Organic Production Regulation

texts differ too much for an inline diff; shown separately

before (02018R0848-20201114)

Article 36
Group of operators
1. Each group of operators shall:
(a) only be composed of members who are farmers or operators that produce algae or aquaculture animals and who in addition may be engaged in processing, preparation or placing on the market of food or feed;
(b) only be composed of members:
(i) of which the individual certification cost represents more than 2 % of each member’s turnover or standard output of organic production and whose annual turnover of organic production is not more than EUR 25000 or whose standard output of organic production is not more than EUR 15000 per year; or
(ii) who have each holdings of maximum:
five hectares,
0,5 hectares, in the case of greenhouses, or
15 hectares, exclusively in the case of permanent grassland;
(c) be established in a Member State or a third country;
(d) have legal personality;
(e) only be composed of members whose production activities take place in geographical proximity to each other;
(f) set up a joint marketing system for the products produced by the group; and
(g) establish a system for internal controls comprising a documented set of control activities and procedures in accordance with which an identified person or body is responsible for verifying compliance with this Regulation of each member of the group.
2. Competent authorities, or, where appropriate, control authorities or control bodies, shall withdraw the certificate referred to in Article 35 for the whole group where deficiencies in the set-up or functioning of the system for internal controls referred to in paragraph 1, in particular as regards failures to detect or address non-compliance by individual members of the group of operators, affect the integrity of organic and in-conversion products.
3. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraphs 1 and 2 of this Article by adding provisions, or by amending those added provisions, in particular as regards:
(a) the responsibilities of the individual members of a group of operators;
(b) the criteria to determine the geographical proximity of the members of the group, such as the sharing of facilities or sites;
(c) the set-up and functioning of the system for internal controls, including the scope, content and frequency of the controls to be carried out and the criteria to identify deficiencies in the set-up or functioning of the system for internal controls.
4. The Commission may adopt implementing acts laying down specific rules concerning:
(a) the composition and dimension of a group of operators;
(b) the documents and record-keeping systems, the system for internal traceability and the list of operators;
(c) the exchange of information between a group of operators and the competent authority or authorities, control authorities or control bodies, and between the Member States and the Commission.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

after (02018R0848-20220101)

Article 36
Group of operators
1. Each group of operators shall:
(a) only be composed of members who are farmers or operators that produce algae or aquaculture animals and who in addition may be engaged in processing, preparation or placing on the market of food or feed;
(b) only be composed of members:
(i) of which the individual certification cost represents more than 2 % of each member’s turnover or standard output of organic production and whose annual turnover of organic production is not more than EUR 25000 or whose standard output of organic production is not more than EUR 15000 per year; or
(ii) who have each holdings of maximum:
five hectares,
0,5 hectares, in the case of greenhouses, or
15 hectares, exclusively in the case of permanent grassland;
(c) be established in a Member State or a third country;
(d) have legal personality;
(e) only be composed of members whose production activities or possible additional activities referred to in point (a) take place in geographical proximity to each other in the same Member State or in the same third country;
(f) set up a joint marketing system for the products produced by the group; and
(g) establish a system for internal controls comprising a documented set of control activities and procedures in accordance with which an identified person or body is responsible for verifying compliance with this Regulation of each member of the group.
The system for internal controls (ICS) shall comprise documented procedures on:
(i) the registration of the members of the group;
(ii) the internal inspections, which include the annual internal physical on-the-spot inspections of each member of the group, and any additional risk-based inspections, in any case scheduled by the ICS manager and conducted by ICS inspectors, whose roles are defined in point (h);
(iii) the approval of new members in an existing group or, where appropriate, the approval of new production units or new activities of existing members upon the approval by the ICS manager on the basis of the internal inspection report;
(iv) the training of the ICS inspectors, which is to take place at least annually and to be accompanied by an assessment of the knowledge acquired by the participants;
(v) the training of members of the group on the ICS procedures and the requirements of this Regulation;
(vi) the control of documents and records;
(vii) the measures in cases of non-compliance detected during the internal inspections, including their follow-up;
(viii) the internal traceability, which shows the origin of the products delivered in the joint marketing system of the group and allows the tracing of all products of all members throughout all stages, such as production, processing, preparation or placing on the market, including estimating and cross-checking the yields of each member of the group;
(h) appoint an ICS manager and one or more ICS inspectors who may be a member of the group. Their positions shall not be combined. The number of ICS inspectors shall be adequate and proportional in particular to the type, structure, size, products, activities and output of organic production of the group. The ICS inspectors shall be competent with regard to the products and activities of the group.
The ICS manager shall:
(i) verify the eligibility of each member of the group regarding the criteria set out in points (a), (b) and (e);
(ii) ensure that there is a written and signed membership agreement between each member and the group, by which the members commit themselves to:
comply with this Regulation,
participate in the ICS and comply with the ICS procedures, including the tasks and responsibilities assigned to them by the ICS manager and the obligation for records keeping,
permit access to production units and premises and be present during the internal inspections carried out by the ICS inspectors and official controls carried out by the competent authority or, where appropriate, the control authority or control body, make available to them all documents and records and countersign the inspection reports,
accept and implement the measures in cases of non-compliances in accordance with the decision of the ICS manager or the competent authority or, where appropriate, the control authority or control body, within the given time-frame,
immediately inform the ICS manager on suspected non-compliance;
(iii) develop the ICS procedures and the relevant documents and records, keep them up to date and make them readily available to the ICS inspectors, and where relevant, to the members of the group;
(iv) draw up the list of the members of the group and keep it up to date;
(v) assign tasks and responsibilities to the ICS inspectors;
(vi) be the liaison between the members of the group and the competent authority or, where appropriate, the control authority or control body, including requests for derogations;
(vii) verify annually the conflict of interest statements of the ICS inspectors;
(viii) schedule internal inspections and ensure their adequate implementation in accordance with the ICS manager’s schedule referred to in point (ii) of the second paragraph of point (g);
(ix) ensure adequate trainings for the ICS inspectors and carry out an annual assessment of ICS inspectors’ competences and qualifications;
(x) approve new members or new production units or new activities of existing members;
(xi) decide on measures in case of non-compliance in line with the ICS measures established by documented procedures in accordance with point g and ensure the follow-up of those measures;
(xii) decide to subcontract activities, including the subcontracting of the tasks of ICS inspectors, and sign relevant agreements or contracts.
The ICS inspector shall:
(i) carry out internal inspections of the members of the group according to the schedule and the procedures provided by the ICS manager;
(ii) draft internal inspection reports on the basis of a template and submit it within a reasonable time to the ICS manager;
(iii) submit at appointment a written and signed statement on conflict of interest and update it annually;
(iv) participate in trainings.
2. Competent authorities, or, where appropriate, control authorities or control bodies, shall withdraw the certificate referred to in Article 35 for the whole group where deficiencies in the set-up or functioning of the system for internal controls referred to in paragraph 1, in particular as regards failures to detect or address non-compliance by individual members of the group of operators, affect the integrity of organic and in-conversion products.
At least the following situations shall be considered as deficiencies in the ICS:
(a) producing, processing, preparing or placing on the market of products from suspended/withdrawn members or production units;
(b) placing on the market of products for which the ICS manager has prohibited the use of reference to organic production in their labelling or advertising;
(c) adding new members to the list of members or changing the activities of existing members without following the internal approval procedure;
(d) not carrying out the annual physical on-the-spot inspection of a member of the group in a given year;
(e) failing to indicate the members which have been suspended or withdrawn in the list of members;
(f) serious deviations in findings between internal inspections carried out by the ICS inspectors and official controls carried out by the competent authority or, where appropriate, the control authority or control body;
(g) serious deficiencies in imposing appropriate measures or carrying out the necessary follow-up in response to non-compliance identified by the ICS inspectors or by the competent authority or, where appropriate, the control authority of control body;
(h) inadequate number of ICS inspectors or inadequate competences of ICS inspectors for the type, structure, size, products, activities and output of organic production of the group.
3. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraphs 1 and 2 of this Article by adding provisions, or by amending those added provisions, in particular as regards:
(a) the responsibilities of the individual members of a group of operators;
(b) the criteria to determine the geographical proximity of the members of the group, such as the sharing of facilities or sites;
(c) the set-up and functioning of the system for internal controls, including the scope, content and frequency of the controls to be carried out and the criteria to identify deficiencies in the set-up or functioning of the system for internal controls.
4. The Commission may adopt implementing acts laying down specific rules concerning:
(a) the composition and dimension of a group of operators;
(b) the documents and record-keeping systems, the system for internal traceability and the list of operators;
(c) the exchange of information between a group of operators and the competent authority or authorities, control authorities or control bodies, and between the Member States and the Commission.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

