02018R0848 — EN — 21.02.2023 — 003.001 — 1This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official
Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links
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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)

Amended by:
Official Journal

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Commission Delegated Regulation (EU) 2020/427 of 13 January 2020
amended by Commission Delegated Regulation (EU) 2021/269 of 4
December 2020
Regulation (EU) 2020/1693 of the European Parliament and of theCouncil of 11 November 2020
Commission Delegated Regulation (EU) 2020/1794 of 16 September
2020
Commission Delegated Regulation (EU) 2021/642 of 30 October 2020
Commission Delegated Regulation (EU) 2021/715 of 20 January 2021
Commission Delegated Regulation (EU) 2021/716 of 9 February 2021
Commission Delegated Regulation (EU) 2021/1006 of 12 April 2021
Commission Delegated Regulation (EU) 2021/1691 of 12 July 2021
Commission Delegated Regulation (EU) 2021/1697 of 13 July 2021
Commission Delegated Regulation (EU) 2022/474 of 17 January 2022
Commission Delegated Regulation (EU) 2023/207 of 24 November
2022

Corrected by:
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Corrigendum, OJ L 270, 29.10.2018, p. 37 (2018/848)
Corrigendum, OJ L 305, 26.11.2019, p. 59 (2018/848)
Corrigendum, OJ L 439, 29.12.2020, p. 32 (2020/1794)
Corrigendum, OJ L 7, 11.1.2021, p. 53 (2018/848)
Corrigendum, OJ L 204, 10.6.2021, p. 47 (2018/848)
Corrigendum, OJ L 321, 15.12.2022, p. 72 (2018/848)

No

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23.3.2020
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20.4.2021
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22.6.2021
22.9.2021
23.9.2021
25.3.2022
1.2.2023

02018R0848 — EN — 21.02.2023 — 003.001 — 2▼B
REGULATION(EU)
2018/848
OF
THE
EUROPEANPARLIAMENT AND OF THE COUNCIL
of 30 May 2018
on organic production and labelling of organic products andrepealing Council Regulation (EC) No 834/2007
CHAPTER ISUBJECT MATTER, SCOPE AND DEFINITIONSArticle 1
Subject matter
This Regulation establishes the principles of organic production andlays down the rules concerning organic production, related certificationand the use of indications referring to organic production in labelling
and advertising, as well as rules on controls additional to those laid
down in Regulation (EU) 2017/625.

Article 2
Scope
1.
This Regulation applies to the following products originating fromagriculture, including aquaculture and beekeeping, as listed in Annex I
to the TFEU and to products originating from those products, wheresuch products are, or are intended to be, produced, prepared, labelled,
distributed, placed on the market, imported into or exported from theUnion:(a) live or unprocessed agricultural products, including seeds and otherplant reproductive material;(b) processed agricultural products for use as food;(c) feed.

This Regulation also applies to certain other products closely linked toagriculture listed in Annex I to this Regulation, where they are, or are
intended to be, produced, prepared, labelled, distributed, placed on themarket, imported into or exported from the Union.

2.
This Regulation applies to any operator involved, at any stage of
production, preparation and distribution, in activities relating to the
products referred to in paragraph 1.

3.
Mass catering operations carried out by a mass caterer as definedin point (d) of Article 2(2) of Regulation (EU) No 1169/2011 are notsubject to this Regulation except as set out in this paragraph.

02018R0848 — EN — 21.02.2023 — 003.001 — 3▼B
Member States may apply national rules or, in the absence thereof,
private standards, on the production, labelling and control of products
originating from mass catering operations. The organic production logoof the European Union shall not be used in the labelling, the presen­tation or the advertising of such products, and shall not be used toadvertise the mass caterer.

4.
Except where otherwise provided, this Regulation applies without
prejudice to related Union legislation, in particular, legislation in thefields of safety of the food chain, animal health and welfare, plant
health and plant reproductive material.

5.
This Regulation applies without prejudice to other specific Union
law relating to the placing of products on the market and, in particular,
to Regulation (EU) No 1308/2013 of the European Parliament and of
the Council (1) and to Regulation (EU) No 1169/2011.

6.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending the list of products set out inAnnex I by adding further products to the list, or by amending those
added entries. Only products which are closely linked to agricultural
products shall be eligible for inclusion in that list.

Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:(1) ‘organic production’ means the use, including during theconversion period referred to in Article 10, of production
methods that comply with this Regulation at all stages of
production, preparation and distribution;(2) ‘organic product’ means a product resulting from organic
production, other than a product produced during the conversion
period referred to in Article 10. The products of hunting or fishingof wild animals are not considered as organic products;(3) ‘agricultural raw material’ means an agricultural product that has
not been subjected to any operation of preservation or processing;(4) ‘preventive measures’ means measures that are to be taken by
operators at every stage of production, preparation and distribution
in order to ensure the preservation of biodiversity and soil quality,
measures for the prevention and control of pests and diseases andmeasures that are to be taken to avoid negative effects on theenvironment, animal health and plant health;(1) Regulation (EU) No 1308/2013 of the European Parliament and of theCouncil of 17 December 2013 establishing a common organisation of themarkets in agricultural products and repealing Council Regulations (EEC)
No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC)No 1234/2007 (OJ L 347, 20.12.2013, p. 671).

02018R0848 — EN — 21.02.2023 — 003.001 — 4▼B(5) ‘precautionary measures’ means measures that are to be taken by
operators at every stage of production, preparation, and distribution
to avoid contamination with products or substances that are notauthorised for use in organic production in accordance with thisRegulation, and to avoid the commingling of organic productswith non-organic products;(6) ‘conversion’ means the transition from non-organic to organic
production within a given period, during which the provisions of
this Regulation concerning organic production apply;(7) ‘in-conversion product’ means a product that is produced during
the conversion period referred to in Article 10;(8) ‘holding’ means all the production units operated under single
management for the purpose of producing live or unprocessed
agricultural products, including products originating from aqua­
culture and beekeeping, referred to in point (a) of Article 2(1) or
products listed in Annex I other than essential oils and yeast;(9) ‘production unit’ means all assets of a holding, such as primary
production premises, land parcels, pasturages, open air areas,
livestock buildings or parts thereof, hives, fish ponds, containment
systems and sites for algae or aquaculture animals, rearing units,
shore or seabed concessions, and premises for the storage of crops,of crop products, of algae products, of animal products, of raw
materials and of any other relevant inputs managed as described inpoint (10), point (11) or point (12);(10) ‘organic production unit’ means a production unit, excluding
during the conversion period referred to in Article 10, which ismanaged in compliance with the requirements applicable toorganic production;(11) ‘in-conversion production unit’ means a production unit, during
the conversion period referred to in Article 10, which ismanaged in compliance with the requirements applicable toorganic production; it may be constituted of land parcels orother assets for which the conversion period referred to in
Article 10 starts at different moments in time;(12) ‘non-organic production unit’ means a production unit which is not
managed in compliance with the requirements applicable toorganic production;(13) ‘operator’ means the natural or legal person responsible for
ensuring that this Regulation is complied with at every stage of
production, preparation and distribution that are under that
person’s control;(14) ‘farmer’ means a natural or legal person, or a group of natural or
legal persons, regardless of the legal status of that group and its
members under national law, who exercises an agriculturalactivity;

02018R0848 — EN — 21.02.2023 — 003.001 — 5▼B(15) ‘agricultural area’ means agricultural area as defined in point (e) ofArticle 4(1) of Regulation (EU) No 1307/2013;(16) ‘plants’ means plants as defined in point (5) of Article 3 of Regu­
lation (EC) No 1107/2009;(17) ‘plant reproductive material’ means plants and all parts of plants,
including seeds, at any stage of growth that are capable of, andintended for, producing entire plants;(18) ‘organic heterogeneous material’ means a plant grouping within asingle botanical taxon of the lowest known rank which:(a) presents common phenotypic characteristics;(b) is characterised by a high level of genetic and phenotypic
diversity between individual reproductive units, so that thatplant grouping is represented by the material as a whole,and not by a small number of units;(c) is not a variety within the meaning of Article 5(2) of Council
Regulation (EC) No 2100/94 (1);(d) is not a mixture of varieties; and(e) has been produced in accordance with this Regulation;(19) ‘organic variety suitable for organic production’ means a variety as
defined in Article 5(2) of Regulation (EC) No 2100/94 which:(a) is characterised by a high level of genetic and phenotypical
diversity between individual reproductive units; and(b) results from organic breeding activities referred to inpoint 1.8.4 of Part I of Annex II to this Regulation;(20) ‘mother plant’ means an identified plant from which plant repro­
ductive material is taken for the reproduction of new plants;(21) ‘generation’ means a group of plants constituting a single step inthe line of descent of plants;(22) ‘plant production’ means production of agricultural crop products
including harvesting of wild plant products for commercial
purposes;(1) Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plantvariety rights (OJ L 227, 1.9.1994, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 6▼B(23) ‘plant products’ means plant products as defined in point (6) of
Article 3 of Regulation (EC) No 1107/2009;(24) ‘pest’ means a pest as defined in Article 1(1) of Regulation (EU)2016/2031 of the European Parliament and of the Council (1);(25) ‘biodynamic preparations’ means mixtures traditionally used inbiodynamic farming;(26) ‘plant protection products’ means the products referred to in
Article 2 of Regulation (EC) No 1107/2009;(27) ‘livestock production’ means the production of domestic or domes­
ticated terrestrial animals, including insects;(28) ‘veranda’ means an additional, roofed, uninsulated, outdoor part ofa building intended for poultry, the longest side usually being
equipped with wire fencing or netting, with an outdoor climate,natural and, where necessary, artificial illumination, and a litteredfloor;(29) ‘pullets’ means young animals of the Gallus gallus species that areof an age of less than 18 weeks;(30) ‘laying hens’ means animals of the Gallus gallus species that are
intended for the production of eggs for consumption and that areof an age of at least 18 weeks;(31) ‘usable area’ means usable area as defined in point (d) of
Article 2(2) of Council Directive 1999/74/EC (2);(32) ‘aquaculture’ means aquaculture as defined in point (25) of
Article 4(1) of Regulation (EU) No 1380/2013 of the European
Parliament and of the Council (3);(33) ‘aquaculture products’ means aquaculture products as defined inpoint (34) of Article 4(1) of Regulation (EU) No 1380/2013;(1) Regulation (EU) 2016/2031 of the European Parliament of the Council of
26 October 2016 on protective measures against pests of plants, amending
Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014of the European Parliament and of the Council and repealing Council
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC,
2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).
(2) Council Directive 1999/74/EC of 19 July 1999 laying down minimum
standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53).
(3) Regulation (EU) No 1380/2013 of the European Parliament and of theCouncil of 11 December 2013 on the Common Fisheries Policy, amending
Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 andrepealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004
and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).

02018R0848 — EN — 21.02.2023 — 003.001 — 7▼B(34) ‘closed recirculation aquaculture facility’ means a facility on land
or in a vessel where aquaculture takes place within an enclosed
environment involving the recirculation of water and which
depends on permanent external energy input to stabilise the envi­
ronment for the aquaculture animals;(35) ‘energy from renewable sources’ means energy from renewablenon-fossil sources such as wind, solar, geothermal, wave, tidal,hydropower, landfill gas, sewage treatment plant gas and biogases;(36) ‘hatchery’ means a place for the breeding, hatching and rearing
through the early life stages of aquaculture animals, in particularfinfish and shellfish;(37) ‘nursery’ means a place where an intermediate aquaculture
production system is applied between the hatchery and grow-out
stages. The nursery stage is completed within the first third of the
production cycle, with the exception of species undergoing a smol­
tification process;(38) ‘water pollution’ means pollution as defined in point (33) of
Article 2 of Directive 2000/60/EC and in point (8) of Article 3
of Directive 2008/56/EC of the European Parliament and of theCouncil (1), in the waters to which each of those Directives
applies;(39) ‘polyculture’ means the rearing in aquaculture of two or more
species, usually from different trophic levels, in the same cultureunit;(40) ‘production cycle’ means the lifespan of an aquaculture animal oralga, from the earliest life stage (fertilised eggs, in the case of
aquaculture animals) to harvesting;(41) ‘locally grown species’ means aquaculture species which areneither alien nor locally absent species within the meaning ofpoints (6) and (7), respectively, of Article 3 of Council Regu­
lation (EC) No 708/2007 (2), as well as the species listed in
Annex IV to that Regulation;(42) ‘veterinary treatment’ means all courses of a curative or preventive
treatment against an occurrence of a specific disease;(43) ‘veterinary medicinal product’ means a veterinary medicinal
product as defined in point (2) of Article 1 of Directive
2001/82/EC of the European Parliament and of the Council (3);(1) Directive 2008/56/EC of the European Parliament and of the Council of
17 June 2008 establishing a framework for community action in the fieldof marine environmental policy (Marine Strategy Framework Directive)(OJ L 164, 25.6.2008, p. 19).
(2) Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use ofalien and locally absent species in aquaculture (OJ L 168, 28.6.2007, p. 1).
(3) Directive 2001/82/EC of the European Parliament and of the Council of
6 November 2001 on the Community code relating to veterinary medicinal
products (OJ L 311, 28.11.2001, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 8▼B(44) ‘preparation’ means the operations of preserving or processing oforganic or in-conversion products, or any other operation that is
carried out on an unprocessed product without altering the initial
product, such as slaughtering, cutting, cleaning or milling, as wellas packaging, labelling or alterations made to the labelling relating
to organic production;(45) ‘food’ means food as defined in Article 2 of Regulation (EC)No 178/2002 of the European Parliament and of the Council (1);(46) ‘feed’ means feed as defined in point (4) of Article 3 of Regu­
lation (EC) No 178/2002;(47) ‘feed materials’ mean feed materials as defined in point (g) of
Article 3(2) of Regulation (EC) No 767/2009 of the European
Parliament and of the Council (2);(48) ‘placing on the market’ means placing on the market as defined inpoint (8) of Article 3 of Regulation (EC) No 178/2002;(49) ‘traceability’ means the ability to trace and follow food, feed or
any product referred to in Article 2(1), and any substance intended
or expected to be incorporated into food, feed or any productreferred to in Article 2(1), through all stages of production, prep­
aration and distribution;(50) ‘stage of production, preparation and distribution’ means any stage
from the primary production of an organic product through its
storage, processing, transport, and sale or supply to the final
consumer, including, where relevant, labelling, advertising,import, export and subcontracting activities;(51) ‘ingredient’ means an ingredient as defined in point (f) of
Article 2(2) of Regulation (EU) No 1169/2011 or, for products
other than food, any substance or product used in the manufacture
or preparation of products that is still present in the finishedproduct, even in altered form;(1) Regulation (EC) No 178/2002 of the European Parliament and of the Councilof 28 January 2002 laying down the general principles and requirements offood law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(2) Regulation (EC) No 767/2009 of the European Parliament and of the Councilof 13 July 2009 on the placing on the market and use of feed, amending
European Parliament and Council Regulation (EC) No 1831/2003 andrepealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC,Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 9▼B(52) ‘labelling’ means any words, particulars, trade marks, brand name,pictorial matter or symbol relating to a product that are placed on
any packaging, document, notice, label, ring or collar that
accompanies or refers to that product;(53) ‘advertising’ means any presentation of products to the public, by
any means other than a label, that is intended or is likely to
influence and shape attitudes, beliefs and behaviours in order todirectly or indirectly promote the sale of products;(54) ‘competent authorities’ means competent authorities as defined inpoint (3) of Article 3 of Regulation (EU) 2017/625;(55) ‘control authority’ means an organic control authority as defined inpoint (4) of Article 3 of Regulation (EU) 2017/625, or an authority
recognised by the Commission or by a third country recognised by
the Commission for the purposes of carrying out controls in third
countries for the import of organic and in-conversion products into
the Union;(56) ‘control body’ means a delegated body as defined in point (5) of
Article 3 of Regulation (EU) 2017/625, or a body recognised by
the Commission or by a third country recognised by theCommission for the purposes of carrying out controls in third
countries for the import of organic and in-conversion products
into the Union;(57) ‘non-compliance’ means non-compliance with this Regulation or
non-compliance with the delegated or implementing acts adopted
in accordance with this Regulation;(58) ‘genetically modified organism’ or ‘GMO’ means a geneticallymodified organism as defined in point (2) of Article 2 ofDirective 2001/18/EC of the European Parliament and of theCouncil (1) which is not obtained through the techniques ofgenetic modification listed in Annex I.B to that Directive;(59) ‘produced from GMOs’ means derived in whole or in part from
GMOs but not containing or consisting of GMOs;(60) ‘produced by GMOs’ means derived by using a GMO as the last
living organism in the production process, but not containing or
consisting of GMOs nor produced from GMOs;(61) ‘food additive’ means a food additive as defined in point (a) of
Article 3(2) of Regulation (EC) No 1333/2008 of the European
Parliament and of the Council (2);(1) Directive 2001/18/EC of the European Parliament and of the Council of
12 March 2001 on the deliberate release into the environment of geneticallymodified organisms and repealing Council Directive 90/220/EEC (OJ L 106,17.4.2001, p. 1).
(2) Regulation (EC) No 1333/2008 of the European Parliament and of theCouncil of 16 December 2008 on food additives (OJ L 354, 31.12.2008,
p. 16).

02018R0848 — EN — 21.02.2023 — 003.001 — 10▼B(62) ‘feed additives’ mean feed additives as defined in point (a) of
Article 2(2) of Regulation (EC) No 1831/2003 of the European
Parliament and of the Council (1);(63) ‘engineered nanomaterial’ means an engineered nanomaterial as
defined in point (f) of Article 3(2) of Regulation (EU)2015/2283 of the European Parliament and of the Council (2);(64) ‘equivalence’ means meeting the same objectives and principles byapplying rules which ensure the same level of assurance ofconformity;(65) ‘processing aid’ means a processing aid as defined in point (b) of
Article 3(2) of Regulation (EC) No 1333/2008 for food and inpoint (h) of Article 2(2) of Regulation (EC) No 1831/2003 forfeed;(66) ‘food enzyme’ means a food enzyme as defined in point (a) of
Article 3(2) of Regulation (EC) No 1332/2008 of the European
Parliament and of the Council (3);(67) ‘ionising radiation’ means ionising radiation as defined inpoint (46) of Article 4 of Council Directive 2013/59/Euratom (4);(68) ‘prepacked food’ means prepacked food as defined in point (e) ofArticle 2(2) of Regulation (EU) No 1169/2011;(69) ‘poultry house’ means a fixed or mobile building for accom­
modating flocks of poultry, which includes all surfaces coveredby roofs, including a veranda; the house may be subdivided into
separate compartments, each accommodating a single flock;(70) ‘soil-related crop cultivation’ means production in living soil or insoil that is mixed or fertilised with materials and products that areallowed in organic production in connection with the subsoil andbedrock;(1) Regulation (EC) No 1831/2003 of the European Parliament and of theCouncil of 22 September 2003 on additives for use in animal nutrition(OJ L 268, 18.10.2003, p. 29).
(2) Regulation (EU) 2015/2283 of the European Parliament and of the Council of
25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011of the European Parliament and of the Council and repealing Regulation (EC)No 258/97 of the European Parliament and of the Council and Commission
Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
(3) Regulation (EC) No 1332/2008 of the European Parliament and of theCouncil of 16 December 2008 on food enzymes and amending Council
Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive
2000/13/EC, Council Directive 2001/112/EC and Regulation (EC)No 258/97 (OJ L 354, 31.12.2008, p. 7).
(4) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic
safety standards for protection against the dangers arising from exposure toionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom,
96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014,p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 11▼B(71) ‘unprocessed products’ means unprocessed products as defined inpoint (n) of Article 2(1) of Regulation (EC) No 852/2004 of theEuropean Parliament and of the Council (1), irrespective of
packaging or labelling operations;(72) ‘processed products’ means processed products as defined inpoint (o) of Article 2(1) of Regulation (EC) No 852/2004, irre­
spective of packaging or labelling operations;(73) ‘processing’ means processing as defined in point (m) of
Article 2(1) of Regulation (EC) No 852/2004; this includes theuse of substances referred to in Articles 24 and 25 of this Regu­
lation but does not include packaging or labelling operations;(74) ‘integrity of organic or in-conversion products’ means the fact thatthe product does not exhibit non-compliance which:(a) in any stage of production, preparation and distribution affects
the organic or in-conversion characteristics of the product; or(b) is repetitive or intentional;(75) ‘pen’ means an enclosure that includes a part in which animals areprovided with protection from adverse weather conditions.

CHAPTER IIOBJECTIVES AND PRINCIPLES OF ORGANIC PRODUCTION

Article 4
Objectives
Organic production shall pursue the following general objectives:(a) contributing to protection of the environment and the climate;(b) maintaining the long-term fertility of soils;(c) contributing to a high level of biodiversity;(d) substantially contributing to a non-toxic environment;(e) contributing to high animal welfare standards and, in particular, tomeeting the species-specific behavioural needs of animals;(f) encouraging short distribution channels and local production in thevarious areas of the Union;(1) Regulation (EC) No 852/2004 of the European Parliament and of the Councilof 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 12▼B(g) encouraging the preservation of rare and native breeds in danger ofextinction;(h) contributing to the development of the supply of plant genetic
material adapted to the specific needs and objectives of organic
agriculture;(i) contributing to a high level of biodiversity, in particular by using
diverse plant genetic material, such as organic heterogeneousmaterial and organic varieties suitable for organic production;(j) fostering the development of organic plant breeding activities inorder to contribute to favourable economic perspectives of theorganic sector.

Article 5
General principles
Organic production is a sustainable management system that is based on
the following general principles:(a) respect for nature’s systems and cycles and the sustainment andenhancement of the state of the soil, the water and the air, of thehealth of plants and animals, and of the balance between them;(b) the preservation of natural landscape elements, such as natural
heritage sites;(c) the responsible use of energy and natural resources, such as water,soil, organic matter and air;(d) the production of a wide variety of high-quality food and otheragricultural and aquaculture products that respond to consumers’
demand for goods that are produced by the use of processes that
do not harm the environment, human health, plant health or animal
health and welfare;▼C2(e) ensuring the integrity of organic production at all stages of the
production, preparation and distribution of food and feed;▼B(f) the appropriate design and management of biological processes,
based on ecological systems and using natural resources which
are internal to the management system, using methods that:(i) use living organisms and mechanical production methods;(ii) practice soil-related crop cultivation and land-related livestock
production, or practice aquaculture which complies with theprinciple of the sustainable exploitation of aquatic resources;

02018R0848 — EN — 21.02.2023 — 003.001 — 13▼B(iii) exclude the use of GMOs, products produced from GMOs, andproducts produced by GMOs, other than veterinary medicinal
products;(iv) are based on risk assessment and the use of precautionary
measures and preventive measures, where appropriate;(g) the restriction of the use of external inputs; where external inputs
are required or the appropriate management practices and methods
referred to in point (f) do not exist, the external inputs shall belimited to:(i) inputs from organic production; in the case of plant repro­
ductive material, priority shall be given to varieties selected
for their ability to meet the specific needs and objectives oforganic agriculture;(ii) natural or naturally-derived substances;(iii) low solubility mineral fertilisers;(h) the adaptation of the production process, where necessary andwithin the framework of this Regulation, to take account of thesanitary status, regional differences in the ecological balance,
climatic and local conditions, stages of development and specifichusbandry practices;(i) the exclusion from the whole organic food chain of animal cloning,of rearing artificially induced polyploid animals and of ionisingradiation;(j) the observance of a high level of animal welfare respecting
species-specific needs.

Article 6
Specificprinciples

applicable to agricultural
aquaculture

activities

andAs regards agricultural activities and aquaculture, organic production
shall, in particular, be based on the following specific principles:(a) the maintenance and enhancement of soil life and natural soil
fertility, soil stability, soil water retention and soil biodiversity,
preventing and combating loss of soil organic matter, soil
compaction and soil erosion, and the nourishing of plants
primarily through the soil ecosystem;(b) the limitation of the use of non-renewable resources and external
inputs to a minimum;(c) the recycling of waste and by-products of plant and animal origin
as input in plant and livestock production;

02018R0848 — EN — 21.02.2023 — 003.001 — 14▼B(d) the maintenance of plant health by preventive measures, inparticular the choice of appropriate species, varieties or hetero­geneous material resistant to pests and diseases, appropriate crop
rotations, mechanical and physical methods and protection of thenatural enemies of pests;(e) the use of seeds and animals with a high degree of genetic
diversity, disease resistance and longevity;(f) in the choosing of plant varieties, having regard to the particu­
larities of the specific organic production systems, focussing on
agronomic performance, disease resistance, adaptation to diverse
local soil and climate conditions and respect for the natural
crossing barriers;(g) the use of organic plant reproductive material, such as plant repro­
ductive material of organic heterogeneous material and of organic
varieties suitable for organic production;(h) the production of organic varieties through natural reproductive
ability and focussing on containment within natural crossing
barriers;(i) without prejudice to Article 14 of Regulation (EC) No 2100/94 andto the national plant variety rights granted under Member States’
national law, the possibility for farmers to use plant reproductive
material obtained from their own farms in order to foster genetic
resources adapted to the special conditions of organic production;(j) in the choosing of animal breeds, having regard to a high degree ofgenetic diversity, the capacity of animals to adapt to local
conditions, their breeding value, their longevity, their vitality andtheir resistance to disease or health problems;(k) the practice of site-adapted and land-related livestock production;(l) the application of animal husbandry practices which enhance theimmune system and strengthen the natural defence against diseases,
including regular exercise and access to open air areas andpastures;(m) the feeding of livestock with organic feed composed of agriculturalingredients resulting from organic production and of natural
non-agricultural substances;(n) the production of organic livestock products derived from animals
that have been raised on organic holdings throughout their lives
since birth or hatching;(o) the continuing health of the aquatic environment and the quality ofsurrounding aquatic and terrestrial ecosystems;

02018R0848 — EN — 21.02.2023 — 003.001 — 15
▼B(p) the feeding of aquatic organisms with feed from sustainably
exploited fisheries in accordance with Regulation (EU)No 1380/2013 or with organic feed composed of agriculturalingredients resulting from organic production, including organic
aquaculture, and of natural non-agricultural substances;(q) avoiding any endangerment of species of conservation interest thatmight arise from organic production.

Article 7Specific principles applicable to the processing of organic food
The production of processed organic food shall be based, in particular,
on the following specific principles:(a) the production of organic food from organic agricultural ingredients;(b) the restriction of the use of food additives, of non-organic
ingredients with mainly technological and sensory functions, andof micronutrients and processing aids, so that they are used to aminimum extent and only in cases of essential technological need orfor particular nutritional purposes;(c) the exclusion of substances and processing methods that might bemisleading as regards the true nature of the product;(d) the processing of organic food with care, preferably through the useof biological, mechanical and physical methods;(e) the exclusion of food containing, or consisting of, engineered
nanomaterials.

