24 Amendments of Martin HÄUSLING related to 2014/0255(COD)
Amendment 20 #
Proposal for a regulation
Title
Title
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 traceability of active substances in the ecosystems and repealing Council Directive 90/167/EEC (Text with EEA relevance)
Amendment 25 #
Proposal for a regulation
Recital 3 a (new)
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 31 #
Proposal for a regulation
Recital 8
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 labelling, prescription and use of medicated feed and intermediate products should not apply to products intended to be exported. Requirements concerning labelling should not apply where the requirements for labelling are more stringent in the export country than in the EU.
Amendment 40 #
Proposal for a regulation
Recital 12
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 possibleshould be avoided or reduced to an absolute minimum. 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 54 #
Proposal for a regulation
Recital 17
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. 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 19
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 72 #
Proposal for a regulation
Recital 20
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)
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 80 #
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) the export to third countries of medicated feed and intermediate products. However, Articles 9, 15, 16 and 17 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries. Article 9 shall not apply where the requirements for labelling are more stringent in the export country than in the EU.
Amendment 104 #
Proposal for a regulation
Article 2 – paragraph 2 – point i a (new)
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 112 #
Proposal for a regulation
Chapter 2 – title
Chapter 2 – title
Manufacture, storage, transport and, placing on the market, traceability of the active substances in the ecosystems
Amendment 114 #
Proposal for a regulation
Article 3 – paragraph 1
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 136 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
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- target feed;
Amendment 144 #
Proposal for a regulation
Article 8
Article 8
Amendment 159 #
Proposal for a regulation
Article 11 a (new)
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 186 #
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
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- 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 201 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
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)
Article 16 – paragraph 1 b (new)
Amendment 213 #
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Feed business operators feedingof medicated feed and holders of 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.
Amendment 219 #
Proposal for a regulation
Article 17
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. Member States shall ensure that manufacturers of medicated feed and farmers are informed where to find these collections systems 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 244 #
Proposal for a regulation
Annex III – paragraph 1 – point 16 a (new)
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)
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 248 #
Proposal for a regulation
Annex IV – point 1 – paragraph 1 – introductory part
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 103% shall apply. For the other active substances, the following tolerances shall apply:
Amendment 251 #
Proposal for a regulation
Annex V a (new)
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).