2014/0255(COD) Medicated feed: manufacture, placing on the market and use
Next event: Final act published in Official Journal 2019/01/07 more...
Lead committee dossier:
Next event: Final act published in Official Journal 2019/01/07 more...
- Draft final act 2018/12/12
- Final act signed 2018/12/11
- End of procedure in Parliament 2018/12/11
- Act adopted by Council after Parliament's 1st reading 2018/11/26
- Council Meeting 2018/11/26
- Commission response to text adopted in plenary 2018/11/21
- Results of vote in Parliament 2018/10/25
- Decision by Parliament, 1st reading 2018/10/25
- Debate in Parliament 2018/10/24
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations 2018/07/10
- Coreper letter confirming interinstitutional agreement 2018/06/27
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | AGRI |
AGUILERA Clara ( S&D)
|
BUDA Daniel ( PPE),
NICHOLSON James ( ECR),
FEDERLEY Fredrick ( ALDE),
SCOTT CATO Molly ( Verts/ALE),
MOI Giulia ( EFDD)
|
| Committee Opinion | ENVI |
LINS Norbert ( PPE)
|
James NICHOLSON ( ECR),
Tibor SZANYI ( S&D)
|
| Committee Opinion | IMCO | ||
| Committee Legal Basis Opinion | JURI |
GUTELAND Jytte ( S&D)
|
Lead committee dossier:
Legal Basis:
TFEU 043, TFEU 168-p4
Legal Basis:
TFEU 043, TFEU 168-p4Subjects
Events
2019/01/07
Final act published in Official Journal
Details
PURPOSE: adopt new rules on medicated feed with a view to ensuring a high level of protection for human and animal health, providing adequate information for users and strengthening the effective functioning of the internal market.
LEGISLATIVE ACT: Regulation (EU) 2019/4 of the European Parliament and of the Council 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.
CONTENT: the Regulation establishes new rules on more responsible ways to produce, sell and use medicated feeds for animals in order to combat the spread of antimicrobial resistance. It will apply to (i) the manufacture, storage and transport of medicated feed and intermediate products; (ii) the placing on the market, including import from third countries, and the use of medicated feed; (iii) the export to third countries of medicated feed.
The new rules clarify, in particular, the following points:
Approval of establishments
Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority.
The competent authority shall approve establishments only where an on-site visit, prior to start-up of the relevant activity, has demonstrated that the system put in place for the manufacture, storage, transport or placing on the market of medicated feed or intermediate products meets the specific requirements of the Regulation.
Feed business operators dealing with some lower risk activities, such as certain types of transport, storage and retail, will be exempted from the approval obligation, but this does not exempt them from the registration obligation.
Cross-contamination
Cross-contamination may occur during manufacture, processing, storage or transport of feed where the same production and processing equipment, including for mobile mixing, storage facilities or means of transport are used for feed with different components.
The Regulation sets out harmonised requirements to prevent cross-contamination of non-target feed with active substances. The Commission may establish, by means of delegated acts, specific maximum levels of cross-contamination for active substances in non-target feed on the basis of a scientific risk assessment performed by the European Food Safety Authority (EFSA) and in cooperation with the European Medicines Agency.
Prescription and use
The new rules specify how to prescribe and use medicated feed containing antimicrobial agents for food producing animals.
The supply of medicated feed to animal keepers shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription for medicated feed. A veterinary prescription for medicated feed shall be issued only after a clinical examination or any other proper assessment of the health status of the animal or group of animals by a veterinarian and only for a diagnosed disease.
Prophylaxis or use of medicated feed to enhance the performance of animals will not be allowed, except, in certain cases, as regards medicated feed containing antiparasitics and immunological veterinary medicinal products.
The use of medicated feed containing antimicrobials for metaphylaxis will only be allowed when the risk of spread of an infection or of an infectious disease is high. The use of medicated feed containing some antiparasitics should be based on the knowledge of the parasite infestation status in the animal or group of animals.
Advertising
The advertising of medicated feed and intermediate products is prohibited. That prohibition shall not apply to advertising made exclusively to veterinarians. The advertising shall not include information in any form that could be misleading or lead to incorrect use of the medicated feed. Medicated feed shall not be distributed for promotional purposes except for small quantities of samples.
ENTRY INTO FORCE: 27.1.2019.
APPLICATION: from 28.1.2022.
2018/12/12
CSL - Draft final act
Documents
2018/12/11
CSL - Final act signed
2018/12/11
EP - End of procedure in Parliament
2018/11/26
EP/CSL - Act adopted by Council after Parliament's 1st reading
2018/11/26
CSL - Council Meeting
2018/11/21
EC - Commission response to text adopted in plenary
Documents
2018/10/25
EP - Results of vote in Parliament
Documents
2018/10/25
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 583 votes to 31 with 6 abstentions a legislative resolution on the for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC.
The European Parliament’s position adopted at first reading under the ordinary legislative procedure amended the Commission proposal as follows:
Purpose : the proposed Regulation shall establish new rules on more responsible ways to produce, sell and use medicated feed to tackle the spread of antimicrobial resistance. It shall apply to: (i) the manufacture, storage and transport of medicated feed and intermediate products; (ii) the placing on the market, including import from third countries, and the use of medicated feed and intermediate products; (iii) the export to third countries of medicated feed and intermediate products.
Composition : the feed business operator manufacturing the medicated feed or intermediate product shall ensure that the medicated feed or intermediate product is manufactured in compliance with the relevant conditions laid down in the veterinary prescription for medicated feed or, in the summary of the product characteristics, related to the veterinary medicinal products to be incorporated in the fee.
Those conditions shall include particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed or intermediate product.
Operators shall also take measures to avoid cross-contamination , i. e. contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment.
The Commission shall be empowered to adopt delegated acts in order to supplement this Regulation by establishing specific maximum levels of cross-contamination for active substances in non-target feed. Those delegated acts shall be based on a scientific risk assessment carried out by EFSA.
Approval of establishments : the competent authority shall approve establishments only where an on-site visit, prior to start-up of the relevant activity , has demonstrated that the system put in place for the manufacture, storage, transport or placing on the market of medicated feed or intermediate products meets the specific requirements.
Feed business operators dealing with some lower risk activities, such as certain types of transport, storage and retail, should be exempted from the approval obligation, however this should not exempt them from the registration obligation.
Prudent use of antibiotics : the amended text emphasises that medical treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.
The new rules shall ban prophylactic (preventive) use of medicated feed or its use for improving animal performance, except in some cases for medicated feed containing antiparasitic and immunological veterinary drugs. Metaphylactic use, i.e. treating the whole group of animals when one is infected, will be allowed only when the risk of spread of infection is high and there is no appropriate alternative.
The use of medicated feed containing some antiparasitics shall be based on the knowledge of the parasite infestation status in the animal or group of animals.
Prescription : in order to ensure the safe use of medicated feed, its supply and use shall be subject to presentation of a valid veterinary prescription for medicated feed which has been issued by a veterinarian after examination or any other proper assessment of the health status of the animals to be treated.
Advertising : the new rules shall prohibit the advertising of medicated feed and intermediate products. That prohibition shall not apply to advertising made exclusively to veterinarians. The advertising shall not include information in any form which could be misleading or lead to incorrect use of the medicated feed. In addition, medicated feed shall not be distributed for promotional purposes except for small quantities of samples.
Imports into the EU : operators importing medicated feed or intermediate products into the EU shall ensure that the use of veterinary medicinal products used for the manufacture of such medicated feed or intermediate products is authorised.
Documents
2018/10/24
EP - Debate in Parliament
2018/07/10
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2018/06/27
CSL - Coreper letter confirming interinstitutional agreement
Documents
2016/04/05
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on Agriculture and Rural Development adopted a report by Clara Eugenia AGUILERA GARCÍA (S&D, ES) on the proposal for a regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC.
The committee recommended that the European Parliament’s position adopted at first reading following the ordinary legislative procedure should amend the Commission proposal as follows:
Legal basis : the proposal should be based on Article 43(2) whereby the ordinary legislative procedure is used for legislation necessary for the pursuit of the objectives of the common agricultural policy.
Scope : this Regulation shall apply to:
the manufacture, storage and transport of medicated feed and intermediate products intended for both food-producing and non-food producing animals; the placing on the market, including import from third countries, and use of medicated feed and intermediate products intended for both food-producing and non-food producing animals.
This Regulation shall not apply to finished veterinary medicinal products to be orally administered that have been approved for use via feed as oral powders (via 'top dressing') or in drinking water . The Commission shall, by 12 months after the date of entry into force of this Regulation, propose a specific legislative proposal on the administration of veterinary medicinal products for use via feed or in drinking water.
Definitions : the report proposes:
to amend the definition of ´ premix for medicated feedingstuffs ´, as the medicated premix is the veterinary medicinal product, which is an appropriate pharmaceutical form primarily authorised to be used incorporated in medicated feedingstuffs in conditions fully in compliance with the conditions of the marketing authorisation; to introduce the definitions of 'antimicrobials'and 'antibiotics' / 'antibacterials' , as well as the definitions of 'preventive treatment (prophylaxis), 'control treatment (metaphylaxis) and 'curative (therapeutic) treatment' as laid down in the Veterinary Medicinal Products proposal; to define ‘ non-target feed’ as an ordinary feed containing no veterinary medicinal products; to define ‘ mobile mixer ’ and ‘on-farm mixer’; to define 'cross-contamination' to mean a contamination resulting from a carry-over or from the transfer in feed of any unintended substance.
General obligations : Members added a provisions stipulating that distributors who supply medicated feed solely for non-food producing animals , which is manufactured and distributed in sealed bags and supplied under prescription directly to the animal holders, shall be exempt from the obligations of feed business operators.
Justification
The exemption proposed facilitates wholesale and retail (veterinary and pharmacist) distribution solely of medicated feed for pets without imposing unnecessary administrative burdens.
Composition : the feed used for the production of medicated feed shall comply with all relevant provisions of Union legislation concerning animal feedingstuffs.
Homogeneous distribution : it is stated that feed business operators manufacturing medicated feed shall ensure the homogeneous distribution (instead of homogeneous incorporation) of the veterinary medicinal product or the intermediate product in the feed.
Carry-over : according to the amended text, feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products shall apply measures to avoid carry-over in accordance with the ALARA (As Low As Reasonably Achievable) principle, in order to avoid risk for animal health, human health or the environment.
The Commission proposes to establish a general 1% carry-over limit for all active substances containing antimicrobials, until such time as specific limits are set for each active substance individually. Members proposed that a 3% general limit for all active substances is more appropriate until specific limits - established by the European Feed and Safety Authority (EFSA) and based on scientific evidence - are fixed for each active substance .
The Commission shall, by means of implementing acts, establish a detailed schedule listing, in order of priority, the different active substances for which specific carry-over limits must be adopted. EFSA and the European Medicines Agency (EMA) shall be consulted as the list is being compiled. By two years after the date of entry into force of this Regulation, the Commission shall submit a report to the European Parliament and to the Council indicating the specific carry-over limits adopted .
Packaging : medicated feed and intermediate products shall be placed on the market only in properly labelled and sealed packages, including sack packaging, or containers. Appropriate derogations should be provided for those instances where the application of that requirement is not necessary to protect human or animal health or consumer interests, and would represent an excessive administrative and technical burden.
Trade with third countries : Members proposed that imports, from third countries, of food producing animals which have been administered medicated feed containing antimicrobial veterinary medicinal products in order to prevent disease shall be prohibited. Similarly, imports of foodstuffs derived from those animals shall be prohibited.
