进口饲料和饲料添加剂申请资料要求
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新饲料添加剂证书[新饲料添加剂申报材料及流程]饲料添加剂是指加入到饲料中,以改善饲料营养价值、促进动物生长和提高饲料利用率的各种化学物质或制剂。
为确保饲料添加剂的安全可靠性,各国都对饲料添加剂进行了严格的监管,并要求饲料添加剂必须获得相关的证书才能在市场上销售和使用。
饲料添加剂证书是指符合国家要求的饲料添加剂申报所需的资质文件,用于证明饲料添加剂的品质安全和合法性。
下面是新饲料添加剂证书的申报材料及流程。
一、申报材料1.饲料添加剂安全性评价报告:包括饲料添加剂的化学成分、生物学特性、毒理学特性、市场占有率等详细信息,以及对动物和人体的影响进行评估。
2.饲料添加剂生产工艺流程图:详细描述饲料添加剂的生产过程及各个环节的控制措施,确保产品的质量和安全。
4.饲料添加剂检测报告:通过实验室对产品进行检测,确保产品符合国家标准和规定。
5.饲料添加剂生产企业的生产许可证和质量管理体系证书:证明企业具备饲料添加剂的生产能力和质量管理体系。
6.饲料添加剂生产企业的安全生产许可证和环保手续:证明企业具备安全生产和环境保护的能力。
二、申报流程1.填写申报表格:申请企业需要填写申报表格,详细描述申请的饲料添加剂的相关信息。
2.提交申报材料:申请企业将填写完整的申报表格及相关材料提交给有关部门。
4.审查验收:有关部门对申报材料进行细致的审查,对企业进行现场验收和取样检测。
5.评审评估:有关部门根据申报材料和现场验收情况,进行饲料添加剂的安全性评估和技术评审。
6.发证公告:经评审评估合格的企业将获得饲料添加剂证书,并进行公告。
7.监督检查:对已取得证书的企业进行定期或不定期的监督检查,确保企业的生产和质量管理体系符合要求。
以上是新饲料添加剂证书的申报材料及流程。
申请企业在申报时,需要准备充分的材料,确保材料的真实性和适用性。
同时,企业需要与有关部门密切合作,按照要求进行申报和审批,保证饲料添加剂的质量和安全性。
进口饲料和饲料添加剂登记管理办法文章属性•【制定机关】农业部(已撤销)•【公布日期】2000.08.17•【文号】中华人民共和国农业部令第38号•【施行日期】2000.08.17•【效力等级】部门规章•【时效性】失效•【主题分类】进出口贸易正文*注:本篇法规已被《农业部关于修订农业行政许可规章和规范性文件的决定》(发布日期:2004年7月1日实施日期:2004年7月1日)修订中华人民共和国农业部令(第38号)《进口饲料和饲料添加剂登记管理办法》于2000年7月18日经农业部常务会议讨论通过,现予发布施行。
部长陈耀邦二000年八月十七日进口饲料和饲料添加剂登记管理办法第一条为加强进口饲料、饲料添加剂监督管理,保证养殖动物的安全生产,根据《饲料和饲料添加剂管理条例》的规定,制定本办法。
第二条本办法所称饲料是指经工业化加工、制作的供动物食用的饲料,包括单一饲料、添加剂预混合饲料、浓缩饲料、配合饲料和精料补充料。
本办法所称饲料添加剂是指饲料加工、制作、使用过程中添加的少量或者微量物质,包括营养性饲料添加剂和一般饲料添加剂。
第三条外国企业生产的饲料和饲料添加剂首次在中华人民共和国境内销售的,应当向中华人民共和国农业部申请登记,取得产品登记证;未取得产品登记证的饲料、饲料添加剂不得在中国境内销售、使用。
第四条进口的饲料、饲料添加剂应当符合安全、有效和不污染环境的原则。
生产国(地区)已淘汰或禁止生产、销售、使用的饲料和饲料添加剂,不予登记。
第五条外国厂商或其代理人申请进口饲料和饲料添加剂产品登记证,应当向中华人民共和国农业部提交下列资料和产品样品:(一)进口饲料或饲料添加剂登记申请表(一式二份,中英文填写)。
(二)代理人需提交生产企业委托登记授权书。
(三)提交申请资料(中英文一式二份),包括下列内容:1、产品名称(通用名称、商品名称);2、生产国(地区)批准在本国允许生产、销售的证明和在其他国家的登记资料;3、产品来源、组成成分和制造方法;4、质量标准和检验方法;5、标签式样、使用说明书和商标;6、适用范围和使用方法或添加量;7、包装规格、贮存注意事项及保质期;8、必要时提供安全性评价试验报告和稳定性试验报告;9、饲喂试验资料及推广应用情况;10、其他相关资料。
进口饲料、饲料添加剂申报指南Application Guidelines for Registration of Imported Feeds and FeedAdditivesNational Feed Industry OfficeApril, 2004Address: National Feed Industry Office, Ministry of AgricultureNo.11, Nongzhanguan Nanli, Beijing, P.R.of China. 100026Tel: 8610-64192831Fax: 8610-64192869IntroductionFeeds and Feed Additives Administration Regulation and Administrative Measures for the Registration of Imported Feeds and Feed Additives specify that foreign enterprises shall apply to the Ministry of Agriculture of the People's Republic of China (MOA) to obtain product registration license for their feed and feed additive products if they are to be place on the market for the first time within the territory of the People's Republic of China. For those feeds and feed additives with no registration license, they are not allowed to be sold or used in the territory of China. In the practice of application, we found that some producers and distributors are unfamiliar with China’s feed regulations, hence resulting in materials submitted in the applications being inadequate or presentations unclear. This Application Guidelines was then compiled to hopefully promote smooth registration procedures for imported feeds and feed additives.CONTENTS1 Scope and Coverage for Registration2 Common Terminology for Feed Industry3 Procedures of Application for licenses of imported feeds and feed additives3.1 Asking for Application Form and Category of Required Materials3.2 Application3.3 Appraisal of the Application Materials3.4 Product Inspection3.5 License Issuing3.6 Inquiries of registration License4 Application Form and Required Materials4.1 Format Requirement for Application Materials4.2 Filling in Application Form4.3 Contents of Required Materials4.4 Additional Information for Pet Food and Aquaculture Feed4.5 Related Regulations and Interpretation for License Application5 Sample Requirements6 Application for Re-registration6.1 Asking for Re-registration Form6.2 Required Materials for Re-registration6.3 Related Regulations for Re-registrationAppendix:1. Application Form for Registration of Imported Feeds and Feed Additives2. A Sample of the Application Form3. Flowchart of Appraisal of imported Feeds and Feed Additives4. A Sample of Chinese Label5. Product Classification6. Application Materials for Appraisal of Imported Products7. Re-registration Form for Imported Feeds and Feed AdditivesApplication Guidelines forRegistration of Imported Feeds and Feed Additives1 Scope and Coverage for RegistrationFeeds and feed additives to be imported to the P.R. of China.2 Common Terminology for Feed Industry (See GB10647- 89)2.1 Feedstuff (Single Feed)Feedstuff originated from only one kind of animal, plant, microbial or mineral source.2.1.1 Energy FeedFeedstuff with less than 18% crude fiber and less than 20% crude protein on dry matter basis.2.1.2 Protein FeedFeedstuff with less than 18% crude fiber and 20% or more crude protein on dry matter basis. 