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| Order of the State Council of the People's Republic of China | | 中华人民共和国国务院令 |
(No. 536) | |
(第536号) |
The Regulation on the Supervision and Administration of the Quality and Safety of Dairy Products, which was adopted at the 28th executive meeting the State Council on October 6, 2008, is hereby promulgated and shall come into force as of the date of promulgation. | |
《乳品质量安全监督管理条例》已经2008年10月6日国务院第28次常务会议通过，现予公布，自公布之日起施行。 |
Premier Wen Jiabao | |
总理 温家宝 |
October 9, 2008 | |
二00八年十月九日 |
Regulation on the Supervision and Administration of the Quality and Safety of Dairy Products | |
乳品质量安全监督管理条例 |
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| Chapter I General Provisions | | 第一章 总则 |
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| Article 1 This Regulation is formulated to strengthen the supervision and administration of the quality and safety of dairy products, ensure the quality and safety of dairy products, ensure the health and life safety of the general public and promote the sound development of the dairy industry. | | 第一条 为了加强乳品质量安全监督管理，保证乳品质量安全，保障公众身体健康和生命安全，促进奶业健康发展，制定本条例。 |
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| Article 2 The term “dairy products” as mentioned in this Regulation refers to fresh milk and dairy products. | | 第二条 本条例所称乳品，是指生鲜乳和乳制品。 |
This Regulation shall apply to the supervision and administration of the quality and safety of dairy products. If any law provides otherwise for the supervision and administration of the quality and safety of dairy products, such provision shall prevail. | |
乳品质量安全监督管理适用本条例；法律对乳品质量安全监督管理另有规定的，从其规定。 |
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| Article 3 The dairy animal raisers, fresh milk purchasers, dairy product production enterprises and sellers shall be responsible for the quality and safety of the dairy products that they produce, purchase, transport or sell. They are the first responsible persons for the quality and safety of dairy products. | | 第三条 奶畜养殖者、生鲜乳收购者、乳制品生产企业和销售者对其生产、收购、运输、销售的乳品质量安全负责，是乳品质量安全的第一责任者。 |
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| Article 4 The local people's governments at and above the county level shall be responsible for the quality and safety of the dairy products within their respective administrative area. | | 第四条 县级以上地方人民政府对本行政区域内的乳品质量安全监督管理负总责。 |
The stockbreeding and veterinary administrative departments of the people's governments at and above the county level shall be responsible for the supervision and administration over the raising of dairy animals and the production and purchase of fresh milk. The quality supervision, inspection and quarantine departments at and above the county level shall be responsible for the supervision and administration over the production, import and export of dairy products. The industry and commerce administrative departments at and above the county level shall be responsible for the supervision and administration over the sale of dairy products. The food and drug administrative departments at and above the county level shall be responsible for the supervision and administration over the catering services relating to dairy products. The health administrative departments of the people's governments at and above the county level shall, according to their functions, be responsible for the comprehensive coordination of supervision and administration of the quality and safety of dairy products, investigate into and deal with major food safety accidents. Other relevant departments of the people's governments at and above the county level shall, within their respective functions, be responsible for other tasks relevant to the supervision and administration over the quality and safety of dairy products. | |
县级以上人民政府畜牧兽医主管部门负责奶畜饲养以及生鲜乳生产环节、收购环节的监督管理。县级以上质量监督检验检疫部门负责乳制品生产环节和乳品进出口环节的监督管理。县级以上工商行政管理部门负责乳制品销售环节的监督管理。县级以上食品药品监督部门负责乳制品餐饮服务环节的监督管理。县级以上人民政府卫生主管部门依照职权负责乳品质量安全监督管理的综合协调、组织查处食品安全重大事故。县级以上人民政府其他有关部门在各自职责范围内负责乳品质量安全监督管理的其他工作。 |
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| Article 5 Any accident of quality and safety of dairy products shall be timely reported and handled in accordance with relevant laws and administrative provisions. Where severe or bad consequences are caused by such an accident, the persons-in-charge of the relevant people's governments and those of the relevant departments who shoulder the leader's responsibilities shall be subjected to liabilities. | | 第五条 发生乳品质量安全事故，应当依照有关法律、行政法规的规定及时报告、处理；造成严重后果或者恶劣影响的，对有关人民政府、有关部门负有领导责任的负责人依法追究责任。 |
