欧盟委员会2002/79/EC号指令

欧盟委员会2002/79/EC号指令 $ 2002年10月2日 修订76/895/EEC、86/362/EEC、86/363/EEC及90/642/EEC理事会指令附件确定粮食、动物源食品及某些植物源产品，包括水果、蔬菜内/表上的杀 虫剂最高残留限量(全文参见EEA) 考虑到成立欧共体条约； 考虑到委员会第2002/71/EC(2) 号指令，特别是其第5条规定最新修订 (1)的理事会1976年11月23日有关确定水果蔬菜内/表化学残留物最高残留的第76/895/EEC号指令； (4) 考虑到委员会第2002/76/EC号指令，尤其是第10条最新修订的理事 (3)会1986年7月24日规定粮食内/表杀虫剂残留物最高限量的86/362/EEC号指令；考虑到第2002/7l/EC号指令，特别是第10条最新修订的理事会 (5)1986年7月24日有关确定动物源食品内表杀虫剂残留物最高限量的第 86/363/EEC号指令； 考虑到2002/76/EC号指令，特别是第7条最新修订的理事会1990年 (6)11月27日有关确定植物源产品，包括水果蔬菜内/表杀虫剂残留最高限量的第90/642/EEC号文件； (1) 第76/895/EEC、86/362/EEC、86/363/EEC和90/642/EEC号指令附件包括的杀虫剂残留物及其最高限量名单； (2) 经现有数据，有充足的信息来确定某些杀虫剂残留物的最高 残留限量，主要包括：齐螨素(abamectin) ，三唑锡(azocyclotin) ，卡呋菊酯(bioresmethrin) ，联苯菊酯(bifenthrin) ，bitertanol，溴螨酯(bromopropylate) ，四螨嗪(clofentezine) ，环丙氨嗪(cyromazine) ，三环锡(cyhexatin) ，fenpropimorph，flucytrinate，hexaconazol，metacrifos，晴菌唑(myclobutanil) ，戊菌唑(penconazole) ，咪鲜胺(prochloraz) ，丙溴磷 (profenofos) ，苄呋菊酯(resmethrin) ，十三吗啉(tridemorph) ，三唑酮 (triadimefon) 和triadimenol (3) 农业操作中的不同方式可导致动物源食品内杀虫剂残留物的产 生，因而需充分考虑许可杀虫剂的使用、监测实验及动物饲料研究所获得 的相关数据。 (4) 审查现有的信息。对许多杀虫剂/农业产品合成物，有足够的数据来计算影响人类健康安全的杀虫剂的最高残留标准。如果标准超过了分析 决定的最低限量，按计算出的标准来确定最高残留限量较恰当。对于某些 合成物，现有信息不充分，不能算出最高残留限量标准时，按分析决定的 最低限量确定较恰当。有时，有关信息虽然充分得当，但设定的一项最高 残留标准高于分析确定的较低残留限量，容易造成消费者长期过分地接触 农药残留物，在这种情况下，以分析确定的较低残留限量作标准较恰当。 (7)，根据欧共体程序及惯例，对 (5) 考虑到世界卫生组织公布的准则消费者长期过度频繁地与可能含杀虫剂残留物的食品接触进行评估。根据 理事会第(EEC) 条法规，确定了齐螨素(abamectin) 的最高残留限量。 (8)(9)2377/90最近由欧盟委员会法规(EC) 1752/2002修订，主要针对含相同物质的兽用药品在用于食品生产的动物上的使用(委员会法规第(EC) (10)3425/93号)。考虑到委员会以最高残留限量为基础对兽用药品的使用及 可接受的日服量作出的规定，得出结论，本指令建议的最高残留限量不会 造成超过可接受的日服量或导致剧烈中毒反应。 (6) 为保证消费者不受未经批准的产品内/表的残留物危害，对第86/362/EEC、86/363/EEC和90/642/EEC号指令涵盖的所有未经批准的产品均按分析得出的较低限量来设定其最高残留限量。 (7) 因此，应对第86/362/EEC，86/363/EEC和90/642/EEC号指令附 件做相应的修改。 (8) 通过世贸组织，欧盟委员会贸易伙伴对该指令建议的限量标准做 了评议，他们的评议也已得到考虑。 (9) 考虑了植物科学委员会的意见，特别是咨询和建议，涉及到植物 保护产品待遇的食品作物的消费者保护(11)。 (10) 本指令规定的措施是根据食物链及动物健康常务委员会的意见 制定的。 从第76/895/EEC号指令附件II中，删除有关“溴螨酯”(bromopropylate) 的内容。 在欧盟86/362/EEC号指令附件II A部分中，添加现指令附件I中列明的杀虫剂：齐螨素(abamectin) 、三唑锡(azocyclotin) 及三环锡(bifenthrin) 、(cyhexatin) 、联苯菊酯bitertanol、溴螨酯(bromopropylate) 、四螨嗪(clofentezine) 、环丙氨嗪(cyromazine) 、fenpropimorph、flucytrinate、hexaconazol、metacrifos、晴菌唑(myclobutanil) 、戊菌唑(penconazole) 、咪鲜胺(prochloraz) 、丙溴磷(profenofos) 、苄呋菊酯(resmethrin) 和卡呋菊酯(bioresmethrin) 、十三吗啉(tridemorph) 、tridemorph、三唑酮(triadimefon) 及triadimenol的最高残留限量。 欧盟86/363/EEC指令的附件II修订如下： (a) A部分中，添加现指令附件II中列明的添加杀虫剂：齐螨素 (abamectin) 、三环锡(bifenthrin) 、联苯菊酯bitertanol、溴螨酯(bromopropylate) 、环丙氨嗪(cyromazine) 、flucytrinate、metacrifos、戊菌唑(penconazole) 、咪鲜胺(prochloraz) 、丙溴磷(profenofos) 、苄呋菊酯(resmethrin) 及卡呋菊酯(bioresmethrin) 、tridemorph、三唑酮(triadimefon) 及triadimenol的最高残留限量。 (b) B部分中，添加现指令附件?中列明的杀虫剂：三唑锡(azocyclotin) 和cyhexatin、fenpropimorph、四螨嗪(clofentezine) 及晴菌唑(myclobutanil) 的最高残留限量。 欧盟90/642/EEC号指令附件II修改如下： (a) 将附件IV列出的杀虫剂：齐螨素(abamectin) 、三唑锡(azocyclotin) 及(cyhexatin) 、三环锡(bifenthrin) 、联苯菊酯bitertanol、溴螨酯 (bromopropylate) 、四螨嗪(clofentezine) 、环丙氨嗪(cyromazine) 、fenpropimorph、flucytrinate、hexaconazol、metacrifos、晴菌唑(myclobutanil) 、戊菌唑(penconazole) 、咪鲜胺(prochloraz) 、丙溴磷(profenofos) 、苄呋菊酯(resmethrin) 和卡呋菊酯(bioresmethrin) 、十三吗啉(tridemorph) 、tridemorph、三唑酮(triadimefon) 及triadimenol的最高残留限量添加到现指 令中去。 (b) 茶叶内的乙硫磷最高残留限量替换成3 mg/kg。 1. 执行4(b) 条所必需的法律、法规及行政规定应于2002年12月31日前在各成员国生效，并给委员会。 这些规定于2003年1月1日起执行。 2. 执行第l、2、3和4(a) 条规定所必需的法律、法规及行政规定应 于2003年5月31日前在各成员国生效，并进一步通报给委员会。 这些规定于2003年8月1日起执行。 3. 当各成员国采纳1，2制定的规定时，应在本指令上附加一份参考 说明，或在官方公布时附加此类说明。各成员国将决定如何准备该参考说 明。 本指令应于《欧共体官方公报》公布后的第7天生效。 本指令发送各成员国。 2002年10月2日于布鲁塞尔 Dayid Byrne 委员会成员 mg/kg 0,01(*) Abamectin(齐螨素) (avermectin) (阿维菌素Bla, 阿维菌素avermectin Blb及阿维菌素Bla的 delta-8,9异构体总数为 0,05(*) Azocyclotin(三唑锡) 及Cyhexatin(三环锡) (三 唑锡及三环锡(cyhexatin) 的总数为 Bifenthrin 0,5小麦、大麦、燕麦、黑 小麦0,05(*) 其它粮食作 物 Bitertano l 0,05(*) 0,05(*) Bromopropylate(溴螨酯) 0,02(*) Clofentezine(四螨嗪) (所有含2-氯 Chlorobenzoyl(2-氯苯甲氯) 成分的总 量,Cofentezine(四螨嗪) 为的半量 Cyromazine 0,05(*) Fenpropimorph 0,5;大麦,小麦,燕麦,黑麦, 斯佩耳特小麦,黑小麦 0,05(*) ;其它粮食作物。 