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原文后附带中文翻译，来源于上海出入境检验检疫局
Commission Directive 2005/87/EC
of 5 December 2005
amending Annex I to Directive2002/32/ECof the European Parliament and of the Council on undesirable substances in animal feed as regards lead, fluorine and cadmium
（Text with EEA relevance（/p>
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [1], and in particular Article 8? thereof,
Having regard to Regulation （EC No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [2], and in particular the third sentence of Article 13? thereof,
Whereas:
? Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited.
? When Directive 2002/32/EC was adopted, the Commission stated that the provisions laid down in Annex I to that Directive would be reviewed on the basis of updated scientific risk assessments and taking into account the prohibition of any dilution of contaminated non-complying products intended for animal feed.
? The Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority （EFSA adopted an opinion on a request from the Commission related to lead as undesirable substance in animal feed on 2 June 2004.
? Contamination of food with lead is of public health concern. Lead accumulates to some extent in kidney and liver tissue, muscle tissues contain very low residual amounts of lead and carry-over into milk is limited. Therefore foods of animal origin are not a major source of human exposure to lead.
? Cattle and sheep seem to be the most sensitive animal species with respect to acute lead toxicity. Individual intoxications have been reported, resulting from ingestion of feed material originating from polluted areas or accidental ingestions of lead sources. However, the levels found in commercial feed materials in the European Union do not induce clinical signs of toxicity.
? The existing legal provisions as regards lead in products intended for animal feed are generally appropriate to ensure that these products do not represent any danger to human health, animal health or adversely affect the livestock production.
? Cattle and sheep seem to be the most sensitive animal species and green fodder is a major component of their daily ration, it is important to provide for a review in view of a possible further reduction of the maximum level of lead in green fodder.
? In addition the establishment of a maximum level of lead for additives belonging to the functional group of trace elements, binders and anti-caking agents and for premixtures is appropriate. The maximum level established for premixtures takes into account the additives with the highest level of lead and not the sensitivity of the different animal species to lead. In order to protect animal and public health, it is therefore the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feedingstuffs.
? The Scientific Panel on contaminants in the Food Chain of the EFSA adopted an opinion on a request from the Commission related to fluorine as undesirable substance in animal feed on 22 September 2004.
?0 Fluoride accumulates particularly in calcifying tissues. In contrast, transmission into edible tissues including milk and eggs is limited. Hence, the fluoride concentrations in foods from animal origin contribute only marginally to human exposure.
?1 In the European Union, fluoride levels in pastures, herbages and compound feeds are generally low and subsequently exposure of animals to fluoride is generally below the level causing detrimental effects. However, in certain distinct geographic areas and incidentally in the proximity of industrial sites with high fluoride emission, excessive exposure to fluoride is associated with dental and skeleton abnormalities.
?2 The existing legal provisions as regards fluorine in products intended for animal feed are appropriate to ensure that these products do not represent any danger to human health, animal health or adversely affect the livestock production.
?3 The extraction procedure used has a large influence on the analytical result and it is therefore appropriate to determine the extraction procedure. Equivalent procedures with demonstrated equal extraction efficiency can be used.
?4 The level for fluorine in marine crustaceans such as marine krill has to be amended in order to take into account new processing techniques to improve the nutritional quality and to reduce the biomass loss but which also results in higher levels of fluorine in the final end product.
?5 Commission Directive 84/547/EEC of 26 October 1984 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs [3] establishes a maximum level for fluorine in vermiculite （E 561? The scope of Directive 2002/32/EC provides for the possibility of the establishment of maximum levels of undesirable substances in feed additives and the rules governing undesirable substances should be collected in a single text for greater clarity.
?6 The Scientific Panel on contaminants in the Food Chain of the EFSA adopted an opinion on a request from the Commission related to cadmium as undesirable substance in animal feed on 2 June 2004.
?7 Contamination of food with cadmium is of public health concern. Accumulation of cadmium in animal tissue is function of dietary concentration and duration of exposure. The short life span of animals like fattening pigs and poultry minimizes the risk of undesirable cadmium concentrations in edible tissues of these animals Ruminants and horses however may be exposed during their entire lifespan to cadmium present in pastures. In distinct regions this may result in an undesirable cadmium accumulation particularly in kidneys.
