(20 111February1China National Certification and Accreditation Administration issued) 1. 1 These Rules are formulated in accordance with the Regulations on Certification and Accreditation in People's Republic of China (PRC), the Administrative Measures on Certification of Organic Products and other relevant regulations.
1.2 these rules stipulate the basic requirements for the procedures and management of certification bodies engaged in organic product certification (hereinafter referred to as certification bodies).
1.3 The certification of organic products sold in People's Republic of China (PRC) shall comply with the provisions of these Rules.
The certification activities of organic products imported from countries/regions that have signed an equivalent memorandum or agreement on organic product certification system with the National Certification and Accreditation Administration (hereinafter referred to as CNCA) shall comply with the relevant provisions of the memorandum or agreement.
1.4 observing the provisions of these rules does not mean that it can be exempted from legal responsibility. 2. 1 Certification institutions engaged in organic product certification activities shall meet the requirements stipulated in the Regulations on Certification and Accreditation of People's Republic of China (PRC), have the technical ability to engage in organic product certification, and be recognized by the National Certification and Accreditation Administration.
2.2 Certification bodies shall submit to CNCA the certification documents that their organic product certification activities conform to these Rules and GB/T 27065 General Requirements for Product Certification Bodies within 0/2 months after obtaining the approval from CNCA. Before submitting the relevant certification documents, the number of certification certificates issued by certification bodies within each approved certification scope shall not exceed 5. 3. 1 Personnel engaged in certification activities shall have the necessary personal qualities; Have relevant professional education and work experience; Received training in organic product production, processing, management, food safety and certification technology, and possessed corresponding knowledge and skills.
3.2 organic product certification inspectors shall obtain the qualification of practicing registration of China Certification and Accreditation Association.
3.3 Certification institutions shall evaluate the ability of their own certification inspectors to meet the needs of implementing organic product certification activities within the corresponding certification scope. 5. 1 certification application
5. 1. 1 The authentication client shall meet the following conditions:
(1) Obtain the legal person qualification registered by the State Administration for Industry and Commerce or relevant institutions;
(2) Having obtained the administrative license prescribed by relevant laws and regulations (if applicable);
(3) The products produced and processed meet the requirements of relevant laws and regulations, safety and health standards and relevant norms of People's Republic of China (PRC);
(4) A documented organic product management system has been established and implemented, and it has been running effectively for more than 3 months;
(5) The product type to be certified should be in the organic product certification catalogue published by CNCA;
(6) The certificate of certification has not been revoked by the certification body for the reasons in 8.5 (1) to (4) within five years;
(7) The certificate of certification has not been revoked by the certification body within one year due to the reasons (5) to (1 1) in 8.5.
5. 1.2 Documents and materials to be submitted by the certification client:
(1) A copy of the certified customer's legal business qualification documents, such as business license, organization code certificate, land use right certificate, contract, etc.
(two) the basic information of the certification client and its organic production, processing and operation:
The name, address and contact information of the certification client; When the authentication subject is not the direct producer or processor of the product, the name, address and contact information of the producer or processor;
General situation of production units or processing sites;
Name, variety and production scale of the products applying for certification, including area, output, quantity, processing capacity, etc. ; Basic information on products that have not applied for certification and products that are organically produced by different production units;
Production history in recent three years, such as the description of agricultural activities such as preventing and controlling diseases, insects and weeds in plant production, the use and harvest of inputs; Collection and description of wild plants; Description of animal and aquaculture feeding methods, disease prevention, input use, animal transportation and slaughter, etc. ;
Apply for and obtain other certifications.
(3) Description of the place of origin (base), including geographical location, land distribution, buffer zone and the use of adjacent land around the place of origin; Description of the surrounding environment of the processing site, factory plan, process flow chart, etc.
(4) The production and processing planning of organic products, including the evaluation of the suitability of the production and processing environment, the description and certification materials of the production mode, processing technology and flow, the management system of inputs such as pesticides, fertilizers and food additives, the establishment of quality assurance, labeling and traceability systems, and the risk control measures for organic production and processing.
(five) the production and processing plan of organic products this year, the sales volume, sales volume and main sales markets of the previous year, etc.
(six) commitment to abide by the law and integrity, accept the supervision and inspection of administrative supervision departments and certification bodies, ensure the authenticity of the materials provided, and implement the statement of organic product standards and technical specifications.