0,05(*) Flucythrinate(以flucythrinate表现时,异构体总 数) Hexaconazole 0,02(*) Methacrifos 0,05(*) Myclobutanil 0,02(*) Penconazole 0,05(*) Prochloraz(prochloraz及其代谢物含1燕麦,大麦0,5黑小麦2,4,6-Trichlorophenol,以prochloraz表示为半triticale,小麦wheat,黑麦量) rye0,05(*) 其它粮食作物 Profenofos 0,05(*) 0,05(*) Resmethrin,包括其它含异构体的混合物(异构 体总量) Tridemorph 0,2大麦,燕麦0,05(*) 其它 粮食作物 Triadimefon及Triadimenol(triadimefon及0,2小麦,大麦,燕麦,黑triadimenol的总量) 麦,0,1(*) 其它粮食作物 (*) 注明分析确定的较低标准 mg/kg(ppm) 附件I及CN编码项下附件I, CN编码 ex 0201, 0202, 0203, 04000040CN0401；编码 0204, 02050000, 0206, 8(3) (4) 项下列明的未 0207, ex 0208, 0209 项下列明加工牛奶及全 00, 0210, 160100及的带壳鲜脂牛奶；其它 1602(1) (4) 列明的肉蛋, 鸟蛋编号为CN编 类, 及肉类, 内脏及及蛋黄按码0401, 0402, 动物脂肪的加工品所(3) (4) 执0405 00及 含脂肪 行。 0406的产品按 (2) (4) 执行 Abamectin (avermectin 0.005(*) 0.01(*) -0, 02牛肝(见第 Bla, avermectin Blb) EC3425/93) 条法规0. 及avermectin B1a的01(*) 其它产品 delta-8, 9异构体总数 Bifenthrin 0.01(*) 0.01(*) 0.1牛脂 0. 05(*) 其它产品 Bitertanol 0.05(*) 0.05(*) 0.05(*) Bromoprylate 0.05(*) 0.05(*) 0.05(*) 00.05(*) 0.05(*) 0.05(*) Flucythrinate(异构体总 量, 以flucythrinate表 示) Methacrifos 0.01(*) 0.01(*) 0.01(*) PenConazole 0.05(*) 0.01(*) 0.05(*) Prochloraz(prochloraz0.02(*) 0.1(*) 0, 2牛脂肪 及其含2, 4, 2.0牛肝 6-Trichlorophenol的代0, 5牛肾 谢物, 按prochloraz表0, 1(*) 其它产品 示, 含量为半) Profenofos 0.05(*) 0.01(*) 0.05(*) 0.1(*) 0.1(*) 0.1(*) Resmethrin, 包括其它 构成异构体的混合物 (异构体总量) Tridemorph 0.05(*) 0.05(*) 0.05 0.1(*) 0.1(*) 0.1(*) Triadimenol及 Triadimefon (Triadimenol及 triadimefon的总量) (*) 注明分析确定的较低限量。 (1) 当食品内的脂肪含量为10%或不足时，残留物与肉骨食品的总重量有 关。在这种情况下，最高残留标准为脂肪含量值的1/10，但必须低于0，0l mg/kg。 (2) 在确定原牛奶及全制牛奶中的残留物时，应以4%的脂肪含量为基础。对于其它动物的原牛奶和全脂奶，残留限量根据脂肪量来表示： 附件I中CN codes 0401，0402，0405 00及0406列出的对其它食品要求： – 当脂肪含量小于2%，取原牛奶和全脂奶限定量的一半为最高残留标 准。 – 当脂肪含量为或超过2%，取原牛奶和全脂奶限定量的25倍为最高残 留标准 (3) 对于蛋类及蛋类产品脂肪含量超过10%，以每脂肪表示最高限量。在 这种情况下，最高标准高于鲜蛋最高限量的10倍。 (4) 当注明的分析确定为较低的限量，脚注l，2及3不适用于这种情况时。 mg/kg(ppm) 附件I, 附件I 附件I CNex0201, CN0401, CN0407 0202, 0203, 0402, 00及 0204, 0505 000408列 02050000, 及0406明的带 0206, 0207, 列出的壳鸡蛋、ex0208, 乳类及 鸟蛋及020900, 乳类产蛋黄。 0210, 160100品 及1602列出 的, 包括脂 肪、肉类加工 品、内脏及动 物脂肪的肉 类品。 0.05(*) 0.01(*) Azocyclotin及Cyhexatin (azocyclotin-0, 2牛肉 及cyhexatin的总量以cyhexatin表示) 0, 05(*) 其 它产品 Cyromazine 0.02(*) 0.2 0, 05(*) 除 绵羊外的所 有产品 0.05(*) 0.02(*) Clofentezine(所有含2-chlorobenzoyl的0, 1牛, 绵羊 化合物总量, 以clofentezine表示减半) 及山羊肝 0, 05(*) 其 它产品 Alpha-(3-hydroxybutyl)–alpha-(4- 0.01(*) 0.01(*) 0.01(*) chloro- phenyl) -1H-1, 2, 4-triazole-1- propanenitrile(RH9090) expressed as myclobutanil) (*) 注明分析确定的较低的限量 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 0.05(*) 1. 不含添加 糖的水果、 鲜、干或未烹 饪过的冷冻 储藏： 0.01(*) 0.2 0.1 0.05(*) 0.02(*) (i) 柑橘水果 葡萄水果 柠檬 酸橙 中国柑橘(包 括棵莱门氏 小橘子及其 它杂交品种) 柑橘 帕米尔橘 其它 0.02(*) 0.1(*) 0.05(*) 0.1(*) 0.05(*) (ii) 坚果(带 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 壳及不带壳) 杏仁 巴西杏仁 腰果 栗子 椰子 榛子 澳洲坚果 美洲山核桃 松子阿月浑 子果 胡桃 其它 0.01(*) 0.3 2 0.5 (iii)梨果 0.2 苹果 0.1 梨 温柏 0.05(*) 其它 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 0.01(*) 0.2 (iv) 坚果 1 杏 1 樱桃 1 桃子包括油 桃和其它类 似杂交品种 0.3 2 0.2 李子 0.05(*) 0.05(*) 0.02(*) 其它 0.05(*) (v) 浆果及小 型水果 0.01(*) 0.2 (a) 葡萄及酿 酒葡萄 0.05(*) 0.02(*) 葡萄 0.3 1 酿酒葡萄 0.1 0.05(*) 0.5 2 (b) 草莓(除 野生品种外) 0.01(*) 0.05(*) 0.05(*) 3 (c) 藤类水果 (除野生品种 外) Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 黑莓 悬钩子 龙眼 3 悬钩子 0.3 其它 0.01(*) 0.05(*) 0.05(*) (d) 其它小型 水果和草莓 (除野生品种 外) 越橘 (Vaccinium myrtillus属果 实) 酸果蔓 0.5 葡萄干(红、 黑、白) 醋栗 0.02(*) 其它 0.01(*) 0.05(*) 0.05(*) 0.02(*) (e) 野浆果和 野果 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 0.01(*) 0.05(*) 0.02(*) (vi) 其它 鳄梨 0.1 3 香蕉 椰枣 无花果 几维果 荔枝 芒果 橄榄 西番莲果 菠萝 木瓜 0.05(*) 0.05(*) 其它 0.05(*) 2. 