?8 Cadmium is toxic to all animal species. In most of the domestic animal species, including pigs which are considered the most sensitive species, gross clinical symptoms are unlikely to occur if dietary cadmium concentrations remain below 5 mg/kg feed.
?9 The existing legal provisions as regards cadmium in products intended for animal feed are appropriate to ensure that these products do not represent any danger to human health, animal health or adversely affect the livestock production.
?0 No maximum level is currently established for pet food and feed materials of mineral origin other than phosphates. It is appropriate to establish a maximum level for these products intended for animal feed. It is appropriate to amend the current maximum level for cadmium for fish feed in order to take into account recent developments in formulating fish feed incorporating higher ratios of fish oil and fishmeal. In addition the establishment of a maximum level of cadmium for additives belonging to the functional group of trace elements, binders and anti-caking agents and for premixtures is appropriate. The maximum level established for premixtures takes into account the additives with the highest level of cadmium and not the sensitivity of the different animal species to cadmium. As provided in Article 16 of Regulation （EC No 1831/2003, in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feedingstuffs.
?1 Directive 2002/32/EC and Directive 84/547/EEC should therefore be amended accordingly.
?2 The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive.
Article 2
Without prejudice to the other conditions for the authorisation of the additive vermiculite, belonging to the group of binders, anti-caking agents and coagulants, laid down in Directive 70/524/EEC, the maximum fluorine content shall be as set out in the Annex to this Directive.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 5
This Directive is addressed to the Member States.
Done at Brussels, 5 December 2005.
For the Commission
Markos Kyprianou
Member of the Commission
[1] OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2005/8/EC （OJ L 27, 29.1.2005, p. 44?
[2] OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation （EC No 378/2005 （OJ L 59, 5.3.2005, p. 8?
[3] OJ L 297, 15.11.1984, p. 40.
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ANNEX
Annex I to Directive 2002/32/EC is amended as follows:
1. Row 2, lead, is replaced by the following:
Undesirable substances | Products intended for animal feed | Maximum content in mg/kg （ppm relative to a feedingstuff with a moisture content of 12 % |
