Canada Organic Regime Operating Manual
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Table of Contents
- General Information
Part A Assessment and Designation of Conformity Verification Bodies
- A.1 Objective
- A.2 Requirements for Entering Into an Agreement
- A.3 Initial Assessment and Designation of the CVB also for Reassessments
- A.4 Monitoring and Surveillance of CVB
- A.5 Renewal of the Agreement Between CFIA and CVB
- A.6 Breach of the Agreement, Suspension and Early Termination
- A.7 Complaints Against CVBs
- A.8 CVB Documents Required for Initial Assessment
- A.9 Canada Organic Regime Assessment Cycle
- A.10 Annual Information From The Designated CVBs
Part B Accreditation of certification bodies
- B.1 Objective
- B.2 Initial CB accreditation
- B.3 Monitoring and surveillance of a CB
- B.4 Reassessments of a CB
- B.5 Appeals of CFIA accreditation decision by a CB
- B.6 Appeals of CVB recommendation decision of a CB
- B.7 Reduction of scope, suspension and cancellation of a CB
- B.8 Complaints against CB
- B.9 Records maintained by the CVB
- B.10 CVB agreement with the CB
- B.11 CB documents required for accreditation application (except the cases when a CB changes their CVB)
- B.12 Requirements when a CB changes CVB under the COR
- B.13 Requirements for voluntary withdrawal of a CFIA accredited CB under the COR
- B.14 Requirements when a CB goes out of business
Part C Certification of Organic Product and CB Requirements
- C.1 Objective
- C.2 Procedures for Certification Under COR
- C.3 Timing of Sale or Distribution of Certified Product
- C.4 Appeal, Complaint and Dispute Procedures of CB
- C.5 Issues Regarding Implementation of the Standard
- C.6 Use of Licenses, Certificates and Marks of Conformity
- C.7 Obligations of the CB Relative to Certifications
- C.8 Records Control by the CB and Operator
- C.9 CB Records
- C.10 Requirements when an operator changes a CB under the COR
- C.11 Requirements When a CB Issues Attestation of Compliance
- C.12 Requirements for grower group certification under COR
- Part D Use of the Canada Organic Logo
- Appendix A - Certificate Template - Informative
- Appendix B - Attestation Template - Informative
Version V15, 2018-02-19
This Canada Organic Regime (COR) Operating Manual contains policies and procedures for activities applicable to the COR. The manual provides an overview of the procedure to be followed when the Canadian Food Inspection Agency (CFIA) and Conformity Verification Bodies (CVB) enter into an Agreement, as well as the procedure to accredit certification bodies (CB) and to certify organic products. The goal in producing this manual is to provide a structure so that services are delivered in a consistent and efficient manner.
The Organic Products Regulations (Regulations) were made pursuant to section 32 of the Canada Agricultural Products Act. The purpose of the Regulations is to establish a system by which the CFIA, as the competent authority in Canada for organic products marketed in interprovincial, export and import trade, shall regulate the use of the "Canada Organic" agricultural product legend (Legend) and organic claims.
The Regulations would facilitate international market access, provide more specific protection to consumers against deceptive and misleading labelling practices, through a uniform approach to organic product certification and labelling, and support further development of the domestic market. The need for a federal regulatory regime has been identified and supported by the Canadian organic industry.
The COR CFIA envisions reviewing and amending the COR Operating Manual every five years. The CFIA might decide to review the COR Operating Manual earlier in cases of outstanding findings from peer reviews, changes to the current Organic Products Regulations or International requirements.
Should there be any discrepancy between the COR Operating Manual and the Regulations, the Regulations shall take precedence.
1 Overview of the Canada Organic Regime (COR)
The COR is a non-traditional regime for the CFIA. The Regulations provide a federal program for the regulation of Canadian organic products. The COR is designed to build on the existing system of domestic accreditation and certification. The CFIA is the competent authority that oversees the COR governing the use of the Legend. The CFIA enters into agreements with Conformity Verification Bodies (CVBs) provided these bodies meet the criteria established by the Regulations and CFIA. For the purpose of the Regulations the CVBs are designated by the CFIA to assess, recommend for accreditation and subsequently monitor certification bodies (CB) meeting the applicable accreditation criteria as set out in the Regulations.
The accredited CBs are responsible for the organic certification of agricultural products and organic product packaging and labelling certification. CBs employ inspectors to assess the practices of organic operators to verify that they comply with the regulations. These inspectors are referred herein as Verification Officers (VO). The VO provides the results of their assessment to their CB for evaluation. The CB, in turn, certifies as organic only those products that comply with requirements of the regulations.
In order to facilitate the import/export activities and to verify that importing country requirements are equivalent or in compliance with the COR , an Equivalency Determination between Canada and another country shall be performed. Such determination may result in reducing the importing country's rate of verification and avoid additional certification in the country of origin.
The CFIA is responsible for compliance verification and enforcement of the regulations which activities include label inspections in the marketplace, and audits of CVBs.
Building on the existing organic certification system, the Regulations set out the functions of the COR's two oversight bodies: CVBs and CBs.
The documents listed below are those referenced by this document. At the time of publication, the editions indicated below were valid. As all documents are subject to revision, parties using this document are encouraged to apply the most recent editions of these documents published.
Additional accreditation criteria for bodies that evaluate quality management systems in companies whose operations are on multiple sites in order to certify their products – CAEQ, 2007
CAN/CGSB-32.310-2006, Organic Production Systems General Principles and Management Standards (to the extent these standards are incorporated by reference into the regulations, - developed by the organic industry and the Canadian General Standards Board)
CAN/CGSB-32.311-2006, Organic Production Systems, Permitted Substances List (as incorporated by reference into the regulations and developed by the organic industry and the Canadian General Standards Board)
Certifying operations with Multiple Production Units, Sites and Facilities under the National Organic Program, Formal recommendation by the National Organic Standards Board (NOSB) to the National Organic Program, 2008
European Commission, Directorate H. Sustainability and quality of agriculture and rural development, H.3 Organic Farming, Guidelines on imports of organic products into the European Union, Rev 1 dated 15.12.2008
IFOAM Requirements for Grower groups
ISO/IEC 17011:2004, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17065 Conformity Assessment – Processes and Services Requirements for bodies operating products
SOR/2009-176, Organic Products Regulations (regulations made under the authority of the Canadian Agricultural Products Act)
- Accreditation cycle:
- The period including the initial assessment or reassessment and the subsequent surveillance years.
- The Canada Agricultural Products Act
- The CFIA established by section 3 of the Canadian Food Inspection Agency Act is responsible for the administration of the COR.
- A systemic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
- Canada Organic Regime (COR):
- The Government of Canada regulated system for organic agricultural products.
- The procedure whereby a CFIA accredited certification body provides written assurance that agricultural products are organic as defined in and for the purposes of the Regulations. Certification of products may be based on a range of inspection activities including verification of management practices, auditing of quality assurance systems, and in/out production balances.
- Certification Body (CB):
- means a body that is accredited as a CB in accordance with section 6 of the Regulations and CFIA shall accredit the applicant as a CB on the recommendation of the CVB.
- means adherence with requirements of laws and government regulations (e.g. Organic Products Regulations).
- Conformity Verification Body (CVB):
- means an entity that shall meet the requirements set out in ISO/IEC 17011 to be able to enter into an agreement with the CFIA under subsection 14(1) of the Canadian Food Inspection Agency Act to assess, recommend the accreditation of and monitor the CB.
- Genetically engineered /modified organisms (GMO):
- means products produced through techniques in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
- Group Certification:
- Certification of an organized group of producers with a central office, similar farming and production system, working according to a common internal quality management system, which is established and subject to continued surveillance by the central office. Group certification applies to the group as a whole. Certificate is issued to the central office of the group and shall not be used by a single group member.
- Internal Control System (ICS):
- is a documented internal quality system within a grower group that allows an external CB to delegate the annual inspection of any group members to an identified body or unit within the grower group.
- Involves the gathering of evidence and information, from a variety of sources, relevant to a suspected violation or offence and is intended to refute the defence of due diligence and/or establish intent.
- Multi-ingredient product:
- A type of agricultural product composed of two or more agricultural products.
- Organic Product:
- An agricultural product that has been certified as organic in accordance with the Organic Product Regulations or that has been recognized as such under section 29 of the Regulations.
- Organic Product Regulations (OPR):
- These are the regulations referred to throughout the COR Operating Manual.
- Opportunity for Improvement (OFI):
- OFI is an opportunity to improve the organization's operating efficiency however if not addressed it might lead to a future non-conformity.
- Verification Audit:
- The purpose of a verification audit conducted by the CVB is to check the accuracy and thoroughness of the most recent inspection although it also offers an opportunity for an operator to comment on his inspection or the overall performance of the certification body should they wish to do so. In a verification audit, the CVB auditor repeats part or the whole of the physical inspection in company with the operator and compares any findings with that of the inspector as recorded in the inspection report. Short, partial checks of records are usually included as well.
- Verification Officer (VO):
- Person assigned by the Certification Body to conduct inspections and having the requisite qualifications and experience to conduct inspections for the purposes of the regulations.
- Witness audit (by CFIA):
- The COR audit team witnesses the activities of the CVB auditor during the initial assessment and the monitoring of a CB.
- Witness Audit (by the CVB):
- The purpose of a witness audit conducted by the CVB is to assess the quality of an inspector's performance through observing an inspection in process. An evaluation is made of the degree to which the inspector follows the policies and procedures of the certification body with regard to the application of scheme requirements by the operator. It is also an opportunity to observe the thoroughness with which inspectors investigate issues and the degree to which they are familiar with the reference standard. Auditors should remain silent during a witness audit although inspectors may be questioned further in private following the conclusion of the inspection. Inspectors should at any rate receive a short exit interview during which they may clarify any unclear issues and are informed of any points that the auditor intends to raise in the report.
4 Revision History
|Version||Date||Reason for the revision||Scope of the revision|
|Feb, 2007||Draft of the COO QMS manual sent for peer review||The entire document|
|Jun 20,2007||Feedback from the peer review incorporated in the COO QMS Manual||The entire document|
|Sep 11, 2007||Feedback from the consultation with the industry||The entire document|
|Oct 2008||CFIA comments||Part A|
|Jan 30, 2009
|Amendments to the 2006 Organic Products Regulations||The entire document|
|Consultation with the CVBs||Modifications to Part B: Accreditation under the COR
Modifications to Part C; Certification under the COR
|Additional comments from the CVBs||Modifications to Part B: Accreditation under the COR
Modifications to Part C; Certification under the COR
|V13||Jun 11, 2010||Edited for style and numbering of document. Include comments from CVBs and CFIA. New Part on grower group requirements. New Part on the Standards Interpretation Committee.||The entire document
New Part F
New Part G
|V14||June 26, 2012||Many editorial changes, addition of some new clauses and requirements||The entire document.|
|V15||March 12, 2018||Many editorial changes.||Removal of Parts E and F and modifications to Preface, References, Definitions, Parts A, B and C.10. Moving Part F under C.12.|
Part A Assessment and Designation of Conformity Verification Bodies
These requirements apply to the CVB's accreditation services provided for the purposes of the Regulations. Participation in the COR accreditation program is not intended to prevent CVBs from carrying out other business activities, especially those involving the accreditation of CBs not covered by the Regulations.
Operations resulting from these other activities however should neither constitute an infringement nor result in conflicts of interest with the accreditation activities performed by the CFIA.
Further consideration shall be given to address COR requirements that shall be additional to those required by ISO/IEC 17011.
To outline the process under which the CFIA shall enter into an agreement with a CVB.
A.2 Requirements for Entering Into an Agreement
Only entities that meet the requirements set out in ISO/IEC 17011 may enter into agreement with the CFIA to assess, recommend for accreditation and monitor certification bodies.
A.3 Initial Assessment and Designation of the CVB also for Reassessments
A.3.1 Application and Documents Screening
- A.3.1.1 Any applicant seeking information from the CFIA regarding the conditions under which CFIA shall enter into an agreement with a CVB may consult the CFIA Web site and access information from the CFIA Organic products Homepage.
- A.3.1.2 Upon request, the CFIA sends to the applicant an information package which contains a list of documents to be provided to initiate an assessment.
- A.3.1.3 The applicants may be either private or government entities.
- A.3.1.4 The applicant shall submit to the CFIA the documents listed in section A.8.
- A.3.1.5 The CFIA (COR team) reviews for adequacy the information supplied by the applicant and sends acknowledgement of receipt within 5 working days after reception of the application and proceeds with the assessment.