Article 8Specific principles applicable to the processing of organic feed
The production of processed organic feed shall be based, in particular,
on the following specific principles:(a) the production of organic feed from organic feed materials;(b) the restriction of the use of feed additives and processing aids, sothat they are used to a minimum extent and only in cases of
essential technological or zootechnical needs or for particular nutri­tional purposes;(c) the exclusion of substances and processing methods that might bemisleading as regards the true nature of the product;

02018R0848 — EN — 21.02.2023 — 003.001 — 16▼B(d) the processing of organic feed with care, preferably through the useof biological, mechanical and physical methods.

CHAPTER III
PRODUCTION RULES

Article 9
General production rules
1.
Operators shall comply with the general production rules laid
down in this Article.
2.
The entire holding shall be managed in compliance with therequirements of this Regulation that apply to organic production.
3.
For the purposes and uses referred to in Articles 24 and 25 and in
Annex II, only products and substances that have been authorised
pursuant to those provisions may be used in organic production,
provided that their use in non-organic production has also been auth­orised in accordance with the relevant provisions of Union law and,
where applicable, in accordance with national provisions based onUnion law.
The following products and substances referred to in Article 2(3) ofRegulation (EC) No 1107/2009 shall be allowed for use in organic
production, provided that they are authorised pursuant to that Regu­
lation:(a) safeners, synergists and co-formulants as components of plant
protection products;(b) adjuvants that are to be mixed with plant protection products.
The use in organic production of products and substances for purposes
other than those covered by this Regulation shall be allowed, provided
that their use complies with the principles laid down in Chapter II.
4.
Ionising radiation shall not be used in the treatment of organic
food or feed, and in the treatment of raw materials used in organic foodor feed.
5.
The use of animal cloning, and the rearing of artificially induced
polyploid animals, shall be prohibited.
6.
Preventive and precautionary measures shall be taken, whereappropriate, at every stage of production, preparation and distribution.
7.
Notwithstanding paragraph 2, a holding may be split into clearlyand effectively separated production units for organic, in-conversion andnon-organic production, provided that for the non-organic production
units:

02018R0848 — EN — 21.02.2023 — 003.001 — 17▼B(a) as regards livestock, different species are involved;(b) as regards plants, different varieties that can be easily differentiatedare involved.
As regards algae and aquaculture animals, the same species may be
involved, provided that there is a clear and effective separation
between the production sites or units.
8.
By way of derogation from point (b) of paragraph 7, in the case of
perennial crops which require a cultivation period of at least three years,
different varieties that cannot be easily differentiated, or the same
varieties, may be involved, provided that the production in question iswithin the context of a conversion plan, and provided that theconversion of the last part of the area related to the production inquestion to organic production begins as soon as possible and iscompleted within a maximum of five years.
In such cases:(a) the farmer shall notify the competent authority, or, where appro­
priate, the control authority or the control body, of the start ofharvest of each of the products concerned at least 48 hours inadvance;(b) upon completion of the harvest, the farmer shall inform thecompetent authority, or, where appropriate, the control authority
or the control body, of the exact quantities harvested from theunits concerned and of the measures taken to separate the products;(c) the conversion plan and the measures to be taken to ensure theeffective and clear separation shall be confirmed each year by thecompetent authority, or, where appropriate, by the control authority
or the control body, after the start of the conversion plan.
9.
The requirements concerning different species and varieties, laid
down in points (a) and (b) of paragraph 7, shall not apply in the case of
research and educational centres, plant nurseries, seed multipliers andbreeding operations.
10.
Where, in the cases referred to in paragraphs 7, 8 and 9, not all
production units of a holding are managed under organic production
rules, the operators shall:(a) keep the products used for the organic and in-conversion production
units separate from those used for the non-organic production units;(b) keep the products produced by the organic, in-conversion andnon-organic production units separate from each other;(c) keep adequate records to show the effective separation of the
production units and of the products.

02018R0848 — EN — 21.02.2023 — 003.001 — 18
▼B
11.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending paragraph 7 of this Article byadding further rules on the splitting of a holding into organic,
in-conversion and non-organic production units, in particular in
relation to products listed in Annex I, or by amending those added rules.

Article 10
Conversion
1.
Farmers and operators that produce algae or aquaculture animals
shall comply with a conversion period. During the whole conversion
period they shall apply all rules on organic production laid down in thisRegulation, in particular the applicable rules on conversion set out inthis Article and in Annex II.

2.
The conversion period shall start at the earliest when the farmer orthe operator that produces algae or aquaculture animals has notified theactivity to the competent authorities, in accordance with Article 34(1),in the Member State in which the activity is carried out and in whichthat farmer or operator’s holding is subject to the control system.

3.
No previous period may be retroactively recognised as being partof the conversion period, except where:(a) the operator’s land parcels were subject to measures which were
defined in a programme implemented pursuant to Regulation (EU)No 1305/2013 for the purpose of ensuring that no products or
substances other than those authorised for use in organic production
have been used on those land parcels; or(b) the operator can provide proof that the land parcels were natural or
agricultural areas that, for a period of at least three years, have notbeen treated with products or substances that are not authorised foruse in organic production.

4.
Products produced during the conversion period shall not bemarketed as organic products or as in-conversion products.

However, the following products produced during the conversion period
and in compliance with paragraph 1 may be marketed as in-conversion
products:(a) plant reproductive material, provided that a conversion period of atleast 12 months has been complied with;(b) food products of plant origin and feed products of plant origin,provided that the product contains only one agricultural crop
ingredient, and provided that a conversion period of at least 12
months before the harvest has been complied with.

02018R0848 — EN — 21.02.2023 — 003.001 — 19
▼B
5.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending point 1.2.2 of Part II of
Annex II by adding conversion rules for species other than thoseregulated in Part II of Annex II on 17 June 2018, or by amending
those added rules.

6.
The Commission shall, where appropriate, adopt implementing
acts specifying the documents to be supplied for the purpose of theretroactive recognition of a previous period in accordance withparagraph 3 of this Article.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 11
Prohibition of the use of GMOs
1.
GMOs, products produced from GMOs, and products produced by
GMOs shall not be used in food or feed, or as food, feed, processing
aids, plant protection products, fertilisers, soil conditioners, plant repro­
ductive material, micro-organisms or animals in organic production.

2.
For the purposes of the prohibition laid down in paragraph 1, withregard to GMOs and products produced from GMOs for food and feed,
operators may rely on the labels of a product that have been affixed orprovided pursuant to Directive 2001/18/EC, Regulation (EC)No 1829/2003 of the European Parliament and of the Council (1) orRegulation (EC) No 1830/2003 of the European Parliament and of
the Council (2) or any accompanying document provided pursuant
thereto.

3.
Operators may assume that no GMOs and no products produced
from GMOs have been used in the manufacture of purchased food andfeed where such products do not have a label affixed or provided, or are
not accompanied by a document provided, pursuant to the legal acts
referred to in paragraph 2, unless they have obtained other information
indicating that the labelling of the products concerned is not in
conformity with those legal acts.

4.
For the purposes of the prohibition laid down in paragraph 1, withregard to products not covered by paragraphs 2 and 3, operators using
non-organic products purchased from third parties shall require thevendor to confirm that those products are not produced from GMOs
or produced by GMOs.
(1) Regulation (EC) No 1829/2003 of the European Parliament and of theCouncil of 22 September 2003 on genetically modified food and feed
(OJ L 268, 18.10.2003, p. 1).
(2) Regulation (EC) No 1830/2003 of the European Parliament and of theCouncil of 22 September 2003 concerning the traceability and labelling ofgenetically modified organisms and the traceability of food and feed products
produced from genetically modified organisms and amending Directive
2001/18/EC (OJ L 268, 18.10.2003, p. 24).

02018R0848 — EN — 21.02.2023 — 003.001 — 20
▼B
Article 12
Plant production rules
1.
Operators that produce plants or plant products shall comply, inparticular, with the detailed rules set out in Part I of Annex II.

2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) points 1.3 and 1.4 of Part I of Annex II as regards derogations;(b) point 1.8.5 of Part I of Annex II as regards the use of in-conversion
and non-organic plant reproductive material;(c) point 1.9.5 of Part I of Annex II by adding further provisions
concerning agreements between operators of agricultural holdings,
or by amending those added provisions;(d) point 1.10.1 of Part I of Annex II by adding further pest- andweed-management measures, or by amending those added measures;(e) Part I of Annex II by adding further detailed rules and cultivation
practices for specific plants and plant products, including rules forsprouted seeds, or by amending those added rules.

Article 13
Specific provisions for the marketing of plant reproductive materialof organic heterogeneous material
1.
Plant reproductive material of organic heterogeneous material may
be marketed without complying with the requirements for registration
and without complying with the certification categories of pre-basic,
basic and certified material or with the requirements for othercategories, which are set out in Directives 66/401/EEC, 66/402/EEC,
68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC,
2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC or acts
adopted pursuant to those Directives.

2.
Plant reproductive material of organic heterogeneous material as
referred to in paragraph 1 may be marketed following a notification of
the organic heterogeneous material by the supplier to the responsible
official bodies referred to in Directives 66/401/EEC, 66/402/EEC,
68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC,
2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC, made bymeans of a dossier containing:(a) the contact details of the applicant;(b) the species and denomination of the organic heterogeneous material;02018R0848 — EN — 21.02.2023 — 003.001 — 21▼B(c) the description of the main agronomic and phenotypic characteris­tics that are common to that plant grouping, including breeding
methods, any available results from tests on those characteristics,
the country of production and the parental material used;(d) a declaration by the applicant concerning the truth of the elements
in points (a), (b) and (c); and(e) a representative sample.
That notification shall be sent by registered letter, or by any othermeans of communication accepted by the official bodies, with confir­
mation of receipt requested.
Three months after the date shown on the return receipt, provided thatno additional information was requested or that no formal refusal forreasons of incompleteness of the dossier or non-compliance as definedin Article 3(57) was communicated to the supplier, the responsible
official body shall be deemed to have acknowledged the notificationand its content.
After having expressly or implicitly acknowledged the notification, theresponsible official body may proceed to the listing of the notified
organic heterogeneous material. That listing shall be free of charge tothe supplier.
The listing of any organic heterogeneous material shall be
communicated to the competent authorities of the other Member
States and to the Commission.
Such organic heterogeneous material shall fulfil the requirements laid
down in the delegated acts adopted in accordance with paragraph 3.
3.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation by settingout rules governing the production and marketing of plant reproductive
material of organic heterogeneous material of particular genera or
species, as regards:(a) the description of the organic heterogeneous material, including therelevant breeding and production methods and parental material
used;(b) the minimum quality requirements for seeds lots, including identity,
specific purity, germination rates and sanitary quality;(c) labelling and packaging;(d) information and samples of production to be kept by the profes­
sional operators;(e) where applicable, maintenance of the organic heterogeneousmaterial.

02018R0848 — EN — 21.02.2023 — 003.001 — 22
▼B
Article 14
Livestock production rules
1.
Livestock operators shall comply, in particular, with the detailed
production rules set out in Part II of Annex II and in any implementing
acts referred to in paragraph 3 of this Article.
2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) points 1.3.4.2, 1.3.4.4.2 and 1.3.4.4.3 of Part II of Annex II by
reducing the percentages as regards the origin of animals, once
sufficient availability on the Union market of organic animals has
been established;(b) point 1.6.6 of Part II of Annex II as regards the limit on organic
nitrogen linked to the total stocking density;(c) point 1.9.6.2(b) of Part II of Annex II as regards the feeding of beecolonies;(d) points 1.9.6.3(b) and (e) of Part II of Annex II as regards theacceptable treatments for the disinfection of apiaries and themethods and treatments to fight against Varroa destructor;(e) Part II of Annex II by adding detailed rules on livestock production
for species other than species regulated in that Part on 17 June
2018, or by amending those added rules, as regards:(i) derogations as regards the origin of animals;(ii) nutrition;(iii) housing and husbandry practices;(iv) health care;(v) animal welfare.
3.
The Commission shall, where appropriate, adopt implementing
acts regarding Part II of Annex II providing rules on:(a) the minimum period to be complied with for feeding of sucklinganimals with maternal milk, referred to in point 1.4.1(g);(b) the stocking density and the minimum surface for indoor andoutdoor areas that are to be complied with for specific livestock
species to ensure that the developmental, physiological and etho­
logical needs of animals are met in accordance with points 1.6.3,
1.6.4 and 1.7.2,

02018R0848 — EN — 21.02.2023 — 003.001 — 23
▼B(c) the characteristics of and technical requirements for the minimum
surface for indoor and outdoor areas;(d) the characteristics of and technical requirements for buildings andpens for all livestock species other than bees, to ensure that thedevelopmental, physiological and ethological needs of animals are
met in accordance with point 1.7.2;(e) requirements for vegetation and the characteristics of protectedfacilities and open air areas.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 15
Production rules for algae and aquaculture animals
1.
Operators that produce algae and aquaculture animals shallcomply, in particular, with the detailed production rules set out inPart III of Annex II and in any implementing acts referred to inparagraph 3 of this Article.
2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) point 3.1.3.3 of Part III of Annex II as regards feed for carnivorous
aquaculture animals;(b) point 3.1.3.4 of Part III of Annex II by adding further specific rules
on feed for certain aquaculture animals, or by amending those added
rules;(c) point 3.1.4.2 of Part III of Annex II as regards veterinary treatments
for aquaculture animals;(d) Part III of Annex II by adding further detailed conditions per
species for broodstock management, breeding and juvenile
production, or by amending those added detailed conditions.
3.
The Commission shall, where appropriate, adopt implementing
acts laying down detailed rules per species or per group of species on
the stocking density, and on the specific characteristics for production
systems and containment systems, in order to ensure that the
species-specific needs are met.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).
4.
For the purpose of this Article and of Part III of Annex II,‘stocking density’ means the live weight of aquaculture animals per
cubic metre of water at any time during the grow-out phase and, inthe case of flatfish and shrimp, the weight per square metre of surface.

02018R0848 — EN — 21.02.2023 — 003.001 — 24
▼B
Article 16
Production rules for processed food1.
Operators that produce processed food shall comply, in particular,
with the detailed production rules set out in Part IV of Annex II and inany implementing acts referred to in paragraph 3 of this Article.

2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) point 1.4 of Part IV of Annex II as regards precautionary measuresand preventive measures to be taken by operators;(b) point 2.2.2 of Part IV of Annex II as regards the types andcomposition of products and substances that are allowed for use
in processed food, as well as conditions under which they may be
used;(c) point 2.2.4 of Part IV of Annex II as regards the calculation of thepercentage of agricultural ingredients referred to in points (a)(ii) and(b)(i) of Article 30(5), including the food additives authorised
pursuant to Article 24 for use in organic production that areconsidered as agricultural ingredients for the purpose of suchcalculations.

Those delegated acts shall not include the possibility of using flavouring
substances or flavouring preparations which are neither natural, within
the meaning of Article 16(2), (3) and (4) of Regulation (EC)No 1334/2008 of the European Parliament and of the Council (1), nororganic.

3.
The Commission may adopt implementing acts laying down thetechniques authorised in the processing of food products.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 17
Production rules for processed feed1.
Operators that produce processed feed shall comply, in particular,
with the detailed production rules set out in Part V of Annex II and inany implementing acts referred to in paragraph 3 of this Article.
(1) Regulation (EC) No 1334/2008 of the European Parliament and of theCouncil of 16 December 2008 on flavourings and certain food ingredientswith flavouring properties for use in and on foods and amending Council
Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC)No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).

02018R0848 — EN — 21.02.2023 — 003.001 — 25
▼B
2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending point 1.4 of Part V of Annex II
by adding further precautionary and preventive measures to be taken by
operators, or by amending those added measures.

3.
The Commission may adopt implementing acts laying down thetechniques authorised for use in the processing of feed products.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 18
Production rules for wine1.
Operators that produce products of the wine sector shall comply,
in particular, with the detailed production rules set out in Part VI of
Annex II.

2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) point 3.2 of Part VI of Annex II by adding further oenologicalpractices, processes and treatments that are prohibited, or byamending those added elements;(b) point 3.3. of Part VI of Annex II.

Article 19
Production rules for yeast used as food or feed1.
Operators that produce yeast to be used as food or feed shallcomply, in particular, with the detailed production rules set out inPart VII of Annex II.

2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending point 1.3 of Part VII of
Annex II by adding further detailed yeast production rules, or byamending those added rules.

Article 20
Absence of certain production rules for specific livestock species
and species of aquaculture animals
Pending the adoption of:(a) additional general rules for other livestock species than thoseregulated in point 1.9 of Part II of Annex II in accordance withpoint (e) of Article 14(2);02018R0848 — EN — 21.02.2023 — 003.001 — 26▼B(b) the implementing acts referred to in Article 14(3) for livestock
species; or(c) the implementing acts referred to in Article 15(3) for species orgroup of species of aquaculture animals;a Member State may apply detailed national production rules for
specific species or groups of species of animals in relation to theelements to be covered by the measures referred to in points (a), (b)and (c), provided that those national rules are in accordance with thisRegulation, and provided that they do not prohibit, restrict or impede
the placing on the market of products which have been produced
outside its territory and which comply with this Regulation.

Article 21
Production rules for products not falling within the categories of
products referred to in Articles 12 to 19
1.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending Annex II by adding detailed
production rules, as well as rules on the obligation to convert, for
products that do not fall within the categories of products referred toin Articles 12 to 19, or by amending those added rules.
Those delegated acts shall be based on the objectives and principles oforganic production laid down in Chapter II and shall comply with thegeneral production rules laid down in Articles 9, 10 and 11 as well as
existing detailed production rules laid down for similar products inAnnex II. They shall lay down requirements concerning, in particular,
the treatments, practices and inputs that are allowed or prohibited, orconversion periods for the products concerned.
2.
In the absence of the detailed production rules referred to inparagraph 1:(a) operators shall, as regards products referred to in paragraph 1,comply with the principles laid down in Articles 5 and 6, mutatis
mutandis with the principles laid down in Article 7, and with thegeneral production rules laid down in Articles 9 to 11;(b) a Member State may, as regards products referred to in paragraph 1,
apply detailed national production rules, provided that those rules
are in accordance with this Regulation, and provided that they do
not prohibit, restrict or impede the placing on the market of
products which have been produced outside its territory andwhich comply with this Regulation.

Article 22
Adoption of exceptional production rules
1.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation by laying
down:02018R0848 — EN — 21.02.2023 — 003.001 — 27▼B(a) the criteria to determine whether a situation qualifies as catastrophic
circumstances deriving from an ‘adverse climatic event’, ‘animal
diseases’, an ‘environmental incident’, a ‘natural disaster’ or a ‘cata­strophic event’, as defined in points (h), (i), (j), (k) and (l) of
Article 2(1) of Regulation (EU) No 1305/2013, respectively, as
well as any comparable situation;(b) specific rules, including possible derogations from this Regulation,
on how Member States are to deal with such catastrophic circum­
stances if they decide to apply this Article; and(c) specific rules on monitoring and reporting in such cases.

Those criteria and rules shall be subject to the principles of organic
production laid down in Chapter II.

2.
Where a Member State has formally recognised an event as anatural disaster as referred to in Article 18(3) or Article 24(3) of Regu­
lation (EU) No 1305/2013, and that event makes it impossible tocomply with the production rules laid down in this Regulation, that
Member State may grant derogations from the production rules for alimited period until organic production can be re-established, subject tothe principles laid down in Chapter II and to any delegated act adopted
in accordance with paragraph 1.

3.
Member States may adopt measures in accordance with thedelegated act referred to in paragraph 1 to allow organic production
to continue or recommence in the event of catastrophic circumstances.

Article 23
Collection, packaging, transport and storage
1.
Operators shall ensure that organic products and in-conversion
products are collected, packaged, transported and stored in accordancewith the rules set out in Annex III.

2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) Section 2 of Annex III;(b) Sections 3, 4 and 6 of Annex III by adding further special rules forthe transport and reception of the products concerned, or byamending those added rules.

02018R0848 — EN — 21.02.2023 — 003.001 — 28
▼B
Article 24
Authorisation of products and substances for use in organic
production
1.
The Commission may authorise certain products and substances
for use in organic production, and shall include any such authorised
products and substances in restrictive lists, for the following purposes:(a) as active substances to be used in plant protection products;(b) as fertilisers, soil conditioners and nutrients;(c) as non-organic feed material of plant, algal, animal or yeast origin
or as feed material of microbial or mineral origin;(d) as feed additives and processing aids;(e) as products for the cleaning and disinfection of ponds, cages, tanks,
raceways, buildings or installations used for animal production;(f) as products for the cleaning and disinfection of buildings and instal­lations used for plant production, including for storage on an agri­
cultural holding;(g) as products for cleaning and disinfection in processing and storage
facilities.
2.
In addition to products and substances authorised in accordancewith paragraph 1, the Commission may authorise certain products andsubstances for use in the production of processed organic food and ofyeast used as food or feed, and shall include any such authorised
products and substances in restrictive lists, for the following purposes:(a) as food additives and processing aids;(b) as non-organic agricultural ingredients to be used for the productionof processed organic food;(c) as processing aids for the production of yeast and yeast products.
3.
The authorisation of the products and substances referred to inparagraph 1 for use in organic production shall be subject to the prin­ciples laid down in Chapter II and to the following criteria, which shallbe evaluated as a whole:(a) they are essential for sustained production and for the use for which
they are intended;(b) all of the products and substances concerned are of plant, algal,
animal, microbial or mineral origin, except in cases where
products or substances from such sources are not available insufficient quantities or qualities or where alternatives are notavailable;

02018R0848 — EN — 21.02.2023 — 003.001 — 29
▼B(c) in the case of products referred to in point (a) of paragraph 1:(i) their use is essential for the control of a pest for which otherbiological, physical or breeding alternatives, cultivation
practices or other effective management practices are notavailable;(ii) if such products are not of plant, algal, animal, microbial or
mineral origin and are not identical to their natural form, theirconditions for use preclude any direct contact with the edible
parts of the crop;(d) in the case of products referred to in point (b) of paragraph 1, theiruse is essential for building or maintaining the fertility of the soil or
to fulfil specific nutritional requirements of crops, or for specificsoil-conditioning purposes;(e) in the case of products referred to in points (c) and (d) ofparagraph 1:(i) their use is necessary to maintain animal health, animal welfare
and vitality and contributes to an appropriate diet fulfilling thephysiological and behavioural needs of the species concernedor their use is necessary to produce or preserve feed because
the production or preservation of feed is not possible without
having recourse to such substances;(ii) feed of mineral origin, trace elements, vitamins or provitamins
are of natural origin, except in cases where products or
substances from such sources are not available in sufficientquantities or qualities or where alternatives are not available;(iii) the use of non-organic feed material of plant or animal origin isnecessary because feed material of plant or animal origin
produced in accordance with organic production rules is notavailable in sufficient quantity;(iv) the use of non-organic spices, herbs and molasses is necessary
because such products are not available in organic form; they
have to be produced or prepared without chemical solvents andtheir use is limited to 1 % of the feed ration for a given
species, calculated annually as a percentage of the dry matterof feed from agricultural origin.

4.
The authorisation of the products and substances referred to inparagraph 2 for use in the production of processed organic food orfor the production of yeast used as food or feed shall be subject tothe principles laid down in Chapter II and to the following criteria,
which shall be evaluated as a whole:02018R0848 — EN — 21.02.2023 — 003.001 — 30
▼B(a) alternative products or substances authorised in accordance with this
Article or techniques compliant with this Regulation are notavailable;(b) it would be impossible to produce or preserve the food or to fulfil
given dietary requirements provided for on the basis of Union legis­
lation without having recourse to those products and substances;(c) they are to be found in nature and may only have undergone mech­anical, physical, biological, enzymatic or microbial processes,
except in cases where products or substances from such sources
are not available in sufficient quantities or qualities;(d) the organic ingredient is not available in sufficient quantity.
5.
The authorisation of the use of chemically synthesised products
and substances, in accordance with paragraphs 1 and 2 of this Article,
shall be strictly limited to cases where the use of external inputs referred
to in point (g) of Article 5 would contribute to unacceptable impacts on
the environment.
6.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending paragraphs 3 and 4 of this
Article by adding further criteria for the authorisation of products andsubstances referred to in paragraphs 1 and 2 of this Article for use inorganic production in general, and in the production of processedorganic food in particular, as well as further criteria for the withdrawalof such authorisations, or by amending those added criteria.
7.
Where a Member State considers that a product or substanceshould be added to or withdrawn from the lists of authorised products
and substances referred to in paragraphs 1 and 2, or that the specifi­
cations of use referred to in the production rules should be amended, it
shall ensure that a dossier giving the reasons for the inclusion, with­drawal or other amendments is officially sent to the Commission and tothe other Member States and is made publicly available, subject toUnion and national legislation on data protection.
The Commission shall publish any requests referred to in this paragraph.
8.
The Commission shall regularly review the lists referred to in this
Article.
The list of non-organic ingredients referred to in point (b) of paragraph
2 shall be reviewed at least once a year.
9.
The Commission shall adopt implementing acts concerning theauthorisation or withdrawal of authorisation of products and substancesin accordance with paragraphs 1 and 2 that may be used in organic
production in general and in the production of processed organic food inparticular, and establishing the procedures to be followed for such auth­orisations and the lists of such products and substances and, whereappropriate, their description, compositional requirements andconditions for use.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

02018R0848 — EN — 21.02.2023 — 003.001 — 31
▼B
Article 25
Authorisation of non-organic agricultural ingredients for processedorganic food by Member States
1.
Where it is necessary in order to ensure access to certain agri­
cultural ingredients, and where such ingredients are not available inorganic form in sufficient quantity, a Member State may, at therequest of an operator, provisionally authorise the use of non-organic
agricultural ingredients for the production of processed organic food on
its territory for a period of maximum six months. That authorisation
shall apply to all operators in that Member State.

2.
The Member State shall immediately notify the Commission andthe other Member States, via a computer system that enables the elec­
tronic exchange of documents and information made available by theCommission, of any authorisation granted for its territory in accordancewith paragraph 1.

3.
The Member State may prolong the authorisation provided for inparagraph 1 two times for a maximum of six months each, provided thatno other Member State has objected by indicating, via the systemreferred to in paragraph 2, that such ingredients are available inorganic form in sufficient quantity.

