Regulatory Measures on Organic Product Certification Management NO. 155 MANUSCRIPT OF STATE GENERAL ADMINISTRATION OF QUALITY SUPERVISION, INSPECTION AND QUARANTINE Chapter I: General Provisions Article 1 (Legislative Purpose and Foundation) The purpose of this regulation is to protect legitimate rights and interests of consumers, producers and sellers, improve the quality of organic products, standardize activities of organic product certification, and promote eco-environmental protection and sustainable development with the requirements of the People's Republic of China Product Quality Act, the People's Republic of China Import and Export Commodity Inspection Act and its implementing regulation, the People s Republic of China Regulation on Certification and Accreditation and other relevant laws as well as administrative regulations. Article 2 (Scope) Any activities involving organic product certification and organic product production, processing and marketing within the territory of the People s Republic of China shall comply with this Measures. Article 3 (Related Definitions) The term organic product in this Measures is defined as a product for human consumption and/or animal feeding, whose production, processing and marketing meet the requirements of the national standard for organic products of the People s Republic of China. The term organic product certification in this Measures is defined as the activities of certification bodies to evaluate the conformity of organic product production, processing and selling processes to the national standard of organic products of the People s Republic of China, according to the requirements of this Measures and the Rules for Implementing the Certification of Organic Products. Article 4 (Management System) Certification and Accreditation Administration of the People s Republic of China (hereinafter referred to as the CNCA) is responsible for organization, implementation, supervision, and comprehensive coordination for domestic organic product certification activities. The quality and technical supervision departments of local governments and the entry-exit inspection and quarantine agencies (hereinafter referred to as Local Certification Supervision Authorities), are responsible for supervision, administration and law 1
enforcement investigation for organic product certification activities within their jurisdiction, in accordance with the provisions of relevant laws and administrative duties. Article 5 (Unified System) The State shall implement a unified organic product certification system, a unified certification directory, unified standards and implementation rules, and a unified certification seal. CNCA is responsible for formulating and revising the organic products certification directory, entitled Rules for Implementing the Certification of Organic Products, and for publishing these rules. Article 6 (International Cooperation and Mutual Recognition) CNCA, based on the principle of harmonization and mutual benefit, collaborates internationally for certification of organic products. International mutual recognition of organic product certification shall be conducted according to an agreement of mutual recognition signed by the State with foreign countries or organizations. Chapter II Implementation of Certification Article 7 (Requirements for Establishing Certification Bodies) Certification Bodies for organic products (hereinafter referred to as CBs) shall be approved by CNCA, and shall obtain legal status before engaging in organic product certification activities. CBs abilities to implement certification activities shall comply with relevant national standards for product certification bodies. Inspectors who engage in certification of organic products should be registered by the national certification personnel registration bodies before undertaking inspection and certification of organic products. Article 8 (Certification Commission) Organic producers, processors (hereinafter collectively referred to as applicants), may voluntarily apply to certification bodies for organic product certification by submitting application materials in accordance with the Rules for Implementing the Certification of Organic Products. CBs shall not accept applications from the applicants who don t meet the environmental requirements of organic production area conforming to the state regulations, or whose products applying for organic certification is not in the organic production certification inventory. 2
Article 9 (Document Review) CBs shall complete document review of applications within 10 days from date received, and decide whether to accept the application. For rejected applications, CBs shall inform the applicant of the reasons for rejection in writing. Within 5 days before on-site inspection, certification bodies shall submit basic applicant information and certification and inspection plans to the CNCA information system. Article 10 (On-Site Inspection, Product analysis and Environmental Monitoring) After accepting the organic product certification application, CBs shall undertake on-site inspection of organic producers and processors in accordance with the Rules for Implementing the Certification of Organic Products; products seeking certification shall be analyzed by testing institutions with statutory qualifications. The environmental monitoring report issued by legally qualified testing organizations should be provided when needed, in accordance with the Rules for Implementing the Certification of Organic Products; other legal and effective environmental monitoring credentials provided by applicant can be recognized. Article 11 (Issuing Certificate) For operations in