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| Article 6 The fresh milk and dairy products shall conform to the national standards for the quality and safety of dairy products. The national standards for the quality and safety of dairy products shall be formulated by the health administrative department of the State Council and be timely amended on the basis of the risk monitoring and assessment results. | | 第六条 生鲜乳和乳制品应当符合乳品质量安全国家标准。乳品质量安全国家标准由国务院卫生主管部门组织制定，并根据风险监测和风险评估的结果及时组织修订。 |
The national standards for the quality and safety of dairy products shall include limits on pathogenic microorganisms, pesticide residues, veterinary drug residues, heavy metals and other substances hazardous to human health, the sanitation requirements during the production and business operation of dairy products, the general methods and operating procedures for the inspection of dairy products, quality requirements relevant to the safety of dairy products and other contents which are necessary to be a component part of the national standards for the quality and safety of dairy products. | |
乳品质量安全国家标准应当包括乳品中的致病性微生物、农药残留、兽药残留、重金属以及其他危害人体健康物质的限量规定，乳品生产经营过程的卫生要求，通用的乳品检验方法与规程，与乳品安全有关的质量要求，以及其他需要制定为乳品质量安全国家标准的内容。 |
The physical characteristics and growth needs of infants shall be taken into full consideration during the formulation of national standards for the quality and safety of infant milk powder so as to ensure the indispensable nutritional ingredients for the growth of infants. | |
制定婴幼儿奶粉的质量安全国家标准应当充分考虑婴幼儿身体特点和生长发育需要，保证婴幼儿生长发育所需的营养成分。 |
Where a health administrative department of the State Council finds, from the disease information and supervision information of the supervisory departments, etc., that a non-edible chemical substance or any other substance that may be hazardous to the human health is added or may have been added to a dairy product, it shall immediately organize a risk assessment and take corresponding monitoring, testing and supervisory measures. . | |
国务院卫生主管部门应当根据疾病信息和监督管理部门的监督管理信息等，对发现添加或者可能添加到乳品中的非食品用化学物质和其他可能危害人体健康的物质，立即组织进行风险评估，采取相应的监测、检测和监督措施。 |
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| Article 7 It is forbidden to add any substance during the production, purchase, storage, transport and sale of fresh milk. | | 第七条 禁止在生鲜乳生产、收购、贮存、运输、销售过程中添加任何物质。 |
It is forbidden to add any a non-edible chemical substance or any other substance that may be hazardous to the human health during the production of dairy products. | |
禁止在乳制品生产过程中添加非食品用化学物质或者其他可能危害人体健康的物质。 |
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| Article 8 The stockbreeding and veterinary administrative department of the State Council shall, jointly with the development and reform department, the industry and information department and the commerce department of the State Council, formulate a national dairy industry development plan, strengthen the construction of dairy resource bases, improve the service system and promote the sound development of the dairy industry. | | 第八条 国务院畜牧兽医主管部门会同国务院发展改革部门、工业和信息化部门、商务部门，制定全国奶业发展规划，加强奶源基地建设，完善服务体系，促进奶业健康发展。 |
The local people's governments at and above the county level shall, under the national dairy industry development plan, reasonably determine the dairy animal raising scale within their respective administrative area, scientifically arrange the production and purchase of fresh milk. | |
县级以上地方人民政府应当根据全国奶业发展规划，合理确定本行政区域内奶畜养殖规模，科学安排生鲜乳的生产、收购布局。 |
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| Article 9 The relevant industrial associations shall intensify industrial self-discipline, advocate good faith in the industry, direct and standardize the production and business operations of dairy animal raisers, fresh milk purchasers, dairy product production enterprises and sellers. | | 第九条 有关行业协会应当加强行业自律，推动行业诚信建设，引导、规范奶畜养殖者、生鲜乳收购者、乳制品生产企业和销售者依法生产经营。 |
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| Chapter II Dairy Animal Raising | | 第二章 奶畜养殖 |