4.
A control authority or a control body recognised in accordancewith Article 46(1) may grant a provisional authorisation, as referred toin paragraph 1 of this Article, for a maximum of six months to operatorsin third countries that request such an authorisation and that are subject
to controls by that control authority or control body, provided that theconditions of that paragraph are fulfilled in the third country concerned.
The authorisation may be prolonged for a maximum of two times six
months each.

5.
Where, after two prolongations of a provisional authorisation, aMember State considers, on the basis of objective information, that theavailability of such ingredients in organic form remains insufficient tomeet the qualitative and quantitative needs of operators, it may make arequest to the Commission in accordance with Article 24(7).

Article 26
Collection of data concerning the availability on the market oforganic and in-conversion plant reproductive material, organic
animals and organic aquaculture juveniles
1.
Each Member State shall ensure that a regularly updated databaseis established for the listing of the organic and in-conversion plant
reproductive material, excluding seedlings but including seed potatoes,
which is available on its territory.

2.
Member States shall have in place systems that allow operatorsthat market organic or in-conversion plant reproductive material, organic
animals or organic aquaculture juveniles, and that are able to supply
them in sufficient quantities and within a reasonable period, to makepublic on a voluntary basis, free of charge, together with their names
and contact details, information on the following:

02018R0848 — EN — 21.02.2023 — 003.001 — 32▼B(a) the organic and in-conversion plant reproductive material, such as
plant reproductive material of organic heterogeneous material or oforganic varieties suitable for organic production, excluding
seedlings but including seed potatoes, which is available; thequantity in weight of that material; and the period of the year of
its availability; such material shall be listed using at least the Latinscientific name;(b) the organic animals for which derogation may be provided inaccordance with point 1.3.4.4 of Part II of Annex II; the numberof available animals categorised by sex; information, if relevant,relating to the different species of animals as regards the breeds
and strains available; the races of the animals; the age of theanimals; and any other relevant information;(c) the organic aquaculture juveniles available on the holding and theirhealth status in accordance with Council Directive 2006/88/EC (1)and the production capacity for each aquaculture species.

3.
Member States may also set up systems which allow operators thatmarket breeds and strains adapted to organic production in accordancewith point 1.3.3 of Part II of Annex II or organic pullets and that areable to supply those animals in sufficient quantities and within areasonable period to make public the relevant information on a
voluntary basis, free of charge, together with names and contact details.

4.
Operators that opt to include information on plant reproductive
material, animals or aquaculture juveniles in the systems referred to inparagraphs 2 and 3 shall ensure that the information is updated
regularly, and shall ensure that the information is withdrawn from thelists once the plant reproductive material, animals or aquaculture
juveniles are no longer available.

5.
For the purpose of paragraphs 1, 2 and 3, Member States may
continue to use relevant information systems that are already inexistence.

6.
The Commission shall make public the link to each of the national
databases or systems on a dedicated website of the Commission, inorder to allow users to have access to such databases or systems
throughout the Union.

7.

The Commission may adopt implementing acts providing:(a) technical details for establishing and maintaining the databases
referred to in paragraph 1 and the systems referred to in paragraph 2;(1) Council Directive 2006/88/EC of 24 October 2006 on animal healthrequirements for aquaculture animals and products thereof, and on theprevention and control of certain diseases in aquatic animals (OJ L 328,
24.11.2006, p. 14).

02018R0848 — EN — 21.02.2023 — 003.001 — 33▼B(b) specifications as regards the collection of information referred to inparagraph 1 and 2;(c) specifications as regards the arrangements for participation in the
databases referred to in paragraph 1 and in the systems referred toin paragraphs 2 and 3; and(d) details as regards the information to be provided by Member Statesin accordance with Article 53(6).
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 27
Obligations and actions in the event of suspicion of non-compliance
Where an operator suspects that a product it has produced, prepared,
imported or has received from another operator does not comply withthis Regulation, that operator shall, subject to Article 28(2):(a) identify and separate the product concerned;(b) check whether the suspicion can be substantiated;(c) not place the product concerned on the market as an organic orin-conversion product and not use it in organic production, unlessthe suspicion can be eliminated;(d) where the suspicion has been substantiated or where it cannot be
eliminated, immediately inform the relevant competent authority, or,where appropriate, the relevant control authority or control body,and provide it with available elements, where appropriate;(e) fully cooperate with the relevant competent authority, or, whereappropriate, with the relevant control authority or control body, inverifying and identifying the reasons for the suspected
non-compliance.

Article 28
Precautionary measures to avoid the presence of non-authorised
products and substances1.
In order to avoid contamination with products or substances thatare not authorised in accordance with the first subparagraph of
Article 9(3) for use in organic production, operators shall take thefollowing precautionary measures at every stage of production, prep­
aration and distribution:(a) put in place and maintain measures that are proportionate andappropriate to identify the risks of contamination of organic
production and products with non-authorised products or
substances, including systematic identification of critical procedural
steps;

02018R0848 — EN — 21.02.2023 — 003.001 — 34▼B(b) put in place and maintain measures that are proportionate andappropriate to avoid risks of contamination of organic production
and products with non-authorised products or substances;(c) regularly review and adjust such measures; and(d) comply with other relevant requirements of this Regulation that
ensure the separation of organic, in-conversion and non-organic
products.

2.
Where an operator suspects, due to the presence of a product or
substance that is not authorised pursuant to the first subparagraph of
Article 9(3) for use in organic production in a product that is intended
to be used or marketed as an organic or in-conversion product, that thelatter product does not comply with this Regulation, the operator shall:(a) identify and separate the product concerned;(b) check whether the suspicion can be substantiated;(c) not place the product concerned on the market as an organic orin-conversion product and not use it in organic production unlessthe suspicion can be eliminated;(d) where the suspicion has been substantiated or where it cannot be
eliminated, immediately inform the relevant competent authority, or,where appropriate, the relevant control authority or control body,and provide it with available elements, where appropriate;(e) fully cooperate with the relevant competent authority, or, whereappropriate, with the relevant control authority or control body, in
identifying and verifying the reasons for the presence of
non-authorised products or substances.

3.
The Commission may adopt implementing acts laying down
uniform rules to specify:(a) the procedural steps to be followed by operators in accordance withpoints (a) to (e) of paragraph 2 and the relevant documents to beprovided by them;(b) the proportionate and appropriate measures to be adopted andreviewed by operators to identify and avoid risks of contaminationin accordance with points (a), (b) and (c) of paragraph 1.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

02018R0848 — EN — 21.02.2023 — 003.001 — 35
▼B
Article 29
Measures to be taken in the event of the presence of non-authorised
products or substances
1.
Where the competent authority, or, where appropriate, the control
authority or control body, receives substantiated information about thepresence of products or substances that are not authorised pursuant to
the first subparagraph of Article 9(3) for use in organic production, or
has been informed by an operator in accordance with point (d) of
Article 28(2), or detects such products or substances in an organic oran in-conversion product:(a) it shall immediately carry out an official investigation in accordancewith Regulation (EU) 2017/625 with a view to determining thesource and the cause in order to verify compliance with the firstsubparagraph of Article 9(3) and with Article 28(1); such investi­
gation shall be completed as soon as possible, within a reasonable
period, and shall take into account the durability of the product andthe complexity of the case;(b) it shall provisionally prohibit both the placing on the market of the
products concerned as organic or in-conversion products and theiruse in organic production pending the results of the investigationreferred to in point (a).

2.
The product concerned shall not be marketed as an organic orin-conversion product or used in organic production where thecompetent authority, or, where appropriate, the control authority orcontrol body, has established that the operator concerned:(a) has used products or substances not authorised pursuant to the firstsubparagraph of Article 9(3) for use in organic production;(b) has not taken the precautionary measures referred to in Article 28(1);or(c) has not taken measures in response to relevant previous requests
from the competent authorities, control authorities or control bodies.

3.
The operator concerned shall be given an opportunity to commenton the results of the investigation referred to in point (a) of paragraph 1.
The competent authority, or, where appropriate, the control authority orcontrol body, shall keep records of the investigation it has carried out.

Where required, the operator concerned shall take such corrective
measures as necessary to avoid future contamination.

4.
By ►M3 31 December 2025 ◄, the Commission shall present areport to the European Parliament and the Council on the implemen­tation of this Article, on the presence of products and substances not
authorised pursuant to the first subparagraph of Article 9(3) for use inorganic production and on the assessment of the national rules referred
to in paragraph 5 of this Article. That report may be accompanied,
where appropriate, by a legislative proposal for further harmonisation.

02018R0848 — EN — 21.02.2023 — 003.001 — 36
▼B
5.
Member States having in place rules providing for products that
contain more than a certain level of products or substances not auth­orised pursuant to the first subparagraph of Article 9(3) for use inorganic production not to be marketed as organic products may
continue to apply those rules, provided that those rules do notprohibit, restrict or impede the placing on the market of products
produced in other Member States as organic products, where those
products were produced in compliance with this Regulation. Member
States that make use of this paragraph shall inform the Commission
without delay.
6.
The competent authorities shall document the results of the inves­tigations referred to in paragraph 1, as well as any measures they havetaken for the purpose of formulating best practices and further measures
to avoid the presence of products and substances not authorised
pursuant to the first subparagraph of Article 9(3) for use in organic
production.
Member States shall make such information available to the otherMember States and to the Commission via a computer system thatenables the electronic exchange of documents and information madeavailable by the Commission.
7.
Member States may take appropriate measures on their territory to
avoid the unintended presence in organic agriculture of products andsubstances not authorised pursuant to the first subparagraph of
Article 9(3) for use in organic production. Such measures shall notprohibit, restrict or impede the placing on the market of products
produced in other Member States as organic or in-conversion
products, where those products were produced in compliance with thisRegulation. Member States that make use of this paragraph shall informthe Commission and the other Member States without delay.
8.
The Commission shall adopt implementing acts laying down
uniform rules to specify:(a) the methodology to be applied by competent authorities, or, whereappropriate, by control authorities or control bodies, for thedetection and evaluation of the presence of products and substances
not authorised pursuant to the first subparagraph of Article 9(3) for
use in organic production;(b) the details and format of the information to be made available byMember States to the Commission and other Member States inaccordance with paragraph 6 of this Article.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).
9.
By 31 March of each year, Member States shall electronicallytransmit to the Commission relevant information about cases
involving contamination with non-authorised products or substances in
the previous year, including information collected at border control
posts, concerning the nature of contamination detected, and in particular
the cause, the source and the level of contamination as well as thevolume and nature of products contaminated. This information shallbe collected by the Commission through the computer system madeavailable by the Commission and shall be used to facilitate the formu­
lation of best practices for avoiding contamination.

02018R0848 — EN — 21.02.2023 — 003.001 — 37
▼B
CHAPTER IV
LABELLING

Article 30
Use of terms referring to organic production
1.
For the purposes of this Regulation, a product shall be regarded as
bearing terms referring to organic production where, in the labelling,
advertising material or commercial documents, such a product, its
ingredients or feed materials used for its production are described interms suggesting to the purchaser that the product, ingredients or feedmaterials have been produced in accordance with this Regulation. In
particular, the terms listed in Annex IV and their derivatives anddiminutives, such as ‘bio’ and ‘eco’, whether alone or in combination,
may be used throughout the Union and in any language listed in that
Annex for the labelling and advertising of products referred to in
Article 2(1) which comply with this Regulation.

2.
For the products referred to in Article 2(1), the terms referred to inparagraph 1 of this Article shall not be used anywhere in the Union, in
any language listed in Annex IV, for the labelling, advertising material
or commercial documents of a product which does not comply with thisRegulation.

Furthermore, no terms, including terms used in trademarks or company
names, or practices shall be used in labelling or advertising if they are
liable to mislead the consumer or user by suggesting that a product or
its ingredients comply with this Regulation.

3.
Products that have been produced during the conversion period
shall not be labelled or advertised as organic products or as
in-conversion products.

However, plant reproductive material, food products of plant origin andfeed products of plant origin that have been produced during theconversion period, which comply with Article 10(4), may be labelled
and advertised as in-conversion products by using the term ‘inconversion’ or a corresponding term, together with the terms referred
to in paragraph 1.

4.
The terms referred to in paragraph 1 and 3 shall not be used for a
product for which Union law requires the labelling or advertising tostate that the product contains GMOs, consists of GMOs or is produced
from GMOs.

5.
For processed food, the terms referred to in paragraph 1 may be
used:(a) in the sales description, and in the list of ingredients where such alist is mandatory pursuant to Union legislation, provided that:02018R0848 — EN — 21.02.2023 — 003.001 — 38
▼B(i) the processed food complies with the production rules set out
in Part IV of Annex II and with the rules laid down inaccordance with Article 16(3);(ii) at least 95 % of the agricultural ingredients of the product byweight are organic; and(iii) in the case of flavourings, they are only used for natural
flavouring substances and natural flavouring preparations
labelled in accordance with Article 16(2), (3) and (4) of Regu­
lation (EC) No 1334/2008 and all of the flavouringcomponents and carriers of flavouring components in theflavouring concerned are organic;▼C4(b) only in the list of ingredients, provided that:(i) less than 95 % of the agricultural ingredients of the product byweight are organic, and provided that those ingredients comply
with the production rules set out in this Regulation; and(ii) the processed food complies with the production rules set out inpoints 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II, withthe exception of the rules on restricted use of non-organic agri­
cultural ingredients set out in point 2.2.1 of Part IV of
Annex II, and with the rules laid down in accordance with
Article 16(3);(c) in the sales description and in the list of ingredients, provided that:(i) the main ingredient is a product of hunting or fishing;(ii) the term referred to in paragraph 1 is clearly related in the sales
description to another ingredient which is organic and different
from the main ingredient;(iii) all other agricultural ingredients are organic; and(iv) the processed food complies with the production rules set out
in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II,
with the exception of the rules on restricted use of non-organic
agricultural ingredients set out in point 2.2.1 of Part IV of
Annex II, and with the rules laid down in accordance with
Article 16(3).
▼B
The list of ingredients referred to in points (a), (b) and (c) of the firstsubparagraph shall indicate which ingredients are organic. The
references to organic production may only appear in relation to theorganic ingredients.
The list of ingredients referred to in points (b) and (c) of the firstsubparagraph shall include an indication of the total percentage oforganic ingredients in proportion to the total quantity of agriculturalingredients.
The terms referred to in paragraph 1, when used in the list ofingredients referred to in points (a), (b), and (c) of the first subparagraphof this paragraph, and the indication of the percentage referred to in thethird subparagraph of this paragraph shall appear in the same colour,
identical size and style of lettering as the other indications in the list ofingredients.

02018R0848 — EN — 21.02.2023 — 003.001 — 39
▼B
6.
For processed feed, the terms referred to in paragraph 1 may be
used in the sales description and in the list of ingredients, provided that:▼C4(a) the processed feed complies with the production rules set out inParts II, III and V of Annex II and with the specific rules laid downin accordance with Article 17(3);▼B(b) all of the ingredients of agricultural origin that are contained in theprocessed feed are organic; and(c) at least 95 % of the dry matter of the product are organic.

7.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending:(a) this Article by adding further rules on the labelling of products
listed in Annex I, or by amending those added rules; and(b) the list of terms set out in Annex IV, taking into account linguistic
developments within the Member States.

8.
The Commission may adopt implementing acts to set detailed
requirements for the application of paragraph 3 of this Article.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 31
Labelling of products and substances used in crop production
Notwithstanding the scope of this Regulation as set out in Article 2(1),products and substances used in plant protection products or as
fertilisers, soil conditioners or nutrients that have been authorised inaccordance with Articles 9 and 24 may bear a reference indicatingthat those products or substances have been authorised for use inorganic production in accordance with this Regulation.

Article 32
Compulsory indications
1.
Where products bear terms as referred to in Article 30(1),including products labelled as in-conversion products in accordancewith Article 30(3):(a) the code number of the control authority or control body to which
the operator that carried out the last production or preparation
operation is subject shall also appear in the labelling; and02018R0848 — EN — 21.02.2023 — 003.001 — 40▼B(b) in the case of prepacked food, the organic production logo of theEuropean Union referred to in Article 33 shall also appear on the
packaging, except in cases referred to in Article 30(3) and points (b)and (c) of Article 30(5).

2.
Where the organic production logo of the European Union is used,
an indication of the place where the agricultural raw materials of which
the product is composed have been farmed shall appear in the samevisual field as the logo and shall take one of the following forms, as
appropriate:(a) ‘EU Agriculture’, where the agricultural raw material has been
farmed in the Union;(b) ‘non-EU Agriculture’, where the agricultural raw material has been
farmed in third countries;(c) ‘EU/non-EU Agriculture’, where a part of the agricultural raw
materials has been farmed in the Union and a part of it has been
farmed in a third country.

For the purposes of the first subparagraph, the word ‘Agriculture’ may
be replaced by ‘Aquaculture’ where appropriate and the words ‘EU’ and‘non-EU’ may be replaced or supplemented by the name of a country,
or by the name of a country and a region, if all of the agricultural raw
materials of which the product is composed have been farmed in thatcountry and, if applicable, in that region.

For the indication of the place where the agricultural raw materials of
which the product is composed have been farmed, as referred to in thefirst and third subparagraphs, small quantities by weight of ingredients
may be disregarded, provided that the total quantity of the disregarded
ingredients does not exceed 5 % of the total quantity by weight ofagricultural raw materials.

The words ‘EU’ or ‘non-EU’ shall not appear in a colour, size and styleof lettering that is more prominent than the name of the product.

3.
The indications referred to in paragraphs 1 and 2 of this Article
and in Article 33(3) shall be marked in a conspicuous place in such a
way as to be easily visible, and shall be clearly legible and indelible.

4.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending paragraph 2 of this Article andArticle 33(3) by adding further rules on labelling, or by amending those
added rules.

5.

The Commission shall adopt implementing acts relating to:(a) practical arrangements for the use, presentation, composition andsize of the indications referred to in point (a) of paragraph 1 andin paragraph 2 of this Article and in Article 33(3);02018R0848 — EN — 21.02.2023 — 003.001 — 41▼B(b) the assignment of code numbers to control authorities and control
bodies;(c) the indication of the place where the agricultural raw materials werefarmed, in accordance with paragraph 2 of this Article and with
Article 33(3).

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 33
Organic production logo of the European Union
1.
The organic production logo of the European Union may be usedin the labelling, presentation and advertising of products which comply
with this Regulation.

The organic production logo of the European Union may also be used
for information and educational purposes related to the existence andadvertising of the logo itself, provided that such use is not liable tomislead the consumer as regards the organic production of specificproducts, and provided that the logo is reproduced in accordance withthe rules set out in Annex V. In such case, the requirements ofArticle 32(2) and point 1.7 of Annex V shall not apply.

The organic production logo of the European Union shall not be used
for processed food as referred to in points (b) and (c) of Article 30(5)and for in-conversion products as referred to in Article 30(3).

2.
Except where used in accordance with the second subparagraph ofparagraph 1, the organic production logo of the European Union is an
official attestation in accordance with Articles 86 and 91 ofRegulation (EU) 2017/625.

3.
The use of the organic production logo of the European Union
shall be optional for products imported from third countries. Where thatlogo appears in the labelling of such products, the indication referred toin Article 32(2) shall also appear in the labelling.

4.
The organic production logo of the European Union shall follow
the model set out in Annex V, and shall comply with the rules set out inthat Annex.

5.
National logos and private logos may be used in the labelling,presentation and advertising of products which comply with this Regu­
lation.

6.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending Annex V as regards the organic
production logo of the European Union and the rules relating thereto.

02018R0848 — EN — 21.02.2023 — 003.001 — 42
▼B
CHAPTER V
CERTIFICATION

Article 34
Certification system
1.
Prior to placing any products on the market as ‘organic’ or as ‘inconversion’ or prior to the conversion period, operators and groups ofoperators referred to in Article 36 which produce, prepare, distribute orstore organic or in-conversion products, which import such products
from a third country or export such products to a third country, or
which place such products on the market, shall notify their activity to
the competent authorities of the Member State in which it is carried out
and in which their undertaking is subject to the control system.

Where the competent authorities have conferred their responsibilities ordelegated certain official control tasks or certain tasks related to otherofficial activities to more than one control authority or control body, theoperators or groups of operators shall indicate in the notificationreferred to in the first subparagraph which control authority or control
body verifies whether their activity complies with this Regulation andprovides the certificate referred to in Article 35(1).

2.
Operators that sell prepacked organic products directly to the final
consumer or user shall be exempted from the notification obligationreferred to in paragraph 1 of this Article and from the obligation to
be in the possession of a certificate referred to in Article 35(2) provided
that they do not produce, prepare, store other than in connection withthe point of sale, or import such products from a third country, or
subcontract such activities to another operator.

3.
Where operators or groups of operators subcontract any of theiractivities to third parties, both the operators or groups of operators andthe third parties to whom those activities have been subcontracted shallcomply with paragraph 1, unless the operator or group of operators has
declared in the notification referred to in paragraph 1 that it remains
responsible as regards organic production and that it has not transferredthat responsibility to the subcontractor. In such cases, the competentauthority, or, where appropriate, the control authority or control body,shall verify that the subcontracted activities comply with this Regu­
lation, in the context of the control it carries out on the operators orgroups of operators that have subcontracted their activities.

4.
Member States may designate an authority or approve a bodywhich is to receive the notifications referred to in paragraph 1.

5.
Operators, groups of operators and subcontractors shall keep
records in accordance with this Regulation on the different activities
they engage in.

6.
Member States shall keep updated lists containing the names andaddresses of operators and groups of operators that have notified theiractivities in accordance with paragraph 1 and shall make public in an02018R0848 — EN — 21.02.2023 — 003.001 — 43
▼B
appropriate manner, including by means of links to a single internet
website, a comprehensive list of this data, together with the information
relating to the certificates provided to those operators and groups ofoperators in accordance with Article 35(1). When doing so, Member
States shall comply with the requirements for the protection of personal
data under Regulation (EU) 2016/679 of the European Parliament andof the Council (1).
7.
Member States shall ensure that any operator or group of operatorsthat complies with this Regulation and, in cases where a fee is collectedin accordance with Articles 78 and 80 of Regulation (EU) 2017/625,
that pays a reasonable fee covering the cost of controls is entitled to becovered by the control system. Member States shall ensure that any feesthat may be collected are made public.
8.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending Annex II as regards therequirements for keeping records.
9.
The Commission may adopt implementing acts to provide details
and specifications regarding:(a) the format and technical means of the notification referred to inparagraph 1;(b) the arrangements for the publication of the lists referred to inparagraph 6; and(c) the procedures and the arrangements for publication of the fees
referred to in paragraph 7.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 35
Certificate
1.
Competent authorities, or, where appropriate, control authorities orcontrol bodies, shall provide a certificate to any operator or group of
operators that has notified its activity in accordance with Article 34(1)and complies with this Regulation. The certificate shall:(a) be issued in electronic form wherever possible;(b) allow at least the identification of the operator or group of operators
including the list of the members, the category of products coveredby the certificate and its period of validity;(1) Regulation (EU) 2016/679 of the European Parliament and of the Council of
27 April 2016 on the protection of natural persons with regard to theprocessing of personal data and on the free movement of such data, andrepealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119,4.5.2016, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 44▼B(c) certify that the notified activity complies with this Regulation; and(d) be issued in accordance with the model set out in Annex VI.

2.
Without prejudice to paragraph 8 of this Article and to
Article 34(2), operators and groups of operators shall not place
products referred to in Article 2(1) on the market as organic products
or in-conversion products unless they are already in possession of acertificate as referred to in paragraph 1 of this Article.

3.
The certificate referred to in this Article shall be an official cer­tificate within the meaning of point (a) of Article 86(1) of Regu­
lation (EU) 2017/625.

4.
An operator or a group of operators shall not be entitled to obtaina certificate from more than one control body in relation to activities
carried out in the same Member State regarding the same category of
products, including cases in which that operator or group of operators
operates at different stages of production, preparation and distribution.

5.
Members of a group of operators shall not be entitled to obtain an
individual certificate for any of the activities covered by the certificationof the group of operators to which they belong.

6.
Operators shall verify the certificates of those operators that are
their suppliers.

7.
For the purposes of paragraphs 1 and 4 of this Article, products
shall be classified in accordance with the following categories:(a) unprocessed plants and plant products, including seeds and otherplant reproductive material;(b) livestock and unprocessed livestock products;(c) algae and unprocessed aquaculture products;(d) processed agricultural products, including aquaculture products, foruse as food;(e) feed;(f) wine;(g) other products listed in Annex I to this Regulation or not coveredby the previous categories.

02018R0848 — EN — 21.02.2023 — 003.001 — 45
▼B
8.
Member States may exempt from the obligation to be in thepossession of a certificate, provided for in paragraph 2, operators thatsell unpacked organic products other than feed directly to the final
consumer, provided that those operators do not produce, prepare, store
other than in connection with the point of sale, or import such products
from a third country, or subcontract such activities to a third party, andprovided that:(a) such sales do not exceed 5 000 kg per year;(b) such sales do not represent an annual turnover in relation to
unpacked organic products exceeding EUR 20 000; or(c) the potential certification cost of the operator exceeds 2 % of thetotal turnover on unpacked organic products sold by that operator.
If a Member State decides to exempt the operators referred to in the firstsubparagraph, it may set stricter limits than those set in the firstsubparagraph.
Member States shall inform the Commission and the other Member
States of any decision to exempt operators pursuant to the first subpara­graph and of the limits up to which such operators are exempted.
9.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 amending the model of the certificate set
out in Annex VI.
10.
The Commission shall adopt implementing acts to provide details
and specifications regarding the form of the certificate referred to inparagraph 1 and the technical means by which it is issued.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

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 beengaged in processing, preparation or placing on the market of foodor 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 25 000 or whose standard output of organic
production is not more than EUR 15 000 per year; or02018R0848 — EN — 21.02.2023 — 003.001 — 46▼B(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;▼M6(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 orin the same third country;▼B(f) set up a joint marketing system for the products produced by thegroup; and(g) establish a system for internal controls comprising a documented setof control activities and procedures in accordance with which an
identified person or body is responsible for verifying compliancewith this Regulation of each member of the group.
▼M6
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 thegroup, 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, whereappropriate, 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 atleast annually and to be accompanied by an assessment of theknowledge 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;

02018R0848 — EN — 21.02.2023 — 003.001 — 47
▼M6(vii) the measures in cases of non-compliance detected during theinternal inspections, including their follow-up;(viii) the internal traceability, which shows the origin of the
products delivered in the joint marketing system of thegroup and allows the tracing of all products of all members
throughout all stages, such as production, processing, prep­
aration or placing on the market, including estimating andcross-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 inparticular to the type, structure, size, products, activities and output
of organic production of the group. The ICS inspectors shall becompetent 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 membershipagreement 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 bepresent during the internal inspections carried out by the
ICS inspectors and official controls carried out by thecompetent 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 appro­
priate, the control authority or control body, within thegiven time-frame,— immediately inform the ICS manager on suspected
non-compliance;(iii) develop the ICS procedures and the relevant documents andrecords, keep them up to date and make them readily
available to the ICS inspectors, and where relevant, to themembers of the group;02018R0848 — EN — 21.02.2023 — 003.001 — 48
▼M6(iv) draw up the list of the members of the group and keep it up todate;(v) assign tasks and responsibilities to the ICS inspectors;(vi) be the liaison between the members of the group and thecompetent 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 im­
plementation in accordance with the ICS manager’sschedule referred to in point (ii) of the second paragraph ofpoint (g);(ix) ensure adequate trainings for the ICS inspectors and carry out
an annual assessment of ICS inspectors’ competences andqualifications;(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 inaccordance with point g and ensure the follow-up of thosemeasures;(xii) decide to subcontract activities, including the subcontractingof 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 groupaccording to the schedule and the procedures provided by the
ICS manager;(ii) draft internal inspection reports on the basis of a template andsubmit 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.
▼B
2.
Competent authorities, or, where appropriate, control authorities orcontrol bodies, shall withdraw the certificate referred to in Article 35 forthe whole group where deficiencies in the set-up or functioning of thesystem 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 andin-conversion products.

