Proposal for a regulation
Article 23 a (new)
Article 23 a Controls 1. Member States shall set up a system of controls and designate one or more competent authorities responsible for controls in respect of the obligations established by this Regulation in conformity with Regulation (EU) No XXX/XXXX (Official controls Regulation) 2. In the context of this Regulation the nature and frequency of the controls shall be determined on the basis of an assessment of the risk of occurrence of irregularities and infringements as regards compliance with the requirements laid down in this Regulation. In any case, all operators with the exception of those referred to in Article 24(1a) of this Regulation, shall be subject to a verification of compliance via on-site inspection performed at least once a year. 3. The competent authority may: (a) confer its control competences to one or more other control authorities. Control authorities shall offer adequate guarantees of objectivity and impartiality, and have at their disposal the qualified staff and resources necessary to carry out their functions; (b) delegate control tasks to one or more control bodies. In that case, the Member States shall designate authorities responsible for the approval and supervision of such bodies. 4. The competent authority may delegate control tasks to a particular control body only if the conditions laid down in (Official control Regulation) are satisfied, and in particular where: (a) there is an accurate description of the tasks that the control body may carry out and of the conditions under which it may carry them out; (b) there is proof that the control body: i. has the expertise, equipment and infrastructure required to carry out the tasks delegated to it; ii. has a sufficient number of suitable qualified and experienced staff; and iii. is impartial and free from any conflict of interest as regards the exercise of the tasks delegated to it; (c) the control body is accredited to the most recently notified version, by a publication in the C series of the Official Journal of the European Union, of European Standard EN 45011 or ISO Guide 65 (General requirements for bodies operating product certification systems), and is approved by the competent authorities; (d) the control body communicates the results of the controls carried out to the competent authority on a regular basis and whenever the competent authority so requests. If the results of the controls indicate non-compliance or point to the likelihood of non-compliance, the control body shall immediately inform the competent authority; (e) there is an effective coordination between the delegating competent authority and the control body. 5. In addition to the provisions of paragraph 5, the competent authority shall take into account the following criteria whilst approving a control body: (a) the standard control procedure to be followed, containing a detailed description of the control measures and precautions that the body undertakes to impose on operators subject to its control; (b) the measures that the control body intends to apply where irregularities and/or infringements are found. 6. The competent authorities shall not delegate the following tasks to the control bodies; (a) the supervision and audit of other control bodies; (b) the competence to grant exceptions. 7. The competent authorities delegating control tasks to control bodies shall organise audits or inspections of control bodies as necessary. If, as a result of an audit or an inspection, it appears that such bodies are failing to carry out properly the tasks delegated to them, the delegating competent authority may withdraw the delegation. It shall withdraw it without delay if the control body fails to take appropriate and timely remedial action. 8. In addition to the provisions of paragraph 8, the competent authority shall: (a) ensure that the controls carried out by the control body are objective and independent; (b) verify the effectiveness of its controls; (c) take cognisance of any irregularities or infringements found and corrective measures applied; (d) withdraw approval of that body where it fails to satisfy the requirements referred to in (a) and (b) or no longer fulfils the criteria indicated in paragraph 5, 6 or fails to satisfy the requirements laid down in paragraphs 11, 12 and 14. 9. Member States shall attribute a code number to each control authority or control body performing control tasks as referred to in paragraph 4. 10. Control authorities and control bodies shall give the competent authorities access to their offices and facilities and provide any information and assistance deemed necessary by the competent authorities for the fulfilment of their obligations according to this Article. 11. The control authorities and control bodies shall ensure that at least the precautionary and control measures referred to in paragraph 2 are applied to operators subject to their control. 12. Member States shall ensure that the control system as set up allows for the traceability of each product at all stages of production, preparation and distribution in accordance with Article 18 of Regulation (EC) No 178/2002, in particular, in order to give consumers guarantees that organic products have been produced in compliance with the requirements set out in this Regulation. 