02018R0848-20201114 → 02018R0848-20220101

Article 46 Recognition of control authorities and control bodies 1. The Commission may adopt implementing acts to recognise control authorities and control bodies that are competent to carry out controls and to issue organic certificates in third countries, to withdraw the recognition of such control authorities and control bodies, and to establish a list of recognised control authorities and control bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 2. Control authorities or and control bodies shall be recognised in accordance with paragraph 1 of this Article for the control of the import of the categories of products listed in Article 35(7) if they fulfil the following criteria: (a) they are legally established in one Member State or third country; (b) they have the capacity to carry out controls to ensure that the conditions set out in points (a), (b)(i) and (c) of Article 45(1) and in this Article are met in relation to organic products and in-conversion products intended for import into the Union; Union, without delegating control tasks; for the purposes of this point, control tasks carried out by persons working under an individual contract or a formal agreement that place them under the management control and the procedures of the contracting control authorities or control bodies shall not be considered as delegation, and the prohibition to delegate control tasks shall not apply to sampling; (c) they offer adequate guarantees of objectivity and impartiality and are free from any conflict of interest as regards the exercise of their control tasks; in particular, they have procedures in place ensuring that the staff performing controls and other actions is free from any conflict of interest, and that the operators are not inspected by the same inspectors for more than 3 years consecutively; (d) in the case of control bodies, they are accredited for the purpose of their recognition in accordance with this Regulation by only one accreditation body under the relevant harmonised standard for Conformity assessment – Requirements for bodies certifying products, processes and services, the reference of which has been published in the Official Journal of the European Union; (e) they have the expertise, equipment and infrastructure required to carry out control tasks, and have a sufficient number of suitable qualified and experienced staff; (f) they have the capacity and (f) the competency to carry out their certification and control activities in accordance with the requirements of this Regulation and in particular Commission Delegated Regulation (EU) 2021/1698 Delegated Regulation (EU) 2021/1698 of 13 July 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council with procedural requirements for the recognition of control authorities and control bodies that are competent to carry out controls on operators and groups of operators certified organic and on organic products in third countries and with rules on their supervision and the controls and other actions to be performed by those control authorities and control bodies (OJ L 336, 23.9.2021, p. 7). for each type of operator (single operator or group of operators) in each third country and for each category of products they want to be recognised for; (g) they have procedures and arrangements in place to ensure the impartiality, the quality, the consistency, the effectiveness and the appropriateness of controls and other actions performed by them; (h) they have sufficient qualified and experienced staff so that controls and other actions can be performed effectively and in due time; (i) they have appropriate and properly maintained facilities and equipment to ensure that staff can perform controls and other actions effectively and in due time; (j) they have procedures in place in order to ensure that their staff have access to the premises of, and documents kept by operators so as to be able to accomplish their tasks; (k) they have internal skills, training and procedures suitable to perform effective controls, including inspections, on operators as well as on the internal control system of a group of operators, if any; (l) their previous recognition for a specific third country and/or for a category of products has not been withdrawn in accordance with paragraph 2a or their accreditation has not been withdrawn or suspended by any accreditation body in accordance with its procedures for the suspension or withdrawal established in accordance with the relevant international standard, in particular the International Organisation for Standardisation (ISO) standard 17011 – Conformity assessment – general requirements for accreditation bodies accrediting conformity assessment bodies, during the 24 months preceding: (i) their request for recognition for the same third country and/or for the same category of products, except where the previous recognition was withdrawn in accordance with point (k) of paragraph 2a; (ii) their request for an extension of the scope of recognition to an additional third country in accordance with Article 2 of Delegated Regulation (EU) 2021/1698, except where the previous recognition was withdrawn in accordance with point (k) of paragraph 2a of this Article; (iii) their request for an extension of the scope of recognition to an additional category of products in accordance with Article 2 of Delegated Regulation (EU) 2021/1698; (m) in the case of control authorities, they are public administrative organisations in the third country for which they request recognition; (n) they meet the procedural requirements laid down in Chapter I of Delegated Regulation (EU) 2021/1698; and (o) they meet any additional criteria that may be laid down in a delegated act adopted pursuant to paragraph 7. 2a. The Commission may withdraw the recognition of a control authority or control body for a specific third country and/or a category of products if: (a) one of the recognition criteria set out in paragraph 2 is no longer met; (b) the Commission has not received the annual report referred to in Article 4 of Delegated Regulation (EU) 2021/1698 by the deadline specified in that Article or the information included in the annual report is incomplete, inaccurate or does not comply with the requirements set out in that Regulation; (c) the control authority or control body does not make available or does not communicate all the information related to the technical dossier referred to in paragraph 4, to the control system applied by it, or to the up-to-date list of operators or groups of operators or to the organic products covered by the scope of its recognition; (d) the control authority or control body does not notify the Commission within 30 calendar days of changes to its technical dossier referred to in paragraph 4; (e) the control authority or control body does not provide information requested by the Commission or by a Member State within the deadlines set, or the information is incomplete, inaccurate or does not comply with the requirements set out in this Regulation, in Delegated Regulation (EU) 2021/1698 and in an implementing act to be adopted pursuant to paragraph 8, or does not cooperate with the Commission, in particular during the investigations of a non-compliance; (f) the control authority or control body does not agree to an on-the-spot examination or audit initiated by the Commission; (g) the result of the on-the-spot examination or audit indicates a systematic malfunctioning of control measures or the control authority or control body is unable to implement all the recommendations made by the Commission after the on-the-spot examination or audit, in their proposed action plan submitted to the Commission; (h) the control authority or control body fails to take adequate corrective measures in response to the non-compliances and infringements observed within a deadline set by the Commission according to the severity of the situation, which shall not be shorter than 30 calendar days; (i) in case an operator changes its control authority or control body, the control authority or control body does not communicate to the new control authority or control body the relevant elements of the control file, including written records, of the operator within a maximum of 30 calendar days after having received the request for transfer from the operator or the new control authority or control body; (j) there is a risk for the consumer to be misled about the true nature of the products covered by the scope of the recognition; or (k) the control authority or control body has not certified any operator for 48 consecutive months in the third country for which it is recognised. 3. The accreditation referred to in point (d) of paragraph 2 may only be granted by: (a) a national accreditation body in the Union in accordance with Regulation (EC) No 765/2008; or (b) an accreditation body outside the Union that is a … 608 unchanged words … to in Article 55(3) to take the measures referred to in paragraph 8 of this Article or to decide on the withdrawal of the recognition of the control authorities and control bodies referred to in paragraph 1 of this Article.