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| Article 10 The state shall take effective measures to encourage, direct and support dairy raisers to improve the quality and safety of fresh milk. The people's governments at and above the province level shall arrange funds from the fiscal budget at the same level to support the dairy industry and encourage credit support to be given to dairy animal raisers and professional production cooperatives of dairy farmers. | | 第十条 国家采取有效措施，鼓励、引导、扶持奶畜养殖者提高生鲜乳质量安全水平。省级以上人民政府应当在本级财政预算内安排支持奶业发展资金，并鼓励对奶畜养殖者、奶农专业生产合作社等给予信贷支持。 |
The state shall establish a dairy animal policy insurance system and offer premium subsidies to dairy animal raisers who buy relevant insurances. | |
国家建立奶畜政策性保险制度，对参保奶畜养殖者给予保费补助。 |
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| Article 11 Stockbreeding and veterinary technology popularization institutions shall provide the dairy animal raisers with such services as raising technology training, popularization of good breeds, prevention and control of diseases, etc. | | 第十一条 畜牧兽医技术推广机构应当向奶畜养殖者提供养殖技术培训、良种推广、疫病防治等服务。 |
The state shall encourage dairy product production enterprises and other relevant producers and business operators to offer dairy animal raisers services they need. | |
国家鼓励乳制品生产企业和其他相关生产经营者为奶畜养殖者提供所需的服务。 |
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| Article 12 To set up a dairy animal farm or community, the following requirements shall be satisfied: | | 第十二条 设立奶畜养殖场、养殖小区应当具备下列条件： |
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| 1. conforming to the dairy animal raising scale determined by the local people's government for the administrative area; | | （一）符合所在地人民政府确定的本行政区域奶畜养殖规模； |
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| 2. having a business site and relevant facilities commensurate with its raising scale; | | （二）有与其养殖规模相适应的场所和配套设施； |
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| 3. having its own stockbreeding and veterinary technicians; | | （三）有为其服务的畜牧兽医技术人员； |
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| 4. having the epidemic prevention conditions as prescribed by laws, administrative regulations, and provisions of the stockbreeding and veterinary administrative department of the State Council; | | （四）具备法律、行政法规和国务院畜牧兽医主管部门规定的防疫条件； |
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| 5. having facilities such as firedamp pool for the comprehensive utilization of the dairy animal dung, waste water and other solid wastes, or having other innocuous disposal facilities; | | （五）有对奶畜粪便、废水和其他固体废物进行综合利用的沼气池等设施或者其他无害化处理设施； |
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| 6. having bylaws on the management of production, sale and transport of fresh milk; and | | （六）有生鲜乳生产、销售、运输管理制度； |
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| 7. meeting other requirements as prescribed by laws and administrative regulations. | | （七）法律、行政法规规定的其他条件。 |
The owner of a dairy animal farm or raising community shall report the name and address of the farm or raising community, breeds of the dairy animals as well as the raising scale to the stockbreeding and veterinary administrative department of the people's government at the county level where the farm or raising community is located for archival purposes. | |
奶畜养殖场、养殖小区开办者应当将养殖场、养殖小区的名称、养殖地址、奶畜品种和养殖规模向养殖场、养殖小区所在地县级人民政府畜牧兽医主管部门备案。 |
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| Article 13 A dairy animal farm shall establish raising archives, which shall contain: | | 第十三条 奶畜养殖场应当建立养殖档案，载明以下内容： |
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| 1. the breeds, number, breeding records, labeling, sources, and dates of entering and exiting the farm; | | （一）奶畜的品种、数量、繁殖记录、标识情况、来源和进出场日期； |
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| 2. the source, name, object, time, and quantity of the feed, feed additives, veterinary drugs, etc.; | | （二）饲料、饲料添加剂、兽药等投入品的来源、名称、使用对象、时间和用量； |
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| 3. the information about the quarantine, disease immunity and sanitization; | | （三）检疫、免疫、消毒情况； |
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| 4. the information about the diseases that attacked the dairy animals, the death and innocuous disposal of the dairy animals after the attack of the diseases; | | （四）奶畜发病、死亡和无害化处理情况； |
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| 5. the information about the production, testing and sale of fresh milk; | | （五）生鲜乳生产、检测、销售情况； |
