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Canada Organic Regime operating manual

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements are being phased in over the following 12 to 30 months. For more information, refer to the SFCR timelines.

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Preface

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.

Part 13 of the Safe Food for Canadians Regulations (SFCR) were made pursuant to section 51 of the Safe Food for Canadians Act. The purpose of the SFCR 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 Logo" and organic claims.

The SFCR 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 5 years. The CFIA might decide to review the COR Operating Manual earlier in cases of outstanding findings from peer reviews, changes to Part 13 of the current SFCR or International requirements.

Should there be any discrepancy between the COR operating manual and the SFCR, the SFCR shall take precedence.

General information

Overview of the Canada Organic Regime (COR)

The COR is a non-traditional regime for the CFIA. The SFCR 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 Canada Organic Logo. The CFIA enters into agreements with Conformity verification bodies (CVBs) provided these bodies meet the criteria established by the SFCR and CFIA. For the purpose of the SFCR, 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 SFCR.

The accredited CBs are responsible for the organic certification of food commodities 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 SFCR set out the functions of the COR's two oversight bodies: CVBs and CBs.

References

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-32.310-2015, Organic production systems general principles and management standards (to the extent these standards are incorporated by reference into the regulations and developed by the organic industry and the Canadian General Standards Board)

CAN/CGSB-32.311-2015, 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)

CAN/CGSB-32.312-2018, Organic production systems: Aquaculture - General principles, management standards and 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 – Requirements for bodies certifying products, processes and services

SOR/2018-108, Part 13 of the Safe Food for Canadians Regulations (regulations made under the authority of the Safe Food for Canadians Act

Definitions

Accreditation cycle
The period including the initial assessment or reassessment and the subsequent surveillance years
Act
The Safe Food for Canadians Act
Agency
The CFIA established by section 3 of the Canadian Food Inspection Agency Act responsible for the administration of the COR.
Audit
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 products.
Certification
The procedure whereby a CFIA accredited certification body provides written assurance that food commodities are organic as defined in and for the purposes of the SFCR. 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 division 8 of Part 13 of the SFCR, and CFIA shall accredit the applicant as a CB on the recommendation of the CVB.
Compliance
means adherence with requirements of laws and government regulations, for example, Part 13 of the SFCR.
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)
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.
Investigation
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 food commodity composed of two or more food commodities.
Nonconformity
Occurrence of a condition that does not conform to the specifications of the prescribed standards (CAN/CGSB-32.310, CAN/CGSB-32.312)
Organic Product
An food commodity that has been certified as organic in accordance with Part 13 of the SFCR or that has been recognized as such under section 2 of the Safe Food for Canadians Act.
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.
Part 13 of the Safe Food for Canadians Regulations (SFCR)
These are the regulations referred to throughout the COR Operating Manual.
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.

Revision history

Table 1: Revision History of this Manual
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
  Jun20,2007 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 (not released) Amendments to the 2006 Organic Products Regulations The entire document
V11 Nov, 2009 (not released) Consultation with the CVBs Modifications to Part B:
Accreditation under the COR
Modifications to Part C;
Certification under the COR
V12 Dec, 2009 (not released) 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.
V16 January 15, 2019 Removal of part D and updates to part C due to SFCR coming into force. Removal of part D and changes to Part C.
All references to the Organic Products Regulations are changed to Part 13 of the Safe Food for Canadians Regulations.
New definitions were added.
V17 April 04, 2019 Added two new appendices to provide clarification on the interpretation of Part 13 of the SFCR relating to issuing organic certification, and enforcing and managing nonconformities under the COR.
Editorial changes to the manual post-SFCR updates.
Appendix C: The family of certification documents.
Appendix D: CB management of NC and enforcement actions under the COR.
Added a new section B.3.17 and new additional content to section A.4.4.
Editorial changes to Part A, B and C, and the reference section of the manual.

Part A Assessment and designation of conformity verification bodies

These requirements apply to the CVB's accreditation services provided for the purposes of the SFCR. 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 SFCR.

Operations resulting from these other activities 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.

A.1 Objective

To outline the process under which the CFIA shall enter into an agreement with a CVB and maintain it.

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.3.2 Document and record review

A.3.3 On-site assessment

A.3.4 Witness audit

A.3.5 Decision review process

A.3.6 Agreement signature

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 first, third and fifth year. In the second and fourth year there shall be a document review based on the CVB annual report.

A.4.4 During the 5 year agreement cycle, the COR audit team shall conduct one witness audit per CVB every year following A.3.4. The COR team may choose to witness a CVB audit at the CB office, CVB witness audit or CVB verification audit.

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 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 5 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 confidential. 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.8.2 Description of CVB decision making structures

A.8.3 Information on CVB's operations

A.8.4 CVB standards, policies and technical procedures (quality manual)

A.8.5 CVB's human resources management

A.8.6 Information, material and forms forwarded to accreditation applicants

A.8.7 Documents concerning rights and obligations of designated CVBs

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.

Table 2: Assessment cycle of CVBs by CFIA
2009 2010 2011 2012 2013 2014
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

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

Return to table note 1 referrer

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.

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 should neither constitute an infringement nor result in conflicts of interest with the certification program accredited by the CFIA.

