Canadian Food Inspection Agency peer review of European Union Organic System

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Abbreviations and special terms used in the report

CA
Competent Authority
CB
Control Body
CFIA
Canadian Food Inspection Agency
COR
Canada Organic Regime
DAA
Danish Agricultural Agency
DAA CU
Danish Agricultural Agency – Control Unit
DCA
Danish Customs Agency
DVFA
Danish Veterinary and Food Administration
DG AGRI
Directorate-General for Agriculture and Rural Development
DG SANTE
Directorate-General for Health and Food Safety
EC
European Commission
EU
European Union
EUCOEA
European Union-Canada Organic Equivalence Arrangement
EGTOP
Expert Group for Technical Advice on Organic Production
FOIA
Freedom of Information Act
ISO
International Standards Organization
MS
Member States
MANCP
Multi-annual National Control Plans
NC
Non-Conformity
NFA
National Food Agency (Livsmedelsverket)
OFIS
Organic Farming Information System
SBA
Swedish Board of Agriculture (Jordbruksverket)
SWEDAC
Board for Accreditation and Conformity Assessment
TRACES
Trade Control and Expert System

Executive summary

This report summarizes observations made during the Canadian Food Inspection Agency's (CFIA) September 2019 on-site peer review of the European Union (EU) Organic Program.

The objective of the peer review was to determine the extent to which the EU competent authority demonstrates conformity with the requirements specified in the EU-Canada Organic Equivalence Arrangement (EUCOEA).

The peer review was conducted from September 16 to 27, 2019. It included meetings with the European Commission (EC) Organic Farming Unit, competent authorities in 2 Member States (MS), 1 Control Body (CB) and 4 production units (farms and processing facilities).

The key elements of the peer review included the following:

1) Authorities

  • Current organic legislative authorities, including regulations, standards, codes of practice, and arrangements. In particular:
    • authority to recognize and certify parties involved in the EU organic system
    • authority to carry out monitoring and surveillance activities
    • authority to respond to non-compliances where risk has been identified such as recalls, other control and enforcement activities

2) Government organization and resources

  • The roles and responsibilities of the various government departments and authorities involved in the implementation of the EU organic system
  • The resources, responsibilities, functions, and coordination between the parties involved in the EU organic system
  • Competencies of the parties involved in the delivery of the EU organic system

3) Enforcement and surveillance activities

  • The role of the EC Organic Farming Unit, the competent authorities in the MS and the CBs in inspection, surveillance, and enforcement of the organic regulations

The peer review determined that the EC has implemented a control system for the certification of organic operators that is supported by good collaboration between the EC and the MS.

This system guarantees that agricultural organic products certified under the EU Organic Regulations can be exported and marketed in Canada as meeting the terms of the EUCOEA.

This report provides a number of recommendations which highlight opportunities for improvement and enhancement of the implementation of the EU organic system.

The observations and recommendations contained in this report are based on information gathered by the assessment team through the CFIA Peer review questionnaire, personal interviews with personnel, and on-site observation. They represent the collective understanding of the members of the assessment team.

1.0 Background

The European Union-Canada Organic Equivalence Arrangement (EUCOEA) was signed in 2011 and amended in 2016 to include organic wine and multi-ingredient products with imported ingredients.

As per the conditions of the arrangement, and following advance notice from the CFIA, the EC agreed to accommodate the CFIA's request to conduct an evaluation (on-site peer review) to verify how the responsible administrative structures of the European organic system are carrying out the requirements of the European organic system.

2.0 Objectives of the on-site peer review

The objective of the peer review was to determine the extent to which the EU competent authority demonstrated conformity with the requirements specified in the EUCOEA (2011).

3.0 Peer review criteria

The following references (regulatory requirements/standards) were used during the on-site peer review:

  • Regulation (EC) No 834/2007 of 28 June 2007
  • Regulation (EC) No 889/2008 of 5 September 2008
  • Regulation (EC) No 1235/2008 of 8 December 2008
  • ISO/IEC 17011:2017
  • ISO/IEC 17065:2012
  • Terms of the EUCOEA

4.0 On-site peer review protocol

The CFIA's peer review team planned and conducted the on-site peer review in a manner which allowed the team to obtain sufficient information to confirm the observations and conclusions described thereafter. The on-site peer review was conducted in accordance with Canada's Organic Regime Peer Review Procedure and included visits to the following organisations:

Organisation Date
EC headquarters September 16, 2019
Member State 1 – Headquarters September 17, 2019
Control Body (CB) – Headquarters September 18, 2019
Processor /Seed storage September 19, 2019
Organic Crops Farm September 20, 2019
Member State 2 – Headquarters September 23, 2019
DVFA Import Control Unit September 24, 2019
Importer/packaging facility September 24, 2019
DAA Control Unit September 25, 2019
Livestock farm September 25, 2019
EC headquarters September 26, 2019
Closing meeting September 27, 2019

As part of the on-site peer review, the CFIA auditor reviewed each level of the EU Organic System (administration, supervision, certification and production) to confirm that the responsible authorities have the necessary controls in place to ensure compliance with the EU Organic Regulations. In doing so, the CFIA auditor:

  • met with representatives from the EC Organic Farming Unit to review the administration of the EU organic systems and to discuss the roles and responsibilities in overseeing the system and the activities of the MS
  • met with representatives from 2 MS responsible for the delivery of the organic system
  • met with representatives from one CB to review their certification processes and procedures
  • witnessed 4 inspections conducted by CB inspectors and competent authorities inspectors at organic farms and organic production operations to confirm their knowledge of the EU organic system

5.0 Overview of the EU organic sector

Organic farming and production has been regulated at the EU level since 1991 for crop production, since 2000 for animal production, and since 2010 organic aquaculture. Currently, the organic supply chain in the EU is covered by Regulation (EC) 834/2007 on organic production and labelling of organic products and its 2 implementing regulations on production, labelling, controls and imports.