13. By 31 January each year at the latest the control authorities and control bodies shall transmit to the competent authorities a list of the operators which were subject to their controls on 31 December of the previous year. A summary report of the control activities carried out during the previous year shall be provided by 31 March each year. 14. Adherence to the control system (a) Any operator who produces, prepares, stores, exports or imports from a third country products in the meaning of Article 1(2) or who places such products on the market shall, prior to placing on the market of any products as organic or in conversion to organic: i. notify his activity to the competent authorities of the Member State where the activity is carried out; ii. submit his undertaking to the control system referred to this Regulation. iii. Where an operator contracts out any of the activities to a third party, that operator shall nonetheless be subject to the requirements referred to in points (i) and (ii), and the subcontracted activities shall be subject to the control system. (b) Member States may exempt from the application of this Article operators who sell pre-packed products directly to the final consumer or user provided they do not produce, prepare, store other than in connection with the point of sale or import such products from a third country or have not contracted out such activities to a third party. (c) Member States shall designate an authority or approve a body for the reception of such notifications. (d) Member States shall ensure that any operator who complies with the rules of this Regulation, and who pays a reasonable fee as a contribution to the control expenses, is entitled to be covered by the control system. (e) The control authorities and control bodies shall keep an updated list containing the names and addresses of operators under their control. This list shall be made available to the interested parties. 15. Documentary evidence (a) The control authorities and the control bodies referred to in Article 27(4) shall provide documentary evidence to any such operator who is subject to their controls and who in the sphere of his activities, meets the requirements laid down in this Regulation. The documentary evidence shall at least permit the identification of the operator and the type or range of products as well as the period of validity. (b) The operator shall verify the documentary evidence of his suppliers. 16. Measures in case of infringements and irregularities (a) Where an irregularity is found as regards compliance with the requirements laid down in this Regulation, the control authority or control body shall ensure that no reference to the organic production method is made in the labelling and advertising of the entire lot or production run affected by this irregularity, where this would be proportionate to the relevance of the requirement that has been violated and to the nature and particular circumstances of the irregular activities. (b) Where a severe infringement or an infringement with prolonged effect is found, the control authority or control body shall prohibit the operator concerned from marketing products which refer to the organic production method in the labelling and advertising for a period to be agreed with the competent authority of the Member State. (c) Information on cases of irregularities or infringements affecting the organic status of a product shall be immediately communicated between the control bodies, control authorities, competent authorities and Member States concerned and, where appropriate, to the Commission. (d) The level of communication shall depend on the severity and the extent of the irregularity or infringement found. 17. Exchange of information Upon a request duly justified by the necessity to guarantee that a product has been produced in accordance with this Regulation, the competent authorities, control authorities and the control bodies shall exchange relevant information on the results of their controls with other competent authorities, control authorities and control bodies. They may also exchange such information on their own initiative. Article 23 b Detailed rules on controls Part I: Minimum control requirements 1. Control arrangements and undertaking by the operator (a) When the control arrangements are first implemented, the operator shall draw up and subsequently maintain: i. a full description of the unit and/or premises and/or activity; ii. all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with the organic production rules; iii. the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products or substances and the cleaning measures to be taken in storage places and throughout the operator's production chain; iv. the specific characteristics of the production method used, where the operator intends to request documentary evidence in accordance with paragraph 6 of this Article. v. Where appropriate, the description and measures provided for in the first subparagraph may be part of a quality system as set up by the operator. (b) The description and the measures referred to in paragraph 1 (a) shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator: i. to perform the operations in accordance with the organic production rules; ii. to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules; iii. to undertake to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production; iv. to accept, in cases where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies in accordance with the control system set up by Member State concerned, the exchange of information between those authorities or bodies; v. to accept, in cases where the operator and/or the subcontractors of that operator change their control authority or control body, the transmission of their control files to the subsequent control authority or control body; vi. to accept, in cases where the operator withdraws from the control system, to inform without delay the relevant