General and specific requirements for the annual report referred to in Article 4
ANNEX IISupplementary provisions
ANNEX II General and specific requirements for the annual report referred to in Article 4 1. The annual report shall update all the elements contained in the technical dossier as set out in Article 1(2). 2. The annual report shall contain the information of the control authority or control body to be updated for the purpose of the annual report and shall include the name and code number of the control authority or control body, mailing address, telephone number, email contact point and website address, which shall include a direct link, with an easy access from the home webpage, to the up-to-date list of operators or groups of operators. 3. For the purposes of the annual report, the technical dosser shall be completed with the following: (a) the control activities of the control authority or control body in the third country or third countries in the previous year, per category of products, as set out in Article 35(7) of Regulation (EU) 2018/848, including the information about the number of operators and groups of operators as well as the number of their members (including subcontractors, if the operators or groups of operators do not remain responsible for the subcontractors) which were subject to their controls on 31 December of the previous year, broken down by third country and category of products; (b) an undertaking that the control authority or control body has performed the required updates of the translation of the production rules according to Article 1(2)(e) of this Regulation or any other relevant documents required for the purposes of Article 46(2) of Regulation (EU) 2018/848 or this Regulation; (c) any update of the internal procedures, including the certification and control system set up by the control authority or control body in compliance with this Regulation; (d) a link to the website of the control authority or control body, with the information required in accordance with Article 17; (e) an annual assessment report of the office(s) where certification decisions are taken, as referred to in point 2.1 of Part A of Annex I: (i) ensuring that the control authority or control body has been satisfactorily assessed by the accreditation body or competent authority in the previous year on its ability to ensure that products imported from third countries comply with Regulation (EU) 2018/848; (ii) confirming that the control authority or control body still has the capacity and the 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, in each third country for which it is recognised; (iii) including any updated information of the annual assessment report as regards the results and an evaluation of: — the checks of the files of the operators or groups of operators; — the list of non-compliances, as well as the number of non-compliances in relation to the number of certified operators or groups of operators; — the handling of non-compliances and complaints, if any, with an explanation on the corrective measures implemented by the operators or groups of operators for the lasting closure of its non-compliances; — the catalogue of measures and its implementation; — the risk analysis procedure; — the annual risk plan; — the sampling strategy, procedure and methodology; — the changes to any of the procedures; — the exchange of information with other control authorities, control bodies and the Commission; — the competence of the staff involved in the inspection and certification process; — the training programmes; — the knowledge and competence of new staff; — the effectiveness and reliability of the activity witnessed and an overall assessment of the performance of the control authority or control body; — other elements that the accreditation body or competent authority considers relevant for the purposes of Regulation (EU) 2018/848; (iv) confirming as regards the extensions of the scope of recognition to additional third countries or categories of products in the previous year, the capacity and competencies of the control authority or control body to perform controls in accordance with this Regulation in each new third country or for each new category of products concerned, if there are active operators or groups of operators. 4. The annual report shall include the following information with regard to cases of non-compliance and the measures taken: (a) the number of physical on-the-spot inspections with and without prior notice; (b) the number of the samples collected in inspections with and without prior notice and where applicable, the actions taken; (c) the number of samples collected due to suspicion, complaints or during an investigation as referred to point (a) of Article 22(1) notified through OFIS as referred to in Article 21(2) (OFIS case); (d) the number of OFIS cases of suspected or established non-compliance; (e) the number of non-compliances found, broken down into minor, major and critical according to the classifications of non-compliances of organic or in-conversion products laid down in Annex IV; (f) measures referred to Annex IV taken in respect of operators or groups of operators in cases of non-compliances. 5. When the control authority or control body has certified operators or groups of operators from another control authority or control body, the annual report of the receiving control authority or control body shall indicate for each transferred operator or group of operators: (a) the name of the operator or group of operators, its geographical location and its previous certificate number; (b) the name of its previous control authority or control body; (c) the date of transfer of the control file; (d) the list and nature of open non-compliances and measures required by the previous control authority or control body, if any; (e) the measures put in place by the operator or group of operators to ensure that the non-compliances will not occur again, and the date(s) of the inspection(s) carried out by the new control authority or control body to verify that corrective measures have been correctly implemented; (f) the indication whether the operator or group of operators was involved in any OFIS case. 6. Concerning high-risk products referred to in Article 8, the following information shall be provided: (a) the list of the operators or groups of operators responsible for the high-risk products; (b) for each operator or group of operators: (i) the inspections carried out, indicating the date of each inspection; (ii) the sampling and analyses carried out; (iii) non-compliances found; (iv) the measures applied; (v) for each operator or group of operators that changed its control authority or control body, the corrective measures and/or sanctions applied if non-compliances were noted in the report of the previous control authority or control body; (c) for each consignment showing a non-compliance: (i) reference to the certificate of inspection for imported consignments; (ii) overview of sampling analysis results that indicate the presence of residues of non-authorised substances; (iii) investigations and follow-up measures taken by the control authority or control body in case of commingling or residues of non-authorised substances found in the consignment, including the decision concerning the consignment as well as confirmation that operators have taken corrective measures. 7. For authorisations for the use of non-organic plant reproductive material in accordance with point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848, the following information shall be provided: (a) scientific and common name (common and Latin name); (b) variety; (c) number of derogations and total weight of seeds or number of plants derogated; (d) number of operators and groups of operators which have been granted an authorisation. 8. For derogations granted in accordance with points 1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 2018/848 for each non-organic livestock species (bovine, equine, ovine, caprine, porcine and cervine animals, rabbits, poultry), the following information shall be provided: (a) scientific and common name (common and Latin name i.e. species and genus); (b) breeds and strains; (c) production purposes: meat, milk, eggs, dual purpose or breeding; (d) number of derogations and total number of animals derogated; (e) number of operators and groups of operators, which have been granted a derogation. 9. For authorisations granted for the use of non-organic aquaculture juveniles in accordance with point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018/848, the following information shall be provided: (a) species and genus (common and Latin name); (b) breeds and strains when applicable; (c) total number of derogations and number of juveniles for each species; (d) number of operators and groups of operators, which have been granted an authorisation. 10. The annual report shall contain any other information deemed relevant to satisfy a specific requirement of Regulation (EU) 2018/848 by the control authority, the control body or the accreditation body.