02018R0848-20201114 → 02018R0848-20220101

ANNEX II DETAILED PRODUCTION RULES REFERRED TO IN CHAPTER III Part I: Plant production rules In addition to the production rules laid down in Articles 9 to 12, the rules set out in this Part shall apply to organic plant production. 1. General requirements 1.1. Organic crops, except those which are naturally grown in water, shall be produced in living soil, or in living soil mixed or fertilised with materials and products allowed in organic production, in connection with the subsoil and bedrock. 1.2. Hydroponic production, which is a method of growing plants which do not naturally grow in water with their roots in a nutrient solution only or in an inert medium to which a nutrient solution is added, is prohibited. 1.3. By way of derogation from point 1.1, the following shall be allowed: (a) the production of sprouts sprouted seeds, which include sprouts, shoots and cress, solely living on the nutritional reserves available in the seeds, by moistening them in clear water, provided that the seeds are organic. The use of growing medium shall be prohibited, except the use of an inert medium intended solely to keep the seeds and moist when the components of that inert medium are authorised in compliance with Article 24; (b) the obtaining of chicory heads heads, including by dipping them in clear water water, provided that the plant reproductive material is organic. The use of a growing medium shall be allowed. allowed only when its components are authorised in compliance with Article 24. 1.4. By way of derogation from point 1.1, the following practices shall be allowed: (a) growing plants for the production of ornamentals and herbs in pots to be sold together with the pot to the final consumer; (b) growing seedlings or transplants … 698 unchanged words … on natural reproductive ability, as well as agronomic performance, disease resistance and adaptation to diverse local soil and climate conditions. All multiplication practices except meristem culture shall be carried out under certified organic management. 1.8.5. Use of in-conversion and non-organic plant reproductive material material. 1.8.5.1. By way of derogation from point 1.8.1, where the data collected in the database referred to in Article 26(1) or the system systems referred to in point (a) of Article 26(2) shows show that the qualitative or quantitative needs of the operator regarding relevant organic plant reproductive material, excluding seedlings, material are not met, the operator may use in-conversion plant reproductive material in accordance with Article 10(4), second subparagraph, point (a), or plant reproductive material authorised in accordance with point 1.8.6. In addition, in case of a lack of availability of organic seedlings, in-conversion seedlings, marketed in compliance with Article 10(4), second subparagraph, point (a), may be used when grown as follows: (a) through a cultivation cycle from seeds to final seedling lasting at least 12 months on a land parcel that, during that same period, has completed a conversion period of at least 12 months; or (b) on an organic or in-conversion land parcel or in containers if covered by the derogation referred to in point 1.4, provided that the seedlings have originated from in-conversion seeds, harvested from a plant grown on a land parcel that has completed a conversion period of at least 12 months. Where organic or in-conversion plant reproductive material or plant reproductive material authorised in accordance with point 1.8.6 is not available in sufficient quality or quantity to fulfil the operator’s needs, competent authorities may authorise the use of in-conversion or non-organic plant reproductive material under subject to points 1.8.5.3 to 1.8.5.8. Such individual authorisation shall be issued only in one of the following situations: (a) where no variety of the species that the operator wants to obtain is registered in the database referred to in Article 26(1) or the systems referred to in Article 26(2); (b) where no operator who markets plant reproductive material, is able to deliver the relevant organic or in-conversion plant reproductive material or plant reproductive material authorised in accordance with point 1.8.6 in time for sowing or planting in situations where the user has ordered the plant reproductive material in reasonable time to allow the preparation and supply of organic or in-conversion plant reproductive material or of plant reproductive material authorised in accordance with point 1.8.6; (c) where the variety that the operator wants to obtain is not registered as organic or in-conversion plant reproductive material or as plant reproductive material authorised in accordance with point 1.8.6 in the database referred to in Article 26(1) or the systems referred to Article 26(2) and the operator is able to demonstrate that none of the registered alternatives of the same species are appropriate in particular to the agronomic and pedo-climatic conditions laid down and necessary technological properties for the production to be obtained; (d) where it is justified for use in points 1.8.5.3, 1.8.5.4 research, test in small-scale field trials, for variety conservation purposes of for product innovation and 1.8.5.5. agreed by the competent authorities of the Member State concerned. Prior to requesting any such derogation, the operator authorisation, operators shall consult the database referred to in Article 26(1) or the systems referred to in Article 26(2) in order to verify whether relevant organic or in-conversion plant reproductive material or plant reproductive material authorised in accordance with point 1.8.6 is available and thus whether their request is justified. When in compliance with Article 6 (i) operators may use both organic and in-conversion plant reproductive material obtained from their own holding, irrespective of the qualitative and quantitative availability according to the database referred to in Article 26(1) or the system referred to in point (a) of Article 26(2) 26(2). 1.8.5.2. By way of derogation from point 1.8.1, operators in order third countries may use in-conversion plant reproductive material in accordance with Article 10(4), second subparagraph, point (a), or plant reproductive material authorised in accordance with point 1.8.6 when organic plant reproductive material is justified to verify whether his be not available in sufficient quality or her request quantity in the territory of the third country in which the operator is justified. 1.8.5.2. located. Without prejudice to relevant national rules, operators in third countries may use both organic and in-conversion plant reproductive material obtained from their own holding. Control authorities or control bodies recognised in accordance with Article 46(1) may authorise operators in third countries to use in-conversion or non-organic plant reproductive material in an organic production unit unit, when organic or in-conversion plant reproductive material or plant reproductive material authorised in accordance with point 1.8.6 is not available in sufficient quality or quantity in the territory of the third country in which the operator is located, under the conditions laid down under in points 1.8.5.3, 1.8.5.4 1.8.5.4, 1.8.5.5 and 1.8.5.5. 1.8.5.8. 1.8.5.3. Non-organic plant reproductive material shall not be treated after harvest with plant protection products other than those authorised for the treatment of seed plant reproductive material in accordance with Article 24(1) of this Regulation, unless chemical treatment has been prescribed in accordance with Regulation (EU) 2016/2031 for phytosanitary purposes by the competent authority authorities of the Member State concerned for all varieties and heterogeneous material of a given species in the area in which the plant reproductive material is to be used. Where the non-organic plant reproductive material treated with the prescribed chemical treatment referred to in the first paragraph is used, the parcel on which the treated plant reproductive material is growing shall be subject, where appropriate, to a conversion period as provided in points 1.7.3 and 1.7.4. 1.8.5.4. The authorisation to use in-conversion or non-organic plant reproductive material shall be obtained before the sowing or planting of the crop. 1.8.5.5. The authorisation to use in-conversion or non-organic plant reproductive material shall be granted only to individual users for one season at a time, and the competent authorities, control authority or body responsible for authorisations shall list the quantities of the authorised plant reproductive material. 1.8.5.6. The competent authorities of the Member States shall create an official list of species, subspecies or varieties (grouped if applicable) for which it is established that organic or in-conversion plant reproductive material is available in sufficient quantities and for the appropriate varieties in their territory. No authorisations shall be issued for the species, subspecies or varieties included in that list in the territory of the Member State concerned pursuant to point 1.8.5.1 unless these are justified by one of the purposes referred to in point 1.8.5.1(d). If the quantity or quality of organic or in-conversion plant reproductive material available for a species, subspecies or variety on the list turns out to be insufficient or inappropriate, due to exceptional circumstances, the competent authorities of the Member States may remove a species, subspecies or variety from the list. The competent authorities of the Member States shall keep their list updated on an annual basis and shall make that list publicly available. By 30 June each year and for the first time by 30 June 2022, the competent authorities of the Member States shall transmit to the Commission and to the other Member States the link to the internet website where the updated list is made publicly available. The Commission shall publish the links to the national updated lists on a dedicated website. 1.8.5.7. By way of derogation from point 1.8.5.5, the competent authorities of the Member States may annually grant a general authorisation to all operators concerned for the use of: (a) a given species or subspecies when and in so far as no variety is registered in the database referred to in Article 26(1) or the system referred to in point (a) of Article 26(2); (b) for a given variety when and in so far as the conditions laid down in point 1.8.5.1(c) are fulfilled. When using a general authorisation, operators shall keep records of the quantity used and competent authority responsible for authorisations shall list the quantities of authorised non-organic plant reproductive material. The competent authorities of the Member States shall keep the list of species, subspecies or varieties for which a general authorisation is issued updated on an annual basis and shall make that list publicly available. By 30 June each year and for the first time by 30 June 2022, the competent authorities of the Member States shall transmit to the Commission and to the other Member States the link to the internet website where the updated list is made publicly available. The Commission shall publish the links to the national updated lists on a dedicated website. 1.8.5.8. Competent authorities shall not authorise the use of non-organic seedlings in the case of seedlings of species that have a cultivation cycle completed in one growing season, from the transplantation of the seedling to the first harvest of product. 1.8.6. Competent authorities or, where appropriate, control authorities or control bodies recognised in accordance with Article 46(1) may authorise operators producing plant reproductive material for use in organic production to use non-organic plant reproductive material, when mother plants or, where relevant, other plants intended for the production of plant reproductive material and produced in compliance with point 1.8.2 are not available in sufficient quantity or quality, and to place such material on the market for use in organic production provided that the following conditions are met: (a) the non-organic plant reproductive material used has not been treated after harvest with plant protection products other than those authorised in accordance with Article 24(1) of this Regulation, unless chemical treatment has been prescribed in accordance with Regulation (EU) 2016/2031 for phytosanitary purposes by the competent authorities of the Member State concerned for all varieties and heterogeneous material of a given species in the area in which the plant reproductive material is to be used. Where non-organic plant reproductive material treated with such prescribed chemical treatment is used, the land parcel on which the treated plant reproductive material is growing shall be subject, where appropriate, to a conversion period as provided in points 1.7.3 and 1.7.4; (b) the non-organic plant reproductive material used is not a seedling of species that have a cultivation cycle completed in one growing season, from the transplantation of the seedling to the first harvest of product; (c) the plant reproductive material is grown in compliance with all other relevant organic plant production requirements; (d) the authorisation to use non-organic plant reproductive material shall be obtained before that material is sown or planted; (e) the competent authority, control authority or control body responsible for the authorisation shall grant the authorisation only to individual users and for one season at a time, and shall list the quantities of the authorised plant reproductive material; (f) by way of derogation from point (e), the competent authorities of the Member States may annually grant a general authorisation for the use of a given species or subspecies or variety of non-organic plant reproductive material and make the list of species, subspecies or varieties publicly available and keep it updated on an annual basis. In that case, those competent authorities shall list the quantities of authorised non-organic plant reproductive material; (g) the authorisations granted in accordance with this paragraph shall expire on 31 December 2036. By 30 June of each year, and for the first time by 30 June 2023, the competent authorities of the Member States shall notify the Commission and the other Member States of the information on the authorisations granted in accordance with the first paragraph. Operators who produce and market the plant reproductive material produced in accordance with the first paragraph shall be allowed to make public, on a voluntary basis, the relevant specific information on the availability of such plant reproductive material in the national systems established in accordance with Article 26(2). Operators that opt to include such information shall ensure that the information is updated regularly, and is withdrawn from the national systems once the plant reproductive material is no longer available. When relying on the general authorisation referred to in point (f), operators shall keep records of the quantity used. 1.9. Soil management and fertilisation 1.9.1. In organic plant production, tillage and cultivation practices shall be used that maintain or increase soil organic matter, enhance soil stability and soil biodiversity, and prevent soil compaction and soil erosion. 