compliance with the requirements for organic product certification, CBs shall issue an organic product certificate to the applicant and allow the applicant to use China s organic product certification seal; for operations not in compliance with the requirements of organic product certification, applicants should be clearly informed of reasons for rejection in writing. CBs shall be responsible for the certification decisions they have made. Article 12 (Record-keeping Requirements) CBs shall ensure that the organic product certification process is complete, objective and true, and keep complete records of the certification process. All records shall be kept on file to ensure the traceability of the certification process and its outcome. Product testing and environmental monitoring institutions shall ensure that results of analysis are true and objective, and shall keep complete archived records of the testing and monitoring process. All records shall be kept on file. Product testing and environmental monitoring institutions, as well as their personnel, shall be responsible for the content and results of the testing reports. The records mentioned in this Article shall be retained for five years. Article 13 (Follow-up Inspection) In accordance with the provisions of the Rules for Implementing the Certification of Organic Products, CBs shall conduct effective follow-up inspections of certified products and their production and processing to ensure that certified products consistently meet certification requirements. 3
Article 14 (Transaction Certificate) CBs shall establish a procedure for issuing transaction certificates to assure that the category, scope and quantity of organic products for sale by the certified organization are consistent with those listed on the organic certificate. Article 15 (Certification of Processed Products with Organic Ingredients) For processed products that contain no less than 95% organic ingredients (by weight or liquid volume excluding water and salt, similarly hereinafter), organic and organic products certification seal shall be used on the product or packages or labels only after obtaining organic certification. Article 16 (Prohibition of Certification of Products with less than 95% Organic Ingredient) CBs shall not undertake certification activities for processed products containing less than 95% organic ingredients. Chapter III Imports of Organic Products Article 17 The relevant responsible authority for organic product regulation in the country or region exporting organic products to China may apply to CNCA for an equivalence evaluation. CNCA shall accept these applications and organize experts to assess the applications. This evaluation will be conducted through document review and on-site inspection. Article 18 For countries or regions exporting organic products to China whose certification system is equivalent to China s organic product certification system, CNCA may sign a cooperation agreement or memorandum with their relevant authority. Organic products exported to China from these countries or regions shall be managed in accordance with the provisions of the cooperative agreement or memorandum. Article 19 Imported products from countries or regions that have no signed cooperation agreement or memorandum with CNCA, when imported as organic products, shall meet the requirements of related rules, regulations and national standards for organic products in China. Article 20 (Entrusting of Imported Organic Products) Manufacturers, distributors, importers or agents of imported organic products 4
(hereinafter referred to as the certified consignor of imported organic products) may apply certification to CBs approved by CNCA. Article 21 (Certification of Imported Organic Product) The consignor for certification of imported organic products shall submit application materials and documents for certification, including application forms, questionnaires, process flow, product formulation, as well as inputs in production and processing, which should be in Chinese as well. Application materials that do not meet the requirements shall not be accepted by CBs. CBs engaged in imported organic products certification activities shall comply with the provisions of this Measure as well as the Rules for Implementing the Certification of Organic Products. Records of certification and inspection, and inspection reports should be in Chinese. Article 22 (Entry Inspection and Quarantine Declaration) When imported organic products are declared for inspection and quarantine, a copy of the Chinese version of the imported organic products certificate, organic transaction certificate, certification seals, product labels should be submitted. Article 23 (Entry Inspection) Local entry-exit inspection and quarantine authorities shall inspect the copies of organic certificates and organic transaction certificates, product labeling and certification seals of declared imported organic products to check whether the products are consistent with the documents. If not, the products shall be refused entry as organic. When necessary, entry-exit inspection and quarantine authorities may undertake sampling test of declared imported organic products to check whether the products meet the requirements of national standards for organic products in China. Article 24 ( Overseas Certification of Organic Products) CBs shall submit the following written materials to CNCA within 30 days from the date of issuing an organic product certificate for an overseas organization: (1) Category, scope and quantity of products certified; (2) Name, address and contact information of certification consignor who hold the certificates; (3) Name, address and contact information of certified product manufacturer and importer; (4) Copies of certificate and inspection report (both Chinese and English versions); (5) Other materials required by CNCA. 5
