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)
Article 17 of Regulation (EC) No 470/2009 requires that the maximum
residue limit (hereinafter ‘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
established in a regulation.
(2)
Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets
out the pharmacologically active substances and their classification regarding
MRLs in foodstuffs of animal origin.
(3)
Aluminium salicylate, basic, is already included in this table according
to which aluminium salicylate, basic, is allowed for (i) the oral use for bovine
species, excluding species producing milk for human consumption; and (ii) the
topical use for all food producing species, excluding fin fish.
(4)
An application for a modification of the existing entry for aluminium
salicylate, basic, has been submitted to the European Medicines Agency
(hereinafter ‘EMA’).
(5)
The EMA, based on the opinion of the Committee for Medicinal Products for
Veterinary Use, has recommended to maintain the ‘No MRL required’ classification
for aluminium salicylate, basic, but only for the topical use of this substance
and only for other food producing species than bovine species, caprine, Equidae,
rabbit and fin fish. The existing entry for bovine species should be replaced by
numerical MRLs as, given that the substance is now proposed for use in adult
animals, the ‘No MRL required’ classification is no longer valid and the
establishment of limits in bovine tissues and milk is required.
(6)
According to Article 5 of Regulation (EC) No 470/2009, the EMA 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.
(7)
The EMA has considered that the extrapolation of the numerical MRLs for
aluminium salicylate, basic, recommended for bovine species to goats, horses and
rabbits is appropriate.
(8)
Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be
amended accordingly.
(9)
The analytical method for the monitoring of the proposed MRLs for
aluminium salicylate, basic, in bovine tissues or in bovine milk is available,
yet not sufficiently validated.
(10)
According to Article 14(4) of Regulation (EC) No 470/2009, a provisional
MRL may be established in cases where scientific data are incomplete, provided
that there are no grounds for supposing that residues of that substance at the
level proposed constitute a hazard to human health.
(11)
The proposed numerical MRLs should therefore be provisional and expire on
31 December 2016.
(12)
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 28 September 2015.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.
Done at Brussels, 29 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 152, 16.6.2009, p. 11.
(2) Commission Regulation (EU) No 37/2010 of 22 December 2009 on
pharmacologically active substances and their classification regarding maximum
residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the
substance ‘aluminium salicylate, basic’ is replaced by the following:
Pharmacologically active Substance
|
Marker residue
|
Animal Species
|
MRL
|
Target Tissues
|
Other Provisions (according to Article 14(7) of Regulation (EC) No
470/2009)
|
Therapeutic Classification
|
‘aluminium salicylate, basic
|
Salicylic acid
|
Bovine, caprine,Equidae, rabbit
|
200 μg/kg
500 μg/kg
1 500 μg/kg
1 500 μg/kg
|
Muscle
Fat
Liver
Kidney
|
文章相关:
热门图片新闻
- 黄金周后省内螃蟹价格不降反升 再等半个月左右 吃蟹性价比最高
- 160元一公斤!南京“天价”香椿芽抢先上市
- 番茄比鸡蛋贵!昆明市场上番茄零售价格上涨
- 火锅里的肉丸子都是肉吗?事实不是你想像的!
- 鸡架泥槽头肉入馅 这样的低价水饺你敢吃吗
|