- A.3.1.6 The application and accompanying documents are reviewed by the COR Lead Auditor to completeness of the application within 15 working days.
- A.3.1.7 When information is missing, the COR Lead Auditor informs the applicant of the necessary additional documentation and indicates that no further processing of the application shall take place until all required information is submitted.
- A.3.1.8 The applicant is required to respond to the clarification questions and document requests within 30 working days or the file shall be closed.
- A.3.1.9 When the COR Lead Auditor determines that the information is complete, the process of document and record review starts.
A.3.2 Document and Record Review
- A.3.2.1 The COR Lead Auditor or other designated CFIA staff shall review all relevant documents and records supplied by the applicant to evaluate its system, as documented, for conformity with the ISO/IEC 17011 requirements as referenced in the Regulations and the additional requirements specified in the COR Operation Manual.
- A.3.2.2 Upon completion of the document review, the COR Lead Auditor prepares Document Review report which indicates any non-conformities (NCs) and opportunities for improvement (OFIs) with the requirements and requests for further information, if necessary.
- A.3.2.3 In some cases, when the number of NCs are very high the COR Lead Auditor may decide to cease the document review and shall notify the applicant accordingly.
- A.3.2.4 The Document Review report is sent to the applicant, with a request to take necessary actions to conform to the applicable requirements.
- A.3.2.5 The CVB has 60 working days to submit evidence of corrective actions for all NCs.
- A.3.2.6 On receipt of the corrective actions COR Lead Auditor reviews the submission and assesses the extent to which the required NCs have been addressed.
- A.3.2.7 Once the COR Lead Auditor assesses that all the amended documents confirm with ISO/IEC 17011 and COR Operating Manual an on- site assessment (audit) shall be arranged.
A.3.3 On-site Assessment
- A.3.3.1 The on-site assessment is conducted by the COR audit team.
- A.3.3.2 The COR audit team prepares and sends to the applicant all the information and documentation needed for the on-site assessment including audit plan and assessment criteria in advance.
- A.3.3.3 During the on-site assessment, the COR audit team shall require access to the following information: organizational setup, personnel, management system documents, internal audit reports, management review reports, accreditation procedures, accreditation records, certification bodies' files, personnel files for the purpose of verifying training records and performance monitoring. The applicant shall ensure this information is available and easily retrievable whether in hard copy or electronic form. Any findings during the on-site audit shall be classified as a NC or an OFI.
- A.3.3.4 The on-site audit shall end with an exit interview where the NCs and OFI shall be presented and discussed.
- A.3.3.5 The applicant shall be given time period of 30 working days to provide corrective actions on the identified NCs from the date of the exit interview. OFIs are to be addressed at the applicant's timeframe.
- A.3.3.6 The COR audit team shall draft out an assessment report which shall include the findings from the on-site assessment.
- A.3.3.7 The draft assessment report shall be provided to the applicant within 30 working days after the on-site audit is completed. It includes the NCs, if any, and OFIs.
- A.3.3.8 The applicant reviews the report content, verifies the accuracy of the facts and submits any corrections to CFIA.
- A.3.3.9 The final assessment report shall be reviewed and approved by the CFIA National Manager responsible for COR and a copy shall be sent to the applicant.
- A.3.3.10 COR Lead Auditor shall verify the implementation of the corrective actions submitted by the applicant before providing recommendation to the CFIA National Manager for decision on entering into an Agreement with the applicant.
- A.3.3.11 In case that the CFIA National Manager decides not to enter into an agreement with the applicant, he shall notify the applicant of its right to request a decision review by the CFIA management of the designation process.
A.3.4 Witness Audit
- A.3.4.1 The witness audit shall be conducted as a means of verifying that the applicant is satisfactorily implementing its procedures.
- A.3.4.2 During the witness audit, the COR audit team shall examine the applicant's auditor's preparation for the audit and the implementation of the CVB's auditing procedures.
- A.3.4.3 The COR audit team and the CVB auditor(s) shall have a closing meeting to discuss any findings identified during the audit in a manner that they are understood and acknowledged by the CVB.
- A.3.4.4 The COR audit team shall draft a witness audit report that shall be shared with the CVB within 30 working days after the witness audit is completed.
- A.3.4.5 The CVB shall review the report content, verify the accuracy of the facts and submit any corrections to CFIA.
- A.3.4.6 The Final witness report shall be approved by the CFIA National Manager before being released.
- A.3.4.7 The witness report shall be issued separately both during the initial and reassessment year and the surveillance years.
A.3.5 Decision Review Process
- A.3.5.1 Any applicant organization can request a review of a designation decision. The request shall be made within 30 working days of notification of the decision in writing to CFIA Executive Director responsible for the Canada Organic Regime. The Executive Director shall review the request and notify the applicant of his decision.
- A.3.5.2 The decision of the Executive Director in this regard shall be final.
A.3.6 Agreement Signature
- A.3.6.1 Based on the results from the final assessment report, the CFIA shall enter into an agreement with the applicant.
- A.3.6.2 The agreement between the CFIA and the CVB expires on the 5th year and shall require renewal every five years following the initial assessment.
A.4 Monitoring and Surveillance of CVB
A.4.1 The CFIA shall monitor the ongoing compliance of the CVB with the Regulations and the Agreement.
A.4.2 The CVB shall submit an annual update report in accordance with A.10.
A.4.3 Under the COR agreement cycle as outlined in section A.9, the CFIA shall conduct CVB on-site surveillance assessment in the 1st, 3rd and 5th year. In the 2nd and 4th year there shall be a document review.
A.4.4 During the five year agreement cycle, the COR audit team shall conduct one witness audit per CVB every year following A.3.4.
A.4.5 The surveillance assessments are conducted following a review of the annual report. During the surveillance assessment the COR audit team shall review the compliance with the agreement and certain elements of the COR.
A.4.6 Following the surveillance assessment the COR audit team shall draft out a surveillance report which shall include the findings from the on-site assessment.
A.4.7 The draft surveillance report shall be provided to the applicant within 30 working days after the on-site audit is completed. It includes the NCs, if any, and OFIs.
A.4.8 The applicant reviews the report content, verifies the accuracy of the facts and submits any corrections to CFIA.
A.4.9 The final report shall be reviewed and approved by the CFIA National Manager responsible for COR and a copy shall be sent to the CVB.
A.4.10 The CVB shall review the report content, verify the accuracy of the facts and submit any corrections to CFIA.
A.4.11 The final surveillance report shall be reviewed and approved by the CFIA National Manager responsible for COR and a copy shall be sent to the CVB.
A.4.12 If any NCs are found during the surveillance the CVB shall be given up to 30 working days to respond.
A.4.13 At any time and upon its own discretion, the CFIA may carry out additional assessments for any NCs with the Agreement Regulations and CFIA requirements. The CFIA shall advise the CVB of this possibility.
A.4.14 The CFIA may conduct unscheduled assessments or visits as a result of valid complaints or changes to the regulations.
A.5 Renewal of the Agreement Between CFIA and CVB
A.5.1 All the CVBs shall undergo full reassessment on the fifth year of the Agreement signature. The procedure for the agreement renewal is the same as the one for initial CVB assessment outlined in A.3 and includes resubmission of all required documentation, on-site assessment and witness audit.
A.5.2 The CVBs shall submit all required documentation eight (8) months prior to the agreement expiration date to allow for the reassessment to be completed in timely manner.
A.6 Breach of the Agreement, Suspension and Early Termination
A.6.1 The CVB understands that its failure to meet any of the terms of the Agreement is considered by the CFIA a breach of the Agreement and as a result, the CFIA could take actions including suspension measures and termination of the Agreement.
A.6.2 If during monitoring of the compliance with the agreement, the CFIA notices NCs, it shall issue a report to the CVB outlining the NCs and the period in which a corrective action plan should be submitted to the CFIA for approval. Upon receipt of the report, the CVB signs it.
A.6.3 Following the report, the CFIA shall provide a notice to the CVB which specifies the period within which the CVB shall have to provide to the CFIA a corrective action plan with defined timeline for approval.
A.6.4 If the CVB fails to provide a corrective action plan within the specified period in the notice, the CFIA shall suspend the CVB.
A.6.5 If the CVB provides to the CFIA a corrective action plan within the specified period in the notice, the CFIA shall verify the adequacy of the proposed corrective action and approve it if it is satisfactory to the CFIA.
A.6.6 If the CFIA is not satisfied with the adequacy of the proposed corrective action, the CFIA shall send a notice for revision to the CVB to revise their corrective action plan with a specified period.
A.6.7 The CVB shall submit to the CFIA a revised corrective action plan for approval within the period specified in the notice for revision.
A.6.8 The CFIA shall review and approve the revised correction action plan if it is satisfactory (The process is on-going until corrective action plan is approved by the CFIA).
A.6.9 The CVB shall implement the corrective action plan as approved by the CFIA. The CVB could be subject to suspension if failing to do so.
A.6.10 The CFIA shall verify the implementation of the corrective action plan and submit a report to the CVB.
A.6.11 If the CVB fails to implement the corrective action plan within the prescribed time period to the CFIA's satisfaction, the CFIA shall submit a report to the CVB outlining the NCs.
A.6.12 The CFIA shall send a notice of suspension to the CVB, outlining the grounds for suspension, the required corrective measures and the period within which those measures shall be implemented to avoid termination of the Agreement.
A.6.13 During the suspension period, the CVB is not authorized to accept new applications for accreditation and conduct initial assessment and reassessment for accreditation however the CVB shall continue conducting its surveillance activities as planned.
A.6.14 Furthermore, the CVB shall provide to the CFIA an updated list of the CBs under their supervision and a list of pending applications for accreditation within five working days after receipt of the notice of suspension.
A.6.15 The CFIA may lift the suspension after it has conducted an assessment to verify that the CVB has implemented the corrective measures within the period specified in the notice of suspension.
A.6.16 The CFIA may, at its sole discretion, terminate the Agreement in the event the CVB does not implement the corrective measures within the period specified in the notice of suspension.
A.6.17 Each Party may decide to terminate the Agreement for any other reasons. That Party shall give to the other Party a minimum of 60 days notice prior to the termination of the Agreement.
A.6.18 In the event that the Agreement is terminated, CFIA shall notify the affected CBs and give them some time to find another assessed CVB to continue their accreditation.
A.7 Complaints Against CVBs
A.7.1 Every complaint concerning a CVB's accreditation activities shall be submitted to the COR Lead Auditor in writing and accompanied by justifying evidence or documents.
A.7.2 The COR Lead Auditor shall acknowledge the complaint within 5 working days in writing.
A.7.3 The COR Lead Auditor shall designate a person from CFIA to follow-up on the complaint or decide to follow-up on the complaint.
A.7.4 The designated person shall gather all required information and prepare a report which is submitted to the COR Lead Auditor at the conclusion of the process.
A.7.5 The complainant shall be informed that the CFIA took appropriate action to correct the situation. However the nature of the action shall remain confident. If no further issues arise, the CFIA shall close the file.
A.7.6 The CFIA maintains the record of each complaint, the corrective and preventive actions taken and the effectiveness of such action.
A.8 CVB Documents Required for Initial Assessment
A.8.1 CVB Documents To Be Submitted Along With The Application For Designation
- A.8.1.1 The Corporate Charter
- A.8.1.2 Any Government Act, Regulation or Decree that gives the CVB the legal authority to accredit prior to becoming a CVB under the COR.
- A.8.1.3 The Corporate structure showing graphically and quantitatively relations of control by shareholders, companies or other groups of the organization.
- A.8.1.4 The general bylaws.
- A.8.1.5 A list of directors, comprising:
- A.188.8.131.52 Members of the board of directors (including specific function, duration of mandate, and affiliation).
- A.184.108.40.206 Board members of a sponsoring organization (if applicable).
- A.8.1.6 The addresses of all locations where the CVB does business and summary of activities from each location.
- A.8.1.7 A copy of the compliance mark (body's name such as it appears on accreditation certificates and any property rights related to it prior to becoming a CVB under the COR).
- A.8.1.8 A copy of the liability insurance for directors and employees.
A.8.2 Description of CVB Decision Making Structures
- A.8.2.1 A description of individuals or Internal bodies making decisions covering:
- A.220.127.116.11 Assessment of applicants,
- A.18.104.22.168 Accreditation of applicants,
- A.22.214.171.124 Appeals,
- A.126.96.36.199 Complaints.
- A.8.2.2 A description of sharing of responsibilities between Head Office and Affiliates (if applicable).
