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Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance)
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The Commission is empowered to adopt delegated acts in accordance with Article 20 amending Annexes I to V, in order to take into account technical progress and scientific developments.
1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.The delegation of power referred to in Articles 7 and 19 shall be conferred on the Commission for a period of five years from 27 January 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 Articles 7 and 19 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.
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 Articles 7 and 19 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.
1.The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 (the ‘Committee’). That Committee is a committee within the meaning of Regulation (EU) No 182/2011.
2.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3.Where the opinion of the Committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the Committee so decides or a simple majority of Committee members so request.
1.Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.
2.Member States shall, by 28 January 2022, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
Article 5 of Regulation (EC) No 183/2005 is amended as follows:
in paragraph 1, point (c) is replaced by the following:
mixing of feed, for the exclusive requirements of their own holdings, without using veterinary medicinal products or intermediate products as defined in Regulation (EU) 2019/4(1) or additives or premixtures of additives, with the exception of silage additives,’;
paragraph 2 is replaced by the following:
‘2.For operations other than those referred to in paragraph 1, including mixing of feed for the exclusive requirements of their own holdings when using veterinary medicinal products or intermediate products as defined in Regulation (EU) 2019/4 or additives or premixtures of additives, with the exception of silage additives, feed business operators shall comply with Annex II, where relevant for the operations carried out.’.
Without prejudice to the date of application referred to in Article 26, the Commission is empowered to adopt the delegated acts provided for in Article 7(3) from 27 January 2019.
Directive 90/167/EEC is repealed.
References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 28 January 2022.
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).’;
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