EU (34.2 billion €) is the second largest single market after the US (40 billion €) and followed by China.

More than half (56%) of EU organic farmland is in 4 countries. The European countries with the largest markets for organic food are Germany (10 billion €), France (7.9 billion €), Italy (3.1 billion €), and Sweden (2.3 billion €).

Denmark has the highest per capita consumption of organic food in the EU, followed by Sweden and Luxembourg.

5.1 EU organic legislation and standards

The EU organic control system is based on the following legal authorities:

  • Regulation (EC) No 834/2007 on organic production and labelling of organic products
  • Regulation (EC) No 889/2008 of 5 September 2008
  • Regulation (EC) No 1235/2008 of 8 December 2008
  • ISO/IEC 17011:2017
  • ISO/IEC 17065:2012
  • Terms of the EUCOEA

5.2 EC Organic farming unit

5.2.1 EC Organic farming unit AGRI. B4 mandate

The Directorate-General for Agriculture and Rural Development (DG AGRI) is responsible for:

  • developing and managing the Organic Production Policy, including EU-wide harmonized rules on organic production as well as rules on labelling, controls and international trade
  • implementing the EU organic production framework, including the EU's Action Plan for organic production to facilitate the growth of organic sector
  • negotiating arrangements and agreements
  • safeguarding the integrity of EU organic production

The Directorate manages a Committee on Organic Production (COP), composed of Member States' representatives and an Expert Group for Technical Advice (EGTOP).

5.2.2 Structure

The EC Organic Farming Unit AGRI. B4 Organics has 4 Sectors:

  1. Sector: Internal Policy and Regulations
  2. Sector: Monitoring of Irregularities
  3. Sector: International
  4. Sector: Control, Monitoring and Supervision
5.2.2.1 Sector: Internal policy and regulations responsibilities

This sector is comprised of 6 people. The sector is responsible for:

  • Implementing the organic legislation on production rules and labelling in the EU
  • Contributing to the development of the policy regarding the EU internal market

This sector works closely with the EGTOP to update the Annexes of regulation 889/2008 of authorized products and substances. The organic Unit has frequent meetings with the MS representatives in the context of the Committee of Organic Production to discuss operational needs.

The MS have the authority to issue derogations to the organic rules. These derogations are notified in Organic Farming Information System (OFIS) and monitored by the sector.

All the letters of interpretation and clarification on the rules are prepared by this sector in consultation with other departments and legal services.

5.2.2.2 Sector: Monitoring of irregularities responsibilities

This sector is comprised of 3 people. The sector is responsible for:

  • Monitoring the OFIS systems for irregularities both concerning European and imported organic products

The sector monitors and accepts the MS notifications and verifies the responses provided by the CBs as a result of their investigations.

5.2.2.3 Sector: International responsibilities

This sector is comprised of 8 people. The sector is responsible for:

  • clarifying the rules for imported organic products
  • managing the list of the recognized CBs under Annex IV of the Regulations 1235/ 2008
  • negotiating organic equivalency recognitions (Annex III of the Regulations 1235/ 2008)
  • cooperating with third countries regarding organic requirements

Currently, this sector is developing secondary regulations for the implementation of the new EU organic regulations.

5.2.2.4 Sector: Control, monitoring and supervision responsibilities

The sector is comprised of 5 people. The sector is responsible for:

  • supervising the competent authorities within the MS for EU and European Free Trade Association States (EFTA)
  • developing of organic farming policy with regards to controls
  • addressing interpretation questions and issues
  • participating in systems audits of the EU MS in collaboration with Directorate-General for Health and Food Safety (DG SANTE)

This sector assesses the annual control reports submitted by the MS under the Multi-annual National Control Plans (MANCPs) and participates in the audits on the MS conducted by DG SANTE.

6.0 Implementation of the EU organic system by the Member States

The MS are responsible for setting up a control system to monitor compliance with EU rules on organic production, processing, import and labelling. Each MS appoints a competent authority (CA) which is ultimately responsible for implementing and monitoring the compliance with the EU organics rules in their country. Usually the competent authority is either or both the Department of Agriculture and the Department of Public Health as well the national food safety authority.

The CA can delegate its role to one or more private CBs, one or more public control authorities or a mixed system with both private CBs and public control authorities.

Regardless of the system chosen, the CA is ultimately responsible for auditing the inspection system within its own area of responsibility.

The majority of MS have delegated control tasks to private CBs. Five MS have conferred their control competences to public control authorities, and 2 have chosen a mixed system.