新鲜,或未 烹饪,冷冻或 风干的蔬菜 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (i) 根茎或块 茎蔬菜 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 甜菜根 胡萝卜 芹菜 山葵 洋姜 欧洲防风草 欧芹 萝卜 波罗门参 甜薯 Swedes瑞曲 油菜 芜青 洋芋 其它 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (ii) 鳞茎蔬菜 大蒜 洋葱 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 葱 小葱 其它 (iii) 果实蔬 菜 0.05(*) (a) 茄属 0.02 0.2 3 0.3 西红柿 0.05 0.2 胡椒 辣椒 0.02 0.2 茄子 0.01(*) 0.05(*) 0.05(*) 0.02(*) 其它 0.02(*) 0.05(*) 0.1 0.5 0.02(*) (b) 葫芦-皮 可食用 黄瓜 小黄瓜 绿皮南瓜 其它 0.02(*) 0.05(*) 0.1 0.5 0.02(*) (c) 葫芦-皮 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 非食用 0.1 瓜类 南瓜 西瓜 0.02(*) 其它 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (d) 甜玉米 0.01(*) 0.05(*) 0.05(*) 0.02(*) (iv) 芸苔类 蔬菜 0.2 (a) 开花类芸 苔 洋蓟(包括 calabrese) 花椰菜 其它 1 (b) 菜头 布鲁塞尔芽 菜 甘蓝菜头 其它 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 0.05(*) (c) 有叶菜 中国大白菜 羽衣甘菜 其它 0.05(*) (d) 大菜头 0.05(*) 0.05(*) 0.02(*) (v) 带叶类蔬 菜及 0.1 2 (a) 莴苣及类 似品种 Cress 野苣 莴苣 宽叶菊苣 其它 0.01(*) 0.05(*) (b) 菠菜及类 似品种 菠菜 甜菜叶(chard 甜菜) Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 其它 0.01(*) 0.05(*) (c) 水芹 0.01(*) 0.05(*) (d) 比利时菊 苣 0.01(*) 0.05(*) (e) 香草 山萝卜 细香葱 欧芹 芹菜叶 其它 0.01(*) 0.05(*) 0.02(*) (vi) 豆类蔬 菜(fresh) 0.5 0.5 豆类(带豆荚) 豆类(无豆荚 without pods) 0.1 豌豆(带豆荚 with pods) 豌豆(无豆荚 without pods) Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 0.05(*) 0.05(*) 其它 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (vii) 杆茎菜 (fresh) 芦笋 刺棘蓟 芹菜 茴香 朝鲜蓟 韭 大黄 其它 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (viii) 真菌 (a) 培植蘑菇 (b) 野蘑菇 3. Pulses 豆类 小扁豆 豌豆 Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 其它 0.02(*) 0.05(*) 0.1(*) 0.1(*) 0.1(*) 0.05(*) 4. 油子 亚麻子 花生 罂粟子 芝麻子 向日葵 油菜子 大豆 芥菜子 棉花子 其它 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) 5. 马铃薯 Earlyand ware potatoes 0.02(*) 0.1(*) 5 0.1(*) 0.1(*) 0.05(*) 6. 茶(干叶及 茎,发醇或山 茶Camellia sinensis) Abamect in Azocyclot(avermeinctin Bla, Cyhexatiavermecn(tin BlbMRLsBromocyhexatinBifentBitertaClofentepro-pyhrin nol zine avermeclate azocyclotitin Bla n cyhexatindelta-8,9 ) ) 0.05(*) 0.1(*) 10 0.1(*) 0.1(*) 0.05(*) 7. 蛇麻草 (干),包括蛇 麻草颗粒及 非浓缩粉末 I (Acts whose publication is obligatory) COMMISSION DIRECTIVE 2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating (1)(2),as last amended by Commission Directive 2002/71/EC,and in to the fixing of maximum levels for pesticide residues in and on fruit and particular Article 5 thereof, vegetables Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing (3)of maximum levels for pesticide residues in and on cereals ,as last amended (4)by Commission Directive 2002/76/EC ,and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the frxing of maximum levels for pesticide residues ill and on foodstuffs of animal (5)origin,as last amended by Directive 2002/71/EC, and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(6),as last amended by Directive 2002/76/EC, and in particular Article 7 thereof, Whereas: (1) The Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC, consist of lists of pesticide residues and their maximum levels. (2) On re-examination of the available data it has been determined that sufficient information exists to permit maximum levels be fixed for certain pesticide residues, namely abamectin, azocyclotin, bioresmethrin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, cyhexatin, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin, tridemorph, triadimefon and triadimenol. (3) Pesticide residues may arise in food of animal origin as a result of agricultural practices. It is necessary to take into account relevant data obtained both from authorised pesticide use and from supervised trials and animal feeding studies. (4) The information available has been reviewed. For many pesticide/agricultural product combinations the data is sufficient to allow the calculation of a maximum residue level at which residues of the pesticide concerned may be considered safe for human health. Where this level exceeds the lower limit of analytical determination it is appropriate to fix the maximum residue level at the level calculated. For some combinations the