect the food business operator’s duty to comply with the requirements of this Regulation.’;

(2)

in Article 8(3), point (a) is replaced by the following:

‘(a)

The Commission is empowered to adopt delegated acts in accordance with Article 11a amending paragraphs 1 and 2 of this Article in order to update the requirements set out in those paragraphs, taking into account changes in Member States’ control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004.’;

(3)

Article 9 is deleted;

(4)

in Article 10, paragraphs 1 and 2 are replaced by the following:

‘1. The Commission is empowered to adopt delegated acts in accordance with Article 11a amending Annexes II and III. The amendments shall have the aim of ensuring and facilitating the achievement of the objectives of this Regulation, taking into account the relevant risk factors, and shall be justified on the basis of:

(a) the experience gained by food business operators and/or competent authorities, in particular on the implementation of HACCP-based systems pursuant to Article 5;

(b) the experience gained by the Commission, in particular on the outcome of its audits;

(c) technological developments and their practical consequences, and consumer expectations with regard to food composition;

(d) scientific advice, particularly new risk assessments;

(e) microbiological and temperature criteria for foodstuffs;

(f) changes in patterns of consumption.

The amendments referred to in the first subparagraph shall concern:

(a) the requirements on the identification marking of products of animal origin;

(b) the objectives of HACCP-based procedures;

(c) the requirements on the food chain information;

(d) the specific hygiene requirements for the premises, including means of transport, where products of animal origin are produced, handled, processed, stored or distributed;

(e) the specific hygiene requirements for the operations involving the production, handling, processing, storage, transport or distribution of products of animal origin;

(f) the rules for the transport of meat while it is warm;

(g) the health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

(h) the extension of Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

(i) the criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

(j) the additional health standards for live bivalve molluscs in cooperation with the relevant Union Reference Laboratory, including:

(i)

limit values and analysis methods for other marine biotoxins;

(ii)

virus testing procedures and virological standards; and

(iii)

sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards;

2. The Commission is empowered to adopt delegated acts in accordance with Article 11a in order to supplement this Regulation by granting derogations from Annex II and III, taking into account the relevant risk factors and provided that such derogations do not affect the achievement of the following objectives of this Regulation:

(a) to facilitate the fulfilment, by small businesses, of the requirements laid down in the Annexes;

(b) to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(c) to accommodate the needs of food businesses situated in regions that are subject to special geographic constraints;

(d) to facilitate the work of establishments producing raw material which is intended for the production of highly refined food products and which has undergone a treatment ensuring its safety.’;

(5)

Article 11 is amended as follows:

(a)

the introductory phrase is replaced by the following:

‘Without prejudice to the general application of Article 9 and Article 10(1), the Commission may lay down the following measures by means of implementing act. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 12(2):’;

(b)

points 1, 5, 6, 7 and 8 are deleted;

(6)

the following Article is inserted:

‘Article 11a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 3(2), Article 8(3)(a) and Article 10(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.

3. The delegation of powers referred to in Article 3(2), Article 8(3)(a) and Article 10(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.

4. 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(18).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 3(2), Article 8(3)(a) and Article 10(1) and (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 the Council.’;

(7)

in Article 12, paragraph 3 is deleted.

10. Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene(19) U.K.

In order to achieve the objectives of Regulation (EC) No 183/2005, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes I, II and III to that Regulation in order to adapt them to technical progress and to supplement that Regulation by defining the specific microbiological criteria and targets, by requiring approval of feed business establishments and by granting derogations from Annexes I, II and III to 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 183/2005 is amended as follows:

(1)

in Article 5(3), the second subparagraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 30a in order to supplement this Regulation by defining the criteria and targets referred to in points (a) and (b) of the first subparagraph.’;

(2)

in Article 10, point (3) is replaced by the following:

‘(3)

approval is required by a Delegated Regulation that the Commission is empowered to adopt in accordance with Article 30a in order to supplement this Regulation.’;

(3)

in Article 27, the second paragraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 30a to amend Annexes I, II and III.’;

(4)

Article 28 is replaced by the following:

‘Article 28 Derogations from Annexes I, II and III

The Commission is empowered to adopt delegated acts in accordance with Article 30a in order to supplement this Regulation by granting derogations from Annexes I, II and III for particular reasons, provided that such derogations do not affect the achievement of the objectives of this Regulation.’;

(5)

the following Article is inserted:

‘Article 30a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 5(3), point (3) of Article 10, Article 27 and Article 28 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.