All private CBs are accredited in accordance with the most recent version of ISO standard 17065:2012 by the national accreditation body in each MS. The audits conducted by the accreditation bodies focus on the technical competence, independence, impartiality and professional integrity of the CBs. The EU organic regulations do not require the public control authorities to be accredited however they are subject to internal audits or may have external audits as per article 4 (6) of the official controls regulation No 882/2004 ( replaced by reg. 2017/625).

As part of the peer review, 2 MS with different control systems were assessed.

The CFIA auditor focused on the role of the CAs in regards to supervising the CBs as well as the certification activities conducted by CBs, import controls, and controls on labelling and marketing of organic products.

6.1 Swedish organic system

The main legal acts for implementation of the EU organic legislation in Sweden are:

  1. Law on Control of Organic Production [Lag 2013:363 om kontroll av ekologisk produktion] and
  2. Government Ordinance on Control of Organic Production [Förordning 2013:1059] om kontroll av ekologisk produktion]
  3. Livsmedelsverkets föreskrifter (LIVSFS 2016:1) om kontroll av ekologisk production
  4. Swedacs föreskrifter (STAFS 2015:8) allmänna råd om ackreditering
  5. Swedacs föreskrifter (STAFS 2013:5) allmänna råd om ackreditering av organ som certifierar produkter
  6. Statens jordbruksverks föreskrifter (2015.29) om ekologisk produktion och kontroll av ekologiska produkter

In addition, the Federation of Swedish Farmers has developed national guidelines for organic production.

The Government Ordinance, Förordning 2013:1059, provides that the competent authorities responsible for the implementation and the oversight of the organic program are the National Food Agency (Livsmedelsverket) (NFA) for food (post-primary production) and the Swedish Board of Agriculture (Jordbruksverket) (SBA) for primary production of food and feed. The Board for Accreditation and Conformity Assessment (SWEDAC) is responsible for the accreditation and approval of CBs.

In Sweden 20% of the land is organic. Of the 7000 operators, most of which are involved in primary production, 36 are importers and 1 is an exporter. However, that is based on a hierarchical system, so if a company has both processing, import and export it will only show as a processor in the statistics.

6.1.1 CB delegation and supervisions

The 3 competent authorities in Sweden have different responsibilities:

  • SWEDAC accredits, approves and supervises the CBs
  • SBA delegates and supervises the CBs, grants derogations and maintains statistical information
  • NFA delegates and supervises the CBs, grants derogations and provides advisory support to the municipalities

Currently there are 6 CBs in Sweden. Their accreditation does not expire as long as there are no major issues and is renewed every 4 years. The delegation scope granted by SBA and NFA mirrors SWEDAC accreditation scope.

The delegation decisions issued by SBA and NFA are based mainly on documentation review.

The control system in place clearly assigns tasks and responsibilities to the involved parties.

In Sweden SWEDAC is responsible for the supervision of the CBs, although the NFA and SBA are also partly involved in supervisory activities. SWEDAC conducts office and witness audits every year and sometimes an SBA representative is also involved. SWEDAC shares with CAs the nonconformities issued during the calendar year.

NFA and SBA are required to conduct their own annual audits (office and witness).

However, the CFIA auditor confirmed that the SBA and NFA have not conducted annual audits every year. The CFIA auditor noted that at one of the CBs the last audit conducted by SBA was in 2016 motivated by the fact this CB has only one client in the SBA area.

The CFIA auditor confirmed that in general, there is no timeframe for addressing the findings (recommendations) issued by the CA as a result of the CB audits.

Nether SWEDAC not the other 2 CAs conduct unscheduled or additional assessments of the CBs.

CBs are required to submit annual reports to the CAs every year. In January each year, the CAs collectively send to all CBs the annual report requirements and the documentation that needs to be submitted. The deadline for the submission is March 15 of each year.

The information submitted by the CBs is used as an input in the MANCP report, and also statistical information required by Eurostat.

The CFIA team verified that the CB visited as part of the peer review provided their annual reports to the CA in a timely manner.

6.1.2 CA communication with the CBs

There are regular co-ordination meetings among the CAs and the CBs. In 2019, there were 2 so called "calibration meetings" on which general certification questions and irregularities were discussed. The records of discussion and the meetings minutes are maintained in a workspace to which the CA, CBs and municipalities have access.

As part of the meetings, NFA, SBA and SWEDAC coordinate and conduct a traceability exercise with the CBs. Eight weeks before the meeting, the CAs select products from the market and request the CBs to trace them back. The outcome from the exercise is discussed during the meeting.

6.1.3 Enforcement and investigation

The NFA and the SBA have developed a Swedish national catalogue of measures for the CBs to use when addressing non-conformities related to compliance with organic production rules and related sanctions. It was revised in 2018 due to some extreme weather conditions.

Both NFA and SBA are authorized to grant derogations. The derogation can be requested by the operators. These are granted and tracked by the CAs. The CAs explained that there were 20 to 40 derogations granted for non-organic breeding animals, 30 to 35 retroactive derogations for conversion period, derogations for non-organic ingredients and for use of non-organic seeds. The CAs specify the deadlines for the derogation. This information is shared with the CBs which are responsible for the follow up with the operators.

6.1.4 Organic database – Integrity

The CAs do not maintain a publicly available list of operators. It is the responsibility of each CB to maintain their list of operators up to date. Some of the CBs upload the certificates while other only list the information from the certificate. The EU control system certifies the production processes, not the products themselves.