2.2 Complete FeedCompound feed which can meet the nutrition requirements from raised animals (except of water).2.3 Concentrate FeedMixture of protein ingredients, trace minerals, vitamins and non-nutritional feed additives according to a certain formula.2.4 Concentrate SupplementCompound feed mixed at a certain formula with many kinds of feed ingredients to supplement nutrition for herbivorous animals fed on roughage (dry, fresh or silage).2.5 Additive PremixPremix of more than two kinds of feed additives with carriers or diluents at a certain formula. 2.6 Compound PremixPremix of two or more kinds of feed additives in the category of trace minerals, vitamins, amino acids and non-nutritional feed additives with carriers or diluents at a certain formula.2.7 Feed AdditiveMinor or trace ingredients added during feed processing, production or utilization. They were categorized into nutritive and non-nutritive feed additives.2.7.1 Nutritive AdditiveTrace or minor substance to supplement nutrition in feed2.7.2 Non-nutritive AdditiveMinor or trace substance added in the feed to ensure or improve feed quality, promote animal production, ensure animal health and improve feed utilization efficiency.a. Anti-oxidant:Additive added to prevent or delay oxidation or damage of some active ingredients in the feed.b. Preservative:Additive added to prevent or inhibit fermentation or decaying of feed.c. Mould inhibitor:Additives added to prevent mold growth in the feed.d. Flavor enhancement:Additives added in the feed to improve feed palatability and animal appetite.e. Color pigment:Additives added to improve color of animal products or feed.f. Binder:Additive added in the feed to improve molding capacity of mash feed or anti-shape damaging capacity of pellet feed.2.7.3 See Appendix 5 for examples of different products.3 Procedures of Application for Licenses of Imported Feeds and Feed Additives (See Appendix 3 for Flow Chart)3.1Asking for Application Form and Category of Required Materials3.1.1 These documents can be acquired from National Feed Industry Office (NFIO).3.1.2 Downloaded from (Application Documents at left bottom section on home page).3.2 ApplicationAn Applicant shall submit original copy of application materials to NFIO. Application materials include Application Form for Registration of Imported Feeds and Feed Additives(see Appendix 1) and Materials Required for Submission.3.3 Appraisal of the Application MaterialsNFIO shall complete the appraisal of the application materials within 15 working days and inform the applicant of the appraisal result.a. If application materials do not meet requirements, NFIO shall inform the applicant via fax to make supplements or corrections. Application shall not be accepted unless required materials are supplemented or corrected in line with related regulations.Documents that fail to meet requirements will not be accepted.b. If application materials meet requirements, NFIO shall inform the applicant in a Note of Acceptance to send a copy of application documents, samples, Note of Acceptance and test fees (charged by test items) to MOA Feed Quality Inspection Center (FQIC) specified in the Note for product quality inspection.3.4 Product InspectionFQIC shall submit test results to NFIO.a. If a product is qualified, FQIC shall prepare and submit a test report to NFIO.b. If the product is not qualified, FQIC shall inform the applicant to submit samples for a second test. And if the second test still fail, this product shall not be registered in the P. R. of China.FQIC shall not release test report to the applicant and the applicant shall not request the report or its copies.3.5 License IssuingQualified Feeds and Feed additives shall be submitted to MOA for Appraisal. Once approved by MOA, a license will be issued.3.5.1 NFIO will inform the applicant about the date for releasing the license or failure of any product to be registered.3.5.2 The applicant shall pay registration fee of RMB 8300 yuan (remittance, cash or check is acceptable except for USD cash) to Department of Finance of MOA upon obtaining the license. 