competent authority and control authority or control body; vii. to accept, in cases where the operator withdraws from the control system, that the control file is kept for a period of at least five years; viii. to accept to inform the relevant control authority or authorities or control body or bodies without delay of any irregularity or infringement affecting the organic status of their product or organic products received from other operators or subcontractors. ix. The declaration provided for in the first subparagraph shall be verified by the control body or control authority that issues a report identifying the possible deficiencies and non-compliances with the organic production rules. The operator shall countersign this report and take the necessary corrective measures. (c) For the application of article 44, paragraph 15 of this Regulation the operator shall notify the following information to the competent authority: i. Name and address of operator; ii. Location of premises and, where appropriate, parcels (land register data) where operations are carried out; iii. Nature of operations and products; iv. Undertaking by the operator to carry out the operation in accordance with the provision laid down in Article 44 and 44a of this Regulation; v. In the case of an agricultural holding, the date on which the producer ceased to apply products not authorised for organic production on the parcels concerned; vi. The name of the approved body to which the operator entrusted control of his undertaking, where the Member State has implemented the control system by approving such bodies. 2. Modification of control arrangements The operator responsible shall notify any change in the description or of the measures referred to in paragraph 1 of this Article and in the initial control arrangements set out in paragraphs 7, 13, 19, 23, 29 and 31 of this Article to the control authority or control body in due time. 3. Control visits (a) The control authority or control body shall carry out at least once a year a physical inspection of all operators, timing of these inspections is determined on risk analysis basis, so as the timing and nature of additional inspections. (b) The control authority or control body shall take and analyse samples for detecting of products not authorised for organic production, for checking production techniques not in conformity with the organic production rules or for detecting possible contamination by products not authorised for organic production. The number of samples to be taken and analysed by the control authority or control body every year shall correspond to at least 5 % of the number of operators under its control. The selection of the operators where samples have to be taken shall be based on the general evaluation of the risk of non- compliance with the organic production rules. This general evaluation shall take into account all stages of production, preparation and distribution. (c) The control authority or control body shall take and analyse samples in each case where the use of products or techniques not authorised for organic production is suspected. In such cases no minimum number of samples to be taken and analysed shall apply. (d) Samples may also be taken and analysed by the control authority or control body in any other case for detecting of products not authorised for organic production, for checking production techniques not in conformity with the organic production rules or for detecting possible contamination by products not authorised for organic production. (e) A control report shall be drawn up after each visit, countersigned by the operator of the unit or his representative. (f) Moreover, the control authority or control body shall carry out random control visits, primarily unannounced, based on the general evaluation of the risk of non-compliance with the organic production rules, taking into account at least the results of previous controls, the quantity of products concerned and the risk for exchange of products. 4. Documentary accounts (a) Stock and financial records shall be kept in the unit or premises and shall enable the operator to identify and the control authority or control body to verify: i. the supplier and, where different, the seller, or the exporter of the products; ii. the nature and the quantities of organic products delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs; iii. the nature and the quantities of organic products held in storage at the premises; iv. the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products which have left the unit or the first consignee's premises or storage facilities; v. in case of operators who do not store or physically handle such organic products, the nature and the quantities of organic products bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees. (b) The documentary accounts shall also comprise the results of the verification at reception of organic products and any other information required by the control authority or control body for the purpose of proper control. The data in the accounts shall be documented with appropriate justification documents. The accounts shall demonstrate the balance between the input and the output. (c) Where an operator runs several production units in the same area, the units for non-organic products, together with storage premises for input products must also be subject to the minimum control requirements. 