(7) Organic production and processing management system documents.
(8) Organic transformation plan (if applicable).
(9) When the certification client is not the direct producer or processor of organic products, a copy of the written contract signed between the certification client and the producer or processor of organic products.
(10) Other relevant materials.
5.2 Certification and acceptance
5.2. 1 The certification body shall at least disclose the following information:
(1) scope and validity period of certification qualification;
(2) Certification procedures and certification requirements;
(3) certification basis;
(4) certification fee standard;
(five) the rights and obligations of the certification body and the certification client;
(6) Procedures for handling complaints, appeals and disputes by certification bodies;
(seven) the provisions and procedures for the approval, revocation, alteration, suspension, restoration and revocation of the certification certificate;
(8) Requirements for certification bodies to use organic product certification marks, certification certificates and certification body marks or names in China;
(9) Requirements for correct publicity by certification bodies.
5.2.2 Review the application
For certified customers who meet the requirements of 5. 1, the certification institution shall review the submitted application documents and materials within 10 working days according to the requirements of organic product certification basis and procedures, and keep the review records to ensure that:
(1) Certification requirements are clearly defined, recorded and understood;
(2) The differences of understanding between certification bodies and certification customers have been resolved;
(3) The certification body has the ability to provide certification services for the application scope, the workplace of the certification client and any special requirements.
5.2.3 Handling of review results
If the application materials are complete and meet the requirements, the application for certification shall be accepted.
If it is not accepted, it shall notify the certification client in writing and explain the reasons.
5.3 Preparation and implementation of on-site inspection
5.3. 1 The certification body shall appoint inspectors with corresponding qualifications and abilities to form an inspection team according to the certification scope corresponding to the applied products. Each inspection team should have at least one professional inspector with registration qualification within the corresponding certification scope.
The same production unit of the same certified customer cannot be continuously inspected by the same inspector for more than 3 years (including 3 years).
Inspection task
Before the on-site inspection, the certification body shall issue an inspection task book to the inspection team, including but not limited to:
(1) Contact information and address of the certification client;
(2) inspection basis, including certification standards, certification implementation rules and other normative documents;
(3) Inspection scope, including product type, production and processing flow and production and processing base, etc. ;
(4) members of the inspection team and inspection time requirements;
(5) Inspection points, including management system, tracking system, use of inputs and packaging identification;
(6) Non-conformities proposed by certification bodies in the previous year (if applicable).
Document review
Before the on-site inspection, the management system documents of the certification entrusting party shall be reviewed to determine their suitability, sufficiency and compliance with the certification requirements, and the review records shall be kept.
inspection plan
5.3.4. 1 The inspection team shall make an inspection plan, which shall be confirmed by the certification entrusting party before the on-site inspection.
If the certification supervision department has any objection to the inspection plan and plan of the certification body, it shall put forward it at least 2 days before the on-site inspection. Certification bodies should communicate with departments in time and coordinate before on-site inspection.
The on-site inspection time in 5.3.4.2 should be arranged at the high-risk stage of the production and processing of products applying for certification. Due to the production season and other reasons, the initial on-site inspection can not cover all products applying for certification, and the on-site supplementary inspection should be carried out within the validity period of the certification certificate.
5.3.4.3 should conduct on-site inspection on all production activities of production units one by one; Organizations in which multiple farmers are jointly responsible for production (such as agricultural cooperatives or companies+farmers) should inspect all farmers. All processing sites should be inspected. If it is necessary to carry out secondary packaging/segmentation in non-production and processing places, on-site inspection should also be carried out in the secondary packaging/segmentation places to ensure the integrity of the certified products.
On-site inspection should also consider the following factors:
The price difference between organic and non-organic products;
-Similarity of farmers' production systems and planting and breeding varieties within the organization;
—— Non-conformities found in previous years' inspections;
-the effectiveness of the organization's internal control system;
-Impact of reprocessing, sub-packaging and segmentation on the integrity of certified products (if applicable).