- A.8.2.3 An Organization Chart related to the general administration of the program including names of persons occupying managerial positions in both Head Office and Affiliates (when it applies).
A.8.3 Information on CVB's Operations
- A.8.3.1 A complete list of all CBs including the name and address of every one to which the CVB has granted accreditation for production of organic products prior to becoming a CVB under the COR.
- A.8.3.2 A copy of the board of Director's latest annual report to members or stockholders.
A.8.4 CVB Standards, Policies and Technical Procedures (Quality Manual)
- A.8.4.1 The Quality Manual related to the accreditation program.
- A.8.4.2 The templates for assessment questionnaires used by auditors.
- A.8.4.3 The templates for audit reports.
- A.8.4.4 Lists of documents included in the file on each CB having requested accreditation.
- A.8.4.5 Copy of IAF evaluation of the CVB or other third party assessment against ISO/IEC 17011 standard (if available).
A.8.5 CVB's Human Resources Management
- A.8.5.1 A complete list of employees associated with the CVB to work on COR accreditation including the status and position held by each one.
- A.8.5.2 A copy of the standard contract with these employees.
- A.8.5.3 The selection criteria for persons making accreditation decisions or in charge of overseeing those who make them.
- A.8.5.4 The name of person or list of the members of the internal body (Committee, etc.) assigned either to make accreditation decisions or to oversee those who make them (with their experience or specific training).
- A.8.5.5 The selection criteria for assessors and experts.
- A.8.5.6 A copy of the standard contract with contract assessors.
- A.8.5.7 A complete list of contract assessors (including their training and years of experience, their commercial or financial affiliation).
- A.8.5.8 A copy of the standard contract used with any subcontractors (if applicable).
A.8.6 Information, Material and Forms Forwarded to Accreditation Applicants
- A.8.6.1 A detailed CVB fee schedule for the various services offered (to be available for review during the on-site assessment by CFIA).
- A.8.6.2 Copies of information documents about the COR accreditation program within the CVB that would be provided to potential clients.
- A.8.6.3 A copy of the application forms to be filled out by applicants.
- A.8.6.4 A list of documents that shall be supplied to the CVB by an applicant's CB.
A.8.7 Documents Concerning Rights and Obligations of Designated CVBs
- A.8.7.1 A copy of the contract (template) between the CVB and the CB, to be signed, when the CB is granted accreditation by CVB prior to becoming a CVB under the COR.
- A.8.7.2 An example of an accreditation certificate issued by the CVB prior to becoming a CVB under the COR.
A.9 Canada Organic Regime Assessment Cycle
The following table outlines the types of audits that the CFIA shall conduct of its designated CVBs in the first 5 years after the COR became effective. This same sequence of events shall be logically extended to cover those years subsequent to those shown below.
|Initial AssessmentTable Note 1||On-site surveillanceTable Note 1||Document review||On-site surveillanceTable Note 1||Document Review||Re-assessmentTable Note 1|
|One Witness audit||One Witness audit||One Witness audit||One Witness audit||One Witness audit||One Witness audit|
- Table Note 1
Scheduled on-site surveillance visit may be replaced by a visit as part of a peer review. The CFIA may conduct unscheduled assessments or visits as a result of valid complaints or changes to the regulations
A.10 Annual Information From The Designated CVBs
This section lists those documents or information that the designated CVBs shall submit annually to the CFIA as a part of the on-going monitoring of the designated CVBs.
The information shall be submitted before the end of the first quarter of the calendar year and shall cover the previous 12 months.
- A.1.1 A list of all CBs under their supervision including those transferred from other CVBs with information concerning their corporate entity, name, business addresses; and a description of the certification services that the CBs undertake.
- A.1.2 The number of CBs who have applied for assessment
- A.1.3 Total number of surveillance audits
- A.1.4 Total number of witness audits
- A.1.5 Total number of verification audits
- A.1.6 Total number of reassessment audits
- A.1.7 Total number of complaints under COR
- A.1.8 Total number of appeals under COR
- A.1.9 Copy of the internal audit report
- A.1.10 Copy of the Management's review
- A.1.11 Information on the personnel change
- Information on policy change
Part B Accreditation of certification bodies
Participation in the Canada Organic Regime (COR) accreditation program is not intended to prevent Certification Bodies (CB) from carrying out other business activities, especially those involving the certification of products not covered by the scope of the Regulations.
Operations resulting from these other activities however should neither constitute an infringement nor result in conflicts of interest with the certification program accredited by the CFIA.
This section outlines the CB accreditation requirements and the requirements for the CVB assessing and monitoring the CB responsible for the certification under the COR.
The CVB shall ensure that CB seeking CFIA accreditation to offer certification under COR are compliant with the requirements of the OPR including ISO/IEC 17065 and the requirements of this manual.
Accreditation is obtained as a result of a rigorous process. The applicant shall undergo an assessment conducted by CVB in accordance with ISO/IEC 17011 to verify the CB's compliance with ISO/IEC 17065, the requirements of the COR Operating Manual, the CFIA Directives and memos.
On the recommendation of the CVB, the CFIA accredits the applicant CB. The CFIA shall provide the accredited CB with an accreditation number. The accreditation number granted by the CFIA to a CB means the latter, being a competent, responsible and qualified party has the financial and organizational capacity to manage a certification program that shall result in consistent and credible certification decisions.
B.2 Initial CB accreditation
B.2.1 Application By CB and document review by CVB
- B.2.1.1 An applicant applying for accreditation under the COR shall submit an application form to a designated CVB.
- B.2.1.2 In addition to the application form, the applicant shall provide all supporting documents as listed in section B.11 , and any additional documents deemed essential for the assessment as requested by the CVB.
- B.2.1.3 The CVB shall send acknowledgement of receipt to the applicant CB within 10 working days, shall notify the CFIA about the application, and proceeds with the assessment.
- B.2.1.4 The applicant shall pay the application fees determined by the CVB.
- B.2.1.5 The CVB shall conduct a resource review (as of ISO/IEC 17011 section 7.3) to assess the CVB's ability to carry out the assessment.
- B.2.1.6 The CVB shall prepare for the assessment (as per section 7.5 of ISO/IEC 17011).
- B.2.1.7 The CVB shall conduct the document review against the COR requirements (including ISO/IEC 17065, OPR, COR Manual, CFIA Directives and Memos) and shall communicate the findings from the document review to the CB. It shall include the identification of any non-conformities (NCs) and/or information requests.
- B.2.1.8 The CVB shall require the applicant CB to provide response for all NCs and information requests. The CVB shall determine which NCs shall be resolved before proceeding with an on-site assessment.
- B.2.1.9 The CVB may communicate with the applicant CB or an independent source, in order to obtain any other information needed to examine the application.
B.2.2 On-site assessment of CB
- B.2.2.1 The CVB shall conduct the assessment following the requirements outlined in section 7.7 of ISO/IEC 17011.
- B.2.2.2 The CVB shall select an assessment team that shall proceed with an on-site assessment covering the applicant's certification activities. The CVB may assign one or more members of its personnel and may also retain the services of external auditors or technical experts or both.
- B.2.2.3 The appointed CVB auditor(s) should not have been employed by a CB in a position within a 2 year period from the appointment.
- B.2.2.4 The criteria relative to a CVB auditor's competence, qualifications and experience shall include, among others:
- B.188.8.131.52 Knowledge and understanding of the COR's requirements including accreditation criteria and procedures;
- B.184.108.40.206 Knowledge of Canadian Organic standards and generally accepted experience such as practical experience in production, processing, inspection or certification management would be a major asset relative to conformity assessments;
- B.220.127.116.11 Knowledge of auditing principles, procedures and methods including interviewing techniques and an ability to draft reports in compliance with ISO/IEC 19011 requirements.
- B.2.2.5 The names of the assigned auditors shall be communicated to the CB, who may, based on serious concerns, object to the assignment of any auditor mentioned. In light of the reasons stated by the CB, the CVB may appoint another auditor or retain the one initially selected.
- B.2.2.6 In circumstances where the applicant CB has more than three offices, including its main office, the CVB shall use a sampling process in order to determine which offices shall be visited, based on the following criteria:
- B.18.104.22.168 An obligatory visit to the main office;
- B.22.214.171.124 The two offices handling most of the applicant's operators;
- B.126.96.36.199 The two offices carrying out the key activities concerning the certification process.
- B.2.2.7 The CVB shall send to the applicant CB the information, documentation and relevant instructions needed to conduct witness audit and verification audits, as well as an estimate of expenses pertaining to this visit.
- B.2.2.8 The CVB auditor(s) shall begin every visit with an opening meeting with the applicant's representatives and at a minimum explain the audit objectives relative to accreditation criteria, review the audit plan, and confirm the scope of the evaluation.
- B.2.2.9 The CVB auditor(s) shall conduct interviews with the relevant CB personnel including managers, employees and contractors, as required.
- B.2.2.10 The CVB auditor(s) shall carry out rigorous examination of a sampling of the applicant CB certification files. The CVB auditor(s) shall randomly select the files to be included in the sample, with consideration given to the CB's certification and geographical scope. The examination of files shall ensure that:
- B.188.8.131.52 The documentation found in a operator's file (e.g. signed contracts, initial and updated production/preparation plans, letter of good standing in case of CB change, inspection reports, certification, certification decision and other correspondence, approved inputs, labels, copies of certificates) are complete and up to date;
- B.184.108.40.206 The inspection reports include sufficient information and evidence as per C.2.3.22, needed to make a proper certification decision;
- B.220.127.116.11 The certification decision made by the applicant CB is in line with the evaluation of the operator's production/preparation plan and the results from the inspection report;
- B.18.104.22.168 The applicant CB has verified the implementation of all corrective measures that were requested from the operator;
- B.22.214.171.124 The applicant CB is operating in accordance with the relevant sections of the ISO/IEC 17065.
- B.2.2.11 The CVB auditor(s) shall base the quantity and selection of files to be examined on the following sampling rules:
- B.126.96.36.199 The CVB auditor(s) shall carry out file reviews according to the table below:
|Number of active operators registered with the CB under COR||Number of files to be reviewed|
|Less than 5||All files are subject to a full review|
|Less than 100||Minimum of 5 full reviewsTable note 2 (the number could be increased at the discretion of the CVB)|
|101 to 240||Minimum of 10Table note 3 files, 5 of which must be full reviews|
|241 to 400||Minimum of 12 files, 6 of which must be full reviews|
|401 to 1000||Minimum of 15 files, 7 of which must be full reviews|
|More than 1000||Minimum of 20 files, 10 of which must be full reviews|
- B.2.2.12 The CVB auditor(s) shall verify the competence of the personnel involved in the certification activities of the CB, within the framework of the positions they occupy. The CVB auditor shall review these employees' competence, training and education and shall conduct interviews with some of them.
- B.2.2.13 The CVB auditor shall conduct at least one witness audit as a means of verifying that the applicant CB is implementing its procedures satisfactorily.
- B.2.2.14 The CVB auditor shall, during the witness audit(s), observe the VO preparation for the inspection and his/her adherence to the CB's inspection procedures.
- B.2.2.15 For CB that do not yet have clients in the organic sector, the CFIA and the CVBs shall jointly determine the appropriate evaluation approach.
- B.2.2.16 The CVB auditor shall present the findings from the on-site visit and the witness audit to the CB in a format determined by the CVB.
- B.2.2.17 The CVB shall establish its own reporting procedures in compliance with ISO/IEC 17011.
- B.2.2.18 The CVB shall allow the applicant CB a time period of 30 working days from receiving the CVB report to submit the specific actions taken or planned to be taken in order to resolve the identified NCs.
- B.2.2.19 Failure to implement the planned corrective actions may result in the CVB not recommending the CB accreditation to the CFIA.
- B.2.2.20 COR Lead Auditor may accompany the CVB assessment team to observe the accreditation process.
B.2.3 CVB recommends accreditation to the CFIA
- B.2.3.1 The CVB shall analyze all relevant information and evidence gathered during the document review and the on-site assessment to determine the competence and extent of conformity of the applicant with the COR requirements, including compliance with OPR, ISO 17065, COR Operating Manual, the CFIA directives and memos. The CVB shall evaluate whether the responses and action taken by the applicant CB to resolve any NC appears sufficient and effective as outlined in sections 7.8.5 and 7.8.6 of the ISO/IEC 17011.
- B.2.3.2 If the CVB determines that the provided information is not sufficient or adequate, further information may be requested and /or additional assessment activities may be conducted.