1.9.2. The fertility and biological activity of the soil shall be maintained and increased: (a) except in the case of grassland or perennial forage, by the use of multiannual crop rotation including mandatory leguminous crops as the main or cover crop for rotating crops and other green manure crops; (b) in the case of greenhouses or perennial crops other than forage, by the use of short-term green manure crops and legumes as well as the use of plant diversity; and (c) in all cases, by the application of livestock manure or organic matter, both preferably composted, from organic production. 1.9.3. Where the nutritional needs of plants cannot be met by the measures provided for in points 1.9.1 and 1.9.2, only fertilisers and soil conditioners that have been authorised pursuant to Article 24 for use in organic production shall be used, and only to the extent necessary. Operators shall keep records of the use of those products. products, including the date or dates on which each product was used, the name of the product, the amount applied and the crop and parcels concerned. 1.9.4. The total amount of livestock manure, as defined in Directive 91/676/EEC, used in the in-conversion and organic production units shall not exceed 170 kg of nitrogen per year/hectare of agricultural area used. That limit shall only apply to the use of farmyard manure, dried farmyard manure and dehydrated poultry manure, composted animal excrement, including poultry manure, composted farmyard manure and liquid animal excrement. 1.9.5. Operators of agricultural holdings may establish written cooperation agreements exclusively with operators of other agricultural holdings and undertakings which comply with the organic production rules, for the purpose of spreading surplus manure from organic production units. The maximum limit referred to in point 1.9.4 shall be calculated on the basis of all of the organic production units involved in such cooperation. 1.9.6. Preparations of micro-organisms may be used to improve the overall condition of the soil or to improve the availability of nutrients in the soil or in the crops. 1.9.7. For compost activation, appropriate plant-based preparations and preparations of micro-organisms may be used. 1.9.8. Mineral nitrogen fertilisers shall not be used. 1.9.9. Biodynamic preparations may be used. 1.10. Pest and weed management 1.10.1. The prevention of damage caused by pests and weeds shall rely primarily on the protection by: natural enemies, the choice of species, varieties and heterogeneous material, crop rotation, cultivation techniques such as biofumigation, mechanical and physical methods, and thermal processes such as solarisation and, in the case of protected crops, shallow steam treatment of the soil (to a maximum depth of 10 cm). 1.10.2. Where plants cannot adequately be protected from pests by measures provided for in point 1.10.1 or in the case of an established threat to a crop, only products and substances authorised pursuant to Articles 9 and 24 for use in organic production shall be used, and only to the extent necessary. Operators shall keep records proving the need for the use of such products. products, including the date or dates on which each product was used, the name of the product, its active substances, the amount applied, the crop and parcels concerned, and the pest or disease to be controlled. 1.10.3. In relation to products and substances used in traps or in dispensers of products and substances other than pheromones, the traps or dispensers shall prevent the products and substances from being released into the environment and shall prevent contact between the products and substances and the crops being cultivated. All traps, including pheromone traps, shall be collected after use and shall be safely disposed of. 1.11. Products used for cleaning and disinfection Only those products for cleaning and disinfection in plant production authorised pursuant to Article 24 for use in organic production shall be used for that purpose. Operators shall keep records of the use of those products including the date or dates on which each product was used, the name of the product, its active substances, and the location of such use. 1.12. Record-keeping obligation Operators shall keep records regarding the parcels concerned and the amount of the harvest. In particular, operators shall keep records of any other external input used on each parcel and, where applicable, keep available documentary evidence on any derogation from production rules obtained in accordance with point 1.8.5. 1.13. Preparation of unprocessed products If preparation operations other than processing are carried out on plants, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations. 2. Detailed rules for specific plants and plant products 2.1. Rules on mushroom production For the production of mushrooms, substrates may be used if they are composed only of the following components: (a) farmyard manure and animal excrement: (i) either from organic production units or from in-conversion units in their second year of conversion; or (ii) referred to in point 1.9.3, only when the product referred to in point (i) is not available, provided that that farmyard manure and animal excrement do not exceed 25 % of the weight of total components of the substrate, excluding the covering material and any added water, before composting; (b) products of agricultural origin, other than those referred to in point (a), from organic production units; (c) peat, not treated with chemical products; (d) wood, not treated with chemical products after felling; (e) mineral products referred to in point 1.9.3, water and soil. 2.2. Rules concerning the collection of wild plants The collection of wild plants and parts thereof growing naturally in natural areas, forests and agricultural areas is considered as organic production, provided that: (a) for a period of at least three years before the collection, those areas were not treated with products or substances other than those authorised pursuant to Articles 9 and 24 for use in organic production; (b) the collection does not affect the stability of the natural habitat or the maintenance of the species in the collection area. Operators shall keep records of the period and location of the collection, the species concerned and the quantity of wild plants collected. Part II: Livestock production rules In addition to the production rules laid down in Articles 9, 10, 11 and 14, the rules laid down in this Part shall apply to organic livestock production. 1. General requirements 1.1. Except in the case of beekeeping, landless livestock production, where the farmer intending to produce organic livestock does not manage agricultural land and has not established a written cooperation agreement with a farmer as regards the use of organic production units or in-conversion production units for that livestock, shall be prohibited. Operators shall keep available documentary evidence on any derogation from livestock production rules obtained in accordance with points 1.3.4.3, 1.3.4.4, 1.7.5, 1.7.8, 1.9.3.1(c) and 1.9.4.2(c). 1.2. Conversion 1.2.1. In the case of simultaneous start of conversion of the production unit, including pasturage or any land used for animal feed, and of the animals existing on this production unit at the beginning of the conversion period of … 1,294 unchanged words … in-conversion production unit. 1.3.4.4.5. In the cases referred to in points 1.3.4.4.1 to 1.3.4.4.4, non-organic animals shall either be kept separate from other livestock or shall be kept identifiable until the end of the conversion period referred to in point 1.3.4.4.4. 1.3.4.5. Operators shall keep records or documentary evidence of the origin of animals, identifying the animals in accordance with appropriate systems (per animal or by batch/flock/hive), of the veterinary records of the animals introduced in the holding, the date of arrival, and the conversion period. 1.4. Nutrition 1.4.1. General nutrition requirements With regard to nutrition, the following rules shall apply: (a) feed for livestock shall be obtained primarily from the agricultural holding where the animals are kept or shall be obtained from organic or in-conversion production units belonging … 612 unchanged words … used for feeding, the total combined percentage of such feed shall not exceed the percentage fixed in point (a). 1.4.3.2. The figures in point 1.4.3.1 shall be calculated annually as a percentage of the dry matter of feed of plant origin. 1.4.4. Record-keeping of the feeding regime Operators shall keep records of the feeding regime and, where relevant, the grazing period. In particular, they shall keep records of the name of the feed, including any form of feed used e.g. compound feed, proportions of various feed materials of rations and proportion of feed from their own holding or the same region and, where relevant, periods of access to grazing areas, periods of transhumance where restrictions apply and documentary evidence of the application of points 1.4.2 and 1.4.3. 1.5. Health care 1.5.1. Disease prevention 1.5.1.1. Disease prevention shall be based on breed and strain selection, husbandry management practices, high-quality feed, exercise, appropriate stocking density and adequate and appropriate housing maintained in hygienic conditions. 1.5.1.2. Immunological veterinary medicinal products may be used. 1.5.1.3. Chemically synthesised allopathic veterinary medicinal products, including antibiotics and boluses of synthesised allopathic chemical molecules, shall not be used for preventive treatment. 1.5.1.4. Substances to promote growth or production (including antibiotics, coccidiostatics and other artificial aids for growth promotion purposes) and hormones and similar substances for the purpose of controlling reproduction or for other purposes (e.g. induction or synchronisation of oestrus) shall not be used. 1.5.1.5. Where livestock is obtained from non-organic production units, special measures such as screening tests or quarantine periods shall apply, depending on local circumstances. 1.5.1.6. Only the products for cleaning and disinfection in livestock buildings and installations authorised pursuant to Article 24 for use in organic production shall be used for that purpose. Operators shall keep records of the use of those products including the date or dates on which the product was used, the name of the product, its active substances, and the location of such use. 1.5.1.7. Housing, pens, equipment and utensils shall be properly cleaned and disinfected to prevent cross-infection and the build-up of disease carrying organisms. Faeces, urine and uneaten or spilt feed shall be removed as often as necessary to minimise smell and … 323 unchanged words … be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC, and shall be at least 48 hours. 1.5.2.6. Treatments related to the protection of human and animal health imposed on the basis of Union legislation shall be allowed. 1.5.2.7. Operators shall keep records or documentary evidence of any treatment applied and, in particular, the identification of the animals treated, the date of treatment, diagnosis, the posology, the name of the treatment product and, where applicable, the veterinary prescription for veterinary care, and the withdrawal period applied before livestock products can be marketed and labelled as organic. 1.6. Housing and husbandry practices 1.6.1. Insulation, heating and ventilation of the building shall ensure that air circulation, dust level, temperature, relative air humidity and gas concentration are kept within limits which ensure the well-being of the animals. The building shall … 898 unchanged words … 1.7.9. 