02018R0848 — EN — 21.02.2023 — 003.001 — 49
▼M6
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 theirlabelling or advertising;(c) adding new members to the list of members or changing theactivities of existing members without following the internal
approval procedure;(d) not carrying out the annual physical on-the-spot inspection of amember of the group in a given year;(e) failing to indicate the members which have been suspended orwithdrawn in the list of members;(f) serious deviations in findings between internal inspections carriedout by the ICS inspectors and official controls carried out by thecompetent authority or, where appropriate, the control authority orcontrol body;(g) serious deficiencies in imposing appropriate measures or carryingout 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 andoutput of organic production of the group.
▼B
3.
The Commission is empowered to adopt delegated acts inaccordance 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 membersof 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;

02018R0848 — EN — 21.02.2023 — 003.001 — 50
▼B(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 thecompetent 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 exa­
mination procedure referred to in Article 55(2).

CHAPTER VI
OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIESArticle 37
Relationship with Regulation (EU) 2017/625 and additional rules forofficial controls and other official activities in relation to organic
production and labelling of organic products
The specific rules of this Chapter shall apply, in addition to the rules
laid down in Regulation (EU) 2017/625, save as otherwise provided forin Article 40(2) of this Regulation, and in addition to Article 29 of thisRegulation, save as otherwise provided for in Article 41(1) of thisRegulation, to the official controls and other official activities
performed to verify throughout the entire process at all stages of
production, preparation and distribution that the products referred toin Article 2(1) of this Regulation have been produced in compliancewith this Regulation.

Article 38
Additional rules on official controls and on action to be taken by
the competent authorities
1.
Official controls performed in accordance with Article 9 of Regu­
lation (EU) 2017/625 for the verification of compliance with this Regu­
lation shall include, in particular:(a) the verification of the application by operators of preventive andprecautionary measures, as referred to in Article 9(6) and in
Article 28 of this Regulation, at every stage of production, prep­
aration and distribution;(b) where the holding includes non-organic or in-conversion production
units, the verification of the records and of the measures orprocedures or arrangements in place to ensure the clear andeffective separation between organic, in-conversion andnon-organic production units as well as between the respective
products produced by those units, and of the substances andproducts used for organic, in-conversion and non-organic
production units; such verification shall include checks on parcels
for which a previous period was recognised retroactively as part ofthe conversion period, and checks on the non-organic production
units;

02018R0848 — EN — 21.02.2023 — 003.001 — 51
▼B(c) where organic, in-conversion and non-organic products are collected
simultaneously by operators, are prepared or stored in the same
preparation unit, area or premises, or are transported to otheroperators or units, the verification of the records and of themeasures, procedures or arrangements in place to ensure that
operations are carried out separated by place or time, that suitablecleaning measures and, where appropriate, measures to prevent
substitution of products are implemented, that organic products
and in-conversion products are identified at all times and thatorganic, in-conversion and non-organic products are stored, before
and after the preparation operations, separated by place or time fromeach other;(d) the verification of the set-up and functioning of the internal control
system of groups of operators;(e) where operators are exempted from the notification obligation inaccordance with Article 34(2) of this Regulation or from the obli­
gation to be in the possession of a certificate in accordance with
Article 35(8) of this Regulation, the verification that therequirements for that exemption have been fulfilled and the verifi­
cation of the products sold by those operators.

2.
Official controls performed in accordance with Article 9 of Regu­
lation (EU) 2017/625 for the verification of compliance with this Regu­
lation shall be performed throughout the entire process at all stages of
production, preparation and distribution on the basis of the likelihood of
non-compliance as defined in point (57) of Article 3 of this Regulation,
which shall be determined taking into account, in addition to theelements referred to in Article 9 of Regulation (EU) 2017/625, inparticular the following elements:(a) the type, size and structure of the operators and groups of operators;(b) the length of time during which operators and groups of operators
have been involved in organic production, preparation anddistribution;(c) the results of the controls performed in accordance with this Article;(d) the point in time relevant for the activities carried out;(e) the product categories;(f) the type, quantity and value of products and their development overtime;(g) the possibility of commingling of products or contamination with
non-authorised products or substances;(h) the application of derogations or exceptions to the rules by
operators and groups of operators;

02018R0848 — EN — 21.02.2023 — 003.001 — 52
▼B(i) the critical points for non-compliance and the likelihood of
non-compliance at every stage of production, preparation anddistribution;(j) subcontracting activities.

3.
In any case, all operators and groups of operators, with the
exception of those referred to in Articles 34(2) and 35(8), shall be
subject to a verification of compliance at least once a year.

The verification of compliance shall include a physical on-the-spot
inspection, except where the following conditions have been satisfied:(a) the previous controls of the operator or group of operatorsconcerned have not revealed any non-compliance affecting the
integrity of organic or in-conversion products during at least threeconsecutive years; and(b) the operator or group of operators concerned has been assessed on
the basis of the elements referred to in paragraph 2 of this Article
and in Article 9 of Regulation (EU) 2017/625 as presenting a low
likelihood of non-compliance.

In this case, the period between two physical on-the-spot inspections
shall not exceed 24 months.

4.
Official controls performed in accordance with Article 9 of Regu­
lation (EU) 2017/625 for the verification of compliance with this Regu­
lation shall:(a) be performed in accordance with Article 9(4) of Regulation (EU)2017/625 while ensuring that a minimum percentage of all official
controls of operators or groups of operators are carried out without
prior notice;(b) ensure that a minimum percentage of additional controls to thosereferred in paragraph 3 of this Article are carried out;(c) be carried out by taking a minimum number of the samples thathave been taken in accordance with point (h) of Article 14 ofRegulation (EU) 2017/625;(d) ensure that a minimum number of operators that are members of agroup of operators are controlled in connection with the verificationof compliance referred to in paragraph 3 of this Article.

5.
The delivery or renewal of the certificate referred to in
Article 35(1) shall be based on the results of the verification ofcompliance referred to in paragraphs 1 to 4 of this Article.

02018R0848 — EN — 21.02.2023 — 003.001 — 53
▼B
6.
The written record to be drawn up regarding each official control
that has been performed to verify compliance with this Regulation inaccordance with Article 13(1) of Regulation (EU) 2017/625 shall becountersigned by the operator or groups of operators as confirmationof their receipt of that written record.
7.
Article 13(1) of Regulation (EU) 2017/625 shall not apply toaudits and inspections carried out by competent authorities in thecontext of their supervisory activities over control bodies to which
certain official control tasks or certain tasks related to other official
activities have been delegated.
8.
The Commission is empowered to adopt delegated acts inaccordance with Article 54:(a) supplementing this Regulation by laying down specific criteria andconditions for the performance of official controls conducted toensure the traceability at all stages of production, preparation anddistribution, and compliance with this Regulation, concerning:(i) checks of documentary accounts;(ii) controls performed on specific categories of operators;(iii) where appropriate, the period within which the controls
provided for in this Regulation, including the physicalon-the-spot inspections referred to in paragraph 3 of this
Article, are to be performed and the particular premises in orarea on which they are to be performed;(b) amending paragraph 2 of this Article by adding further elements
based on practical experience, or by amending those added
elements.
9.

The Commission may adopt implementing acts to specify:(a) the minimum percentage of all official controls of operators orgroups of operators that are to be carried out without prior noticeas referred to in point (a) of paragraph 4;(b) the minimum percentage of additional controls referred to inpoint (b) of paragraph 4;(c) the minimum number of samples referred to in point (c) of
paragraph 4;(d) the minimum number of operators that are members of a group of
operators referred to in point (d) of paragraph 4.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

02018R0848 — EN — 21.02.2023 — 003.001 — 54
▼B
Article 39
Additional rules on actions to be taken by the operators and groupsof operators
1.
In addition to the obligations laid down in Article 15 of Regu­
lation (EU) 2017/625, operators and groups of operators shall:(a) keep records to demonstrate their compliance with this Regulation;(b) make all declarations and other communications that are necessary
for official controls;(c) take relevant practical measures to ensure compliance with thisRegulation;(d) provide, in form of a declaration to be signed and updated asnecessary:(i) the full description of the organic or in-conversion production
unit and of the activities to be performed in accordance withthis Regulation;(ii) the relevant practical measures to be taken to ensurecompliance with this Regulation;(iii) an undertaking:— to inform in writing and without undue delay buyers of the
products and to exchange relevant information with thecompetent authority, or, where appropriate, with thecontrol authority or control body, in the event that asuspicion of non-compliance has been substantiated, thata suspicion of non-compliance cannot be eliminated, orthat non-compliance that affects the integrity of the
products in question has been established,— to accept the transfer of the control file in the case ofchange of control authority or control body or, in thecase of withdrawal from organic production, the keepingof the control file for at least five years by the last control
authority or control body,— to immediately inform the competent authority or theauthority or body designated in accordance with
Article 34(4) in the event of withdrawal from organic
production, and— to accept the exchange of information among those auth­orities or bodies in the event that subcontractors are subject
to controls by different control authorities or control bodies.
2.
The Commission may adopt implementing acts to provide details
and specifications regarding:(a) the records for demonstrating compliance with this Regulation;

02018R0848 — EN — 21.02.2023 — 003.001 — 55
▼B(b) the declarations and other communications that are necessary for
official controls;(c) the relevant practical measures for ensuring compliance with thisRegulation.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 40
Additional rules on the delegation of official control tasks and tasks
related to other official activities
1.
Competent authorities may delegate to control bodies certain
official control tasks and certain tasks related to other official activities
only if the following conditions, in addition to those set out in Chapter
III of Regulation (EU) 2017/625, are satisfied:(a) the delegation contains a detailed description of the delegatedofficial control tasks and tasks related to other official activities,
including reporting obligations and other specific obligations, andof the conditions under which the control body may carry them out.
In particular, the control body shall have submitted the following to
the competent authorities for prior approval:(i) its risk assessment procedure, which is to determine, inparticular, the basis for the intensity and frequency of theverification of compliance of the operators and groups ofoperators, which is to be established on the basis of theelements referred to in Article 9 of Regulation (EU)2017/625 and of Article 38 of this Regulation, and which is
to be followed for official controls on operators and groups ofoperators;(ii) the standard control procedure, which is to contain a detailed
description of the control measures that the control bodyundertakes to apply to the operators and groups of operatorsthat are subject to its controls;(iii) a list of measures that are in conformity with the common
catalogue referred to in Article 41(4), and that are to be
applied to operators and groups of operators in cases ofsuspected or established non-compliance;(iv) the arrangements for the effective monitoring of the official
control tasks and tasks related to other official activities
carried out in relation to operators and groups of operatorsand the arrangements for reporting on those tasks.

The control body shall notify subsequent amendment of theelements referred to in points (i) to (iv) to the competent authority;02018R0848 — EN — 21.02.2023 — 003.001 — 56▼B(b) those competent authorities have procedures and arrangements inplace to ensure the supervision of control bodies, including toverify that the delegated tasks are carried out effectively, inde­
pendently and objectively, in particular as regards the intensityand frequency of the verification of compliance.

At least once a year, competent authorities shall, pursuant to point (a) of
Article 33 of Regulation (EU) 2017/625, organise audits of the control
bodies to whom they have delegated official control tasks or tasks
related to other official activities.

2.
By way of derogation from Article 31(3) of Regulation (EU)2017/625, competent authorities may delegate to a control body thedecision concerning the tasks provided for in point (b) of Article 138(1)and in Article 138(2) and (3) of that Regulation.

3.
For the purpose of point (b)(iv) of Article 29 of Regulation (EU)2017/625, the standard for the delegation of certain official control tasks
and certain tasks related to other official activities to verify compliancewith this Regulation which is relevant in relation to the scope of thisRegulation is the most recently notified version of the international
harmonised standard for ‘Conformity assessment – Requirements forbodies certifying products, processes and services’, the reference of
which has been published in the Official Journal of the European
Union.

4.
Competent authorities shall not delegate the following official
control tasks and tasks related to other official activities to control
bodies:(a) the supervision and audit of other control authorities or control
bodies;(b) the power to grant derogations other than derogations for the use ofplant reproductive material not obtained from organic production;(c) the authority to receive notifications of activities by operators orgroups of operators under Article 34(1) of this Regulation;(d) the assessment of the likelihood of non-compliance with theprovisions of this Regulation that determine the frequency withwhich physical checks are to be performed on organic consignments
prior to their release for free circulation into the Union inaccordance with Article 54 of Regulation (EU) 2017/625;(e) the establishment of the common catalogue of measures referred toin Article 41(4) of this Regulation.

5.
Competent authorities shall not delegate official control tasks ortasks related to other official activities to natural persons.

02018R0848 — EN — 21.02.2023 — 003.001 — 57
▼B
6.
Competent authorities shall ensure that information received fromcontrol bodies pursuant to Article 32 of Regulation (EU) 2017/625 andinformation on the measures applied by control bodies in the case of
established or likely non-compliance is collected and used by thecompetent authorities in order to supervise the activities of thosecontrols bodies.

7.
Where a competent authority has fully or partially withdrawn thedelegation of certain official control tasks or certain tasks related toother official activities in accordance with point (b) of Article 33 ofRegulation (EU) 2017/625, it shall decide whether any certificatesissued by the control bodies concerned before the date of that partial
or full withdrawal are to remain valid, and shall inform the operatorsconcerned of that decision.

8.
Without prejudice to point (b) of Article 33 of Regulation (EU)2017/625, before fully or partly withdrawing the delegation of official
control tasks or tasks related to other official activities in the cases
referred to in that point, competent authorities may fully or partly
suspend that delegation:(a) for a period that shall not exceed 12 months, during which thecontrol body is to remedy the shortcomings identified during
audits and inspections or to address the non-compliance about
which information was shared with other control authorities andcontrol bodies, with competent authorities as well as with theCommission in accordance with Article 43 of this Regulation; or(b) for the period during which the accreditation referred to inpoint (b)(iv) of Article 29 of Regulation (EU) 2017/625, inconnection with Article 40(3) of this Regulation, is suspended.

Where the delegation of official control tasks or tasks related to otherofficial activities has been suspended, the control bodies concerned shallnot issue certificates referred to in Article 35 for those parts for which
the delegation has been suspended. Competent authorities shall decide
whether any certificates issued by the control bodies concerned before
the date of that partial or full suspension are to remain valid, and shallinform the operators concerned of that decision.

Without prejudice to Article 33 of Regulation (EU) 2017/625, thecompetent authorities shall lift the suspension of the delegation of
official control tasks or tasks related to other official activities assoon as possible once the control body has remedied the shortcomings
or non-compliances referred to in point (a) of the first subparagraph oronce the accreditation body has lifted the suspension of the accreditationreferred to in point (b) of the first subparagraph.

9.
Where a control body to whom competent authorities havedelegated certain official control tasks or certain tasks related to otherofficial activities has also been recognised by the Commission inaccordance with Article 46(1) of this Regulation to carry out control
activities in third countries, and the Commission intends to withdraw or
has withdrawn the recognition of that control body, competent auth­orities shall organise audits or inspections on the control body as02018R0848 — EN — 21.02.2023 — 003.001 — 58
▼B
regards its activities in the Member State(s) concerned in accordancewith point (a) of Article 33 of Regulation (EU) 2017/625.
10.

The control bodies shall transmit to the competent authorities:(a) a list of the operators which were subject to their controls on 31
December of the previous year by 31 January of each year; and(b) information on the official controls and other official activities
carried out in the previous year to support the preparation of thepart on organic production and labelling of organic products of theannual report referred to in Article 113 of Regulation (EU)2017/625 by 31 March of each year.
11.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation as regards
conditions for the delegation of official control tasks and tasks related
to other official activities to control bodies additional to the conditions
laid down in paragraph 1 of this Article.

Article 41▼C5
Additional rules on actions in the event of suspected and establishednon-compliance, and common catalogue of measures▼B
1.
Subject to Article 29, where a competent authority, or, whereappropriate, a control authority or control body, suspects or receives
substantiated information, including information from other competentauthorities, or, where appropriate, from other control authorities orcontrol bodies, that an operator intends to use or to place on themarket a product which may not be in compliance with this Regulation
but which bears terms referring to the organic production, or where suchcompetent authority, control authority or control body has been
informed by an operator of a suspicion of non-compliance in accordancewith Article 27:(a) it shall immediately carry out an official investigation in accordancewith Regulation (EU) 2017/625 with a view to verifying compliancewith this Regulation; such investigation shall be completed as soon
as possible, within a reasonable period, and shall take into accountthe durability of the product and the complexity of the case;(b) it shall provisionally prohibit both the placing on the market of the
products concerned as organic or in-conversion products and theiruse in organic production pending the results of the investigationreferred to in point (a). Before taking such a decision, the competentauthority, or, where appropriate, the control authority or control
body, shall give the operator an opportunity to comment.
2.
In the event that the results of the investigation referred to inpoint (a) of paragraph 1 do not show any non-compliance affecting
the integrity of organic or in-conversion products, the operator shallbe allowed to use the products concerned or to place them on themarket as organic or in-conversion products.

02018R0848 — EN — 21.02.2023 — 003.001 — 59
▼B
3.
Member States shall take any measures, and provide for any
necessary sanctions, to prevent fraudulent use of the indications
referred to in Chapter IV of this Regulation.
4.
Competent authorities shall provide a common catalogue of
measures for cases of suspected non-compliance and establishednon-compliance to be applied in their territory, including by control
authorities and control bodies.
5.
The Commission may adopt implementing acts to specify uniform
arrangements for the cases where competent authorities are to takemeasures in relation to suspected or established non-compliance.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 42▼C5
Additional rules on measures in the event of non-complianceaffecting integrity▼B
1.
In the event of non-compliance affecting the integrity of organic orin-conversion products throughout any of the stages of production,
preparation and distribution, for example as result of the use of
non-authorised products, substances or techniques, or commingling
with non-organic products, competent authorities, and, where appro­
priate, control authorities and control bodies, shall ensure, in addition
to the measures to be taken in accordance with Article 138 of Regu­
lation (EU) 2017/625, that no reference is made to organic production in
the labelling and advertising of the entire lot or production run
concerned.
2.
In the event of serious, or repetitive or continued non-compliance,competent authorities, and, where appropriate, control authorities andcontrol bodies, shall ensure that the operators or the groups ofoperators concerned, in addition to the measures laid down inparagraph 1 and any appropriate measures taken in particular inaccordance with Article 138 of Regulation (EU) 2017/625, areprohibited from marketing products which refer to organic production
for a given period, and that their certificate referred to in Article 35 besuspended or withdrawn, as appropriate.

Article 43
Additional rules on the exchange of information
1.
In addition to the obligations laid down in Article 105(1) and
Article 106(1) of Regulation (EU) 2017/625, competent authorities
shall immediately share information with other competent authorities,
as well as with the Commission, on any suspicion of non–compliancethat affects the integrity of organic or in-conversion products.
Competent authorities shall share that information with other competentauthorities and the Commission via a computer system that enables theelectronic exchanges of documents and information made available by
the Commission.

02018R0848 — EN — 21.02.2023 — 003.001 — 60
▼B2.
In cases where suspected or established non-compliance has been
identified with regard to products under the control of other control
authorities or control bodies, control authorities and control bodies
shall immediately inform those other control authorities or control
bodies.
3.
Control authorities and control bodies shall exchange otherrelevant information with other control authorities and control bodies.
4.
Upon receiving a request for information that is justified by theneed to guarantee that a product has been produced in accordance withthis Regulation, control authorities and control bodies shall exchangewith other competent authorities, as well as with the Commission,
information on the results of their controls.
5.
Competent authorities shall exchange information on the super­
vision of the control bodies with national accreditation bodies as
defined in point (11) of Article 2 of Regulation (EC) No 765/2008 of
the European Parliament and of the Council (1).
6.
Competent authorities shall take appropriate measures andestablish documented procedures in order to ensure that information
about the results of controls is communicated to the paying agency inaccordance with its needs for the purpose of Article 58 of Regu­
lation (EU) No 1306/2013 of the European Parliament and of theCouncil (2) and the acts adopted on the basis of that Article.
7.
The Commission may adopt implementing acts to specify the
information to be provided by the competent authorities, control auth­orities and control bodies in charge of the official controls and otherofficial activities in accordance with this Article, the relevant recipientsof that information and the procedures in accordance with which thisinformation is to be provided, including the functionalities of thecomputer system referred to in paragraph 1.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

CHAPTER VII
TRADE WITH THIRD COUNTRIESArticle 44
Export of organic products
1.
A product may be exported from the Union as an organic productand may bear the organic production logo of the European Union,
provided that it complies with the rules for organic production under
this Regulation.
(1) Regulation (EC) No 765/2008 of the European Parliament and of the Councilof 9 July 2008 setting out the requirements for accreditation and market
surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(2) Regulation (EU) No 1306/2013 of the European Parliament and of theCouncil of 17 December 2013 on the financing, management and monitoringof the common agricultural policy and repealing Council Regulations (EEC)
No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC)No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).

02018R0848 — EN — 21.02.2023 — 003.001 — 61
▼B
2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation as regards
documents intended for customs authorities in third countries, inparticular as regards the issuing of organic export certificates in elec­
tronic form wherever possible and the provision of assurances thatexported organic products comply with this Regulation.

Article 45
Import of organic and in-conversion products
1.
A product may be imported from a third country for the purposeof placing that product on the market within the Union as an organic
product or as an in-conversion product, provided that the following
three conditions are met:(a) the product is a product as referred to in Article 2(1);(b) one of the following applies:(i) the product complies with Chapters II, III and IV of this Regu­
lation, and all operators and groups of operators referred to in
Article 36, including exporters in the third country concerned,
have been subject to controls by control authorities or control
bodies recognised in accordance with Article 46, and thoseauthorities or bodies have provided all such operators, groupsof operators and exporters with a certificate confirming thatthey comply with this Regulation;(ii) in cases where the product comes from a third country which isrecognised in accordance with Article 47, that productcomplies with the conditions laid down in the relevant trade
agreement; or(iii) in cases where the product comes from a third country which isrecognised in accordance with Article 48, that productcomplies with the equivalent production and control rules ofthat third country and is imported with a certificate ofinspection confirming this compliance that was issued by thecompetent authorities, control authorities or control bodies ofthat third country; and(c) the operators in third countries are able at any time to provide theimporters and the national authorities in the Union and in thosethird countries with information allowing the identification of theoperators that are their suppliers and the control authorities orcontrol bodies of those suppliers, with a view to ensuring the tracea­
bility of the organic or in-conversion product concerned. That
information shall also be made available to the control authorities
or control bodies of the importers.
2.
The Commission may, in accordance with the procedure set out in
Article 24(9), grant specific authorisations for the use of products andsubstances in third countries and in the outermost regions of the Union,
taking into account differences in the ecological balance in plant or
animal production, specific climatic conditions, traditions and local
conditions in those areas. Such specific authorisations may be granted
for a renewable period of two years and shall be subject to the prin­ciples laid down in Chapter II and to the criteria set out in Article 24(3)and (6).

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3.
When providing for the criteria for determining whether a situation
qualifies as catastrophic circumstances, and when laying down specificrules on how to deal with such circumstances in accordance with
Article 22, the Commission shall take into account differences in theecological balance, climate and local conditions in third countries and in
the outermost regions of the Union.
4.
The Commission shall adopt implementing acts to lay down
specific rules concerning the content of the certificates referred to inpoint (b) of paragraph 1, the procedure to be followed for their issuance,
their verification and the technical means by which the certificate isissued, in particular as regards the role of competent authorities,
control authorities and control bodies, ensuring the traceability andcompliance of imported products intended to be placed on the Union
market as organic products or as in-conversion products as referred to inparagraph 1.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).
5.
Compliance with the conditions and measures for the import oforganic products and in-conversion products referred to in paragraph 1
into the Union shall be ascertained at border control posts, inaccordance with Article 47(1) of Regulation (EU) 2017/625. The
frequency of the physical checks referred to in Article 49(2) of that
Regulation shall depend on the likelihood of non-compliance as
defined in point (57) of Article 3 of this Regulation.

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 toestablish a list of recognised control authorities and control bodies.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).
▼M102.
Control authorities and control bodies shall be recognised inaccordance with paragraph 1 for the control of the import of thecategories of products listed in Article 35(7) if they fulfil thefollowing 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 theconditions set out in points (a), (b)(i) and (c) of Article 45(1)and in this Article are met in relation to organic products andin-conversion products intended for import into the 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 tosampling;

02018R0848 — EN — 21.02.2023 — 003.001 — 63
▼M10(c) they offer adequate guarantees of objectivity and impartiality andare free from any conflict of interest as regards the exercise of theircontrol tasks; in particular, they have procedures in place ensuringthat the staff performing controls and other actions is free from any
conflict of interest, and that the operators are not inspected by thesame 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 tocarry out control tasks, and have a sufficient number of suitable
qualified and experienced staff;(f) they have the capacity and the competency to carry out their certifi­
cation and control activities in accordance with the requirements ofthis Regulation and in particular Commission DelegatedRegulation (EU) 2021/1698 (1) for each type of operator (single
operator or group of operators) in each third country and foreach category of products they want to be recognised for;(g) they have procedures and arrangements in place to ensure theimpartiality, the quality, the consistency, the effectiveness and theappropriateness 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 andequipment to ensure that staff can perform controls and otheractions 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 toperform effective controls, including inspections, on operators aswell as on the internal control system of a group of operators, ifany;(l) their previous recognition for a specific third country and/or for acategory of products has not been withdrawn in accordance withparagraph 2a or their accreditation has not been withdrawn orsuspended by any accreditation body in accordance with its
procedures for the suspension or withdrawal established inaccordance with the relevant international standard, in particular(1) Delegated Regulation (EU) 2021/1698 of 13 July 2021 supplementing Regu­
lation (EU) 2018/848 of the European Parliament and of the Council withprocedural requirements for the recognition of control authorities and control
bodies that are competent to carry out controls on operators and groups ofoperators certified organic and on organic products in third countries and withrules on their supervision and the controls and other actions to be performedby those control authorities and control bodies (OJ L 336, 23.9.2021, p. 7).