Inspection and implementation
Review the management system of the certification client according to the requirements of the certification basis, verify the consistency between the production and processing process and the documents submitted by the certification client according to Article 5. 1.2, and confirm the consistency between the production and processing process and the certification basis. The inspection process shall at least include:
(1) Inspection of production and processing processes and places. If the production unit has non-organic production or processing, it should also check the non-organic part;
(2) Interviews with production and processing managers, internal inspectors and operators;
(3) Review the management system documents and records specified in GB/T 19630.4;
(4) Summary accounting of the output and sales volume of certified products;
(5) Evaluation and verification of traceability system of products, certification marks and packaging marks;
(6) Internal inspection and evaluation of continuous improvement;
(7) Confirm the quality of producing area and production and processing environment, and evaluate the potential pollution risk of organic production and processing;
(8) sample collection;
(9) Verify the corrective and/or corrective measures (if applicable) taken for the nonconformities proposed in the previous year.
Before the end of the inspection, the inspection team shall summarize the inspection situation, clarify and confirm the existing nonconformities to the respondent and the certification entrusting party, and explain the existing problems.
Sample testing
5.3.6. 1 All products applying for certification shall be tested, and the test items shall be determined on the basis of risk assessment. If it is impossible to collect samples before the issuance of the certification certificate, it shall be tested within the validity period of the certificate.
5.3.6.2 certification bodies shall entrust testing institutions with legal qualifications to test samples.
The residue of substances allowed for organic production or processing in 5.3.6.3 shall comply with relevant laws and standards. Prohibited substances in organic production and processing shall not be detected.
5.3.7 Environmental quality status of producing areas
The certification entrusting party shall issue a supervision (inspection) report on the environmental quality of the place of origin by a qualified supervision (inspection) institution to prove that the environmental quality of the place of origin meets the requirements specified in GB/T 19630 Organic Products. The client of the water and soil test report shall be the certification client.
Organic conversion requirements
5.3.8. 1 Production units that fail to maintain organic certification need to undergo organic conversion again and obtain organic certification again.
5.3.8.2's organic conversion plan must be approved by the certification body, and must be verified and confirmed by the certification body every year after the implementation of the conversion plan. Production units that have not completed the conversion according to the conversion plan cannot be certified.
input
5.3.9. The substances listed in1GB/T19630.1appendices A and B and GB/T 19630.2 are allowed to be used in organic production or processing.
In 5.3.9.2, for the input not listed in GB/T 19630. 1 Appendices A and B or GB/T 19630.2 Appendices A and B, the certification client shall submit an application to the certification body before using it, detailing the necessity and ingredients, source of ingredients, method of use, conditions of use, usage amount and quantity. Certification bodies shall conduct evaluation according to the requirements of GB/T 19630. 1 Appendix C or GB/T 19630.2 Appendix C. If it meets the requirements after evaluation, it can only be used after being reported to CNCA for approval by the certification body.
5.3.9.3 CNCA may publish a temporary supplementary list of organic production and processing inputs on the basis of expert evaluation.
5.3. 10 inspection report
5.3. 10. 1 The certification body shall specify the format of the inspection report.
5.3. 10.2 Sufficient information shall be provided through written documents such as inspection records and inspection reports, so that the certification body can make an objective certification decision.
5.3. 10.3 The inspection report shall include the inspection team's judgment on whether the production and processing activities of the certification entrusting party meet the certification requirements through risk assessment, the evaluation on the operational effectiveness of its management system, the information collected during the inspection, the explanation of compliance and non-compliance with the certification requirements, and the judgment on the quality and safety status of its products, etc.
5.3. 10.4 The inspection team shall evaluate the overall implementation of standards by the certification entrusting party, but shall not make a written conclusion on whether the certification entrusting party has passed the certification.
5.4 Certification Decision
5.4. 1 The certification body shall make a certification decision on the basis of on-site inspection, product testing and environmental quality evaluation of the country of origin. At the same time, the factors that should be considered in the certification decision should also include: the characteristics of product production and processing, the stability of enterprise management system, the management of local agricultural and veterinary drugs and the overall integrity level of society.
Certification institutions shall issue certification certificates to certified customers who meet the certification requirements (see Annex 1 and 2 for the basic format).
For certified customers who do not meet the certification requirements, the certification body shall clearly explain the reasons for their failure in writing.
5.4.2 The certification entrusting party shall be granted certification if it meets one of the following conditions:
(1) The audit evidence of production and processing activities and management system meets the requirements of these Rules and certification standards;
(2) Although the production and processing activities, management system and other audit certificates do not fully meet the requirements of these Rules and certification standards, the certification client has completed the correction or (and) corrective measures for nonconformities within the prescribed time limit and passed the verification of the certification body.
