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Commission Regulation (EC) No 889/2008Show full title

Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

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TITLE IVU.K.CONTROLS

CHAPTER 1U.K.Minimum control requirements

Article 63U.K.Control arrangements and undertaking by the operator

1.When the control arrangements are first implemented, the operator shall draw up and subsequently maintain:

(a)a full description of the unit and/or premises and/or activity;

(b)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;

(c)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[F1;]

[F2(d) the specific characteristics of the production method used, where the operator intends to request documentary evidence in accordance with Article 68(2).]

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.

2.The description and the measures referred to in paragraph 1 shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator:

(a)to perform the operations in accordance with the organic production rules;

(b)to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules;

(c)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[F3;]

[F4(d)to accept, in cases where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies F5..., the exchange of information between those authorities or bodies;

(e) 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;

(f) 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;

(g) 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;

(h) 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.]

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.

3.For the application of Article 28(1) of Regulation (EC) No 834/2007 the operator shall notify the following information to the competent authority:

(a)Name and address of operator;

(b)Location of premises and, where appropriate, parcels (land register data) where operations are carried out;

(c)Nature of operations and products;

(d)Undertaking by the operator to carry out the operation in accordance with the provision laid down in Regulation (EC) No 834/2007 and this Regulation;

(e)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;

(f)The name of the approved body to which the operator entrusted control of his undertaking, where [F6that body is approved in accordance with the control system].

Article 64U.K.Modification of control arrangements

The operator responsible shall notify any change in the description or of the measures referred to in Article 63 and in the initial control arrangements set out in Articles 70, 74, 80, 82, 86 and 88 to the control authority or control body in due time.

Article 65U.K.Control visits

1.The control authority or control body shall carry out at least once a year a physical inspection of all operators.

[F32. 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.

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.

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.]

3.A control report shall be drawn up after each visit, countersigned by the operator of the unit or his representative.

4.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.

Article 66U.K.Documentary accounts

1.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:

(a)the supplier and, where different, the seller, or the exporter of the products;

(b)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;

(c)the nature and the quantities of organic products held in storage at the premises;

(d)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;

(e)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.

2.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.

3.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.

Article 67U.K.Access to facilities

1.The operator shall:

(a)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;

(b)provide the control authority or control body with any information reasonably necessary for the purposes of the control;

(c)submit, when requested by the control authority or control body, the results of its own quality assurance programmes.

2.In addition to the requirements set out in paragraph 1, importers and first consignees shall submit the information on imported consignments referred to in Article 84.

[F1Article 68 U.K. Documentary evidence

1. For the purpose of the application of Article 29(1) of Regulation (EC) No 834/2007 the control authorities and control bodies shall use the model of the documentary evidence set out in Annex XII to this Regulation.

[F4In case of electronic certification as referred to in Article 29(3) of Regulation (EC) No 834/2007, 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.]

2. If an operator subject to the controls of the control authorities and control bodies as referred to in paragraph 1 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 Annex XIIa.

Applications for complementary documentary evidence shall contain in box 2 of the model set out in Annex XIIa the relevant entry listed in Annex XIIb.]

Article 69U.K.Vendor declaration

For the purpose of the application of Article 9(3) of Regulation (EC) No 834/2007 the vendor declaration that products supplied have not been produced from or by GMOs may follow the model set out in Annex XIII to this Regulation.

CHAPTER 2U.K.Specific control requirements for plants and plant products from farm production or collection

Article 70U.K.Control arrangements

1.The full description of the unit referred to in Article 63(1)(a) shall:

(a)be drawn up even where the operator limits his activity to the collection of wild plants;

(b)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

(c)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.

2.In case of collection of wild plants, the practical measures referred to in Article 63(1)(b) shall include any guarantees given by third parties which the operator can provide to ensure that the provisions of Article 12(2) of Regulation (EC) No 834/2007 are complied with.

Article 71U.K.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.

Article 72U.K.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 Article 71 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.

Article 73U.K.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 Chapter 1 and this Chapter of this Title.

[F7CHAPTER 2a U.K. Specific control requirements for seaweed

Article 73a U.K. Control arrangements for seaweed

When the control system applying specifically to seaweed is first implemented, the full description of the site referred to in Article 63(1)(a) shall include:

(a)

a full description of the installations on land and at sea;

(b)

the environmental assessment as outlined in Article 6b(3) where applicable;

(c)

the sustainable management plan as outlined in Article 6b(4) 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.

Article 73b U.K. Seaweed Production Records

1. 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:

(a) list of species, date and quantity harvested;

(b) date of application, type and amount of fertiliser used.

2. For collection of wild seaweeds the register shall also contain:

(a) history of harvesting activity for each species in named beds;

(b) harvest estimate (volumes) per season;

(c) sources of possible pollution for harvest beds;

(d) sustainable annual yield for each bed.]

CHAPTER 3U.K.Control requirements for livestock and livestock products produced by animal husbandry

Article 74U.K.Control arrangements

1.When the control system applying specifically to livestock production is first implemented, the full description of the unit referred to in Article 63(1)(a) shall include:

(a)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;

(b)a full description of the installations for the storage of livestock manure.

2.The practical measures referred to in Article 63(1)(b) shall include:

(a)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;

(b)where appropriate, as regards the spreading of manure, the written arrangements with other holdings as referred to in Article 3(3) complying with the provisions of the organic production rules;

(c)a management plan for the organic-production livestock unit.

Article 75U.K.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.

Article 76U.K.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 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.

Article 77U.K.Control measures on veterinary medicinal products for livestock

Whenever veterinary medicinal products are used the information according to Article 76(e) 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.

Article 78U.K.Specific control measures on beekeeping

1.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 Article 13(2), 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.

2.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.

3.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.

4.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.

5.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.

6.The removals of the supers and the honey extraction operations shall be entered in the register of the apiary.

Article 79U.K.Several production units run by the same operator

Where an operator manages several production units, as provided for in Articles 17(1), 40 and 41, the units which produce non-organic livestock or non-organic livestock products shall also be subject to the control system as laid down in Chapter 1 and this Chapter of this Title.

[F7CHAPTER 3a U.K. Specific control requirements for aquaculture animal production

Article 79a U.K. 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 Article 63(1)(a) shall include:

(a)

a full description of the installations on land and at sea;

(b)

the environmental assessment as outlined in Article 6b(3) where applicable;

(c)

the sustainable management plan as outlined in Article 6b(4) where applicable;

(d)

in the case of molluscs a summary of the special chapter of the sustainable management plan as required by Article 25q(2).

Article 79b U.K. 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.

Article 79c U.K. Specific control visits for bivalve molluscs

For bivalve mollusc production inspection visits shall take place before and during maximum biomass production.

Article 79d U.K. 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 Chapter 1and this Chapter.]

CHAPTER 4U.K. [F8Control requirements for units for preparation of plant, seaweed, livestock and aquaculture animal products and foodstuffs composed thereof]

Article 80U.K.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 Article 63(1)(a) 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.

CHAPTER 5U.K. [F8Control requirements for imports of organic products from third countries]

Article 81U.K.Scope

This Chapter 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.

Article 82U.K.Control arrangements

1.In the case of the importer, the full description of the unit referred to in Article 63(1)(a) shall include the importer's premises and of his import activities, indicating the points of entry of the products into [F9Great Britain] 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 Article 63(2) 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, [F10when these storage facilities are situated outside of Great Britain, by a control body or authority approved by the Secretary of State for control in that country.]

2.In the case of the first consignee, the full description of the unit referred to in Article 63(1)(a) shall show the facilities used for the reception and storage.

3.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 Article 63(2) may be formalised within one single report.

Article 83U.K.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 [F11Great Britain] shall be provided.

Article 84U.K.Information on imported consignments

The importer shall, in due time, inform the control body or control authority of each consignment to be imported into [F12Great Britain], 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 32 of Regulation (EC) No 834/2007, the documentary evidence referred to in that Article;

(ii)

in case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, 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.

[F13The importer shall transmit the information referred to in the first and second paragraphs by using the electronic [F14import control system operated in Great Britain.]]

Article 85U.K.Control visits

The control authority or control body shall check the documentary accounts referred to in Article 83 of this Regulation and the certificate referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 or the documentary evidence referred to in Article 32(1)(c) 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 Article 63(2) of this Regulation for each of these facilities.

CHAPTER 6U.K.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

Article 86U.K.Control arrangements

With regard to the operations, which are contracted out to third parties, the full description of the unit referred to in Article 63(1)(a) 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 Title V of Regulation (EC) No 834/2007;

(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.

CHAPTER 7U.K.Control requirements for units preparing feed

Article 87U.K.Scope

This Chapter applies to any unit involved in the preparation of products referred to in Article 1(2)(c) of Regulation (EC) No 834/2007 on its own account or on behalf of a third party.

Article 88U.K.Control arrangements

1.The full description of the unit referred to in Article 63(1)(a) shall indicate:

(a)the facilities used for the reception, preparation and storage of the products intended for animal feed before and after the operations concerning them;

(b)the facilities used for the storage of other products used to prepare feedingstuffs;

(c)the facilities used to store products for cleaning and disinfection;

(d)where necessary, the description of the compound feedingstuff that the operator intends to produce, in accordance with [F15Regulation (EC) No 767/2009], and the livestock species or class for which the compound feedingstuff is intended;

(e)where necessary, the name of the feed materials that the operator intends to prepare.

2.The measures to be taken by operators, as referred to in Article 63(1)(b), to guarantee compliance with the organic production rules shall include the indications of measures referred to in Article 26.

3.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.

Article 89U.K.Documentary accounts

For the purposes of proper control of the operations, the documentary accounts referred to in Article 66 shall include information on the origin, nature and quantities of feed materials, additives, sales and finished products.

Article 90U.K.Control visits

The control visit referred to in Article 65 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.

CHAPTER 8U.K.Infringements and exchange of information

Article 91U.K.Measures in case of suspicion of infringements and irregularities

1.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.

2.Where [F16the 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 [F17production method, the 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 [F18set by the 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.

F193.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F3 Article 92 U.K. Exchange of information between control authorities, control bodies and competent authorities

1.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.

2.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 Article 63(2) 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.

3.Where the operator withdraws from the control system, the control authority or control body of that operator shall, without delay, inform the competent authority.

4.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 F20... in accordance with Article 27 of Regulation (EC) No 834/2007.

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.

5.[F21The relevant authority] 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 27 of Regulation (EC) No 834/2007, including procedures for the exchange of information for the purpose of verifying documentary evidence referred to in Article 29(1) of that Regulation.

6.[F22The relevant authority] 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 Article 65 of this Regulation 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 (1) .

F23 Article 92a U.K. Exchange of information between different Member States and the Commission

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 92b U.K. Publication of information

[F24The relevant authority] shall make available to the public, in an appropriate manner including publication on the internet, the updated lists referred to in Article 28(5) of Regulation (EC) No 834/2007 containing updated documentary evidence related to each operator, as provided for in Article 29(1) of that Regulation and using the model set out in Annex XII to this Regulation. [F25The relevant authority] shall duly observe the requirements of the protection of personal data as laid down in [F26Regulation (EU) 2016/679].]

[F4CHAPTER 9 U.K. Supervision by competent authorities

Article 92c U.K. Supervisory activities relating to control bodies

1.The supervisory activities by competent authorities delegating control tasks to control bodies in accordance with Article 27(4)(b) of Regulation (EC) No 834/2007 shall focus on the evaluation of the operational performance of those control bodies, taking into account the results of the work of the national accreditation body as referred to in Article 2(11) of Regulation (EC) No 765/2008 of the European Parliament and of the Council (2).

Those supervisory activities shall include an assessment of the internal procedures of the control bodies for the controls, the management and examination of control files in the light of the obligations established by Regulation (EC) No 834/2007 and the verification of handling of non-conformities and the handling of appeals and complaints.

2.The competent authorities shall require control bodies to submit documentation on their risk analysis procedure.

The risk analysis procedure shall be designed in such a way that:

(a)the result of the risk analysis provides the basis for determining the intensity of the unannounced or announced annual inspections and visits;

(b)additional random control visits carried out in accordance with Article 65(4) of at least 10 % of operators under contract in accordance with the risk category are performed;

(c)at least 10 % of all inspections and visits carried out in accordance with Article 65(1) and (4) are unannounced;

(d)the selection of operators to be submitted to unannounced inspections and visits is determined on the basis of the risk analysis and that these are planned according to the level of risk.

3.Competent authorities delegating control tasks to control bodies shall verify that the staff of the control bodies has sufficient knowledge, including knowledge of the risk elements affecting the organic status of products, qualifications, training and experience with respect to organic production in general and with the relevant [F27retained EU law] in particular and that appropriate rules on rotation of inspectors are in force.

4.Competent authorities shall have documented procedures for the delegation of tasks to control bodies in accordance with Article 27(5) of Regulation (EC) No 834/2007 and for the supervision in accordance with this Article, detailing the information to be submitted by control bodies.

Article 92d U.K. Catalogue of measures in case of irregularities and infringements

Competent authorities shall adopt and communicate to control bodies that have been delegated control tasks, a catalogue at least listing infringements and irregularities affecting the organic status of products and corresponding measures to be applied by control bodies in case of infringements or irregularities by operators under their control who are involved in organic production.

Competent authorities may include other relevant information in the catalogue on their own initiative.

Article 92e U.K. Annual inspection of control bodies

Competent authorities shall organise an annual inspection of the control bodies that have been delegated control tasks in accordance with Article 27(4)(b) of Regulation (EC) No 834/2007. For the purposes of the annual inspection, the competent authority shall take into account the results of the work of the national accreditation body as referred to in Article 2(11) of Regulation (EC) No 765/2008. During the annual inspection, the competent authority shall, in particular, verify:

(a)

the compliance with the control body’s standard control procedure as submitted by the control body to the competent authority in accordance with Article 27(6)(a) of Regulation (EC) No 834/2007;

(b)

that the control body has a sufficient number of suitable qualified and experienced staff in accordance with Article 27(5)(b) of Regulation (EC) No 834/2007 and that training concerning risks affecting the organic status of products has been implemented;

(c)

that the control body has and follows documented procedures and templates for:

(i)

the annual risk analysis in accordance with Article 27(3) of Regulation (EC) No 834/2007;

(ii)

preparing a risk-based sampling strategy, conducting sampling and laboratory analysis;

(iii)

information exchange with other control bodies and with the competent authority;

(iv)

initial and follow-up controls of operators under their control;

(v)

the application and follow-up to the catalogue of measures to be applied in case of infringements or irregularities;

(vi)

observing the requirements of the protection of personal data for the operators under its control as laid down by the F28... competent authority F29... and in accordance with [F30Regulation (EU) 2016/679].

Article 92f U.K. Organic data in the multi-annual national control plan and annual report

[F31The relevant authority] shall ensure that their multi-annual national control plans referred to in Article 41 of Regulation (EC) No 882/2004 cover the supervision of controls performed on the organic production in accordance with this Regulation and to include the specific data on that supervision, hereinafter referred to as ‘ the organic data ’, in the annual report referred to in Article 44 of Regulation (EC) No 882/2004. The organic data shall cover the topics listed in Annex XIIIb to this Regulation.

The organic data shall be based on information on the controls performed by the control bodies and/or control authorities and on audits performed by the competent authority.

The data shall be presented according to the templates provided for in Annex XIIIc to this Regulation as from 2015 for the year 2014.

[F31The relevant authority] may insert the organic data as an organic chapter of their national control plan and their annual report.]

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