02018R0848 — EN — 21.02.2023 — 003.001 — 64
▼M10
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 ofDelegated Regulation (EU) 2021/1698, except where theprevious recognition was withdrawn in accordance withpoint (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 ofDelegated 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 adelegated 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 acategory 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 therequirements set out in that Regulation;(c) the control authority or control body does not make available ordoes not communicate all the information related to the technicaldossier referred to in paragraph 4, to the control system applied byit, or to the up-to-date list of operators or groups of operators or tothe organic products covered by the scope of its recognition;(d) the control authority or control body does not notify theCommission within 30 calendar days of changes to its technicaldossier 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 thedeadlines 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 noncompliance;02018R0848 — EN — 21.02.2023 — 003.001 — 65
▼M10(f) the control authority or control body does not agree to an on-thespot examination or audit initiated by the Commission;(g) the result of the on-the-spot examination or audit indicates asystematic malfunctioning of control measures or the control
authority or control body is unable to implement all the recommen­
dations 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 andinfringements 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, thecontrol authority or control body does not communicate to the newcontrol authority or control body the relevant elements of thecontrol file, including written records, of the operator within amaximum of 30 calendar days after having received the request
for transfer from the operator or the new control authority orcontrol 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 isrecognised.
▼B
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 signatory of amultilateral recognition arrangement under the auspices of the Inter­national Accreditation Forum.
4.
Control authorities and control bodies shall submit a request forrecognition to the Commission. Such request shall consist of a technicaldossier containing all information that is necessary to ensure that thecriteria set out in paragraph 2 are met.
The control authorities shall provide the latest assessment report issued
by the competent authority, and the control bodies shall provide theaccreditation certificate issued by the accreditation body. Where appro­
priate, control authorities or control bodies shall also provide latest
reports on the regular on-the-spot evaluation, surveillance and multi­
annual re-assessment of their activities.
5.
Based on the information referred to under paragraph 4 and on
any other relevant information relating to the control authority or control
body, the Commission shall ensure appropriate supervision of therecognised control authorities and control bodies by regularly
reviewing their performance and recognition. For the purposes of thatsupervision, the Commission may request additional information fromthe accreditation bodies or the competent authorities, as appropriate.

02018R0848 — EN — 21.02.2023 — 003.001 — 66
▼B
6.
The nature of the supervision referred to in paragraph 5 shall be
determined on the basis of an assessment of the likelihood of
non-compliance, taking into account, in particular, the activity of thecontrol authority or control body, the type of products and operators
under its control and the changes in the production rules and control
measures.
The recognition of control authorities or of control bodies referred to inparagraph 1 shall in particular be withdrawn without delay, in
accordance with the procedure referred to in that paragraph, whereserious or repetitive infringements as regards the certification or thecontrols and actions laid down in accordance with paragraph 8 havebeen detected and where the control authority or control body concerned
has failed to take appropriate and timely remedial action in reaction to arequest by the Commission within a period determined by theCommission. Such period shall be determined in accordance with theseverity of the problem and in general shall not be less than 30 days.
7.
The Commission is empowered to adopt delegated acts inaccordance with Article 54:(a) amending paragraph 2 of this Article by adding further criteria tothose laid down therein for the recognition of the control authorities
and control bodies referred to in paragraph 1 of this Article and forthe withdrawal of such recognition, or by amending those added
criteria;(b) supplementing this Regulation as regards:(i) the exercise of the supervision of the control authorities andcontrol bodies recognised by the Commission in accordancewith paragraph 1, including on-the-spot examinations; and(ii) the controls and other actions to be performed by those control
authorities and control bodies.
8.
The Commission may adopt implementing acts to ensure theapplication of the measures to be taken in relation to cases ofsuspected or established non-compliance, in particular those affecting
the integrity of organic or in-conversion products imported under therecognition provided for in this Article. Such measures may consist in
particular in the verification of the integrity of organic or in-conversion
products before placing the products on the market within the Union
and, where appropriate, in the suspension of the authorisation for theplacing on the market of such products within the Union as organic
products or in-conversion products.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).
9.
On duly justified imperative grounds of urgency relating to unfair
practices or practices which are incompatible with the principles andrules on organic production, the protection of consumers’ confidence or
the protection of fair competition between operators, the Commission
shall adopt immediately applicable implementing acts in accordancewith the procedure referred to in Article 55(3) to take the measuresreferred to in paragraph 8 of this Article or to decide on the withdrawalof the recognition of the control authorities and control bodies referred
to in paragraph 1 of this Article.

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Article 47
Equivalence under a trade agreement
A recognised third country referred to in point (b)(ii) of Article 45(1) isa third country which the Union has recognised under a trade agreement
as having a system of production meeting the same objectives andprinciples by applying rules which ensure the same level of assuranceof conformity as those of the Union.

Article 48
Equivalence under Regulation (EC) No 834/2007
1.
A recognised third country referred to in point (b)(iii) of
Article 45(1) is a third country which has been recognised for the
purposes of equivalence under Article 33(2) of Regulation (EC)No 834/2007, including those recognised under the transitional
measure provided for in Article 58 of this Regulation.
That recognition shall expire on ►M3 31 December 2026 ◄.
2.
On the basis of annual reports to be sent to the Commission, by 31
March of each year, by the third countries referred to in paragraph 1
regarding the implementation and enforcement of the control measuresestablished by them, and in the light of any other information received,
the Commission shall ensure appropriate supervision of the recognised
third countries by regularly reviewing their recognition. For thispurpose, the Commission may request the assistance of Member
States. The nature of the supervision shall be determined on the basisof an assessment of the likelihood of non-compliance, taking into
account in particular the volume of exports to the Union from thethird country concerned, the results of the monitoring and supervisory
activities carried out by the competent authority and the results ofprevious controls. The Commission shall regularly report to theEuropean Parliament and the Council on the outcome of its review.
3.
The Commission shall, by means of an implementing act, establish
a list of the third countries referred to in paragraph 1 and may amendthat list by means of implementing acts.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).
4.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation as regards
the information to be sent by the third countries listed in accordancewith paragraph 3 of this Article which is necessary for the supervisionof their recognition by the Commission, as well as the exercise of thatsupervision by the Commission, including through on-the-spot
examination.
5.
The Commission may adopt implementing acts to ensure theapplication of measures in relation to cases of suspected or establishednon-compliance, in particular those affecting the integrity of organic orin-conversion products imported from third countries referred to in this
Article. Such measures may consist in particular in the verification of
the integrity of organic or in-conversion products before placing the
products on the market within the Union and, where appropriate, inthe suspension of the authorisation for the placing on the market ofsuch products within the Union as organic products or in-conversion
products.

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Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

Article 49
Report from the Commission on the application of Articles 47 and48
By ►M3 31 December 2022 ◄, the Commission shall present a reportto the European Parliament and the Council on the state of applicationof Articles 47 and 48, in particular as regards the recognition of third
countries for the purpose of equivalence.

CHAPTER VIII
GENERAL PROVISIONSSECTION 1

Free movement of organic and in-conversion products
Article 50
Non-prohibition and non-restriction of the marketing of organicand in-conversion products
Competent authorities, control authorities and control bodies shall not,on grounds that relate to the production, labelling or presentation of the
products, prohibit or restrict the marketing of organic or in-conversion
products subject to control by another competent authority, control
authority or control body located in another Member State where
those products comply with this Regulation. In particular, no official
controls and other official activities other than those under
Regulation (EU) 2017/625 shall be performed and no fees for official
controls and other official activities other than those provided for in
Chapter VI of that Regulation shall be collected.

SECTION 2

Information, reporting and related derogations
Article 51
Information relating to the organic sector and trade1.
Each year Member States shall transmit to the Commission theinformation necessary for the implementation and monitoring of theapplication of this Regulation. As far as possible, such information
shall be based on established sources of data. The Commission shalltake into account the data needs and synergies between potential data
sources, in particular their use for statistical purposes where appropriate.
2.
The Commission shall adopt implementing acts as regards thesystem to be used for transmitting the information referred to inparagraph 1, the details of information to be transmitted, and the dateby which that information is to be transmitted.
Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

02018R0848 — EN — 21.02.2023 — 003.001 — 69
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Article 52
Information
1.

relating to the competent authorities,
authorities and control bodies

controlMembers States shall keep a regularly updated list of:(a) the names and addresses of the competent authorities; and(b) the names, addresses and code numbers of the control authorities
and control bodies.

Member States shall transmit those lists, and any change thereof, to theCommission and make them public, except where such transmission andpublication has already taken place in accordance with Article 4(4) ofRegulation (EU) 2017/625.

2.
Based on the information provided for under paragraph 1, theCommission shall regularly publish on the internet an updated list ofcontrol authorities and control bodies referred to in point (b) ofparagraph 1.

Article 53
Derogations, authorisations and report
1.
The derogations from the use of organic plant reproductive
material and from the use of organic animals provided in points 1.8.5
of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of
Annex II, with the exception of point 1.3.4.4.2 of Part II of
Annex II, shall expire on ►M3 31 December 2036 ◄.

2.
From ►M3 1 January 2029 ◄, based on the conclusions as
regards availability of organic plant reproductive material and animals
presented in the report provided for in paragraph 7 of this Article, theCommission shall be empowered to adopt delegated acts in accordancewith Article 54 amending this Regulation by:(a) ending the derogations referred to in point 1.8.5 of Part I of
Annex II and in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II,
with the exception of point 1.3.4.4.2 of Part II of Annex II, at an
earlier date than ►M3 31 December 2036 ◄ or extending thembeyond that date; or(b) ending the derogation referred to in point 1.3.4.4.2 of Part II of
Annex II.

3.
From ►M3 1 January 2027 ◄, the Commission shall beempowered to adopt delegated acts in accordance with Article 54
amending point (b) of Article 26(2) to extend the scope of theinformation system referred to in Article 26(2) to pullets andpoint 1.3.4.3 of Part II of Annex II to base the derogations concerning
pullets on the data collected in accordance with this system.

02018R0848 — EN — 21.02.2023 — 003.001 — 70
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4.
From ►M3 1 January 2026 ◄, the Commission shall beempowered to adopt delegated acts in accordance with Article 54,
based on the information as regards availability of organic protein
feed for poultry and porcine animals made available by Member
States in accordance with paragraph 6 of this Article or presented in
the report referred to in paragraph 7 of this Article, ending the auth­orisations to use non-organic protein feed in the nutrition of poultry andporcine animals referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part IIof Annex II at an earlier date than ►M3 31 December 2026 ◄ or
extending them beyond that date.

5.
When extending the derogations or authorisations referred to inparagraphs 2, 3 and 4, the Commission shall do so only for as long as it
has information, in particular information provided by Member States inaccordance with paragraph 6, that confirms the unavailability on theUnion market of the plant reproductive material, animal or feed
concerned.

6.
By 30 June of each year, Member States shall make available to
the Commission and to the other Member States:(a) information provided in the database referred to in Article 26(1) andin the systems referred to in Article 26(2) and, if relevant, in thesystems referred to in Article 26(3);(b) information on the derogations granted in accordance withpoint 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4
of Part II of Annex II; and(c) information on the availability on the Union market of organic
protein feed for poultry and porcine animals and on the authoris­
ations granted in accordance with points 1.9.3.1(c) and 1.9.4.2(c) ofPart II of Annex II.

7.
By ►M3 31 December 2026 ◄, the Commission shall present areport to the European Parliament and the Council on the availability on
the Union market of and, if relevant, on the causes of limited access to:(a) organic plant reproductive material;(b) organic animals covered by the derogations referred to in points
1.3.4.3 and 1.3.4.4 of Part II of Annex II;(c) organic protein feed intended for the nutrition of poultry andporcine animals subject to the authorisations referred to in points
1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II.

In drawing up that report, the Commission shall take into account, inparticular, the data collected in accordance with Article 26 and theinformation relating to the derogations and the authorisations referred
to in paragraph 6 of this Article.

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CHAPTER IXPROCEDURAL, TRANSITIONAL AND FINAL PROVISIONSSECTION 1

Procedural provisions
Article 54
Exercise of the delegation
1.
The power to adopt delegated acts is conferred on the Commission
subject to the conditions laid down in this Article.

2.
►C1 The power to adopt delegated acts referred to in Article 2(6),Article 9(11), Article 10(5), Article 12(2), Article 13(3), Article 14(2),Article 15(2), Article 16(2), Article 17(2), Article 18(2), Article 19(2),Article 21(1), Article 22(1), Article 23(2), Article 24(6), Article 30(7),Article 32(4), Article 33(6), Article 34(8), Article 35(9), Article 36(3),Article 38(8), Article 40(11), Article 44(2), Article 46(7), Article 48(4),Article 53(2), (3) and (4), Article 57(3) and Article 58(2) shall be
conferred on the Commission for a period of five years from17 June 2018. ◄ The Commission shall draw up a report in respectof the delegation of power no later than nine months before the end of
the five-year period. The delegation of power shall be tacitly extended
for periods of an identical duration, unless the European Parliament or
the Council opposes such extension not later than three months before
the end of each period.

3.
The delegation of power referred to in Article 2(6), Article 9(11),Article 10(5), Article 12(2), Article 13(3), Article 14(2), Article 15(2),Article 16(2), Article 17(2), Article 18(2), Article 19(2), Article 21(1),Article 22(1), Article 23(2), Article 24(6), Article 30(7), Article 32(4),Article 33(6), Article 34(8), Article 35(9), Article 36(3), Article 38(8),Article 40(11), Article 44(2), Article 46(7), Article 48(4), Article 53(2),(3) and (4), Article 57(3) and Article 58(2) may be revoked at any timeby the European Parliament or by the Council. A decision to revoke
shall put an end to the delegation of the power specified in thatdecision. It shall take effect on the day following the publication of
the decision in the Official Journal of the European Union or at a later
date specified therein. It shall not affect the validity of any delegatedacts already in force.

4.
Before adopting a delegated act, the Commission shall consult
experts designated by each Member State in accordance with the prin­ciples laid down in the Interinstitutional Agreement of 13 April 2016 on
Better Law-Making.

5.
As soon as it adopts a delegated act, the Commission shall notify
it simultaneously to the European Parliament and to the Council.

02018R0848 — EN — 21.02.2023 — 003.001 — 72
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6.
A delegated act adopted pursuant to Article 2(6), Article 9(11),Article 10(5), Article 12(2), Article 13(3), Article 14(2), Article 15(2),Article 16(2), Article 17(2), Article 18(2), Article 19(2), Article 21(1),Article 22(1), Article 23(2), Article 24(6), Article 30(7), Article 32(4),Article 33(6), Article 34(8), Article 35(9), Article 36(3), Article 38(8),Article 40(11), Article 44(2), Article 46(7), Article 48(4), Article 53(2),(3) and (4), Article 57(3) and Article 58(2) shall enter into force only if
no objection has been expressed either by the European Parliament orby the Council within a period of two months of notification of that act
to the European Parliament and the Council or if, before the expiry ofthat period, the European Parliament and the Council have bothinformed the Commission that they will not object. That period shallbe extended by two months at the initiative of the European Parliament
or of the Council.

Article 55
Committee procedure
1.
The Commission shall be assisted by a committee called the‘Organic Production Committee’. That committee shall be acommittee within the meaning of Regulation (EU) No 182/2011.

2.
Where reference is made to this paragraph, Article 5 of Regu­
lation (EU) No 182/2011 shall apply.

3.
Where reference is made to this paragraph, Article 8 of Regu­
lation (EU) No 182/2011, in conjunction with Article 5 thereof, shallapply.

4.
Where the Committee delivers no opinion, the Commission shallnot adopt the draft implementing act and the third subparagraph of
Article 5(4) of Regulation (EU) No 182/2011 shall apply.

SECTION 2

Repeal and transitional and final provisions
Article 56
RepealRegulation (EC) No 834/2007 is repealed.

However, that Regulation shall continue to apply for the purpose ofcompleting the examination of pending applications from third
countries, as provided for in Article 58 of this Regulation.

References to the repealed Regulation shall be construed as references
to this Regulation.

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Article 57
Transitional measures relating to control authorities and control
bodies recognised under Article 33(3) of Regulation (EC)No 834/2007
1.
The recognition of control authorities and control bodies granted
under Article 33(3) of Regulation (EC) No 834/2007 shall expire by►M3 31 December 2024 ◄ at the latest.

2.
The Commission shall, by means of an implementing act, establish
a list of the control authorities and control bodies recognised under
Article 33(3) of Regulation (EC) No 834/2007, and may amend thatlist by means of implementing acts.

Those implementing acts shall be adopted in accordance with the exa­
mination procedure referred to in Article 55(2).

3.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation as regards
the information to be sent by the control authorities and control
bodies referred to in paragraph 2 of this Article which is necessary
for the purpose of the supervision of their recognition by theCommission, as well as the exercise of that supervision by theCommission, including through on-the-spot examination.

Article 58
Transitional measures relating to applications from third countries
submitted under Article 33(2) of Regulation (EC) No 834/2007
1.
The Commission shall complete the examination of applications
from third countries which have been submitted under Article 33(2) ofRegulation (EC) No 834/2007 and which are pending on 17 June 2018.
That Regulation shall apply to the examination of such applications.

2.
The Commission is empowered to adopt delegated acts inaccordance with Article 54 supplementing this Regulation by laying
down the procedural rules necessary for the examination of the appli­
cations referred to in paragraph 1 of this Article, including on theinformation to be submitted by third countries.

Article 59
Transitional measures relating to the first recognition of control
authorities and control bodies
By way of derogation from the date of application referred to in thesecond paragraph of Article 61, Article 46 shall apply from 17 June2018 insofar as necessary in order to allow a timely recognition ofcontrol authorities and control bodies.

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Article 60
Transitional measures for stocks of organic products produced inaccordance with Regulation (EC) No 834/2007
Products produced in accordance with Regulation (EC) No 834/2007
before ►M3 1 January 2022 ◄ may be placed on the market after thatdate until stocks are exhausted.

Article 61
Entry into force and application
This Regulation shall enter into force on the third day following that ofits publication in the Official Journal of the European Union.
▼M3
It shall apply from 1 January 2022.
▼B
This Regulation shall be binding in its entirety and directly applicable inall Member States.

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ANNEX IOTHER PRODUCTS REFERRED TO IN ARTICLE 2(1)— Yeasts used as food or feed,— maté, sweetcorn, vine leaves, palm hearts, hop shoots, and other similar
edible parts of plants and products produced therefrom,— sea salt and other salts for food and feed,— silkworm cocoon suitable for reeling,— natural gums and resins,— beeswax,— essential oils,— cork stoppers of natural cork, not agglomerated, and without any binding
substances,— cotton, not carded or combed,— wool, not carded or combed,— raw hides and untreated skins,— plant-based traditional herbal preparations.

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ANNEX IIDETAILED 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, shallbe produced in living soil, or in living soil mixed or fertilised withmaterials 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, isprohibited.

1.3.

By way of derogation from point 1.1, the following shall be allowed:▼M7(a) the production of sprouted seeds, which include sprouts, shoots
and cress, solely living on the nutritional reserves available in theseeds, 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 theseeds moist when the components of that inert medium are auth­orised in compliance with Article 24;(b) the obtaining of chicory heads, including by dipping them in clear
water, provided that the plant reproductive material is organic. The
use of a growing medium shall be allowed only when its
components are authorised in compliance with Article 24.

▼B
1.4.

By way of derogation from point 1.1, the following practices shall beallowed:(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 in containers for furthertransplanting.

1.5.

By way of derogation from point 1.1, growing crops in demarcatedbeds shall only be allowed for the surfaces that have been certified asorganic for that practice before 28 June 2017 in Finland, Sweden and
Denmark. No extension of those surfaces shall be permitted.

That derogation shall expire on ►M3 31 December 2031 ◄.

By ►M3 31 December 2026 ◄, the Commission shall present areport to the European Parliament and the Council on the use ofdemarcated beds in organic agriculture. That report may be accom­
panied, where appropriate, by a legislative proposal on the use ofdemarcated beds in organic agriculture.

02018R0848 — EN — 21.02.2023 — 003.001 — 77
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1.6.

All plant production techniques used shall prevent or minimise any
contribution to the contamination of the environment.

1.7.

Conversion

1.7.1.

For plants and plant products to be considered as organic products, theproduction rules laid down in this Regulation shall have been appliedwith respect to the parcels during a conversion period of at least two
years before sowing, or, in the case of grassland or perennial forage,
during a period of at least two years before its use as organic feed, or,in the case of perennial crops other than forage, during a period of atleast three years before the first harvest of organic products.

1.7.2.

Where the land or one or more parcels thereof have been contaminatedwith products or substances not authorised for use in organic
production, the competent authority may decide to extend theconversion period for the land or parcels concerned beyond theperiod referred to in point 1.7.1.

1.7.3.

In the case of treatment with a product or a substance not authorisedfor use in organic production, the competent authority shall require a
new conversion period in accordance with point 1.7.1.
That period may be shortened in the following two cases:(a) treatment with a product or a substance not authorised for use inorganic production as part of a compulsory control measure forpests or weeds, including quarantine organisms or invasive
species, imposed by the competent authority of the Member
State concerned;(b) treatment with a product or a substance not authorised for use inorganic production as part of scientific tests approved by thecompetent authority of the Member State concerned.

1.7.4.

In the cases referred to in points 1.7.2 and 1.7.3, the length of theconversion period shall be fixed taking into account the following
requirements:(a) the process of degradation of the product or substance concerned
must guarantee, at the end of the conversion period, an insig­
nificant level of residues in the soil and, in the case of aperennial crop, in the plant;(b) the harvest following the treatment may not be placed on themarket as organic or in-conversion products.

1.7.4.1.

Member States shall inform the Commission and the other Member
States of any decision taken by them which lays down compulsory
measures related to treatment with a product or a substance not auth­orised for use in organic production.

1.7.4.2.

In the case of treatment with a product or a substance which is not
authorised for use in organic production, point 1.7.5(b) shall not apply.

1.7.5.

In the case of land associated with organic livestock production:(a) the conversion rules shall apply to the whole area of the
production unit on which animal feed is produced;(b) notwithstanding point (a), the conversion period may be reduced to
one year for pasturages and open air areas used by non-herbivore
species.

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1.8.

Origin of plants including plant reproductive material

1.8.1.

For the production of plants and plant products other than plant repro­
ductive material, only organic plant reproductive material shall be
used.

1.8.2.

To obtain organic plant reproductive material to be used for the
production of products other than plant reproductive material, themother plant and, where relevant, other plants intended for plant repro­
ductive material production shall have been produced in accordancewith this Regulation for at least one generation, or, in the case of
perennial crops, for at least one generation during two growing
seasons.

1.8.3.

When choosing organic plant reproductive material, operators shallgive preference to organic plant reproductive material suitable fororganic agriculture.

1.8.4.

For the production of organic varieties suitable for organic production,
the organic breeding activities shall be conducted under organic
conditions and shall focus on enhancement of genetic diversity,
reliance 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 carriedout under certified organic management.

1.8.5.

Use of in-conversion and non-organic plant reproductive material.

1.8.5.1.

►M11 By way of derogation from point 1.8.1, where the datacollected in the database referred to in Article 26(1) or the systems
referred to in Article 26(2) show that the qualitative or quantitativeneeds of the operator regarding relevant organic plant reproductive
material are not met, the operator may use in-conversion plant repro­
ductive material in accordance with Article 10(4), second
subparagraph, point (a), or plant reproductive material authorised inaccordance with point 1.8.6. ◄

▼M4

▼M11
In addition, in case of a lack of availability of organic seedlings, ‘inconversion 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 atleast 12 months on a land parcel that, during that same period, hascompleted 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 thatthe seedlings have originated from in-conversion seeds, harvested
from a plant grown on a land parcel that has completed aconversion 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 notavailable in sufficient quality or quantity to fulfil the operator’s needs,
competent authorities may authorise the use of non-organic plant
reproductive material subject to points 1.8.5.3 to 1.8.5.8.

02018R0848 — EN — 21.02.2023 — 003.001 — 79
▼M11
Such individual authorisation shall be issued only in one of thefollowing situations:(a) where no variety of the species that the operator wants to obtain isregistered in the database referred to in Article 26(1) or thesystems 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 accordancewith point 1.8.6 in time for sowing or planting in situations
where the user has ordered the plant reproductive material inreasonable time to allow the preparation and supply of organic
or in-conversion plant reproductive material or of plant repro­
ductive material authorised in accordance with point 1.8.6;(c) where the variety that the operator wants to obtain is not registeredas organic or in-conversion plant reproductive material or as plant
reproductive material authorised in accordance with point 1.8.6 inthe 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 inparticular to the agronomic and pedo-climatic conditions andnecessary technological properties for the production to beobtained;(d) where it is justified for use in research, test in small-scale fieldtrials, for variety conservation purposes of for product innovation
and agreed by the competent authorities of the Member State
concerned.
Prior to requesting any such 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 orin-conversion plant reproductive material or plant reproductive
material authorised in accordance with point 1.8.6 is available andthus whether their request is justified.

▼M4
When in compliance with Article 6 (i) operators may use both organicand 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 systemreferred to in point (a) of Article 26(2).
1.8.5.2.

►M11 By way of derogation from point 1.8.1, operators in third
countries may use in-conversion plant reproductive material inaccordance 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 be not available
in sufficient quality or quantity in the territory of the third country inwhich the operator is 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.

▼M11
Control authorities or control bodies recognised in accordance with
Article 46(1) may authorise operators in third countries to use
non-organic plant reproductive material in an organic production
unit, when organic or in-conversion plant reproductive material orplant reproductive material authorised in accordance with point 1.8.6
is not available in sufficient quality or quantity in the territory of thethird country in which the operator is located, under the conditions laid
down in points 1.8.5.3, 1.8.5.4, 1.8.5.5 and 1.8.5.8.

02018R0848 — EN — 21.02.2023 — 003.001 — 80
▼M4
1.8.5.3.