5. Access to facilities (a) The operator shall: i. give the control authority or control body, for control purposes, access to all parts of the unit and all premises, as well as to the accounts and relevant supporting documents; ii. provide the control authority or control body with any information reasonably necessary for the purposes of the control; iii. submit, when requested by the control authority or control body, the results of its own quality assurance programmes. (b) In addition to the requirements set out in subparagraph (a), importers and first consignees shall submit the information on imported consignments. 6. Documentary evidence (a) For the purpose of the application of paragraph 16 of Article 44 of this Regulation the control authorities and control bodies shall use the model of the documentary evidence set out in [Annex ... to this Regulation]. In case of electronic certification as referred to [...of this Regulation], the signature in box 8 of the documentary evidence shall not be required if the authenticity of the documentary evidence is otherwise shown by a tamper-proof electronic method. (b) If an operator subject to the controls of the control authorities and control bodies as referred to in subparagraph (a) so requests within a time period to be indicated by those control authorities and control bodies, the control authorities and control bodies shall provide complementary documentary evidence confirming the specific characteristics of the production method used by means of the model set out in [...]. Applications for complementary documentary evidence shall contain in box 2 of the model set out in [...]. 7. Vendor declaration For the purpose of the application of Article 9 (3a) of this Regulation the vendor declaration that products supplied have not been produced from or by GMOs [may follow the model set out in Annex ... to this Regulation.] Part II: Specific control requirements for plants and plant products from farm production or collection 8. Control arrangements (a) The full description of the unit referred to in paragraph 1(a)(i) of this Article shall: i. be drawn up even where the operator limits his activity to the collection of wild plants; ii. indicate the storage and production premises and land parcels and/or collection areas and, where applicable, premises where certain processing and/or packaging operations take place; and iii. specify the date of the last application on the parcels and/or collection areas concerned of products, the use of which is not compatible with the organic production rules. (b) In case of collection of wild plants, the practical measures referred to in paragraph 1(a)(ii) of this Article shall include any guarantees given by third parties which the operator can provide to ensure that the provisions of [rules for collection of wild plants...] are complied with. 9. Communications Each year, before the date indicated by the control authority or control body, the operator shall notify the control authority or control body of its schedule of production of crop products, giving a breakdown by parcel. 10. Plant production records Plant production records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. In addition to paragraph 9 of this Article such records shall provide at least the following information: (a) as regards the use of fertiliser: date of application, type and amount of fertiliser, parcels concerned; (b) as regards the use of plant protection products: reason and date of treatment, type of product, method of treatment; (c) as regards purchase of farm inputs: date, type and amount of purchased product; (d) as regards harvest: date, type and amount of organic or in conversion crop production. 11. Several production units run by the same operator Where an operator runs several production units in the same area, the units producing non-organic crops, together with storage premises for farm input products shall also be subject to the general and the specific control requirements laid down in Part 1 and this Part of this Article. Part III: Specific control requirements for seaweed 12. Control arrangements for seaweed When the control system applying specifically to seaweed is first implemented, the full description of the site referred to in paragraph 1(a)(i) of this Article shall include: (a) a full description of the installations on land and at sea; (b) the environmental assessment as outlined in [...] where applicable; (c) the sustainable management plan as outlined in [...] where applicable; (d) for wild seaweed a full description and a map of shore and sea collection areas and land areas where post collection activities take place shall be drawn up. 13. Seaweed Production Records (a) Seaweed production records shall be compiled in the form of a register by the operator and kept available for the control authorities or control bodies at all times at the premises of the holding. It shall provide at least the following information i. list of species, date and quantity harvested; ii. date of application, type and amount of fertiliser used. (b) For collection of wild seaweeds the register shall also contain: i. history of harvesting activity for each species in named beds; ii. harvest estimate (volumes) per season; iii. sources of possible pollution for harvest beds; iv. sustainable annual yield for each bed. Part IV: Control requirements for livestock and livestock products produced by animal husbandry 14. Control arrangements (a) When the control system applying specifically to livestock production is first implemented, the full description of the unit referred to in paragraph 1(a)(i) of this Article shall include: i. a full description of the livestock buildings, pasturage, open air areas, etc., and, where applicable, the premises for the storage, packaging and processing of livestock, livestock products, raw materials and inputs; ii. a full description of the installations for the storage of livestock manure. (b) The practical measures referred to in paragraph 1(a)(ii) of this Article shall include: i. a plan for spreading manure agreed with the control body or authority, together with a full description of the areas given over to crop production; ii. where appropriate, as regards the spreading of manure, the written arrangements with other holdings as referred to in point 1.5.5. of Annex II Part I of this Regulation complying with the provisions of the organic production rules; iii. a management plan for the organic- production livestock unit. 15. Identification of livestock The livestock shall be identified permanently using techniques adapted to each species, individually in the case of large mammals and individually or by batch in the case of poultry and small mammals. 