6.1.5 Certification and supervision of operators

The CFIA auditor visited the headquarters of one CB. The CB has a well-developed quality system and related procedures. The CB uses an electronic database to save and track all certification related activities and information. The CB received their accreditation for organic certification by SWEDAC in 2014 and received delegation by SBA in 2015 and NFA in 2016.

In compliance with ISO 17065, the CB has developed impartiality procedures to ensure employees are free of any conflict of interest.

The CB has well-established certification systems which allow them to schedule the operators' inspections in a timely manner while ensuring a good rotation of inspectors.

The duration of inspection varies depending on the nature and complexity of processing facility. During each inspection, inspectors are required to verify the inputs used by the operators. The CB explained that the onus is on the operators to use only authorized products and substances listed in the Annexes of the EC Reg. 889/2008.

As a result of the inspections, the CB inspectors issue findings to the operator. Usually, the operator is given 28 days to address the non-conformities. The CB explained that there is no suspension process if no actions are taken after 28 days.

All inspectors are trained on sampling. The sampling plan developed by the CB covers at least 5% of the operators under contract and focuses on genetically modified organisms, antibiotics and pesticides.

In accordance with clause 6.1.2 of ISO 17065, the CB has implemented procedures to ensure that on-site inspections are conducted by trained inspectors. The inspectors are subject to a formal performance monitoring process (witness audit) conducted by the CB.

The CFIA auditor confirmed that the CB is aware of the EU recognition (equivalency) arrangements with third countries for the purpose of imported ingredients.

6.1.6 Organic operators inspections

The CFIA auditor visited one seed storage/ drying facility and one crop farm/packing facility. The CFIA auditor witnessed 2 inspections conducted by 2 inspectors employed by 2 different CBs.

Both inspected facilities had conventional and organic production. The facilities had controls in place to segregate and differentiate between conventional and organic product during production, packaging and storage.

Before conducting the inspections, the inspectors prepared for the inspections using information available in the electronic database. This included all information pertaining to the farms such as the organic system plan, past reports and organisational information of the operator.

The inspections included an opening meeting, a tour of the operation, a review of relevant documentation, inputs verification, a traceability exercise, and a closing meeting.

No samples were taken as part of the inspections. The inspectors explained that they are required to do at least one input-output (mass) balance.

The CFIA auditor noted that one of the operators used inputs before submitting information of their use for verification to the CB. The inspector explained that this is not a requirement under the EU Organic system to verify the inputs in advance and the onus is on the operator to ensure that only substances listed in the EU regulations are used.

The inspector confirmed that the responsibility for applying permitted inputs remains with the operator and the CBs rely and trust independent organizations to generate a list of approved inputs which lists various trade names.

As stipulated in the EU regulations, each MS needs to maintain organic seed databases to better connect farmers with suppliers. The seed database lists the varieties for which seed or seed potatoes obtained by the organic production method are available on one MS' territory.

According to the regulations, farmers are obliged to use organic seeds if they are entered in the database. The CFIA auditor noted that the inspector referred to the organic seed database when verifying the type of seeds used by the farmer.

The inspector conducting the inspection at the seed storage/drying facility reviewed the organic certificates that accompanied each batch and matched them with the receiving forms. It was noted that the organic certificates do not list the organic products in a consistent manner which makes it difficult to trace back the product. There was discussion between the facility representative and the inspector about the validity of the organic certificates because sometimes a harvest from a previous year with an expired certificate is delivered to the seed cleaning facility.

At the end of the inspections, the CB inspectors conducted a closing meeting. Both inspectors explained the findings. It was observed that the one of the inspectors did not refer to the national catalogue of measures when issuing the irregularity and allowed the operator to negotiate the timeframe for addressing it.

It was noted that an exit report was not left with the operator at one of the facilities because this inspection was part of a bigger one that covers more than one location.

6.1.7 Management of consumers' complaints

The Swedish Consumer Agency is the competent authority for control of marketing regardless if companies are organic or not. The municipalities control food labelling.

6.2 Danish organic system

The main legal acts for implementation of the EU organic legislation in Denmark are:

  • Organic Law No 21 as of January 4 2017
  • Order on Organic production No 1316 as of November 19 2018 (DAA)
  • Order on Organic production No 1404 as of December 3 2018 (DVFA)

The control system for organic production in Denmark is based on CAs. Organic production in Denmark is under the control of Danish Agricultural Agency (DAA) and Danish Veterinary and Food Administration (DVFA). Both DAA and DVFA are designated as CAs to control organic production and for co-ordinating import controls on organic products.

In Denmark 10.5% of the total Danish agricultural production area was organic in 2018. There are 3794 organic farmers of which 42% produce livestock (2018).

6.2.1 Structure and responsibilities of the CAs

The tasks and responsibilities between DVFA and DAA in the area of organic production are clearly divided and described in cooperation agreements between the 2 CAs.

DAA oversees rules on organic production for organic agricultural farms and associated supply operators. There are 20 administrative staff at central level and around 45 inspectors that are involved in the organic certification. Approximately 25% of the inspectors are conducting only organic inspections. The rest, work full time for the Danish authorities conducting other inspections including the organic ones as well.