Prescriptions : the supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law, following a proper assessment of the health status of the animals concerned.
Members called for prescriptions for medicated feed containing veterinary medicinal products which have anabolic, anti-inflammatory, anti-infectious (other than anthelmintic), anti-cancer, hormonal or psychotropic properties or substances only to be issued by a veterinarian after a clinical examination and diagnosis.
For medicated feed containing antibiotics , a physical examination and diagnosis shall be carried out for every prescription issued.
The duration of the treatment shall follow the valid summary of product characteristics (SPC) of the authorised veterinary medicinal product incorporated into the medicated feed and should not exceed three weeks in the case of medicated feed with incorporated veterinary medicinal products containing active substances with the potential to select resistance.
Significant and imminent health risks may be grounds for the limited and non-routine prophylactic use of vaccines and anti-parasitical treatments .
Use in food-producing animals : the Commission proposal sets limits for the quantities of medicated feed that suppliers are allowed to provide to farmers (one month’s supply or 2 weeks for antimicrobials).
Members considered that setting time limits of this type in an EU regulation is inappropriate. They suggested the quantities required for a treatment shall be determined in accordance with the summary of product characteristics included in the marketing authorisation of the veterinary medicinal product included in the prescription.
Use of medicated feed containing antimicrobials : Members stated that the prophylactic use of medicated feed containing antibiotics shall not be allowed unless such use is permitted under the veterinary medicinal products. The use of antibiotics to enhance the performance of food-producing animals shall be prohibited.
Prophylaxis with antibiotics shall not be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions. However, such prophylaxis may be permitted in very exceptional cases before a disease is diagnosed or clinical signs of disease are present on the basis of the epidemiological and clinical knowledge of the veterinarian.
Annexes : in annex IV, the report proposes changes to the permitted tolerances of deviations from the amount of an active substance indicated on the label, in order to adapt them to the proportions used in the manufacture of medicated feed.
Documents
2016/03/15
EP - Vote in committee, 1st reading
2015/12/15
CSL - Debate in Council
Documents
2015/12/15
CSL - Council Meeting
2015/09/03
EP - Specific opinion
Documents
2015/07/02
EP - Amendments tabled in committee
Documents
2015/06/18
EP - Committee opinion
Documents
2015/06/11
EP - GUTELAND Jytte (S&D) appointed as rapporteur in JURI
2015/05/20
EP - Committee draft report
Documents
2015/01/21
ESC - Economic and Social Committee: opinion, report
Documents
2014/12/04
EP - AGUILERA Clara (S&D) appointed as rapporteur in AGRI
2014/11/13
EP - LINS Norbert (PPE) appointed as rapporteur in ENVI
2014/11/10
IT_SENATE - Contribution
Documents
2014/11/03
ES_PARLIAMENT - Contribution
Documents
2014/10/20
EP - Committee referral announced in Parliament, 1st reading
2014/09/10
EC - Document attached to the procedure
Documents
2014/09/10
EC - Document attached to the procedure
Documents
2014/09/10
EC - Legislative proposal published
Details
PURPOSE: to ensure a high level of protection of human and animal health, providing adequate information for users and strengthen the effective functioning of the internal market.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: livestock production occupies a very important place in the agriculture of the Union. There are 13.7 million animal holdings in the EU. The value of livestock farming output in the EU is EUR 157 billion.
In addition, the protection of animal health constitutes one of the general objectives of EU food law.
The rules concerning medicated feed have significant influence on the keeping and on the rearing of animals, including non-food producing animals, and on the production of products of animal origin.
Council Directive 90/167/EEC constitutes the Union’s regulatory framework for the manufacture, placing on the market and use of medicated feed.
Experience with the application of Directive 90/167/EEC has shown that further measures should be taken to strengthen the effective functioning of the Internal Market and to explicitly give and improve the possibility to treat non-food producing animals by medicated feed.
IMPACT ASSESSMENT: the impact assessment identified the following main axes along which the system has to change in order to answer the stakeholders concerns: residues of veterinary medicines in feed, imprecise dosage of veterinary medicines, impossible market access to medicated feed for pets and barriers to intra EU trade of medicated feed. The impact assessment concluded that an EU Regulation with detailed rules would have the most positive impacts and would provide for the best way forward to achieve the objectives for the EU.
The impact assessment concluded that an EU Regulation with detailed rules would have the most positive impacts and would provide for the best way forward to achieve the objectives for the EU.
CONTENT: the proposed Regulation seeks to update the current legislation on medicated feed by repealing Directive 90/167/EEC which sets out the conditions under which medicated animal feed may be manufactured, placed on the market and used within the EU.
The main elements of the proposed Regulation include:
Scope : the scope of the proposed Regulation covers the manufacture, placing on the market and use of medicated feed for use in pets and in food-producing animals within the Union. It does not apply to veterinary medicinal products used as the medicinal component of medicated feed (previously called "medicated premixes"), which are dealt with under the veterinary medicinal products legislation.
Manufacture, composition, placing on the market and use of medicated feed : the proposal:
ensure that the general manufacture requirements laid down in Regulation (EC) No 183/2005 apply; stipulates that medicated feed may only be manufactured from veterinary medicinal products authorised under the veterinary medicinal products legislation; sets rules for the approval of feed business operators and rules they need to comply with in order to manufacture medicated feed; lays down rules for the homogenous incorporation of the veterinary medicinal products into the medicated feed and requirements in order to avoid carry-over of active substances from veterinary medicinal products into non target feed.
Labelling : the proposal provides that as regards labelling, the general provisions laid down in Regulation (EC) No 767/2009 on the placing on the market and use of feed should apply and that it be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed. It should also ensure that:
specific rules for the prescription, the validity of the prescription, the use of medicated feed containing antimicrobials in food-producing animals and the quantities required for the treatment of animals with medicated feed are laid down; manufacturers, distributors and users of medicated feed are keep daily records for the effective tracing of medicated feed; for veterinary medicinal products authorised at national level, the Regulation sets Intra-Union rules for trade of medicated feed in order to prevent distortions in competition.
DELEGATED ACT: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.
Documents
Documents
- Final act published in Official Journal: Regulation 2019/4
- Final act published in Official Journal: OJ L 004 07.01.2019, p. 0001
- Draft final act: 00043/2018/LEX
- Commission response to text adopted in plenary: SP(2018)755
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading: T8-0422/2018
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: GEDA/A/(2018)007840
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2018)007840
- Committee report tabled for plenary, 1st reading: A8-0075/2016
- Debate in Council: 3437
- Specific opinion: PE564.927
- Amendments tabled in committee: PE560.826
- Committee opinion: PE546.581
- Committee draft report: PE549.334
- Economic and Social Committee: opinion, report: CES5960/2014
- Contribution: COM(2014)0556
- Contribution: COM(2014)0556
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2014)0271
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2014)0272
- Legislative proposal published: COM(2014)0556
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SWD(2014)0271
- Document attached to the procedure: EUR-Lex SWD(2014)0272
- Economic and Social Committee: opinion, report: CES5960/2014
- Committee draft report: PE549.334
- Committee opinion: PE546.581
- Amendments tabled in committee: PE560.826
- Specific opinion: PE564.927
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2018)007840
- Commission response to text adopted in plenary: SP(2018)755
- Draft final act: 00043/2018/LEX
- Contribution: COM(2014)0556
- Contribution: COM(2014)0556
| Amendments | Dossier |
| 540 |
2014/0255(COD)
2015/04/28
ENVI
234 amendments...
Amendment 100 #
Proposal for a regulation Article 2 – paragraph 2 – point i i) ' on-farm mixer ' : a feed business operator manufacturing medicated feed
Amendment 101 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) 'antimicrobials': an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans.
Amendment 102 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) „antimicrobials" mean any compound with a direct action on microorganisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials, anti-virals, antifungals and anti-protozoals.
Amendment 103 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) 'antimicrobials: any compound with a direct action on microorganisms used for treatment or prevention of infections. Antimicrobials include anti- bacterials/antibiotics, anti-virals, antifungals and anti-protozoals.
Amendment 104 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) 'group treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected.
Amendment 105 #
Proposal for a regulation Article 2 – paragraph 2 – point i b (new) (ib) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 106 #
Proposal for a regulation Article 2 – paragraph 2 – point i b (new) (ib) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 107 #
Proposal for a regulation Article 2 – paragraph 2 – point i c (new) (ic) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 108 #
Proposal for a regulation Article 2 – paragraph 2 – point i c (new) (ic) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 109 #
Proposal for a regulation Article 2 – paragraph 2 – point i d (new) (id) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection.
Amendment 110 #
Proposal for a regulation Article 2 – paragraph 2 – point i d (new) (id) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 111 #
Proposal for a regulation Chapter 2 – title Manufacture, storage, transport, import and placing on the market
Amendment 112 #
Proposal for a regulation Chapter 2 – title Manufacture, storage, transport
Amendment 113 #
Proposal for a regulation Article 3 – paragraph 1 Feed business operators established in the Union or in third countries trading with Union Member States shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I.
Amendment 114 #
Proposal for a regulation Article 3 – paragraph 1 Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I. Holders of food-producing animals shall not be allowed to prepare their own medicated feed containing antimicrobial veterinary medicinal products.
Amendment 115 #
Proposal for a regulation Article 3 – paragraph 1 a (new) 1a. Distributors who supply medicated feed solely for non-food producing animals, distributed in sealed bags on prescription and sent to the holders of the animals, shall be exempt from the requirements applying to feed business operators.
Amendment 116 #
Proposal for a regulation Article 4 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: ' HACCP ' ) system as provided for in Regulation (EC) No 183/2005. Established control systems for on-farm mixers may be retained, provided it is ensured that the principles of the HACCP are complied with.
Amendment 117 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid
Amendment 118 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to
Amendment 119 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid or minimise carry-over.
Amendment 120 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to
Amendment 121 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 Amendment 122 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall
Amendment 123 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt
Amendment 124 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances in non-target feed on the basis of a scientific risk assessment by the European Food Safety Authority (EFSA).
Amendment 125 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of
Amendment 126 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances to avoid risk for animal health, human health or the environment.
Amendment 127 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 Amendment 128 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – introductory part Where no specific carry-over limits have been set for an active substance, the
Amendment 129 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – introductory part Where no specific carry-over limits have been set for an active substance,
Amendment 130 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – introductory part Where no specific carry-over limits have been set for an active substance
Amendment 131 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a Amendment 132 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a Amendment 133 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a Amendment 134 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a Amendment 135 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a Amendment 136 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a (a) for antimicrobial active substances, 0.1% of the active substance in the last batch of
Amendment 137 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a (a) for antimicrobial active substances,
Amendment 138 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b Amendment 139 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b Amendment 140 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b Amendment 141 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b Amendment 142 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b (b) for the other active substances,
Amendment 143 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b (b) for
Amendment 144 #
Proposal for a regulation Article 8 Amendment 145 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued. This provision shall not apply to
Amendment 146 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may not be manufactured and stored before the prescription referred to in Article 15 is issued.
Amendment 147 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued.
Amendment 148 #
Proposal for a regulation Article 9 – paragraph 1 1. In addition to Article 11(1), Articles 12 and 14 of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products, where these are not fed directly to livestock, shall comply with Annex III to this Regulation.