B.1 Objective

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 Part 13 of the SFCR 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.2.2 On-site assessment of CB

Table 3: Number of files to be reviewed for CB initial accreditation
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 reviews Table note 2 (the number could be increased at the discretion of the CVB)
101 to 240 Minimum of 10 Table 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.2.3 CVB recommends accreditation to the CFIA

B.2.4 CFIA grants the accreditation

B.2.5 Requirements for granting accreditation number to the CB

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 Part 13 of the SFCR, 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 12 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.3.6 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.

Table 4: Number of files to be reviewed during each CB surveillance visit
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.

Table 5: Number witness audits to be performed over the CB accreditation cycle
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 audit
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.

Table 6: Number of verification audits to be performed over the CB accreditation cycle
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.3.11 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:

  1. if the CB does not have any operators after two consecutive surveillance assessments in an Accreditation cycle
  2. 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.3.17 At any time during the accreditation period the CVB may accept request from the CB to extend the scope of accreditation. The CVB shall have documented procedure to address such request. The CVB shall recommend to the CFIA scope expansion when the CVB is confident that the CB has fulfilled the requirements for accreditation.

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 SFCR.

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.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 SFCR , 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 349 of the SFCR.

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.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:

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:

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.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.11.2 Description of decision making structures

B.11.3 Information on CB's operations

B.11.4 Standards, policies and technical procedures (quality manual)

B.11.5 CB human resources management

B.11.6 Information material and forms forwarded to an applicant

B.11.7 Documents concerning rights and obligations of certified operators

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.12.2 Requirements on sending CVB

B.12.3 Requirements on receiving CVB

B.12.4 Requirements on CFIA

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.13.2 Requirements on CVB

B.13.3 Requirements on CFIA

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.14.2 Requirements on CVB

B.14.3 Requirements on CFIA

B.14.4 Requirements on the operators

Part C Certification of organic product and CB requirements

C.1 Objective

This section provides guidance on the certification process including application for certification, evaluation, decision on certification and continuation of the certification under the Canada Organic Regime (COR). It also provides requirements on the CB. The CVB shall verify how 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

C.2.1.1 The CFIA accredited CB shall ensure that person seeking certification of their products or packaging and labelling activities make an application as defined by the CB, in accordance with Division 4 of Part 13 of the Safe Food for Canadian Regulations (SFCR).

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 clause 344(2) of the SFCR. In addition, the application shall include the name(s) of CBs 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 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.2.1.4 The CB shall verify whether the applicant holds other types of certifications - packaging and labelling certificate and/or attestation of compliance.

C.2.1.5 The CB shall verify that the applicant does not hold a valid Canadian Organic Standards certificate for an identical/same product, issued by another CFIA accredited CB.

C.2.1.6 The CB shall verify the submitted documentation for completeness and to determine if it has the competence and capacity to perform the certification activity.

C.2.2 Application evaluation

C.2.2.1 The CB shall document its procedure for its evaluation activities. The CB shall evaluate the application against the requirements set out in CAN/CGSB-32.310, CAN/CGSB-32.311 and CAN/CGSB-32.312 as applicable to the nature of the product and production system.

C.2.2.2 The CB shall verify that the substances and the materials used in the production of organic products comply with CAN/CGSB 32.311 and CAN/CGSB-32.312 as applicable to the nature of the product and production system. The CB must maintain a procedure and documentation to support its determination about the status of input compliance.

C.2.2.3 The CB can determine input compliance with CAN/CGSB 32.311 or CAN/CGSB-32.312 as applicable to the nature of the product and production system by contacting the supplier/formulator/manufacturer to obtain full disclosure of the ingredients in the input material and the processes used to produce the ingredients and the input material.

C.2.2.4 The CB may consult with another CFIA accredited CB that has already evaluated a specified input material and, accept that CB's assessment of the input's compliance with CAN/CGSB 32.311 or CAN/CGSB-32.312.

C.2.2.5 The CB may consult with a third party organisation that is accredited under ISO 17065 to conduct input evaluation.

C.2.2.6 The CB shall take responsibility for all input evaluation activities outsourced to a third party.

C.2.2.7 The CB shall periodically confirm that input product formulations and processes have not changed. This shall generally be annually, but where a longer interval can be justified, must be at least once every 5 years.

C.2.2.8 The CB shall file a complaint to the CVB or directly to the CFIA if the CB has evidence that another CB has approved an ineligible input. The CVBs shall come to collective decision on the status of the input in timely manner.

C.2.2.9 The CB shall schedule an on-site inspection of the applicant to determine compliance with CAN/CGSB-32.310, CAN/CGSB-32.311 and/or CAN/CGSB-32.312, as applicable to the nature of the product and production system.

C.2.2.10 The timing of the on-site inspection shall take place during the production season in cases involving producer operations. This period begins as soon as the 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.2.2.11 In cases involving processing operations, on-site inspections may be carried out any time during the year. On the other hand, for separated production (that is, when both certifiable and non-certifiable products are manufactured at the same facility), the inspection shall be carried out at the time when the products that are targeted for certification are being processed. If the CB determines 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.2.2.12 The CB shall ensure that the applicant is contacted to arrange the logistics of the on-site inspection.

C 2.2.13 The CB shall record the VO selected to conduct on-site inspection. It is recommended that verification officers not be scheduled to inspect the same operation for more than 3 consecutive years. If there are extenuating circumstances and the VO inspects the same operation for more than 3 consecutive years, the justification must be recorded.