information available is inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other positions the information is adequate but demonstrates that the setting of a maximum residue level above the lower limit of analytical determination may give rise to an unacceptable, acute or chronic exposure of the consumer to the residues. In such cases, it is appropriate to fix maximum residue levels at the lower limit of analytical determination. (5) The lifetime exposure and the acute exposure of consumers to these pesticides via food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the Community procedures and practices taking account of guidelines published by the World Health (7). For abamectin, maximum residue limits have been established Organisation (8)in accordance with Council Regulation (EEC) No 2377/90. as last amended (9)by Commission Regulation (EC) No 1752/2002 resulting from the use of vet- erinary medicinal products containing the same substance for the treatment of (10)food-producing animal species (Commission Regulation (EC) No 3425/93. These uses and the evaluation of the acceptable daily intake provided by the Committee for Veterinary Medicinal Products on which these maximum residue limits were based were taken into account. It has been concluded that the maximum residue levels proposed in this Directive do not lead to the acceptable daily intakes being exceeded or to acute toxic effects. (6) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set maximum residue levels at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC. 86/363/EEC and 90/642/EEC (7) Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (8) The Community's trading partners have been consulted about the levels proposed in this Directive through the World Trade Organisation, and their comments on theselevels have been considered. (9) The opinions of the Scientific Committee for Plants, and in particular advice (11). and recommendations concerning the protection of consumers of food crops (10) The measures provided for in this Directive are in accordance with the treated with plant protection products, have been taken into accountopinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS DIRECTIVE: Article 1 In Annex II to Directive 76/895/EEC, the entry relating to ‘bromopropylate’ is deleted. Article 2 In part A of Annex II to Directive 86/362/EEC the maximum pesticide residue levels for abamectin, azocydotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, fiucytrinate, hexaconazole, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol listed in Annex I to the present Directive are added. Article 3 Annex II to Directive 86/363/EEC is amended as follows: (a) in part A maximum pesticide residue levels for abamectin, bifenthrin, bitertanol, bromopropylate, cyromazine, flucytrinate, metacrifos, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex II to the present Directive are added; (b) in part B the maximum pesticide residue levels for azocyclotin and cyhexatin, fenpropimorph, clofentezine and myclobutanil, listed in Annex III to the present Directive are added. Article 4 Annex II to Directive 9016421EEC is amended as follows: (a) the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and biores- methfin, tridemorph, triadimefon and triadimenol, listed in Annex IV to the present Directive are added: (b) the maximum pesticide residue level for ethion in tea is replaced by 3 mg/kg. Article 5 1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 4(b) of the present Directive by 31 December 2002. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 January 2003. 2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with of Artides 1, 2 and 3 and Article 4(a) by 31 May 2003. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 August 2003. 