Amendment 149 #
Proposal for a regulation Article 9 – paragraph 1 1. In addition to Article 11(1)
Amendment 150 #
Proposal for a regulation Article 9 – paragraph 2 2. Where containers are used instead of packag
Amendment 151 #
Proposal for a regulation Article 9 – paragraph 3 Amendment 152 #
Proposal for a regulation Article 9 – paragraph 3 3.
Amendment 153 #
Proposal for a regulation Article 10 Medicated feed and intermediate products shall be placed on the market only in properly labelled and sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.
Amendment 154 #
Proposal for a regulation Article 10 Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused. Appropriate derogations should be provided for in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent excessive burden for the feed business operators.
Amendment 155 #
Proposal for a regulation Article 10 Amendment 156 #
Proposal for a regulation Article 11 Amendment 157 #
Proposal for a regulation Article 11 – title Intra
Amendment 158 #
Proposal for a regulation Article 11 – paragraph 1 a (new) Amendment 159 #
Proposal for a regulation Article 11 a (new) Article 11a Traceability of the active substances disseminated in the ecosystems The prescription givers shall fill in a register of the prescriptions of active substances. The register shall be kept up to date at the level of competent authorities for water management, for the sake of traceability of the dissemination of chemicals in the ecosystems.
Amendment 160 #
Proposal for a regulation Article 12 Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate
Amendment 161 #
Proposal for a regulation Article 12 Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority. Where on-farm mixers include medicinal products solely for use on their own farms, they shall notify their activity to the competent authority.
Amendment 162 #
Proposal for a regulation Article 15 – paragraph 1 1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm
Amendment 163 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The
Amendment 164 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V. The
Amendment 165 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The
Amendment 166 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The
Amendment 167 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in A
Amendment 168 #
Proposal for a regulation Article 15 – paragraph 2 – subparagraph 1 a (new) Metaphylactic use of medicated feed shall be duly justified by the veterinarian issuing the prescription. To that end, prescribing veterinarians shall assess the health and hygiene conditions at animal holdings, including aquaculture holdings, and the preventive bio-safety measures taken there.
Amendment 169 #
Proposal for a regulation Article 15 – paragraph 2 a (new) 2a. Prescribing veterinarians may not sell medicated feed.
Amendment 170 #
Proposal for a regulation Article 15 – paragraph 3 Amendment 171 #
Proposal for a regulation Article 15 – paragraph 4 Amendment 172 #
Proposal for a regulation Article 15 – paragraph 4 4. The prescription shall be valid for a maximum period of six months for non- food
Amendment 173 #
Proposal for a regulation Article 15 – paragraph 4 4. The prescription shall be valid
Amendment 174 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds and after having knowledge of the feeding systems the possibilities of mixing and other relevant farm specificities. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.
Amendment 175 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 176 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 177 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription
Amendment 178 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 179 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 18 #
Proposal for a regulation Title Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the import, manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (Text with EEA relevance)
Amendment 180 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used. The off-label use of medicated feed with antimicrobials authorised for human use only shall be forbidden.
Amendment 181 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 182 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for a
Amendment 183 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for the group of animals
Amendment 184 #
Proposal for a regulation Article 15 – paragraph 5 – subparagraph 1 a (new) Veterinarians qualified to prescribe medicated feed in accordance with applicable national law shall not retail medicated feed.
Amendment 185 #
Proposal for a regulation Article 15 – paragraph 6 6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the active substance of the veterinary medicinal product
Amendment 186 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. For medicated feed containing antimicrobial veterinary medicinal products, feed business operators supplying such medicated feed to the holder of food-
Amendment 187 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. Feed business operators supplying medicated feed to the holder of food- producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed
Amendment 188 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. Feed business operators supplying medicated feed to the holder of food- producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed
Amendment 189 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. Feed business operators supplying medicated feed to the holder of food- producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed
Amendment 19 #
Proposal for a regulation Title Proposal for a
Amendment 190 #
Proposal for a regulation Article 16 – paragraph 1 – point a Amendment 191 #
Proposal for a regulation Article 16 – paragraph 1 – point a Amendment 192 #
Proposal for a regulation Article 16 – paragraph 1 – point a Amendment 193 #
Proposal for a regulation Article 16 – paragraph 1 – point b Amendment 194 #
Proposal for a regulation Article 16 – paragraph 1 – point b Amendment 195 #
Proposal for a regulation Article 16 – paragraph 1 – point b Amendment 196 #
Proposal for a regulation Article 16 – paragraph 1 – point b Amendment 197 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment or
Amendment 198 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment or t
Amendment 199 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1a. Before repeated prescription, it is necessary for the veterinarian to evaluate how the effected animals reacted to the treatment and whether or not the treatment can be stopped or needs to be continued or changed.
Amendment 20 #
Proposal for a regulation Title Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the manufacture, placing on the market
Amendment 200 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1a. Before a repeated prescription, it is necessary for the veterinarian to do a sensitivity check and to evaluate if the treatment can be stopped or needs to be continued or changed.
Amendment 201 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1a. For medicated feed not containing antimicrobial veterinary medicinal products, feed business operators supplying medicated feed to the holder of food-producing animals, or on-farm mixers of medicated feed for food- producing animals shall ensure that the quantities supplied or mixed do not exceed the quantities provided in the prescription.
Amendment 202 #
Proposal for a regulation Article 16 – paragraph 1 b (new) Amendment 203 #
Proposal for a regulation Article 16 – paragraph 2 2.
Amendment 204 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing anti
Amendment 205 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall
Amendment 206 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial
Amendment 207 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to
Amendment 208 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food-producing
Amendment 209 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to
Amendment 21 #
Proposal for a regulation Citation 5 a (new) Having regard to the European Parliament’s own initiative report entitled ‘Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance’ (A8-9999/2015 of XX/yy/2015),
Amendment 210 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial
Amendment 211 #
Proposal for a regulation Article 16 – paragraph 3 (3) When administering medicated feed, the holder of food-producing animals
Amendment 212 #
Proposal for a regulation Article 16 – paragraph 4 4. Feed business operators feeding food- producing animals with medicated feed shall keep records in accordance with
Amendment 213 #
Proposal for a regulation Article 16 – paragraph 4 4. Feed business operators
Amendment 214 #
Proposal for a regulation Article 16 a (new) Article 16a Use in non-food producing animals The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific conditions in which medicated feed may be used to treat non-food producing animals. Such conditions shall be based on scientific evidence and shall define the species of non-food producing animals as well as the specific health conditions which may be treated with medicated feed.
Amendment 215 #
Proposal for a regulation Article 16 a (new) Article 16a Use in pet animals The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific conditions in which medicated feed may be used to treat pet animals.
Amendment 216 #
Proposal for a regulation Article 16 a (new) Article 16 Authorisation of the use of medicated feed for pets The Commission may adopt delegated acts authorising the production and placing on the market of medicated feed for pets provided that there is sound scientific evidence of the benefits of this method for administering veterinary medicines and the risks of over-administration and under-administration are taken into account. The Commission shall stipulate the species of pet that may be treated with medicated feed.
Amendment 217 #
Proposal for a regulation Article 17 Member States, in cooperation with regional and local authorities, shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription.
Amendment 218 #
Proposal for a regulation Article 17 Amendment 219 #
Proposal for a regulation Article 17 Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription.
Amendment 22 #
Proposal for a regulation Recital 2 (2) Livestock production, animal health and welfare, occup
Amendment 220 #
Proposal for a regulation Article 18 The Commission shall
Amendment 222 #
Proposal for a regulation Article 19 – paragraph 1 1.
Amendment 223 #
Proposal for a regulation Article 19 – paragraph 2 2. The delegation of power referred to in Articles 7, 16a and 18 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 224 #
Proposal for a regulation Article 19 – paragraph 2 2.
Amendment 225 #
Proposal for a regulation Article 19 – paragraph 2 2. The delegation of power referred to in Articles 7, 16a and 18 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 226 #
Proposal for a regulation Article 19 – paragraph 3 3. The delegation of powers referred to in Articles 7, 16a and 18 may be revoked at any time by the European Parliament or by the
Amendment 227 #
Proposal for a regulation Article 19 – paragraph 3 3. The delegation of powers referred to in Articles 7, 16a and 18 may be revoked at any time by the European Parliament or by the Council. A decision of revocation 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.
Amendment 228 #
Proposal for a regulation Article 19 – paragraph 5 5. A delegated act adopted pursuant to Articles 7, 16a and 18 shall enter into force only if no objection has been expressed either
Amendment 229 #
Proposal for a regulation Article 19 – paragraph 5 5. A delegated act adopted pursuant to Articles 7, 16a and 18 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.
Amendment 23 #
Proposal for a regulation Recital 2 (2) Livestock production occupies a
Amendment 230 #
Proposal for a regulation Article 23 This
Amendment 231 #
Proposal for a regulation Annex I – section 1 – point 5 5. Drainage facilities shall be adequate for the purpose intended; they shall be designed and constructed to avoid the risk of contamination of feed and of the environment; in particular, they shall prevent water contamination by antimicrobials, especially antibiotics and anti-parasites or substances classifiable as endocrine disruptors in animals and humans.
Amendment 232 #
Proposal for a regulation Annex I – section 1 – point 6 a (new) 6a. Feed used as the basis for medicated feed shall not be derived from genetically modified organisms.
Amendment 233 #
Proposal for a regulation Annex I – section 3 – point 2 2. Technical or organisational measures shall be taken to avoid or minimise, any cross-
Amendment 234 #
Proposal for a regulation Annex I – section 3 – point 2 2. Technical or organisational measures shall be taken to
Amendment 235 #
Proposal for a regulation Annex I – section 3 – point 3 3. The presence of undesirable substances within the meaning of Directive 2002/32/EC and of other contaminants in relation to human and animal health shall
Amendment 236 #
Proposal for a regulation Annex I – section 3 – point 4 4. The products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to
Amendment 237 #
Proposal for a regulation Annex I – section 6 – point 2 – point i (i) information on the
Amendment 238 #
Proposal for a regulation Annex I – section 6 – point 2 – point i (i) information on the
Amendment 239 #
Proposal for a regulation Annex I – section 6 – point 2 – point i (i) information on the
Amendment 24 #
Proposal for a regulation Recital 3 (3) The pursuit of a high level of protection of human health is one of the fundamental objectives of food law, as
Amendment 240 #
Proposal for a regulation Annex I – section 6 – point 2 – subparagraph 2 Apart from the documents that are permanent in nature, the documents shall be kept for
Amendment 241 #
Proposal for a regulation Annex II – point 1 1. Mobile mixers or on-farm mixers shall only use veterinary medicinal products at inclusion rates above 2 kg/t of feed. By way of derogation, smaller inclusion rates may be specified in the veterinary prescription: - to adjust the quantity of medicated feed produced to the size of the herd; - if the prescription, production and use take place under the supervision of the veterinarian monitoring the herd; and - if the farmer and the veterinarian monitoring the herd are subject to an external process control.
Amendment 242 #
Proposal for a regulation Annex III – paragraph 1 – point 4 4. the batch reference number of the medicated feed or intermediate product and the country of manufacture;
Amendment 243 #
Proposal for a regulation Annex III – paragraph 1 – point 9 9. a recommendation to read the package leaflet of the veterinary medicinal products, including a hyperlink where it can be found, a warning that the product is only for the treatment of animals
Amendment 244 #
Proposal for a regulation Annex III – paragraph 1 – point 16 a (new) (16a) Information that inappropriate disposal of medicated feed poses serious threats to the environment and may contribute to antimicrobial resistance. Information on where and how to appropriately dispose of unused material.