? | ? | ? |
"2.Lead [1] | Feed materials with the exception of: | 10 |
C green fodder [2] | 30 [3] |
C phosphates and calcareous marine algae | 15 |
C calcium carbonate | 20 |
C yeasts | 5 |
Additives belonging to the functional group of compounds of trace elements except | 100 |
C zinc oxide | 400 [3] |
C manganous oxide, iron carbonate, copper carbonate | 200 [3] |
Additives belonging to the functional groups of binders and anti-caking agents except | 30 [3] |
C clinoptilolite of volcanic origin | 60 [3] |
Premixtures | 200 [3] |
Complementary feedingstuffs with the exception of | 10 |
C mineral feedingstuffs | 15 |
Complete feedingstuffs | 5 |
2. Row 3, Fluorine, is replaced by the following:
Undesirable substances | Products intended for animal feed | Maximum content in mg/kg （ppm relative to a feedingstuff with a moisture content of 12 % |
? | ? | ? |
"3.Fluorine [4] | Feed materials with the exception of: | 150 |
C feedingstuffs of animal origin with the exception of marine crustaceans such as marine krill | 500 |
C marine crustaceans such as marine krill | 3000 |
C phosphates | 2000 |
C calcium carbonate | 350 |
C magnesium oxide | 600 |
C calcareaous marine algae | 1000 |
Vermiculite （E 561 | 3000 [5] |
Complementary feedingstuffs | |
C containing 4 % phosphorus | 500 |
C containing > 4 % phosphorus | 125 per 1 % phosphorus |
Complete feedingstuffs with the exception of | 150 |
C complete feedingstuffs for cattle sheep and goats | |
C C in lactation | 30 |
C C other | 50 |
C complete feedingstuffs for pigs | 100 |
C complete feedingstuffs for poultry | 350 |
C complete feedingstuffs for chicks | 250 |
3. Row 6, cadmium, is replaced by the following:
Undesirable substances | Products intended for animal feed | Maximum content in mg/kg （ppm relative to a feedingstuff with a moisture content of 12 % |
? | ? | ? |
"6.Cadmium [4] | Feed materials of vegetable origin | 1 |
Feed materials of animal origin | 2 |
Feed materials of mineral origin except | 2 |
C phosphates | 10 |
Additives belonging to the functional group of compounds of trace elements except | 10 |
C copper oxide, manganous oxide, zinc oxide and manganous sulphate monohydrate | 30 [7] |
Additives belonging to the functional groups of binders and anti-caking agents | 2 |
Premixtures | 15 [7] |
Mineral feedingstuffs | |
C containing < 7 % phosphorus | 5 |
C containing 7 % phosphorus | 0,75 per 1 % phosphorus, with a maximum of 7,5 |
Complementary feedingstuffs for pet animals | 2 |
Other complementary feedingstuffs | 0,5 |