3.6 Inquiries of registration LicenseThe approval of registration will be announced on MOA Bulletin and also on the web site: . An applicant can inquire about commodity name, manufacturer and registration number of any approved product.4 Application Form and Required Materials Required4.1 Format requirement for application materialsa. One set of original application materials and a copy of it shall be submitted for each product.b. The application materials shall be in both Chinese and English, with Chinese version coming first.c. The English version shall be printed on formal stationery paper heading with manufacturer’s name and with signature or seals.d. The Chinese translation of the application materials shall be the same with the English version, and unrelated information about the products shall not be submitted.e. If materials submitted by the manufacturer are not in English, they shall be translated intoEnglish and Chinese.f. Application materials in Chinese shall be printed with A4 paper, in #4 or small#4 fonts.There’s no specific limitations for the English version.g. Application Form shall be on the first page of the whole set of application materials, whichshall be bounded in durable document folders.4.2 Filling in Application Form (Please see Appendix 2 for the Sample)4.2.1 Commodity nameImported feed and feed additives marketed in the P. R. of China shall have a Chinese name, which shall be defined according to GB/T 10647 Standard. A product shall be named after its real nature, instead of a simple translation of the English pronunciation.4.2.2 Common nameIt means a name that can reflect the nature of a feed and feed additive.4.2.3 Product classification (See Appendix 5)Refer to Common Terminology In Feed Industry (See Section 2).4.2.4 AppearanceIt means color, shape (mash, pellet, crystal and block) and physical properties (e.g. odor, solidity or liquidity)4.2.5 Major and minor ingredients and their contentsSpecification for key nutrition should be filled in the blank under “key ingredient and content”.Other items such as specification of hygiene and heavy metal shall be filled in under “other ingredient and content”.4.2.6 Manufacturer’s name and addressDetailed name and address of the manufacturer shall be filled in as exactly the same as indicated in the free sale certificate, except thata. An applicant is a group company:Name of the producer shall be given, though the group company, to which the producer is affiliated, shall be registered as the applicant. If the group company produces a same product in different countries, this product shall be registered by each of the producers in these countries before being exported to China. If the group company has several plants in different regions in one country, then this product shall also be registered by each of these plants, i.e., one license for one plant or one product. If there’s no specific name for a plant, it can be specified as “xxx plant” under “xxx group company”.b. An applicant places an order with another manufacturer for processing. The actual manufacturer should be filled in “manufacturer column” (co-manufacturer), and the consigner shall be filled in “applicant column”. Co-manufacturing contract or verification letter to the consigner by the co-manufacturer (printed on letterhead paper of the co-manufacturer, and signed by responsible person or properly stamped) is required to verify that the product is co-manufactured with the requirement from the consigner. Co-manufacturer is responsible for the production and the consigner for the sales of the product.c. An applicant is registering for fish meal. When the manufacturer applies, themanufacturer’s name and address shall be given under the columns of “manufacturer” and “applicant”. In this circumstance, distributor has nothing to do with the application.When the first distributor applies, the name and address of the first distributor shall be filled in the column of “applicant”. Under such circumstances, names and addresses of all theproducers shall be given in the one of “manufacturer”. Extra pages can be used if the space is not enough. (Distributors shall submit a list of producers with whom it has relations in fish meal trade, including producers’ name s and addresses). An original copy of application materials is needed only from one of the producers (see 4.3.1-4.3.9).4.2.7 Name and address of applicanta. For most products, manufacturers are the applicants.b. When a group company is an applicant, the plant manufacturing the product shall submit a letter (original and in English) to explain its relationship with the group company.c. When the first distributor is the applicant (only for fish meal), the plant shall submit