Amendment 245 #
Proposal for a regulation Annex III – paragraph 1 – point 16 a (new) For medicated feed containing antibiotics: the request to use antibiotics only as a last resort and in a most prudent and responsible manner
Amendment 246 #
Proposal for a regulation Annex 4 Amendment 247 #
Proposal for a regulation Annex IV – heading 1 Amendment 248 #
Proposal for a regulation Annex IV – point 1 – paragraph 1 – introductory part Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of
Amendment 249 #
Proposal for a regulation Annex V – point 1 1. Surname, forename, address and professional membership number of the
Amendment 25 #
Proposal for a regulation Recital 3 a (new) (3a) Prevention of disease is better than cure. Medicinal treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.
Amendment 250 #
Proposal for a regulation Annex V – point 2 2. Issue date and signature or electronic identification of the
Amendment 251 #
Proposal for a regulation Annex V a (new) Annex Va Preventive measures Preventive measures to be used before resorting to antimicrobial treatment of entire groups (metaphylaxis): - using good healthy breeding stock that grows naturally, with suitable genetic diversity - conditions that respect the behavioural needs of the species, including social interactions/ hierarchies - stocking densities that do not increase risk of disease transmission - isolation of sick animals away from the rest of the group - (for chickens and smaller animals) subdivision of flocks into smaller, physically separated groups - Implementation of existing animal welfare rules pursuant to Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23), Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33), Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28).
Amendment 26 #
Proposal for a regulation Recital 3 a (new) Amendment 27 #
Proposal for a regulation Recital 4 (4)
Amendment 28 #
Proposal for a regulation Recital 4 (4) Experience with the application of Directive 90/167/EEC has shown that further measures should be taken to strengthen the effective functioning of the Internal Market and to explicitly give
Amendment 29 #
Proposal for a regulation Recital 6 (6) As a type of feed, medicated feed falls within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council6, of Regulation (EC) No
Amendment 30 #
Proposal for a regulation Recital 7 (
Amendment 31 #
Proposal for a regulation Recital 8 (8) Without prejudice to the general obligations laid down in Article 12 of Regulation (EC) No 178/2002 concerning exports of feed to third countries, the provisions of this Regulation should apply to medicated feed and intermediate products which are manufactured, stored, transported or placed on the market within the Union with the intention to be exported. However, the specific requirements concerning
Amendment 32 #
Proposal for a regulation Recital 9 (9) Medicated feed should be manufactured
Amendment 33 #
Proposal for a regulation Recital 9 (9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the
Amendment 34 #
Proposal for a regulation Recital 9 a (new) (9a) Flock medication in feed and water often increases the unnecessary use of antibiotics and therefore individual injections of antibiotics should be preferred.
Amendment 35 #
Proposal for a regulation Recital 9 b (new) (9b) Effects of the use of medicated feed on the medicalisation of the environment should be further studied.
Amendment 36 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of
Amendment 37 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of ‘carry-over’ is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term ‘cross-contamination’ is to be considered as a contamination resulting from a carry- over or from the transfer in feed of any unintended substance. Carry-over of active substances contained in medicated feed to non-target feed should be
Amendment 38 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of "carry-over" is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term "cross-contamination" is to be considered as a contamination resulting from a carry- over or from the transfer in feed of any unintended substance. Carry-over of active substances contained in medicated feed to non-target feed should be avoided or kept as low as possible. In order to protect animal health, human health and the environment, maximum levels of carry- over for active substances contained in medicated feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority and taking into account the application of good manufacturing practice
Amendment 39 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of ‘carry-over’ is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term ‘cross-contamination’ is to be considered as a contamination resulting from a carry- over or from the transfer in feed of any unintended substance. Carry-over of active substances contained in medicated feed to non-target feed should be avoided or kept as low as possible. In order to protect animal health, human health and the environment, maximum limits for levels of carry-
Amendment 40 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of ‘carry-over’ is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term
Amendment 41 #
Proposal for a regulation Recital 12 a (new) (12a) Carry-over of active substances contained in medicated feed to non-target feed should be avoided or kept as low as possible. In order to protect animal health, human health and the environment, maximum levels of carry- over for active substances contained in medicated feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority and taking into account the application of good manufacturing practice and the ALARA (As Low As Reasonably Achievable) principle. General limits should be set out in this Regulation, taking into account the unavoidable carry-over and the risk caused by the active substances concerned.
Amendment 42 #
Proposal for a regulation Recital 13 (13) Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed.
Amendment 43 #
Proposal for a regulation Recital 13 (13) Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed.
Amendment 44 #
Proposal for a regulation Recital 14 (14) Medicated feed should be marketed in specially labelled sealed containers for safety reasons and to protect the user’s interest.
Amendment 45 #
Proposal for a regulation Recital 14 (14) Medicated feed should be marketed in sealed containers for safety reasons and to protect user's interest, but appropriate derogations should be provided for in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent excessive burden for the feed business operators.
Amendment 46 #
Proposal for a regulation Recital 15 a (new) (15a) Although it could, potentially, resolve the administration problems encountered by pet owners, the administration of medicated feed to pets should be the subject of further research, in particular in order to assess the risks of over-administration and under- administration;
Amendment 47 #
Proposal for a regulation Recital 16 a (new) (16a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines.
Amendment 48 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated.
Amendment 49 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription
Amendment 50 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated.
Amendment 51 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use
Amendment 52 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued for a limited period of time after examination of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 53 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription
Amendment 54 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated.
Amendment 55 #
Proposal for a regulation Recital 18 (18) In order to ensure a particularly prudent use of medicated feed for food- producing animals and therefore provide the basis for the assurance of a high level of protection of public health, including animal health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-
Amendment 56 #
Proposal for a regulation Recital 18 (18) In order to ensure a p
Amendment 57 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 58 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit or prohibit the use of medicated feed containing antimicrobials for food- producing animals, especially in the case of certain new or antimicrobials critically important for humans. Preventive use or use to enhance the performance of food- producing animals should in particular not be allowed.
Amendment 59 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials
Amendment 60 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 61 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public
Amendment 62 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 63 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 64 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 65 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Antibiotics critically important for human use should not be used at all. Preventive use or use to enhance the performance of food-producing animals should in particular not be allowed. Metaphylaxis for large animals such as pigs and cows should not be allowed, as they should be treated individually.
Amendment 66 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use or use to enhance the performance of food-producing animals should
Amendment 67 #
Proposal for a regulation Recital 19 a (new) (19a) The One Health concept, endorsed by the World Health Organisation, recognises that human health, animal health and ecosystems are interconnected and it is therefore essential for both animal and human health to ensure prudent use of antimicrobial medicines in food-producing animals.
Amendment 68 #
Proposal for a regulation Recital 19 a (new) (19a) Notes with great concern the high number of animals infected with bacteria that are resistant to antibiotics, and the risk of carry-over of these bacteria from infected meat to consumers.
Amendment 69 #
Proposal for a regulation Recital 19 b (new) (19b) The WHO has identified food products of animal origin as the main potential route of contamination for transmission of resistant bacteria and resistant genes from food-producing animals to humans.
Amendment 70 #
Proposal for a regulation Recital 19 b (new) (19b) The issue of off-label use of antibiotics is a concern for animal medicine as well as human medicine.
Amendment 71 #
Proposal for a regulation Recital 20 (20) A system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal health, human health or the environment. Member States should set up such a system as and where necessary, in cooperation with regional and local authorities.
Amendment 72 #
Proposal for a regulation Recital 20 (20) A system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal, human health or the environment. Collection points should keep records on the return of unconsumed medicated feed containing antimicrobial veterinary medicinal products.
Amendment 73 #
Proposal for a regulation Recital 20 a (new) (20a) A register of the prescriptions of active substances should be kept up to date at the level of competent authorities for water management, for the sake of traceability of the dissemination of chemicals in the ecosystems.
Amendment 74 #
Proposal for a regulation Recital 21 (21) In order to comply with the objective of this Regulation and to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the establishment of specific carry-over limits, the conditions under which medicated feed may be used to treat non-food producing animals and of the amendment to the Annexes to this Regulation. Those Annexes concern provisions on feed business operators obligations related to the manufacture, storage, transport and placing on the market of medicated feed and intermediate products, the incorporation of the veterinary medicinal product into feed, the labelling particulars for medicated feed and intermediate products, the permitted tolerances for the compositional labelling of medicated feed or intermediate products and the specimen form to be used for the veterinary prescription. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant
Amendment 75 #
Proposal for a regulation Recital 21 (21) In order to comply with the objective of this Regulation and to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the
Amendment 76 #
Proposal for a regulation Recital 24 (24) Since the Union is conducting negotiations with a partner whose practices are far removed from the Union's objectives, the objective of this
Amendment 77 #
Proposal for a regulation Article 1 – paragraph 1 – introductory part This
Amendment 78 #
Proposal for a regulation Article 1 – paragraph 1 – point a (a) the manufacture, storage and transport of medicated feed and intermediate products intended for pets, non-food producing animals and food-producing animals;
Amendment 79 #
Proposal for a regulation Article 1 – paragraph 1 – point b (b) the placing on the market, including import, and use of medicated feed and intermediate products intended for pets, non-food producing animals and food- producing animals;
Amendment 80 #
Proposal for a regulation Article 1 – paragraph 1 – point c (c) the export to third countries of medicated feed and intermediate products. However, Articles
Amendment 81 #
Proposal for a regulation Article 1 – paragraph 1 – point c c) the export to third countries of medicated feed and intermediate products. However,
Amendment 82 #
Proposal for a regulation Article 1 – paragraph 1 a (new) This Regulation shall not apply to pet animals unless a delegated act is adopted in accordance with Articles 16a and 19.
Amendment 83 #
Proposal for a regulation Article 1 – paragraph 1 a (new) Amendment 84 #
Proposal for a regulation Article 1 – paragraph 1 a (new) This Regulation shall not apply to finished medicinal products to be orally administered that have been approved for use via feed or drinking water. Accordingly, the approval requirement set out in Recital 16 shall not apply to farms which use such medicinal products for their own herd.
Amendment 85 #
Proposal for a regulation Article 1 – paragraph 1 a (new) Without prejudice to the adoption of delegated acts under Article 16a and Article 19, this Regulation shall not apply to pets.
Amendment 86 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c) the definitions of 'food-producing animal', 'non-food producing animals', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed',
Amendment 87 #
Proposal for a regulation Article 2 – paragraph 1 – point c a (new) (ca) the definition of ‘pet’: the species listed in Annex I to Regulation (EU) No 576/2013 of 12 June 2013;
Amendment 88 #
Proposal for a regulation Article 2 – paragraph 1 – point d (d) the definition of 'establishment' and 'feed business operator' as laid down in Article 3 of Regulation (EC) No 183/2005;
Amendment 89 #
Proposal for a regulation Article 2 – paragraph 1 – point f a (new) fa) the definition of ‘antimicrobial' as laid down in Article 4 of Regulation XXXX/201X of the European Parliament and of the Council on veterinary medicinal products.
Amendment 90 #
Proposal for a regulation Article 2 – paragraph 1 – point f b (new) fb) the definition of ‘antibiotic' as laid down in Article 4 of Regulation XXXX/201X of the European Parliament and of the Council on veterinary medicinal products.