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| 6. other contents as required by the stockbreeding and veterinary administrative department of the State Council. | | （六）国务院畜牧兽医主管部门规定的其他内容。 |
The owner of a dairy animal raising community shall gradually establish raising archives. | |
奶畜养殖小区开办者应当逐步建立养殖档案。 |
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| Article 14 When raising dairy animals, it is forbidden to use the feed, feed additives, veterinary drugs and other substances which are banned by the state and which have direct or potential harm to animals and humans. | | 第十四条 从事奶畜养殖，不得使用国家禁用的饲料、饲料添加剂、兽药以及其他对动物和人体具有直接或者潜在危害的物质。 |
It is forbidden to sell fresh milk produced by dairy animals during the prescribed drug-using period and withdrawal period. | |
禁止销售在规定用药期和休药期内的奶畜产的生鲜乳。 |
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| Article 15 A dairy animal raiser shall ensure that the dairy animals meet the health standards as prescribed by the stockbreeding and veterinary administrative department of the State Council and that the dairy animals receive compulsory immunity. | | 第十五条 奶畜养殖者应当确保奶畜符合国务院畜牧兽医主管部门规定的健康标准，并确保奶畜接受强制免疫。 |
An animal epidemic prevention and control institution shall regularly test the health of dairy animals. Where any dairy animal does not conform to the health standards upon test, it shall immediately segregate it, give medical treatment to it or dispose of it innocuously. | |
动物疫病预防控制机构应当对奶畜的健康情况进行定期检测；经检测不符合健康标准的，应当立即隔离、治疗或者做无害化处理。 |
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| Article 16 A dairy animal raiser shall do a good job in the animal epidemic prevention for the dairy animals and the raising sites. When finding any dairy animals which are attacked or may be attacked by an epidemic disease, he shall immediately report it, stop the production of fresh milk and take such control measures as segregation so as to prevent the spread of the epidemic disease. | | 第十六条 奶畜养殖者应当做好奶畜和养殖场所的动物防疫工作，发现奶畜染疫或者疑似染疫的，应当立即报告，停止生鲜乳生产，并采取隔离等控制措施，防止疫病扩散。 |
A dairy animal raiser shall timely clear, transport and dispose of the egesta and waste produced in raising dairy animals. | |
奶畜养殖者对奶畜养殖过程中的排泄物、废弃物应当及时清运、处理。 |
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| Article 17 A dairy animal raiser shall abide by the fresh milk production technical procedures formulated by the stock-breeding veterinary administrative department of the State Council. A person directly engaging in milking shall have a valid health certificate. | | 第十七条 奶畜养殖者应当遵守国务院畜牧兽医主管部门制定的生鲜乳生产技术规程。直接从事挤奶工作的人员应当持有有效的健康证明。 |
A dairy animal raiser shall timely wash and disinfect the milking facilities and fresh milk storing facilities so as to avoid pollution to the fresh milk. | |
奶畜养殖者对挤奶设施、生鲜乳贮存设施等应当及时清洗、消毒，避免对生鲜乳造成污染。 |
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| Article 18 The fresh milk shall be refrigerated. Any fresh milk which has not been refrigerated after the lapse of more than 2 hours shall not be sold. | | 第十八条 生鲜乳应当冷藏。超过2小时未冷藏的生鲜乳，不得销售。 |
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| Chapter III Purchase of Fresh Milk | | 第三章 生鲜乳收购 |
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| Article 19 The stockbreeding and veterinary administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government shall, in light of the distribution of local dairy sources and under the principle of facilitating dairy animal raisers and promoting the dairy animal raising on a large scale, scientifically plan and reasonably arrange the construction of fresh milk purchase stations. Where necessary, the fresh milk may be purchased at a fixed place in a centralized manner. | | 第十九条 省、自治区、直辖市人民政府畜牧兽医主管部门应当根据当地奶源分布情况，按照方便奶畜养殖者、促进规模化养殖的原则，对生鲜乳收购站的建设进行科学规划和合理布局。必要时，可以实行生鲜乳集中定点收购。 |
The state shall encourage dairy product production enterprises to set up fresh milk purchase stations on their own initiative or purchase existing fresh milk purchase stations under the plan and arrangements. | |
国家鼓励乳制品生产企业按照规划布局，自行建设生鲜乳收购站或者收购原有生鲜乳收购站。 |