a letter to explain that the distributor has been authorized to market the fish meal in the P. R. of China.4.2.8 AgencyName, telephone and fax numbers, as well address of the agency shall be provided.4.2.9 Signature and dateDocuments shall be signed by a person authorized by the applicant.4.3 Contents of required materials4.3.1 Certificate of Free Sale (CFS) approved by country or region of origin and materials for registration in other countriesCFS is a certificate that proves production and sales are permitted in a country of origin. CFS is issued by an official department that is in charge of manufacturing of feed or the product itself to certify that the producer is legal in manufacturing the product. CFS also certifies that the product can be safely used as feed or feed additive, and free to sell and export without limitations in and from the country of origin. Name and detailed address of the producer shall be provided in the certificate.If a country of origin is not English speaking, CFS, health certificate or official stamp, which is not in English, shall be notarized by the Chinese embassies in the country. Other application materials are not required for notarization.Chambers of commerce, associations or official notarization departments have no authorities to issue CFS for any products other than fish meal from Peru and Chile.It is operational to provide a copy of an import license once obtained in other countries.4.3.2 Origin, composition and manufacturing method4.3.2.1 OriginInformation about the origin shall be provided, either of animal, plant or basic chemicals for the synthetic process.4.3.2.2 Ingredient compositionComposition or effective ingredients shall be explained, including chemical structure, if there’s any, and detailed name of raw material. For plants and microbes, their names shall be detailed down to genus and strains.4.3.2.3 Manufacturing methodIt includes processing flowchart and literal explanation.Processing flowchart should be logical in describing technical conditions and methods for the key steps. Explanation shall focus on the control indicators for major steps and the whole process of quality control.For microbial products, name, origin and culture media ingredients of the strain shall be additionally provided.4.3.3 Quality Standard, Testing Method, Quality Testing Report and Health Certificate4.3.3.1 Quality StandardA producer shall apply with national standard, industrial standard or standard within the company.The quality standard covers appearance, sense perception, physi-chemical and hygiene indexes.Appearance and sense perception: color, smell and physical appearance.Physi-chemical index: Specification for key nutrition and processing quality of the product shall be provided with ceiling and bottom levels.Hygiene index: limitation for safe usage of toxins, harmful substances or pathogenic microbes of natural, secondary and exogenous sources. These include heavy metals (Pb, As, Hg, Cd), fluorine, nitrite (for fish meal only, calculated as NaNO2) and pathogenic microbes (salmonella, total bacteria count, molds and aflatoxin B1)4.3.3.2 Testing MethodsTesting methods shall be provided for key nutrition and hygienic conditions. Standard code is needed if the testing methods follow the international practice. For example, with national, AOAC and ISO standards, only standard code is needed for such nutrition as crude protein, crude fat, moisture, crude fiber and crude ash. Otherwise, some more information shall be provided like detailed steps of testing, reagents and concentrations, instruments and calculation methods.4.3.3.3 Quality testing reporta.For animal origin protein feed (such as fish meal, meat and bone meal, whey, etc.), a genuine and legal testing report shall be issued by department concerned in the country of origin.b. For other feed and feed additives, a testing reports issued by the producer is acceptable. It is required that the sample used for testing shall be in the same batch with the one to be registered. Moreover, all quality indicators shall be included in the testing report.4.3.3.4 Health certificatea. For fish meal, it shall be certified that no animal origin protein or fat other than fish meal is contained in the product.b. For meat and bone meal (MBM), it is to certify that what origin it is from (such as MBM originated from cattle, pig, or chicken) and that all raw materials are from healthy animals from non-epidemic areas.c. For whey, it is to certify that the fresh milk is supplied by healthy animals and