DVFA oversees the rules on importing, marketing, processing, labelling and production in aquaculture farms and in organic food establishments. There are 7 people at central level and around 200 inspectors involved partly in the organic certification.

The CFIA auditor confirmed that regular meetings are held between the CAs to discuss specific issues relating to organic production. Other channels of communication such as letters and the frequent exchange of e-mails have been established and verified during the visit.

6.2.2 Certification and supervision of operators

It was confirmed that DAA has around 45 trained organic inspectors who work in 4 local offices.

Meetings are held between the Central unit and the representatives from the local offices 4 times a year to exchange information and discuss issues.

Both DAA and DVFA inspectors are qualified to conduct other types of inspections such as food safety, traceability as well. Usually the organic inspection can be combined with another type of inspection.

Inspectors are witnessed by a supervisor to verify the quality of the inspection. All inspectors are observed every 3 years.

All certified organic producers are subject to annual inspection. Producers are notified of these inspections 14 days in advance. 5% of the inspections are without notification.

DAA uses risk assessment approach to determine the risk scope of each operator.

DAA inspectors take samples that correspond to 5% of all operators under their control. The main crops that are subject to testing are corn, rapeseed and wheat.

The farmers are required to submit annual digital registration through a specific IT system. The local offices plan and conduct the inspections based on this information. The data on livestock and plans generated based on this information is used by the DAA inspectors when preparing for the on-site inspection. The inspectors have access to the information online during the inspection and transfer it to the basic inspection report.

All food establishments including those processing organic food are registered, authorized and approved by DFVA. The DFVA inspectors work from 4 local food control units. The Central Administration meets with representatives from the food control units twice a year to discuss various certification issues.

6.2.3 Organic operators inspections

The CFIA auditor visited one importer/packing facility and one livestock (pig) farm.

The facility produces both organic and conventional products. The CFIA auditor observed one DAA and one DFVA inspector.

The DFVA inspectors conduct cross-checking by choosing a certificate of imported product and send it to the MS from which the product was brought to confirm that the product was actually brought to Denmark.

It is the responsibility of the company to comply with the labelling requirements. The inspector takes only a sample to verify compliance. As part of the inspection, the inspector traced back some of the ingredients in one of the products.

In the EU imported product usually comes to one MS and then it is often exported to another MS. According to the interviewed inspector, it is neither possible nor required to go back to the farmer (producer) of the organic product. The focus of the exercise is to trace back one step in the supply chain.

CFIA auditor was not able to observe the mass balance exercise. The inspector made an attempt to conduct one on a specific product however some of the certificates were not available due to technical issues and the inspector decided to come back again another time to complete it.

The DVFA inspectors are required to leave a copy of the inspection report with the establishment. Atthe witness inspection it was not the case because the inspector was not able to finish the inspection.

The last 4 reports including the organic reports for each establishment are made publicly available by the DVFA. Each establishment has its own website which also publishes the inspection report.

The CFIA auditor visited a pig farm along with officials and an inspector from the DAA, where the various control points were discussed in detail. It was not an official control. It was explained that only part of the DAA inspectors do only organic inspections in Denmark.

6.3 EC monitoring and supervision of the MS

MS are required to:

  • set up the control system
  • ensure compliance with the control system
  • take measures in case of infringements and irregularities
  • exchange information with other MS and the Commission

The EU has established procedures for verifying that adequate controls are being carried out by the MS. The 2 main tools are the annual reports submitted by MS and the regular audits conducted by DG SANTE.

6.3.1 MS annual reports

As required by Regulation (EC) No 882/2004 each MS prepares and submits a Multi-Annual Control Plan (MANCP) on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. The Member States submit annual reports related to the organic activities under the MANCP as per Article 92f and Annexes XIIIb and XIIIc of Com. Reg. (EC) No 889/2008.

Each MS reports to the European Commission on the results of the controls carried out on organic operators and on the measures taken in case of non-compliance.

The CFIA auditor confirmed that currently, the deadline for submitting the reports is June 30 for the pervious calendar year. With the implementation of the new regulations the deadline will be August 30.

The CFIA auditor noted that not all MS meet the deadline for submitting the annual reports. It was confirmed that the EC sends reminder letters and also presents regularly the state-of-play regarding the submission and assessment of the annual reports at the COP meetings.

The purpose of presenting the state-of-play regarding the ARs to COP is to raise the issues related to the AR timeliness and the quality of data. The EC can initiate an EU-pilot if the MS doesn't submit the AR.

The EC has an internal checklist that is used to assess the quality of the annual reports. EC sends a follow up letter to the MS regarding the completion of the annual report and its assessment. The letter includes a list of complimentary information (missing or insufficient) that is required as well as the deadline for responding. Usually it is 30 days.

The EC does not have set timelines for reviewing the AR. The ARs are reviewed as they are received with exception of certain cases(such as for an MS audit scheduled by DG SANTE).

As part of the discussion with the EC, the CFIA auditor confirmed that due to competing priorities sometime there is a delay in reviewing and assessing the reports.