- B.2.3.3 The CVB shall decide to either recommend or not recommend the accreditation of the applicant CB to the CFIA.
- B.2.3.4 The CVB shall only recommend the applicant CB for accreditation if all identified NCs have been adequately addressed by the applicant and when the CVB is confident that the applicant CB has fulfilled the requirements for accreditation.
- B.2.3.5 The CVB shall send to the CFIA the recommendation decision in writing and shall provide to the CFIA a copy of the CVB evaluation report on the applicant CB and any other relevant information to support the accreditation recommendation.
- B.2.3.6 If the CVB refuses to recommend the accreditation of the applicant CB, the CVB shall send a notice to the applicant CB by registered mail or email (with confirmation of receipt from the applicant), stating the reason for the decision. The applicant CB has the right to request that the CFIA review the CVB decision within 30 working days after receipt of the notice.
- B.2.3.7 The CFIA shall review the CVB recommendation. If the CFIA decides to confirm the CVB recommendation, it shall send a copy of its decision with the reason, in writing, to the applicant CB and copy to the CVB.
- B.2.3.8 If the CFIA does not confirm the CVB recommendation, the CFIA shall follow-up with the CVB to discuss their recommendation.
- B.2.3.9 The CFIA shall review the applicant CB documentation and conduct its own assessment, if necessary.
- B.2.3.10 The CFIA shall inform the applicant CB and the CVB on its decision to accredit or not to accredit.
B.2.4 CFIA grants the accreditation
- B.2.4.1 The CFIA shall review the CVB's recommendation and shall make the decision on whether to grant accreditation based on the submitted information.
- B.2.4.2 The CFIA shall inform the applicant CB and the CVB of the accreditation decision made by the CFIA by issuing an accreditation letter.
- B.2.4.3 The CFIA shall grant accreditation valid for five years beginning on the date the accreditation number is granted by the CFIA.
- B.2.4.4 The CB shall be re-assessed, recommended by a CVB and accredited by the CFIA for another five years before the end of the accreditation cycle in order to have its accreditation renewed once this period has ended.
B.2.5 Requirements for granting accreditation number to the CB
- B.2.5.1 CFIA shall assign the CB an accreditation number allowing it to provide certification services under the COR and shall issue a letter which specifies the certification scope and geographical scope for which the accreditation is granted.
- B.2.5.2 The CFIA shall assign an accreditation number no later than 14 working days after the accreditation decision.
- B.2.5.3 The CB shall keep the same accreditation number that they have received originally as long as their accreditation remains valid.
B.3 Monitoring and surveillance of a CB
B.3.1 The CVBs shall be responsible for on- going monitoring of the accredited CB in compliance with the COR requirements including OPR, ISO 17065, COR Operating Manual, the CFIA directives and memos.
B.3.2 The CVBs shall document their procedures and plans for carrying out periodic on-site assessments and other surveillance activities to verify that the accredited CB continue to fulfill the COR requirements. In cases of extenuating circumstances such as natural disasters, political unrest, the CVBs may modify their surveillance activities.
B.3.3 The surveillance visits shall target the verification of specific CB's certification program elements.
B.3.4 After the initial accreditation, the CVB shall conduct an on-site surveillance of the CB within twelve months of the initial accreditation date.
B.3.5 Prior to conducting an on-site assessment the CVB shall request from the CB updated information, on a date specified by the CVB and review it. The information from the CB shall include the following:
- B.3.5.1 Changes in the CB information;
- B.3.5.2 Major changes to the CB policies, procedures and protocols;
- B.3.5.3 Information on complaints and appeals;
- B.3.5.4 The most recent internal audit report;
- B.3.5.5 The most recent management review report;
- B.3.5.6 All reported misuses of the Canada organic logo received by the CB;
- B.3.5.7 All changes in the CB certification personnel that are critical to the operation of its certification activities;
- B.3.5.8 Complete list of certified operations in the COR including name, address and phone number of the certified entity, the type of the operation certified (crops, livestock, processing, wild crop). If provided via a directory on the Internet, it is acceptable provide the URL to the directory instead;
- B.3.5.9 Complete list of operations certified to the terms of Canada's organic equivalence arrangements including name, address and phone number of the certified entity, the scope of certification and their locations. If provided through a directory on the Internet, it is acceptable to provide the URL to the directory instead;
B.3.6 Over the length of the accreditation cycle, for each surveillance visit, the CVB auditor shall examine a number of files, proportional to the number of the active operators registered with the CB, and based on the numbers shown in the table below.
|Number of active operators registered with the CB under COR||Number of files to be reviewed|
|Less than 100||Minimum of 5 full reviewsTable note 4 (the number could be increased at the discretion of the CVB)|
|101 to 240||Minimum of 6 files, 5 of which must be full reviewsTable note 5|
|241 to 400||Minimum of 8 files, 6 of which must be full reviewsTable note 5|
|401 to 1000||Minimum of 10 files, 7 of which must be full reviewsTable note 5|
|More than 1000||Minimum of 12 files, 8 of which must be full reviewsTable note 5|
B.3.7 The CVB shall, over the length of the accreditation cycle, conduct witness audits according to the table below as a means of verifying that the accredited CB implements its procedures as written.
|Number of active operators registered with the CB under COR||Total number of witness audits over the CB accreditation cycle|
|Less than 100||1 witness audits|
|101 to 240||2 witness audits|
|241 to 400||3 witness audits|
|401 to 1000||4 witness audits|
|More than 1000||5 witness audits|
B.3.8 The CVB shall, over the length of the CB accreditation cycle, conduct verification audits according to the table below to verify the information included in the operators' files.
|Number of active operators registered with the CB under COR||Total verification audits over the CB accreditation cycle|
|Less than 100||1 verification audit|
|101 to 1000||2 verification audits|
|More than 1000||3 verification audits|
B.3.9 The CVB shall choose the operator for the verification and witness audits. CVB should take into consideration the CB schedule for the upcoming on-site inspections when selecting the operator for witness audits.
B.3.10 During the verification audit the CVB auditor shall verify, among other matters, that:
- B.3.10.1 The operator has on hand a copy of the CB's certification requirements, as well as any requests for corrective measures submitted to the operator by the CB from the previous CB inspection;
- B.3.10.2 The certified products/ activities are within the scope of the OPR;
- B.3.10.3 The inspection report adequately describes the production system;
- B.3.10.4 The inspection process was able to adequately reveal points of non-compliance with the standard.
B.3.11 The CVB auditor shall record the findings from the on–site visit, the witness audit and the results from the verification audits .The format of each report shall be determined by the CVB.
B.3.12 The CVB shall inform the CB of the results from the surveillance activities by issuing a letter indicating that the CB continues to maintain its compliance with the COR. The CVB shall send a copy of this letter to the CFIA.
B.3.13 The CVB may conduct additional assessments as a result of complaints or significant changes that have affected CB operations at the expense of the CB, at any time during the accreditation period, or upon its own initiative.
B.3.14 The CVB shall impose sanctions such as recommend to the CFIA suspension of the CB if:
- if the CB does not have any operators after two consecutive surveillance assessments in an Accreditation cycle,
- the CB has failed to effectively implement the corrective actions or where the visit reveals that the CB has failed to effectively implement the corrective actions related to conditions that have previously been considered fulfilled.
B.3.15 The CFIA may conduct an unscheduled assessment of an accredited CB at any time during the accreditation period as a result of complaints or concerns, or at its own discretion.
B.3.16 At the request of the CFIA, the CVBs shall compile, review and submit the annual information from the CB using the CFIA template. The following information will be included in the CB annual report:
- B.3.16.1 A list of operators in a spreadsheet, including:
- legal name of the operator
- address of the operator
- type of operation (primary, processing, packaging and labelling, attestation) and
- generic names of the certified products
- B.3.16.2 Number of new certificates (both organic products and packaging)
- B.3.16.3 Number of annual inspections and un-announced inspections
- B.3.16.4 Number of non-conformities and samples taken
- B.3.16.5 Number of complaints
B.4 Reassessments of a CB
B.4.1 The CB shall apply for reassessment in a timely manner to allow the CVB to complete all assessment activities before the accreditation expires.
B.4.2 In the event of reassessment the CVB shall follow the requirements for initial assessment outlined in section B.2 except the requirement for surveillance visit within 12 months.
B.4.3 Following the reassessment, the CVB shall follow the requirements for accreditation recommendation outlined in section B 2.3.
B.4.4 The CB shall continue to be responsible for providing access to records, files and other related documentation to the CVB and the CFIA during reassessment and continued accreditation oversight activities.
B.5 Appeals of CFIA accreditation decision by a CB
B.5.1 Any applicant CB has the right to request that the CFIA review the accreditation decision. The appeal against the decision shall be made within 30 working days of notification of that decision pursuant of the Regulations.
B.5.2 The appeal shall be filed in writing along with all the necessary supporting documents.
B.5.3 The CFIA shall give the final decision on the appeal. The decision of the CFIA in this regard shall be final.
B.6 Appeals of CVB recommendation decision of a CB
B.6.1 The CVB shall document their own appeal policy and procedure to deal with appeals against final recommendations made by the CVB to the CFIA and also against specific CVB decisions.
B.6.2 The CVB policies shall address appeals of the following decisions as minimum:
- B.6.2.1 Decision whether to proceed with a visit;
- B.6.2.2 Decision regarding any additional visit;
- B.6.2.3 Decision to terminate an evaluation process;
- B.6.2.4 Decision whether to recommend the reduction of accreditation scope to CFIA.
B.7 Reduction of scope, suspension and cancellation of a CB
B.7.1 The CVB shall recommend to the CFIA suspension of the accreditation of a CB if the CB has not complied with any provision of the Act, the Regulations, ISO/IEC 17065 or the Operating Manual.
B.7.2 The CVB shall document procedures for identification and management of NCs and recommendations for CB suspension to the CFIA as per section 9 of the Regulations.
B.7.3 The CVB may apply one or more of the following sanctions in an event of NC with the surveillance/accreditation contract, failure to fulfill conditions or breach of the accreditation requirements:
- B.7.3.1 issuance of warning letter;
- B.7.3.2 impose additional conditions and insist on corrective action according to a timetable;
- B.7.3.3 recommend to the CFIA to reduce the accreditation scope;
- B.7.3.4 recommend to the CFIA suspension of the CB with a specified timeframe for addressing the corrective actions;
- B.7.3.5 recommend to the CFIA accreditation cancellation.
B.8 Complaints against CB
B.8.1 The CVB shall document its policies and procedures that outline how complaints related to accredited CB and their operators are handled by the CVB.
B.8.2 The CVB shall acknowledge receipt of any complaint received from the CFIA within 5 working days.
B.8.3 The CVB shall begin the investigation of the complaint as per its own procedures, or forward the complaint to the appropriate CB for investigation if the complaint is on a certified organic product, producer or CB personnel.
B.8.4 When passing complaints to the appropriate CB, the CVB shall ensure that
B.8.5 Within 20 working days, the CVB shall inform the CFIA of the following:
- the status of the complaint
- what actions have or will be taken to resolve the complaint
- the expected timeline for resolution of the complaint
- requests for additional information as required
B.8.6 The CVB shall endeavour to close all complaints received in a timely manner. Upon closure of the complaint the CVB shall provide the CFIA with the following:
- confirmation that the CVB considers the complaint adequately closed
- a summary of the actions the CVB/CB took to close the complaint
- any important follow-up information (e.g. unannounced audit to verify, grounds for suspension, etc.)
B.8.7 The CFIA shall inform the CVB that the complaint is considered closed once the CFIA has reviewed the information provided and determines that no additional information is required.
B.8.8 In case that the complaints cannot be resolved between the CB and the CVB, the CFIA is the final step to hear the issue.
B.9 Records maintained by the CVB
B.9.1 The CVB shall maintain records on the CB they recommended for accreditation to demonstrate that the requirements for accreditation, including competence, have been effectively fulfilled. The records to be maintained include:
- B.9.1.1 general features of the CB, including corporate entity, name, addresses, legal status and human and technical resources;
- B.9.1.2 general information concerning the CB such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of accreditation;
- B.9.1.3 clearly defined scope of accreditation;
- B.9.1.4 a contract to fulfill the requirements for accreditation and the other obligations of the CB, including submitting all necessary documentation requested in section B.11;
- B.9.1.5 a description of the conformity assessment services that the CB undertakes, and a list of standards, methods, or proceduresfor which the CB seeks accreditation, including limits of capability where applicable;
- B.9.1.6 a copy (on paper or in electronic form) of the quality manual of the CB, and relevant associated documents and records (refer to section B.11).