C.2.2.14 The CB shall allow the applicant to refuse the selected VO in case of conflict of interest.

C.2.2.15 The CB shall ensure that the assigned VO conducts an opening meeting with a representative of the applicant to confirm the inspection objectives, scope and criteria.

C.2.2.16 The CB shall ensure that all production and processing operations (for example, fields, crops, plants, livestock, buildings, facilities and vehicles), including packaging and labelling and any subcontracted activities upon which an operator relies to produce and/or prepare each product included within its application are inspected by the assigned VO who will verify that the standards are fully applied and correspond to the submitted production or preparation specifications.

C.2.2.17 The CB shall ensure that the land, premises and equipment not included in the scope of certification are identified and included in the application. The VO must verify the list is complete and correct including, at a minimum, the following: crop areas or harvesting zones; harvest storage locations; preparation, processing and packaging sites, a complete list of phytosanitary products used by the operator. Further, the VOs must verify the operator maintains a record of application dates and locations for phytosanitary products.

C.2.2.18 The CB shall verify that prohibited substances have not been, and are not being, applied to the operation.

C.2.2.19 The CB shall ensure that the VO conducts a review of record keeping, to verify that the organic plan submitted to the CB accurately reflects the operation and is in compliance with CAN/CGSB-32.310 or CAN/CGSB-32.312 as applicable to the operation and nature of production. Records to be verified shall include records related to production (for example, inventory, sales, purchases, organic certificates for each ingredient received) and to management (for example, accounting, complaints); as well as appropriate product packaging and labelling.

C.2.2.20 The CB shall ensure that the VO identifies and inspects areas of risk (for example, potential contamination from neighbouring farm, flooding, undeclared split production).

C.2.2.21 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.2.2.22 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 and for the corresponding inputs included in the products sold and on inventory. The calculation sample shall include more than one run of the product and at least one prominent commodity. The VO shall strive to review different commodity every year, if applicable. However, if justified by the VO, additional commodity(ies) may be included in this calculation. This justification shall be recorded in the inspection report.

C.2.2.23 The CB shall ensure that the VO performs products/ingredients trace back audits while on site. Products and/or their ingredient components must be traceable to the operators own production locations (fields/plots) or suppliers as applicable to the product and nature of the operation.

C.2.2.24 The CB shall ensure that the VO interviews people knowledgeable within the operation at the time of inspection.

C.2.2.25 The CB shall ensure that the VO:

C.2.2.26 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.2.3 Review

C.2.3.1 The CB shall inform the operator of all NCs and shall require from the operator to respond to the NC report issued by the Certification Body within 30 days of its receipt. The response shall either provide evidence of completion of corrective action(s) 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 NC as long as they are justified and documented.

C.2.3.2 The CB shall ensure that corrective actions aiming to address all nonconformities have been implemented by the operator by conducting an on-site visit or other appropriate forms of verification.

C.2.3.3 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 subject of the certification request.

C.2.4 Certification decision

C.2.4.1 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.2.4.2 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.2.4.3 The decision to certify a product and/or packaging and labelling activities shall be taken if the CB determines that all procedures and activities contained in the organic plan are in compliance with the SFCR requirements and that the applicant is able to operate in accordance with its plan and after the correction of all nonconformities. This decision is valid until the results of the next annual evaluation are known and a new decision is made or unless the CB is made aware of information to cause the CB to act (for example, suspension or cancellation). This information can come from an external source or from the CB's own efforts.

C.2.4.4 The CB shall provide the applicant with a certificate that confirms the certification of the organic product and/or certification of packaging and labelling activities of the organic product. These certificates shall include the following:

C.2.4.5 Packaging and labelling activities certificate shall include the period of validity, the type(s) of organic products to which the certification applies.

C.2.4.6 The certification of a product, once issued, shall remain valid unless suspended or cancelled by the CB according to the requirements of the SFCR.

C.2.4.7 The CB shall follow the SFCR requirements for cancellation in case of voluntary withdrawal by the operator.

C.2.5 Procedure for continuation of certification

C.2.5.1 The CB shall document the procedures to verify annually that the SFCR requirements for certification continue to be met by the holder of certificate.

C.2.5.2 The CB shall require the holder of the certificate to submit the information specified in Part 13 of the SFCR once every 12-month period, which begins on the day on which the certificate is issued. The CB shall require the holder of the certificate to submit their intention to maintain certification no later than the date that is 6 months prior to the end of that period and the completed recertification documentation in a time frame specified by the CB and as appropriate to the nature of the operation.

C.2.5.3 The CB shall proceed with an on-site inspection to verify compliance with the applicable requirements as outlined in C.2.2 when the holder of certificate submits all information requested by the CB.

C.2.5.4 The CB shall ensure that the VO verifies on-site that any changes in the organic standards and the CB requirements have been effectively implemented by the operator.

C.2.5.5 The CB shall ensure that the VO verifies on-site that previously submitted corrective actions have been, and remain, fully implemented.

C.2.5.6 The CB shall ensure that the renewal certification process is completed prior to the end of the 12 month period. The CB shall justify and document delays greater than 12 months in case the inspection visit must occur on a date beyond a period of 12 months following the inspection from the previous year. This postponement shall not exceed 3 months.