3. The delegation of power referred to in Article 5(3), point (3) of Article 10, Article 27 and Article 28 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.

4. 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(20).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 5(3), point (3) of Article 10, Article 27 and Article 28 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 31, paragraph 3 is deleted.

11. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004(21) U.K.

In order to achieve the objectives of Regulation (EC) No 1394/2007, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes to that Regulation to adapt them to technical and scientific progress. 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 1394/2007 is amended as follows:

(1)

Article 24 is replaced by the following:

‘Article 24 Amendments to the Annexes

The Commission is empowered to adopt delegated acts in accordance with Article 25a amending the Annexes to adapt them to technical and scientific progress, after consulting the Agency.’;

(2)

the following Article is inserted:

‘Article 25a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 24 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.

3. The delegation of power referred to in Article 24 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.

4. 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(22).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 24 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 26, paragraph 3 is deleted.

12. Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides(23) U.K.

In order to set a framework for Union action to achieve the sustainable use of pesticides, 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 2009/128/EC in order to take account of scientific and technical progress. 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 2009/128/EC is amended as follows:

(1)

in Article 5, paragraph 3 is replaced by the following:

‘3. The Commission is empowered to adopt delegated acts in accordance with Article 20a amending Annex I in order to take account of scientific and technical progress.’;

(2)

in Article 8, paragraph 7 is replaced by the following:

‘7. The Commission is empowered to adopt delegated acts in accordance with Article 20a amending Annex II in order to take account of scientific and technical progress.’;

(3)

in Article 14(4), the second subparagraph is replaced by the following:

‘The Commission is empowered to adopt delegated acts in accordance with Article 20a amending Annex III in order to take account of scientific and technical progress.’;

(4)

in Article 15(1), the second subparagraph is replaced by the following:

‘The Commission shall be empowered to adopt delegated acts in accordance with Article 20a amending Annex IV in order to take account of scientific and technical progress.’;

(5)

the following Article is inserted:

‘Article 20a Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 5(3), Article 8(7), Article 14(4) and Article 15(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.

3. The delegation of power referred to in Article 5(3), Article 8(7), Article 14(4) and Article 15(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.

4. 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(24).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 5(3), Article 8(7), Article 14(4) and Article 15(1) 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.’;

(6)

in Article 21, paragraph 2 is deleted.

(1)

OJ L 18, 22.1.2000, p. 1.

(2)

OJ L 123, 12.5.2016, p. 1.’.

(3)

OJ L 106, 17.4.2001, p. 1.

(4)

OJ L 123, 12.5.2016, p. 1.’;

(5)

OJ L 311, 28.11.2001, p. 67.

(6)

OJ L 123, 12.5.2016, p. 1.’.

(7)

OJ L 140, 30.5.2002, p. 10.

(8)

OJ L 123, 12.5.2016, p. 1.’;

(9)

OJ L 31, 1.2.2002, p. 1.

(10)

OJ L 123, 12.5.2016, p. 1.’;

(11)

OJ L 268, 18.10.2003, p. 24.

(12)

OJ L 123, 12.5.2016, p. 1.’;

(13)

OJ L 268, 18.10.2003, p. 29.

(14)

OJ L 123, 12.5.2016, p. 1.’;

(15)

OJ L 309, 26.11.2003, p. 1.

(16)

OJ L 123, 12.5.2016, p. 1.’;

(17)

OJ L 139, 30.4.2004, p. 55.

(18)

OJ L 123, 12.5.2016, p. 1.’;

(19)

OJ L 35, 8.2.2005, p. 1.

(20)

OJ L 123, 12.5.2016, p. 1.’;

(21)

OJ L 324, 10.12.2007, p. 121.

(22)

OJ L 123, 12.5.2016, p. 1.’;

(23)

OJ L 309, 24.11.2009, p. 71.

(24)

OJ L 123, 12.5.2016, p. 1.’;