5.4.3 If the production and processing activities of the certification entrusting party are under any of the following circumstances, the certification will not be granted:
(1) provides false information and is dishonest;
(2) No management system has been established or the established management system has not been effectively implemented;
(3) using or polluting prohibited substances during production and processing;
(4) The product is found to contain prohibited substances;
(5) The quality of the products applied for certification does not meet the mandatory requirements of relevant national laws, regulations and/or standards;
(6) Re-processing, sub-packaging and segmentation outside the certified on-site inspection site;
(7) Major product quality and safety problems occur within one year or the organic product certification certificate is revoked due to product quality and safety problems;
(8) The correction or (and) corrective measures for nonconformities are not completed within the specified time limit, or the submitted correction or (and) corrective measures do not meet the certification requirements;
(nine) the environment of the place of origin has been polluted by inspection;
(10) Other items that do not meet the requirements of the Rules and/or organic standards and cannot be corrected.
complain
If the certified customer disagrees with the certification decision, he can appeal to the certification body within 10 working days. The certification body shall handle the complaint within 30 working days from the date of receiving it, and notify the certification client in writing of the handling result.
If the certification client believes that the behavior of the certification body has seriously infringed upon its legitimate rights and interests, he may directly appeal to the certification supervision department. 6. 1 The certification institution shall conduct on-site inspection on the certified institution at least once a year. Certification institutions shall reasonably determine the frequency of on-site inspections according to the types and risks of products applying for certification, the stability of the management system of production enterprises and the overall situation of local integrity level. If the same certified variety has multiple production seasons within the validity period of the certificate, on-site inspection shall be conducted in each production season.
In addition, certification bodies should also conduct unannounced on-site inspection on at least 5% of the certified institutions every year on the basis of risk assessment.
6.2 The certification body shall obtain the change information of the certified organization in time, and effectively manage the certified organization to ensure that it continuously meets the certification requirements.
6.3 In the contract signed with the certification client, the certification institution shall clearly stipulate that the certification institution shall establish an information notification system and timely notify the certification institution of the following information:
(1) Legal status, business status, organization status or ownership change information;
(2) Changes in organizational management;
(three) the change of contact address and location;
(4) Information on the management system, production, processing, operation status or process change of organic products;
(five) certification of major animal and plant epidemic information around the production, processing and business premises of products;
(six) important information about the quality and safety of organic products produced, processed and operated, such as serious quality and safety problems found by the relevant departments or major consumer complaints;
(seven) the certified institution is punished for violating the laws and regulations of the state on the safety management of agricultural products and food;
(8) The purchased raw materials or products do not meet the requirements of the certification basis;
(9) Information on recovery and disposal of nonconforming products;
(10) Other important information.
6.4 Sales Certificate
6.4. 1 The certification body shall formulate the application and handling procedures for the sales certificate, and require the certification body to apply for the sales certificate from the certification body before selling the certified products.
6.4.2 Certification bodies shall review the supply agreements signed between certification bodies and customers, as well as the sales scope and quantity of certified products. If it meets the requirements, a sales certificate of organic products will be issued.
6.4.3 When selling certified products, the certification body shall hand over the sales certificate to the purchasing unit. The certification body shall keep a copy of the sales certificate for the certification body to review.
6.4.4 See Annex 3 for the basic format of the sales certificate. 7. 1 The certified organization shall apply to the certification body for re-certification at least 3 months before the expiry of the certification certificate.
When the certified organization's organic product management system and production and processing technology have not changed, the application review and document review procedures can be appropriately simplified.
7.2 The certification body shall conduct re-certification inspection within the validity period of the certification certificate. If the re-certification inspection cannot be carried out within the validity period of the certification certificate due to force majeure, the certified organization shall submit a written application to the certification institution within the validity period of the certificate, explaining the reasons. Upon confirmation by the certification body, re-certification can be implemented within 3 months after the validity of the certification certificate, but it shall not exceed 3 months. Products produced during the extended period shall not be sold as organic products.
7.3 On-site inspection cannot be conducted within the validity period of the certification certificate, and the production units that have not been re-certified within the 3-month extension period need to be re-certified.