16. Livestock records Livestock records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. Such records shall provide a full description of the herd or flock management system comprising at least the following information: (a) as regards animals arriving at the holding: origin and date of arrival, conversion period, identification mark and veterinary record; (b) as regards livestock leaving the holding: age, number of heads, weight in case of slaughter, identification mark and destination; (c) details of any animals lost and reasons thereof; (d) as regards feed: type, including feed supplements, proportions of various ingredients of rations, amount of particular feeds fed and periods of access to free-range areas, periods of transhumance where restrictions apply; (e) as regards disease prevention and treatment and veterinary care: date of treatment, details of the diagnosis, the posology; type of treatment product, the indication of the active pharmacological substances involved method of treatment and veterinary prescription for veterinary care with reasons and withdrawal periods applying before livestock products can be marketed labelled as organic. (f) as regards interventions on animals carried out on conditions referred in point 1.7.9a. of Annex II Part II of this Regulation: date of intervention, type of intervention, method of its performance and identification numbers of treated animals. 17. Control measures on veterinary medicinal products for livestock Whenever veterinary medicinal products are used the information according to paragraph 16 (e) of this Regulation is to be declared to the control authority or body before the livestock or livestock products are marketed as organically produced. Livestock treated shall be clearly identified, individually in the case of large animals; individually, or by batch, or by hive, in the case of poultry, small animals and bees. 18. Specific control measures on beekeeping (a) A map on an appropriate scale listing the location of hives shall be provided to the control authority or control body by the beekeeper. Where no areas are identified in accordance with [...], the beekeeper shall provide the control authority or control body with appropriate documentation and evidence, including suitable analyses if necessary, that the areas accessible to his colonies meet the conditions required in this Regulation. (b) The following information shall be entered in the register of the apiary with regard to the use of feeding: type of product, dates, quantities and hives where it is used. (c) Whenever veterinary medicinal products are to be used, the type of product, including the indication of the active pharmacological substance, together with details of the diagnosis, the posology, the method of administration, the duration of the treatment and the legal withdrawal period shall be recorded clearly and declared to the control body or authority before the products are marketed as organically produced. (d) The zone where the apiary is situated shall be registered together with the identification of the hives. The control body or authority shall be informed of the moving of apiaries by a deadline agreed on with the control authority or body. (e) Particular care shall be taken to ensure adequate extraction, processing and storage of beekeeping products. All the measures to comply with this requirement shall be recorded. (f) The removals of the supers and the honey extraction operations shall be entered in the register of the apiary. 19. Several production units run by the same operator Where an operator manages several production units, as provided for in [...], the units which produce non-organic livestock or non-organic livestock products shall also be subject to the control system as laid down in Part of this Article. Part V: Specific control requirements for aquaculture animal production 20. Control arrangements for aquaculture animal production When the control system applying specifically to aquaculture animal production is first implemented, the full description of the unit referred to in paragraph 1(a)(i) of this Article shall include: (a) a full description of the installations on land and at sea; (b) [the environmental assessment as outlined in ... where applicable]; (c) [the sustainable management plan as outlined in ... where applicable]; (d) [in the case of molluscs a summary of the special chapter of the sustainable management plan as required by ...] 