B.10 CVB agreement with the CB
B.10.1 The CVB shall prepare and implement surveillance agreement (contract) between the CB and CVB that outlines the rights and duties of the CB and the CVB which shall be signed by the CB and the CVB.
B.10.2 The CVB shall provide a sample of this agreement as part of the application package provided to the CB.
B.11 CB documents required for accreditation application (except the cases when a CB changes their CVB)
This section lists those documents or information that the applicant CB is to submit to the CVB as part of its initial and reassessment application as a CB.
B.11.1 Documents pertaining to the CB
- B.11.1.1 The Corporate Charter.
- B.11.1.2 The corporate structure showing graphically and quantitatively relations of control by shareholders, companies or other groups for the organization.
- B.11.1.3 The general by laws.
- B.11.1.4 A list of directors, comprising:
- members of the board of directors (including specific function, duration of mandate, and affiliation)
- board members of a sponsoring organization (if applicable)
- B.11.1.5 The addresses of all locations where the firm does business and summary of activities from each location.
- B.11.1.6 A copy of the compliance mark (body's name such as it appears on the label or certified product) and any property rights related to it.
- B.11.1.7 In the case of CB already accredited by an official organization (e.g. another accreditation body), a copy of the accreditation certificate for the CB from the other organization.
B.11.2 Description of decision making structures
- B.11.2.1 A description of individuals or internal bodies making decisions covering:
- product certification
- brand name control (certifying body's name and logo)
- along with their mandate, their procedures, and the manner in which they are designated
- B.11.2.2 A description of sharing of responsibilities between Head Office and Affiliates (if applicable).
- B.11.2.3 An organization chart related to the general administration of the program including names of persons occupying managerial positions in both Head Office and Affiliates (if applicable).
B.11.3 Information on CB's operations
- B.11.3.1 Copy of the latest annual financial statements, including balance sheet, revenues and expenses.
- B.11.3.2 List of countries, provinces or states in which the body is carrying out certification activities.
- B.11.3.3 Complete list of all firms including the name and address of every one to which the body has granted a compliance certificate, in the one or more fields for which it has applied for accreditation:
- a compliance certificate for the certified products
- a certificate of recognition for any inputs or services
- B.11.3.4 Copy of the Board of Director's latest annual report to members or stockholders.
B.11.4 Standards, policies and technical procedures (quality manual)
- B.11.4.1 The Quality Manual related to the certification program.
- B.11.4.2 Templates of inspection questionnaires used by VO.
- B.11.4.3 Templates of inspection reports.
- B.11.4.4 List of documents included in the file for each operator having requested certification.
B.11.5 CB human resources management
- B.11.5.1 A complete list of certification employees including the status and position held by each one.
- B.11.5.2 A copy of the standard contract with certification employees.
- B.11.5.3 The selection criteria for persons making certification decisions and persons in charge of overseeing people who make certification decisions.
- B.11.5.4 The name of persons or list of the members of the internal body (committee, etc.) assigned either to make certification decisions or to oversee those who make them (with their experience or specific training).
- B.11.5.5 The selection criteria for the VOs.
- B.11.5.6 Copy of standard contract between the CB and VO.
- B.11.5.7 Complete list of VOs (including their training and years of experience, their commercial or financial affiliation).
- B.11.5.8 A copy of the standard contract used with any other type of subcontractors (if applicable).
B.11.6 Information material and forms forwarded to an applicant
- B.11.6.1 A detailed fee schedule for the certification services offered.
- B.11.6.2 Copies of information documents about the certification program.
- B.11.6.3 Copy of the application forms to be filled by applicants.
- B.11.6.4 Copies of production or preparation compliance plan forms to be filled annually by applicants.
B.11.7 Documents concerning rights and obligations of certified operators
- B.11.7.1 Contract(s) to be signed by certification applicants, regulating the use of marks of compliance (licenses).
- B.11.7.2 Copy of the certificate issued by the CB in accordance with the COR and equivalency arrangement (if applicable).
- B.11.7.3 Electronic copy of a label using the name of the CB and Canada Organic Logo.
B.12 Requirements when a CB changes CVB under the COR
This section is applicable to the situation where a CFIA accredited CB chooses to change their CVB.
B.12.1 Requirements on CB
- B.12.1.1 The CB shall submit an application form to another designated CVB and notify the current CVB of the decision to change.
- B.12.1.2 The CB shall provide all supporting documents as requested by the receiving CVB.
- B.12.1.3 The CB shall pay the application fees determined by the receiving CVB.
- B.12.1.4 The CB shall return its previous Accreditation Letter to the CFIA immediately after receiving an updated letter from the CFIA after the change has been completed.
B.12.2 Requirements on sending CVB
- B.12.2.1 The CVB shall inform the CFIA immediately when a CB notifies them of their intention to change CVBs.
- B.12.2.2 The CVB shall provide to the CFIA the results from the last CB audit (copy of the most recent audit reports, associated NCs status and any outstanding issues).
B.12.3 Requirements on receiving CVB
- B.12.3.1 The CVB shall send acknowledgement of receipt to the applicant CB within 10 working days and shall notify the CFIA immediately about the application.
- B.12.3.2 After CFIA reviews the documentation provided by the sending CVB, and after discussion between the receiving CVB and the CFIA, the receiving CVB shall:
- B.188.8.131.52 Accept the compliance status of the CB with further oversight activities as agreed by the CFIA and the receiving CVB.
- B.184.108.40.206 Send a recommendation letter to the CFIA to confirm that the CVB will take over the monitoring of the CB and to request amendment to the current CB accreditation letter.
- B.220.127.116.11 Take over the monitoring of the CB from the point in the accreditation cycle established by the sending CVB.
B.12.4 Requirements on CFIA
- B.12.4.1 The CFIA shall verify the CB status with the sending CVB and shall request the CVB provide to the CFIA, the results from the last CB audit (copy of the most recent audit reports, associated NCs status and any outstanding issues).
- B.12.4.2 The CFIA shall review the documentation provided by the sending CVB and shall discuss the CB status with the receiving CVB to ensure that the change is smooth and without negative impact. The CFIA shall discuss with the receiving CVB the outstanding requirements of the accreditation cycle.
- B.12.4.3 The CFIA shall issue a revised Accreditation letter to the CB after receiving a recommendation letter from the receiving CVB.
- B.12.4.4 The CFIA shall change only the name of the CVB on the revised Accreditation letter.
- B.12.4.5 The CFIA shall request the CB to return to the CFIA the previous Accreditation letter once they receive the revised letter.
B.13 Requirements for voluntary withdrawal of a CFIA accredited CB under the COR
This section is to address the situation when a CB accredited by CFIA wishes to withdraw voluntarily its CFIA accreditation under COR.
B.13.1 Requirements on CB
- B.13.1.1 The CB shall send a written notice to the CVB that monitors the CB activities under COR.
- B.13.1.2 The CB shall submit to the CVB the list of holders of certifications and a list of pending applications for certification as per Section10 from OPR.
- B.13.1.3 The CB shall notify the holders of certifications within 3 months after the CB has sent the written notice to the CVB to give them sufficient time to find another Certification body.
- B.13.1.4 The CB shall surrender the CFIA accreditation letter before it expires.
B.13.2 Requirements on CVB
- B.13.2.1 The CVB shall acknowledge the receipt of the CB notification within 10 working days.
- B.13.2.2 The CVB shall notify the CFIA immediately when a CB has indicated its intention to withdraw its accreditation.
- B.13.2.3 The CVB shall submit a recommendation letter to the CFIA for decision on the withdrawal of accreditation.
- B.13.2.4 The CVB shall ensure that any reference to the COR on the CB's website and on CB promotional materials is removed.
B.13.3 Requirements on CFIA
- B.13.3.1 The CFIA shall review the CVB recommendation letter.
- B.13.3.2 The CFIA shall send, upon recommendation from the CVB, a Notice of Cancellation to the CB as per clause 9(6) b) of the Regulations.
- B.13.3.3 The CFIA shall remove the CB name from the list of the CFIA accredited Certification Bodies on the date of the accreditation cancellation.
B.14 Requirements when a CB goes out of business
This section is to address the situation when a CB accredited by CFIA goes out of business.
The term "going out of business" is broad and includes a spectrum of financial states of a CB. One end of the spectrum could include a CB that is experiencing financial difficulty, but is still operational and able to meet their financial obligations, but may become insolvent in the future. The other end of the spectrum could include a CB that has declared bankruptcy. Also included in between the two ends of the spectrum might be CBs that are insolvent but not yet bankrupt and who may file a proposal to avoid bankruptcy.
B.14.1 Requirements on CB
- B.14.1.1 The CB shall notify immediately its CVB in cases where it plans to stop certifying organic products or it may become unable to continue to certify organic products.
- B.14.1.2 The CB shall provide to the CVB the list of holders of certifications and the list of pending applications for certification as per section 10 of the OPR.
- B.14.1.3 The CB shall not accept new applications for certification during this period of financial uncertainty but shall make every effort to complete the certification process of the existing applicants.
B.14.2 Requirements on CVB
- B.14.2.1 The CVB shall request the CB to provide the list of holders of certifications and the list of pending applications for certification as per section10 of the OPR when the CVB becomes aware that the CB is planning to stop certifying organic products or it may become unable to continue to certify organic products.
- B.14.2.2 The CVB shall notify the CB of its inability to accept new applications if the CVB has determined that the CB is planning to stop certifying organic products or it may become unable to continue to certify organic products.
- B.14.2.3 The CVB shall monitor the certification activities of this CB to ensure that it makes every effort to complete any ongoing certifications.
- B.14.2.4 The CVB shall work with the CFIA and the CB to inform the operators at the appropriate time.
- B.14.2.5 The CVB shall send a recommendation for accreditation cancellation to the CFIA if the CB ceases to conduct business.
B.14.3 Requirements on CFIA
- B.14.3.1 The CFIA shall cancel the accreditation of the CB under section 9 (6) of the OPR in cases when the CB ceases to conduct business.
- B.14.3.2 The CFIA and the CVB shall work together to ensure that all the proper actions are taken as per the OPR.
B.14.4 Requirements on the operators
- B.14.4.1 It the responsibility of the operator to apply to a new CB within the time prescribed in section 12 of the OPR and follow the steps as described in part C 2.8.of the COR Manual if they wish to continue their certification.
Part C Certification of Organic Product and CB Requirements
This section provides information about the certification cycle, including application for certification, evaluation, decision on certificationand continuation of thecertification under the Canada Organic Regime (COR). It also provides requirements on the CB. The CVB shall verify that the CB meets these requirements during every initial, surveillance or reassessment audit conducted by the CVB.
C.2 Procedures for Certification Under COR
C.2.1 Application for Initial Certification of Agricultural Product
- C.2.1.1 The CFIA accredited CB shall ensure that operators seeking certification of their organic product or process shall make an application as defined by the CB.
- C.2.1.2 The CB shall require that the applicant provide all the relevant documents and information deemed essential to the assessment as described in Section 12 (2) from the Regulations and section C.7. These documents shall include, as a minimum:
- C.18.104.22.168 production description, production and/or preparation specifications for products to which the application applies;
- C.22.214.171.124 maps and plans;
- C.126.96.36.199 list of inputs (ingredients and agricultural substances);
- C.188.8.131.52 a copy of organic production and/or preparation plans;
- C.184.108.40.206 names of Certification Bodies to which prior applications for certification were submitted by the applicant within the previous years, including all details pertaining to processing the application, and the resulting decision.
- C.2.1.3 The CB shall send acknowledgement of the application reception to the applicant before continuing with the application review.
- C.2.1.4 The CB shall ensure that the applicant pays the fees for certification according to the CB's contract for services and in accordance with the CB's fee schedule.
- C.2.1.5 The CB shall verify that the applicant does not hold more than one product certification to the Canadian Organic standard for any given operation site under the Canada Organic Regime.
- C.2.1.6 The CB shall verifythe accuracy of submitted documentation and its conformance to the requirements of the organic standard.
C.2.2 Preparation for on-Site Inspection
- C.2.2.1 The CB shall document its procedure for its evaluation activities. The CB shall evaluate the products of the applicant against the requirements set out in CAN/CGSB-32.310 and CAN/CGSB-32.311.
- C.2.2.2 The CB shall not permit the operators to choose or to recommend the VO except in cases of conflict of interest.
- C.2.2.3 The CB shall record the VO selected to evaluate the conformance of the operator's product or process.