3. When Member States adopt the provisions provided for in paragraphs 1 and 2, 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. Article 6 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States. Done at Brussels, 2 October 2002. For the Commission David BYRNE Member of the Commission ANNEX 1 Pesticide residues Maximum levels in mg/kg Abamectin (sum of avermectin Bla, avermectin 0,01(*) Blab and delta-8,9 isomer of avermectin Bla) Azocyclotin and Cyhexatin (sum of azocyclotin 0,05(*) and cyhexatin expressed as cyhexatin) Bifenthrin 0,5wheat, barley, oats, triticale 0,05(*) other cereals Bitertanol 0,05(*) Bromopropylate 0,05(*) Clofentezine (sum of all compounds containing 0,02(*) the 2-chlorobenzoyl moiety expressed as clofentezine) Cyromazine 0,05(*) Fenpropimorph 0,5;barley, wheat, oats, rye, spelt, triticale 0,05(*) ;other cereals Flucythrinate(expressed as flucythrinate, sum of 0,05(*) isomers) Hexaconazole 0,02(*) Methacrifos 0,05(*) Myclobutanil 0,02(*) Penconazole 0,05(*) Prochloraz(sum of prochloraz and its metabolites 1 oats, barley containing the 2,4,6-Trichlorophenol moiety 0,5 triticale, wheat, rye, expressed as prochloraz) 0,05(*) other cereals Profenofos 0,05(*) Resmethrin, including other mixtures of 0,05(*) constituent isomers (sum of isomers) Tridemorph 0.2 barley oats 0.05(*) other cereals Triadimefon and Triadimenol (sum of 0,2wheat, barley, oats, rye triadimefon and triadimenol) triticale 0,1(*) other cereals (*) Indicates lower limit of analytical detection. ANNEX II Maximum levels in mg/kg(ppm) Of fat contained in In raw cow’s milk In shelled meat, preparations of and whole cream fresh eggs, in meat, offals and cow’s milk Listed birds/ eggs animal fats listed in in Annex 1 under and egg yolks Pesticide residues Annex1 under CN CN code 0401;for listed in codes ex 0201, 0202, the other food Annex 1 0203, 0204, stuffs in CN codes under CN 02050000, 0206, 0401, 0402, 0405 codes 040700 0207, ex 0208, 0209 00 and 0406 in and 0408(3) 00, 0210, 160100 accordance with(2) (4) and 1602(1) (4) (4) Abamectin (sum of -0, 02 cattle liver 0.005(*) 0.01(*) avermectin Bla, (see Regulation avermectin Blb and EC3425/93) delta-8,9 isomer of 0. 01(*) other avermectin Bla) products Bifenthrin 0.1 cattle fat 0.01(*) 0.01(*) 0. 05(*) other products Bitertanol 0.05(*) 0.05(*) 0.05(*) Bromoprylate 0.05(*) 0.05(*) 0.05(*) Flucythrinate(sum of 00.05(*) 0.05(*) 0.05(*) isomers, expressed as flucythrinate) Methacrifos 0.01(*) 0.01(*) 0.01(*) PenConazole 0.05(*) 0.01(*) 0.05(*) Prochloraz(sum of 0, 2 bovine fat 0.02(*) 0.1(*) prochloraz and its 2, 0 bovine liver metabolites containing the 0, 5 bovine kidney 2,4,6-Trichlorophenol 0, 1(*) other moiety, expressed as products prochloraz) Profenofos 0.05(*) 0.01(*) 0.05(*) Resmethrin, including 0.1(*) 0.1(*) 0.1(*) other mixtures of constituent isomers (sum of isomers) Tridemorph 0.05(*) 0.05(*) 0.05 Triadimenol and 0.1(*) 0.1(*) 0.1(*) Triadimefon (sum of Triadimenol and triadimefon) (*) Indicates lower limit of analytical determination。 (1) In the case of foodstuffs with a fat content of 10% or less by weight, the residue is related to the toral weight of the boned foodstuff, In such cases, the maximum level is one tenth of the value related to fat content, but must be no less than 0.01 mg/kg。 (2) In determining the residues in raw low’s milk and whole cream cow’s milk, a fat content of 4% by weight should be taken as a basis, for raw milk and whole cream milk of another animal origin the residues are expressed on the basis of the fat. For the other foodstuffs listed in Annex Iunder CN codes 0401, 0402, 040500 and 0406: – with a fat content of less than 2% by weight, the maximum level is taken as half that set for raw milk and whole cream milk。 – with a fat content of 2% or more by weight, the maximum level is expressed in mg/kg of fat, In such cases. The maximum level is 25 times that set for raw milk and whole cream milk. (3) For eggs and egg products with a fat content higher than 10%, the maximum level is expressed in mg/kg fat. In this case, the maximum level is 10 times higher than the maximum level for fresh eggs。 (4) Footnores 1,2 and 3 do not apply in cases where the lower limit of analytical determination is indicated。 ANNEX III Maximum levels in mg/kg(ppm) In meat including In milk In shelled fat, preparations and milk fresh eggs, of meat, offals products in birds and animal fats as listed in eggs and listed in Annex Annex I egg yolks Pesticide residues Iunde , CN codes under CN listed in ex0201, 0202, codes AnnexI 0203, 0204, 0401, under CN 02050000, 0206, 0402, 0505 codes 0207, ex0208, 00 and 0407 00 020900, 0210, 0406 and 0408 160100 and 1602 Azocyclotin and Cyhexatin (sum 0, 2 Meat of 0.05(*) 0.05(*) of azocyclotin and cyhexatin cattle expressed as cyhexatin) 0, 05(*) other products Fenpropimorph carboxylic acid 0.3 liver of cattle, 0.01 0.01(*) (BF 421-2) expressed as goat, pig and fenpropimorph sheep 0.05 kidney of cattle goat, pig and sheep 0.01(*) poultry meat, fat, edible offal 0.02 meat of cattle, goat, pig and sheep 0.01 other products Cyromazine 0, 05(*) all 0.02(*) 0.2 products except sheep Clofentezine(sum of all 0, 1 liver of 0.05(*) 0.02(*) compoumds containing the cattle, sheep and 2-chlorobenzoyl moiety expressed goat as clofentezine) 0, 05(*) other products Alpha-(3-hydroxybutyl)–alpha-(4- 0.01(*) 0.01(*) 0.01(*) chlorophenyl) -1H-1, 2, 4-triazole-1- propanenitrile(RH9090) expressed as myclobutanil) (*) Indicates lower limit of analytical determination. ANNEX IV PESTICIDE RESIDUES AND MRLs (mg/kg) AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) 1. Fruit, fresh, 0.05(*) dried or uncooked, preserved by freezing, not containing added sugar, nuts (i) Citrus fruit 0.01(*) 0.2 0.1 0.05(*) 0.02(*) Grapefruit Lemons Limes Mandarins(incl udingclemen tines and other hybrids) Oranges Pomelos Others (ii) TREE 0.02(*) 0.1(*) 0.05(*) 0.1(*) 0.05(*) NUTS (shelled or unshelled) AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) POME 0.01(*) 0.3 2 0.5 FRUIT Apples 0.2 Pears 0.1 Quinces Others 0.05(*) (iv) STONE 0.01(*) 0.2 FRUIT Apricots 1 Cherries 1 AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Peaches 1 (including nectarines and similar hybrids) Plums 0.3 2 0.2 Others 0.05(*) 0.05(*) 0.02(*) (v) BERRIES 0.05(*) AND SMALL FRUIT (a) table and 0.01(*) 0.2 wine grapes Table grapes 0.05(*) 0.02(*) Wine grapes 0.3 1 (b) strawberries 0.1 0.05(*) 0.5 2 (other than wild) (c) cane fruit 0.01(*) 0.05(*) 0.05(*) 3 (other than wild) Blackberries Dewberries Loganberries Raspberries 3 Others 0.3 AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) (d) other small 0.01(*) 0.05(*) 0.05(*) fruit and berries (other than wild) Bilberries (fruit of species Vaccinium myrtillus) Cranberries Currants(red, 0.5 black and white) Gooseberries Others 0.02(*) (e) wild berries 0.01(*) 0.05(*) 0.05(*) 0.02(*) and wild fruit (vi) 0.01(*) 0.05(*) 0.02(*) MISCELLANE OUS Avocados Bananas 0.1 3 Dates Figs Kiwi AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Kumquat Litchis Mangoes Olives Passion fruit Pineapples Papaya Others 0.05(*) 0.05(*) 2. Vegetables, 0.05(*) fresh or uncooked, frozen or dry (i) ROOT AND 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) TUBER VEGETABLES beetrot carrots Celeriac Horseradish Jerusalem artichokes Parsnip Parsley root AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Radishes Salsify Sweet potatoes Swedes Turnips Yam Others (ii) BULB 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) VEGETABLES Garlic Onions Shallots Spring onions Others (iii) Fruiting vegetables (a) solanacea 0.05(*) Tomatoes 0.02 0.2 3 0.3 Peppers 0.05 0.2 Chilli peppers Aubergines 0.02 0.2 Others 