Non-organic plant reproductive material shall not be treated after
harvest with plant protection products other than those authorised forthe treatment of plant reproductive material in accordance with
Article 24(1) of this Regulation, unless chemical treatment has beenprescribed in accordance with Regulation (EU) 2016/2031 for phytos­
anitary 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 the non-organic plant reproductive material treated with theprescribed chemical treatment referred to in the first paragraph isused, the parcel on which the treated plant reproductive material is
growing shall be subject, where appropriate, to a conversion period asprovided in points 1.7.3 and 1.7.4.

1.8.5.4.

The authorisation to use non-organic plant reproductive material shallbe obtained before the sowing or planting of the crop.

1.8.5.5.

The authorisation to use non-organic plant reproductive material shallbe granted to individual users for one season at a time, and thecompetent 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 thequantity 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 circum­
stances, 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, thecompetent authorities of the Member States shall transmit to theCommission 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 ofthe 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 isregistered in the database referred to in Article 26(1) or the systemreferred to in point (a) of Article 26(2);(b) for a given variety when and in so far as the conditions laid downin point 1.8.5.1(c) are fulfilled.
When using a general authorisation, operators shall keep records of thequantity used and competent authority responsible for authorisations shalllist 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 isissued 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, thecompetent authorities of the Member States shall transmit to theCommission 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.

02018R0848 — EN — 21.02.2023 — 003.001 — 81
▼M11
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 theseedling to the first harvest of product.

1.8.6.

Competent authorities or, where appropriate, control authorities orcontrol bodies recognised in accordance with Article 46(1) may
authorise operators producing plant reproductive material for use inorganic 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 compliancewith point 1.8.2 are not available in sufficient quantity or quality, andto 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 beentreated after harvest with plant protection products other thanthose authorised in accordance with Article 24(1) of this Regu­
lation, unless chemical treatment has been prescribed inaccordance 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 withsuch 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 inpoints 1.7.3 and 1.7.4;(b) the non-organic plant reproductive material used is not a seedlingof species that have a cultivation cycle completed in one growing
season, from the transplantation of the seedling to the first harvestof product;(c) the plant reproductive material is grown in compliance with allother 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 shalllist the quantities of the authorised plant reproductive material;(f) by way of derogation from point (e), the competent authorities ofthe 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 thequantities 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, thecompetent authorities of the Member States shall notify theCommission and the other Member States of the information on theauthorisations 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 tomake 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 oncethe 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.

02018R0848 — EN — 21.02.2023 — 003.001 — 82
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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 andincreased:(a) except in the case of grassland or perennial forage, by the use ofmultiannual 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 measuresprovided for in points 1.9.1 and 1.9.2, only fertilisers and soil condi­
tioners that have been authorised pursuant to Article 24 for use inorganic production shall be used, and only to the extent necessary.
►M9 Operators shall keep records of the use of those products,
including the date or dates on which each product was used, thename 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 agriculturalarea 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 cooperationagreements exclusively with operators of other agricultural holdings
and undertakings which comply with the organic production rules, forthe purpose of spreading surplus manure from organic production
units. The maximum limit referred to in point 1.9.4 shall be calculatedon the basis of all of the organic production units involved in suchcooperation.

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 thesoil or in the crops.

1.9.7.

For compost activation, appropriate plant-based preparations and prep­
arations of micro-organisms may be used.

1.9.8.

Mineral nitrogen fertilisers shall not be used.

1.9.9.

Biodynamic preparations may be used.

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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 andphysical 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 measuresprovided for in point 1.10.1 or in the case of an established threat to acrop, only products and substances authorised pursuant to Articles 9
and 24 for use in organic production shall be used, and only to theextent necessary. ►M9 Operators shall keep records proving the needfor the use of such products, including the date or dates on which eachproduct was used, the name of the product, its active substances, theamount 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 theenvironment and shall prevent contact between the products andsubstances 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. ►M9 Operators shall keep records of the use of
those products including the date or dates on which each product wasused, the name of the product, its active substances, and the locationof such use. ◄1.12.

Record-keeping obligation
Operators shall keep records regarding the parcels concerned and theamount of the harvest. ►M9 In particular, operators shall keep
records of any other external input used on each parcel and, whereapplicable, keep available documentary evidence on any derogationfrom 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 onplants, 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 suchoperations.

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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 arecomposed 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 inpoint (i) is not available, provided that that farmyard manureand 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 inpoint (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 innatural 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 thoseauthorised 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.

▼M9
Operators shall keep records of the period and location of thecollection, the species concerned and the quantity of wild plants
collected.

▼BPart II: Livestock production rules
In addition to the production rules laid down in Articles 9, 10, 11 and 14, therules 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 cooperationagreement with a farmer as regards the use of organic production
units or in-conversion production units for that livestock, shall be
prohibited.

02018R0848 — EN — 21.02.2023 — 003.001 — 85
▼M9Operators shall keep available documentary evidence on any dero­
gation from livestock production rules obtained in accordance withpoints 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).

▼B
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 theanimals existing on this production unit at the beginning of theconversion period of this production unit as referred to in points
1.7.1 and 1.7.5(b) of Part I, animals and animal products may beconsidered organic at the end of the conversion period of the
production unit, even if the conversion period laid down inpoint 1.2.2 of this Part for the type of animal concerned is longer
than the conversion period for the production unit.
By derogation from point 1.4.3.1, in the case of such simultaneousconversion and during the conversion period of the production unit,
animals present in this production unit since the beginning of theconversion period may be fed with in-conversion feed produced on
the in-conversion production unit during the first year of conversion
and/or with feed in accordance with point 1.4.3.1 and/or with organic
feed.
Non-organic animals may be introduced into an in-conversion
production unit after the start of the conversion period in accordancewith point 1.3.4.

1.2.2.

Conversion periods specific to the type of animal production are set
out as follows:(a) 12 months in the case of bovine animals and equine animals formeat production, and in any case no less than three quarters of
their lifetime;(b) six months in the case of ovine animals, caprine animals andporcine animals and animals for milk production;(c) 10 weeks for poultry for meat production, except for Peking
ducks, brought in before they are three days old;(d) seven weeks for Peking ducks brought in before they are threedays old;(e) six weeks in the case of poultry for egg production brought in
before they are three days old;(f) 12 months for bees.
During the conversion period, the wax shall be replaced with wax
coming from organic beekeeping.
However, non-organic beeswax may be used:(i) where beeswax from organic beekeeping is not available on
the market;(ii) where it is proven free of contamination with products or
substances not authorised for use in organic production; and(iii) provided that it comes from the cap;

02018R0848 — EN — 21.02.2023 — 003.001 — 86▼B(g) three months for rabbits;(h) 12 months for cervine animals.

1.3.

Origin of animals

1.3.1.

Without prejudice to the rules on conversion, organic livestock shallbe born or hatched and raised on organic production units.

1.3.2.

With regard to the breeding of organic animals:(a) reproduction shall use natural methods; however, artificial insemi­
nation shall be allowed;(b) reproduction shall not be induced or impeded by treatment withhormones or other substances with a similar effect, except as aform of veterinary therapeutic treatment in the case of an indi­vidual animal;(c) other forms of artificial reproduction, such as cloning and embryotransfer, shall not be used;(d) the choice of breeds shall be appropriate to the principles oforganic production, shall ensure a high standard of animal
welfare and shall contribute to the prevention of any sufferingand to avoiding the need for the mutilation of animals.

1.3.3.

When choosing breeds or strains, operators shall consider giving pref­
erence to breeds or strains with a high degree of genetic diversity, thecapacity of animals to adapt to local conditions, their breeding value,
their longevity, their vitality and their resistance to disease or healthproblems, all without impairment of their welfare. In addition, breeds
or strains of animals shall be selected to avoid specific diseases orhealth problems associated with some breeds or strains used inintensive production, such as porcine stress syndrome, possibly
leading to pale-soft-exudative (PSE) meat, sudden death, spontaneousabortion and difficult births requiring caesarean operations. Preference
shall be given to indigenous breeds and strains.

To choose the breeds and strains in accordance with the firstparagraph, operators shall use the information available in thesystems referred to in Article 26(3).

1.3.4.

Use of non-organic animals

1.3.4.1.

By way of derogation from point 1.3.1, for breeding purposes,
non-organically raised animals may be brought to an organic
production unit when breeds are in danger of being lost to farming
as referred to in point (b) of Article 28(10) of Regulation (EU)No 1305/2013 and acts adopted on the basis thereof. In such case,the animals of those breeds need not necessarily be nulliparous.

1.3.4.2.

By way of derogation from point 1.3.1, for the renovation of apiaries,
20 % per year of the queen bees and swarms may be replaced by
non-organic queen bees and swarms in the organic production unit,
provided that the queen bees and swarms are placed in hives withcombs or comb foundations coming from organic production units.
In any case, one swarm or queen bee may be replaced per year bya non-organic swarm or a queen bee.

02018R0848 — EN — 21.02.2023 — 003.001 — 87
▼B
1.3.4.3.

By way of derogation from point 1.3.1, where a flock is constituted forthe first time, or is renewed or reconstituted, and where the qualitativeand quantitative needs of farmers cannot be met, the competentauthority may decide that non-organically reared poultry may bebrought into an organic poultry production unit, provided that thepullets for the production of eggs and poultry for meat production
are less than three days old. Products derived from them may only
be considered as organic if the conversion period specified in point 1.2
has been complied with.

1.3.4.4.

By way of derogation from point 1.3.1, where the data collected in thesystem referred to in point (b) of Article 26(2) shows that the quali­
tative or quantitative needs of the farmer regarding organic animals are
not met, competent authorities may authorise the introduction of
non-organic animals into an organic production unit, subject to theconditions provided for in points 1.3.4.4.1 to 1.3.4.4.4.

Prior to requesting any such derogation, the farmer shall consult thedata collected in the system referred to in point (b) of Article 26(2) inorder to verify whether his or her request is justified.

For operators in third countries, control authorities and control bodies
recognised in accordance with Article 46(1) may authorise the intro­
duction of non-organic animals into an organic production unit whereorganic animals are not available in sufficient quality or quantity in the
territory of the country where the operator is located.

1.3.4.4.1. For breeding purposes, non-organic young animals may be introduced
when a herd or flock is constituted for the first time. They shall bereared in accordance with the organic production rules immediately
after they are weaned. In addition, the following restrictions shallapply on the date on which those animals enter the herd or flock:(a) bovine animals, equine animals and cervine animals shall be lessthan six months old;(b) ovine animals and caprine animals shall be less than 60 days old;(c) porcine animals shall weigh less than 35 kg;(d) rabbits shall be less than three months old.

1.3.4.4.2. For breeding purposes, non-organic adult male and non-organic nulli­parous female animals may be introduced for the renewal of a herd or
flock. They shall be reared subsequently in accordance with theorganic production rules. In addition, the number of female animals
shall be subject to the following restrictions per year:(a) up to a maximum of 10 % of adult equine animals or bovine
animals and 20 % of the adult porcine animals, ovine animals,
caprine animals, rabbits or cervine animals may be introduced;(b) for units with fewer than 10 equine animals, cervine animals orbovine animals or rabbits, or with fewer than five porcine animals,
ovine animals or caprine animals, any such renewal shall belimited to a maximum of one animal per year.

02018R0848 — EN — 21.02.2023 — 003.001 — 88
▼B
1.3.4.4.3. The percentages set in point 1.3.4.4.2 may be increased up to 40 %,provided that the competent authority has confirmed that any offollowing conditions is fulfilled:(a) a major extension to the farm has been undertaken;(b) one breed has been replaced with another;(c) a new livestock specialisation has been initiated.

1.3.4.4.4. In the cases referred to in points 1.3.4.4.1, 1.3.4.4.2 and 1.3.4.4.3,
non-organic animals may only be considered as organic if theconversion period specified in point 1.2 has been complied with.
The conversion period laid down in point 1.2.2 shall start, at theearliest, once the animals are introduced into the 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 inpoint 1.3.4.4.4.

▼M9
1.3.4.5.

Operators shall keep records or documentary evidence of the origin ofanimals, 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▼B

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 fromorganic or in-conversion production units belonging to otherholdings in the same region;(b) livestock shall be fed with organic or in-conversion feed that meetsthe animal’s nutritional requirements at the various stages of its
development; restricted feeding shall not be permitted in livestock
production unless justified for veterinary reasons;(c) livestock shall not be kept in conditions or on a diet which may
encourage anaemia;(d) fattening practices shall always respect the normal nutritional
patterns for each species and the animals’ welfare at each stageof the rearing process; force-feeding is forbidden;(e) with the exception of porcine animals, poultry and bees, livestock
shall have permanent access to pasture whenever conditions allow
or shall have permanent access to roughage;

02018R0848 — EN — 21.02.2023 — 003.001 — 89▼B(f) growth promoters and synthetic amino-acids shall not be used;(g) suckling animals shall preferably be fed on maternal milk for aminimum period laid down by the Commission in accordance withpoint (a) of Article 14(3); milk replacers containing chemicallysynthesised components or components of plant origin shall not
be used during that period;(h) feed materials of plant, algal, animal or yeast origin shall beorganic;(i) non-organic feed materials of plant, algal, animal or yeast origin,
feed materials of microbial or of mineral origin, feed additives andprocessing aids may be used only if they have been authorised
pursuant to Article 24 for use in organic production.

1.4.2.

Grazing

1.4.2.1.

Grazing on organic landWithout prejudice to point 1.4.2.2, organic animals shall graze onorganic land. However, non-organic animals may use organic
pasturage for a limited period each year, provided that they havebeen raised in an environmental friendly way on land supported
under Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU)No 1305/2013 and that they are not present on the organic land at
the same time as organic animals.

1.4.2.2.

Grazing on common land and transhumance

1.4.2.2.1. Organic animals may graze on common land, provided that:(a) the common land has not been treated with products or substances
not authorised for use in organic production for at least three
years;(b) any non-organic animals which use the common land have beenraised in an environmental friendly way on land supported under
Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU)No 1305/2013;(c) any livestock products from organic animals that were produced
during the period when those animals grazed on common land are
not considered as organic products unless adequate segregationfrom non-organic animals can be proved.

1.4.2.2.2. During the period of transhumance, organic animals may graze on
non-organic land when they are being moved on foot from one
grazing area to another. During that period, organic animals shall be
kept separate from other animals. The uptake of non-organic feed, inthe form of grass and other vegetation on which the animals graze,
shall be allowed:(a) for a maximum of 35 days covering both the outward and return
journeys; or(b) for a maximum of 10 % of the total feed ration per year,
calculated as a percentage of the dry matter of feedstuffs of agri­
cultural origin.

02018R0848 — EN — 21.02.2023 — 003.001 — 90
▼B
1.4.3.

In-conversion feed

1.4.3.1.

For agricultural holdings that produce organic livestock:(a) up to 25 % on average of the feed formula of rations may
comprise in-conversion feed from the second year of conversion.
This percentage may be increased to 100 % if this in-conversion
feed comes from the holding where the livestock is kept; and(b) up to 20 % of the total average amount of feed fed to livestock
may originate from the grazing or harvesting of permanentpastures, perennial forage parcels or protein crops sown underorganic management on lands in their first year of conversion,
provided that those lands are part of the holding itself.

When both types of in-conversion feed referred to in points (a) and (b)are being 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 apercentage of the dry matter of feed of plant origin.

1.4.4.

Record-keeping of the feeding regime▼M9
Operators shall keep records of the feeding regime and, where
relevant, the grazing period. In particular, they shall keep records ofthe 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 whererestrictions apply and documentary evidence of the application ofpoints 1.4.2 and 1.4.3.

▼B
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, appro­
priate 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 chemicalmolecules, 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 ofcontrolling reproduction or for other purposes (e.g. induction orsynchronisation 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.

02018R0848 — EN — 21.02.2023 — 003.001 — 91
▼B
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. ►M9 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 anddisinfected 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 to avoid
attracting insects or rodents. Rodenticides, to be used only in traps,
and products and substances authorised pursuant to Articles 9 and 24
for use in organic production may be used for the elimination of
insects and other pests in buildings and other installations where
livestock are kept.

1.5.2.

Veterinary treatment

1.5.2.1.

Where animals become sick or injured despite preventive measures toensure animal health, they shall be treated immediately.

1.5.2.2.

Disease shall be treated immediately to avoid suffering of the animal.
Chemically synthesised allopathic veterinary medicinal products,
including antibiotics, may be used where necessary, under strict
conditions and under the responsibility of a veterinarian, when theuse of phytotherapeutic, homeopathic and other products is inappro­
priate. In particular, restrictions with respect to courses of treatment
and withdrawal periods shall be defined.

1.5.2.3.

Feed materials of mineral origin authorised pursuant to Article 24 foruse in organic production, nutritional additives authorised pursuant to
Article 24 for use in organic production, and phytotherapeutic andhomeopathic products shall be used in preference to treatment withchemically synthesised allopathic veterinary medicinal products,
including antibiotics, provided that their therapeutic effect iseffective for the species of animal and for the condition for which
the treatment is intended.

1.5.2.4.

With the exception of vaccinations, treatments for parasites andcompulsory eradication schemes, where an animal or a group ofanimals receives more than three courses of treatments with chemicallysynthesised allopathic veterinary medicinal products, including anti­
biotics, within 12 months, or more than one course of treatment if
their productive lifecycle is less than one year, neither the livestock
concerned nor produce derived from such livestock shall be sold asorganic products, and the livestock shall be subject to the conversion
periods referred to in point 1.2.

1.5.2.5.

The withdrawal period between the last administration to an animal ofa chemically synthesised allopathic veterinary medicinal product,
including of an antibiotic, under normal conditions of use, and the
production of organically produced foodstuffs from that animal shallbe 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 healthimposed on the basis of Union legislation shall be allowed.

02018R0848 — EN — 21.02.2023 — 003.001 — 92
▼M9
1.5.2.7.

Operators shall keep records or documentary evidence of any treatment
applied and, in particular, the identification of the animals treated, thedate 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 permit plentiful natural ventilation andlight to enter.

1.6.2.

Housing for livestock shall not be mandatory in areas with appropriate
climatic conditions enabling animals to live outdoors. In such cases,
animals shall have access to shelters or shady areas to protect themfrom adverse weather conditions.

1.6.3.

The stocking density in buildings shall provide for the comfort,
well-being and species-specific needs of the animals, and shalldepend in particular on the species, the breed and the age of theanimals. It shall also take account of the behavioural needs of theanimals, which depend in particular on the size of the group and theanimals’ sex. The density shall ensure the animals’ welfare byproviding them with sufficient space to stand naturally, to move, tolie down easily, to turn round, to groom themselves, to assume all
natural postures and to make all natural movements, such as stretching
and wing flapping.

1.6.4.

The minimum surface for indoor and outdoor areas, and the technicaldetails relating to housing, laid down in the implementing acts referred
to in Article 14(3), shall be complied with.

1.6.5.

Open air areas may be partially covered. Verandas shall not be
considered as open air areas.

1.6.6.

The total stocking density shall not exceed the limit of 170 kg oforganic nitrogen per year and hectare of agricultural area.

1.6.7.

To determine the appropriate density of livestock referred to inpoint 1.6.6, the competent authority shall set out the livestock units
equivalent to the limit referred to in point 1.6.6, following the figureslaid down in each of the specific requirements per type of animal
production.

1.6.8.

Cages, boxes and flat decks to raise livestock shall not be used for any
livestock species.

1.6.9.

When livestock is treated individually for veterinary reasons, it shallbe kept in spaces that have a solid floor and shall be provided withstraw or appropriate bedding. The animal must be able to turn aroundeasily and to lie down comfortably at full length.

1.6.10.

Organic livestock may not be reared in a pen on very wet or marshy
soil.

▼B

02018R0848 — EN — 21.02.2023 — 003.001 — 93
▼B
1.7.

Animal welfare

1.7.1.

All persons involved in keeping animals and in handling animals
during transport and slaughter shall possess the necessary basic
knowledge and skills as regards the health and the welfare needs ofthe animals and shall have followed adequate training, as required inparticular in Council Regulation (EC) No 1/2005 (1) and Council
Regulation No (EC) 1099/2009 (2), to ensure proper application of
the rules set out in this Regulation.

1.7.2.

Husbandry practices, including stocking densities and housing
conditions, shall ensure that the developmental, physiological andethological needs of the animals are met.

1.7.3.

Livestock shall have permanent access to open air areas that allow theanimals to exercise, preferably pasture, whenever weather and seasonal
conditions and the state of the ground allow, except where restrictions
and obligations related to the protection of human and animal healthhave been imposed on the basis of Union legislation.

1.7.4.

The number of livestock shall be limited with a view to minimising
overgrazing, poaching of soil, erosion, and pollution caused byanimals or by the spreading of their manure.

1.7.5.

Tethering or isolation of livestock shall be prohibited, except in
relation to individual animals for a limited period and insofar as thisis justified for veterinary reasons. The isolation of livestock may only
be authorised, and only for a limited period, where workers’ safety iscompromised or for animal welfare reasons. Competent authorities
may authorise the tethering of cattle in farms with a maximum of
50 animals (excluding young stock) where it is not possible to keep
the cattle in groups appropriate to their behaviour requirements,
provided they have access to pastures during the grazing period, andhave access to open air areas at least twice a week when grazing is notpossible.

1.7.6.

Duration of transport of livestock shall be minimised.

1.7.7.

Any suffering, pain and distress shall be avoided and shall be kept to aminimum during the entire life of the animal, including at the time ofslaughter.

1.7.8.

Without prejudice to developments in Union legislation on animal
welfare, tail-docking of sheep, beak trimming undertaken in the first
three days of life, and dehorning may exceptionally be allowed, but
only on a case-by-case basis and only when those practices improve
the health, welfare or hygiene of the livestock or where workers’
safety would otherwise be compromised. Disbudding may beallowed only on a case by case basis when it improves the health,welfare or hygiene of the livestock or where workers’ safety would
otherwise be compromised. The competent authority shall only
authorise such operations where the operator has duly notified andjustified the operations to that competent authority and where theoperation is to be carried out by qualified personnel.

(1) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals
during transport and related operations and amending Directives 64/432/EEC and93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).
(2) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection ofanimals at the time of killing (OJ L 303, 18.11.2009, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 94
▼B
1.7.9.

Any suffering to the animals shall be reduced to a minimum byapplying adequate anaesthesia and/or analgesia and by carrying out
each operation at only the most appropriate age by qualified personnel.

1.7.10.

Physical castration shall be allowed in order to maintain the quality of
products and traditional production practices, but only under theconditions set out in point 1.7.9.

1.7.11.

The loading and unloading of animals shall be carried out without theuse of any type of electrical or other painful stimulation to coerce theanimals. The use of allopathic tranquillisers, prior to or duringtransport, shall be prohibited.

1.7.12.

Operators shall keep records or documentary evidence of any specificoperation 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, thefollowing data shall be recorded, where relevant: age, number ofanimals, weight of slaughter animals, appropriate identification (peranimal or by batch/flock/hive) date of departure and destination.

1.8.

Preparation of unprocessed products▼M9▼B
If preparation operations other than processing are carried out onlivestock, 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 suchoperations.

1.9.

Additional general rules

1.9.1.

For bovine animals, ovine animals, caprine animals and equine
animals

1.9.1.1.

Nutrition
With regard to nutrition, the following rules shall apply:(a) at least 60 % of the feed shall come from the farm itself or, if thisis not feasible or such feed is not available, shall be producedin cooperation with other organic or in-conversion production
units and feed operators using feed and feed material from thesame region. This percentage shall be raised to 70 % as from►M3 1 January 2024 ◄;(b) animals shall have access to pasturage for grazing wheneverconditions allow;(c) notwithstanding point (b), male bovine animals over one year old
shall have access to pasturage or an open air area;(d) where animals have access to pasturage during the grazing period
and where the winter housing system allows the animals to movefreely, the obligation to provide open air areas during the wintermonths may be waived;(e) rearing systems shall be based on maximum use of grazing
pasturage, by reference to the availability of pastures in the
different periods of the year;02018R0848 — EN — 21.02.2023 — 003.001 — 95
▼B(f) at least 60 % of the dry matter in daily rations shall consist ofroughage, fresh or dried fodder, or silage. This percentage may be
reduced to 50 % for animals in dairy production for a maximum
period of three months in early lactation.

1.9.1.2.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) housing shall have smooth, but not slippery floors;(b) housing shall be provided with a comfortable, clean and dry laying
or rest area of sufficient size, which shall consist of a solid
construction which is not slatted. Ample dry bedding strewn
with litter material shall be provided in the rest area. The littershall comprise straw or other suitable natural material. The litter
may be improved and enriched with any mineral product that is
authorised pursuant to Article 24 as a fertiliser or soil conditioner
for use in organic production;(c) notwithstanding point (a) of the first subparagraph of Article 3(1)and the second subparagraph of Article 3(1) of Council Directive
2008/119/EC (1), the housing of calves in individual boxes shall be
forbidden after the age of one week, unless for individual animals
for a limited period, and insofar as this is justified for veterinary
reasons;(d) when a calf is treated individually for veterinary reasons, it shallbe kept in spaces that have a solid floor and shall be provided withstraw bedding. The calf must be able to turn around easily and tolie down comfortably at full length.

1.9.2.

For cervine animals

1.9.2.1.

Nutrition
With regard to nutrition, the following rules shall apply:(a) at least 60 % of the feed shall come from the farm itself or, if thisis not feasible or such feed is not available, shall be producedin cooperation with other organic or in-conversion production
units and feed operators using feed and feed material from thesame region. This percentage shall be raised to 70 % as from►M3 1 January 2024 ◄;(b) animals shall have access to pasturage for grazing wheneverconditions allow;(c) where animals have access to pasturage during the grazing period
and where the winter housing system allows the animals to movefreely, the obligation to provide open air areas during the wintermonths may be waived;(d) rearing systems shall be based on maximum use of grazing
pasturage by reference to the availability of pastures in the
different periods of the year;(1) Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards
for the protection of calves (OJ L 10, 15.1.2009, p. 7).

02018R0848 — EN — 21.02.2023 — 003.001 — 96▼B(e) at least 60 % of the dry matter in daily rations shall consist ofroughage, fresh or dried fodder, or silage. This percentage may be
reduced to 50 % for female cervine animals in milk production fora maximum period of three months in early lactation;(f) natural grazing shall be ensured in a pen during the period ofvegetation. Pens that cannot provide feed by grazing during theperiod of vegetation shall not be allowed;(g) feeding shall only be allowed in the event of a shortage of grazing
due to poor weather conditions;(h) farmed animals in a pen shall be provided with clean and fresh
water. If a natural source of water that is easily accessible toanimals is not available, watering places shall be provided.