- C.2.2.4 The CB shall ensure that the operator is contacted to arrange the logistics of the on-site inspection.
C.2.3 on-Site Inspection
- C.2.3.1 The CB shall ensure that the inspection covers the entire agricultural production system being managed by the operator, even if only part of the operator's operations were targeted by the certification application.The inspection of an operation site shall cover all production and processing operations, including packaging and labelling pertaining to the product.
- C.2.3.2 The CB shall ensure that systems and facilities upon which an operator relies to produce and/or prepare each product included within its application is to be visited by the assigned VO to ensure that the standards are fully applied and correspond to the submitted production or preparation specifications.
- C.2.3.3 The CB shall ensure that the assigned VO conducts an introductory meeting with a representative of the operator.
- C.2.3.4 The CB shall ensure that the land, premises and equipment not included in thecertification application are identified and checked, andshall at a minimum include the following: crop areas orharvesting zones; harvest storage locations; preparation,processing and packaging sites; application dates forphytosanitary products.
- C.2.3.5 The CB shall verify that prohibited substances have not been, andare not being, applied to the operation.
- C.2.3.6 The CB shall ensure that the VO conducts a review of record keeping, to verify that the organic plan previously submitted to the CB accurately reflects the operation and is in compliance with the Canadian Organic Standard. Records to be verified include records related to production (ex: inventory, sales, purchases) and to management (e.g., accounting, complaints); as well as appropriate product packaging and labelling.
- C.2.3.7 The CB shall ensure that the VO conducts a visual examination of each production unit (e.g. fields, crops, plants, livestock, buildings, facilities and vehicles) where production or preparation of agricultural and food products are carried out.
- C.2.3.8 The CB shall ensure that the VO witnesses the way the operator proceeds at a given point within the production cycle, thus implying that the inspection shall be carried out when grounds, premises, and activities subjected to compliance requirements may be observed.
- C.2.3.9 The CB shall ensure that the inspection includes non-organic units where there is reason to suspect undeclared split production of similar products, and in any situation revealing high risk of cross-contamination; where agricultural producers carry out split production, inspections shall allow visual determination of what is being planted in all cultivated fields within the production unit.
- C.2.3.10 The CB shall ensure that the VO identifies and investigates areas of risk (e.g. potential contamination from neighbouring farm, flooding).
- C.2.3.11 The CB shall ensure that for producers, the VO obtains an estimate of the potential yield for the coming year, as well as an audit of the balance in the quantities produced and sold over the previous period, and including amounts still in inventory during this same period.
- C.2.3.12 The CB shall ensure that for applicants performing operations related to food preparation (processing and/or packaging), the VO calculates the input/output balance for acquired commodities for a product, and for the corresponding inputs included in the products sold and on inventory.The calculation sample shall include the most prominent commodities for at least 10% of all commodities used in all products with a minimum of one and maximum of 5. However, if justified by the VO, a different or additional commodity may be included in this calculation. This justification shall be recorded in the inspection report.
- C.2.3.13 The CB shall ensure that the VO performs traceback audits applying to certain products taken from the supplier's inventory or from a commercial outlet where its products have been placed for sale.
- C.2.3.14 The CB shall ensure that the VO verifies that changes in the standards and requirements of the CBhave been effectively implemented by the operator.
- C.2.3.15 The CB shall ensure that the VO verifies that previously imposed conditions have been fulfilled;
- C.2.3.16 The CB shall require pre-harvest or post-harvest testing of any agricultural input used or agricultural product to be sold, labelled or represented as being in compliance with the requirements of the Canadian Organic standards when there is a reason to suspect that the agricultural input or product has come into contact with a prohibited substance, method or ingredient in the production and handling of organic products.
- C.2.3.17 The CB shall ensure that when samples are taken by the VO, the VO shall provide the operator with a receipt for each sample.
- C.2.3.18 The CB shall require sampling and testing, in an event of a complaint concerning the use of or contamination with prohibited substance, as part of the investigation of the complaint.
- C.2.3.19 The CB shall investigate if it has a suspicion that an organic product contains even a trace amount of a GMO. The CB shall require sampling and testing in an event of suspicion of the presence of GMO.
- C.2.3.20 The CB shall ensure that the VO interviews people knowledgeable with the operation at present.
- C.2.3.21 The CB shall ensure that the VO:
- C.220.127.116.11 conducts a closing meeting at the end of the visit, intended to inform the operator's management of inspection results as well as findings made concerning the compliance with certification requirements, without any corrective action request from the VO.
- C.18.104.22.168 provides opportunity for the operator to confirm the accuracy of information collected during the inspection;
- C.22.214.171.124 provides a summary of this review to the operator;
- C.126.96.36.199 addresses the need for any additional information as well as any issues of concern.
- C.2.3.22 The VO shall submit to the CB a report mentioning verification results and findings as to the conformity with all certification requirements, and including the following data as a minimum:
- C.188.8.131.52 date, time and duration of inspection;
- C.184.108.40.206 names of interviewees;
- C.220.127.116.11 identification of land and premises visited on the production/handling site;
- C.18.104.22.168 types of documentation audits performed (in/out balance sheet, yields/sales, audit trails by batches, etc).
C.2.4 Timing of on-Site Inspections
- C.2.4.1 In cases involving producer operations, the timing of on-site inspection shall take place during the production season. This period begins as soon as all operations subject to inspection (seeding, tapping, etc.) begin and ends with the packaging or placing in containers for storage of products to be certified.
- C.2.4.2 In cases involving processing operations, on-site inspections may be carried out any time during the year. on the other hand, for separated production (i.e., when both certifiable and non-certifiable products are manufactured at the same facility), the inspection shall be carried out at time when the products that are targeted for certification are being processed.If the CBdetermines it is not possible to conduct the inspection while organic product is being processed, the CB shall record the reason(s) supporting this determination. The CB shall then arrange for the inspection to be conducted at a time when the facilities and activities that demonstrate compliance or capacity to comply can be assessed. There shall be no more than two consecutive years without an inspection when organic product is being processed.
C.2.5 Evaluation Report
- C.2.5.1 The CB shall require from the operator to respond to the non conformity report issued by the Certification body within 30 days of its receipt. The response shall either provide evidence of completion of corrective action taken to address each NC or present a plan with milestones as to how each NC will be addressed. This plan shall include a completion date not exceeding 90 days from receipt of the NCs. The CB shall accept times greater than those stated for the closure of a nonconformance as long as they are justified and documented.
C.2.6 Nonconformity Follow-Up
- C.2.6.1 The CB shall ensure that corrective actions aiming to address all nonconformities have been implemented by the operator by conducting on-site visit or other appropriate forms of verification.
- C.2.6.2 The CB shall inform the applicant that at any point within the certification cycle, preceding the CB's decision, the applicant may request that the processing of its application be stopped. The applicant shall be informed that they are liable for the costs of services provided up to the time of withdrawal of its application. In such case, the CB shall not issue a decision regarding the products that were the subject of the certification request.
- C.2.6.3 If a CB has reason to believe that an applicant for initial certification has wilfully made a false statement regarding its production system and operations related to the products included in the application, the CB may deny certification, without issuing a notification of non-compliance.
- C.2.6.4 The CB shall issue a written notice of denial of certification to any applicant to whom it denies certification, either because operations resulting in the products included in the application are still noncompliant with requirements or simply because the applicant did not respond to the notification of non-compliance. This notice shall state the reason(s) for denial and the applicant's right to:
- C.22.214.171.124 file an appeal of the denial;
- C.126.96.36.199 reapply for certification to any accredited CB, including the one who denied certification.
C.2.7 Certification Decision
- C.2.7.1 The decision to certify a product shall be taken if the CB determines that all procedures and activities contained in the organic plan are in compliance with OPR requirements and that the applicant is able to conduct operations in accordance with this plan and after the correctionof all nonconformities. This decision is valid until the results of the next annual evaluation are known and a new decision is madeor unless the CB is made aware of information to cause the CB to act (e.g. suspension or withdrawal). This information can come from an external source or from the CB's own efforts.
- C.2.7.2 The CB shall issue documents to the applicant confirming the organic certification of the product. These documents shall include the following:
- C.188.8.131.52 the scope of the certification granted, including, as appropriate:
- C.184.108.40.206.1 the products certified, which shall be identified by type or range of products including their specific name and if applicable, the one or more trademarks under which they are being marketed;
- C.220.127.116.11.2 the product standards or other normative documents concerning, under which each product or product type is certified;
- C.18.104.22.168.3 the applicable certification system (as defined by ISO Guide 67) with the type(s) of operations and subject of the evaluation by the CB, among the following:
- crop production;
- livestock production;
- grain production;
- maple syrup production;
- specialized production ( bee-keeping, etc);
- food processing;
- subsequent packaging (labelling modification following an operation of breaking down or regrouping on products already certified);
- C.22.214.171.124 the date on which the certification was granted;
- C.126.96.36.199 the date by which the operator shall submit application for subsequent annual inspection;
- C.188.8.131.52 the location of all operations covered by this certification (town, province/state, country);
- C.184.108.40.206 in the case of product packaging and labelling certification, the date on which the certification document expires.
- C.2.7.3 The certification of a product, once issued, shall remain valid unless suspended or cancelled by the CB according to the requirements of the OPR.
- C.2.7.4 The CB shall follow the OPR requirements for cancellation under clause 20 (6) in case of voluntary withdrawal by the operator.
C.2.8 Procedure for Continuation of Certification
- C.2.8.1 The CB shall document the procedures to verify annually that the criteria for certification continue to be met by the operator.
- C.2.8.2 The CB shall require that the operator apply annually for continued organic certification.
- C.2.8.3 The CB shall proceed when the operator submits all information requested by the CB and pays annual certification fees.
- C.2.8.4 The CB shall initiate suspension or cancellation in cases where the application is not submitted within the time prescribed in the OPR (section 12 (1)).
- C.2.8.5 The CB shall evaluate applications for continued certification to verify that all the requirements for certification are met resulting either in continuation of the certification or initiation of suspension and cancellation.
- C.2.8.6 The CB evaluation for continued certification shall include asa minimum:
- C.220.127.116.11 Anon-site inspection to each location where each operator is operating, to verify compliance with the applicable requirements as outlined in C 2.3.
- C.18.104.22.168 If an inspection visit shall occur on a date beyond a period of twelve months following the inspection from the previous year, this postponement shall not exceed six months, shall be justified and shall be documented.
- C.22.214.171.124 When the interval between two regular inspections has exceeded twelve months, the CB shall make sure that subsequent inspections restore the parity between the number of calendar years and the number of regular inspections over a given period.
- C.2.8.7 The CB shall make its certification decision for continued certification as outlined in C.2.7.
C.2.9 Additional Inspections
- C.2.9.1 In addition to the annual inspections the CB shall plan and conduct unannounced inspections representing 3% of primary producers (minimum one)and 5% of other operators (minimum one) to which it grants certificates for products under the Canada Organic Regime The CB shall document the procedure covering the frequency and selection criteria for these additional unannounced on-site inspections. In cases where it is not possible to conduct an unannounced inspection (e.g. for reasons related to site access or any other factors supported by a justification), advance notice may be given providing that this notice period does not allow time to cover up non-compliances that might exist. In any case the notice shall be not more than 24 hours. The CB shall document the reasons for any advance notice.
- C.2.9.2 Unannounced inspections may be limited in scope and may cover only certain aspects of the operation. The operators chosen for unannounced inspections may be random, risk based, or as a result of a complaint or investigation. The CB is not obliged to disclose to the operator the reason for the unannounced or additional inspection.
- C.2.9.3 The CB shall comply with any requests from the Canada Organic Office or the CVB that additional inspections be conducted by the CB when the compliance of the operation is in doubt or for other valid reasons.
C.2.10 Suspension and Cancellation
- C.2.10.1 The CB shall suspend an organic certification as per Section 20 from the Regulations as amended from time to time.
- C.2.10.2 The CB shall report to its CVB all suspensions and cancellations it issues on the 25thof each month, in case such decisions are made, or shall be provided as defined by the CVB. All suspensions and cancellation reports shall include the name of the operator, the date of issue and the reason for the action.
- C.2.10.3 The CB shall reinstate suspended certification only after the CFIA has been notified and the date of the certification reinstatement is posted on the CFIA published list of suspended and cancelled organic certifications
- C.2.10.4 The CB shall not grant certification to an operator who had its certification previously cancelled and whose name appears on the CFIA published list of suspended and cancelled organic certifications unless the operator has submitted an application for certification of agricultural product to a CFIA accredited CB as per section C.2, has completed the organic certification process and the CB has received a conformation from the CFIA that the date of the certification reinstatement is posted on the CFIA list.