no animal origin protein or fat other than dairy products is contained in the product.d. For fat type product, it is to certify that no dioxin exists in the product.e. Health certificate is a must for a product originated from epidemic areas and suspected of animal origin.f. In other cases, no health certificate is required.4.3.4 Label and trademark4.3.4.1 A label in original and Chinese is required.a. Original label includes the picture and literal explanation on an imported package. A Photo of the label is also acceptable.b. For feed and feed additives to be marketed within the territory of China, a label in Chinese shall be required according to Feed Label Standard (GB 10648-1999). (See appendix 4)4.3.4.2 TrademarkA trademark is necessary, only if the product has been registered in China.4.3.5 Application scope, method and dosageIt means coverage of animals, dosage and notices for using different kinds of feed products. 4.3.6 Package, storage conditions and shelf lifePackaging materials and net weight for each package shall be specified.Storage requirements cover location, conditions and ways of storage.Shelf life means the valid period since the date of production.4.3.7 Providing reports on safety evaluation and stability testing when necessaryThey are only necessary for the feed additives marked with “*” in No. 318 MOA Announcement and those products not listed in this Announcement.4.3.8 Report on feed efficiency and status of extensiona. Report on feed efficiency (i.e. trial feeding reports) and status of extension in other countries or regions are required for imported feed additives to be registered.b. It is not necessary for animal origin feeds permitted by China, such as fish meal, meat and bone meal, whey, fish oil, pet food and aquaculture feed.4.3.9 Letter of authorizationAn applicant shall submit a letter from the producer authorizing the applicant to register the product. No such document is required if the producer register by itself.4.4 Additional information about pet food, aquaculture feed and feed for ornamental fishes4.4.1 The application materials shall be separated respectively for cat food and dog food, and also for dry food and canned food. It means one set of application materials shall be prepared for each categories of dry cat food, canned cat food, dry dog food, and canned dog food. It also is the same case with the registration licenses.4.4.2 For ornamental fish (cat and dog) feed, application materials shall be submitted based on different breeds and ages. For instance, the materials shall be listed in the order of seedling carp, parr carp and matured carp; and in the case of golden fish, it shall be in the order of seedling golden fish, parr golden fish and matured golden fish.4.4.3 For the items mentioned in Section4.3.1-4.3.9. , the materials provided shall be different for the compound feeds of different varieties, with different tastes or for animals at different ages. Of course, some of the items are exempt from that, such as the free sale certificate, manufacturing method and testing methods.4.4.4 For the compound feeds with the same ingredients and of the same quality, but with different pellet size, it is required to describe in the manuals the reasonable sizes for animals at different ages.4.4.5 For the compound feeds of the same quality, but with different colors and tastes, it is required to specify the names of pigments and flavors added in the products.4.4.6 An sample for testing shall be of the same type with the one submitted for registration.A certain amount of testing fee will be collected based on different series of products. Additional 200 USD will be charged for one more taste or shape of the same series.4.5Related regulations and interpretations for license application4.5.1 There are 191 kinds of feed and feed additives that have been approved for use by China. Please see No. 318 MOA Announcement for details.4.5.2 There’s no requirements for a producer of any approved animal origin feed to submit the materials mentioned in Section 4.3.7 and 4.3.8. For instance, protein feeds like fish meal, meat and bone meal, compound feeds like aquaculture feed and pet food, and energy feeds like fish oil and animal fat.4.5.3 For feeds and feed additives that have not been approved or registered by their countries or origins of origin, trial feeding and safety evaluation must be conducted when applied for registration in China. The applicants will cover all the expenditures for the trials and evaluation. (Please see Article 8 of