Amendment 91 #
Proposal for a regulation Article 2 – paragraph 2 – point b b) ' intermediate
Amendment 92 #
Proposal for a regulation Article 2 – paragraph 2 – point c Amendment 93 #
Proposal for a regulation Article 2 – paragraph 2 – point d d) ' non-target feed ' : medicated feed which is not intended to contain a specific veterinary medicinal product;
Amendment 94 #
Proposal for a regulation Article 2 – paragraph 2 – point f Amendment 95 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) 'distributor': any feed business operator that supplies medicated feed, packaged and ready for use, to other distributors and directly to the animal holder;
Amendment 96 #
Proposal for a regulation Article 2 – paragraph 2 – point g g) ' distributor ' : any feed business operator that supplies medicated feed, packaged and ready for use, to the animal holder or, in the case of non-food producing animals, to other distributors who are authorised to distribute veterinary medicinal products;
Amendment 97 #
Proposal for a regulation Article 2 – paragraph 2 – point h h) ' mobile mixer ' : a feed business operator with a feed establishment consisting of a specifically equipped
Amendment 98 #
Proposal for a regulation Article 2 – paragraph 2 – point h h) ' mobile mixer ' : a feed business operator with a feed establishment consisting of a specifically equipped
Amendment 99 #
Proposal for a regulation Article 2 – paragraph 2 – point i i) ' on-farm mixer ' : a feed business operator manufacturing medicated feed
source: 554.992
2015/07/02
AGRI
306 amendments...
Amendment 100 #
Proposal for a regulation Article 2 – paragraph 1 – point f a (new) (fa) the definitions of 'antimicrobials' and 'antibiotics' as laid down in Regulation (EU) 2015/... (Veterinary Medicinal Products);
Amendment 101 #
Proposal for a regulation Article 2 – paragraph 2 – point a (a) 'medicated feed': a mixture of one
Amendment 102 #
Proposal for a regulation Article 2 – paragraph 2 – point a (a) 'medicated feed': a mixture of one
Amendment 103 #
Proposal for a regulation Article 2 – paragraph 2 – point a (a) 'medicated feed':
Amendment 104 #
Proposal for a regulation Article 2 – paragraph 2 – point a (a) 'medicated feed': a
Amendment 105 #
Proposal for a regulation Article 2 – paragraph 2 – point a (a) 'medicated feed': a mixture of one or more veterinary medicinal products or intermediate products with
Amendment 106 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) 'intermediate
Amendment 107 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) 'intermediate
Amendment 108 #
Proposal for a regulation Article 2 – paragraph 2 – point f Amendment 109 #
Proposal for a regulation Article 2 – paragraph 2 – point f (f) 'medicated feed business operator': any natural or
Amendment 110 #
Proposal for a regulation Article 2 – paragraph 2 – point f (f) 'medicated feed business operator': any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under their control, including brokers and livestock farmers using medicated feed intended for the animals in their possession;
Amendment 111 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) 'distributor': any feed business operator that supplies medicated feed, packaged and
Amendment 112 #
Proposal for a regulation Article 2 – paragraph 2 – point h Amendment 113 #
Proposal for a regulation Article 2 – paragraph 2 – point h (h) 'mobile mixer': a feed business operator with
Amendment 114 #
Proposal for a regulation Article 2 – paragraph 2 – point i (i) 'on-farm mixer': a feed business operator manufacturing medicated feed on
Amendment 115 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) 'antimicrobial': an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans. Antimicrobials are inclusive of anti-bacterials, anti-virals, anti-fungals and antiprotozoals;
Amendment 116 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) "antimicrobials" mean any compound with a direct action on microorganisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials, anti-virals, anti- fungals and anti-protozoals.
Amendment 117 #
Proposal for a regulation Article 2 – paragraph 2 – point i a (new) (ia) ‘antimicrobials’: a general term for any compound with a direct action on micro-organisms used for treatment or prevention of infections;
Amendment 118 #
Proposal for a regulation Article 2 – paragraph 2 – point i b (new) Amendment 119 #
Proposal for a regulation Article 2 – paragraph 2 – point i c (new) (ic) ‘anti-parasites’: medicine substance used in the treatment of parasitic diseases of varied aetiology;
Amendment 120 #
Proposal for a regulation Article 2 – paragraph 2 – point i d (new) (id) 'cross-contamination': a contamination resulting from a carry-over or from the transfer in feed of any unintended substance;
Amendment 121 #
Proposal for a regulation Article 2 – paragraph 2 – point i e (new) (ie) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 122 #
Proposal for a regulation Article 2 – paragraph 2 – point i e (new) (ie) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 123 #
Proposal for a regulation Article 2 – paragraph 2 – point i e (new) (ie) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 124 #
Proposal for a regulation Article 2 – paragraph 2 – point i e (new) (ie) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 125 #
Proposal for a regulation Article 2 – paragraph 2 – point i e (new) (ie) 'prevention of diseases': treatment of the group of animals without clinical signs of disease;
Amendment 126 #
Proposal for a regulation Article 2 – paragraph 2 – point i f (new) (if) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 127 #
Proposal for a regulation Article 2 – paragraph 2 – point i f (new) (if) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be infected;
Amendment 128 #
Proposal for a regulation Article 2 – paragraph 2 – point i f (new) (if) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 129 #
Proposal for a regulation Article 2 – paragraph 2 – point i f (new) (if) 'group treatment (metaphylaxis)': treatment of a group of animals including clinically healthy individuals presumed to be infected, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 130 #
Proposal for a regulation Article 2 – paragraph 2 – point i f (new) (if) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 131 #
Proposal for a regulation Article 2 – paragraph 2 – point i g (new) (ig) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 132 #
Proposal for a regulation Article 2 – paragraph 2 – point i g (new) (ig) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 133 #
Proposal for a regulation Article 2 – paragraph 2 – point i g (new) (ig) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 134 #
Proposal for a regulation Article 2 – paragraph 2 – point i h (new) (ih) 'medicated feed manufacturer': any medicated feed business operator that manufactures medicated feed;
Amendment 135 #
Proposal for a regulation Article 2 – paragraph 2 – point i h (new) (ih) 'medicated feed manufacturer': any medicated feed business operator that manufactures medicated feed;
Amendment 136 #
Proposal for a regulation Article 2 – paragraph 2 – point i i (new) (ii) 'broker': any person active in the buying or selling of medicated feed (excluding the distribution of medicated feed), which operations do not involve the physical handling thereof but rather the trading thereof, independently and in the name of a physical or legal person;
Amendment 137 #
Proposal for a regulation Article 2 – paragraph 2 – point i i (new) (ii) 'broker': any person active in the buying or selling of medicated feed (excluding the distribution of medicated feed), which operations do not involve the physical handling thereof but rather the trading thereof, independently and in the name of a physical or legal person;
Amendment 138 #
Proposal for a regulation Article 3 – paragraph 1 Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I. Holders of food-producing animals shall not be allowed to prepare their own medicated feed containing antimicrobial veterinary medicinal products.
Amendment 139 #
Proposal for a regulation Article 3 – paragraph 1 Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with
Amendment 140 #
Proposal for a regulation Article 3 – paragraph 1 Amendment 141 #
Proposal for a regulation Article 3 – paragraph 1 Amendment 142 #
Proposal for a regulation Article 3 – paragraph 1 Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with
Amendment 143 #
Proposal for a regulation Article 3 – paragraph 1 a (new) A Member State may introduce national provisions prohibiting or regulating, within its territory, mobile mixers.
Amendment 144 #
Proposal for a regulation Article 3 – paragraph 1 a (new) 1a. A Member State may impose restrictions for prohibiting or regulating the use of mobile mixers in its territory.
Amendment 145 #
Proposal for a regulation Article 3 – paragraph 1 a (new) 1a. A Member State may impose restrictions for prohibiting or regulating the use of mobile mixers in its territory.
Amendment 146 #
Proposal for a regulation Article 3 – paragraph 1 b (new) 1b. Care should be taken to ensure that the medicated feed handling requirements imposed by the Regulation and secondary legislation on feed business operators, in particular on-farm mixers, are feasible and practical.
Amendment 147 #
Proposal for a regulation Article 3 – paragraph 1 c (new) 1c. By way of derogation from paragraph 1, the provisions of Chapter II shall not apply to livestock farmers who only use medicated feed for their own animals.
Amendment 148 #
Proposal for a regulation Article 3 – paragraph 1 c (new) 1c. By way of derogation from paragraph 1, the provisions of Chapter II shall not apply to livestock farmers who only use medicated feed for their own animals.
Amendment 149 #
Proposal for a regulation Article 4 – paragraph 1 Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: 'HACCP' ) system as provided for in Regulation (EC) No 183/2005. Mixtures consisting of feedstuffs and medications approved for oral use which are manufactured for immediate on-farm administration shall be exempt from the written procedure.
Amendment 150 #
Proposal for a regulation Article 4 – paragraph 1 Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: 'HACCP' ) system as provided for in Regulation (EC) No 183/2005. Established control systems for on-farm mixers may be retained, provided it is ensured that the principles of the HACCP are complied with.
Amendment 151 #
Proposal for a regulation Article 5 – paragraph 1 1. Medicated feed and intermediate products shall only be manufactured from
Amendment 152 #
Proposal for a regulation Article 5 – paragraph 2 – point a (a) the
Amendment 153 #
Proposal for a regulation Article 5 – paragraph 2 – point b (b) the medicated feed is manufactured in compliance with the relevant conditions laid down in the prescription of the attending veterinarian and in the summary of
Amendment 154 #
Proposal for a regulation Article 5 – paragraph 2 – point b (b) the medicated feed is manufactured in compliance with the relevant conditions laid down in the summary of the product characteristics referred to in Article 14 of Directive 2001/82/EC, related to the veterinary medicinal products to be incorporated in the medicated feed; this includes, in particular, provisions relating to possible interactions between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed;
Amendment 155 #
Proposal for a regulation Article 5 – paragraph 2 – point b (b) the medicated feed is manufactured in compliance with the relevant conditions laid down in the summary of the product characteristics referred to in Article 14 of Directive 2001/82/EC, related to the
Amendment 156 #
Proposal for a regulation Article 5 – paragraph 2 – point c Amendment 157 #
Proposal for a regulation Article 5 – paragraph 2 – point c Amendment 158 #
Proposal for a regulation Article 5 – paragraph 2 – point d (d)
Amendment 159 #
Proposal for a regulation Article 5 – paragraph 2 – point d a (new) Amendment 160 #
Proposal for a regulation Article 5 – paragraph 2 – point d b (new) (db) the feed used for the production of medicated feed complies with all relevant conditions of Union legislation concerning animal feedingstuffs;
Amendment 161 #
Proposal for a regulation Article 5 – paragraph 2 – point d c (new) (dc) the medicated feed is produced in line with the rules defined in the summary of the product characteristics in such a way as to ensure its stability during the prescribed treatment period;
Amendment 162 #
Proposal for a regulation Article 6 – paragraph 1 1.
Amendment 163 #
Proposal for a regulation Article 6 – paragraph 2 2. The Commission may, by means of implementing acts, establish criteria for the homogenous incorporation of the veterinary medicinal product into the medicated feed or into the intermediate product, taking into account the specific properties of the veterinary medicinal products and of the m
Amendment 164 #
Proposal for a regulation Article 6 – paragraph 2 2. The Commission may, by means of implementing acts, establish criteria for the homogenous incorporation of the veterinary medicinal product into the medicated feed or into the intermediate product, taking into account the specific properties of the veterinary medicinal products and of the m
Amendment 165 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to
Amendment 166 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid carry-over, in accordance with the ALARA principle, in order to avoid risk for animal health, human health or the environment.