1.7.11. The loading and unloading of animals shall be carried out without the use of any type of electrical or other painful stimulation to coerce the animals. The use of allopathic tranquillisers, prior to or during transport, shall be prohibited. 1.7.12. Operators shall keep records or documentary evidence of any specific operation applied and justifications for the application of point 1.7.5, 1.7.8, 1.7.9 or 1.7.10. As regards animals leaving the holding, the following data shall be recorded, where relevant: age, number of animals, weight of slaughter animals, appropriate identification (per animal or by batch/flock/hive) date of departure and destination. 1.8. Preparation of unprocessed products If preparation operations other than processing are carried out on livestock, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations. 1.9. Additional general … 1,757 unchanged words … disinfected during this time. In addition, when the rearing of each batch of poultry has been completed, runs shall be left empty during a period to be established by the Member States in order to allow vegetation to grow back. The operator shall keep records or documentary evidence of the application of such period. Those requirements shall not apply where poultry are not reared in batches, are not kept in runs and are free to roam throughout the day; (d) poultry shall have access to an open air area for at least one third of … 699 unchanged words … honey and pollen for the bees to survive the winter; (b) bee colonies may only be fed where the survival of the colony is endangered due to climatic conditions. In such case, bee colonies shall be fed with organic honey, organic pollen, organic sugar syrups, or organic sugar. 1.9.6.3. Health care With regard to health care, the following rules shall apply: (a) for the purposes of protecting frames, hives and combs, in particular from pests, only rodenticides used in traps, and appropriate products and substances authorised … 446 unchanged words … during honey extraction operations; (h) brood combs shall not be used for honey extraction; (i) beekeeping shall not be considered as organic when practiced in regions or areas designated by Member States as regions or areas where organic beekeeping is not practicable. 1.9.6.6. Record-keeping obligations Operators shall keep a map on an appropriate scale or geographic coordinates of the location of hives to be provided to the control authority or control body demonstrating that the areas accessible to the colonies meet the requirements of this Regulation. The following information shall be entered in the register of the apiary with regard to feeding: name of the product used, dates, quantities and hives where the product is used. The zone where the apiary is situated shall be recorded together with the identification of the hives and the period of moving. All the measures applied shall be recorded in the register of the apiary, including the removals of the supers and the honey extraction operations. The amount and dates of the collection of honey shall also be recorded. Part III: Production rules for algae and aquaculture animals 1. General requirements 1.1. Operations shall be situated in locations that are not subject to contamination with products or substances not authorised for use in organic production, or with pollutants that would compromise … 404 unchanged words … Preparation of unprocessed products If preparation operations, other than processing, are carried out on algae or aquaculture animals, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations. 1.11. Operators shall keep available documentary evidence on any derogation from production rules for aquaculture animals obtained in accordance with points 3.1.2.1(d) and (e). 2. Requirements for algae In addition to the general production rules laid down in Articles 9, 10, 11 and 15, and where relevant in Section 1 of this Part, the rules laid down in this Section shall apply to the organic collection and production of algae. Those rules shall apply mutatis mutandis to the production of phytoplankton. 2.1. Conversion 2.1.1. The conversion period for a production unit for algae collection shall be six months. 2.1.2. The conversion period for a production unit for algae cultivation shall be a period of six months or one full production cycle, whichever is the longer. 2.2. Production rules for algae 2.2.1. The collection of wild algae and parts thereof is considered as organic production provided that: (a) the growing areas are suitable from a health point of view and are of high ecological status as defined by Directive 2000/60/EC, or are of equivalent quality to: the production zones classed as A and B in Regulation (EC) No 854/2004 of the European Parliament and of the Council Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206)., until 13 December 2019, or the corresponding classification areas set out in the implementing acts adopted by the Commission in accordance with Article 18(8) of Regulation (EU) 2017/625, from 14 December 2019; (b) the collection does not affect significantly the stability of the natural ecosystem or the maintenance of the species in the collection area. 2.2.2. The cultivation of algae shall take place in areas with environmental and health characteristics at least equivalent to those outlined in point 2.2.1(a) in order to be considered organic. In addition the following production rules shall apply: (a) sustainable practices shall be used in all stages of production, from the collection of juvenile algae to harvesting; (b) to ensure that a wide gene-pool is maintained, the collection of juvenile algae in the wild shall take place on a regular basis so as to maintain and increase the diversity of indoor culture stock; (c) fertilisers shall not be used, except in indoor facilities, and only if they have been authorised pursuant to Article 24 for use in organic production for this purpose. Operators shall keep records of the use of those products, including the date or dates on which each product was used, the name of the product, and the amount applied, with information on the lots/tanks/basins concerned. 2.3. Algae cultivation 2.3.1. Algae culture at sea shall only utilise nutrients naturally occurring in the environment, or from organic aquaculture animal production, preferably located nearby as part of a polyculture system. 2.3.2. In facilities on land where external nutrient sources are used, the nutrient levels in the effluent water shall be verifiably the same, or lower, than the inflowing water. Only nutrients of plant or mineral origin authorised pursuant to Article 24 for use in organic production may be used. Operators shall keep records of the use of those products, including the date or dates on which the product are used, the name of the product, and the amount applied with information on the lots/tanks/basins concerned. 2.3.3. Culture density or operational intensity shall be recorded and shall maintain the integrity of the aquatic environment by ensuring that the maximum quantity of algae which can be supported without negative effects on the environment is not exceeded. 2.3.4. Ropes … 802 unchanged words … to breeding, the following rules shall apply: (a) hormones and hormone-derivates shall not be used; (b) the artificial production of monosex strains, except by hand-sorting, the induction of polyploidy, artificial hybridisation and cloning shall not be used; (c) appropriate strains shall be chosen. 3.1.2.3. Juvenile production In the larval rearing of marine fish species, rearing systems (preferably the mesocosm or large volume rearing) may be used. Those rearing systems shall meet the following requirements: (a) the initial stocking density shall be below 20 eggs or larvae per litre; (b) the larval rearing tank shall have a volume of minimum 20 m3; and (c) the larvae shall feed on the natural plankton developing in the tank, supplemented as appropriate by externally produced phytoplankton and zooplankton. 3.1.2.4. Operators shall keep records of the origin of animals, identifying the animals/batches of animals, the date of arrival and type of species, the quantities, the organic or non-organic status, and the conversion period. 3.1.3. Nutrition 3.1.3.1. With regard to feed for fish, crustaceans and echinoderms, the following rules shall apply: (a) animals shall be fed with feed that meets the animals’ nutritional requirements at the various stages of its development; (b) feeding regimes shall be designed with the following priorities: (i) animal health and welfare; (ii) high product quality, including the nutritional composition of the product, which shall ensure high quality of the final edible product; (iii) low environmental impact; (c) the plant fraction of feed shall be organic and the feed fraction derived from aquatic animals shall originate from organic aquaculture or from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013; (d) non-organic feed materials of plant, animal, algal or yeast origin, feed materials of mineral or microbial origin, feed additives, and processing aids shall only be used if they have been authorised under this Regulation for use in organic production; (e) growth promoters and synthetic amino-acids shall not be used. 3.1.3.2. With regard to bivalve molluscs and other species which are not fed by man, but instead feed on natural plankton, the following rules shall apply: (a) such filter-feeding animals shall receive all their nutritional requirements from nature, except in the case of juveniles reared in hatcheries and nurseries; (b) the growing areas shall be suitable from a health point of view and shall either be of high ecological status as defined by Directive 2000/60/EC or of good environmental status as defined by Directive 2008/56/EC or of equivalent quality to: the production zones classed as A in Regulation (EC) No 854/2004, until 13 December 2019, or the corresponding classification areas set out in the implementing acts adopted by the Commission in accordance with Article 18(8) of Regulation (EU) 2017/625, from 14 December 2019. 3.1.3.3. Specific rules on feed for carnivorous aquaculture animals Feed for carnivorous aquaculture animals shall be sourced with the following priorities: (a) organic feed of aquaculture origin; (b) fish meal and fish oil from organic aquaculture trimmings sourced from fish, crustaceans or molluscs; (c) fish meal and fish oil and feed material of fish origin derived from trimmings of fish, crustaceans or molluscs already caught for human consumption in sustainable fisheries; (d) fish meal and fish oil and feed material of fish origin derived from whole fish, crustaceans or molluscs caught in sustainable fisheries and not used for human consumption; (e) organic feed materials of plant or animal origin; plant material shall not exceed 60 % of total ingredients. origin. 3.1.3.4. Specific rules on feed for certain aquaculture animals In the grow-out phase, fish in inland waters, penaeid shrimps and freshwater prawns and tropical freshwater fish shall be fed as follows: (a) they shall be fed with feed naturally available in ponds and lakes; (b) where natural feed referred to in point (a) is not available in sufficient quantities, organic feed of plant origin, preferably grown on the farm itself, or algae may be used. Operators shall keep documentary evidence of the need to use additional feed; (c) where natural feed is supplemented in accordance with point (b): (i) the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) may consist of a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries; (ii) the feed ration of siamese catfish (Pangasius spp.) may consist of a maximum of 10 % fishmeal or fish oil derived from sustainable fisheries. In the grow-out phase and in earlier life stages in nurseries and hatcheries, organic cholesterol may be used to supplement the diets of penaeid shrimps and freshwater prawns (Macrobrachium spp.), in order to secure their quantitative dietary need. 3.1.3.5. Operators shall keep records of specific feeding regimes, in particular, on the name and quantity of feed and the use of additional feed, and the respective animals/batches of animals fed. 3.1.4. Health care 3.1.4.1. Disease prevention With regard to disease prevention, the following rules shall apply: (a) disease prevention shall be based on keeping the animals in optimal conditions by appropriate siting, taking into account, inter alia, the species’ requirements for good water … 507 unchanged words … shall apply. Where the indicated limits for allopathic treatments are exceeded, the aquaculture animals concerned shall not be marketed as organic products; (e) the use of parasite treatments, other than through compulsory control schemes operated by Member States, shall be limited as follows: (i) for salmon, to twice maximum two courses of treatment per year, or once to one course of treatment per year where the production cycle is less than 18 months; (ii) for all species other than salmon, to two courses of treatment per year, or to one course of treatment per year where the production cycle is less than 12 months; (iii) for all species, to no more than four courses of treatment in total, regardless of the length of the production cycle of the species; (f) the withdrawal period for allopathic veterinary treatments and parasite treatments in accordance with point (d), including treatments under compulsory control and eradication schemes, shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC or, where this period is not specified, 48 hours; (g) any use of veterinary medicinal products shall be declared to the competent authority, or, where appropriate, to the control authority or control body, before the animals are marketed as organic products. Treated stock shall be clearly identifiable. 