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| Article 20 A fresh milk purchase station shall be set up by a dairy product production enterprise, dairy animal farm or professional production cooperative of dairy farmers that has made industrial and commercial registration, shall meet the following conditions and shall obtain a fresh milk purchase license issued by the stockbreeding and veterinary administrative department of the local people's government at the county level: | | 第二十条 生鲜乳收购站应当由取得工商登记的乳制品生产企业、奶畜养殖场、奶农专业生产合作社开办，并具备下列条件，取得所在地县级人民政府畜牧兽医主管部门颁发的生鲜乳收购许可证： |
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| 1. conforming to the plan and arrangements for the construction of fresh milk purchase stations; | | （一）符合生鲜乳收购站建设规划布局； |
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| 2. having a purchase site that meets the environmental protection and sanitation requirements; | | （二）有符合环保和卫生要求的收购场所； |
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| 3. having the cooling, refrigeration and fresh-keeping facilities and low temperature transport equipment which are commensurate with its purchased milk volume; | | （三）有与收奶量相适应的冷却、冷藏、保鲜设施和低温运输设备； |
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| 4. having the experiment, measurement and testing instruments and equipment which are commensurate with the test items; | | （四）有与检测项目相适应的化验、计量、检测仪器设备； |
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| 5. having practitioners who have passed the training and who hold valid health certificates; and | | （五）有经培训合格并持有有效健康证明的从业人员； |
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| 6. having rules on the sanitation management and on ensuring milk quality and safety. | | （六）有卫生管理和质量安全保障制度。 |
A fresh milk purchase license shall be valid for 2 years. No fresh milk purchase station is required to go through the industrial and commercial registration. | |
生鲜乳收购许可证有效期2年；生鲜乳收购站不再办理工商登记。 |
It is forbidden for any other entity or individual to set up any fresh milk purchase station. It is forbidden for any other entity or individual to purchase fresh milk. | |
禁止其他单位或者个人开办生鲜乳收购站。禁止其他单位或者个人收购生鲜乳。 |
The state shall support and subsidize fresh milk purchase stations so as to improve their mechanical milking and fresh milk refrigeration transport capacities. | |
国家对生鲜乳收购站给予扶持和补贴，提高其机械化挤奶和生鲜乳冷藏运输能力。 |
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| Article 21 A fresh milk purchase station shall timely wash and disinfect the milking facilities and fresh milk storage and transport facilities so as to avoid contaminating the fresh milk. | | 第二十一条 生鲜乳收购站应当及时对挤奶设施、生鲜乳贮存运输设施等进行清洗、消毒，避免对生鲜乳造成污染。 |
A fresh milk purchase station shall, under the national standards for the quality and safety of dairy products, regularly test the fresh milk it purchases. No test fee shall be collected from dairy animal raisers. | |
生鲜乳收购站应当按照乳品质量安全国家标准对收购的生鲜乳进行常规检测。检测费用不得向奶畜养殖者收取。 |
A fresh milk purchase station shall keep the quality of fresh milk. | |
生鲜乳收购站应当保持生鲜乳的质量。 |
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| Article 22 A fresh milk purchase station shall establish fresh milk purchase, sale and test records. The fresh milk purchase, sale and test records shall contain the animal owner's name, quantity of a single purchase, test result of fresh milk, where it is sold to, etc., and preserve such records for 2 years. | | 第二十二条 生鲜乳收购站应当建立生鲜乳收购、销售和检测记录。生鲜乳收购、销售和检测记录应当包括畜主姓名、单次收购量、生鲜乳检测结果、销售去向等内容，并保存2年。 |
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Article 23 The price administrative departments of the local people's governments at and above the county level shall strengthen the monitoring and circular reporting of the fresh milk prices, timely release the market supply and demand information and price information. Where necessary, a local people's government at or above the county level may establish a fresh milk price coordination committee consisting of the administrative departments of price and stockbreeding and veterinary, and representatives of the industrial association, dairy product production enterprises, fresh milk purchasers and dairy animal raisers so as to determine the reference prices for fresh milk transactions and make the said reference prices available for both the purchaser and seller to sign contracts.
．．．．．． | | 第二十三条 县级以上地方人民政府价格主管部门应当加强对生鲜乳价格的监控和通报，及时发布市场供求信息和价格信息。必要时，县级以上地方人民政府建立由价格、畜牧兽医等部门以及行业协会、乳制品生产企业、生鲜乳收购者、奶畜养殖者代表组成的生鲜乳价格协调委员会，确定生鲜乳交易参考价格，供购销双方签订合同时参考。
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