The CFIA auditor reviewed 4 MS annual reports and noted the following:

  • The supervision activities reported by the CAs confirmed that not all CAs conduct annual office, witness and review audits at all CBs
  • There is no consistency amongst the CAs within a MS when it comes to grading the findings from the surveillance activities, for example observations vs non conformities (major and minor). However, the Commission is working towards a harmonized approach with the empowerment of the new Regulation EU 848/2018
  • The timeframe for addressing these findings vary from one CA to another within a MS
  • Control bodies that are required to refer to a catalogue of measures in case on non-compliances. The CFIA auditor observed that the CAs within one MS are not consistent when classifying the findings and addressing them
  • The CAs are required to set-up the national catalogue of measures and supervise the consistent implementation of the catalogue of measures by the CBs. The purpose of the catalogue of measures is to ensure that the CBs or control authorities use the same principles to classify the non-compliances and impose the appropriate measures. However, it was explained that the exact time for implementation of corrective actions is decided on case by case basis by the inspector

6.3.2 MS audits

The audits of the MS are carried out by DG SANTE in collaboration with representatives from DG AGRI (Organic Farming Unit) who participate in the audit.

DG AGRI has established the criteria for choosing the MS subject to auditing base on risk assessment. The following is considered:

  • MS not yet audited
  • Annual report review
  • OFIS irregularities
  • Other information concerning irregularities/infringements
  • Risk of fraud

Usually 3 MS are subject to audits every year. Between 2014 and the end of 2019 DG SANTE carried out 21 audits in EU MS.

DG SANTE has a standard pre-audit questionnaire and pre-audit plan. These are adjusted to the specific circumstances in each MS and the audit for the organic control system is tailored to meet the needs of the DG AGRI.

The preliminary findings are based on the annual reports and the irregularities reported in OFIS. The draft audit report is prepared by DG SANTE and shared with the Organic Farming Unit before it is sent to the MS. The MS is required to send the follow up action plan to DG SANTE within 25 working days which is revised and assessed by both DG SANTE and DG AGRI.

If the EU legislation on organic production has not been properly applied, the EC can send a pre-infringement letter (also called EU Pilots) to the MS or initiate an infringement procedure. EU Pilot inquiries are useful tools for engaging in a dialogue with the MS.

Both MS that CFIA visited were subject to DG SANTE audits in the past and have taken action to improve their control systems. It was noted that most of the observations were addressed through changes in the legal framework, coordination with the accreditation body or amongst the competent authorities.

However, the CFIA auditor noted that some observations related to the audit findings have not been adequately addressed. One of the visited MS has just begun the implementation of DG SANTE recommendation from 2015 audit regarding CBs supervision.

6.3.3 Exchange of information on irregularities

OFIS is the platform for information exchange between the EC, MS, equivalent third countries and equivalent control bodies on irregularities for imported products. MS should notify the EC and other MS of any irregularities without delay via OFIS. OFIS is organized in 3 modules:

  • INEU for irregularities notified by a MS to another MS
  • INTC for irregularities notifies by a MS to a CB operating in third countries or to an equivalent third country
  • ALERT which is to flag irregularities detected by MS on its own territory to inform other MS

The EC has established procedures for monitoring and follow up on irregularities as per Article 30 of Com. Reg. (EC) No 834/2007 and Articles 91, 92 and 92.a of Com. Reg. (EC) No 889/2008.

As soon as an irregularity is reported in OFIS the MS, the equivalent third countries or the equivalent Control Body are required to take action within 30 working days. The competent authorities in the MS contact the competent authority of the MS in which the product is produced or the relevant CB via OFIS and request further information and follow up actions. The CB has the responsibility to trace back the product.

For products imported via the equivalency arrangements, the EC monitors OFIS notifications.

The EC screens the irregularities every day. It was discussed that 95% of the cases are chemical residues, 54% of which are single residues cases. The EC receives 5 to 10 irregularities a day which are tracked in a monitoring table. The EC team verifies whether the MS meet the deadlines for response and monitors the responses.

EC issues guidelines for additional controls for imported high risk commodities based on the numbers, origin and the type of the irregularities. These guidelines are re-assessed every year.

6.3.4 Management of organic complaints

EC has established a system whereby complaints and enquiries are recorded in a central registry (CHAP). After registration and assessment, the EC determines how best to handle these. In most of the cases the complaint is shared with the MS for follow up.

7.0 EC import controls for organic products

The EU import system is governed by Implementing Regulation (EC) No 1235/2008.

Currently there are 2 different systems for importing organic products into the EU:

  • Equivalent Third Countries

Countries whose system of organic production complies with the principles and production rules set out in the EU organic regulations and whose control measures are of equivalent effectiveness to those laid down in EU organic regulations.

  • CBs recognised for the purpose of equivalence

For countries where there is not an equivalent organic regulation, a list of CBs and Control Authorities competent to carry out controls and issue certificates for the purpose of equivalence is defined in Annex IV of Commission Regulation (EC) No 1235/2008. The supervision of the CBs is done by the DG AGRI (Organic Unit). DG SANTE conducts 5 to 6 audits on the recognised CBs every year.

In 2017, the Commission introduced a new system of electronic certification to better monitor imports of organic products, and this system was added to the existing TRACES (TRAde Control and Expert System) certification tool. This e-certification system was implemented to reduce the administrative burden for operators and authorities, and provide much more comprehensive statistical data on organic imports.