C.2.5.7 When the interval between 2 regular inspections has exceeded 12 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.2.5.8 The CB shall verify that all the requirements for certification are met resulting either in continuation of the certification or initiation of suspension and cancellation.

C.2.5.9 The CB shall make its certification decision for continued certification as outlined in C.2.4.

C.2.6 Additional inspections

C.2.6.1 In addition to the annual inspections the CB shall plan and conduct unannounced inspections representing 5% of the holders of certificates (minimum one) to which CB grants certificates for products and/or packaging and labelling certificate under the COR.

C.2.6.2 The CB shall document the procedure covering the frequency and selection criteria for these unannounced on-site inspections. In cases where it is not possible to conduct an unannounced inspection (for example, 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.2.6.3 Unannounced inspections shall be limited in scope and shall cover only certain aspects of the operation. The criteria used in choosing operators for unannounced inspections shall be random, risk based, and as a result of a complaint or investigation. The CBs should apply a combination of all 3 above mentioned criteria when planning the unannounced inspections for each year. The CB is not obliged to disclose to the operator the reason for the unannounced or additional inspection.

C.2.6.4 The CB shall consider the following examples when developing risk-based criteria for unannounced inspections, as a minimum:

C.2.6.5 The CBs shall apply a checklist of risk based criteria when evaluating the risk to which the integrity of organic products can be compromised. The CB shall define individual scores that can be applied to each risk criteria. These scores should be added to calculate a total score for each operator. Based on the scores, the CB will determine which operators are selected for unannounced inspections.

C.2.6.6 The CB shall comply with any requests from the CFIA 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.2.7 Sampling and testing

C.2.7.1 The CBs shall develop sampling and testing procedure incorporating the following sampling criteria:

C.2.7.2 The CB shall ensure that the verification officers (VOs) are trained on how to sample, label, and store products under proper chain of custody until samples are submitted for testing.

C.2.7.3 The CB shall ensure that the VOs are provided with the proper sampling equipment at the time of the inspection as per specific sampling protocols provided by the laboratory.

C.2.7.4 The CB should consider referring to Codex Alimentarius Commission (Codex) for information on recommended methods of sampling for the determination of chemical residues as guidance.

C.2.7.5 The CB shall be responsible for maintaining the chain of custody of samples prior to submission to the laboratories.

C.2.7.6 The CB shall have a legally binding contract with laboratory(s) that hold current accreditation to ISO/IEC 17025: 2005 - General Requirements for the Competence of Testing and Calibration of Laboratories, and for which the scope of accreditation allows for the testing of the specific substance in food.

C.2.7.7 CFIA accredited CBs must maintain records to demonstrate that they conduct chemical residue sampling and testing of their operators products and follow up on chemical residue results that were forwarded to them for action

C.2.7.8 The CB shall require pre-harvest or post-harvest testing of any organic product to be sold, labelled or represented as being in compliance with the requirements of the CAN/CGSB-32.310, CAN/CGSB-32.311 and/or CAN/CGSB-32.312 as applicable to the nature of the product and production system when there is a reason to suspect that the organic product has come into contact with a prohibited substance, method or ingredient in the production and handling of organic products.

C.2.7.9 The CB may sample and test as part of an investigation of a complaint concerning the use of or contamination with prohibited substance. Intentional use of prohibited substances by an operator shall result in the CB initiating the suspension and cancellation process as per Part 13 of the SFCR.

C.2.7.10 The CB shall investigate if there is suspicion that an organic product has been contaminated by or commingled with genetically engineered (GE) materials. The investigation may include sampling and testing for GE presence.

C.2.8 Suspension and cancellation

C.2.8.1 The CB shall suspend and cancel a certification as per Part 13 of the SFCR.

C.2.8.2 The CB shall report to its CVB all suspensions, change of a CB by an operator, and cancellations it issues on the 25th of each month, in case such decisions are made, or shall be provided as defined by the CVB. All reports shall include the name of the holder of certificate, the date of issue and the reason for the action.

C.2.8.3 The CB shall not grant certification to an applicant who had its certification previously cancelled and whose name appears on the CFIA published list of cancelled organic certifications unless the applicant has submitted an application for certification to a CFIA accredited CB as per section C.2, and has completed the evaluation process and closed all the non-conformities.

C.2.8.4 The CB shall submit to the CFIA a request for removing the name of the holder of certificate from the list of cancelled holders of certificates posted on the CFIA web site.

C.2.8.5 The CB shall proceed with granting a certification after receiving conformation from the CFIA that the operator is removed from the CFIA list.

C.3 Timing of sale or distribution of certified product

C.3.1 When certification is requested, the CB shall ensure that the applicant does not offer for sale any product "represented as organic" or bearing the word organic or its derivatives until the applicant receives the certificate from the CB.

C.4 Complaint and appeal

C.4.1 The CB shall document procedures to ensure that it deals with the complaints and appeal by applicant, certificate holder or other party pertaining to certification in accordance with the requirements specified in ISO 17065.

C.4.2 The CB documented procedures shall deal with, as a minimum:

C 4.3 The CB shall communicate the next steps to the certificate holder in case the holder is not satisfied with the CB appeal process. The certificate holder can submit a complaint against the CB to the CVB responsible for the oversight of the CB.