Complete feedingstuffs for cattle, sheep and goats and feedingstuffs for fish except | 1 |
C complete feedingstuffs for pets | 2 |
C complete feedingstuffs for calves, lambs and kids and other complete feedingstuffs | 0,5 |
[1] Maximum levels refer to an analytical determination of lead, whereby extraction is performed in nitric acid ? % w/w for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.
[2] Green fodder includes products intended for animal feed such as hay, silage, fresh grass, etc.
[3] The levels shall be reviewed by 31 December 2007 with the aim of reducing the maximum levels."
[4] Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.
[5] The levels shall be reviewed by 31 December 2007 with the aim of reducing the maximum levels."
[6] Maximum levels refer to an analytical determination of cadmium, whereby extraction is performed in nitric acid ? % w/w for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.
[7] The levels shall be reviewed by 31 December 2007 with the aim of reducing the maximum levels."
欧共体委员会、/p>
根据缔结的欧共体条约、/p>
根据2002??日的欧盟指令2002/32/EC号中对动物饲料中不良物质的规定，尤其是第8条、/p>
根据2003??2日的欧盟指令?831/2003号中对动物营养中使用的添加剂的规定，尤其是第13条、/p>
1.欧盟指令2002/32/EC号规定，禁止将不良物质含量超过附件I中最大限量的产品用作动物饲料、/p>
2.当欧盟指?002/32/EC号被采用时，委员会认为基于最新的科学风险评估并考虑禁止在动物饲料中使用有害产品，附件I中的条款应被修订、/p>
3.2004??日，欧洲食品安全局食品链污染物科学专家小组采纳了委员会关于铅是动物饲料中的不良物质的观点、/p>
4.食物中的铅污染一直备受关注。铅在很大程度上富积在肝和肾，肌肉组织中的残留量很低，进入奶制品中的有限。因此动物食品不是人类摄入铅的主要来源、/p>
5.对急性铅中毒牛和羊被认为是最为敏感的动物种类，由于饲喂来自污染区域的物质或是偶然食用含铅物质，导致个体中毒的事件已有所报道。然而，欧盟制定的商业饲料中的铅标准尚不能诱发铅中毒的临床表现、/p>
6.现存的法律关于铅在用于动物饲料的产品中的规定是总体上确保这些产品不会对人类和动物健康有害或严重影响畜产品、/p>
7.牛和羊是被认为是最敏感的动物，而青饲料是她们日粮中主要的组成部分，为了尽可能的降低青饲料中铅的最大含量，重新修订标准是很有必要的、/p>
8.在含痕量元素粘和剂、抗块结剂的预混料中规定铅的最大含量标准是适合的，预混料中铅的最大限量的制定考虑的是添加剂中铅含量的最高水平而未将各种不同动物品种对铅的敏感性考虑在内。为了保护动物和公众健康，预混料生产商有责任确保符合预混料的最大含量标准，此外预混料的使用说明也要符合配合饲料和全价饲料的最大限量要求、/p>
9.2004??2日，欧洲食品安全局食品链污染物科学专家小组采纳了关于氟是动物饲料中不良物质的观点、/p>
10.氟易在在含钙组织中积累，相反，传送到可食用的组织如奶和蛋确是有限的，因此人类来源于动物源性食品中富集的氟远不如直接摄入的、/p>
11.在欧盟国家中，牧场、中药和复合饲料中氟含量一般很低，且动物对氟的摄入量基本不会导致有害影响。然而，在特定的边远地区及其周围或接近氟排放很高的工业区，过度摄入氟会使牙齿和骨骼发育不正常、/p>
12.现存的法律关于氟在用于动物饲料的产品中的规定是总体上确保这些产品不会对人类和动物健康有害或严重畜产品、/p>
13.使用的提取方法会对分析结果产生很大的影响，因此，必须选自合适的提取方法。可以达到相同的提取效果的提取方法也可以使用、/p>
14.由于考虑新的技术程序增加了营养质量、降低生物损耗，但是也导致了成品中高水平的氟含量，海产甲壳类中如磷虾中氟的含量必须被制定、/p>
15.1984?0?6日，委员会指?4/547/EEC修订了理事会指令70/524/EEC关于在饲料添加剂中蛭石（E561）增加建立一个氟的最高限量。指?002/32/EC 提供了建立饲料添加剂中不良物质最高限量的可能性，并且控制不良物质的规定应该被收集到一个单独的文件中确保更加透明、/p>
16.2004??日，欧洲食品安全局食品链污染物科学专家小组采纳了关于镉是动物饲料中不良物质的观点、/p>
17.食物中镉的污染关系公众健康。在动物组织中镉的富集是饮食和持久的摄入的标志。生命周期比较短的动物如育肥猪和家禽中可食用的组织镉危害比较低。反刍动物和马在它们的整个生命中会在牧场度过。在一些边远的地方，这可能会导致镉在肾中大量积累、/p>
18.镉对所有动物都是有毒的，在一些圈养的动物品种，猪被认为是最敏感的动物。如果日粮中镉的含量始终保持?mg/kg 以下，临床症状则可能不发生、/p>
19.现存的法律关于镉在用于动物饲料的产品中的规定是总体上确保这些产品不会对人类和动物健康有害或严重影响畜产品、/p>
20.除磷酸盐外，对宠物食品和矿物源饲喂材料没有建立最大量标准。很有必要对这些动物饲料产品建立最大限量。考虑到最近鱼料中添加了大量的鱼油和鱼粉，有必要对鱼料设立镉的最大限量。此外对属痕量元素化合物功能组的添加剂和属粘和剂、抗块结剂功能组添加剂、预混料建立镉的最大限量标准也是必须的。对预混料建立最大限量考虑到了添加剂中镉的最高限量而非不同动物种类对镉的敏感性。。在指令1831/2003 16中，为了保护动物和公众的健康 预混料生产商有责任确保符合预混料的最大含量标准，此外预混料的使用说明也要符合配合饲料和全价饲料的最大限量标准、/p>
21.欧盟指令2002/32/EC?4/547/EC号规定应当被相应的修订、/p>
22.本指令中的措施与食物链和动物健康常任委员会的观点一致、/p>
兹采用本指令９/p>
条例1
欧盟指令2002/32/EC附件I根据本指令作相应修改、/p>
条例2
为了公正的处理其他规定中饲料添加剂问题，指令71/124/EEC中的属粘合剂、抗块结剂功能组添加剂的最大氟含量依据本指令附件执行、/p>
条例3
1.在本指令生效?2个月后，各成员国必须使其法律、法规或行政法规符合本指令。他们必须立即同委员会沟通这些规定以及这些规定同本指令之间的相关性、/p>
当成员国采纳这些措施时，他们必须附一参考说明于本指令，或在他们的官方出版物上附上这样的参考说明。各成员国自行决定如何陈述参考说明、/p>
2. 各成员国应当同委员会提交本指令所辖领域的有关国内法规的条款的正文、/p>
条例4
本指令在《欧盟官方公报》上发表20天后生效、/p>
条例5
本指令通知到各成员国、/p>
2005?2?日于布鲁塞尔
附件
欧盟指令2002/32/EC中的附件I作如下修正：
1、第2列中，铅，作如下替换９/p>
| 不良物质 | 用作动物饲料的产?/span> | 最大限量（mg/kg）（ppm）（涉及含水量为12%的饲料） |
| ＇span lang="EN-US">1（/span> | ?（/span> | ?（/span> |
| 2铅（*（/span> | 饲料原料，不包括９/p> ---青饲斘/p> ---磷酸盐及含钙的海生藻籺/p> ---碳酸盐凝固物 ---酵母 属痕量元素化合物功能组的添加剂，不包括： ---氧化锋/p> ---氧化锰、碳酸铁、磷酸铜 属粘合剂、抗块结剂功能组添加剂，不包括： 火上喷发物的斜发沸石 预混合剂 配合饲料，不包括９/p> ---矿物质饲斘/p> 全价饲料 |
30?**（/p> 15 10 5 100 400?**（/p> 200?**（/p> 30?**（/p> 60?**（/p> 200?**（/p> 10 15 5 |
?）铅最大分析检测量，即将提取物置于硝酸?% w/w）中以沸腾的温度处理30分钟，也可以使用其它能取得相同提取效果的提取程序 ?*）青饲料包括干草、青贮及鲜草等用于动物饲料的产品 ?**）为了减少最大限量，该限值将?007?2?1重新审核 |
||
2、第3列中，氟，作如下替换
| 不良物质 | 用作动物饲料的产?/span> | 最大限量（mg/kg）（ppm）（涉及含水量为12%的饲料） |
| ＇span lang="EN-US">1（/span> | ＇span lang="EN-US">2（/span> | ＇span lang="EN-US">3（/span> |
| 3氟（*（/span> | 饲料原料，不包括９/p> ----动物源性饲料（不包括海生甲壳类动物成分，如磷虾（/p> ----海生甲壳类动物成分，如磷虽/p> ----磷酸盏/p> ----碳酸钘/p> ----氧化?/p> ----含钙的海生藻籺/p> 蛭石（E 561（/p> 配合饲料 含有4%的磷 含有?%的磷 全价饲料，不包括 ----用于哺乳期牛、绵羊和山羊的全价饲斘/p> ----其它 用于猪的全价饲料 用于禽类的全价饲斘/p> 用于小鸡的全价饲斘/p> |
150 500 3000 2000 350 600 1000 3000?*（/p> 500 125（每1%的磷酸盐（/p> 250 30 50 100 250 250 |
?）氟最大分析检测量，即将提取物置于盐酸?N ）中室温处理20分钟，也可以使用其它能取得相同提取效果的提取程序 ?*）为了减少最大限量，该限值将?007?2?1重新审核 |
||
3、第6列中镉作如下替换
| 不良物质 | 用作动物饲料的产?/span> | 最大限量（mg/kg）（ppm）（涉及含水量为12%的饲料） |
| ?（/span> | ?（/span> | ?（/span> |
| 6镉（*（/span> | 植物源性的饲料 动物源性的饲料 矿物质源性的饲料，不包含 ---磷酸盏/p> 属痕量元素化合物功能组的添加剂，不包?/p> ---氧化铜、氧化锰、氧化锌和硫酸锰 属粘合剂、抗块结剂功能组添加剂： 矿物质饲斘/p> 包含?%的磷 包含7%的磷 用于宠物的配合饲斘/p> 其它配合饲料 用于牛、绵羊、山羊的全价饲料及用于鱼的饲料，不包?/p> ----用于宠物的全价饲斘/p> ---用于犊牛、小山羊、小绵羊的全价饲料及其它全价饲料 |
1 2 2 10 10 30?*（/p> 2 15?*）、/p> 5 0.75（每1%中的磷，最大值为7.5（/p> 2 0.5 1 2 0.5 |
?）镉最大分析检测量，即将提取物置于硝酸?% w/w）中以沸腾的温度处理30分钟，也可以使用其它能取得相同提取效果的提取程序 ?*）为了减少最大限量，该限值将?007?2?1重新审核 |
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地区９/font>