21. Aquaculture animal production records The following information shall be provided by the operator in the form of a register which shall be kept up to date and made available for the control authorities or control bodies at all times at the premises of the holding (a) the origin, date of arrival and conversion period of animals arriving at the holding: (b) the number of lots, the age, weight and destination of animals leaving the holding; (c) records of escapes of fish; (d) for fish the type and quantity of feed and in the case of carp and related species a documentary record of the use additional feed; (e) veterinary treatments giving details of the purpose, date of application, method of application, type of product and withdrawal period; (f) disease prevention measures giving details of fallowing, cleaning and water treatment. 22. Specific control visits for bivalve molluscs For bivalve mollusc production inspection visits shall take place before and during maximum biomass production. 23. Several production units run by the same operator When an operator manages several production units as provided for in Articles 25c, the units which produce non- organic aquaculture animals shall also be subject to the control system as laid down in Part I of this Article. Part VI: Control requirements for units for preparation of plant, seaweed, livestock and aquaculture animal products and foodstuffs composed thereof 24. Control arrangements In the case of a unit involved in the preparation for its own account or for account of a third party, and including in particular units involved in packaging and/or re-packaging of such products or units involved in labelling and/or re- labelling of such products, the full description of the unit referred to in paragraph 1(a)(i) of this Article shall show the facilities used for the reception, the processing, packaging, labelling and storage of agricultural products before and after the operations concerning them, as well as the procedures for the transport of the products. Part VII: Control requirements for imports of organic products from third countries: 25. Scope This Part applies to any operator involved, as importer and/or as first consignee, in the import and/or reception, for its own account or for account of another operator, of organic products. 26. Control arrangements (a) In the case of the importer, the full description of the unit referred to in paragraph 1(a)(i) of this Article shall include the importer's premises and of his import activities, indicating the points of entry of the products into the Community and any other facilities the importer intends to use for the storage of the imported products pending their delivery to the first consignee. In addition, the declaration referred to in paragraph 1(b) of this Article shall include an undertaking by the importer to ensure that any facilities that the importer will use for storage of products are submitted to control, to be carried out either by the control body or control authority or, when these storage facilities are situated in another Member State or region, by a control body or authority approved for control in that Member State or region. (b) In the case of the first consignee, the full description of the unit referred to in paragraph 1(a) of this Article shall show the facilities used for the reception and storage. (c) Where the importer and the first consignee are the same legal person and operate in one single unit, the reports referred to in the second subparagraph of paragraph 1(b) of this Article may be formalised within one single report. 27. Documentary accounts The importer and the first consignee shall keep separate stock and financial records, unless where they are operating in one single unit. On request of the control authority or control body, any details on the transport arrangements from the exporter in the third country to the first consignee and, from the first consignee's premises or storage facilities to the consignees within the Community shall be provided. 28. Information on imported consignments The importer shall, in due time, inform the control body or control authority of each consignment to be imported into the Community, providing: (a) the name and address of the first consignee; (b) any details the control body or authority may reasonably require, i. in case of products imported in accordance with Article 28 of this Regulation, the documentary evidence referred to in that Article; ii. in case of products imported in accordance with Article 31 of this Regulation, a copy of the certificate of inspection referred to in that Article. On the request of the control body or control authority of the importer, the latter shall forward the information referred to in the first paragraph to the control body or control authority of the first consignee. 29. Control visits The control authority or control body shall check the documentary accounts referred to in paragraph 26 of this Article and the certificate referred to in Article 31 of this Regulation or the documentary evidence referred to in Article 28 of the latter Regulation. Where the importer performs the import operations by different units or premises, he shall make available on request the reports referred to in the second subparagraph of paragraph 1(b) of this Article for each of these facilities. Part VIII: Control requirements for units involved in the production, preparation or import of organic products and which have contracted out to third parties in part or in total the actual operations concerned 30. Control arrangements With regard to the operations, which are contracted out to third parties, the full description of the unit referred to in paragraph 1(a)(i) of this Article shall include: (a) a list of the subcontractors with a description of their activities and an indication of the control bodies or authorities to which they are subject; (b) written agreement by the subcontractors that their holding will be subject to the control regime of Article 44 of this Regulation; (c) all the practical measures, including inter alia an appropriate system of documentary accounts, to be taken at the level of the unit to ensure that the products the operator places on the market can be traced to, as appropriate, their suppliers, sellers, consignees and buyers. Part IX: Control requirements for units preparing feed 31. Scope This Part applies to any unit involved in the preparation of products referred to in Article 2(1)(c) of this Regulation on its own account or on behalf of a third party. 32. Control arrangements (a) The full description of the unit referred to in paragraph 1(a)(i) of this Article shall indicate: i. the facilities used for the reception, preparation and storage of the products intended for animal feed before and after the operations concerning them; ii. the facilities used for the storage of other products used to prepare feedingstuffs; iii. the facilities used to store products for cleaning and disinfection; iv. where necessary, the description of the compound feedingstuff that the operator intends to produce, in accordance with Article 5(1)(a) of Directive 79/373/EEC, and the livestock species or class for which the compound feedingstuff is intended; v. where necessary, the name of the feed materials that the operator intends to prepare. (b) The measures to be taken by operators, as referred to in paragraph 1(b) of this Article to guarantee compliance with the organic production rules shall include the indications of measures referred to in Article 13. (c) The control authority or control body shall use these measures to carry out a general evaluation of the risks attendant on each preparation unit and to draw up a control plan. This control plan shall provide for a minimum number of random samples depending on the potential risks. 33. Documentary accounts For the purposes of proper control of the operations, the documentary accounts referred to in paragraph 4 of this Article shall include information on the origin, nature and quantities of feed materials, additives, sales and finished products. 34. Control visits The control visit referred to in paragraph 3 shall comprise a full physical inspection of all premises. Moreover, the control authority or control body shall make targeted visits based on a general evaluation of the potential risks of non- compliance with the organic production rules. The control body or authority shall pay particular attention to the critical control points pointed out for the operator, with a view to establishing whether the surveillance and checking operations are carried out correctly. All the premises used by the operator for the conduct of his activities may be checked as frequently as the attendant risks warrant. Part X: Infringements and exchange of information 35. Measures in case of suspicion of infringements and irregularities (a) Where an operator considers or suspects that a product which he has produced, prepared, imported or that he has received from another operator, is not in compliance with organic production rules, he shall initiate procedures either to withdraw from this product any reference to the organic production method or to separate and identify the product. He may only put it into processing or packaging or on the market after elimination of that doubt, unless it is placed on the market without indication referring to the organic production method. In case of such doubt, the operator shall immediately inform the control body or authority. The control authority or control body may require that the product cannot be placed on the market with indications referring to the organic production method until it is satisfied, by the information received from the operator or from other sources, that the doubt has been eliminated. In any case, where a level of non-authorised substance detected in a product is higher than the threshold as defined in article 20, such product cannot bear reference to organic production. (b) Where a control authority or control body has a substantiated suspicion that an operator intends to place on the market a product not in compliance with the organic production rules but bearing a reference to the organic production method, this control authority or control body can require that the operator may provisionally not market the product with this reference for a time period to be set by that control authority or control body. Before taking such a decision, the control authority or control body shall allow the operator to comment. This decision shall be supplemented by the obligation to withdraw from this product any reference to the organic production method if the control authority or control body is sure that the product does not fulfil the requirements of organic production. However, if the suspicion is not confirmed within the said time period, the decision referred to in the first subparagraph shall be cancelled not later than the expiry of that time period. The operator shall cooperate fully with the control body or authority in resolving the suspicion. (c) Member States shall take whatever measures and sanctions are required to prevent fraudulent use of the indications referred to in Chapter IV of this Regulation. 