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(EU) 2015/151:就药理学活性物质脱氧土霉素(doxycycline),修?EU) No 37/2010附录(amending the Annex to Regulation (EU) No 37/2010 as regards the substance ‘doxycycline?

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放大字体缩小字体2015-02-10 11:43:29 来源9a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.026.01.0013.01.ENG" target="_blank" rel="nofollow">EUROPE浏览次数9span id="hits">2641
核心提示:欧盟发布委员会实施条例(EU) 2015/151,对(EU) No 37/2010附录?中条目“脱氧土霉素”进行修正,脱氧土霉素最大残留限量适用于所有食用动物的肌肉、脂肪、肝脏和肾脏,其限量值分别为100 μg/kg?00 μg/kg?00 μg/kg?00 μg/kg、/div>
发布单位
EUROPEAN COMMISSION
EUROPEAN COMMISSION
发布文号 (EU) 2015/151
发布日期 2015-01-31 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 (EU) No 37/2010附录?规定,允许对牛、猪和家禽使用药理学活性物质脱氧土霉素,其残留限量要求适用于牛的肌肉、肝脏和肾脏(生产供人类食用乳的牛除外),猪和家禽(生产供人类食用禽蛋的家禽除外)的肌肉、皮肤和脂肪、肝脏及肾脏。欧洲药品管理局收到一份关于扩大脱氧土霉素使用范围的申请。根?EC) No 470/2009?条相关规定,欧洲药品管理局可考虑将一种特定食品中某种药理学活性物质的最大残留限量应用于其他同类食品中,或将一类或多类食品中某种药理学活性物质的最大残留限量应用于其他种类食品中。兽药产品委员会建议针对兔制定脱氧土霉素的最大残留限量,并且将脱氧土霉素在牛、猪、家禽和兔中的最大残留限量应用到所有食用动物中。因此,应对(EU) No 37/2010附录?中条?ldquo;脱氧土霉?rdquo;进行相应修正,脱氧土霉素最大残留限量适用于所有食用动物的肌肉、脂肪、肝脏和肾脏,其限量值分别为100 g/kg?00 g/kg?00 g/kg?00 g/kg、/td>

  COMMISSION IMPLEMENTING REGULATION (EU) 2015/151

  of 30 January 2015

  amending the Annex to Regulation (EU) No 37/2010 as regards the substance doxycycline

  (Text with EEA relevance)

  THE EUROPEAN COMMISSION,

  Having regard to the Treaty on the Functioning of the European Union,

  Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,

  Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

  Whereas:

  (1)

  The maximum residue limit (MRL) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is to be established in accordance with Regulation (EC) No 470/2009.

  (2)

  Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).

  (3)

  Doxycycline is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine, porcine and poultry species, applicable to muscle, liver and kidney in bovine species, excluding animals producing milk for human consumption, and to muscle, skin and fat, liver and kidney in porcine and poultry species, excluding animals producing eggs for human consumption.

  (4)

  An application for the extension of the existing entry for doxycycline to rabbits has been submitted to the European Medicines Agency.

  (5)

  In accordance with Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for doxycycline for rabbits, and the extrapolation of the MRLs for doxycycline from bovine, porcine, poultry and rabbit species to all food-producing species.

  (6)

  The entry for doxycycline in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for all food-producing species, applicable to muscle, fat, liver and kidney, excluding animals producing milk or eggs for human consumption.

  (7)

  It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.

  (8)

  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

  HAS ADOPTED THIS REGULATION:

  Article 1

  The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.

  Article 2

  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

  It shall apply from 1 April 2015.

  This Regulation shall be binding in its entirety and directly applicable in all Member States.

  Done at Brussels, 30 January 2015.

  For the Commission

  The President

  Jean-Claude JUNCKER

ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance doxycycline is replaced by the following:
Pharmacologically active Substance
Marker residue
Animal Species
MRLs
Target Tissues
Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)
Therapeutic Classification
Doxycycline
Doxycycline
All food producing species
100 g/kg
300 g/kg
300 g/kg
600 g/kg
Muscle
Fat
Liver
Kidney
For fin fish the muscle MRL relates to muscle and skin in natural proportions.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to skin and fat in natural proportions.
Not for use in animals from which milk or eggs are produced for human consumption.
Anti-infectious agents/Antibiotics


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