原文后附帶中文翻譯，來源于上海出入境檢驗檢疫局
Commission Directive 2005/87/EC
of 5 December 2005
amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards lead, fluorine and cadmium
（Text with EEA relevance）
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（1） 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（2） thereof,
Whereas:
（1） 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.
（2） 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.
（3） 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.
（4） 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.
（5） 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.
（6） 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.
（7） 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.
（8） 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.
（9） 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.
（10） 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.
（11） 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.
（12） 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.
（13） 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.
（14） 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.
（15） 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.
（16） 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.
（17） 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.
（18） 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.
（19） 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.
（20） 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.
（21） Directive 2002/32/EC and Directive 84/547/EEC should therefore be amended accordingly.
（22） 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 % |
（1） | （2） | （3） |
"2.Lead [1] | Feed materials with the exception of: | 10 |
– green fodder [2] | 30 [3] |
– phosphates and calcareous marine algae | 15 |
– calcium carbonate | 20 |
– yeasts | 5 |
Additives belonging to the functional group of compounds of trace elements except | 100 |
– zinc oxide | 400 [3] |
– manganous oxide, iron carbonate, copper carbonate | 200 [3] |
Additives belonging to the functional groups of binders and anti-caking agents except | 30 [3] |
– clinoptilolite of volcanic origin | 60 [3] |
Premixtures | 200 [3] |
Complementary feedingstuffs with the exception of | 10 |
– 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 % |
（1） | （2） | （3） |
"3.Fluorine [4] | Feed materials with the exception of: | 150 |
– feedingstuffs of animal origin with the exception of marine crustaceans such as marine krill | 500 |