Amendment 167 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to
Amendment 168 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to
Amendment 169 #
Proposal for a regulation Article 7 – paragraph 1 1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid carry-over or restrict the levels determined by the European Food Safety Authority.
Amendment 170 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 Amendment 171 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 Amendment 172 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of
Amendment 173 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific
Amendment 174 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific
Amendment 175 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances. Limits shall be based on the opinion of the European Food Safety Authority.
Amendment 176 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances to avoid risk for animal and human health or for the environment.
Amendment 177 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 a (new) (1a) Carry-over limits for each specific substance shall be determined by the Commission on the basis of a scientific risk assessment carried out by the European Food Safety Authority (EFSA).
Amendment 178 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph -2 Amendment 179 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – introductory part Where no specific carry-over limits have been set for an active substance, the
Amendment 180 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 a Carry-over limits for specific active substances shall be determined by a scientific risk assessment carried out by the European Food Safety Authority (EFSA), where such limits have not been already determined.
Amendment 181 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a Amendment 182 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a (a) for antimicrobial active substances, 0.1% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non-
Amendment 183 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a (a) for antimicrobial active substances,
Amendment 184 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point a (a) for
Amendment 185 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b Amendment 186 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b (b) for the other active substances,
Amendment 187 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b (b) for the other active substances,
Amendment 188 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 – point b (b) for the other active substances, 3% of the maximum permitted dose of the active substance in
Amendment 189 #
Proposal for a regulation Article 7 – paragraph 2 a (new) 2a. In Member States where reduction to these levels will be burdensome, the Commission and Member States shall promote potential funding sources to provide assistance to farmers to meet these targets, from within the European Agricultural Guarantee Fund or EU Health Programme, for example.
Amendment 190 #
Proposal for a regulation Article 7 – paragraph 2 b (new) 2b. The Commission shall be empowered to adopt implementing acts for establishing criteria in respect of: -the definition of the batch, pursuant to this Article; -the analytical methods that must be employed by medicated feed business operators; -the sampling methods and analytical methods that must be employed by medicated feed business operators and the competent authorities in order to check that the specific carry-over limits have been complied with. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Amendment 191 #
Proposal for a regulation Article 7 – paragraph 2 b (new) 2b. The Commission shall be empowered to adopt implementing acts for establishing criteria in respect of: - the definition of the batch, pursuant to this Article; - the analytical methods that must be employed by medicated feed business operators; - the sampling methods and analytical methods that must be employed by medicated feed business operators and the competent authorities in order to check that the specific carry-over limits have been complied with. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Amendment 192 #
Proposal for a regulation Article 7 – paragraph 2 c (new) Amendment 193 #
Proposal for a regulation Article 7 – paragraph 2 c (new) 2c. A detailed schedule listing, in order of priority, the different active substances for which specific carry-over limits must be adopted shall be established by way of an implementing act. The agencies (EFSA and EMA) shall be consulted as the list is being compiled. 24 months from the date of entry into force of this Regulation, the Commission shall submit a report to the European Parliament and to the Council, indicating the specific carry-over limits adopted.
Amendment 194 #
Proposal for a regulation Article 8 – paragraph 1 Amendment 195 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may not be manufactured and stored before the prescription referred to in Article 15 is issued.
Amendment 196 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued. This provision shall not apply to
Amendment 197 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued. This provision shall not apply to on-farm mixers, mobile mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with Articles 10 or 11 of Directive 2001/82/EC unless justified on the basis of epidemiological and clinical knowledge.
Amendment 198 #
Proposal for a regulation Article 8 – paragraph 1 Medicated feed and intermediate products may be manufactured and stored for production-related reasons before the prescription referred to in Article 15 is issued. In such cases the nature and quantity of the medicated feed which is manufactured or stored must be notified to the competent authority. This provision shall not apply to on-farm mixers or mobile mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with Articles 10 or 11 of Directive 2001/82/EC.
Amendment 199 #
Proposal for a regulation Article 9 – paragraph 1 1. In addition to Articles 11(1),
Amendment 200 #
Proposal for a regulation Article 9 – paragraph 1 1. In addition to Article 11(1), Articles 1
Amendment 201 #
Proposal for a regulation Article 9 – paragraph 1 1. In addition to Article 11(1), Articles 12 and 14 of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products, where these are not fed directly to livestock, shall comply with Annex III to this Regulation.
Amendment 202 #
Proposal for a regulation Article 9 – paragraph 3 3.
Amendment 203 #
Proposal for a regulation Article 9 – paragraph 3 3.
Amendment 204 #
Proposal for a regulation Article 9 – paragraph 3 3. Permitted tolerances for discrepancies between the labelled compositional values
Amendment 205 #
Proposal for a regulation Article 10 – paragraph 1 Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused. Appropriate derogations should be provided for those instances where the application of this requirement is not necessary to protect human or animal health or consumer interests, and would represent an excessive administrative and technical burden.
Amendment 206 #
Proposal for a regulation Article 10 – paragraph 1 Medicated feed and intermediate products shall be placed on the market only in sealed packages – including sack packaging – or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.
Amendment 207 #
Proposal for a regulation Article 11 a (new) Article 11a Trading with non-EU countries Imports, from non-EU countries, of food- producing animals which have been administered medicated feed containing antimicrobial veterinary medicinal products in order to prevent disease shall be prohibited. Similarly, imports of foodstuffs derived from those animals shall be prohibited.
Amendment 208 #
Proposal for a regulation Article 11 b (new) Article 11b Traceability of the active substances disseminated in ecosystems The professionals giving a prescription shall fill in a register of prescriptions of active substances. The register will be kept up to date at the level of competent authorities for water management or the environment, to enable traceability of the dispersal of chemicals in ecosystems.
Amendment 209 #
Proposal for a regulation Article 12 – paragraph 1 Amendment 210 #
Proposal for a regulation Article 12 – paragraph 1 Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority. This shall not apply to agricultural establishments which feed on-farm-manufactured medicated feed to their own animals.
Amendment 211 #
Proposal for a regulation Article 12 – paragraph 1 Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent public authority.
Amendment 212 #
Proposal for a regulation Article 12 – paragraph 1 a (new) Member States should establish competent authorities for approval of the manufacturers and wholesalers of medicated feedingstuffs.
Amendment 213 #
Proposal for a regulation Article 15 – paragraph 1 1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription issued by a veterinarian and to the conditions laid
Amendment 214 #
Proposal for a regulation Paragraph 15 – subparagraph 1 1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription issued after the veterinary examination and the establishment of a veterinary diagnosis, or following a regular animal health check visit, and to the conditions laid down in paragraphs 2 to 6.
Amendment 215 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The
Amendment 216 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in A
Amendment 217 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V, based on Article 110 of the Regulation on Veterinary Medicinal Products1 a . The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The person issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance. __________________ 1a Commission Proposal COM (2014)558 final
Amendment 218 #
Proposal for a regulation Article 15 – paragraph 2 2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The
Amendment 219 #
Proposal for a regulation Article 15 – paragraph 3 3. With the exception of medicated feed for
Amendment 220 #
Proposal for a regulation Article 15 – paragraph 3 – subparagraph 1a (new) The duration of the treatment should follow the valid SPC of the authorised medicated premix incorporated into the medicated feed and should not exceed three weeks in case of medicated feed with incorporated medicated premixes containing active substances with the potential to select resistance.
Amendment 221 #
Proposal for a regulation Article 15 – paragraph 3 a (new) Amendment 222 #
Proposal for a regulation Article 15 – paragraph 4 Amendment 223 #
Proposal for a regulation Article 15 – paragraph 4 4. The prescription shall be valid from the date of issuance for a maximum period of six months for non-
Amendment 224 #
Proposal for a regulation Article 15 – paragraph 4 4. The prescription shall be valid for a maximum period of six months for
Amendment 225 #
Proposal for a regulation Article 15 – paragraph 4 4. The prescription shall be valid for a maximum period of six months for non- food producing animals and three
Amendment 226 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 227 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals
Amendment 228 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 229 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for individual animals or a group of animals examined by the
Amendment 230 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 231 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 232 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the
Amendment 233 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds and after having knowledge of the feeding systems, the possibilities of mixing and other relevant farm specificities. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.
Amendment 234 #
Proposal for a regulation Article 15 – paragraph 5 5. The prescribed medicated feed may be used only for groups of animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with
Amendment 235 #
Proposal for a regulation Paragraph 15 – subparagraph 5 5. The prescribed medicated feed may be used only for animals examined by the authorised person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.
Amendment 236 #
Proposal for a regulation Article 15 – paragraph 6 6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the veterinary medicinal product and the quantity of medicated feed calculated on the basis of the relevant parameters. The daily dose shall be incorporated in a quantity of medicated feed that ensures the uptake of the daily dose by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration
Amendment 237 #
Proposal for a regulation Article 15 – paragraph 6 6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the veterinary medicinal product and the quantity of medicated feed calculated on the basis of the relevant parameters. The daily dose of the veterinary medicinal product shall be incorporated in a quantity of feed that ensures the uptake of the daily dose by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration.
Amendment 238 #
Proposal for a regulation Article 15 – paragraph 6 6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate
Amendment 239 #
Proposal for a regulation Paragraph 15 – subparagraph 6 6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the veterinary medicinal product calculated on the basis of the relevant parameters taking into account the product characteristics and, where appropriate, the geographical or season-related circumstances.
Amendment 240 #
Proposal for a regulation Article 15 – paragraph 6 a (new) 6a. The prescribing party shall be required, in accordance with Article 5(2)(d), to satisfy himself that the medicated feed and the feed commonly used to feed treated animals do not contain, as active substances, the same coccidiostat.
Amendment 241 #
Proposal for a regulation Article 15 – paragraph 6 b (new) 6b. Member States may authorise qualified people to prescribe, in accordance with the applicable national laws and pursuant to the conditions set out under Article 10 of Directive 2001/82/CE, medicated feed containing several veterinary medicinal products. However, the prescription of medicated feed containing several veterinary medicinal products comprising one or more antibiotic substances shall not be authorised.
Amendment 242 #
Proposal for a regulation Article 15 – paragraph 6 b (new) Amendment 243 #
Proposal for a regulation Article 16 – title Use in food-producing and non-food producing animals
Amendment 247 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. Feed business operators supplying medicated feed to the holder of
Amendment 248 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. Feed business operators supplying medicated feed to the holder of food- producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed
Amendment 249 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1. For medicated feed containing antimicrobial veterinary medicinal products, feed business operators supplying such medicated feed to the holder of food-
Amendment 250 #
Proposal for a regulation Article 16 – paragraph 1 – introductory part 1.
Amendment 251 #
Proposal for a regulation Article 16 – paragraph 1 – point a Amendment 252 #
Proposal for a regulation Article 16 – paragraph 1 – point a Amendment 253 #
Proposal for a regulation Article 16 – paragraph 1 – point b Amendment 254 #
Proposal for a regulation Article 16 – paragraph 1 – point b Amendment 255 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment
Amendment 256 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products, unless prescribed for longer by a veterinarian in exceptional cases with veterinarian justification.
Amendment 257 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment or t
Amendment 258 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products or the quantities required for a duration mentioned in the summary of the product characteristics, unless otherwise specifically authorised under Regulation (EU) 2015/... (Veterinary Medicinal Products).