1.9.2.2.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) cervine animals shall be provided with hiding places, shelters andfences that do not harm animals;(b) in red deer pens, animals must be able to roll in the mud to ensureskin grooming and body temperature regulation;(c) any housing shall have smooth, but not slippery floors;(d) any housing shall be provided with a comfortable, clean and drylaying or rest area of sufficient size, consisting of a solid
construction which is not slatted. Ample dry bedding strewn
with litter material shall be provided in the rest area. The littershall comprise straw or other suitable natural material. The litter
may be improved and enriched with any mineral product auth­orised pursuant to Article 24 as a fertiliser or soil conditioner
for use in organic production;(e) feeding places shall be installed in areas protected from theweather and accessible both to animals and to persons attending
to them. The soil where feeding places are located shall beconsolidated, and the feeding apparatus shall be equipped with aroof;(f) if permanent access to feed cannot be ensured, the feeding places
shall be designed so that all animals can feed at the same time.

1.9.3.

For porcine animals

1.9.3.1.

Nutrition
With regard to nutrition, the following rules shall apply:(a) at least 30 % of the feed shall come from the farm itself or, if thisis not feasible or such feed is not available, shall be produced incooperation with other organic or in-conversion production units
and feed operators using feed and feed material from the same
region;02018R0848 — EN — 21.02.2023 — 003.001 — 97
▼B(b) roughage, fresh or dried fodder, or silage shall be added to thedaily ration;(c) where farmers are unable to obtain protein feed exclusively fromorganic production, and the competent authority has confirmedthat organic protein feed is not available in sufficient quantity,
non-organic protein feed may be used until ►M3 31 December
2026 ◄ provided that the following conditions are fulfilled:(i) it is not available in organic form;(ii) it is produced or prepared without chemical solvents;(iii) its use is limited to the feeding of piglets of up to 35 kg withspecific protein compounds; and(iv) the maximum percentage authorised per period of 12 months
for those animals does not exceed 5 %. The percentage of thedry matter of feed from agricultural origin shall be calculated.

1.9.3.2.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) the housing shall have smooth, but not slippery floors;(b) the housing shall be provided with a comfortable, clean and drylaying or rest area of sufficient size, consisting of a solid
construction which is not slatted. Ample dry bedding strewn
with litter material shall be provided in the rest area. The littershall comprise straw or other suitable natural material. The litter
may be improved and enriched with any mineral product auth­orised pursuant to Article 24 as a fertiliser or soil conditioner
for use in organic production;(c) there shall always be a bed made of straw or other suitablematerial large enough to ensure that all pigs in a pen can lie
down at the same time in the most space-consuming way;(d) sows shall be kept in groups, except in the last stages ofpregnancy and during the suckling period, during which time thesow must be able to move freely in her pen and her movement
shall only be restricted for short periods;(e) without prejudice to any additional requirements for straw, a few
days before expected farrowing, sows shall be provided with aquantity of straw or other suitable natural material sufficient toenable them to build nests;(f) exercise areas shall permit dunging and rooting by porcine
animals. For the purposes of rooting, different substrates may beused.

02018R0848 — EN — 21.02.2023 — 003.001 — 98
▼B
1.9.4.

For poultry

1.9.4.1.

Origin of animals
To prevent the use of intensive rearing methods, poultry shall either bereared until they reach a minimum age or else shall come fromslow-growing poultry strains adapted to outdoor rearing.
The competent authority shall define the criteria of slow-growing
strains or draw up a list of those strains and provide this information
to operators, other Member States and the Commission.
Where slow-growing poultry strains are not used by the farmer, theminimum age at slaughter shall be as follows:(a) 81 days for chickens;(b) 150 days for capons;(c) 49 days for Peking ducks;(d) 70 days for female Muscovy ducks;(e) 84 days for male Muscovy ducks;▼C2(f) 92 days for Mulard ducks;▼B(g) 94 days for guinea fowl;(h) 140 days for male turkeys and roasting geese; and(i) 100 days for female turkeys.
1.9.4.2.

Nutrition
With regard to nutrition, the following rules shall apply:(a) at least 30 % of the feed shall come from the farm itself or, if thisis not feasible or such feed is not available, be produced in co­operation with other organic or in-conversion production units andfeed operators using feed and feed material from the same region;(b) roughage, fresh or dried fodder, or silage shall be added to thedaily ration;(c) where farmers are unable to obtain protein feed exclusively fromorganic production for poultry species, and the competentauthority has confirmed that organic protein feed is not available
in sufficient quantity, non-organic protein feed may be used until►M3 31 December 2026 ◄, provided that the following
conditions are fulfilled:(i) it is not available in organic form;(ii) it is produced or prepared without chemical solvents;(iii) its use is limited to the feeding of young poultry with specificprotein compounds; and02018R0848 — EN — 21.02.2023 — 003.001 — 99
▼B(iv) the maximum percentage authorised per period of 12 months
for those animals does not exceed 5 %. The percentage of thedry matter of feed of agricultural origin shall be calculated.

1.9.4.3.

Animal welfare
Live plucking of poultry shall be prohibited.

1.9.4.4.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) at least one third of the floor area shall be solid, that is, not ofslatted or of grid construction, and shall be covered with a littermaterial such as straw, wood shavings, sand or turf;(b) in poultry houses for laying hens, a sufficiently large part of thefloor area available to the hens shall be available for the collectionof bird droppings;▼M9(c) buildings shall be emptied of livestock between each batch ofpoultry that has been reared. The buildings and fittings shall becleaned and disinfected during this time. In addition, when therearing of each batch of poultry has been completed, runs shall beleft empty during a period to be established by the Member Statesin 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 roamthroughout the day;▼B(d) poultry shall have access to an open air area for at least one thirdof their life. However, laying hens and finisher poultry shall haveaccess to an open air area for at least one third of their life, except
where temporary restrictions have been imposed on the basis ofUnion legislation;(e) continuous daytime open air access shall be provided from asearly an age as practically possible and whenever physiologicaland physical conditions allow, except where temporary
restrictions have been imposed on the basis of Union legislation;(f) by way of derogation from point 1.6.5, in the case of breeding
birds and pullets aged under 18 weeks, when the conditions
specified in point 1.7.3 as regards restrictions and obligations
related to the protection of human and animal health imposedon the basis of Union legislation are met and prevent breeding
birds and pullets aged under 18 weeks from having access to open
air areas, verandas shall be considered as open air areas and, insuch cases, shall have a wire mesh barrier to keep other birds out;(g) open air areas for poultry shall permit fowl to have easy access toadequate numbers of drinking troughs;(h) open air areas for poultry shall be covered mainly with vegetation;

02018R0848 — EN — 21.02.2023 — 003.001 — 100▼B(i) under conditions where feed availability from the range area islimited, for example, due to long term snow cover or arid weather
conditions, supplementary feeding of roughage shall be included
as part of poultry diets;(j) where poultry are kept indoors due to restrictions or obligations
imposed on the basis of Union legislation, they shall havepermanent access to sufficient quantities of roughage andsuitable material in order to meet their ethological needs;(k) water fowl shall have access to a stream, pond, lake or a poolwhenever the weather and hygienic conditions permit, in order torespect their species-specific needs and animal welfare
requirements; when weather conditions do not permit suchaccess, they shall have access to water which enables them to
dip their head therein so as to clean plumage;(l) natural light may be supplemented by artificial means to provide amaximum of 16 hours light per day, with a continuous nocturnal
rest period without artificial light of at least eight hours;(m) the total usable surface area for fattening poultry in poultry housesof any production unit shall not exceed 1 600 m2;(n) not more than 3 000 laying hens shall be allowed in a single
compartment of a poultry house.
1.9.5.

For rabbits

1.9.5.1.

Nutrition
With regard to nutrition, the following rules shall apply:(a) at least 70 % of the feed shall come from the farm itself or, if thisis not feasible or such feed is not available, shall be produced incooperation with other organic or in-conversion production units
and feed operators using feed and feed material from the same
region;(b) rabbits shall have access to pasturage for grazing wheneverconditions allow;(c) rearing systems shall be based on maximum use of grazing
pasturage by reference to the availability of pastures in the
different periods of the year;(d) fibrous feed such as straw or hay shall be provided when grass is
not sufficient. Forage shall comprise at least 60 % of the diet.

1.9.5.2.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) housing shall be provided with a comfortable, clean and dry laying
or rest area of sufficient size, consisting of a solid construction
which is not slatted. Ample dry bedding strewn with litter material
shall be provided in the rest area. The litter shall comprise straw orother suitable natural material. The litter may be improved andenriched with any mineral product authorised pursuant to Article 24
as a fertiliser or soil conditioner for use in organic production;

02018R0848 — EN — 21.02.2023 — 003.001 — 101▼B(b) rabbits shall be kept in groups.

(c) rabbit farms shall use robust breeds adapted to outdoor conditions;(d) rabbits shall have access to:(i) covered shelter including dark hiding places;(ii) an outdoor run with vegetation, preferably pasture;(iii) a raised platform on which they can sit, either inside or out;(iv) nesting material for all nursing does.

1.9.6.

For bees

1.9.6.1.

Origin of animals
For beekeeping, preference shall be given to the use of Apis mellifera
and their local ecotypes.

1.9.6.2.

Nutrition
With regard to nutrition, the following rules shall apply:(a) at the end of the production season hives shall be left with
sufficient reserves of honey and pollen for the bees to survive
the winter;▼M1(b) bee colonies may only be fed where the survival of the colony isendangered due to climatic conditions. In such case, bee colonies
shall be fed with organic honey, organic pollen, organic sugar
syrups, or organic sugar.

▼B
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, inparticular from pests, only rodenticides used in traps, and appro­
priate products and substances authorised pursuant to Articles 9
and 24 for use in organic production shall be permitted;(b) physical treatments for disinfection of apiaries such as steam or
direct flame shall be permitted;(c) the practice of destroying the male brood shall only be permitted
for the purpose of isolating the infestation of Varroa destructor;(d) if, despite all preventive measures, the colonies become sick orinfested, they shall be treated immediately and, if necessary, may
be placed in isolation apiaries;

02018R0848 — EN — 21.02.2023 — 003.001 — 102▼B(e) formic acid, lactic acid, acetic acid and oxalic acid, as well as
menthol, thymol, eucalyptol or camphor, may be used in casesof infestation with Varroa destructor;(f) if a treatment is applied with chemically synthesised allopathic
products, including antibiotics, other than products and substances
authorised pursuant to Articles 9 and 24 for use in organic
production, for the duration of that treatment, the treatedcolonies shall be placed in isolation apiaries and all the wax
shall be replaced with wax coming from organic beekeeping.
Subsequently, the conversion period of 12 months laid down inpoint 1.2.2 shall apply to those colonies.

1.9.6.4.

Animal welfareWith regard to beekeeping, the following additional general rules shallapply:(a) the destruction of bees in the combs as a method associated withthe harvesting of apiculture products shall be prohibited;(b) mutilation such as clipping the wings of queen bees shall be
prohibited.

1.9.6.5.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) apiaries shall be placed in areas which ensure the availability ofnectar and pollen sources consisting essentially of organically
produced crops or, where appropriate, of spontaneous vegetation
or non-organically managed forests or crops that are only treatedwith low environmental impact methods;(b) apiaries shall be kept at sufficient distance from sources that may
lead to the contamination of apiculture products or to the poor
health of the bees;(c) the siting of the apiaries shall be such that, within a radius of 3 km
from the apiary site, nectar and pollen sources consist essentiallyof organically produced crops or spontaneous vegetation or crops
treated with low environmental impact methods equivalent to those
provided for in Articles 28 and 30 of Regulation (EU)No 1305/2013 which cannot affect the qualification of beekeeping
production as being organic. That requirement does not apply
where flowering is not taking place, or the bee colonies aredormant;(d) the hives and materials used in beekeeping shall be made basicallyof natural materials presenting no risk of contamination to theenvironment or the apiculture products;(e) the beeswax for new foundations shall come from organic
production units;(f) only natural products such as propolis, wax and plant oils may be
used in the hives;02018R0848 — EN — 21.02.2023 — 003.001 — 103▼B(g) synthetic chemical repellents shall not be used during honeyextraction operations;(h) brood combs shall not be used for honey extraction;(i) beekeeping shall not be considered as organic when practiced inregions or areas designated by Member States as regions or areas
where organic beekeeping is not practicable.

▼M9
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 tothe colonies meet the requirements of this Regulation.
The following information shall be entered in the register of the apiarywith regard to feeding: name of the product used, dates, quantities andhives 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 shallalso be recorded.

▼B
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 inorganic production, or with pollutants that would compromise theorganic nature of the products.

1.2.

Organic and non-organic production units shall be adequately
separated in accordance with the minimum separation distances set
by Member States, where applicable. Such separation measures shallbe based on the natural situation, separate water distribution systems,
distances, the tidal flow, and the upstream and the downstream
location of the organic production unit. Algae and aquaculture
production shall not be considered as organic when practiced at
locations or in areas designated by Member State authorities aslocations or areas which are unsuitable for such activities.

1.3.

An environmental assessment that is appropriate to the production unit
shall be required for any new operators applying for organic
production and producing more than 20 tonnes of aquaculture
products per year to ascertain the conditions of the production unit
and its immediate environment and likely effects of its operation. The
operator shall provide the environmental assessment to the control
authority or control body. The content of the environmental assessment
shall be based on Annex IV to Directive 2011/92/EU of the European
Parliament and of the Council (1). If the production unit has alreadybeen subject to an equivalent assessment, that assessment may be used
for this purpose.

(1) Directive 2011/92/EU of the European Parliament and of the Council of 13 December
2011 on the assessment of the effects of certain public and private projects on theenvironment (OJ L 26, 28.1.2012, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 104▼B
1.4.

Mangrove destruction shall not be permitted.

1.5.

The operator shall provide a sustainable management plan propor­
tionate to the production unit for aquaculture and algae harvesting.

1.6.

The plan shall be updated annually and shall detail the environmental
effects of the operation and the environmental monitoring to beundertaken, and shall list the measures to be taken to minimise
negative impacts on the surrounding aquatic and terrestrial
environments, including, where applicable, nutrient discharge into
the environment per production cycle or per annum. The plan shallrecord the surveillance and repair of technical equipment.

1.7.

Defensive and preventive measures taken against predators inaccordance with Directive 92/43/EEC and national rules shall berecorded in the sustainable management plan.

1.8.

Where applicable, coordination shall take place with the neighbouring
operators in drawing up the management plan.

1.9.

Aquaculture and algae business operators shall draw up as part of thesustainable management plan a waste reduction schedule to be put inplace at the commencement of operations. Where possible, the use ofresidual heat shall be limited to energy from renewable sources.

1.10.

Preparation of unprocessed products
If preparation operations, other than processing, are carried out onalgae or aquaculture animals, the general requirements laid down inpoints 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis
mutandis to such operations.

▼M9
1.11.

Operators shall keep available documentary evidence on any dero­
gation from production rules for aquaculture animals obtained inaccordance with points 3.1.2.1(d) and (e).

2.

Requirements for algae▼B
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 andproduction 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 shallbe six months.

2.1.2.

The conversion period for a production unit for algae cultivation shallbe a period of six months or one full production cycle, whichever isthe 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 areof high ecological status as defined by Directive 2000/60/EC, or
are of equivalent quality to:02018R0848 — EN — 21.02.2023 — 003.001 — 105▼B— the production zones classed as A and B in Regulation (EC)No 854/2004 of the European Parliament and of theCouncil (1), 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 thenatural ecosystem or the maintenance of the species in thecollection area.

2.2.2.

The cultivation of algae shall take place in areas with environmental
and health characteristics at least equivalent to those outlined inpoint 2.2.1(a) in order to be considered organic. In addition thefollowing production rules shall apply:(a) sustainable practices shall be used in all stages of production, fromthe collection of juvenile algae to harvesting;(b) to ensure that a wide gene-pool is maintained, the collection ofjuvenile 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 ifthey have been authorised pursuant to Article 24 for use in organic
production for this purpose. ►M9 Operators shall keep records ofthe use of those products, including the date or dates on which
each product was used, the name of the product, and the amountapplied, 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, thenutrient levels in the effluent water shall be verifiably the same, or
lower, than the inflowing water. Only nutrients of plant or mineralorigin authorised pursuant to Article 24 for use in organic production
may be used. ►M9 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 shallmaintain the integrity of the aquatic environment by ensuring thatthe maximum quantity of algae which can be supported without
negative effects on the environment is not exceeded.

(1) 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 ofanimal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206).

02018R0848 — EN — 21.02.2023 — 003.001 — 106▼B
2.3.4.

Ropes and other equipment used for growing algae shall be re-used or
recycled where possible.

2.4.

Sustainable collection of wild algae

2.4.1.

A once-off biomass estimate shall be undertaken at the outset of algae
collection.

2.4.2.

Documentary accounts shall be maintained in the unit or premises andshall enable the operator to identify and the control authority or control
body to verify that the collectors have supplied only wild algae
produced in accordance with this Regulation.

2.4.3.

Collection shall be carried out in such a way that the amounts
collected do not cause a significant impact on the state of theaquatic environment. Measures such as collection technique,minimum sizes, ages, reproductive cycles or size of remaining algae
shall be taken to ensure that algae can regenerate and to ensure thatby-catches are prevented.

2.4.4.

If algae are collected from a shared or common collection area, docu­
mentary evidence produced by the relevant authority designated by theMember State concerned shall be available showing that the totalcollection complies with this Regulation.

3.

Requirements for aquaculture animals
In addition to the general production rules laid down in Article 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 production of speciesof fish, crustaceans, echinoderms and molluscs. Those rules also shallapply mutatis mutandis to the production of zooplankton,
micro-crustaceans, rotifers, worms and other aquatic feed animals.

3.1.

General requirements

3.1.1.

Conversion
The following conversion periods for aquaculture production units
shall apply for the following types of aquaculture facilities including
the existing aquaculture animals:(a) for facilities that cannot be drained, cleaned and disinfected, aconversion period of 24 months;(b) for facilities that have been drained, or fallowed, a conversion
period of 12 months;(c) for facilities that have been drained, cleaned and disinfected, aconversion period of six months;(d) for open water facilities, including those producing bivalve
molluscs, a conversion period of three months.

3.1.2.

Origin of aquaculture animals

3.1.2.1.

With regard to the origin of the aquaculture animals, the following
rules shall apply:

02018R0848 — EN — 21.02.2023 — 003.001 — 107▼B(a) organic aquaculture shall be based on the rearing of young stock
originating from organic broodstock and from organic production
units;(b) locally grown species shall be used, and breeding shall aim to
produce strains which are better adapted to production conditions,ensuring good animal health and welfare and good utilisation of
feed resources. Documentary evidence of their origin andtreatment shall be provided for the competent authority, or,where appropriate, the control authority or control body;(c) species shall be chosen which are robust and can be produced
without causing significant damage to wild stocks;(d) for breeding purposes, wild-caught or non-organic aquaculture
animals may be brought into a holding only in duly justified
cases where no organic breed is available or where new genetic
stock for breeding purposes is brought into the production unit
after an authorisation has been granted by the competentauthority with a view to improving the suitability of genetic
stock. Such animals shall be kept under organic management for
at least three months before they may be used for breeding. For
animals that are on the IUCN Red List of endangered species, theauthorisation to use wild-caught specimens may only be granted in
the context of conservation programmes recognised by the relevantpublic authority in charge of the conservation effort;(e) for on-growing purposes, the collection of wild aquaculture
juveniles shall be specifically restricted to the following cases:(i) natural influx of fish or crustacean larvae and juveniles whenfilling ponds, containment systems and enclosures;(ii) restocking of wild fry or crustacean larvae of species that are
not on the IUCN Red List of endangered species in extensive
aquaculture farming inside wetlands, such as brackish water
ponds, tidal areas and costal lagoons, provided that:— the restocking is in line with management measuresapproved by the relevant authorities to ensure thesustainable exploitation of the species concerned, and— the animals are fed exclusively with feed naturally
available in the environment.

By way of derogation from point (a), Member States may
authorise the introduction for on-growing purposes on an organic
production unit of a maximum of 50 % of non-organic juvenilesof species that were not developed as organic in the Union by►M3 1 January 2022 ◄, provided that at least the latter two
thirds of the duration of the production cycle are managed underorganic management. Such derogation may be granted for a
maximum period of two years and shall not be renewable.

For aquaculture holdings situated outside the Union, such dero­
gation may only be granted by control authorities or control bodies
that have been recognised in accordance with Article 46(1) for
species that were not developed as organic in either the territoryof the country in which the holding is located or the Union. Such
derogation may be granted for a maximum period of two years
and shall not be renewable.

02018R0848 — EN — 21.02.2023 — 003.001 — 108▼B
3.1.2.2.

With regard to breeding, the following rules shall apply:(a) hormones and hormone-derivates shall not be used;(b) the artificial production of monosex strains, except byhand-sorting, the induction of polyploidy, artificial hybridisationand cloning shall not be used;(c) appropriate strains shall be chosen.

▼M1
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 thetank, supplemented as appropriate by externally produced phyto­plankton and zooplankton.

▼M9
3.1.2.4.

Operators shall keep records of the origin of animals, identifying theanimals/batches of animals, the date of arrival and type of species, thequantities, 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, thefollowing rules shall apply:▼B(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 aqua­
culture or from fisheries that have been certified as sustainable
under a scheme recognised by the competent authority in linewith the principles laid down in Regulation (EU) No 1380/2013;

02018R0848 — EN — 21.02.2023 — 003.001 — 109▼B(d) non-organic feed materials of plant, animal, algal or yeast origin,
feed materials of mineral or microbial origin, feed additives, andprocessing 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 shallapply:(a) such filter-feeding animals shall receive all their nutritional
requirements from nature, except in the case of juveniles rearedin hatcheries and nurseries;(b) the growing areas shall be suitable from a health point of view andshall 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 thefollowing 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 forhuman consumption in sustainable fisheries;(d) fish meal and fish oil and feed material of fish origin derived fromwhole fish, crustaceans or molluscs caught in sustainable fisheries
and not used for human consumption;▼M1(e) organic feed materials of plant or animal origin.

▼B
3.1.3.4.

Specific rules on feed for certain aquaculture animals

In the grow-out phase, fish in inland waters, penaeid shrimps andfreshwater prawns and tropical freshwater fish shall be fed as follows:02018R0848 — EN — 21.02.2023 — 003.001 — 110▼B(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 insufficient quantities, organic feed of plant origin, preferablygrown on the farm itself, or algae may be used. Operators shallkeep 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 consistof a maximum of 10 % fishmeal or fish oil derived fromsustainable fisheries.

▼M7
In the grow-out phase and in earlier life stages in nurseries andhatcheries, organic cholesterol may be used to supplement the dietsof penaeid shrimps and freshwater prawns (Macrobrachium spp.), in
order to secure their quantitative dietary need.

▼M9
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, andthe respective animals/batches of animals fed.

3.1.4.

Health care

3.1.4.1.

Disease prevention▼B

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 quality, flow
and exchange rate, the optimal design of the holdings, the appli­
cation of good husbandry and management practices, including
regular cleaning and disinfection of premises, high-quality feed,
appropriate stocking density, and breed and strain selection;(b) immunological veterinary medicines may be used;(c) an animal health management plan shall detail biosecurity anddisease prevention practices including a written agreement for
health counselling, proportionate to the production unit, withqualified aquaculture animal health services who shall visit thefarm at a frequency of not less than once per year or, in thecase of bivalve shellfish, not less than once every two years;

02018R0848 — EN — 21.02.2023 — 003.001 — 111▼B(d) holding systems, equipment and utensils shall be properly cleaned
and disinfected;(e) bio-fouling organisms shall be removed only by physical means orby hand and where appropriate returned to the sea at a distancefrom the farm;(f) only substances for cleaning and disinfection of equipment andfacilities authorised pursuant to Article 24 for use in organic
production may be used;(g) with regard to fallowing, the following rules shall apply:(i) the competent authority, or, where appropriate, control
authority or control body, shall determine whether fallowing
is necessary and shall determine the appropriate duration
which shall be applied and documented after each production
cycle in open water containment systems at sea;(ii) it shall not be mandatory for bivalve mollusc cultivation;(iii) during fallowing the cage or other structure used for aqua­
culture animal production is emptied, disinfected and left
empty before being used again;(h) where appropriate, uneaten fish-feed, faeces and dead animals shallbe removed promptly to avoid any risk of significant environmen­
tal damage as regards water status quality, to minimise diseaserisks, and to avoid attracting insects or rodents;(i) ultraviolet light and ozone may only be used in hatcheries andnurseries;(j) for biological control of ectoparasites, preference shall be given to
the use of cleaner fish and to the use of freshwater, marine waterand sodium chloride solutions.

3.1.4.2.

Veterinary treatments
With regard to veterinary treatments, the following rules shall apply:(a) disease shall be treated immediately to avoid suffering to theanimal. Chemically synthesised allopathic veterinary medicinal
products, including antibiotics, may be used where necessary,
under strict conditions and under the responsibility of aveterinarian, where the use of phytotherapeutic, homeopathic andother products is inappropriate. Where appropriate, restrictions
with respect to courses of treatment and withdrawal periods shallbe defined;(b) treatments related to the protection of human and animal healthimposed on the basis of Union legislation shall be allowed;(c) when despite preventive measures to ensure animal health referred
to in point 3.1.4.1 a health problem arises, veterinary treatments
may be used in the following order of preference:02018R0848 — EN — 21.02.2023 — 003.001 — 112▼B(i) substances from plants, animals or minerals in a homoeo­
pathic dilution;(ii) plants and their extracts not having anaesthetic effects; and(iii) substances such as trace elements, metals, natural immunos­
timulants or authorised probiotics;(d) the use of allopathic treatments shall be limited to two courses oftreatment per year, with the exception of vaccinations andcompulsory eradication schemes. However, in the cases of a
production cycle of less than a year, a limit of one allopathic
treatment shall apply. Where the indicated limits for allopathic
treatments are exceeded, the aquaculture animals concerned shallnot be marketed as organic products;▼M7(e) the use of parasite treatments, other than through compulsory
control schemes operated by Member States, shall be limited asfollows:(i) for salmon, to maximum two courses of treatment per year, orto 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 theproduction 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 thespecies;▼B(f) the withdrawal period for allopathic veterinary treatments andparasite 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 thecompetent 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.

▼M9
3.1.4.3.

Record-keeping of disease prevention
Operators shall keep records of the disease prevention measuresapplied giving details of fallowing, cleaning and water treatment,
and of any veterinary and other parasite treatment applied and inparticular, the date of treatment, diagnosis, the posology, the nameof the treatment product, and veterinary prescription for veterinarycare, where applicable, and withdrawal periods applied before aqua­
culture products can be marketed and labelled as organic.