Administrative Measures for the Registration of Imported Feeds and Feed Additives)4.5.4 For feeds and feed additives that have been approved by exporting countries, while not approved for use in China, trial feeding and, if necessary, safety evaluation shall be conductedwhen they are imported by China. Both plans and implementer of the trial or evaluation shall be examined and approved by MOA. The applicants will cover all the expenditures for the trials and evaluation. (Please see Article 9 of Administrative Measures for the Registration of Imported Feeds and Feed Additives).4.5.5 For an imported feed or feed additive with complete application materials and qualified testing results, a license will be issued once upon the approval by the MOA. A product subjective to Article 8 and 9 will receive a license from the MOA after the results of trial feeding and safety evaluation are submitted for consideration of the China National Feed Appraisal Committee. (Please see Article 11 of Administrative Measures for the Registration of Imported Feeds and Feed Additives).4.5.6 For a feed or feed additive that has been approved for production and use in its country of origin, but not in China, its applicant is required to submit application materials according to the requirements from the Category of Application Materials for Appraisal of Imported Products(See Appendix 6). The National Feed Appraisal Committee will organize experts concerned to review these materials.5 Sample RequirementsThe registration of each product requires three samples originated from different batches of raw materials. Each sample shall weigh no less than 200 grams in solidity or 200 ml in liquidity. A testing report for the sample shall be enclosed in the application materials.6 Re-registration6.1 Asking for application form for Re-registration (See Appendix 7)6.1.1 The form is available from NFIO.6.1.2 It can also be downloaded from (See Application Materials at the bottom to the left of the home page)6.2 Requirements for the application materialsTwo copies of the previous license;Two copies of application forms for re-registration (printed in both Chinese and English);Two copies of quality standard specification and manuals;One original copy of authorization letter;and re-registration fee of RMB 4150 yuan for each product.6.2.1 Letter of authorizationA letter shall be submitted by a producer to authorize its distributor, partner or representative to re-register its product on behalf of the producer.No letter of authorization is required in case that a producer or its branch or representative office in China conducts the procedures of re-registration.6.3 Regulations for re-registration6.3.1 The license of registration for imported feeds and feed additives is valid for five years. If a product continues to be marketed within the territory of China after its license expires, re-registration shall be applied within 6 months before the expiry date of the previous license. (See Article 14 of Administrative Measures for the Registration of Imported Feeds and Feed Additives)6.3.2 For a feed or feed additive that are not re-registered on time or not qualified in the sample test for once, its samples shall be submitted for reexamination. A producer whose license has been suspended, however, has no chance for re-registration. (See Article 16 of Administrative Measures for the Registration of Imported Feeds and Feed Additives).6.3.3 Re-registration is not available for any feed or feed additive that has been suspended for production or use in its country or region of origin, or that has failed to pass through the sample test for twice successively in China. (See Article 17 of Administrative Measures for the Registration of Imported Feeds and Feed Additives).6.3.4 A feed or feed additive that has been changed in its producer’s address, quality standard, formula or application scope, shall be re-registered in time. (See Article 18 of Administrative Measures for the Registration of Imported Feeds and Feed Additives).*Applicant: Companies or individuals that apply for registration in MOA. They can be branch company, representative office, distributor, partner or authorized individuals of the producer or applying companies.Appendix 1进口饲料和饲料添加剂申请表Application Form for Registration of Imported Feeds and Feed AdditivesAppendix 2: A Sample of Application Form进口饲料和饲料添加剂申请表Application Form for Registration of Imported Feeds and Feed AdditivesAppendix 3进口饲料和饲料添加剂审批流程图Flowchart of Appraisal of Imported Feeds and Feed AdditivesAppendix 4 A sample of Chinese Labels进口饲料级乳清粉Imported Feed-Grade Whey许可证号:外饲准字200( )号 License Number: Foreign Registration 200 ( )1、本产品符合饲料卫生标准This product is in compliance with feed hygienic standard2、产品成分分析保证值 Product guaranteed analysis specification3Ingredients composition:This product is spray dried with pure whey4、产品标准编号:本产品符合加拿大XXXX 标准。