C.5 Issues regarding implementation of the standard

C.5.1 The CB shall notify all of its certificate holders of any amendments to the Regulations or the Standards within 2 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, CAN/CGSB-32.311 and CAN/CGSB-32.312 for applicants to come into compliance with any changes to the requirements.

C 5.3 Some of the revisions in the standards may require more than 12 months to implement, such as barn renovations to comply with new flock sizes, exit spaces and natural lighting in poultry installations. When applicable, any period longer than 12 months is specified within the standards.

C 5.4 The CB shall update application documentation, training materials, certification procedures and checklists to reflect the most recent versions of the Canadian Organic Standards.

C.5.5 If an interpretation of an applicable Standard is required by the CB or a certificate holder at any point during certification activities, it can be sought from the standards interpretation committee (SIC).

C.5.6 It is likely that the need for interpretation requests to the SIC will occur during a certification cycle of a certificate holder by a CB. In such cases, where both parties agree there is need for interpretation or clarification and the interpretation request is submitted by the CB, the issue that is the subject of the request will be set aside by the CB (for example, the nonconformity will be placed on hold) until the response from the SIC is returned.

C.5.7 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 the issuance of certification documents.

C.5.8 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.5.9 If changes are required by the certificate holder to comply with the interpretation of the SIC, the CB shall not suspend or withdraw 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.5.10 In cases where the CB and the certificate holder do not agree that the issue needs an interpretation, the CB shall rely on Part 1.4 of CAN/CGSB-32.310 or Part 1.4 of CAN/CGSB-32.312 when interpreting the issue. The certificate holder 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.5.11 The CB shall adhere to the interpretations of the Canadian organic standards (CAN/CGSB 32.310, CAN/CGSB 32.311, and CAN/CGSB 32.312) provided by the SIC and considered official by the CFIA, to achieve uniform and consistent application of the rules to all operators through various CBs.

C.5.12 The CBs shall inform their certificate holders about these interpretations.

C.6 Use of licenses, certificates and marks of conformity

C.6.1 The CB shall ensure that all certified products are labelled in accordance with the SFCR.

C.6.2 The CB shall have procedures to monitor the holders of certificates using its certification mark and its name and marketing organic products to detect any improper reference to the Canada Organic Regime or fraudulent use of the CB name and certificates.

C.6.3 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.6.4 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.6.5 The CB shall have procedures ensuring that the holders of certificates 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 multi-ingredient organic product unless it verifies that the organic ingredients used in the product formulation have been certified as organic in accordance with Part 13 of the SFCR by a CFIA accredited CB or to the terms of an organic equivalence arrangement by a CB accredited under the existing organic equivalency arrangements.

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 will 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 legally enforceable agreement with each certificate holder that specifies the rights and responsibilities relevant to its certification activities including information about the CB appeal process and provisions to cover liabilities in situations where there is a significant risk of being sued.

C.7.6 The CB shall define and document the competence of the personnel for each function in the certification process including the VOs. The CB shall ensure that its personnel has professional training and experience relevant to the COR, including specific training with respect to the Canadian organic standards and the certification requirements outlined in C.2.

C.7.7 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 12 months preceding its application to the CB.

C.7.8 The CB shall assign personnel to perform each evaluation task as per ISO 17065.

C.7.9 The CB shall establish procedures for evaluating and monitoring the performance of the personnel including the VO which should at minimum include initial assessment of competence and annual performance review, and regular field evaluation of the VOs. The frequency of the field evaluation shall be defined and developed by the CB. The CB may consider the number of VO inspections, VO's experience, and quality of the inspection reports in developing the frequency requirements. The CB shall record the performance of the personnel including the VOs' monitoring.

C.7.10 The CB shall document the 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 and parallel production.

C.7.11 The CB shall document the minimum requirements for any audit trail, in relation to traceability.

C.7.12 The CB shall document its sampling and testing requirements.

C.7.13 The CB shall document its deadlines for presentation of the VO report to the CB.

C.7.14 The CB shall have procedures to address cases when an operator does not renew a certification from a previous year to ensure that the CB shall formally notify this operator in a timely manner that its certification is cancelled.

C.7.15 The CB shall exchange any information deemed confidential with other CFIA accredited CBs and/or CFIA to verify the validity of information on a holder of certificate. Such exchange is still considered to be and shall be managed as confidential by the receiving party.

C.8 Records control by the CB and operator

C.8.1 The CB shall document procedures to ensure it maintains a record system that complies with the SFCR requirements.

C.8.2 The CB shall ensure that its records are to be kept for a minimum of 5 years. This requirement shall also be documented by the CB.

C.8.3 The CB shall ensure that the operator maintains 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 or CAN/CGSB-32.312 for a minimum of 5 years.

C.9 CB records

C.9.1 The CB shall maintain all data listed below and shall provide it to the CVB and the CFIA 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.9.2 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 and/or the CFIA upon request.

C.9.4 The CB shall maintain records of the following:

C.9.5 The CB 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 (for example, 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 345(2) of the SFCR.

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 the sending (current) 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 (for example, 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

C.11.1 Scope

As per Part 13 of the SFCR, a CFIA accredited CB upon request shall issue a document referred to as an "attestation of compliance" to a person that conducts physical activities with respect to the organic product (for example, slaughtering where the meat is not packaged and labelled, storing, seed cleaning and other custom services for bulk organic products where the ownership of the products remains with the primary producer/processor) which is not yet in an impermeable package, with the exception of retail and transport.