Amendment 259 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month'
Amendment 260 #
Proposal for a regulation Article 16 – paragraph 1 – point b (b) the quantities required for one month's treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products for food- producing and fur animals.
Amendment 261 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1a. For medicated feed not containing antimicrobial veterinary medicinal products, feed business operators supplying medicated feed to the holder of food-producing animals, or on-farm mixers of medicated feed for food- producing animals shall ensure that the quantities supplied or mixed do not exceed the quantities provided in the prescription.
Amendment 262 #
Proposal for a regulation Article 16 – paragraph 1 b (new) 1b. Member States shall ensure that holders of food-producing animals apply the preventive measures listed in Annex Va before resorting to the use of medicated feed containing antimicrobials for metaphylaxis. (This amendment is linked to the amendment introducing a new Annex Va.)
Amendment 263 #
Proposal for a regulation Article 16 – paragraph 1 c (new) 1c. Before a repeated prescription, it is necessary for the veterinarian to do a sensitivity check and to evaluate if the treatment can be stopped or needs to be continued or changed.
Amendment 264 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used
Amendment 265 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to
Amendment 266 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial antibiotic veterinary medicinal products shall not be used to prevent diseases in food-producing animals
Amendment 267 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall
Amendment 268 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing anti
Amendment 269 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in
Amendment 270 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases
Amendment 271 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used
Amendment 272 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing anti
Amendment 273 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used
Amendment 274 #
Proposal for a regulation Article 16 – paragraph 2 2.
Amendment 275 #
Proposal for a regulation Article 16 – paragraph 2 2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in
Amendment 276 #
Proposal for a regulation Article 16 – paragraph 4 Amendment 277 #
Proposal for a regulation Article 16 – paragraph 4 4. Feed business operators
Amendment 278 #
Proposal for a regulation Article 16 – paragraph 4 4. Feed business operators feeding food- producing animals with medicated feed shall keep records in accordance with
Amendment 279 #
Proposal for a regulation Article 16 – paragraph 4 4. Feed business operators feeding food- producing animals with medicated feed shall keep records in accordance with Article 69 of Directive 2001/82/EC. Those records shall be kept for five years after the date of administration of medicated feed, including when the animal is slaughtered during the five-year period. Member States shall ensure that the data in those records is collected and transferred to the Union database on veterinary medicinal products as provided in Articles51 and 54 of Regulation (EU) 2015/…(Veterinary Medicinal Products )
Amendment 280 #
Proposal for a regulation Article 16 – paragraph 4 a (new) 4a. Packaged medicated feed to be fed to food-producing animals must be stored separately. Silos that once contained medicated feed must be emptied before being loaded with other types of feed, and cleaned regularly.
Amendment 281 #
Proposal for a regulation Article 16 – paragraph 4 b (new) 4b. The prescribed medicated feed may be used only for animals under the care of the person who issued the prescription and only in accordance with the prescription.
Amendment 282 #
Proposal for a regulation Article 17 – title Collection systems of
Amendment 283 #
Proposal for a regulation Article 17 – title Collection systems of
Amendment 284 #
Proposal for a regulation Article 17 – paragraph 1 Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription. Member States shall also ensure that manufacturers of medicated feed and farmers are informed where to find collection points and how to get their unused leftovers of medicated feed to these collection points. Member States shall ensure that operators of collection points keep records of the medicated feed collected. Those records shall be kept for five years after collection.
Amendment 285 #
Proposal for a regulation Article 17 – paragraph 1 Amendment 286 #
Proposal for a regulation Article 17 – paragraph 1 Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription. Under such circumstances, the justification for such surpluses shall be expressly recorded in the veterinary record.
Amendment 287 #
Proposal for a regulation Article 17 – paragraph 1 Member States shall ensure that
Amendment 288 #
Proposal for a regulation Article 17 – paragraph 1 Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired
Amendment 289 #
Proposal for a regulation Article 17 – paragraph 1 Member States shall
Amendment 290 #
Proposal for a regulation Article 17 – paragraph 1 a (new) Business operators shall provide data needed for calculation of the volume of the sales of veterinary medicinal products incorporated into the final medicated feed to the competent national authority of the Member State. Member States shall collect relevant and comparable data on the volume of sales of medicated feed containing antimicrobial active substances. Member States shall send data on the volume of sales of medicated feed containing antimicrobial active substances to the competent European authority. That European authority shall analyse the data and publish an annual report.
Amendment 291 #
Proposal for a regulation Annex 1 – section 1 – point 2 – point c (c) allow the machinery coming into contact with feed except of machinery for moist feed to be dried following any wet cleaning process.
Amendment 292 #
Proposal for a regulation Annex 1 – section 2 – point 1 – paragraph 1 1.
Amendment 293 #
Proposal for a regulation Annex 1 – section 2 – point 1 – paragraph 2 Amendment 294 #
Proposal for a regulation Annex 1 – section 2 – point 2 2.
Amendment 295 #
Proposal for a regulation Annex 1 – section 2 – point 2 a (new) 2a. Any person entering a manufacturing area must wear protective equipment that is appropriate for the operations performed therein. Operators must ensure that their hands do not come into direct contact with unprotected products or with any machinery that has come into contact with the products.
Amendment 296 #
Proposal for a regulation Annex 1 – section 3 – point 2 2. Technical or organisational measures shall be taken to
Amendment 297 #
Proposal for a regulation Annex 1 – section 3 – point 2 2. Technical or organisational measures shall be taken to
Amendment 298 #
Proposal for a regulation Annex 1 – section 3 – point 3 3. The presence of undesirable substances within the meaning of Directive 2002/32/EC and of other contaminants in relation to human and animal health shall
Amendment 299 #
Proposal for a regulation Annex 1 – section 4 – point 1 1.
Amendment 300 #
Proposal for a regulation Annex 1 – section 6 – point 2 – point i (i) information on the
Amendment 301 #
Proposal for a regulation Annex 1 – section 6 – point 2 – point i (i) for the distributor who supplies to the animal holder information on the person who has issued the prescription, including at least his name and address.
Amendment 302 #
Proposal for a regulation Annex 1 – section 7 – title PHARMACOVIGILANCE, COMPLAINTS AND PRODUCT
Amendment 303 #
Proposal for a regulation Annex 1 – section 7 – point 1 1.
Amendment 304 #
Proposal for a regulation Annex 1 – section 7 – point 2 a (new) 2a. Medicated feed business operators, with the exception of holders of animals, shall report, to the competent authority and to the holder of the marketing authorisation of the veterinary medicinal product included in the composition of the medicated feed, any suspected adverse reactions to the medicated feed. The appropriate information collected from these reports shall be entered in the veterinary pharmacovigilance system described under Title VII of Directive 2001/82/EC.
Amendment 305 #
Proposal for a regulation Annex 1 – section 7 a (new) Section 7a OPERATIONS CARRIED OUT BY THIRD PARTIES Any subcontracted activity shall fall under an appropriately defined, agreed upon and monitored contract so as to avoid any misunderstandings that could lead to work or products of an insufficient quality. A written contract shall be drawn up between the subcontracting party and the subcontractor in order to clearly establish each party's obligations. The contract shall clearly set out the ways in which the qualified people responsible for manufacture, transport and quality control operations shall fulfil their responsibilities. A written contract shall cover the manufacturing and/or analytical and/or transport activities assigned by the subcontracting party, and all the technical provisions taken in relation thereto. All the provisions contained in the contract, including any proposed technical modifications or other provisions, must comply with the provisions of this Regulation.
Amendment 307 #
Proposal for a regulation Annex 2 – point 2 2. The daily dose of the veterinary medicinal product shall be incorporated in a
Amendment 308 #
Proposal for a regulation Annex 2 – point 2 2. The daily dose of the veterinary medicinal product shall be incorporated in a
Amendment 309 #
Proposal for a regulation Annex 3 – introductory part The label of medicated feed and intermediary products shall include
Amendment 310 #
Proposal for a regulation Annex 3 – point 1 (1) the expression 'Medicated feed' or 'Intermediate product for medicated feed' supplemented by the expression 'complete' or 'complementary', as appropriate
Amendment 311 #
Proposal for a regulation Annex 3 – point 2 Amendment 312 #
Proposal for a regulation Annex 3 – point 3 (3) the approval number of the person responsible for the labelling and of the manufacturer if different from the person responsible for labelling, in accordance with Article 12;
Amendment 313 #
Proposal for a regulation Annex 3 – point 3 (3) the approval number of the person responsible for the labelling and of the manufacturer if different from the person responsible for labelling, in accordance with Article 12;
Amendment 314 #
Proposal for a regulation Annex 3 – point 4 Amendment 315 #
Proposal for a regulation Annex 3 – point 5 Amendment 316 #
Proposal for a regulation Annex 3 – point 6 (6) the veterinary medicinal products with name, active substance,
Amendment 317 #
Proposal for a regulation Annex 3 – point 6 (6) the veterinary medicinal products with name, active substance, strength, added amount
Amendment 318 #
Proposal for a regulation Annex 3 – point 6 (6) the veterinary medicinal products with name, active substance
Amendment 319 #
Proposal for a regulation Annex 3 – point 7 (7)
Amendment 320 #
Proposal for a regulation Annex 3 – point 7 (7)
Amendment 321 #
Proposal for a regulation Annex 3 – point 9 (9) a recommendation to read the package leaflet of the veterinary medicinal products, including a hyperlink where it can be found, a warning that the product is only for the treatment of animals, a
Amendment 322 #
Proposal for a regulation Annex 3 – point 10 Amendment 323 #
Proposal for a regulation Annex 3 – point 11 Amendment 324 #
Proposal for a regulation Annex 3 – point 12 Amendment 325 #
Proposal for a regulation Annex 3 – point 13 Amendment 326 #
Proposal for a regulation Annex 3 – point 14 Amendment 327 #
Proposal for a regulation Annex 3 – point 15 (15) the instructions for use, in accordance with the
Amendment 328 #
Proposal for a regulation Annex 3 – point 15 (15) the instructions for use in line with the
Amendment 329 #
Proposal for a regulation Annex 3 – point 16 a (new) (16a) information that inappropriate disposal of medicated feed poses serious threats to the environment and may contribute to antimicrobial resistance.
Amendment 330 #
Proposal for a regulation Annex 3 – point 16 b (new) (16b) information on where and how to appropriately dispose of unused material.
Amendment 331 #
Proposal for a regulation Annex 3 – point 16 c (new) (16c) For medicated feed containing antimicrobials: the request to use antimicrobials only as a last resort and in a most prudent and responsible manner.
Amendment 333 #
Proposal for a regulation Annex 4 – point 1 – paragraph 1 1. The tolerances laid down in this point shall include technical
Amendment 334 #
Proposal for a regulation Annex 4 – point 1 – paragraph 1 1. The tolerances laid down in this point shall include technical
Amendment 335 #
Proposal for a regulation Annex 4 – point 1 – paragraph 1 1. The tolerances laid down in this point shall include technical
Amendment 336 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of
Amendment 337 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an
Amendment 338 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an
Amendment 339 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an
Amendment 340 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of 10 % shall apply. For the other active substances, the following tolerances shall apply:
Amendment 341 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 – table Amendment 342 #
Proposal for a regulation Annex 4 – point 1 – paragraph 2 – table Amendment 343 #
Proposal for a regulation Annex 4 – point 2 Amendment 344 #
Proposal for a regulation Annex 4 – point 2 Amendment 345 #
Proposal for a regulation Annex 4 – point 2 Amendment 346 #
Proposal for a regulation Annex 5 a (new) Amendment 41 #
Draft legislative resolution Citation 1 – having regard to Article 294(2) and Article 43(2) and Article 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8- 0143/2014),
Amendment 42 #
Proposal for a regulation Recital 2 (2) Livestock production, animal health and welfare occup
Amendment 43 #
Proposal for a regulation Recital 2 a (new) (2a) In accordance with the principle of subsidiarity, Member States should be free to set rules on the manufacture, placing on the market and use of medicated feed for all animals suitable to their territory; accordingly Council Directive 90/167/EEC should be repealed.