All organic products imported into the EU must be accompanied by a Certificate of Inspection (COI). This certificate can be issued by a CB recognised by the EU or a CA of a country recognised by the EU. All importers in the EU have to be certified. The control of the importers and the first consignees is the responsibility of the MS.

7.1. Import controls in Sweden

NFA is responsible for import controls on food and SBA is for feed and vegetative propagating material. In 2018 Swedish customs verified importers by reviewing the COI. The COI review was done through TRACES.

7.2. Import controls in Denmark

DAA is responsible for import controls on organic feed, seed grain, seed, plants and parts of plants. DVFA is responsible for import controls on organic food and organic aquaculture products.

In Denmark the relevant authorities share tasks; DAA or DVFA is verifying and the Danish Customs Agency (DCA) is endorsing the COI before releasing the consignment.

During the meeting with representatives from the DVFA organic import unit it was verified that all importers inform DVFA or DAA (pre-notification by email) on every imported consignment before the COI is presented to customs (DCA). The importer is required to confirm the arrival time at the first consignee as well.

The import unit carries out a documentary check of the imported product, and decides whether the consignment has to be covered by further controls such as identity check, physical check or laboratory analysis. This activity is reflected and made available in TRACES NT in the COI for import of organic products to customs. Information on the exact date of arrival of the consignment and the relevant documents are also sent to the inspectors and local offices responsible for controlling the importer and the first consignee. A similar process occurs at DAA.

A physical check or a laboratory analysis check of the imported product may be carried out at the importer or first consignee by the DVFA or DAA inspectors. The imports are required to keep the organic COI for 5 years.

At the same visit at the organic import unit the Danish Customs Agency mobile control unit was visited in order to get a full impression of the procedures for verification and endorsement of the COI's. A specific COI was checked on-line using the TRACES system.

At the time of the peer review in 2019 there were 13 shipments of organic products from Canada.

8.0 EC communication with the MS and technical committees

The CFIA auditor confirmed that the communication between the different parties involved in the implementation of the EU organic regulations is well established and open.

OFIS is a key tool used by the MS and the EC to exchange agricultural data on organic products and provide up-to-date information to the general public.

The EC works closely with all MS when developing or implementing new requirements, rules or guidelines. Representatives of all MS sit on the Committee on organic production. Switzerland, Norway and Iceland participate as well but cannot vote. It is a formal committee established as per Article 37 of Reg. 834/2007 and is chaired by the EC. The committee is a key link between the EC and the MS. It meets regularly to discuss any proposed changes to the current set of rules. In 2019, 7 meetings were held.

The EGTOP assists the EC in the preparation of legislative proposals and policy initiatives. EGTOP assesses requests from the MS to amend technical annexes of the regulations and supports the EC when updating the list of authorized products and substances in the Annexes of the EC Reg. 889/2008.

The Civil Dialogue Group (CDG) is comprised of representatives from non-government organisations such as producers, consumers, trade organisations as well as environmental charities. The role of this civil dialogue group is to assist the EC in maintaining a regular dialogue on all matters related to organic farming as well as to monitor the EC organic policy and make contributions based on their on-the-ground experience.

The MS are also co-reporters in the recognition and the monitoring of third countries and CBs.

The EC regularly provides trainings to the CA and CBs, and private sector organisations on any changes to the regulation, updates in the organic program or any upcoming challenges or issues faced.

The EC initiative Better Training Safer Food offers various trainings including specific trainings on organic farming.

The visited MS expressed their satisfaction with this initiative which aims at further improving the knowledge of the control requirements for organic products by bringing together participants from different MS.

9.0 Closing meeting

A closing meeting was held with representatives of the EC Organic Farming Unit on September 27, 2019. During the meeting,the CFIA auditorpresented a summary of the observations and recommendations. The EC Organic Farming Unit had the opportunity to discuss these findings. Next steps were then discussed and agreed upon.

10.0 Overall conclusions

  • All parties involved in the peer review from the staff at the EC B4 – Organics, the Competent Authorities (CAs), the CBs to the operators, were helpful, responsive, and accommodating to the peer review team during the visit
  • There is strong commitment and understanding from all parties involved in the implementation of the EU Organic Regulations
  • The EC B4 – Organics has strengthened the monitoring and the supervision of the CAs responsible for the implementation of the organic requirements
  • The OFIS system allows for efficient irregularities monitoring and exchange of information between CBs and CAs
  • The collaboration between EC B4 – Organics and the CAs is good.
  • All organic products imported into the EU have the appropriate electronic certificate of inspection (e-COI). These are administered through the Trade Control and Expert System (TRACES)
  • Overall, the reviewed MS provide good oversight of the implementation of the EU organic requirements in their respective countries
  • The CAs maintain the National Organic Seed database which is extremely useful for both CAs and the operators
  • The EC and the MS have good understanding of the EU-Canada Organic Equivalency Arrangement and the requirements to accept organic products imported from Canada and to export organic products to Canada

11.0 Observations

DG AGRI (Organic Farming Unit) is invited to provide response on the CFIA observations listed in the table below:

No CFIA Observations
1. Not all MS submit the annual reports on time and quality varies however the EC follows up on these issues and improvements have been noted.
2. There is general confusion amongst MS about how operators have to be reported in the OFIS system and this affects the verification of the additional inspections carried out by the CBs.
3. The supervision activities reported by the CAs indicate that not all CAs conduct annual office, witness and review audits.
4. Not all recommendations from DG SANTE audits are implemented in a timely manner. One of the visited MS has just started the implementation of a recommendation from 2015 regarding supervision of CBs.
5. No evidence could be found that MS conduct review audits.
6. There is no consistency amongst the CAs when it comes to grading the findings from the surveillance activities for example observations vs non conformities (major and minor). The timeframe for addressing these vary from one CA to another within a single MS.
7. The CAs developed a catalogue of measures however it was observed that it is not applied consistently by the CBs inspectors. It was noted that the exact time for implementation of corrective actions is decided on case by case basis by the inspector.
8. The certificates issued to the operators are generic and are not consistent when listing the specific products subject to certification. This created challenges to one of the inspectors who was verifying the type of products delivered to the seed cleaning facility.

12.0 Next steps

The DG AGRI (Organic Farming Unit) provided response to the CFIA observations listed in this report. These are included in Annex A.

The final report will be posted on the CFIA external website as per the terms of the EUCOEA.

Annex A: Summary of EC response to the Canadian Food Inspection Agency (CFIA) observations from the peer review report on EU organic System (2019)

No CFIA Observations EC Response to Observations

1.

Not all MS submit the annual reports on time and quality varies.

The Commission has taken measures to improve the issues of timing and content of the Annual Reports with concrete results. There is a substantial improvement in the timing of submission of the Annual Reports. In 2016 only 4 ARs were received on time (deadline 30/06/reporting year+1) and in 2019 this number rose to 15.

The organic data in the Annual Reports constitute only a small part of the global document of the MS.

The Commission Implementing Regulation (EU) 2019/723, which was adopted on 2 May 2019, establishes a standard model form for MS Annual reports under Article 113(1) of Regulation (EU) 2017/625 (OCR). This new model is expected to facilitate considerably both the timely submission of the Annual Reports and the quality of the data.

In addition, the Commission systematically sends follow up letters to the MS in order to request supplementary information of clarifications. A follow-up letter was sent to the relevant MSs, in order to request additional information or clarification as regards missing organic data and related topics.

2.

There is general confusion about how operators have to be reported in the OFIS system and this affects the verification of the additional inspections carried out by the CBs.

The MS shall enter the data on control of operators by using the predefined categories of operators in table 1 of the Annex XIIc of Regulation (EC) 889/2000.

The Commission is assessing the compliance with the minimum control requirements by checking the following:

  1. Do all tables of Annex XIIIc give data split by CB?
  2. Do all tables of Annex XIIIc give data split by type of operator?
  3. Does the total number of operators, broken down by CB/CtrA and by category of operator, match?
  4. Does the number of annual inspections carried out by each CB/CtrA at least equal to the total number of their registered operators?
  5. Does the number of additional risk based inspections carried by each CB/CtrA correspond to at least 10% of their registered operators? (if not, is an explanation given?)

When there is doubt about the total number of operators under control the Commission asks the competent authority with the follow up letter to verify the total number of operators and whether the minimum control requirements of the regulation have been respected.

The MS submit annex XIIIc in OFIS on a voluntary basis, there is no legal requirement for it.

3.

The supervision activities reported by the CAs indicate that not all CAs conduct annual office, witness and review audits.

When assessing the AR the Commission is checking the following points on supervision:

  1. Did the CA carry out annual audits of all CB/CtrAs?
  2. What is the number of operator files checked by the CA during of the office audits?
  3. Did the CA carry out review/witness audits of operators and how many?

If there is no sufficient information the Commission requests from the CA of the MS to provide additional information and clarifications

4.

Not all recommendations from DG SANTE audits are implemented in a timely manner. One of the visited MS has just started the implementation of a recommendation from 2015 regarding supervision of CBs.

The scope of MS audit follow up is to verify the delivery of actions in the Action Plan attached to the final audit report.

The follow up is done by the General follow-up audits and administrative follow up.

The information gathered during the follow up is presented in the MS country profiles.

5.

No evidence could be found that MS conduct review audits.

As explained above the Commission is checking the supervision activities of the CAs in the MS in the course of the assessment of the ARs and the system audits in MS and acts accordingly

6.

There is no consistency amongst the CAs when it comes to grading the findings from the surveillance activities for example observations vs non conformities (major and minor). The timeframe for addressing these vary from one CA to another within a single MS.

The MS have the competence to establish a catalogue of measures in case on non-compliances

The Commission is working towards a harmonised approach with the empowerment of the new Regulation EU 848/2018

7.

The CAs developed a catalogue of measures however it was observed that it is not applied consistently by the CBs inspectors. It was noted that the exact time for implementation of corrective actions is decided on case by case basis by the inspector.

The CAs shall check whether the CBs apply in a uniform manner the national catalogue of measures in the course of their supervision activities. If there is discrepancy the CA shall request from the CB to comply.

8.

The certificates issued to the operators are generic and are not consistent when listing the specific products subject to certification. This created challenges to one of the inspectors who was verifying the type of products delivered to the seed cleaning facility.

In EU the scope of the certificate is certify the organic operator and their activities. It is not a product certificate.

The CBs issue the certificates according to the model XII of the Regulation (EC) 889/2008
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