3.1.4.3. Record-keeping of disease prevention Operators shall keep records of the disease prevention measures applied giving details of fallowing, cleaning and water treatment, and of any veterinary and other parasite treatment applied and in particular, the date of treatment, diagnosis, the posology, the name of the treatment product, and veterinary prescription for veterinary care, where applicable, and withdrawal periods applied before aquaculture products can be marketed and labelled as organic. 3.1.5. Housing and husbandry practices 3.1.5.1. Closed recirculation aquaculture animal production facilities shall be prohibited, with the exception of hatcheries and nurseries or facilities for the production of species used for organic feed organisms. 3.1.5.2. Artificial heating or cooling of water shall only be permitted in hatcheries and nurseries. Natural borehole water may be used to heat or cool water at all stages of production. 3.1.5.3. The husbandry environment of the aquaculture animals shall be designed in such a way that, in accordance with their species-specific needs, the aquaculture animals: (a) have sufficient space for their welfare and have the relevant stocking density laid down in the implementing acts referred to in Article 15(3); (b) are kept in water of good quality with, inter alia, an adequate flow and exchange rate, sufficient oxygen levels and keeping a low level of metabolites; (c) are kept in temperature and light conditions in accordance with the requirements of the species and having regard to the geographic location. In considering the effects of stocking density on the welfare of produced fish, the condition of the fish (such as fin damage, other injuries, growth rate, behaviour expressed and overall health) and the water quality shall be monitored and taken into account. In the case of freshwater fish, the bottom type shall be as close as possible to natural conditions. In the case of carp and similar species: the bottom shall be natural earth, organic and mineral fertilisation of the ponds and lakes shall be carried out only with fertilisers and soil conditioners that have been authorised pursuant to Article 24 for use in organic production, with a maximum application of 20 kg nitrogen/ha, treatments involving synthetic chemicals for the control of hydrophytes and plant coverage present in production waters shall be prohibited. Operators shall keep records of monitoring and maintenance measures concerning animal welfare and water quality. In case of fertilisation of ponds and lakes, the operators shall keep records of the application of fertilisers and soil conditioners, including the date of application, the name of the product, the amount applied, and the location of the application concerned. 3.1.5.4. The design and construction of aquatic containment systems shall provide flow rates and physiochemical parameters that safeguard the animals’ health and welfare, and that provide for their behavioural needs. The specific characteristics for production systems and containment systems for species … 428 unchanged words … only in the following cases: (a) exceptional cases of a change in temperature, a drop in atmospheric pressure or accidental water pollution; (b) occasional stock management procedures, such as sampling and sorting; (c) in order to assure the survival of the farm stock. Operators shall keep records of such uses, indicating whether applied under point (a) (b) or (c). 3.1.6.6. Appropriate measures shall be taken to keep the duration of the transport of aquaculture animals to a minimum. 3.1.6.7. Any suffering shall be kept to a minimum during the entire life of the animal, including at the time of slaughter. 3.1.6.8. … 725 unchanged words … point 1.2 shall ensure that the produced processed products comply with this Regulation at all times. 1.4. Operators shall comply with and implement the procedures referred to in point 1.2, and, without prejudice to Article 28, shall in particular,: (a) take precautionary measures and keep records of those measures; (b) implement suitable cleaning measures, monitor their effectiveness and keep records of those operations; (c) guarantee that non-organic products are not placed on the market with an indication referring to organic production. 1.5. The preparation of processed organic, in-conversion and non-organic products shall be kept separate from each other in time or space. Where organic, in-conversion and non-organic products, in any combination, are prepared or stored in the preparation unit concerned, the operator shall: (a) inform the competent authority, or, where appropriate, the control authority or control body, accordingly; (b) carry out the operations continuously until the production run has been completed, separately in place or time from similar operations performed on any other kind of product (organic, in-conversion or non-organic); (c) store organic, in-conversion and non-organic products, before and after the operations, separate by place or time from each other; (d) keep available an updated register of all operations and quantities processed; (e) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges between organic, in-conversion and non-organic products; (f) carry out operations on organic or in-conversion products only after suitable cleaning of the production equipment. 1.6. Products, substances and techniques that reconstitute properties that are lost in the processing and storage of organic food, that correct the results of negligence in the processing of organic food, or that otherwise may be misleading as to the true nature of products intended to be marketed as organic food, shall not be used. 1.7. Operators shall keep available documentary evidence on authorisations for the use of non-organic agricultural ingredients for the production of processed organic food in accordance with Article 25 if they have obtained or used such authorisations. 2. Detailed requirements for the production of processed food 2.1. The following conditions shall apply to the composition of processed organic food: (a) the product shall be produced mainly from agricultural ingredients or products intended for use as food listed in Annex … 543 unchanged words … for infants and young children (OJ L 339, 6.12.2006, p. 16)., their use is authorised by that Directive. 2.2.3. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose. Operators shall keep records of the use of those products, including the date or dates on which each product was used, the name of the product, its active substances and the location of such use. 2.2.4. For the purpose of the calculation referred to in Article 30(5), the following rules shall apply: (a) certain food additives authorised pursuant to Article 24 for use in organic production shall be calculated as agricultural ingredients; (b) preparations and substances referred to in points (a), (c), (d), (e) and (f) of point 2.2.2 shall not be calculated as agricultural ingredients; (c) yeast and yeast products shall be calculated as agricultural ingredients. 2.3. Operators shall keep records of any input used in the food production. In case of production of composite products, complete recipes/formulae showing the quantities of input and output shall be kept available for the competent authority or control body. Part V: Processed feed production rules In addition to the general production rules laid down in Articles 9, 11 and 17, the rules laid down in this Part shall apply to the organic production of processed feed. 1. General requirements for the production of processed feed 1.1. Feed additives, processing aids and other substances and ingredients used for processing feed, and any processing practice used, such as smoking, shall comply with the principles of good manufacturing practice. 1.2. Operators that produce processed feed shall establish and update appropriate procedures based on a systematic identification of the critical processing steps. 1.3. The application of the procedures referred to in point 1.2 shall ensure that the produced processed products comply with this Regulation at all times. 1.4. Operators shall comply with and implement the procedures referred to in point 1.2, and, without prejudice to Article 28, shall in particular: (a) take precautionary measures and keep records of those measures; (b) implement suitable cleaning measures, monitor their effectiveness and keep records of those operations; (c) guarantee that non-organic products are not placed on the market with an indication referring to organic production. 1.5. The preparation of processed organic, in-conversion and non-organic products shall be kept separate from each other in time or space. Where organic, in-conversion and non-organic products, in any combination, are prepared or stored in the preparation unit concerned, the operator shall: (a) inform the control authority or control body accordingly; (b) carry out the operations continuously until the production run has been completed, separately in place or time from similar operations performed on any other kind of product (organic, in-conversion or non-organic); (c) store organic, in-conversion and non-organic products, before and after the operations, separate by place or time from each other; (d) keep available an updated register of all operations and quantities processed; (e) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges between organic, in-conversion and non-organic products; (f) carry out operations on organic or in-conversion products only after suitable cleaning of the production equipment. 2. Detailed requirements for the production of processed feed 2.1. Organic feed materials, or in-conversion feed materials, shall not enter simultaneously with the same feed materials produced by non-organic means into the composition of the organic feed product. 2.2. Any feed materials used or processed in organic production shall not have been processed with the aid of chemically synthesised solvents. 2.3. Only non-organic feed material of plant, algal, animal or yeast origin, feed material of mineral origin, and feed additives and processing aids authorised pursuant to Article 24 for use in organic production may be used in the processing of feed. 2.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose. Operators shall keep records of the use of those products, including the date or dates on which each product was used, the name of the product, its active substances, and the location of such use. 2.5. Operators shall keep records of any input used in the feed production. In the case of production of composite products, complete recipes/formulae showing the quantities of input and output shall be kept available for the competent authority or control body. Part VI: Wine 1. Scope 1.1. In addition to the general production rules laid down in Articles 9, 10, 11, 16 and 18, the rules laid down in this Part shall apply to the organic production of the products of the wine sector as referred to in point (l) of Article 1(2) of Regulation (EU) No 1308/2013. 1.2. Commission Regulations (EC) No 606/2009 Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1). and (EC) No 607/2009 Commission Regulation (EC) No 607/2009 of 14 July 2009 laying down certain detailed rules for the implementation of Council Regulation (EC) No 479/2008 as regards protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products (OJ L 193, 24.7.2009, p. 60). shall apply, save as explicitly provided otherwise in this Part. 2. Use of certain products and substances 2.1. Products of the wine sector shall be produced from organic raw material. 2.2. Only products and substances authorised pursuant to Article 24 for use in organic production may be used for the making of products of the wine sector, including during the oenological practices, processes and treatments, subject to the conditions and restrictions laid down in Regulation (EU) No 1308/2013 and Regulation (EC) No 606/2009, and in particular in Annex I A to the latter Regulation. 2.3. Operators shall keep records of the use of any product and substance used in the wine production and for cleaning and disinfection, including the date or dates on which each product was used, the name of the product, its active substances, and where applicable, the location of such use. 3. Oenological practices and restrictions 3.1. Without prejudice to Sections 1 and 2 of this Part and to specific prohibitions and restrictions provided for in points 3.2, 3.3 and 3.4, only oenological practices, processes and treatments, including the restrictions provided for … 454 unchanged words … production; (b) products and substances referred to in points (a), (b) and (e) of point 2.2.2 of Part IV. 1.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose.1.5. Operators shall keep records of any product and substance used for yeast production and for cleaning and disinfection, including the date or dates on which each product was used, the name of the product, its active substances, and the location of such use.