With respect to transportation of organic products which are not packaged or labelled, the CBs must verify that the organic integrity of the product is maintained by reviewing an affidavit signed by the truck company or other methods.

In cases when a service provider does not hold an attestation of compliance, it is the responsibility of the certificate holder to ensure that these services/activities are conducted in accordance with the COR requirements. These activities have to be included in the certificate holder/applicant's organic system plan and be verified by the CB as part of the certificate holder/applicant's on-site inspection.

C.11.2 Procedure for issuing attestation of compliance under COR

C.11.2.1 The CB shall verify that the activities are being conducted in accordance with CAN/CGSB 32.310 or CAN/CGSB 32.312 to maintain the integrity of the organic product.

C.11.2.2 The CB shall follow the steps outlined under C.2 of the COR operating manual as applicable to the activity conducted. As a minimum the CB shall:

C.11.2.3 The CFIA accredited CBs shall:

C.11.2.4 The CFIA accredited CBs shall accept an "attestation of compliance" issued by any CFIA accredited CB as meeting the SFCR 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 grower group organizations

C.12.1.1 The grower group shall only seek certification with a CB accredited by CFIA under the COR that is accredited to certify grower groups.

C 12.1.2 The CVB shall assess the ability of the CB to perform the group certification and recommend it for accreditation to the CFIA. A CB shall be accredited for grower group scope if they have policies and procedures to verify compliance of the group and the individual group members.

C.12.1.3 The grower group composed of production units, sites, or facilities, shall be recognized as a "person" according to Part 13 of SFCR.

C.12.1.4 The grower group may be organized on itself, that is, as a co-operative, or as a structured group of producers affiliated to a processor.

C.12.1.5 All members of the grower group shall apply similar production systems and should be in geographical proximity. Only small farmers can be members of the group covered by group certification. Large farms can also belong to the group but have to be inspected annually by the CB.

C.12.1.6 The grower group shall be established formally, based on written agreements with its members. It shall have a central management, established decision procedures and be a legal entity.

C.12.1.7 The grower group shall have in place an effective and documented internal control system.

C.12.1.8 The management of the grower group shall sign a legally enforceable agreement with the CB specifying the responsibilities of both parties. The management shall obtain signed obligations from all grower group members to comply with the Canada organic standards and to permit inspection by the CB, the CVB or the CFIA.

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 ensure 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. Internal inspectors designated by the grower group shall carry out internal controls.

C.12.2.4. Adequate number of internal inspectors shall be identified from within the group. The internal inspectors shall be trained and, ensure that potential conflicts of interest are limited.

C.12.2.5 The internal inspectors shall carry out at least 1 annual inspection visit to each individual operator including visits to fields and facilities.

C.12.2.6 The internal control system shall contain appropriate records including:

C.12.2.7 The internal control system shall have a mechanism to remove non- compliant group members from the list. The CB should be notified when a (non-compliant) member is sanctioned and/or when voluntarily withdrawn.

C.12.2.8 The internal control system shall record all non-conformities. The ICS shall require from the operator to respond to the NC report issued by the ICS within 30 working 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 working days from receipt of the NCs. The ICS shall accept times greater than those stated for the closure of a NC as long as they are justified and documented.

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, CAN/CGSB 32.311 and CAN/CGSB 32.312.

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 geographical location in which it functions. A sample of all sites under the grower group's responsibility shall be subject to inspection visits by the CB. The CB may justify exceptions to this rule based on risk assessment.

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.12.3.3.1 factors related to the magnitude of the grower group

C.12.3.3.2 factors related to the characteristics 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.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. In addition, the CB shall conduct a verification audit to assess the findings of the ICS against the CB findings.

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:

C.12.4.3 In cases of high risk situations the CB may increase the number of the annually inspected members to at least 2 times the square root of the number of the members in the grower group (for example, ICS has issued a lot of internal sanctions, or 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 a timely manner anytime there are changes to the status of the members and changes to the group as a whole.

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 Records

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 have had its operations or product certified cannot 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 Part 13 of the SFCR, in cases where the grower group's internal control system fails to act on these non-compliances.

Appendix A - Certificate template - Informative

Organic Certificate

Pursuant to Part 13 of the Safe Food for Canadians Regulations (SFCR)

Issued by: … (Insert CB name, address)

Certification number: …

Certificate Holder name and address: …

This certification is based on compliance with the CAN/CGSB 32.310-2015 / CAN/CGSB 32.311-2015 General Principles and Management Standards and Permitted Substances Lists

and/or

CAN/CGSB 32.312-2018 Organic Production Systems -Aquaculture - General principles, management standards and permitted substances lists

and/or

The terms of the US/Canada organic equivalence agreement (when applicable)

Certification type and % organic content: …

(Product listing addendum for certified products)

Date on which the updated certificate 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 Part 13 of the Safe Food for Canadians Regulations (SFCR)

Signed by:

(CB authorized representative)

Dated:

Appendix B - Attestation template - Informative

Attestation of Compliance

Pursuant to Part 13 of the Safe Food for Canadians Regulations (SFCR)

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 Organic Production Systems General Principles and Management Standards CAN/CGSB-32.310 and Permitted Substances Lists CAN/CGSB-32.311-2015, 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 [CB name].