0.01(*) 0.05(*) 0.05(*) 0.02(*) AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) (b) 0.02(*) 0.05(*) 0.1 0.5 0.02(*) cucurbits-edibl e peel Cucumbers Gherkins Courgettes Others (c) 0.02(*) 0.05(*) 0.1 0.5 0.02(*) cucurbits-inedi ble peel Melons 0.1 Squashes Watermelons Others 0.02(*) (d) sweetcom 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (iv) 0.01(*) 0.05(*) 0.05(*) 0.02(*) BRASSICA VEGETABLES (a) flowering 0.2 brassica Broccoli (including calabrese) Cauliflower AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Others (b) head 1 brassica Brussels sprouts Head cabbage Others (c) leafy 0.05 brassica (*) Chinese cabbage Kale Others (d) kohlrabi 0.05 (*) (v) LEAF 0.05 0.05 0.02 VEGETABLES (*) (*) (*) AND FRESH (a) lettuce and 0.1 2 similar Cress Lamb’s lettuce Lettuce AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Scarole(broad-l eaf endive) Others (b) spinach and 0.01 0.05 similar (*) (*) Spinach Beet leaves (chard) Others (c)water cress 0.01 0.05 (*) (*) (d) witloof 0.01 0.05 (*) (*) (e) herbs 0.01 0.05 (*) (*) Chervil Chives Parsley Celery leaves Others (vi) LEGUME 0.01(*) 0.05(*) 0.02(*) VEGETABLES (fresh) AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) Beans(with 0.5 0.5 pods) Bean(without pods) Peas(with 0.1 pods) Peas(without pods) Others 0.05(*) 0.05(*) (vii) STEM 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) VEGETABLES (fresh) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Others (viii) FUNGI 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) (a) cultivated AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) mushrooms (b) wild mushrooms 3. Pulses 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) Beans Lentils Peas Others 4. oil seed 0.02(*) 0.05(*) 0.1(*) 0.1(*) 0.1(*) 0.05(*) Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed Soya bean Mustard seed Cotton seed Others 5. potatoes 0.01(*) 0.05(*) 0.05(*) 0.05(*) 0.05(*) 0.02(*) Earlyand ware potatoes AzocyclotAbamectin in and (sum of Groups and Cyhexatiavermectin examples of n(sum of Bla, individual azocyclotiBromoavermectin BifentBitertaClofentproducts to n and pro-pyBlb and hrin nol ez-ine which the cyhexatin late delta-8,9 MRLs would expressed isomer of apply as aver-mecticyhexatinn Bla) ) 6. Tea (dried 0.02(*) 0.1(*) 5 0.1(*) 0.1(*) 0.05(*) leaves and stalks, fermented or otherwise, Camellia sinensis) 7. Hops (dried), 0.05(*) 0.1(*) 10 0.1(*) 0.1(*) 0.05(*) including hop pellets and unconcentrated powder (*) Indicates lower limit of analytical determination. 2002年10月30日 欧盟委员会， 考虑到建立欧共体条约; 考虑到1990年6月26日的理事会法规No(EEC) 2377/90，它制定了确定动物源性食品的兽用药品最高残留限量的欧共体程序(1)，由欧委会法 (2)规(EC)1752/2002最新修订。特别是它的第6和8条规定； ： (1) 根据第(EEC) No 2377/90条法规，必须逐步对在欧盟范围内使用 的兽用药物产品的所有药理活性物质规定最高残留限量，来对用于食品加 工的动物进行管理： (2) 只有在欧共体范围内，就兽药产品，对所有相关信息进行核查后， 涉及消费者的动物源性食品残留物的安全性及其对食品加工业的影响，才 能确定最高残留限量。 (3) 在对动物源性食品内的兽药产品的残留物规定最高残留限量同 时，有必要对可能含有残留物的动物种类、经处理的动物相关肌肉组织(靶标组织) 内可能存在的水平、及与残留物监控相关(标记残留物) 的残留物特性也做出规定； (4) 在残留物控制方面，按欧共体立法的规定，通常应对肝或肾等关 键组织规定最高残留限量。因为通常国际贸易范围内流动的兽类尸体均被 去除肝或肾，所以，最高残留限量总是针对肌肉或脂肪组织建立的； (5) 对拟用于孵化鸟、哺乳期动物或蜜蜂的兽药产品，也必须对卵、 奶或蜂蜜规定最高残留限量； (6) 欧盟(EEC) 第2377/90号法规附件II中应加入碱性水杨酸铝(Aluminium alicylate) 和omeprazole； (7) 为允许完成科学研究，应在欧盟(EEC) 第2377/90条法规附件III 中添加tulathromycin及氰戊菊酯(fenvalerate) ； (8) 本法规生效前，应给予适当的时间，以准许各成员国根据欧洲议(3)号指令，考虑本法规规定，对已批准的兽用药物 会及理事会200l/82/EC投放市场而进行必要的调整。 (9) 本法规规定的措施符合兽用药物产品常务委员会的意见； ： 根据本附件的规定，修订欧盟2377/90法规附件II和III。 本法规应于《欧盟官方公报》公布后的第三天生效。 公布后的第60天开始执行。 本法规具有全权约束力，直接应用于所有成员国。 2002年10月30日于布鲁塞尔 Erkki Liikanen 委员会成员 1. 无机化学物 碱性水杨酸铝 牛 仅用于口服;不适用于生产人类消费 奶的动物. 2. 有机化学物 Omeprazole 马 仅用于口服 1. 抗感染剂 1.2 抗菌素 1.2.2 大环内酯物 MRLs 100 脂肪 (2R，3S，4R，5R，8R，ug/kg 此临时10R，11R，12S，13S，性3000ug/14R) -2-ethyl-3，4，10，牛 肝脏 MRLskg 13-tetrahydroxy-3，5，截止至8，10，12，3000ug/2004年肾 14-hexamethyl-11- [[3，kg Tulathrom7月14，6-trideoxy-3- ycin 日；不100ug/k皮肤和脂(dimethyla-mino) -β适用于g 肪 -D- 生产人xylo-hexopyranosyl)ox3000ug/类消费猪 肝脏 y]-1-oxa-6-azacylopentkg 奶的动-decan-15-tulathromyci物。 