02018R0848-20201114 → 02018R0848-20220101

ANNEX III COLLECTION, PACKAGING, TRANSPORT AND STORAGE OF PRODUCTS 1. Collection of products and transport to preparation units Operators may carry out the simultaneous collection of organic, in-conversion and non-organic products only where appropriate measures have been taken to prevent any possible mixture or exchange between organic, in-conversion and non-organic products and to ensure the identification of the organic and in-conversion products. The operator shall keep the information relating to collection days, hours, the circuit and date and time of the reception of the products available to the control authority or control body. 2. Packaging and transport of products to other operators or units 2.1. Information to be provided 2.1.1. Operators shall ensure that organic products and in-conversion products are transported to other operators or units, including wholesalers and retailers, only in appropriate packaging, containers or vehicles closed in such a manner that substitution alteration, including substitution, of the content cannot be achieved without manipulation or damage of the seal and provided with a label stating, without prejudice to any other indications required by Union law: (a) the name and address of the operator and, where different, of the owner or seller of the product; (b) the name of the product or a description of the compound feedstuff accompanied by a reference to organic production; product; (c) the name or the code number of the control authority or control body to which the operator is subject; and (d) where relevant, the lot identification mark in accordance with a marking system either approved at national level or agreed with the control authority or control body and which permits the linking of the lot with the records referred to in Article 34(5). 2.1.2. Operators shall ensure that compound feed authorised in organic production transported to other operators or holdings, including wholesalers and retailers, are provided with a label stating, in addition to any other indications required by Union law: (a) the information provided in point 2.1.1; (b) where relevant, by weight of dry matter: (i) the total percentage of organic feed materials; (ii) the total percentage of in-conversion feed materials; (iii) the total percentage of feed materials not covered by points (i) and (ii); (iv) the total percentage of feed of agricultural origin; (c) where relevant, the names of organic feed materials; (d) where relevant, the names of in-conversion feed materials; and (e) for compound feed that cannot be labelled in accordance with Article 30(6), the indication that such feed may be used in organic production in accordance with this Regulation. 2.1.3. Without prejudice to Directive 66/401/EEC, operators shall ensure that on the label of the packaging of a mixture of fodder plant seeds containing organic and in-conversion or non-organic seeds of certain different plant species for which an authorisation has been issued under the relevant conditions laid down in point 1.8.5 of Part I of Annex II to this Regulation, information is provided on the exact components of the mixture, shown by percentage by weight of each component species, and where appropriate varieties. In addition to the relevant requirements under Annex IV to Directive 66/401/EEC, that information shall include besides the indications required in the first paragraph of this point also the list of the component species of the mixture that are labelled as organic or in-conversion. The minimum total percentage by weight of organic and in-conversion seeds in the mixture shall be at least 70 %. In case the mixture contains non-organic seeds, the label shall also include the following statement: The use of the mixture is only allowed within the scope of the authorisation and in the territory of the Member State of the competent authority which authorised the use of this mixture in conformity with point 1.8.5 of Annex II to Regulation (EU) 2018/848 on organic production and labelling of organic products. The information referred to in points (a) to (d) 2.1.1 and 2.1.2 may also be presented solely on an accompanying document, if such a document can be undeniably linked with the packaging, container or vehicular transport of the product. This accompanying document shall include information on the supplier or the transporter. 2.2. The closing of packaging, containers or vehicles shall not be required where: (a) the transport takes place directly between two operators, both of which are subject to the organic control system; (b) the transport includes only organic or only in-conversion products; (c) the products are accompanied by a document giving the information required under point 2.1; and (d) both the expediting and the receiving operators keep documentary records of such transport operations available for the control authority or control body. 3. Special rules for transporting feed to other production or preparation units or storage premises When transporting feed to other production or preparation units or storage premises, operators shall ensure that the following conditions are met: (a) during transport, organically produced feed, in-conversion feed, and non-organic feed are effectively physically separated; (b) vehicles or containers which have transported non-organic products are only used to transport organic or in-conversion products if: (i) suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing the transport of organic or in-conversion products and the operators keep records of those operations; (ii) all appropriate measures are implemented, depending on the risks evaluated in accordance with control arrangements, and where necessary, operators guarantee that non-organic products cannot be placed on the market with an indication referring to organic production; (iii) the operator keeps documentary records of such transport operations available for the control authority or control body; (c) the transport of finished organic or in-conversion feed is separated physically or in time from the transport of other finished products; (d) during transport, the quantity of products at the start and each individual quantity delivered in the course of a delivery round is recorded. 4. Transport of live fish 4.1. Live fish shall be transported in suitable tanks with clean water which meets their physiological needs in terms of temperature and dissolved oxygen. 4.2. Before transport of organic fish and fish products, tanks shall be thoroughly cleaned, disinfected and rinsed. 4.3. Precautions shall be taken to reduce stress. During transport, the density shall not reach a level which is detrimental to the species. 4.4. Records shall be kept for operations referred to in points 4.1, 4.2 and 4.3. 5. Reception of products from other operators of or units On receipt of an organic or in-conversion product, the operator shall check the closing of the packaging, container or vehicle where it is required and the presence of the indications provided for in Section 2. The operator shall cross-check the information … 441 unchanged words … of organic or in-conversion products and the operators shall keep records of those operations. 7.5. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in organic production shall be used in storage facilities for that purpose.