Chapter IV Certificates and Seals Article 25 (Certification and Seals) CNCA shall develop the principal format and coding rules of organic certificate, and organic certification seals, as well as its coding rules. Article 26 (Certificate Validity) The period of validity for an organic product certificate is one year. Article 27 (Content of Certificates) Organic product certificates shall include the following information: (1) Name and address of the certification consigor who hold the certificates; (2) Name and address of the producers, processors and production units for the certified products; (3) Quantity, production acreage and varieties of the products that have been certified; (4) Organic certification category; (5) Organic product standards and technical specifications respected; (6) Name of the CB and signature of the responsible person, certification date, and validity date. Article 28 (Changes of Certificates) For consignors who hold a certificate, during the period of validity, application for changes to the certificate shall be submitted to the CB within 15 days since one of the following issues occurs. The CB shall change the certificate within 30 days from the date of receipt of the application for change. (1) Name or legal nature of the consignor, organic producer or processor changes; (2) Product variety and quantity is reduced; (3) Or other needed changes to certificate occur. Article 29 (Withdrawing Certification) A CB shall withdraw the certification within 30 days and publicly announce this, in the following cases: (1) Failure to apply for an extension of certification before its expiry; (2) Certified products are no longer in production; (3) Certification consignor applies to withdraw certification; (4) Other circumstances that require certification to be withdrawn. Article 30 (Suspending Certification) A CB shall suspend the certificate for 1-3 months within 15 days and publicly 6
announce this, if one of the following issues occurs: (1) The use of certificates or seals fails to comply with applicable rules; (2) The production, processing and management system of the certified products do not meet certification requirements, and effective correction or corrective measures can be taken during the suspension period. (3) Other issues that need to suspend the certificate. Article 31 (Revoking Certification) A CB shall revoke the certificate within 7 days and publicly announce this, if one of the following issues occurs: (1) The quality of certified products is not in line with requirements of relevant national regulations and standards, or prohibited substances are detected in certified products. (2) Substances prohibited by the national organic product standards are used in the production and processing of the certified products, or certified products are contaminated by prohibited substances. (3) A certified consignor makes false declaration or conceals required information regarding certified products. (4) A certified consignor uses the certification seal beyond the scope of the certificate. ( 5 ) The environmental quality of the certified production base does not meet certification requirements. (6)The production, processing, selling or management system of the certified products does not meet certification requirements, and the company fails to take effective correction or corrective measures during the suspension period; (7) Certified products are reprocessed, re-packaged and partitioned in production and processing sites that are not indicated in the certificate; (8) A certified consignor fails to take effective measures to deal with major complaints of related parties; (9) A certified consignor is penalized by relevant administration for violating the laws and regulations on national agricultural products, food safety management. (10) A certified organization does not accept the supervision by regulatory authorities and certification bodies; (11) Other issues that need to revoke the certificates. Article 32 (Certification Seals) Organic certification seal in this Measures means the organic product certification seal of China. The terms 中国有机产品 (in Chinese) and organic (in English) are indicated on the organic product certification seal of China. The seal is as follows: 7
Article 33 (Rules for Use of Certification Seal) The organic product certification seal shall be used in accordance with the category, the scope and the quantity defined in the certificate. CBs shall comply with the coding rules of CNCA and provide a unique number (hereinafter referred to as organic code) for each certification seal, and ensure each certification seal can be traced back to the corresponding certificate and certified products, as well as its production, processing unit by effective anti-counterfeiting and traceability technology. Article 34(Rules for Use of Certification Seals) Certified consignors shall use the China organic product certification seal together with the organic code and the CB s name on the certified products or on the smallest product package for sale. The China certification seal may be printed on labels of the certified products, brochures and marketing materials, the size of which may be reduced or enlarged, but the shape or color of which shall not be change. Article 35 (Prohibited Activities) Individuals or organizations are forbidden from using labels or text referencing organic production that mislead the public, such as 有机 (in Chinese) or organic on products or on the smallest product package for sale in the following cases: (1) Products that have not been certified; (2) Certified products that are reprocessed, re-packaged and partitioned in production and processing sites that are not indicated on the certificate. Article 36(Rules on Suspension and Revocation of Certificates) 8