注:“寸”表示必需的申请材料。
注:“寸”表示必需的申请材料。
进口饲料和饲料添加剂登记申请表(示范文本)流水号Applicant Form for Registration of Import Feed or FeedAdditives-Sample1.境内代理机构应当如实向农业农村部提交有关材料,对翻译材料的准确性负责。
2.境外企业、境内代理机构隐瞒有关情况或者提供虚假材料的,按照《进口饲料和饲料添加剂登记管理办法》第二十九条规定承担相应的法律责任。
1.The domestic agent should submit the genuine documents to the MOA and take full responsibility for the accuracy of the translations.2.According to Article 29 of the Measures for the Administration of Registration of Import Feed and Feed Additives, foreign company and domestic agent have to bear corresponding legal liabilities if they hide relevant information on purpose or provide forged documents.进口饲料和饲料添加剂续展登记申请表(示范文本)流水号Applicant Form for Re-registration of Import Feed and FeedAdditives-Sample变更原因:(说明变更原因) Reasons for Alteration境内代理机构负责人签字: Signature of Domestic Agent盖章:(Seal )1.境内代理机构应当如实向农业农村部提交有关材料,对翻译材料的准确性负责。
饲料添加剂公告附件1:进口饲料和饲料添加剂登记材料要求一、登记范围由外国企业生产的、首次在中华人民共和国境内销售和使用的饲料和饲料添加剂。
我国香港、澳门特别行政区和台湾省生产的饲料和饲料添加剂产品参照本要求登记。
《饲料和饲料添加剂管理条例》所称饲料,是指经工业化加工、制作的供动物食用的饲料,包括单一饲料、添加剂预混合饲料、浓缩饲料、配合饲料和精料补充料。
《饲料和饲料添加剂管理条例》所称饲料添加剂,是指饲料加工、制作、使用过程中添加的少量或者微量物质,包括营养性饲料添加剂和一般饲料添加剂。
二、登记材料的格式要求(一)登记材料包括《进口饲料和饲料添加剂登记申请表》(见表1,以下简称《申请表》)和申请材料(具体内容见表2《进口饲料和饲料添加剂申请材料一览表》,以下简称《申请材料一览表》),如果登记产品为中华人民共和国尚未允许使用的饲料或饲料添加剂,需要经过全国饲料评审委员会组织专家进行评审通过后方可进行登记。
(二)登记材料要求中英文对照,中文在前,英文在后。
如生产国为非英语语种国家,还应附具本语种登记材料。
所有登记材料一式两份,原件和复印件各一份。
(三)外文登记材料原件要求用生产厂家的信头纸出具,并由负责人签字或者加盖公章。
(四)中文登记材料应使用A4规格纸、小四号宋体打印。
(五)登记材料中不应夹带与申报产品无关的信息。
(六)登记材料应按《申请材料一览表》的顺序装订成册并标注页码,《申请表》置于登记材料的首页。
三、《申请表》的填写《申请表》的填写应中、英文对照。
(一)通用名称:能够反映饲料和饲料添加剂产品的真实属性。
(二)商品名称:在中国销售和使用时拟采用的名称,不得完全用外文字母、符号、汉语拼音或数字表示。
(三)产品类别:应与生产国批准的产品类别一致,同时应符合我国《饲料工业通用术语》(GB/T 10647)的要求。
(四)外观:说明产品的颜色、气味、形状(粉末、颗粒、结晶、块状)和状态(固态、液态)。
新饲料、新饲料添加剂申报指南全国饲料工作办公室鼓励研究、创制新饲料、新饲料添加剂是我国饲料工业坚持发展的基本产业政策之一。
为便于申报单位(生产者或研制者)更好地了解新饲料、新饲料添加剂的申报程序,提高申报材料的科学性和完整性,特制定本指南。
1范围本指南阐述了新饲料、新饲料添加剂的申报程序、申报材料要求及相关说明。
本指南适用于新饲料、新饲料添加剂申报。
2 名词解释2.1 新饲料、新饲料添加剂:是指我国研制、尚未批准使用的单-饲料和饲料添加剂。
2.2 创新型新饲料、新饲料添加剂:是指在我国境内研究、创制的,国外尚无报导的单一饲料及饲料添加剂。
2.3 国外批准生产、销售的产品:是指在其它国家己批准生产、销售,国内研制、尚未批准使用的单一饲料及饲料添加剂(受专利保护的产品除外)。
2.4 移植型新饲料、新饲料添加剂:是指已在我国境内其它行业使用,首次应用于饲料的单一饲料及饲料添加剂。
3 申报程序3.1 申报新产品的单位(生产者或研制者),到全国饲料工作办公室(以下简称全国饲料办)或全国饲料评审委员会办公室(以下简称评审办)索取申请表和申报材料项目表,也可从网上下载()。
3.2 填写申请表,并按要求准备申报材料。
申报材料一律使用A4规格纸,小4号字打印,装订成册。
申请表格式见附件1,申报材料项目表见附件2。
3.3 申报单位(生产者或研制者)到所在省(市)级饲料管理部门备案,由省(市)级饲料管理部门在申请表上盖章。
3.4 申报单位(生产者或研制者)将申请表和全套申报材料一式三份报送全国饲料办,由全国饲料办盖章接收,并将全套申报材料转交评审办进行形式审查。
3.5 形式审查后,申报材料完整的,评审办做出受理决定并通知申请单位(生产者或研制者)。
申报材料不完整的,通知申请单位(生产者或研制者)限期补齐,未按规定补齐材料的,不予受理。
申请单位(生产者或研制者)接到受理通知后,按规定缴纳新产品登记费8300元。
3.6 被受理产品,评审办组织专家预审并将预审意见反馈申请单位(生产者或研制者)。
进口饲料和饲料添加剂登记申请材料要求(四)(九)使用目的、适用范围和使用方法详细说明产品的功能用途、适用范围、添加量及使用时的注意事项。
产品在使用过程中有最高限量要求的,还应当提供最高限量值。
(十)包装材料、包装规格、保质期和贮存条件说明产品所使用的包装材料、单位包装的净含量、保质期、贮存条件和贮存注意事项。
北京鑫金证—代理进口饲料及饲料添加剂的注册、登记、备案等。
(十一)生产地以外其他国家、地区的登记材料和产品推广应用情况产品在其他国家、地区获得进口许可的,还应提供相关登记许可证明文件复印件,并简要描述在生产地及其他国家、地区的推广应用情况。
(十二)需技术评审的产品还应提交以下申请材料1.有效组分的化学结构鉴定报告或动物、植物、微生物的分类鉴定报告化学上可定义物质:应准确鉴定申报产品的有效组分,并说明确认实验所用主要仪器和测试方法。
例如,红外光谱、紫外光谱、质谱、核磁共振、化学官能团的特征反应等。
鉴定报告应由生产地认证的机构或中国省部级以上大专院校、科研单位、检测机构等出具。
酶制剂:应提供能够证明酶制剂来源与结构的鉴定报告。
鉴定报告应由生产地认证的机构或中国省部级以上大专院校、科研单位、检测机构等出具。
微生物:应通过菌株的形态学、生理生化特性、分子生物学特性等方法,鉴定至少到种。
菌种鉴定报告应由国际公认的菌种保藏机构出具。
微生物发酵制品:应提供前款所述微生物的菌种鉴定报告。
上述鉴定报告出具机构不得与申报产品的研制单位、生产企业存在利害关系。
2.有效性评价试验报告对于需要通过靶动物试验评定有效性的产品,应提供由农业部指定的评价试验机构出具的试验报告;靶动物有效性试验应按照农业部发布的技术指南或国家、行业标准进行。
农业部技术指南、国家或行业标准规定的可以进行数据外推的情形除外。
北京鑫金证—代理进口饲料及饲料添加剂的注册、登记、备案等。
对于不需要通过靶动物试验评定有效性的产品,应根据产品用途,提供依据规范或公认的方法测定的特性效力的试验报告,如抗氧化剂效力和防霉剂效力测试等。
饲料添加剂生产许可申报材料要求一、许可范围(一)在中华人民共和国境内生产饲料添加剂的企业(以下简称企业)。
(二)饲料添加剂是指在饲料加工、制作、使用过程中添加的少量或者微量物质,包括营养性饲料添加剂和一般饲料添加剂。
饲料添加剂品种见《饲料添加剂品种目录》。
分为以下几种:1.利用有机制备、无机制备、生物发酵、提取等生产工艺直接生产获得的饲料添加剂产品;2.在上述生产工艺中同时得到的两种或两种以上饲料添加剂产品混合物;3.对上述饲料添加剂产品进行精制、脱水、包被等工艺处理而获得的饲料添加剂产品。
(三)本要求适用于以下情形:1.设立:指企业首次申请生产许可;2.续展:指企业生产许可有效期满继续生产;3.增加或更换生产线:增加生产线指企业在同一厂区增建已获得许可产品的生产线;更换生产线指企业对已有生产线的关键设备或生产工艺进行重大调整;4.增加产品品种:指企业申请增加生产许可范围以外的产品;5.迁址:指企业迁移出原生产地址,搬迁至新的生产地址;6.变更:指企业名称变更、法定代表人变更、注册地址或注册地址名称变更、生产地址名称变更。
二、申报材料格式要求(一)企业应当按照《饲料添加剂生产许可申报材料一览表》的要求提供相关材料。
(二)申报材料应当使用A4规格纸、小四号宋体打印,按照《饲料添加剂生产许可申报材料一览表》顺序编制目录、装订成册并标注页码。
表格不足时可加续表。
申报材料应当清晰、干净、整洁。
(三)申报材料中企业提供的工商营业执照、组织机构代码证、劳动合同、职业资格证书、产品标准、环保证明、微生物菌种来源证明、产品主成分指标检测方法验证结论等证明材料的复印件应当加盖企业公章。
(四)申报材料一式两份(包括纸质文件和电子文档光盘),其中一份报送农业部,省级饲料管理部门留存一份。
(五)申报材料电子文档采用PDF格式,相关证明文件应为原件扫描件,文件名为企业全称。