- C.2.10.5 The CB shall submit to the CFIA a request for having the date of the certification reinstatement posted on the CFIA list of suspended and cancelled organic certifications within 5 working days from the certification decision
- C.2.10.6 The CFIA shall post the date of the certification reinstatement on the CFIA list of suspended and cancelled organic certifications and shall send a conformation to the CB within 5 working days from the CB request receipt
C.3 Timing of Sale or Distribution of Certified Product
- C.3.1 When certification is requested, the CB shall ensure that theoperator does not put up for sale any product "represented as organic" or bearing the word organic or its derivatives until it has been informed by the CB that the products are certified.
C.4 Appeal, Complaint and Dispute Procedures of CB
- C.4.1 The CB shall document procedures to ensure that it deals with the appeals, complaints and disputes by an applicant or other party pertaining to certification.
- C.4.2 The CB documented procedures shall deal with, as a minimum:
- C.4.2.1 appeals related to certification decisions;
- C.4.2.2 complaints or disputes from operators regarding the CB's program application;
- C.4.2.3 complaints or disputes from outside persons or organizations about the CB's operation.
C.5 Issues Regarding Implementation of the Standard
- C.5.1 The CB shall notify all its operators of any amendments to the regulations or the standards within two months after their publication
- C.5.2 The CB shall allow a period of up to 12 months after the publication date of an amendment to CAN/CGSB-32.310 and CAN/CGSB-32.311 for applicant to come into compliance with any changes to the requirements.
- C.5.3 If at any point during certification activities, interpretation of an applicable standard is required, it can be sought from the Standards Interpretation Committee (SIC). Refer to Part G for details about this committee and on how to request an interpretation.
- C.5.4 It is likely that the need for interpretation requests to the SIC will occur during a certification cycle of an operator by a CB. In such cases, where both parties agree there is need for interpretation or clarification andthe interpretation request is submitted by the CB, the issue that is the subject of the request will be set aside by the CB(e.g. the nonconformity will be placed on hold) until the response from the SIC is returned.
- C.5.5 In these cases, between the time when the interpretation request to the SIC is submitted and the response from the committee returned, any certification work affected by the interpretation shall proceed as normal, up to and including the issuance of certification documents.
- C.5.6 When the response from the SIC is received, the outstanding issue shall be revisited and appropriate actions taken by the CB or the operator or both as required.
- C.5.7 If changes are required by the operator to comply with the interpretation of the SIC, the CB shall not suspend or withdrawal any certification it has issued that is affected by this interpretation as long as the operator has made the required changes in a time frame that is no less than the time permitted for any other non-conformance issued by the CB.
- C.5.8 In cases where the CB and the operator do not agree that the issue needs an interpretation, the CB shall rely on CAN/CGSB-32.310, section II - General Principles of Organic Production and Par. 1.4.1. when interpreting the issue. The operator is still able to make a complaint to the CVB about the CB and/or ask the SIC for an interpretation and request a reconsideration of the issue at a later date.
C.6 Use of Licenses, Certificates and Marks of Conformity
- C.6.1 The CB shall have a signed license agreement with each operator for products which it has certified.
- C.6.2 The CB shall ensure that all certified products are labelled in accordance with the OPR.
- C.6.3 The CB shall withdraw the agreement if the operator:
- C.6.3.1 ceases doing business with the CB or;
- C.6.3.2 cannot demonstrate that it is able to comply with the applicable standards for operations included in its certification application.
- C.6.4 The CB shall have procedures to monitor products using its certification mark and its name and being sold on the market, to detect any improper or fraudulent use of their mark and mandatory labelling (section 25 of the OPR).
- C.6.5 The CB shall have written rules authorizing the use of its mark (including the recognition of product labels on which it shall be displayed) and is responsible for delivering the organic certificates.
- C.6.6 The CB shall have written procedures for dealing with abusive use, false statements regarding a product's certification or the incorrect use of its certification marks.
- C.6.7 The CB shall have procedures ensuring that its operators do not allow its certification mark be used in any way likely to lead to confusion among consumers.
C.7 Obligations of the CB Relative to Certifications
- C.7.1 The CB shall not issue a certificate for any product unless all the ingredients have been certified as organic in accordance with the OPR or that has been certified as organic under section 27 of the OPR.
- C.7.2 When a subjective judgment is required to determine compliance, the CB shall document explanatory information, assuring consistent and uniform application of the requirements and certification decisions.
- C.7.3 The CB shall ensure that when it identifies and assigns responsibilities and tasks to members of its staff, impartiality is not in jeopardy.
- C.7.4 The CB shall identify the management (committee, group or person) which have overall responsibility for undertaking monitoring, inspection and certification activities as defined within the accreditation criteria, including execution of inspection, controls, evaluation and certification.
- C.7.5 The CB shall have a signed agreement with each operator that specifies the rights and responsibilities relevant to its certification activities.
- C.7.6 The CB shall include provisions to cover liabilities in situations where there is a significant risk of being sued.
- C.7.7 The CB shall document the minimal qualifications required for VO. The CB shall ensure relevant professional training or experience in compliance with the CB's Quality Management System requirements including training with respect to the Canada Organic Regime.
- C.7.8 The CB shall have a signed agreement with the VO to refuse any work that would create a conflict-of-interest situation with the enterprise that is applying for certification, either because of a family link, or because of a business relationship with the applicant during the twelve months preceding its application to the CB.
- C.7.9 The CB shall document its rules for inspection.
- C.7.10 The CB shall record the VO selection for a given inspection.
- C.7.11 The CB shall record the annual VO performance appraisal.
- C.7.12 The CB shall document the grounds on which an applicant might refuse the choice of VO and shall inform the operator of these grounds, prior to, or along with, the name of the VO being provided to the operator.
- C.7.13 The CB shall document frequency and estimated duration of on-site inspection, taking into account the intensity of the production system, the production type, the company's size, the results of the previous verification, complaints received, parallel production.
- C.7.14 The CB shall document the minimum requirements for any audit trail, in relation to traceability.
- C.7.15 The CB shall document its sampling and testing requirements.
- C.7.16 The CB shall document itsdeadlines for presentation of the VO report to the CB.
- C.7.17 The CB shall have procedures to address cases when an operator does not renew a certification of its product from a previous year to ensure that the CB shall formally notify this operator in a timely manner that its certification is withdrawn.
- C.7.18 The CB shall exchange information with other CBs and /or CFIA to verify the validity of the information on an operator.
C.8 Records Control by the CB and Operator
- C.8.1 The CB shall document procedures that ensure it maintains a record system that complies with the OPR requirements.
- C.8.2 The CB shall ensure that its records are to be kept for a minimum of five years. This requirement shall also be documented by the CB.
- C.8.3 The CB shall ensure that the operator maintain records and relevant supporting documents concerning the inputs, production, preparation and handling of crops, livestock and organic products that are or are intended to be sold, labelled or otherwise represented as organic in accordance with the CAN/CGSB-32.310.
C.9 CB Records
- C.9.1 The CB shall record all data listed below and shall provide it to the CVB and COO annually by the end of the calendar year for each operator granted certification. For those elements of this information provided via the Internet, it is acceptable to provide the URL to this information instead. For those elements of this information not provided via the Internet, that information shall still be provided annually by the CB and the CVB shall transfer it to the CFIA.
- C.9.1.1 Legal (corporate) name of operator.
- C.9.1.2 Full address of the of operator's head office including phone numbers and fax numbers.
- C.9.1.3 Type of operation (primary, processing or exporter).
- C.9.1.4 Generic names of the products certified.
- C.9.1.5 one example of a package using the certification marking (an electronic copy is acceptable).
- C.9.2 The CB shall maintain records of all major changes that took place during the previous year and that have affected corporate structure and directors, the administrative structure, the main managers of the organization and members of the committees. It shall provide this information to the CVB or the CFIA upon request.
- C.9.3 The CB shall maintain records of all modifications made to policies, internal procedures and regulations governing the organization and its certification system. It shall provide this information to the CVB or the CFIA upon request.
- C.9.4 The CB shall maintain records of the certificates newly issued, renewed, suspended and withdrawn listed by operator category under the COR. It shall provide this information to the CVB or the CFIA upon request.
C.10 Requirements when an operator changes a CB under the COR
C.10.1 Requirements on the operator
- C.10.1.1 The operator who decides to change their current CB (sending) to a new CB (receiving) shall submit an application for certification as a new applicant, complete an application form prescribed by the new CB (receiving) and follow the application requirements as per C.2.1 of the COR Operating Manual.
- C.10.1.2 The operator shall notify their current CB of their intent to change the CB and shall request a "letter of good standing" to be sent to the new CB (receiving), confirming that all non-conformities (NCs) and any contract conditions (e.g. outstanding fees) have been addressed. The current CB shall send this letter directly to the new CB. If necessary, the receiving CB can directly request additional information to the sending CB.
- C.10.1.3 The operator shall maintain their current certification until the new certification process is complete and the new CB has issued documents confirming the certification of the operator's products as per Section 13 (2) of OPR.
- C.10.1.4 The operator shall stop using their certificate issued from the sending CB after the new certification process is complete and the operator has received the new certificate.
- C.10.1.5 The operator shall not use up existing supplies of labels which identify their previous CB on products they produce from the moment the operator receives the new certificate. New labels identifying the new CB must be used at once.
- C 10.1.6 The operator may sell certified prepackaged products labelled with the name of the previous CB as long as these products were packaged before the CB change and an inventory list was provided to both CBs.
C.10.2 Requirements on sending CB
- C.10.2.1 The sending (current) CB shall, upon request by the operator, send a letter of good standing to the new CB (receiving) confirming that all NCs and any contract conditions (e.g. outstanding fees) have been addressed by the operator. A letter of good standing shall only be issued when all NCs have been addressed by the operator.
- C.10.2.2 The sending CB shall continue to monitor the operator's compliance with COR requirements and shall ensure that the operator resolves any outstanding NCs before the new certificate is issued by the new (receiving) CB.
- C.10.2.3 The sending CB shall notify the operator that it terminates the certification agreement with the operator and will no longer monitor the compliance of this operator once the new CB confirms that a new certificate has been issued to the operator.
- C.10.2.4 Upon receiving confirmation from the new CB that a new certificate has been issued to the operator, the sending CB shall require the operator to immediately stop the use of any labels or advertising which identify the sending CB on the operator's products.
- C 10.2.5 The sending CB shall allow the operator to retain a copy of the current certificate only when the operator can demonstrate that previously certified products are still in inventory.
- C 10.2.6 The sending CB shall report the cancellation in a monthly report to the CFIA as a "cancellation due to a CB change".
C.10.3 Requirements on the receiving (new) CB
- C.10.3.1 The receiving CB shall require the operator to submit an application for certification as a new applicant, complete an application form prescribed by the new CB (receiving) and follow the application requirements as per C.2.1 of the COR Operating Manual.
- C.10.3.2 The receiving CB shall request information on the name of the applicant's current (sending) CB.
- C.10.3.3 The receiving CB shall review the information provided by the sending CB including the letter of good standing.
- C.10.3.4 The receiving CB shall schedule and conduct an on-site inspection of the operator's facility as per C.2.3 of the COR Operating Manual prior to making a certification decision.
- C.10.3.5 The receiving CB shall issue a new certificate only after the certification process is complete and the applicant has been determined to be in compliance with all the COR requirements. The initial date on the new certificate shall be the date on which the receiving CB issued the certificate.
- C.10.3.6 The receiving CB shall inform the sending CB within 5 working days that the receiving CB has issued a new certificate to the operator.
C.11 Requirements When a CB Issues Attestation of Compliance
This section is to address situations when a CB accredited by CFIA provides a formal "Attestation of Compliance" to service providers who perform contractual work for operators with certified product and where the service is not eligible for certification under section 14 of the OPR. An attestation of compliance will recognize the services as being in accordance with CAN/CGSB 32.310 and 32.311 to maintain the integrity of the organic product and eliminate the need for multiple inspections resulting from verification for the certification of the final product every time a different operator contracts the services.
An attestation of compliance is a written document issued by a Certification Body confirming that the provision of a service through a particular activity taking place within the production or manufacturing process of a certified product is in full accordance with CAN/CGSB 32.310 and 32.311 as prescribed in the Organic Products Regulations, 2009.This means that although the service provider does not hold a certification, the Certification Body has verified that the product subjected to this service remains compliant with the CAN/CGSB 32.310 and 32.311.