During the suspension period, the certified consignor shall be suspended from using certificate and China certification seal. After the revocation of certificates, the certified consignor shall return the certificate and certification seal to CBs. Chapter V Supervision and Management Article 37 (CNCA Regulatory Responsibilities) CNCA undertakes routine and non-periodic supervision for inspection and certification activities of the organic products. Article 38 (Regulatory Responsibilities of Local Certification Authorities) The local certification authorities shall, in compliance with their respective duties, supervise organic product certification activities, and investigate violations of organic production, processing and sale within their jurisdiction, in accordance with the law. Local entry-exit inspection and quarantine authorities are responsible for inspection of foreign invested certification bodies, imported organic products, and the production, processing, and sale activities of organic products for export. Local quality and technical supervision authorities are responsible for supervision of the domestic certification bodies, and the production, processing, and sale activities of domestic produced or processed organic products for domestic market. Article 39 (Regulatory Supervision of Local Certification Authorities) Regulatory supervision of local certification authorities include: (1) Supervise the certification activities to check if they comply with this Measures and with the Rules for Implementing the Certification of Organic Products. (2) Supervise and make sampling test of certified products; (3) Supervise and inspect the certification,production, processing,importing and marketing organizations of certified products; (4) Supervise and inspect the organic certificate and certification seal; (5) Supervise organic product certification consulting activities to check if they comply with the relevant provisions; (6) Investigate and deal with complaints and appeals of certification and consultation activities of organic product; (7) Investigate illegal activities according to the law. Article 40 (Information System) The CNCA information system regularly publishes dynamic information on organic product certification. CBs shall submit organic product certification information in a timely manner to the information system, and obtain a certificate number through the system before the certificates are issued. 9
CBs shall upload information of certification seal and organic code to the information system before issuing the certification seals to the certified organizations. According to the submitted and uploaded certification information by CBs through the information system, local certification authorities can carry out supervision and inspection of organic product certification activities within their jurisdiction. Article 41 (Records) The certification consignors, sales units and individuals of certified organic products should establish complete product quality and safety traceability system and the production, processing, sales documentation system in the process of production, processing, packaging, storage, transportation and sales. Article 42 (Seller Obligations) Activities of sales organizations and individuals for organic product purchase, storage and transport, sale shall comply with the provisions of national standards for organic products, ensure that the categories, scope and quantity of organic products are consistent with the information on the transaction certificate, and that a copy of organic certificate and transaction certificate of organic products can be provided to the administrative supervision authorities or consumers. Article 43 (Risk Alerts) Certification authorities may issue risk alerts of the organic certification area, certified products or certified organizations, certification bodies based on the animal and plant epidemic information or environmental pollution risk alert released by the national authorities, and the findings of supervising inspection, consumer complaints and the media reports. Certification activities are strictly limited during the risk alert period. Article 44(Exiting Mechanism) If certified organizations provide false information, illegally apply prohibited substances, use organic certification seals beyond the certified scope or cause major accidents in product quality and safety, CBs shall not accept certification applications from these organizations and their production and processing sites within five years. Article 45 (Provisions of Appeal and Complaint) When a certified organization disagrees with the certification decision or conclusions of a CB, they can appeal to the CB. If, after this, they still disagree with the handling conclusion of the CB, they can appeal to CNCA. Article 46 (Provisions of Public Report and Supervision) Any organization or individual shall report violations in organic product certification activities to CNCA or local certification regulatory authorities. CNCA and the local certification regulatory authorities shall investigate and handle these activities and keep informant identity confidential. 10