texts differ too much for an inline diff; shown separately

before (02018R0848-20201114)

ANNEX VI
MODEL OF CERTIFICATE
Certificate pursuant to Article 35(1) of Regulation (EU) 2018/848 on organic production and labelling of organic products
1. Document number:
2. (tick one box as appropriate)
Operator
Group of operators – see annex
3. Name and address of operator or group of operators:
4. Activit(y)(ies) of the operator or group of operators (choose as appropriate):
Agricultural production
Preparation
Distribution
Storing
Import
Export
Placing on the market
5. Name, address and code number of control authority or control body of the operator or group of operators:
6. Categor(y)(ies) of products as referred to in Article 35(7) of Regulation (EU) 2018/848 and production methods (choose as appropriate):
unprocessed plants and plant products, including seeds and other plant reproductive material
Production method:
organic production excluding during the conversion period
production during the conversion period
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
livestock and unprocessed livestock products
Production method:
organic production excluding during the conversion period
production during the conversion period
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
algae and unprocessed aquaculture products
Production method:
organic production excluding during the conversion period
production during the conversion period
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
processed agricultural products, including aquaculture products, for use as food
Production method:
production of organic products
production of in-conversion products
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
feed
Production method:
production of organic products
production of in-conversion products
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
wine
Production method:
production of organic products
production of in-conversion products
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
other products listed in Annex I to Regulation (EU) 2018/848 or not covered by previous categories (please specify):
Production method:
production of organic products
production of in-conversion products
organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market)
Certificate validity period from … to …
This document has been issued in accordance with Regulation (EU) 2018/848 to certify that the operator or group of operators (choose as appropriate) meets the requirements of that Regulation.
Date, place:
Signature on behalf of the issuing control authority or control body:
Annex – List of members of group of operators as defined in Article 36 of Regulation (EU) 2018/848
Name of member Address

after (02018R0848-20220101)

ANNEX VI
MODEL OF THE CERTIFICATE
CERTIFICATE PURSUANT TO ARTICLE 35(1) OF REGULATION (EU) 2018/848 ON ORGANIC PRODUCTION AND LABELLING OF ORGANIC PRODUCTS
Part I: Mandatory elements
Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
1. Document number 2. (choose as appropriate)
Operator
Group of operators – see point 9
3. Name and address of the operator or group of operators: 4. Name and address of the competent authority, or, where appropriate, control authority or control body of the operator or group of operators and code number in the case of control authority or control body:
5. Activity or activities of the operator or group of operators (choose as appropriate)
Production
Preparation
Distribution/Placing on the market
Storing
Import
Export
6. Category or categories of products as referred to in Article 35(7) of Regulation (EU) 2018/848 of the European Parliament and of the Council
 and production methods (choose as appropriate)
(a) unprocessed plants and plant products, including seeds and other plant reproductive material
Production method:
□ organic production excluding during the conversion period
□ production during the conversion period
□ organic production with non-organic production
(b) livestock and unprocessed livestock products
Production method:
□ organic production excluding during the conversion period
□ production during the conversion period
□ organic production with non-organic production
(c) algae and unprocessed aquaculture products
Production method:
□ organic production excluding during the conversion period
□ production during the conversion period
□ organic production with non-organic production
(d) processed agricultural products, including aquaculture products, for use as food
Production method:
□ production of organic products
□ production of in-conversion products
□ organic production with non-organic production
(e) feed
Production method:
□ production of organic products
□ production of in-conversion products
□ organic production with non-organic production
(f) wine
Production method:
□ production of organic products
□ production of in-conversion products
□ organic production with non-organic production
(g) other products listed in Annex I to Regulation (EU) 2018/848 or not covered by the previous categories
Production method:
□ production of organic products
□ production of in-conversion products
□ organic production with non-organic production
This document has been issued in accordance with Regulation (EU) 2018/848 to certify that the operator or group of operators (choose as appropriate) complies with that Regulation.
7. Date, place
Name and signature on behalf of the issuing competent authority, or, where appropriate, control authority or control body: 8. Certificate valid from……….[insert date] to……….[insert date]
9. List of members of the group of operators as defined in Article 36 of Regulation (EU) 2018/848
Name of member Address or other form of member identification
Part II: Specific optional elements
One or more elements to be completed if so decided by the competent authority or, where appropriate, the control authority or control body that issues the certificate to the operator or group of operators in accordance with Article 35 of Regulation (EU) 2018/848.
1. Directory of products
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
Name of the product and/or Combined Nomenclature (CN) code as referred to in Council Regulation (EEC) No 2658/87
 for products within the scope of Regulation (EU) 2018/848 □ Organic
□ In-conversion
2. Quantity of products
Name of the product and/or CN code as referred to in Regulation (EEC) No 2658/87 for products within the scope of Regulation (EU) 2018/848 □ Organic
□ In-conversion Quantity estimated in kilograms, litres or, where relevant, in number of units
3. Information on the land
Name of the product □ Organic
□ In-conversion
□ Non-organic Surface in hectares
4. List of premises or units where the activity is performed by the operator or group of operators
Address or geolocation Description of the activity or activities as referred to in point 5 of part I
5. Information on the activity or activities carried out by the operator or group of operators and whether the activity is, or the activities are performed for their own purpose or as a subcontractor carrying out the activity or activities for another operator, while the subcontractor remains responsible for the activity or activities performed
Description of the activity or activities as referred to in point 5 of part I □ Carrying out activity/activities for own purpose
□ Carrying out activity/activities as a subcontractor for another operator, while the subcontractor remains responsible for the activity or activities performed
6. Information on the activity or activities carried out by the subcontracted third party in accordance with Article 34(3) of Regulation (EU) 2018/848
Description of the activity or activities as referred to in point 5 of part I □ Operator or group of operators remains responsible
□ Subcontracted third party is responsible
7. List of subcontractors carrying out an activity or activities for the operator or group of operators in accordance with Article 34(3) of Regulation (EU) 2018/848, for which the operator or group of operators remains responsible as regards organic production and for which it has not transferred that responsibility to the subcontractor
Name and address Description of the activity or activities as referred to in point 5 of part I
8. Information on the accreditation of the control body in accordance with Article 40(3) of Regulation (EU) 2018/848
(a) name of the accreditation body;
(b) hyperlink to the accreditation certificate.
9. Other information