3000ug/n等效物 肾 kg 2. 抗寄生虫剂 2.2 抗皮外寄生虫剂 2.2.3 合成除虫菊酯 25 肌肉 ug/kg 250 此临时性脂肪 ug/kg 氰戊菊酯(RR,SS,RS牛 MRLs截止至氰戊菊酯 和SR异构体之和 2004年7月125 肝脏 日。 ug/kg 25 肾 ug/kg COMMISSION REGULATION (EC) No 1937/2002 of 30 October 2002 amending Annexes II and to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Howing regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(1) ,as last amended by Commission Regulation (EC) No 1 752/2002(2),and in particular Articles 6 and 8 thereof, Whereas: (1) In accordance with Regulation (EEC) No 2377/90, "maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals. (2) Maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs. (3) In establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained "from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue) . (4) For the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney. However, the liver and kidney are frequently removed from carcases moving in interna- tional trade, and maximum residue limits should therefore also always be established for muscle or fat tissues. (5) In the case of veterinary medicinal products intended for use in laying birds, lactating animals or honey bees, maximum residue limits must also be established for eggs, milk or honey. (6) Aluminium salicylate, basic and omeprazole should be inserted into Annex II to Regulation (EEC) No 2377/90. (7) In order to allow for the completion of scientific studies, tulathromycin and fenvalerate should be inserted into Annex ? to Regulation (EEC) No 2377/90. (8) An adequate period should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC(3) of the European Parliament and of the Council to take account of the provisions of this Regulation. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, HAS ADOPTED THE FOLLOWING REGULATION: Article 1 Annexes II and III to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. Article 2 This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Communities. It shall apply from the 60th day following its publication. This Regulation shall be binding in its entirety and directly applicabe in all Member States. Done at Brussels, 30 October 2002. For the CommissionErkki LIIKANEN Member of the Commission ANNEX A. Annex to Regulation (EEC) No 2377/90 is amended as follows: 1. Inorganic chemicals Pharmacologically active substance (s) Animal species Other provisions Aluminium salicylate, basic bovine For oral use only; Not for use in animals from which milk is produced for human consumption 2. Organic compounds Pharmacologically active substance (s) Other provisions Animal species Omeprazole Equidae For oral use only B. Annex III to Regulation (EEC) No 2377/90 is amended as follows: 1. Anti-infectious agents 1.2 Antibiotics 1.2.2 Macrolides Pharmacologically Marker residue Animal MRLs Target Other provisions active substance (s) species tissues 100 Fat ug/kg (2R，3S，4R，5R，8R， 10R，11R，12S，13S，14R) 3000ug/Bovine Liver -2-ethyl-3，4，10，kg Provisional MRLs expire 13-tetrahydroxy-3，5，8，on 1 july 2004; not for 3000ug/Kidney use in animals from 10，12，14-hexamethyl-11- kg Tulathromycin which milk is produced [[3，4，6- rideoxy-3- 100ug/kSkin and for human consumption (dimethyla-mino) -β-D- g fat Provisional MRLs expire xylo-hexopyranosyl]oxy]-1on 1 july 2004 3000ug/-oxa-6-azacylopent-decan-1porcine Liver kg 5-one expressed as tulathromycin equivalents 3000ug/kidney kg 2. Antiparasitic agents - 52 - 2.2 Agents acting against ectoparasites 2.2.3 Pyrethroids Pharmacologically Marker residue Animal MRLs Target Other provisions active substace (s) species tissues 25 Muscle ug/kg 250 Fat ug/kg Fenvalerate(sum of RR, SS, Fenvalerate RS and SR isomers) 25 Provisional MRLs expire Bovine Liver ug/kg on 1 july 2004 25 Kidney ug/kg 40 milk ug/kg - 53 - - 54 -