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 Part 13 of the Safe Food for Canadians Regulations (SFCR).

CB's representative signature:

Print name:

Date of issue:

Appendix C - The family of certification documents

Documentation requirements for verification of continued organic integrity under the Canada Organic Regime

(Interpretation of Part 13 of the SFCR)

The "family" of certification documents

Because an organic product carries its certification until the next point of transformation, operators may require different types of document to attest to a product's organic status and integrity. These documents are:

  1. organic product certificate
  2. certificate for labelling and/or packaging activities
  3. attestation of compliance for a service provider conducting activities, excluding packaging and labelling activities

These documents are considered the "family" of documents, which can be issued by a CFIA-accredited certification body (CB) in order to attest to the organic integrity of a product. For products and ingredients imported to Canada, parties within the Canada Organic Regime (COR) shall recognize organic certificates from equivalent organic systems.

The COR operating manual requires that all CFIA-accredited CBs accept certification documents including attestation of compliance, issued by another CFIA-accredited CB or any CB recognized under equivalency arrangements as meeting the SFCR requirements for the maintenance of organic integrity.

Whenever a document is issued, there must be verification that the operator requesting certification complies with the Canadian Organic Standards, such as requirements related to the organic plan.

Types of documentation issued by the CBs to verify continued organic integrity under COR
Type of Documentation Description
Organic Product Certificate CBs shall issue certificates confirming the organic status of a product, verified to be produced or processed in compliance with the Canadian Organic Standards as per section 345(2) of the SFCR. Product certificates do not expire; however, section 346(1) of the SFCR requires the certification holder to submit updated information annually.
Certificate of packaging and labelling activities CBs shall issue certificate of packaging or labelling activities to an operator as per clause 348(2) of the SFCR.
Attestation of compliance document CBs may issue an attestation of compliance confirming that the service provider conducted an activity on behalf of an organic operator in compliance with the Canadian organic standards as per clause 344(2)(c) of the SFCR. The CB shall issue the attestation of compliance in accordance with C.11 of the COR operating manual.
Expiry/renewal of documentation
Type of document Expiry/Renewal
Organic Product Certificate Does not expire.
A certificate must be issued for an organic product on an annual basis as per 345(2) of the SFCR.
Organic Packaging and Labelling Certificate Remains in effect for a period of 12 months beginning on the day on which it is granted as per section 348 (3) of the SFCR.
Attestation of Compliance Remains in effect for a period of 12 months beginning on the day it was granted as per C.11 of the COR operating manual.
Example scenarios
# Operator Scenario Type of Document
1 Farmer (primary producer) The primary producer sells an organic product to a retailer or manufacturer without any processing or transformation. Organic Product Certificate
Any transport or handling of the product included in the organic plan by the farmer is covered by this certificate.
Subsequent activities such as processing, transformation, packaging, and labelling by other parties are not covered by the organic product certificate issued to the primary producer.
2 Trader - Domestic Distributor The trader sells an organic product to a retailer such as bulk products obtained from a farmer or manufacturer. The product has not been transformed but the trader wishes to show that the organic integrity of the product has been maintained. Organic product certificate
The trader may apply for product certification and sell the organic product under this documentation (e.g. as the organic integrity has been verified, the name and address of the supplier are not required to be disclosed to the buyer).
However, traders or distributors can still trade organic products without applying for organic product certificate, provided that organic integrity has not been compromised and the full documentation chain for these products is on hand and provided as required by either the certification body or the CFIA inspectors.
3 Trader - Exporter – Equivalency Arrangement - Certificate of Inspection required The exporter sells an organic product to an export market with whom Canada has an equivalency arrangement and the competent authority of the export market requires a "Certificate of Inspection" as is the case with the European Union, Switzerland and Japan. Organic product certificate and Certificate of Inspection
The certificate of inspection should be issued by the CB that certified the product as organic.
4 Trader - Exporter – Equivalency Arrangement – Certificate of Inspection not required The exporter sells an organic product to an export market with whom Canada has an Equivalency Arrangement but no Certificate of Inspection is required (e.g. United States and Costa Rica) Organic product certificate
Canadian organic products exported to the U.S. under the USCOEA must be accompanied by a valid organic product certificate issued by a Canadian Food Inspection Agency (CFIA) accredited certification body, which includes the following attestation statement, "Certified in compliance with the terms of the U.S.-Canada Organic Equivalency Arrangement".
5 Trader - Exporter – No Equivalency Arrangement The exporter sells an organic product to an export market with whom Canada does not have an Equivalency Arrangement Organic product certificate should be issued if the product is marketed in Canada.
Import requirements of the country where the product will be marketed must be met.
6 Re-packager/Re-labeller (processor) An operator purchases an organic product but changes its container (for example, from bulk to single-package), changes its packaging, or provides a new label (i.e. changing or adding information to the original package). Organic product certificate
7 Retailer (sale of bulk product from bins) A retailer purchases bulk product for sale in its store and back-fills the bins as levels get lower. These bins are labelled "organic" and carry the Canada Organic Logo. Organic product certificate
Retailers, who choose to blend, further prepare, package or label organic products and use the Canada Organic Logo are required to obtain certification under the federal system.
8 Retailer (repackaging of bulk product into small packages) A retailer purchases bulk product for sale in its store and re-packages i.e., makes individual-sale units available. These packages are labelled "organic" and carry the Canada Organic Logo. Organic product certificate
Retailers, who choose to blend, further prepare, package or label organic products but choose not to use the Canada Organic Logo, and do not cross provincial lines, are not required to obtain certification under the federal system. The Canada Organic Retailing Practices Guide is recommended for best management practices in such situations. However, in certain provinces, the retailer may have to obtain certification under a provincial regime
9 Brand owner (products under a private label) A brand owner buys (under contract) prepackaged products via third-party producers or manufacturers and markets them under their own brand of product. Organic product certificate
The brand owner may apply for product certification and sell the product under this documentation. It is not necessary to disclose the name and address of the original supplier on the packaging as long as the brand owner’s name and address is included. The label must display the name of the CB which issued the final organic product certificate. The certification is not mandatory if the name and address of the original supplier is disclosed on the final packaging.
10 Manufacturer/ processor A manufacturer/ processor buys organic product from a trader or producer and transforms it into a new product. Organic Product Certificate
All organic ingredients must be accompanied by their organic product certificate, and the manufactured/processed products must be issued organic product certificates by a CB under the COR.
11 Contract packaging and labelling activitiesContract service providers that only package and label organic products on behalf of the organic product certificate holder Certificate for packaging or labelling activities
12 Contract services excluding packaging and labelling and final product preparation i.e., services conducted on behalf of the organic product certificate holder. Contract service providers (e.g. for slaughter, transport, storage, seed cleaning, etc. excluding packaging and labelling) who perform contractual work for operators in relation to certified organic products but the ownership of the product continuously rests with the holder of the organic certificate. Attestation of Compliance
  1. To be issued in accordance with section C.11 of the COR Operating Manual,
    or
  2. the service provider must be included in the on-site verification of the CB for the product certification.
13 On-site services or equipment (e.g. mobile juicers) A certified operation (e.g. a farm) leases or loans equipment or has services that are performed on-site, but the ownership of the organic product continuously rests with the organic product certificate holder.None
If the organic plan includes this situation, and the CB is able to verify compliance to the standards, including cleaning requirements, then the equipment or service may be covered by the original organic product certificate.
or
Attestation of Compliance
May be issued in accordance with section C.11 of the COR Operating Manual.