02018R0848 — EN — 21.02.2023 — 003.001 — 113▼B
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 inhatcheries and nurseries. Natural borehole water may be used to heator 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-specificneeds, the aquaculture animals:(a) have sufficient space for their welfare and have the relevant
stocking density laid down in the implementing acts referred toin 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 therequirements 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, otherinjuries, growth rate, behaviour expressed and overall health) and thewater 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 beenauthorised 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 hydro­
phytes and plant coverage present in production waters shall be
prohibited.

▼M9
Operators shall keep records of monitoring and maintenance measuresconcerning animal welfare and water quality. In case of fertilisation ofponds and lakes, the operators shall keep records of the application offertilisers and soil conditioners, including the date of application, thename of the product, the amount applied, and the location of theapplication concerned.

▼B
3.1.5.4.

The design and construction of aquatic containment systems shallprovide flow rates and physiochemical parameters that safeguard theanimals’ health and welfare, and that provide for their behaviouralneeds.

02018R0848 — EN — 21.02.2023 — 003.001 — 114▼B
The specific characteristics for production systems and containment
systems for species or group of species laid down in the implementing
acts referred to in Article 15(3) shall be complied with.

3.1.5.5.

Rearing units on land shall meet the following conditions:(a) flow-through systems shall allow the monitoring and control of theflow rate and water quality of both in-flowing and out-flowing
water;(b) at least 10 % of the perimeter (‘land-water interface’) area shallhave natural vegetation.

3.1.5.6.

Containment systems at sea shall meet the following conditions:(a) they shall be located where water flow, depth and water-bodyexchange rates are adequate to minimise the impact on theseabed and the surrounding water body;(b) they shall have suitable cage design, construction and maintenancewith regard to their exposure to the operating environment.

3.1.5.7.

Containment systems shall be designed, located and operated tominimise the risk of escape incidents.

3.1.5.8.

If fish or crustaceans escape, appropriate action shall be taken to
reduce the impact on the local ecosystem, including recapture whereappropriate. Records shall be kept.

3.1.5.9.

For aquaculture animal production in fishponds, tanks or raceways,
farms shall be equipped with either natural-filter beds, settlement
ponds, biological filters or mechanical filters to collect waste
nutrients or use algae or animals (bivalves) which contribute toimproving the quality of the effluent. Effluent monitoring shall be
carried out at regular intervals where appropriate.

3.1.6.

Animal welfare

3.1.6.1.

All persons involved in keeping aquaculture animals shall possess thenecessary basic knowledge and skills as regards the health and thewelfare needs of those animals.

3.1.6.2.

The handling of aquaculture animals shall be minimised, and shall be
undertaken with the greatest care. Proper equipment and protocols
shall be used to avoid stress and physical damage associated withhandling procedures. Broodstock shall be handled in such a manneras to minimise physical damage and stress, and shall be handled underanaesthesia where appropriate. Grading operations shall be kept to aminimum and shall only be used where required to ensure fish welfare.

3.1.6.3.

The following restrictions shall apply to the use of artificial light:

02018R0848 — EN — 21.02.2023 — 003.001 — 115▼B(a) for prolonging natural day length, it shall not exceed a maximumthat respects the ethological needs, geographical conditions andgeneral health of the animals; this maximum shall not exceed
14 hours per day, except where necessary for reproductive
purposes;(b) abrupt changes in light intensity shall be avoided at thechangeover time through the use of dimmable lights or back­ground lighting.
3.1.6.4.

Aeration shall be permitted to ensure animal welfare and health. Mech­anical aerators shall be preferably powered by renewable energy
sources.

3.1.6.5.

Oxygen may only be used for uses linked to animal health and welfare
requirements and for critical periods of production or transport, andonly in the following cases:(a) exceptional cases of a change in temperature, a drop in atmos­
pheric pressure or accidental water pollution;(b) occasional stock management procedures, such as sampling andsorting;(c) in order to assure the survival of the farm stock.

▼M9
Operators shall keep records of such uses, indicating whether applied
under point (a) (b) or (c).

▼B
3.1.6.6.

Appropriate measures shall be taken to keep the duration of thetransport of aquaculture animals to a minimum.

3.1.6.7.

Any suffering shall be kept to a minimum during the entire life of theanimal, including at the time of slaughter.

3.1.6.8.

Eyestalk ablation, including all similar practices such as ligation,
incision and pinching, is prohibited.

3.1.6.9.

Slaughter techniques shall render fish immediately unconscious andinsensible to pain. Handling prior to slaughter shall be performed ina way that avoids injuries while keeping suffering and stress at aminimum. Differences in harvesting sizes, species, and production
sites shall be taken into account when considering optimal slaughtering
methods.

3.2.

Detailed rules for molluscs

3.2.1.

Origin of seedWith regard to the origin of seed, the following rules shall apply:(a) wild seed from outside the boundaries of the production unit may
be used in the case of bivalve shellfish, provided that there is no
significant damage to the environment, provided that it ispermitted by local legislation and provided that the wild seedcomes from:(i) settlement beds which are unlikely to survive winter weather
or are surplus to requirements; or(ii) natural settlement of shellfish seed on collectors;

02018R0848 — EN — 21.02.2023 — 003.001 — 116▼B(b) for the cupped oyster (Crassostrea gigas), preference shall begiven to stock which is selectively bred to reduce spawning in
the wild;(c) records shall be kept of how, where and when wild seed wascollected to allow traceability back to the collection area;(d) wild seed may only be collected after the competent authority has
granted authorisation to do so.

3.2.2.

Housing and husbandry practices
With regard to housing and husbandry practices, the following rules
shall apply:(a) production may be carried out in the same area of water as organic
finfish and algae production, in a polyculture system that shall be
documented in the sustainable management plan. Bivalve molluscs
may also be grown together with gastropod molluscs, such as
periwinkles, in polyculture;(b) organic bivalve mollusc production shall take place within areasdelimited by posts, floats or other clear markers and shall, whereappropriate, be restrained by net bags, cages or other man mademeans;(c) organic shellfish farms shall minimise risks to species of conser­
vation interest. If predator nets are used, their design shall not
permit diving birds to be harmed.

3.2.3.

Cultivation
With regard to cultivation, the following rules shall apply:(a) cultivation on mussel ropes and other methods listed in the im­
plementing acts referred to in Article 15(3) may be used in organic
production;(b) the bottom cultivation of molluscs is only permitted where no
significant environmental impact is caused at the collection andgrowing sites. A survey and report supporting the evidence ofminimal environmental impact shall be added as a separate
chapter to the sustainable management plan, and shall be
provided by the operator to the competent authority, or, whereappropriate, to the control authority or control body, before
starting operations.

3.2.4.

Management
With regard to management, the following rules shall apply:(a) production shall use a stocking density not in excess of that used
for non-organic molluscs in the locality. Sorting, thinning andstocking density adjustments shall be made according to thebiomass and to ensure animal welfare and high product quality;02018R0848 — EN — 21.02.2023 — 003.001 — 117▼B(b) biofouling organisms shall be removed by physical means or byhand and where appropriate returned to the sea away from mollusc
farms. Molluscs may be treated once during the production cyclewith a lime solution to control competing fouling organisms.

3.2.5.

Specific cultivation rules for oysters
Cultivation in bags on trestles shall be permitted. Those or otherstructures in which the oysters are contained shall be set out so as
to avoid the formation of a total barrier along the shoreline. Stock shallbe positioned carefully on the beds in relation to tidal flow to optimise
production. Production shall meet the requirements set out in the im­
plementing acts referred to in Article 15(3).

Part IV: Processed food production rules
In addition to the general production rules laid down in Articles 9, 11 and 16, therules laid down in this Part shall apply to the organic production of processed
food.

1.

General requirements for the production of processed food

1.1.

Food additives, processing aids and other substances and ingredientsused for processing food and any processing practice applied, such as
smoking, shall comply with the principles of good manufacturing
practice (1).

1.2.

Operators producing processed food shall establish and update appro­
priate procedures based on a systematic identification of criticalprocessing steps.

1.3.

The application of the procedures referred to in point 1.2 shall ensurethat the produced processed products comply with this Regulation at
all times.

1.4.

Operators shall comply with and implement the procedures referred toin point 1.2, and, without prejudice to Article 28, shall in particular,:▼M9(a) take precautionary measures and keep records of those measures;▼B(b) implement suitable cleaning measures, monitor their effectivenessand 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 combi­
nation, are prepared or stored in the preparation unit concerned, theoperator shall:(a) inform the competent authority, or, where appropriate, the control
authority or control body, accordingly;(1) Good manufacturing practices (GMPs) as defined in Article 3(a) of Commission Regu­
lation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice formaterials and articles intended to come into contact with food (OJ L 384, 29.12.2006,
p. 75).

02018R0848 — EN — 21.02.2023 — 003.001 — 118▼B(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 andafter 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 andnon-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 theresults 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 ofprocessed organic food in accordance with Article 25 if they haveobtained or used such authorisations.

2.

Detailed requirements for the production of processed food

2.1.

The following conditions shall apply to the composition of processedorganic food:

▼M9

▼B

(a) the product shall be produced mainly from agricultural ingredientsor products intended for use as food listed in Annex I; for the
purpose of determining whether a product has been produced
mainly from those products, added water and salt shall not betaken into account;(b) an organic ingredient shall not be present together with the same
ingredient in non-organic form;(c) an in-conversion ingredient shall not be present together with thesame ingredient in organic or non-organic form.

2.2.

Use of certain products and substances in processing of food2.2.1.

Only food additives, processing aids and non-organic agriculturalingredients authorised pursuant to Article 24 or Article 25 for use inorganic production, and the products and substances referred to inpoint 2.2.2 may be used in the processing of food, with the
exception of products and substances of the wine sector, for which
point 2 of Part VI shall apply, and with the exception of yeast, forwhich point 1.3 of Part VII shall apply.

02018R0848 — EN — 21.02.2023 — 003.001 — 119▼B
2.2.2.

In the processing of food, the following products and substances may
be used:(a) preparations of micro-organisms and food enzymes normally usedin food processing, provided that food enzymes to be used as foodadditives have been authorised pursuant to Article 24 for use inorganic production;(b) substances and products defined in points (c) and (d)(i) of
Article 3(2) of Regulation (EC) No 1334/2008 that have beenlabelled as natural flavouring substances or natural flavouring
preparations in accordance with Article 16(2), (3) and (4) of that
Regulation;(c) colours for stamping meat and eggshells in accordance with
Article 17 of Regulation (EC) No 1333/2008;(d) natural colours and natural coating substances for the traditional
decorative colouring of the shell of boiled eggs produced with theintention of placing them on the market at a given period of theyear;(e) drinking water and organic or non-organic salt (with sodium
chloride or potassium chloride as basic components) generally
used in food processing;(f) minerals (trace elements included), vitamins, amino acids andmicronutrients, provided that:(i) their use in food for normal consumption is ‘directly legallyrequired’, in the meaning of being directly required byprovisions of Union law or provisions of national law
compatible with Union law, with the consequence that the
food cannot be placed at all on the market as food fornormal consumption if those minerals, vitamins, amino acids
or micronutrients are not added; or(ii) as regards food placed on the market as having particularcharacteristics or effects in relation to health or nutrition or
in relation to needs of specific groups of consumers:— in products referred to in points (a) and (b) of Article 1(1)of Regulation (EU) No 609/2013 of the European
Parliament and of the Council (1) their use is authorisedby that Regulation and acts adopted on the basis of
Article 11(1) of that Regulation for the products
concerned, or— in products regulated by Commission Directive
2006/125/EC (2), their use is authorised by that Directive.
(1) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June2013 on food intended for infants and young children, food for special medical purposes,
and total diet replacement for weight control and repealing Council Directive 92/52/EEC,
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive
2009/39/EC of the European Parliament and of the Council and Commission
Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
(2) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based
foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

02018R0848 — EN — 21.02.2023 — 003.001 — 120▼B
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.
►M9 Operators shall keep records of the use of those products,
including the date or dates on which each product was used, thename of the product, its active substances and the location of suchuse. ◄

2.2.4.

For the purpose of the calculation referred to in Article 30(5), thefollowing rules shall apply:(a) certain food additives authorised pursuant to Article 24 for use inorganic 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 agriculturalingredients;(c) yeast and yeast products shall be calculated as agriculturalingredients.

▼M9
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.

▼B
Part V: Processed feed production rules
In addition to the general production rules laid down in Articles 9, 11 and 17, therules 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 ingredientsused 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 thecritical processing steps.

1.3.

The application of the procedures referred to in point 1.2 shall ensurethat the produced processed products comply with this Regulation at
all times.

1.4.

Operators shall comply with and implement the procedures referred toin point 1.2, and, without prejudice to Article 28, shall in particular:▼M9(a) take precautionary measures and keep records of those measures;▼B(b) implement suitable cleaning measures, monitor their effectivenessand keep records of those operations;(c) guarantee that non-organic products are not placed on the market
with an indication referring to organic production.

02018R0848 — EN — 21.02.2023 — 003.001 — 121▼B
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 combi­
nation, are prepared or stored in the preparation unit concerned, theoperator 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 andafter 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 andnon-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 nothave 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.
►M9 Operators shall keep records of the use of those products,
including the date or dates on which each product was used, thename of the product, its active substances, and the location of suchuse. ◄

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.

02018R0848 — EN — 21.02.2023 — 003.001 — 122▼BPart 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 theorganic production of the products of the wine sector as referred toin point (l) of Article 1(2) of Regulation (EU) No 1308/2013.

1.2.

Commission Regulations (EC) No 606/2009 (1) and (EC)No 607/2009 (2) shall apply, save as explicitly provided otherwise inthis 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 thewine sector, including during the oenological practices, processes andtreatments, subject to the conditions and restrictions laid down inRegulation (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 substanceused in the wine production and for cleaning and disinfection,
including the date or dates on which each product was used, thename of the product, its active substances, and where applicable, thelocation of such use.

3.

Oenological practices and restrictions

3.1.

Without prejudice to Sections 1 and 2 of this Part and to specificprohibitions and restrictions provided for in points 3.2, 3.3 and 3.4,
only oenological practices, processes and treatments, including the
restrictions provided for in Article 80 and Article 83(2) of Regu­
lation (EU) No 1308/2013, in Article 3, Articles 5 to 9 and Articles
11 to 14 of Regulation (EC) No 606/2009, and in the Annexes to those
Regulations used before 1 August 2010 shall be permitted.

3.2.

The use of the following oenological practices, processes andtreatments shall be prohibited:

▼M9

▼B

(a) partial concentration through cooling in accordance with point (c)of Section B.1 of Part I of Annex VIII to Regulation (EU)No 1308/2013;(b) elimination of sulphur dioxide by physical processes in accordancewith point 8 of Annex I A to Regulation (EC) No 606/2009;(c) electrodialysis treatment to ensure the tartaric stabilisation of thewine in accordance with point 36 of Annex I A to Regulation (EC)No 606/2009;(1) 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).
2( ) 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).

02018R0848 — EN — 21.02.2023 — 003.001 — 123▼B(d) partial dealcoholisation of wine in accordance with point 40 ofAnnex I A to Regulation (EC) No 606/2009;(e) treatment with cation exchangers to ensure the tartaric stabilisationof the wine in accordance with point 43 of Annex I A to
Regulation (EC) No 606/2009.
3.3.

The use of the following oenological practices, processes andtreatments is permitted under the following conditions:(a) heat treatments in accordance with point 2 of Annex I A to
Regulation (EC) No 606/2009, provided that the temperaturedoes not exceed 75 °C;(b) centrifuging and filtration with or without an inert filtering agent
in accordance with point 3 of Annex I A to Regulation (EC)No 606/2009, provided that the size of the pores is not smaller
than 0,2 micrometres.

3.4.

Any amendment introduced after 1 August 2010 concerning the oeno­
logical practices, processes and treatments provided for in
Regulation (EC) No 1234/2007 or Regulation (EC) No 606/2009
may apply to the organic production of wine only after thosemeasures have been included as permitted in this Section and, if
required, after an evaluation in accordance with Article 24 of thisRegulation.
Part VII: Yeast used as food or feed

In addition to the general production rules laid down in Articles 9, 11, 16, 17 and19, the rules laid down in this Part shall apply to the organic production of yeast
used as food or feed.
1.

General requirements

1.1.

For the production of organic yeast, only organically produced
substrates shall be used. However, until ►M3 31 December
2024 ◄, the addition of up to 5 % non-organic yeast extract or
autolysate to the substrate (calculated in weight of dry matter) isallowed for the production of organic yeast where operators areunable to obtain yeast extract or autolysate from organic production.

1.2.

Organic yeast shall not be present in organic food or feed together
with non-organic yeast.

1.3.

The following products and substances may be used in the production,
confection and formulation of organic yeast:(a) processing aids authorised pursuant to Article 24 for use in organic
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 foryeast production and for cleaning and disinfection, including the dateor dates on which each product was used, the name of the product, its
active substances, and the location of such use.

▼M902018R0848 — EN — 21.02.2023 — 003.001 — 124▼B
ANNEX IIICOLLECTION,

1.

PACKAGING, TRANSPORTPRODUCTSAND

STORAGE

OF

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 identi­
fication of the organic and in-conversion products. The operator shall keep
the information relating to collection days, hours, the circuit and date andtime of the reception of the products available to the control authority orcontrol body.

2.

Packaging and transport of products to other operators or units

2.1.

Information to be provided▼M5
2.1.1. Operators shall ensure that organic products and in-conversion products
are transported to other operators or units, including wholesalers andretailers, only in appropriate packaging, containers or vehicles closed insuch a manner that alteration, including substitution, of the content cannot
be achieved without manipulation or damage of the seal and provided witha label stating, without prejudice to any other indications required byUnion law:(a) the name and address of the operator and, where different, of theowner or seller of the product;(b) the name of the product;(c) the name or the code number of the control authority or control bodyto which the operator is subject; and(d) where relevant, the lot identification mark in accordance with amarking system either approved at national level or agreed with thecontrol 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;02018R0848 — EN — 21.02.2023 — 003.001 — 125▼M5(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 Regu­
lation, information is provided on the exact components of the mixture,
shown by percentage by weight of each component species, and whereappropriate 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 thecomponent species of the mixture that are labelled as organic orin-conversion. The minimum total percentage by weight of organic andin-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 inconformity 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 2.1.1 and 2.1.2 may be presented
solely on an accompanying document, if such a document can be
undeniably linked with the packaging, container or vehicular transportof the product. This accompanying document shall include informationon the supplier or the transporter.

▼B
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:

02018R0848 — EN — 21.02.2023 — 003.001 — 126▼B(a) during transport, organically produced feed, in-conversion feed, andnon-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 beenchecked, have been carried out before commencing the transportof 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 whichmeets their physiological needs in terms of temperature and dissolved
oxygen.

4.2.

Before transport of organic fish and fish products, tanks shall bethoroughly 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.

►C6 Reception of products from other operators or units ◄On receipt of an organic or in-conversion product, the operator shall checkthe closing of the packaging, container or vehicle where it is required andthe presence of the indications provided for in Section 2.

The operator shall cross-check the information on the label referred to in
Section 2 with the information on the accompanying documents. The
result of those verifications shall be explicitly mentioned in the records
referred to in Article 34(5).

6.

Special rules for the reception of products from a third country
Where organic or in-conversion products are imported from a third
country, they shall be transported in appropriate packaging or containers,
closed in a manner that prevents the substitution of the content andbearing the identification of the exporter and any other marks andnumbers that serve to identify the lot, and shall be accompanied by thecertificate of control for import from third countries where appropriate.

02018R0848 — EN — 21.02.2023 — 003.001 — 127▼B
On receipt of an organic or in-conversion product imported from a third
country, the natural or legal person to whom the imported consignment isdelivered and who receives it for further preparation or marketing shallcheck the closing of the packaging or container and, in the case of
products imported in accordance with point (b)(iii) of Article 45(1),shall check that the certificate of inspection referred to in that Article
covers the type of product contained in the consignment. The result of
this verification shall be explicitly mentioned in the records referred to in
Article 34(5).
7.

Storage of products

7.1.

Areas for the storage of products shall be managed in such a way as toensure identification of lots and to avoid any mixing or contamination
with products or substances not in compliance with the organic production
rules. Organic and in-conversion products shall be clearly identifiable at
all times.

7.2.

No input products or substances other than those authorised pursuant to
Articles 9 and 24 for use in organic production shall be stored in organic
or in-conversion plant and livestock production units.

7.3.

Allopathic veterinary medicinal products, including antibiotics, may be
stored in agricultural and aquaculture holdings provided that they havebeen prescribed by a veterinarian in connection with the treatment referred
to in points 1.5.2.2 of Part II and 3.1.4.2(a) of Part III of Annex II, thatthey are stored in a supervised location and that they are entered in therecords referred to in Article 34(5).

7.4.

Where operators handle organic, or in-conversion or non-organic products
in any combination and the organic or in-conversion products are stored instorage facilities in which also other agricultural products or foodstuffs are
stored:(a) the organic or in-conversion products shall be kept separate from theother agricultural products or foodstuffs;(b) every measure shall be taken to ensure identification of consignments
and to avoid mixtures or exchanges between organic, in-conversion
and non-organic products;(c) suitable cleaning measures, the effectiveness of which has beenchecked, shall have been carried out before the storage of organic
or in-conversion products and the operators shall keep records ofthose 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.

02018R0848 — EN — 21.02.2023 — 003.001 — 128▼B
ANNEX IVTERMS REFERRED TO IN ARTICLE 30
BG:биологичен.

ES:

ecológico, biológico, orgánico.

CS:ekologické, biologické.

DA:økologisk.

DE:ökologisch, biologisch.

ET:mahe, ökoloogiline.

EL:βιολογικό.

EN:

organic.

FR:

biologique.

GA:

orgánach.

HR:ekološki.

IT:

biologico.

LV:bioloģisks, ekoloģisks.

LT:ekologiškas.

LU:

biologesch, ökologesch.

HU:ökológiai.

MT:

organiku.

NL:

biologisch.

PL:ekologiczne.

PT:biológico.

RO:

ecologic.

SK:

ekologické, biologické.

SL:ekološki.

FI:

luonnonmukainen.

SV:ekologisk.

02018R0848 — EN — 21.02.2023 — 003.001 — 129▼B
ANNEX VORGANIC PRODUCTION LOGO OF THE EUROPEAN UNION AND
CODE NUMBERS
1.

Logo

1.1. The organic production logo of the European Union shall comply with themodel below:

1.2. The reference colour in Pantone is Green Pantone No 376 and Green (50 %Cyan + 100 % Yellow), when a four-colour process is used.
1.3. The organic production logo of the European Union may also be used inblack and white as shown, only where it is not practicable to apply it incolour:1.4. If the background colour of the packaging or label is dark, the symbols may
be used in negative format, using the background colour of the packaging orlabel.
1.5. If a logo is used in colour on a coloured background which makes it
difficult to see, a delimiting outer line around the logo can be used to
improve contrast with the background colours.
1.6. Where there are indications in a single colour on the packaging, the organic
production logo of the European Union may be used in the same colour.

02018R0848 — EN — 21.02.2023 — 003.001 — 130▼B
1.7. The organic production logo of the European Union shall have a height of atleast 9 mm and a width of at least 13,5 mm; the proportion ratioheight/width shall always be 1:1,5. Exceptionally, the minimum size may
be reduced to a height of 6 mm for very small packages.
1.8. The organic production logo of the European Union may be associated withgraphical or textual elements referring to organic production under thecondition that they do not modify or change the nature of the organic
production logo of the European Union, nor any of the indications
defined in accordance with Article 32. When associated to national or
private logos using a green colour different from the reference colour
provided for in point 1.2, the organic production logo of the European
Union may be used in that non-reference colour.
2.

Code numbers
The general format of the code numbers shall be as follows:
AB-CDE-999
where:(a) ‘AB’ is the ISO code for the country where the controls take place;(b) ‘CDE’ is a term, indicated in three letters to be decided by theCommission or each Member State, like ‘bio’ or ‘öko’ or ‘org’ or‘eko’ establishing a link with organic production; and(c) ‘999’ is the reference number, indicated in maximum three digits, to be
assigned by:(i) each Member State’s competent authority to the control authorities
or control bodies to which it has delegated control tasks;(ii) the Commission, to:— the control authorities and control bodies recognised by theCommission pursuant to Article 46,— to the competent authorities of third countries recognised by theCommission pursuant to Article 48.

02018R0848 — EN — 21.02.2023 — 003.001 — 131▼M12
ANNEX VI
MODEL OF THE CERTIFICATECERTIFICATE PURSUANT TO ARTICLE 35(1) OF REGULATION (EU) 2018/848 ON ORGANICPRODUCTION AND THE LABELLING OF ORGANIC PRODUCTS (1)Part I: Mandatory elements
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 andcode number in the case of control authority orcontrol 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 theEuropean Parliament and of the Council (1) 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(1) Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling oforganic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

02018R0848 — EN — 21.02.2023 — 003.001 — 132▼M12(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 orgroup of operators (choose as appropriate) complies with that Regulation.

7. Date, place
Name and signature on behalf of the issuingcompetent authority, or, where appropriate, control
authority or control body, or qualified electronic seal:

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, thecontrol authority or control body that issues the certificate to the operator or group of operators in accordancewith Article 35 of Regulation (EU) 2018/848.
1.

Directory of products
Name of the product and/or Combined Nomenclature (CN) code asreferred to in Council Regulation (EEC) No 2658/87 (1) for products
within the scope of Regulation (EU) 2018/848□□

Organic
In-conversion(1) 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).

02018R0848 — EN — 21.02.2023 — 003.001 — 133▼M12
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 □

3.

□
□
□

Organic
In-conversion
Non-organic

Surface in hectares

List of premises or units where the activity is performed by the operator or group of operators
Address or geolocation

5.

Quantity
estimatedinkilograms, litres or, where
relevant, in number of units

Information on the land

Name of the product4.

Organic
In-conversion

Description of the activity or activities as referred to in point 5of part I

Information on the activity or activities carried out by the operator or group of operators and whether theactivity 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 asreferred 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

02018R0848 — EN — 21.02.2023 — 003.001 — 134▼M12
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 asreferred to in point 5 of part I

7.

Description of the activity or activities as referred to in point 5of part I

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.

Operator or group of operators remains responsible
Subcontracted third party is responsible

List of subcontractors carrying out an activity or activities for the operator or group of operators in accordancewith 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 subcon­
tractorName and address

8.

□
□

Other information