An "Attestation of compliance" shall be applicable for the following types of custom services:
- C.11.1.1 The services identified as being exempt for certification in section 19 of the OPR, i.e."The slaughtering of organic livestock, or the transportation and storage of organic livestock or an organic product".
- C.11.1.2 Other custom services for bulk product such as seed cleaning where the ownership of the product remains with the primary producer.
C.11.2 Procedure for issuing attestation of compliance under COR
- C.11.2.1 The CB shall have written procedure for verifying compliance of the service offered.
- C.11.2.2 The CB shall follow the steps outlined under C.3 of the COO Operating Manual as applicable to the service offered. At a minimum the CB shall:
- C.126.96.36.199 require the service provider to complete an application form;
- C.188.8.131.52 request an organic plan and relevant documents which demonstrate how the integrity of the organic product is maintained;
- C.184.108.40.206 verify compliance to CAN/CGSB 32-310 and 3.11as applicable to the service offered;
- C.220.127.116.11 conduct an annual inspection at a time when organic product is being handled or according to C2.4.2.
- C.18.104.22.168 conduct non-compliance follow-up according to C.2.6.
- C.11.2.3 The CFIA accredited CBs shall:
- C.22.214.171.124 issue an "Attestation of Compliance" using the template included in the Appendix 1 of the COO Operating Manual;
- C.126.96.36.199 suspend or cancel an "Attestation of Compliance" as required, according to C2.10.
- C.11.2.4 The CFIA accredited CBs shall accept an "Attestation of Compliance" issued by any CFIA accredited CB as meeting the OPR requirements for maintenance of integrity and shall not require any further verification
C.12 Requirements for grower group certification under COR
C.12.1 Requirements for multi-site organization
- C.12.1.1 The multi-site operation composed of production units, sites, or facilities, shall be organized as a "person" according to Section 12 (1) of OPR. Pursuant to the section 2 of the Canada Agricultural Products Act, a person is defined as meaning "an individual, a corporation, an association or an organization."
- C.12.1.2 The grower group may be organized on itself i.e. as a co-operative, or as a structured group of producers affiliated to a processor.
- C.12.1.3 All members of the grower group shall apply similar production systems and should be in geographical proximity.
- C.12.1.4 The grower group shall be established formally, based on written agreements with its members. It shall have central management, established decision procedures and be a legal entity.
- C.12.1.5 The grower group shall have in place an effective and documented internal control system.
- C.12.1.6 The management of the grower group shall sign a written contract with the CB specifying the responsibilities of the grower group and of the internal control system. The management shall obtain signed obligations from all grower group members to comply with the Canada Organic standard and to permit inspection by the CB, the CVB or the CFIA.
- C.12.1.7 The grower group shall only seek certification with a CB accredited by CFIA under the COR that is qualified to perform certification of operations with multiple production units, sites, and facilities and. A CB shall be considered qualified if they have policies and procedures to verify compliance of the group and the individual group members. The CVB shall assess the ability of the CB to perform the group certification.
- C.12.1.8 The practices of the grower group operation shall be uniform and reflect a consistent process or methodology, using the same inputs and processes.
- C.12.1.9 Participation in the grower group shall be limited to those members who market their organic production only through the grower group, unless the member is individually certified.
C.12.2 Requirements for internal control system
- C.12.2.1 The grower group shall document and implement an Internal Control System (ICS), with supervision and documentation of production practices and inputs used at each sub-unit, and collected at each production unit, site, or facility to insure compliance with the Canada Organic Regime.
- C.12.2.2 The internal control system shall include a contractual arrangement with each member of the grower group.
- C.12.2.3 The internal control system shall be implemented by competent personnel and internal inspectors designated by the grower group shall carry out internal controls.
- C.12.2.4 The internal inspectors shall be suitable trained and ensure that potential conflicts of interest are limited.
- C.12.2.5 The internal inspectors shall carry out at least one annual inspection visit to each individual operator including visits to field and facilities.
- C.12.2.6 The internal control system shall contain appropriate records including:
- C.188.8.131.52 production description, production and/or preparation specifications for products to which the application applies;
- C.184.108.40.206 maps, description of the farms and the facilities of all members;
- C.220.127.116.11 list of inputs (ingredients and agricultural substances);
- C.18.104.22.168 a copy of organic production and/or preparation plans;
- C.22.214.171.124 remedial actions required by the CB during the previous certification cycle, as well as any corrective measures implemented by members concerning these requests;
- C.126.96.36.199 a complete list of group members.
- C.12.2.7 The internal control system shall have a mechanism to remove non- compliant group members from the list.
- C.12.2.8 The internal control system shall record all non-compliances as well as the corrective actions imposed with agreed time for completion.
C.12.3 Initial certification
- C.12.3.1 The CB shall evaluate the effectiveness of the internal control system to assess compliance of all members with the requirements set out in CAN/CGSB 32.310 and CAN/CGSB 32.311.
- C.12.3.2 The certification inspection of the grower group by the CB shall include an assessment of the risks to organic integrity within the grower group and the environment in which it functions. A sample of all sites under the grower group's responsibility shall be subject to inspection visits by the CB.
- C.12.3.3 The percentage of group members subject to the initial and the annual certification inspection shall be based on the results of a risk assessment. For normal risk situation, it shall not be lower than the square root of the total number of units under the responsibility of the group. If the risk is higher than normal, the resulting number of the preceding formula shall be multiplied by 1.2, whereas with a high risk, it shall be multiplied by 1.4. Factors to define the risk shall include:
- C.188.8.131.52 factors related to the magnitude of the grower group
- Organisation size and sites' size
- Value of the products
- Numbers of years the grower group has functioned
- Number of new members registered yearly
- Staff turnover
- The management structure of the internal control system
- C.184.108.40.206 factors related to the characteristics of the grower group
- Variations in the product systems
- Risks for intermingling and/or contamination
- Geographical dispersion of the sites
- Degree of uniformity among the production units, sites or facilities
- C.220.127.116.11 factors related to the magnitude of the grower group
- C.12.3.4 The CB shall assign VOs who have appropriate training on inspection of internal control systems.
- C.12.3.5 During the certification inspection the VO shall determine whether:
- C.18.104.22.168 all internal control documentation is in place;
- C.22.214.171.124 internal inspections of all group members have been carried out annually;
- C.126.96.36.199 new group members are only included after successful resolution of any non-compliances found during the internal inspection, according to the procedures agreed with the CB;
- C.188.8.131.52 all non-compliances have been dealt with appropriately by the internal control system;
- C.184.108.40.206 inspection records have been maintained by the internal control system.
- C.12.3.6 The VO shall carry out a witness audit to determine whether the inspections of the internal control system are conducted as written.
C.12.4 Maintenance of certification
- C.12.4.1 Each year the CB shall define and justify a risk-based sample of members subject to annual inspection.
- C.12.4.2 The members visited by the CB shall be predominantly different from one year to another. Some of the selection criteria of the sites being subject to visits may include:
- Results from internal control system inspection;
- Complaint files;
- Significant variations of the sites' size;
- Modifications since the last certification.
- C.12.4.3 The CB shall increase the number of the annually inspected members to at least three times the square root of the number of the members in the grower group in cases of high risk situations (e.g. ICS has issued lot of internal sanctions , a lot of new grower members).
- C.12.4.4 The CB shall ensure that the grower group maintains an updated list of all members and informs the CB in timely manner any time when changes to the status of the members occurs.
- C.12.4.5 The CB shall ensure that the grower group has established procedures for adding new members to the grower group.
- C.12.5.1 The CB shall ensure that the grower group has record-keeping protocols for the individual production units, sites, or facilities within a grower group.
- C.12.5.2 The CB shall maintain records of sample inspection to ensure that over time the inspections are representative of the grower group as a whole and take into account any previously identified risk.
C.12.6 Certification documents
- C.12.6.1 The CB shall provide certification documents to the grower group as a whole. Members within a grower group that has had its operations or product certified cannot not possess individual certificates unless that member has obtained its own certification independent from the grower group.
C.12.7 Suspension and cancellation
- C.12.7.1 The CB shall hold the grower group as a whole responsible for compliance of all members.
- C.12.7.2 The CB shall have a documented suspension policy in the event of non-compliance by the grower group or a member.
- C.12.7.3 The CB shall suspend or cancel the certification granted to the grower group as a whole, in accordance with Section 21 from the Regulations, in cases where the grower group's internal control system fails to act on these non-compliances.
Part D Use of the Canada Organic Logo
To ensure that use of the Canada Organic logo is well controlled and administered by setting up application procedures for the use of the logo for marketing, advertising or information purposes.
D.2 Use of the Logo for Marketing, Advertising or Information Purposes
Stakeholders such as CB, operators and others may request to use the logo, on their advertising materials, brochures, posters, hand-outs, in newspapers and other publications, on television, etc. CFIA policy is to grant the use of the Logo, provided that certain conditions are met.
- D.3.1 Upon receipt of an inquiry by the CFIA, an application form COO-F- 010 shall be emailed, faxed, or mailed to the applicant. The application form shall include the name, address, contact details, intended use, duration of use, and other relevant details.
- D.3.2 The CFIA's Terms and Conditions for Use of the Logo for marketing, advertising or information purposes shall be included with the application along with a Statement that, by signing, the applicant agrees to these terms and conditions. The application shall be completed and signed and returned to the CFIA.
- D.3.3 The application shall be reviewed by the COO Program Administrator and either approved or rejected by the COO National Manager. The COO shall notify the applicant of the decision within five working days.
- D.3.4 All application forms shall be retained in COO records.
- D.3.5 The COO shall maintain a list of stakeholders that have received permission for use of the Logo for marketing, advertising or information purposes.
- D.3.6 The COO shall require a copy of any brochures, posters, hand-outs, newspapers and other publications documents where the logo is advertised.
D.4 Terms and Conditions for Use of Logo
D.4.1 Authorized Use
- D.4.1.1 The applicant is only entitled to use and display the Logo for marketing, advertising or information purposes as indicated in the application.
- D.4.1.2 The applicant shall agree to:
- D.220.127.116.11 only reproduce the Logo using an authorized electronic file or reproof obtained from the CFIA, in accordance with the specifications outlined in Schedule 2 from the Regulations;
- D.18.104.22.168 display the Logo on the website with the "copy" function disabled, such that it cannot be copied and altered.
- D.4.1.3 The applicant shall agree not to:
- D.22.214.171.124 use, advertise or display the Logo or permit the use, advertisement, or display of the Logo on, or in association with any agricultural product;
- D.126.96.36.199 use, advertise or display the Logo or permit the use, advertisement, or display of the Logo in any way which implies that the CFIA or the CVB approved a product or service;
- D.188.8.131.52 sublicense the use of the logo;
- D.184.108.40.206 alter or deface the Logo in any manner, including but not limited to, by way of adding or deleting any written or figurative element to said logo.
D.4.2 Quality Control
- D.4.2.1 The CFIA shall at it entire and sole discretion monitors the use of the Logo by the applicant.
Appendix A - Certificate Template - Informative
Pursuant to the Organic Products Regulations, 2009
Issued by ( insert CB name, address)
Operator name and address:
This certification is based on compliance with the
CAN/CSGB -32.310/ 32.311-2006 General Principles and Management Standards and Permitted Substances Lists
The terms of the US / Canada organic equivalence agreement (when applicable)
(Product listing addendum for certified products)
Date on which the certification is issued:
Date by which the operator shall submit application for subsequent annual inspection:
This certification remains valid unless suspended or cancelled by the (insert the name of the CB) pursuant to the Organic Products Regulations, 2009.
(CB authorized representative)
Appendix B - Attestation Template - Informative
Attestation of Service
Issued by: [name of CB]
[address of CB]
Verified Enterprise:[enterprise name]
[enterprise address – line 1]
[address – line 2]
Enterprise number: [number]
Type of Service:[type of service ]
Effective period of verification:[12-month period]
This attestation is based on the requirements of the Canadian CAN/CGSB-32.310 and Permitted Substances Lists CAN/CGSB-32.311 – 2006, as amended from time to time.
This document expires at the end of 12 months (the termination date of the effective period identified above) or when cancelled by the [CBname].
This document confirms that the products listed on page 2 are handled in compliance with the CAN/CGSB-32.310 and CAN/CGSB-32.311 and the Organic Products Regulations.
CB's representative signature:
Date of issue:
- Date modified: