Executive Order on organic foodstuffs etc.

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From this document you will learn the answers to the following questions:

  • What kind of order must be issued to order organic monitoring?

  • What type of monitoring must be used on non - food products?

  • What regulation must be observed when organic products are being monitored?

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1 Executive Order on organic foodstuffs etc. Pursuant to Section 6, subsections 1-2, Section 7, subsection 3, Section 13, Section 14, Section 15 and Section 24, subsection 2, according to Act No. 463 dated 17 June 2008, Danish Organics Act, it is stipulated after authorisation: Chapter 1 Scope Section 1. This Executive Order concerns: 1) Foodstuffs of agricultural origin to be marketed with indication of the organic method of production (organic foodstuffs). 2) Organic animals delivered for transport to slaughter. 3) Fodder with animal content intended for dogs, cats and other pets (organic non-food products) to be marketed with indication of the organic method of production. Chapter 2 Non-food products Section 2. Organic non-food products may only contain such ingredients of non-agricultural origin as are listed in Annex 1, part A of this Executive Order. Subsection 2. In pre-processing of organic non-food products or ingredients of these, that are of agricultural origin, only such products may be used as are listed in Annex 1, part B of this Executive Order. Chapter 3 Application and monitoring Section 3. Businesses must make an application to the regional foodstuff authority and submit to organic monitoring if they: 1) prepare organic foodstuffs or non-food products, 2) market or store organic foodstuffs or non-food products in bulk, or 3) import organic foodstuffs or non-food products from third countries. Subsection 2. Retail businesses need not make applications for simple preparation where: 1) Preparation takes place in sight of the customer or in the immediate vicinity of the customer, 2) foodstuffs or non-food products still bear their original marking and are therefore clearly seen to be organic following preparation, or 3) no changes are made to the physical form of the organic foodstuffs or non-food products. Subsection 3. If organic foodstuffs or non-food products are separated from their original packaging in connection with simple preparation, cf. subsection 2, batch numbers must be marked in the immediate vicinity of the relevant organic foodstuffs or non-food products. The batch number must be clearly separated from information intended for the consumer. Subsection 4. Large kitchens (cf. definition in bekendtgørelse om økologisk storkøkkendrift, Executive Order on Organic Operation of Large Kitchens) need not make applications for the preparation of organic foodstuffs, cf. subsection 1, no. 1. Subsection 5. Notwithstanding subsection 4, large kitchens wishing to use the organic designation in marketing organic dishes or organic parts of dishes must make applications for the preparation of organic foodstuffs, cf. subsection 1, no.1, when the dishes or parts of dishes concerned are made using organic ingredients that are not only present in organic form in the kitchen. Subsection 6. The marketing of foodstuffs referred to in subsection 5 must take place in accordance with the provisions of Council Regulations and Commission Regulations, but the large kitchens referred to in subsection 5 are not affected by Commission Regulation Section III, Chapter I. Section 4. Businesses that pursue one of the abovementioned activities for which the application obligation applies in connection with primary production need only make applications for such activities to the regional foodstuff authority if the activities concerned must be registered or authorised by the regional foodstuff authority in respect of the bekendtgørelse om autorisation og registrering af fødevarevirksomheder samt egenkontrol (autorisationsbekendtgørelsen) (Executive Order on Authorisation and Registration of Foodstuff Enterprises and Internal Quality Control ( Executive Order on Authorisation ). Subsection 2. However, no application need be made to the regional foodstuff authority in cases where registration must take place solely in accordance with the Executive Order on Authorisation s Section 5, subsection 2, no. 1-3 or no. 5-6.

2 Subsection 3. Notwithstanding subsection 1, businesses pursuing activities excepted from the requirement for authorisation or registration under the Executive Order on Authorisation Section 5, subsection 5 or Section 14, no. 1, in pursuance of activities in Section 3, subsection 1, must make applications for these to the regional foodstuff authority. Section 5. Businesses subject to organic monitoring must observe the provisions in Annex 2 of this Executive Order on accounting requirements and the articles in Commission Regulation Section IV on monitoring with reference to businesses. Subsection 2. The DVFA may rule that trading agents and others, conducting marketing of organic foodstuffs or non-food products are covered by Annex 2, where necessary, in order to carry out effective monitoring in respect of this Executive Order. Section 6. For businesses subject to organic monitoring, an organic report will be prepared by the regional foodstuff authority. This organic report will lay down specific conditions for the activities to be monitored. Subsection 2. The owner of the business must prepare a full description of the unit or premises and the activity. This description will be included in the organic report. Subsection 3. The owner of the business must establish all specific measures, including internal quality control procedures, to be implemented in connection with the unit, premises or activity so as to ensure that this Executive Order and the Council Regulation are upheld. This description will be included in the organic report. Subsection 4. All businesses must supplement the descriptions in subsections 2 and 3 with the declaration in Commission Regulation Article 63, subsection 2. Subsection 5. The business is obliged to keep records for documentation of implementation and observance of the conditions in the organic report. This documentation must be accessible at all times to the DVFA and the regional foodstuff authority and must be kept archived for at least 5 years. Subsection 6. The activities which are to undergo organic monitoring may not be re-commenced until the final organic report is issued by the regional foodstuff authority to the enterprise owner. Subsection 7. The regional foodstuff authority may amend the organic report should a monitoring-related reason for this arise. Section 7. Sodium nitrite (E250) and potassium nitrate (E252) may only be used in the preparation of organically produced meat products following prior consent from the DVFA. Subsection 2. Such consent may be given on condition that the DVFA is satisfied that there is no technological alternative that would provide the same health guarantee or make it possible to maintain the specific characteristics of the product. Chapter 4 Amendment or cessation of activities Section 8.The regional foodstuff authority must be informed of amendments to the conditions and activities described in the organic report at least four weeks in advance. The business must, at the same time, submit revised descriptions, cf. Section 6, subsections 2 and 3, to the regional foodstuffs authority. Subsection 2. Once the regional foodstuff authority has approved the revised descriptions and issued an amendment to the organic report, the amended activities may re-commence. Subsection 3. If activities have not been carried out for a period of one year, the organic report may be withdrawn. Subsection 4. In case of cessation of activities, the enterprise owner must immediately notify the regional foodstuffs authority to which the application was made. The organic report is thereafter void. Chapter 5 Marking with code number and organic mark ( Ø mark ) Section 9. Organic foodstuffs and non-food products must be marked with the code number of the monitoring authority to which the business carrying out the last element of the preparation process is answerable, cf. Annex 3. Subsection 2. Marking with the monitoring code number, cf. Annex 3, may only be supplemented with the explanatory text økologikontrolmyndighed ( organic monitoring authority ) and the name of that authority. If the name of the monitoring authority is used, the explanatory text økologikontrolmyndighed ( organic monitoring authority') must appear. Section 10. Businesses subject to organic monitoring by the regional foodstuff authority may place the organic monitoring mark ('Ø mark) on organic foodstuffs and non-food products in accordance with the guidelines set in Annex 4. Subsection 2. When the organic monitoring mark is used on non-food products, Council Regulation article 23, subsection 4, letter a and Section 2 of this Executive Order must be observed. Subsection 3. When the organic monitoring mark is used on prepared organic foodstuffs, Council Regulation article 23, subsection 4, letter a, must be observed. Subsection 4. The Ø mark without the text statskontrolleret økologisk ( state-certified organic ) may not be reproduced on organic foodstuffs and non-food products, but can be used in the marketing of organic foodstuffs and non-food products.

3 Chapter 6 Import of organic foodstuffs Section 11. The import of organic foodstuffs and non-food products from a non-approved third country, cf. Import Regulation article 19, may take place provided that prior notice of this is given to the regional foodstuff authority or that import takes place with permission from a competent authority in another EU member state. Import may also take place provided that the imported organic foodstuffs are certified by a monitoring body listed in Annex I or IV of the Import Regulation. Section 12. Prior to import of organic foodstuffs imported under article 33 of the Council Regulation, a copy of the original inspection certificate, cf. Import Regulation, must be submitted to the DVFA. The copy of the inspection certificate must reach the DVFA no later than one full working day prior to the shipment s arrival at the customs reception point. The copy of the inspection certificate must be sent by fax or electronically as a scanned copy. Subsection 2. The DVFA must be informed of the time that the shipment will arrive at its first recipient in Denmark no later than when the copy of the inspection certificate is submitted. Subsection 3. The DVFA must be informed of the time that the shipment will arrive at its first recipient in Denmark no later than one full working day prior to import of organic foodstuffs imported under article 32 of the Council Regulation, and receive a copy of the supplier documentation, cf. Import Regulation Annex II. Section 13. With organic foodstuffs imported under article 33 of the Council Regulation, the original inspection certificate must be submitted to the customs authorities before the shipment may be released for free circulation. Subsection 2. In case of assignation under a suspensive procedure subject to preparation, the original inspection certificate must be submitted to the customs authorities. Following lifting of the suspensive procedure, the inspection certificate must again be submitted to the customs authorities before the shipment may be released for free circulation. Subsection 3. In case of assignation under a suspensive procedure subject to splitting up, the original inspection certificate must be submitted to the customs authorities. Subsection 4. When the resultant batches are to be sent on, a batch inspection certificate for each batch must be submitted to the customs authorities, who will undertake verification before the batch can be released for free circulation. The importer completes the batch inspection certificate in accordance with Import Regulation article 13, subsection 5. Subsection 5. Prior to splitting into batches, a copy of the endorsed inspection certificate must be sent to the DVFA together with the original batch inspection certificate for each batch. The DVFA conducts endorsement of batch inspection certificates. Chapter 7 Documentation concerning supplier of organic foodstuffs etc. Section 14. Prior to the commencement of supply of organic foodstuffs and non-food products and thereafter at least once per calendar year, the business must obtain the documentation described in Council Regulation article 29 showing that the supplier is covered by organic monitoring. Subsection 2. Confirmation must be issued by a monitoring body approved under the Council Regulation and may be in the form of a copy. Subsection 3. In case of import from third countries, the inspection certificate is regarded as sufficient documentation regarding the supplier, cf. subsection 1. Chapter 8 Monitoring authorities access to documentation Section 15. Businesses not registered and subject to organic monitoring, cf. Sections 3 and 4, but subject to monitoring under the general foodstuffs legislation, must, on request from the regional foodstuffs authority or the DVFA, supply documentation on the purchasing and sales of organic foodstuffs and non-food products from and to enterprise owners subject to organic monitoring. Chapter 9 Exemption Section 16. The DVFA may, in certain circumstances, grant exemption from the provisions of Section 2, Section 5, subsection 1, Section 6, subsection 5 and subsection 6, Section 8, subsections 1, 2 and 4 and Section 9. Chapter 10 Penalty provisions

4 Section 17. A fine is imposed on those who: 1) Transgress Section 2, Section 3, subsections 1, 3, 5 and 6, Section 4, subsection 3, Section 5, subsection 1, Section 6, subsections 2-6, Section 7, subsection 1, Section 8, subsections 1-2 and 4, Section 9, Section 10, subsections 2 and 3 and Sections ) transgress a condition set in the organic report described in Section 6, subsection 1, or 3) fail to provide support or give information under Section 15. Subsection 2. A fine is imposed on those who: 1) Transgress Council Regulation (Council Regulation 834/2007 dated 28 June 2007) article 6, article 8, article 14, article 23, subsections 1-4, article 24, subsections 1-2, article 25, subsection 1, article 28, subsection 1, article 29, subsection 2, article 32, subsection 1 and article 33, subsection 1. 2) transgress Import Regulation (Commission Regulation (EC) no. 1235/2008) article 13, subsection 1, subsection 7, letter d and subsection 9 and article 14, subsections ) transgress Commission Regulation (Commission Regulation (EC) no. 889/2008 dated 5 September 2008) article 18, articles 26-27, articles 30-31, articles 33-35, article 57, article 62, article 91, subsection 1 and article 92, subsection 1. Subsection 3. Criminal liability may be imposed on companies, etc. (legal persons) under the rules of Chapter 5 of the Danish Criminal Code. Chapter 11 Commencement and transition provisions Section 18. This Executive Order comes into force on 1 January Subsection 2. Executive Order no. 605 dated 15 June 2006 on organic foodstuffs etc. is revoked. However, enterprise owners may, during a transitional period expiring on 1 January 2010, continue to use the Ø mark in accordance with Section 12 of that Executive Order. Danish Veterinary and Foodstuffs Administration, 12 December 2008 Anders Munk Jensen / Lene Guldborg Annex 1 A. Permitted ingredients of non-agricultural origin in organic non-food products E 270 Lactic acid E 325 Sodium lactate E 330 Citric acid E 331 Sodium citrate E 406 Agar E 407 Carrageenan E 410 Locust bean gum E 412 Guar gum E 440 (i) Pectin Additives: Other ingredients: - Drinking water - Salt (with sodium chloride or potassium chloride as basic substances) Micro-organism preparations (bacteria cultures, mould and yeast fungi), provided they are used in accordance with European - Parliament and Council Regulation (EC) no. 1831/2003 dated 22 September 2003 on additives for use in animal nutrition and Council Directive 82/471/EEC dated 30 June concerning certain products used in animal nutrition. Minerals (including trace elements), vitamins, amino acids and other nitrogen compounds are only permitted where there is a - legal requirement for them to be used in the particular organic non-food product. B. Products of agricultural origin that may be used in the preparation of organic non-food products their and ingredients - Drinking water

5 - Salt (sodium chloride) - Micro-organism preparations (bacteria cultures, mould and yeast fungi) and enzymes. Annex 2 Accounting requirements Definitions Ingredients: Foodstuffs, animals and non-food products (foodstuffs etc.) intended for use in preparation of organic foodstuffs etc. by the business. Finished goods: Foodstuffs etc. and products thereof, not intended for further preparation by the business but intended for further marketing as organic. Incoming ingredients: Purchased/received ingredients and other ingredients added to stock. Outgoing ingredients: Ingredients used for production (preparation), sold/delivered or discarded ingredients and other ingredients taken from stock. Ingoing finished goods: Purchased/received finished goods, including return goods, finished goods produced (prepared) by the enterprise owner and other finished goods added to stock. Outgoing finished goods: Sold/delivered or discarded finished goods and other finished goods outgoing from stock. Supplier: The business from which a batch is physically delivered. 1. General accounting requirements The enterprise owner shall keep up-to-date accounts ensuring traceability of organic foodstuffs. The accounts shall be accessible at all times. The data of the accounts shall be documentable for the DVFA and the regional foodstuffs authority and the accounts and pertaining original documents, including balances and documents listed in section 3, shall be kept for at least five years. Accounts shall contain the following: 1.1. Running registrations There shall be ongoing registration of: a) All incoming and outgoing ingredients and all incoming and outgoing finished goods, with indication of date, type, quantity, origin and use. b) Preparation, including quantities used of ingredients, produced (prepared) finished goods, wastage, discards, rejections and the like. Enterprises that do not handle conventional foodstuffs etc. are exempted from the requirement for running registration of ingredients included in production (preparation) and of wastage and/or accrual in connection with production, provided that the quantity of ingredients, including wastage and/or accrual percentage, can be derived from a formula or production description. Retail enterprises not handling conventional foodstuffs etc. may further be exempted from the other requirements under letter b, whereby the regional foodstuff authority considers that effective controls would nonetheless be assured. Conditions for this shall be described in the organic report Balances Periodical balances shall be prepared for each individual type of organic ingredient and finished good. Any quality and size categories must also be included as special types.

6 Enterprise owners not handling conventional foodstuffs etc. shall not prepare periodical balances. Instead, such enterprise owners shall prepare balances on request from the DVFA or the regional foodstuff authority. It will be a condition that the organic report contain a description and an example of the preparation and organisation of the balance. Retail enterprises not handling conventional foodstuffs etc. may omit to prepare type-by-type balances and instead prepare overall balances for related ingredients and finished goods. It will be a condition that the regional foodstuff authority considers that effective control would continue to be assured and that the organic report contain a description and an example of the preparation and organisation of the balance Balance period The period to be observed in the balances is set in the organic report and shall be a minimum of monthly and a maximum of six-monthly. For enterprise owners preparing, storing or handling organic foodstuffs etc. in batches or in limited periods of the year, the above interval may be departed from in order to achieve the greatest possible coordination between periods of activity and balances. It is a condition that the regional foodstuff authority considers that effective control would continue to be assured. The period to be observed in the balances shall be described in the organic report Statements of stock holding and of incoming and outgoing ingredients and finished goods For use in the preparation of balances, the following shall be done: a) Physical statement made of stock holding of each individual type of ingredient/finished good at period start (initial stock holding) and period end (final stock holding) b) Statement prepared for each individual type of ingredient/finished good of total incoming and outgoing quantities for the period. Enterprise owners shall not include any outgoing quantities of ingredients that may have been excepted from running registration, cf. point 1.1, in their preparation of the statements described under letter b Settlement Each balance shall include a settlement of the total incoming and outgoing quantities of the particular type of ingredient or finished good, in which consideration is given to the discrepancy between initial and final stock holdings. If the settlement shows a considerable discrepancy, the enterprise owner shall enter in the accounts the likely cause and describe the corrective measures put in place with a view to reducing the discrepancy in the next statement period Evaluating the balance between consumption of ingredients and production of finished goods At the end of each statement period, an evaluation shall be made of whether the quantities of ingredients that have, according to the balances, been used in the production of finished goods balance with the quantities of finished goods that have, according to the balances, been produced. This evaluation shall be based on formulae used and expected production wastage/accrual. If it is found that there is a considerable discrepancy, the enterprise owner shall enter in the accounts the likely cause and describe the corrective measures put in place with a view to reducing the discrepancy in the next statement period. Such an evaluation shall be done for each type of finished good. The result of the evaluation shall be recorded and documented in the form of the calculations that are its basis. 2. Deviations from general accounting requirements This section concerns only organic foodstuffs etc. that are not prepared by an enterprise owner. Such foodstuffs etc. which are solely stored and/or marketed shall be regarded as finished goods, given that: in the definition of incoming finished goods the condition finished goods prepared by the enterprise owner is disregarded 1. and 2. those requirements listed under point 1 that apply to ingredients are disregarded Bulk storage of organic foodstuffs etc. not finally packaged and bulk marketing of organic foodstuffs etc. not finally packaged from the premises of the enterprise owner For the above activities the requirements of point 1.1., letter b and point 1.3 are disregarded.

7 2.2. Bulk storage of finally-packaged organic foodstuffs etc. and bulk marketing of finally-packaged organic foodstuffs etc. from the premises of the enterprise owner For the above activities the requirements of point 1.1., letter b and points are disregarded. However, the DVFA or the regional foodstuff authority may, if required or for use in spot checks, require the preparation of a balance, cf to Bulk storage of organic foodstuffs etc. packaged for transportation in connection with transportation/distribution where no changes are made to batches transportation packaging, marking or accompanying documents For the above activities, the requirements of points are disregarded. The following information on each handled batch shall be given in the accounts: 1. Identification information for batch. 2. Name and address of supplier and recipient. Enterprise owners carrying out the above activity shall not be regarded as suppliers in this instance Bulk marketing (without storage or other handling) of organic foodstuffs etc. For the above activities, the requirements of points are disregarded Documentation for purchasing and sales The enterprise owner shall be able to document purchasing and sales of organic foodstuffs etc. Documentation shall include the following information: - type, including any quality and size categories, - date (of delivery or receipt), - quantity, - recipient (name and address) and purchaser (name and address), if the latter differs from the recipient, - supplier (name and address) and vendor (name and address), if the latter differs from the supplier and - organic status Cases where the enterprise owner has paid carried out If the enterprise owner has preparation or storage carried out as paid work, the enterprise owner shall secure: - documentation showing that the paid activity is covered by organic monitoring, cf. point 3.2. documentation for the quantity of organic foodstuffs etc. produced or stored as a paid activity, showing the information listed - under Documentation requirement for received organic foodstuffs etc Documentation regarding the batch The enterprise owner shall ensure that an original document issued by the supplier accompanies every received batch of organic foodstuffs etc. If this document is not the invoice, reference shall be made to the document in the invoice. The document shall include the following information: 1. Name and address of supplier (and vendor, if the latter differs from the supplier). 2. Authorisation number (for operations authorised under rules on the organic production method set in light of the Organic Act (økologiloven) 3. Information enabling identification of the batch. 4. Information on the batch minimum quantity and type, including any quality and size categories. 5. Indication of organic status. 6. Delivery date. The enterprise owner shall ensure that the batch is in accordance with the information in the document.

8 Purchases from retail shops or wholesale enterprises where sales take place by self-service In exception to the requirement in point 3.1, documentation concerning the batch may, in case of purchase of organic foodstuffs etc. from retail shops or from wholesale enterprises where sales take place by self-service, be secured by till slip or receipt, provided that the following (minimum) information is provided: a) Name and address (minimum: town) of shop. b) Description of goods. c) Reference to organic status. d) Quantity or number. e) Purchase date Deliveries from primary enterprises where the recipient stipulates the quantity delivered In cases of deliveries from primary enterprises where the recipient stipulates the quantity delivered, the requirement for an original document issued by the supplier to be included with every batch may be replaced by a supplier contract containing procedures that ensure that the supplier makes an estimated statement of the quantity before the batch leaves the primary enterprise and that this quantity is registered. These procedures shall further ensure that the information described under point 3.1, no.s 1-6, is given on the settlement documents held by the supplier and recipient. 3.2 Documentation for import from third country In case of import from third countries, the inspection certificate is regarded as sufficient documentation regarding the batch, cf. point 3.1. Annex 3 Code numbers for monitoring authorities Code number DK-Ø-1 DK-Ø-2 DK-Ø-3 DK-Ø-4 DK-Ø-5 DK-Ø-6 DK-Ø-7 DK-Ø-8 DK-Ø-9 DK-Ø-10 The Ø mark must be: Monitoring authority Aalborg monitoring department Viborg monitoring department Herning monitoring department Århus monitoring department Vejle monitoring department Esbjerg monitoring department Haderslev monitoring department Odense monitoring department Ringsted monitoring department Rødovre monitoring department and Bornholm local office Organic certification mark ( Ø mark) Annex 4 1. Red in tones corresponding to pantone 032 C or equivalent to overprint of 100 % yellow and 100 % magenta in fourcolour printing, or 2. black. The mark shall be reproduced on a white or light background, with relative distances, placements and proportions as shown here:

9 On coloured surfaces or photos, the Ø mark shall be reproduced in a white rectangle with rounded corners, as shown below: However, the Ø with the crown may be used without text on egg shells or cheese wax or as a special meat stamp. The meat stamp may be placed immediately adjacent to the mandatory health markings on slaughtered carcasses and organs of organically farmed animals. When the stamp is used, the general rules on colourings for stamping meat shall be observed. Official notes 1) This Executive Order contains provisions necessary for the application of the following regulations: Council Regulation no. 834/2007 dated 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) no. 2092/91 (OJ L , p. 1-23) (in this Executive Order called the Council Regulation ) and Commission Regulation no. 889/2008 dated 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 (OJ L 250, 18 September 2008) (in this Executive Order called the Commission Regulation ) and Commission Regulation (EC) no. 1235/2008 dated 8 December 2008 laying down detailed rules for the implementation of Council Regulation (EC) no. 834/2007 as regards the arrangements for imports of organic products from third countries (OJ L 334, 12 December 2008, p ) (in this Executive Order called the Import Regulation ). Parts of the above regulations are incorporated into this Executive Order. Under article 249 of the EU Treaty, a regulation comes into force immediately in all member states. The reproduction of these provisions in the Executive Order is thus solely founded on practical considerations and does not affect the direct validity of the abovementioned regulations in Denmark.

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