(六)增加或更换生产线、增加产品品种的,仅提供与申请事项相关的资料。
附件1:进口饲料和饲料添加剂申请资料要求(征求意见稿)一、申请范围由境外企业生产的、首次在中国境内销售和使用的饲料和饲料添加剂。
我国香港、澳门特别行政区和台湾省生产的饲料和饲料添加剂产品依照本要求申请登记。
《饲料和饲料添加剂管理条例》所称饲料,是指经工业化加工、制作的供动物食用的产品,包括单一饲料、添加剂预混合饲料、浓缩饲料、配合饲料和精料补充料。
《饲料和饲料添加剂管理条例》所称饲料添加剂,是指在饲料加工、制作、使用过程中添加的少量或者微量物质,包括营养性饲料添加剂和一般饲料添加剂。
进口饲料和饲料添加剂应当遵循安全、有效的原则,并符合生产地和中国相关法律法规和技术标准要求。
生产地未批准生产、使用或禁止生产、使用的饲料、饲料添加剂,不予登记。
二、申请资料的格式要求(一)申请资料包括《进口饲料和饲料添加剂登记申请表》(见表1,以下简称《申请表》)和申请材料(具体内容见表2《进口饲料和饲料添加剂申请材料一览表》,以下简称《申请材料一览表》),如果申请产品为中华人民共和国尚未允许使用的饲料或饲料添加剂,或者属于《进口饲料和饲料添加剂登记管理办法》中规定的特殊情形,需要经过全国饲料评审委员会组织专家进行评审通过后方可进行登记。
(二)申请资料要求中、英、外文对照,中文在前,英文在次、外文在后。
如生产国为非英语语种国家,还应附具本语种登记材料,材料须翻译为英文或中文,翻译文件应当由中国境内公证机关公证,确保与原文内容一致。
所有申请资料一式两份,原件和复印件各一份。
(三)外文登记材料原件要求用生产厂家的文头纸出具,并由负责人签字或者加盖公章;翻译件由代理机构文头纸出具并加盖公章。
(四)中文登记材料应使用A4规格纸、小三号宋体打印,内容完整,不得涂改。
(五)申请资料中不应夹带与申报产品无关的信息。
(六)申请资料首页为目录,整套资料应按《申请资料一览表》的顺序打孔装订成册并标注页码;申请资料一共分为十三项,各项资料之间应当使用明显的区分标志,并标明各项资料名称及在目录中的序号;官方证明文件或公证文件不得随意拆分装订。
(七)非首次申报的申请资料应当提供不予批准通知书或不予受理通知书复印件,补充资料可另装订成册并将再次申报的理由置于首页。
三、《申请表》的填写《申请表》应中、英文对照填写,签字处应当由代理机构负责人签字并加盖公章。
(一)通用名称:能够反映饲料和饲料添加剂产品的真实属性,可以表明产品主要原料或描述产品用途等的文字。
(二)商品名称:包括生产国销售和使用的外文名称和在中国销售和使用时拟采用的中文名称,中文名称简明、易懂、符合中文语言习惯。
不得完全用外文字母、符号、汉语拼音或数字表示,不得误导、欺骗消费者。
(三)产品类别:应与生产国批准的产品类别一致,同时应符合我国《饲料工业通用术语》(GB/T 10647)的要求。
(四)感官:说明产品的颜色、气味、形状(粉末、颗粒、结晶、块状)和状态(固态、液态)。
(五)产品保质期:用“个月或(若干年、天)”表示。
(六)载体名称及含量:含有载体的产品须填写,如没有的请填写“无”。
(八)产品质量标准:包括产品的有效成分含量和卫生指标限量,应与申请资料中的产品质量标准一致。
(九)适用范围:指明产品饲喂对象和饲喂阶段。
(十)使用方法或添加量:指明产品使用方法或添加量;对于预混合饲料、浓缩饲料和精料补充料,还应指出相应配套的推荐配方及其他注意事项;有最高限量要求的,还应当指明最高限量。
(十一)生产厂家及地址:产品的生产厂家名称和工厂地址,不得用总公司和经销商的名称和地址代替,不得只填写信箱号。
对于鱼粉,如果是工船加工的,须填写工船名称及编号。
(十二)申请企业及地址:一般应与生产厂家的名称和地址相同,也可填写总公司的名称和地址。
对于鱼粉,如果是工船加工的,也可填写总公司名称和地址,并标明为海上生产。
(十三)代理机构:代理申请进口登记的单位名称、邮政编码、通讯地址、联系人、联系电话及传真。
四、申请资料内容(一)代理机构的资质证明1.由境外企业委托其常驻中国代表机构申请进口登记的,应当提供《外国企业常驻中国代表机构登记证》复印件并加盖本企业公章。
2.由境外企业委托其他代理机构申请进口登记的,应当提供代理机构法人营业执照和组织机构代码证复印件并加盖企业公章。
(二)委托书1.境外企业委托境内代理机构办理产品进口登记的委托书。
委托书应当由境外企业和在华代理机构共同签署,并经生产国公证机构公证。
委托书应包括委托和被委托单位名称及地址、登记产品名称等信息。
2.委托书中应明确代理机构对提供的申请资料的真实性和翻译资料的准确性负责,代理机构应当按照农业部颁布的《进口饲料和饲料添加剂管理办法》第二十八条规定承担相应的法律责任。
3.委托加工产品还须提供生产厂家和申请企业共同签署的委托加工协议书,并经生产国公证机构公证。
(三)生产国批准在本国允许生产、销售的证明和在其他国家的登记资料1.登记产品及其主要成分在生产国允许作为饲料或饲料添加剂生产、使用的证明文件。
对于源自微生物产品及发酵制品,还应提供生产国权威机构出具的菌种保藏证明文件,包括菌种的属名、种名和菌株保藏编号。
2.由生产国官方机构出具的允许生产厂家合法生产该产品的证明文件。
3.生产国官方机构出具的自由销售证明,应体现产品的名称、生产厂家的名称和具体地址,并证明该产品在本国生产、销售和使用不受任何限制。
4.如果该产品在其他国家获得进口许可,应当提供相关的证明文件或登记许可证复印件。
5.官方证明文件应到中国驻生产国大使馆进行确认,由非英语语种出具的官方证明文件还应提供生产国官方翻译机构出具的英语或中文翻译件,原件和翻译件一并公证。
(四)产品理化性质理化性质包括感官性状(色、味、存在状态等)和物理化学参数(例如沸点,熔点、比重、折光率、在常见溶媒中的溶解度、对光或热的稳定性等)。
(五)产品来源、组成成分1.产品来源:说明产品的动物性、植物性来源或化工合成使用的所有初始原料。
微生物菌种要提供属、种的名称和菌株的编号。
发酵产品还需提供菌种名称、来源和培养基成分。
2.组成成分:产品的原料组成或有效组分,原料名称尽可能详细,有化学结构的应提供化学结构式。
3.转基因产品:遵照国家有关规定办理。
(六)产品制造方法产品生产工艺流程图和文字说明。
流程图应体现生产过程中的关键步骤并注明相应环节所用设备及型号。
文字说明应体现流程中的技术条件和方法、关键步骤技术参数,简要说明生产所用原料、设备、生产过程中的各步骤等。
(七)质量标准、检测方法和质量检测报告1.质量标准:产品的质量标准应与生产国有关管理机构批准质量规格和认可的检测方法一致。
质量标准应包括各种有效成分的含量、产品中各种有害物质的控制指标。
2.检测方法:采用国际标准化组织/国际电工委员会(ISO/IEC)、美国公职化学分析家协会(AOAC)等国际标准的,应标明标准编码;采用其他检测方法的,应提供详细的检验操作规程。
3.质量检测报告:每个产品应提供3个不同批号样品的质量检测报告,每个批号两份样品;动物性饲料及其产品,应提供由生产国官方认可的第三方检测机构出具的质量检测报告;对于二噁英高风险产品还应当提供由生产国官方认可的第三方检测机构出具的质量检测报告。
(八)生产地使用标签式样、中文标签式样及商标1.生产地使用标签:是该产品在生产国使用的标签实样或清晰照片,2. 中文标签式样:在中国境内拟采用的中文标签,应当符合《饲料标签》标准(GB 10648)。
3.商标:已在中国注册商标的产品,应提供商标式样。
(九)使用目的、适用范围和使用方法详细说明产品的适用动物范围、功能用途,在不同动物饲料中的添加量及使用时的注意事项;有最高限量要求的,还应提供最高限量。
(十)包装规格、包装材料、贮存条件、保质期和注意事项1.包装规格:应说明产品的包装材料及单位净重。
必要时,提供产品原始包装袋真实剪样。
2.贮存注意事项:包括贮存场所、贮存条件和贮存方式。
3.保质期:应标明产品的生产日期及保质期限。
(十一)推广应用情况提供该产品在生产国及其他国家的推广应用情况。
(十二)主要参考文献提供产品开发、研究和生产中参考的文献资料。
(十三)技术评审产品还应当提交以下申请资料1. 有效组分的化学结构鉴定报告或动物、植物和微生物的分类鉴定报告有效组分为化学上可定义的物质:应说明确认实验所用仪器和测试的方法。
例如,红外紫外光谱、质谱或核磁共振的谱图,化学官能团的特征反应等,并附第三方出具的规范、真实的鉴定报告。
有效组分为动物、植物和微生物及其产品:应进行分类鉴定,分类鉴定到属、种,必要时到亚种或株,动物、植物分类鉴定应由权威机构承担,微生物鉴定应由农业部指定的机构承担,并出具规范、真实的鉴定报告。
2. 饲喂效果试验报告、残留消解动态以及毒理学安全性评价报告农业部认可的试验机构出具的饲喂效果、残留消解动态以及毒理学安全性评价报告。
申请饲料添加剂进口登记的,还应当提供该饲料添加剂在养殖动物产品中残留可能对人体健康造成影响的分析评价报告。
试验方案需经农业部审查。
试验费用由申请人承担。
需要在中国境内补充安全性评价试验的,试验承担单位由农业部认可,试验方案需经农业部审查,试验费用由申请人承担。
3. 稳定性试验报告、环境影响报告和污染防治措施4. 有最高限量要求的,还应当提供有效组分在饲料产品中的检测方法。
五、质量复核检验的样品要求申请人在收到受理通知单后,应当在15个工作日内将申请产品的样品和受理通知单送交农业部指定的检测机构进行产品质量复核检验。
每个产品须提供3个不同批号的样品进行质量复核检验,每个批号2份样品;每份样品不少于检测需要量的5倍。
样品包装材料应与申报材料一样,包装完整。
检测费用由申请人承担。
必要时,申请人应当协助提供检测机构需要的标准品或化学对照品。
表1进口饲料和饲料添加剂登记申请表表2:注:“√”表示必需的申请材料。
进口饲料和饲料添加剂续展登记材料要求一、续展登记范围进口饲料和饲料添加剂产品进口登记证期满后,仍需继续在中国境内销售和使用,应当在进口登记证有效期届满六个月前内申请续展登记。
二、申请资料的格式要求同《进口饲料和饲料添加剂登记材料要求》中第二项申请资料格式要求。
三、《饲料和饲料添加剂续展登记申请表》(以下简称《申请表》)的填写应中、英文对照。
(一)产品商品名称(二)产品通用名称(三)原进口登记证编号、发证日期:按进口登记证上的内容填写。
(四)生产厂家及地址:产品的生产厂家名称和工厂地址,不得用总公司和经销商的名称和地址代替,不得只填写信箱号。
对于鱼粉,如果是工船加工的,须填写工船名称及编号。
(五)申请企业及地址:一般应与生产厂家的名称和地址相同,也可填写总公司的名称和地址。
对于鱼粉,如果是工船加工的,也可填写总公司名称和地址,并标明为海上生产。