Appendix D - CB management of nonconformities and enforcement actions under the Canada Organic Regime

Click on image for larger view
A flow chart showing the CBs regulatory authorities for enforcement actions under Part 13 of the SFCR. Description follows.

Description for flow chart showing the CBs regulatory authorities for enforcement actions
  1. The CB issues a notification of nonconformity (NC) to an operator/applicant and requests that the operator responds to the notification within 30 days of its receipt, as per clause 349(2)(a) of the SFCR and section C.2.3.1 of the COR operating manual. The response shall either provide evidence of completion of corrective action taken to address the nonconformity or, a plan with milestones as to how the nonconformity will be addressed.
    1. After the response is provided, the CB assesses the information and verifies that the operator has addressed all the nonconformities before determining whether to close the NC. If the NC is closed, the CB makes a certification decision. Depending on the circumstance, the certification decision could be either to lift a suspension of an existing organic operator or to issue organic certification to an applicant/operator.
    2. In the case where the CB determines that the NC is not closed, the operator may request for a one-time extension from their CB in order to submit corrective action to address the nonconformity. The CB then reassesses the information provided and determines whether to close the NC. If the NC is closed a certification decision will be made. If the NC is not closed, the CB issues a notification of suspension to the operator as per clauses 349(1) and 349(4) of the SFCR.
  2. The CB issues a notification of nonconformity (NC) to an operator and requests that the operator responds to the notification within 30 days of its receipt, but the operator does not provide a response. In this case, the CB must issue a notice of suspension to the operator in accordance with clauses 349(1) and 349(4) of the SFCR.
  3. After the CB issues a notification of suspension to an operator, the operator has 30 days to take corrective action or submit a corrective action plan to their CB as per clause 349 of the SFCR. The CB assesses the information provided and determines whether or not the information is adequate.
    1. If the information is adequate, the CB determines whether or not to close the NC and a certification decision is made accordingly.
    2. If the information is inadequate, the CB notifies the operator of the grounds for cancellation and provides the operator an opportunity to be heard.
    3. The CB issues the operator a notification of cancellation as per clause 350 of the SFCR.
  4. After the CB issues a notification of suspension to an operator, if the operator did not provide a response or provided the CB with inadequate response, the CB must notify the operator of the grounds for cancellation and provide the operator an opportunity to be heard.
  5. The CB issues the operator a notification of cancellation as per clause 350 of the SFCR.

Additional information

  1. The Notification of Suspension has to be issued separately from the Notification of Proposed Cancellation (that is, grounds for cancellation).
  2. Suspension and cancellation are two separate processes. Only in the case of clause 350(1)(b) of the SFCR that the CB can proceed directly with a Notification of Proposed Cancellation without suspending the operator. The CB has to give the operator the opportunity to be heard.
  3. Under the SFCR the CBs are required to have an appeal process in line with ISO/IEC17065 and the operator has to be informed about this process when notified about cancellation. This process is considered compliant with the SFCR requirement for "opportunity to be heard".
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