– marine crustaceans such as marine krill | 3000 |
– phosphates | 2000 |
– calcium carbonate | 350 |
– magnesium oxide | 600 |
– calcareaous marine algae | 1000 |
Vermiculite （E 561） | 3000 [5] |
Complementary feedingstuffs | |
– containing ≤ 4 % phosphorus | 500 |
– containing > 4 % phosphorus | 125 per 1 % phosphorus |
Complete feedingstuffs with the exception of | 150 |
– complete feedingstuffs for cattle sheep and goats | |
– – in lactation | 30 |
– – other | 50 |
– complete feedingstuffs for pigs | 100 |
– complete feedingstuffs for poultry | 350 |
– 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 % |
（1） | （2） | （3） |
"6.Cadmium [4] | Feed materials of vegetable origin | 1 |
Feed materials of animal origin | 2 |
Feed materials of mineral origin except | 2 |
– phosphates | 10 |
Additives belonging to the functional group of compounds of trace elements except | 10 |
– 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 | |
– containing < 7 % phosphorus | 5 |
– 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 |
– complete feedingstuffs for pets | 2 |
– 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 （5 % 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 （5 % 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."
歐共體委員會。
根據締結的歐共體條約。
根據2002年5月7日的歐盟指令2002/32/EC號中對動物飼料中不良物質的規定，尤其是第8條。
根據2003年9月22日的歐盟指令第1831/2003號中對動物營養中使用的添加劑的規定，尤其是第13條。
1.歐盟指令2002/32/EC號規定，禁止將不良物質含量超過附件I中最大限量的產品用作動物飼料。
2.當歐盟指令2002/32/EC號被采用時，委員會認為基于最新的科學風險評估并考慮禁止在動物飼料中使用有害產品，附件I中的條款應被修訂。
3.2004年6月2日，歐洲食品安全局食品鏈污染物科學專家小組采納了委員會關于鉛是動物飼料中的不良物質的觀點。
4.食物中的鉛污染一直備受關注。鉛在很大程度上富積在肝和腎，肌肉組織中的殘留量很低，進入奶制品中的有限。因此動物食品不是人類攝入鉛的主要來源。
5.對急性鉛中毒牛和羊被認為是最為敏感的動物種類，由于飼喂來自污染區域的物質或是偶然食用含鉛物質，導致個體中毒的事件已有所報道。然而，歐盟制定的商業飼料中的鉛標準尚不能誘發鉛中毒的臨床表現。
6.現存的法律關于鉛在用于動物飼料的產品中的規定是總體上確保這些產品不會對人類和動物健康有害或嚴重影響畜產品。
7.牛和羊是被認為是最敏感的動物，而青飼料是她們日糧中主要的組成部分，為了盡可能的降低青飼料中鉛的最大含量，重新修訂標準是很有必要的。
8.在含痕量元素粘和劑、抗塊結劑的預混料中規定鉛的最大含量標準是適合的，預混料中鉛的最大限量的制定考慮的是添加劑中鉛含量的最高水平而未將各種不同動物品種對鉛的敏感性考慮在內。為了保護動物和公眾健康，預混料生產商有責任確保符合預混料的最大含量標準，此外預混料的使用說明也要符合配合飼料和全價飼料的最大限量要求。
9.2004年9月22日，歐洲食品安全局食品鏈污染物科學專家小組采納了關于氟是動物飼料中不良物質的觀點。
10.氟易在在含鈣組織中積累，相反，傳送到可食用的組織如奶和蛋確是有限的，因此人類來源于動物源性食品中富集的氟遠不如直接攝入的。
11.在歐盟國家中，牧場、中藥和復合飼料中氟含量一般很低，且動物對氟的攝入量基本不會導致有害影響。然而，在特定的邊遠地區及其周圍或接近氟排放很高的工業區，過度攝入氟會使牙齒和骨骼發育不正常。
12.現存的法律關于氟在用于動物飼料的產品中的規定是總體上確保這些產品不會對人類和動物健康有害或嚴重畜產品。
13.使用的提取方法會對分析結果產生很大的影響，因此，必須選自合適的提取方法。可以達到相同的提取效果的提取方法也可以使用。
14.由于考慮新的技術程序增加了營養質量、降低生物損耗，但是也導致了成品中高水平的氟含量，海產甲殼類中如磷蝦中氟的含量必須被制定。
15.1984年10月26日，委員會指令84/547/EEC修訂了理事會指令70/524/EEC關于在飼料添加劑中蛭石（E561）增加建立一個氟的最高限量。指令2002/32/EC 提供了建立飼料添加劑中不良物質最高限量的可能性，并且控制不良物質的規定應該被收集到一個單獨的文件中確保更加透明。
16.2004年6月2日，歐洲食品安全局食品鏈污染物科學專家小組采納了關于鎘是動物飼料中不良物質的觀點。
17.食物中鎘的污染關系公眾健康。在動物組織中鎘的富集是飲食和持久的攝入的標志。生命周期比較短的動物如育肥豬和家禽中可食用的組織鎘危害比較低。反芻動物和馬在它們的整個生命中會在牧場度過。在一些邊遠的地方，這可能會導致鎘在腎中大量積累。
18.鎘對所有動物都是有毒的，在一些圈養的動物品種，豬被認為是最敏感的動物。如果日糧中鎘的含量始終保持在5mg/kg 以下，臨床癥狀則可能不發生。
19.現存的法律關于鎘在用于動物飼料的產品中的規定是總體上確保這些產品不會對人類和動物健康有害或嚴重影響畜產品。
20.除磷酸鹽外，對寵物食品和礦物源飼喂材料沒有建立最大量標準。很有必要對這些動物飼料產品建立最大限量。考慮到最近魚料中添加了大量的魚油和魚粉，有必要對魚料設立鎘的最大限量。此外對屬痕量元素化合物功能組的添加劑和屬粘和劑、抗塊結劑功能組添加劑、預混料建立鎘的最大限量標準也是必須的。對預混料建立最大限量考慮到了添加劑中鎘的最高限量而非不同動物種類對鎘的敏感性。。在指令1831/2003 16中，為了保護動物和公眾的健康， 預混料生產商有責任確保符合預混料的最大含量標準，此外預混料的使用說明也要符合配合飼料和全價飼料的最大限量標準。
21.歐盟指令2002/32/EC和84/547/EC號規定應當被相應的修訂。
22.本指令中的措施與食物鏈和動物健康常任委員會的觀點一致。
茲采用本指令：
條例1
歐盟指令2002/32/EC附件I根據本指令作相應修改。
條例2
為了公正的處理其他規定中飼料添加劑問題，指令71/124/EEC中的屬粘合劑、抗塊結劑功能組添加劑的最大氟含量依據本指令附件執行。
條例3
1.在本指令生效的12個月后，各成員國必須使其法律、法規或行政法規符合本指令。他們必須立即同委員會溝通這些規定以及這些規定同本指令之間的相關性。
當成員國采納這些措施時，他們必須附一參考說明于本指令，或在他們的官方出版物上附上這樣的參考說明。各成員國自行決定如何陳述參考說明。
2. 各成員國應當同委員會提交本指令所轄領域的有關國內法規的條款的正文。
條例4
本指令在《歐盟官方公報》上發表20天后生效。
條例5
本指令通知到各成員國。
2005年12月5日于布魯塞爾
附件
歐盟指令2002/32/EC中的附件I作如下修正：
1、第2列中，鉛，作如下替換：
| 不良物質 | 用作動物飼料的產品 | 最大限量（mg/kg）（ppm）（涉及含水量為12%的飼料） |
| （1） | （2） | （3） |
| 2 鉛（*） | 飼料原料，不包括： ---青飼料 ---磷酸鹽及含鈣的海生藻類 ---碳酸鹽凝固物 ---酵母 屬痕量元素化合物功能組的添加劑，不包括： ---氧化鋅 ---氧化錳、碳酸鐵、磷酸銅 屬粘合劑、抗塊結劑功能組添加劑，不包括： 火上噴發物的斜發沸石 預混合劑 配合飼料，不包括： ---礦物質飼料 全價飼料 |
30（***） 15 10 5 100 400（***） 200（***） 30（***） 60（***） 200（***） 10 15 5 |
| （*）鉛最大分析檢測量，即將提取物置于硝酸（5% w/w）中以沸騰的溫度處理30分鐘，也可以使用其它能取得相同提取效果的提取程序 （**）青飼料包括干草、青貯及鮮草等用于動物飼料的產品 （***）為了減少最大限量，該限值將在2007年12月31重新審核 | ||
2、第3列中，氟，作如下替換
| 不良物質 | 用作動物飼料的產品 | 最大限量（mg/kg）（ppm）（涉及含水量為12%的飼料） |
| （1） | （2） | （3） |
| 3 氟（*） | 飼料原料，不包括： ----動物源性飼料（不包括海生甲殼類動物成分，如磷蝦） ----海生甲殼類動物成分，如磷蝦 ----磷酸鹽 ----碳酸鈣 ----氧化錳 ----含鈣的海生藻類 蛭石（E 561） 配合飼料 含有≤4%的磷 含有＞4%的磷 全價飼料，不包括 ----用于哺乳期牛、綿羊和山羊的全價飼料 ----其它 用于豬的全價飼料 用于禽類的全價飼料 用于小雞的全價飼料 | 150 500 3000 2000 350 600 1000 3000（**） 500 125（每1%的磷酸鹽） 250 30 50 100 250 250 |
| （*）氟最大分析檢測量，即將提取物置于鹽酸（1N ）中室溫處理20分鐘，也可以使用其它能取得相同提取效果的提取程序 （**）為了減少最大限量，該限值將在2007年12月31重新審核 | ||
3、第6列中鎘作如下替換
| 不良物質 | 用作動物飼料的產品 | 最大限量（mg/kg）（ppm）（涉及含水量為12%的飼料） |
| （1） | （2） | （3） |
| 6 鎘（*） | 植物源性的飼料 動物源性的飼料 礦物質源性的飼料，不包含 ---磷酸鹽 屬痕量元素化合物功能組的添加劑，不包括 ---氧化銅、氧化錳、氧化鋅和硫酸錳 屬粘合劑、抗塊結劑功能組添加劑： 礦物質飼料 包含＜7%的磷 包含≥7%的磷 用于寵物的配合飼料 其它配合飼料 用于牛、綿羊、山羊的全價飼料及用于魚的飼料，不包含 ----用于寵物的全價飼料 ---用于犢牛、小山羊、小綿羊的全價飼料及其它全價飼料 | 1 2 2 10 10 30（**） 2 15（**）。 5 0.75（每1%中的磷，最大值為7.5） 2 0.5 1 2 0.5 |
| （*）鎘最大分析檢測量，即將提取物置于硝酸（5% w/w）中以沸騰的溫度處理30分鐘，也可以使用其它能取得相同提取效果的提取程序 （**）為了減少最大限量，該限值將在2007年12月31重新審核 | ||