Chapter VI Penalty Provisions Article 47 (Provisions for Fraudulent and Illegal Trade of Certification Seal) Activities of forgery, fraudulent, illegal trade of certification seal are illegal and shall be punished according to the requirements of the People's Republic of China Product Quality Act and People s Republic of Chian Import and Export Commodity Inspection Act and applicable laws, regulations and rules. Article 48 (Provisions of Forgery, Fraudulent, Illegal Trading, Transferring and altering of Certification certificate) Any Organization or person who forge, falsify, illegally use, illegally trade, transfer, or alter certificates for organic certification shall be instructed to rectify and be fined 30,000RMB by local certification regulatory authorities. Violation of Provision 2, Article 40, a CB issues a certificate with their own code, shall be considered as falsifying certificates. Article 49 Violation of Provisions 2, Article 8 of this Measure, a CB issues an organic certificates to the applicants who don t meet the environmental requirements for organic production area, or whose products applying for organic certification is not in the organic production certification directory, shall be instructed to rectify and be fined 30,000RMB. The illegal gains shall be confiscated if have. Article 50 (Misleading Logo Penalty) Violation of the Article 35 of this Measures, use of 有机 (in Chinese), ORGANIC or other words or images on the package or label of the products that may mislead the public, shall be instructed to rectify and shall be fined 30,000 RMB by local certification regulatory authorities. Article 51 (Penalty of Certification Bodies) CNCA should warn and order CBs to make corrective action that will be announced, when CBs has any of the following issues: (1) does not upload its organic product certification seal, organic codes to the designated CNCA information system in accordance with Provisions 2, Article 40 of this Measures. (2) does not submit the relevant certification information to the designated CNCA information system in accordance with Provisions 2, Article 9 of this Measures or provides information inconsistent with the facts. (3) does not submit relevant materials to the CNCA in accordance with Article 24. Article 52 (Penalty of Certification Bodies) 11
When the Article 14 of this Measures is violated that the quantities of organic transaction certificates issued by a CB, surpass the actual quantities of organic products produced or processed by certified organization, the CB are ordered to be make corrective actions and be imposed a fine from 10,000 RMB to 30,000RMB. Article 53 (Penalty of Certification Bodies) When the Article 16 of this Measures is violated that a CB conduct organic certification for the processed products which contains less than 95% organic ingredients, the CB shall be ordered to make corrective actions and be imposed a fine under 30,000RMB. Article 54 When the Article 30 and 31of this Measures is violated that a CBs doesn t suspend or revoke the organic certificate and announce in time, the CB shall be punished according to Article 60 of the People s Republic of China Regulation on Certification and Accreditation. Article 55 (Penalty to Certified organization) A certified organization is ordered to make corrective actions and be imposed a fine from 10,000 to 30,000 RMB when issues happen as following: (1)Violating the provision of Article 15 of this Measures that processed products not certified are labeled as organic products; (2)Using certification seals out of accordance with Provision 1, Article 33 and Article 34 of this Measures; (3)Continuing to use the certificate and certification seal during suspension or after withdrawal and revocation of certification. Article 56(Penalty for Refusing Supervision and Inspection) A CB or certified organization that refuse to accept the supervision and inspection of CNCA or local certification regulatory authorities shall be given a deadline by which they must take corrective actions, and will be fined 30,000 RMB if they fail to make corrections by that date. Article 57 (Penalty for Evading Inspection or Refusing to Provide True Situation of Imported Organic Products) When imported organic products are inspected and quarantined, those refusing to provide information on the true situation of imported organic products for obtaining relevant certificates from entry-exit inspection and quarantine agencies, or who evade the inspection shall be punished by entry-exit inspection and quarantine agencies according to Article 48, Implementing Regulations of the People's Republic of China Import and Export Commodity Inspection Act. 12
Article 58 (Other Penalties for Violations) Other violations of the organic product certification activities shall be punished in accordance with the provisions of relevant laws, administrative regulations and departmental rules. Chapter VII Supplementary Article 59 (Charges) Structural fee charts for certification shall be in conformity with the provisions of relevant laws and administrative regulations of the State on pricing. Article 60 Organic products for export shall meet the requirements of importing countries or regions. Article 61 The term organic ingredient in this Measures refers to any substance (including additives) using and existing (including modifying forms) in products during the production and processing of organic products. Article 62 (Right of Interpretation) The State General Administration of Quality Supervision, Inspection and Quarantine shall be officially responsible for the explanation of this Measures. Article 63 (Effective Date) This Measures shall be effective from April 1, 2014. Regulatory Measures on Organic Product Certification Management (No. 67 Manuscript) issued by State General Administration of Quality Supervision, Inspection and Quarantine in November 5, 2004 will be abolished at the same time. 13