36. Exchange of information between control authorities, control bodies and competent authorities (a) Where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies, the control authorities or control bodies shall exchange the relevant information on the operations under their control. (b) Where operators and/or their subcontractors change their control authority or control body, the change shall be notified without delay to the competent authority by the control authorities or control bodies concerned. The previous control authority or control body shall hand over the relevant elements of the control file of the operator concerned and the reports referred to in the second subparagraph of paragraph 1(b) to the subsequent control authority or control body. The new control authority or control body shall ensure that non-conformities noted in the report of the previous control authority or control body have been or are being addressed by the operator. (c) Where the operator withdraws from the control system, the control authority or control body of that operator shall, without delay, inform the competent authority. (d) Where a control authority or control body finds irregularities or infringements affecting the organic status of products, it shall without delay inform the competent authority of the Member State which designated or approved it in accordance with Article 44. That competent authority may require, on its own initiative, also any other information on irregularities or infringements. In case of irregularities or infringements found with regard to products under the control of other control authorities or control bodies, it shall also inform those authorities or bodies without delay. (e) Member States shall take the appropriate measures and establish documented procedures to enable exchange of information between all control authorities they have designated and/or all control bodies they have approved in accordance with Article 44 of this Regulation, including procedures for the exchange of information for the purpose of verifying documentary evidence referred to in Article 28 of that Regulation. (f) Member States shall take the appropriate measures and establish documented procedures in order to ensure that information on the results of inspections and visits as referred to in paragraph 3 of this Article is communicated to the paying agency in accordance with the needs of that paying agency as provided for in Article 33(1) of Commission Regulation (EU) No 65/2011. 37. Exchange of information between different Member States and the Commission (a) Where a Member State finds irregularities or infringements relating to the application of this Regulation with regard to a product coming from another Member State and bearing indications as referred to in Chapter IV of Regulation, it shall notify the Member State which designated the control authority or approved the control body, the other Member States and the Commission without delay via the system referred to in [...]. (b) Where a Member State finds irregularities or infringements as regards compliance of the products imported in accordance with Articles 28-31 of this Regulation with the requirements laid down in that Regulation or Regulation [...], it shall notify the other Member States and the Commission without delay via the system referred to in [...]. (c) Where a Member State finds irregularities or infringements as regards compliance of the products imported in accordance with [...], it shall notify the Member State which issued the authorisation, the other Member States and the Commission without delay via the system referred to in [...] of this Regulation. The notification shall be sent to the other Member States and to the Commission in case the irregularity or infringement is found with regard to products for which the Member State itself issued the authorisation referred to in [...]. (d) The Member State which receives a notification relating to non-compliant products in accordance with paragraph 1 or 3 or the Member State which issued the authorisation referred to [...] for a product for which an irregularity or infringement was found, shall investigate the origin of the irregularities or infringements. It shall take appropriate action immediately. It shall inform the Member State which sent the notification, the other Member States and the Commission of the result of the investigation and of the action taken by replying to the original notification via the system referred to in [...]. The reply shall be sent within 30 calendar days from the date of the original notification. (e) The Member State which sent the original notification may ask the replying Member State for additional information, if needed. In any case, after receiving a reply or additional information from a notified Member State, the Member State which sent the original notification shall make the necessary entries and updates in the system referred to in [...]. 38. Publication of information Member States shall make available to the public, in an appropriate manner including publication on the internet, the updated lists referred to in paragraph 15 (e) of Article 44 containing updated documentary evidence related to each operator, as provided for in paragraph 16 (a) of that Regulation and using the model set out in [...]. The Member States shall duly observe the requirements of the protection of personal data as laid down in Directive 95/46/EC of the European Parliament and of the Council. Article 23 c Controls of a group of operators 1. Along the rules set in Articles 26, 44 and 44a of this Regulation which shall be met by a group of operators, including internal controls of this group, and which shall be a subject of annual physical inspection of this group by relevant accredited control body/control authority, at least one member of the group is a subject of thorough annual on-site inspection according the Articles 44 and 44a of this Regulation by the accredited control body/control authority in addition. Different member of a group is selected every year.