Amendment 44 #
Proposal for a regulation Recital 3 a (new) (3a) Medicinal treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.
Amendment 45 #
Proposal for a regulation Recital 6 (6) As
Amendment 46 #
Proposal for a regulation Recital 6 (6) As a type of feed, medicated feed falls within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council6, of Regulation (EC) No 767/2009 of the European Parliament and of the Council7, of Regulation (EC) No 1831/2003 of the European Parliament and of the Council8 and of Directive 2002/32/EC of the European Parliament and of the Council9. Specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment, personnel, animal welfare, manufacture quality control, storage and transport, record-keeping, complaints and product recalls, the application of procedures based on the hazard analysis and critical control points (HACCP) principles and labelling. __________________ 6 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1). 7 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (OJ L 229, 1.9.2009, p. 1). 8 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). 9 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).
Amendment 47 #
Proposal for a regulation Recital 6 (6) As a type of feed, medicated feed and intermediate products fall
Amendment 48 #
Proposal for a regulation Recital 9 (9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals. The inclusion rates set should as a matter of principle be geared to a farm’s average needs. To take account of the specific features of the small-scale farming sector, and in particular to enable small or remote farms to optimise livestock care, it should be permissible to retain established control systems provided it is ensured that the prescription, production and use of medicated feed take place under the instructions and supervision of a veterinarian and are subject to an external process control.
Amendment 49 #
Proposal for a regulation Recital 9 (9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. The holder of the authorisation of the veterinary medicinal products is responsible for compatibility assessment. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals.
Amendment 50 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the
Amendment 51 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of ‘carry-over’ is used specifically to designate the transfer of traces of an active substance contained in a medicated
Amendment 52 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of
Amendment 53 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of ‘carry-over' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term ‘cross-contamination' is to be considered as a contamination resulting from a carry-over or from the transfer in feed of any unintended substance. Carry-over of active substances
Amendment 54 #
Proposal for a regulation Recital 12 (12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of ‘carry-over' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term ‘cross-contamination' is to be considered as a contamination resulting from a carry-over or from the transfer in feed of any unintended substance. Carry-over
Amendment 55 #
Proposal for a regulation Recital 13 (13) Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed.
Amendment 56 #
Proposal for a regulation Recital 13 (13) Labelling of medicated feed should
Amendment 57 #
Proposal for a regulation Recital 14 Amendment 58 #
Proposal for a regulation Recital 14 (14) Medicated feed should be marketed in sealed containers for safety reasons and to protect user's interest.
Amendment 59 #
Proposal for a regulation Recital 16 (16) Feed business operators manufacturing, whether they operate in a feed mill, with a specially equipped lorry or on-farm, storing, transporting or placing on the market medicated feed and intermediate products, should be approved by the competent authority, in line with the approval system laid down in Regulation (EC) No 183/2005, in order to ensure both feed safety and product traceability. Provision should be made for a transition procedure concerning establishments already approved under Directive 90/167/EEC. Establishments which administer medications to animals orally in the form of medicated feed should not be obliged to obtain an approval.
Amendment 60 #
Proposal for a regulation Recital 16 (16) Feed business operators manufacturing, whether they operate in a feed mill, with a specially equipped lorry or on-farm, storing, transporting or placing on the market medicated feed and intermediate products, should be approved by the competent authority, in line with the approval system laid down in Regulation (EC) No 183/2005, in order to ensure both feed safety and product traceability. Provision should be made for a transition procedure concerning establishments already approved under Directive 90/167/EEC. The approval and registration procedure under Regulation (EC) No 183/2005 should take account of the specific features of primary production with a view to ensuring that in particular small or remote farms can optimise livestock care through the use of medicated feed.
Amendment 61 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated.
Amendment 62 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated.
Amendment 63 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should
Amendment 64 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination and after a veterinary diagnosis has been established, or following a regular visit for checking the health of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 65 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been
Amendment 66 #
Proposal for a regulation Recital 17 (17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid written or electronic veterinary prescription which has been issued, for a limited period of time, by a veterinarian or another professional person qualified to do so in accordance with applicable national law after examination and diagnosis of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 67 #
Proposal for a regulation Recital 17 a (new) (17a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines.
Amendment 68 #
Proposal for a regulation Recital 18 (18) In order to ensure a particularly prudent use, by which is meant appropriate use of medicines according to prescription, of medicated feed for food- producing and non-food producing animals and therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-
Amendment 69 #
Proposal for a regulation Recital 18 (18) In order to ensure a particularly prudent use of medicated feed for food- producing animals and therefore provide the basis for the assurance of a high level of protection of animal health and public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-
Amendment 70 #
Proposal for a regulation Recital 18 (18) In order to ensure a particularly prudent use of medicated feed for
Amendment 71 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to
Amendment 72 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use, with the exception of situations when such medication is required for preventing the outbreak of epizootics, or use to enhance the performance of food-producing animals should in particular not be allowed.
Amendment 73 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 74 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for
Amendment 75 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials
Amendment 76 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials
Amendment 77 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals.
Amendment 78 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of
Amendment 79 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for
Amendment 80 #
Proposal for a regulation Recital 19 (19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use or use to enhance the performance of food-producing animals should
Amendment 81 #
Proposal for a regulation Recital 19 a (new) (19a) Metaphylaxis for large animals such as pigs and cows should not be allowed, as they should be treated individually.
Amendment 82 #
Proposal for a regulation Recital 19 b (new) (19b) In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as of 1 January 2006 should be strictly adhered to and properly enforced.
Amendment 83 #
Proposal for a regulation Recital 19 c (new) (19c) Alternative measures to prevent diseases diagnosed in individuals spreading through whole groups of animals should be prioritised before resorting to treatment with antimicrobials, such as physical separation from the group or rearing in smaller groups of animals.
Amendment 84 #
Proposal for a regulation Recital 20 (20) A system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal, human health or the environment. Records should be kept at collection points on the return of unconsumed medicated feed containing antimicrobial veterinary medicinal products.
Amendment 85 #
Proposal for a regulation Recital 20 a (new) (20a) A register of the prescriptions of active substances should be kept up to date at the level of competent authorities for water management, to enable the traceability of the dispersion of chemicals in ecosystems.
Amendment 86 #
Proposal for a regulation Article 1 – paragraph 1 – point a (a) the manufacture, storage and transport of medicated feed and intermediate products intended for both non-food and food-producing animals;
Amendment 87 #
Proposal for a regulation Article 1 – paragraph 1 – point a (a) the manufacture, storage and transport of medicated feed and intermediate products for food-producing and non-food producing animals;
Amendment 88 #
Proposal for a regulation Article 1 – paragraph 1 – point b (b) the placing on the market, including import, and use of medicated feed and intermediate products intended for both non-food and food-producing animals;
Amendment 89 #
Proposal for a regulation Article 1 – paragraph 1 – point b (b) the placing on the market, including import from third countries, and use of medicated feed and intermediate products;
Amendment 90 #
Proposal for a regulation Article 1 – paragraph 1 – point b (b) the placing on the market, including import from third countries, and use of medicated feed and intermediate products;
Amendment 91 #
Proposal for a regulation Article 1 – paragraph 1a (new) 1a. This Regulation shall not apply to ready-prepared medications for oral administration which are approved for use in feedstuffs or drinking water, or to mixtures of such medications with feedstuffs which are manufactured for direct administration in livestock holdings.
Amendment 92 #
Proposal for a regulation Article 1 – paragraph 1 a (new) 1a. This Regulation shall not apply to finished veterinary medicinal products to be orally administered that have been approved for use via feed as oral powders intended for small group medication or for use via drinking water.
Amendment 93 #
Proposal for a regulation Article 2 – paragraph 1 – point b (b) the definitions of 'feed additive', 'antimicrobials', 'antibiotic' and 'daily ration' as laid down in Article 2(2) of Regulation (EC) No 1831/2003;
Amendment 94 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c) the definitions of 'food-producing animal', 'non-food producing animal', 'fur animal', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', 'labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;
Amendment 95 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c) the definitions of 'food-producing animal' and 'non-food producing animals', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', 'labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;
Amendment 96 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c) the definitions of 'food-producing animal', 'non-food producing animal', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', 'labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;
Amendment 97 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c) the definitions of 'food-producing animal', 'non-food producing animals', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', 'labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;
Amendment 98 #
Proposal for a regulation Article 2 – paragraph 1 – point d (d) the definition of 'establishment' and 'feed business operator' as laid down in Article 3 of Regulation (EC) No 183/2005;
Amendment 99 #
Proposal for a regulation Article 2 – paragraph 1 – point f (f) the definitions of 'veterinary medicinal product', 'withdrawal period', 'strength
source: 560.826
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History
(these mark the time of scraping, not the official date of the change)
2021-12-18Show (21) Changes | Timetravel
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Amending Regulation (EC) No 183/2005 2003/0071(COD)
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Repealing Directive 90/167/EEC Amending Regulation (EC) No 183/2005 2003/0071(COD)
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2020-01-19Show (13) Changes | Timetravel
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2019-07-12Show (6) Changes | Timetravel
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2019-07-06Show (24) Changes | Timetravel
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2018-09-12Show (10) Changes | Timetravel
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2017-03-19Show (3) Changes | Timetravel
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2017-03-14Show (1) Changes | Timetravel
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2017-03-13Show (1) Changes | Timetravel
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CELEX:52014PC0556:EN
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2017-03-12Show (1) Changes | Timetravel
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2017-02-16Show (13) Changes | Timetravel
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2016-09-02Show (1) Changes | Timetravel
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2016-08-31Show (1) Changes | Timetravel
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2016-08-30Show (1) Changes | Timetravel
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2016-08-29Show (1) Changes | Timetravel
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2016-08-28Show (1) Changes | Timetravel
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2016-08-27Show (1) Changes | Timetravel
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2016-08-04Show (1) Changes | Timetravel
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2016-08-02Show (1) Changes | Timetravel
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2016-08-01Show (1) Changes | Timetravel
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2016-07-31Show (1) Changes | Timetravel
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2016-07-30Show (1) Changes | Timetravel
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2016-07-27Show (1) Changes | Timetravel
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2016-07-25Show (1) Changes | Timetravel
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2016-07-22Show (1) Changes | Timetravel
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2016-07-21Show (1) Changes | Timetravel
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2016-07-20Show (1) Changes | Timetravel
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2016-07-18Show (1) Changes | Timetravel
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2016-06-15Show (1) Changes | Timetravel
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2016-05-22Show (2) Changes | Timetravel
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2016-04-08Show (1) Changes | Timetravel
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2016-04-05Show (1) Changes | Timetravel
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2016-04-04Show (1) Changes | Timetravel
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2016-03-28Show (1) Changes | Timetravel
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2016-03-25Show (1) Changes | Timetravel
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