General requirements for the supervision of control authorities and control bodies
1. The supervisory activities of the Commission in respect of control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 shall focus on the evaluation of the operational performance of the control authorities and control bodies, taking into account the results of the work of the accreditation bodies referred in point (d) of Article 46(2) of that Regulation.
2. The intensity and frequency of the supervisory activities carried out by the Commission shall be adapted according to the risk of non-compliances in accordance with Article 46(6) of Regulation (EU) 2018/848.
3. Control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 shall maintain the ability to meet the conditions and criteria set out in points (a), (b)(i) and (c) of Article 45(1) and Article 46(2) of that Regulation as set out in the technical dossier at the moment of their recognition. They shall also maintain the capacity and competencies to implement the control requirements, conditions and measures set out in Article 46(2) and (6) of Regulation (EU) 2018/848 and in this Regulation.
For that purpose, they shall demonstrate:
(a)
that they have effectively implemented their activities according to the conditions and criteria referred to in the first subparagraph; and
(b)
compliance with their operating procedures and the effectiveness of their control measures.
4. For the purpose of the annual report, the control bodies shall ensure that witness audits are carried out in accordance with Sections 1 and 2 of Part B of Annex I to this Regulation and the following rules:
(a)
the duration period between two witness audits shall not exceed 4 years;
(b)
the number of witness audits carried out for the initial request for recognition shall not be considered for the calculation of the total number of witness audits to be carried out during the 4 years referred to in point (a);
(c)
one additional witness audit shall be carried out:
(i)
every 2 years in those third countries where the high-risk product as referred to in Article 8 is produced or processed;
(ii)
for every 10 third countries recognised. This additional witness audit shall be carried out within 4 years;
(d)
more witness audits shall be performed at the request of the Commission or of the accreditation body based on a risk analysis of, in particular, the following factors:
(i)
the number of inspectors;
(ii)
the number of operators;
(iii)
the type of activities carried out by the operators;
(iv)
the number of witness audits carried out by the accreditation body;
(v)
the irregularities concerning the control bodies;
(vi)
the number of certified groups of operators and the size of them;
(vii)
the critical findings for the control bodies or the specific inspector or inspectors;
(viii)
the nature of the products and the risk of fraud;
(ix)
Commission feedback based on the previous annual report of the control body;
(x)
suspicions of fraud by operators.
(xi)
the volume of products imported from a third country into the Union and the activity of the control authority or control body in recognised third countries.
5. Control authorities and control bodies shall submit documentation on their risk- analysis procedure at the Commission’s request.
6. For the purpose of supervision of the control authorities and control bodies recognised by the Commission, the latter may be assisted by two Member States to act as co-reporters for the examination of technical dossiers submitted by control authorities and control bodies for initial recognition or the extension of their scope of recognition, the management and review of the list of recognised control authorities and control bodies and the evaluation of the operational performance, including annual reports, of the control authorities and control bodies.
7. The Commission may divide the requests between the Member States proportionally with the number of votes of each Member State in the Committee on organic production.
Annual report
By 28 February every year, the control authority or control body shall submit an annual report to the Commission.
That annual report shall set out the activities of the control authority or control body in the previous year in accordance with Annex II
It shall be submitted in one of the official languages of the Union and in English if the official language chosen is not English.
On–the-spot examinations and audits
1. The Commission shall regularly organise risk-based on-the-spot examinations and/or audits of the control authorities and control bodies to evaluate the quality and effectiveness of the controls carried out by each control authority or control body. Those examinations and audits may be coordinated with the relevant accreditation body. The Commission may be accompanied by independent experts during these on-the-spot examinations and audits.
2. The Commission may request any further information, including the presentation of one or more ad-hoc on-the-spot examination reports established by independent experts that it designates.
3. On-the-spot examinations and audits may include:
(a)
a visit to the offices or premises of the control authorities and control bodies, their outsourced services and operators or groups of operators under their control, in the Union and in third countries;
(b)
a document review of the relevant documents describing the structure, functioning and quality management of the control authorities or control bodies;
(c)
a document review of staff files, including evidence of their competencies, training records, conflict of interest statements and records of evaluation and supervision of staff;
(d)
a check of operators’ or groups of operators’ files in order to verify the treatment of non-compliances and complaints, the minimum control frequency, the use of a risk-based approach in the conduct of inspections, the implementation of follow-up visits and visits without prior notice, the sampling policy and the exchange of information with other control bodies and control authorities;
(e)
a review audit, which is the inspection of operators or groups of operators to verify compliance with the standard control and risk assessment procedures of the control authority or control body and to verify its effectiveness, taking into account the evolution of the operators’ situation from the last inspection of the control authority or control body;
(f)
a witness audit, which is the evaluation of the performance of the physical on-the-spot inspection carried out by an inspector of the control authority or control body.
Traceability checks
The Commission may perform traceability checks on products or consignments covered by the scope of the recognition of a control authority or control body recognised in accordance with Article 46(1) of Regulation (EU) 2018/848.
For the purpose of tracing the ingredients or production phases of an organic product, the Commission may ask information from the competent authorities or from control authorities or control bodies involved in the control of those products falling under their supervision.
The Commission may perform traceability checks based on the annual risk assessment performed by it, complaints received by the Commission or Member States, or randomly.
The Commission shall perform traceability checks in a timeframe defined by it, which shall be communicated in time to the relevant competent authorities, control authorities and control bodies involved.
Ad hoc request by the Commission
The Commission may, at any time, based on a substantial analysis proving the necessity, make ad-hoc requests for information to a control authority or control body.
List of high-risk products
Control authorities and control bodies operating in respect of third countries shall apply Article 9(8), second subparagraph, and Articles 12(5) and 16(6) of this Regulation in respect of the high-risk products originating from third countries as listed in an implementing act adopted pursuant to Article 46(8) of Regulation (EU) 2018/848 on the basis of a selection made after major, critical or repetitive non-compliances affecting the integrity of organic or in-conversion products or production.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
