32018R0848 en
32018R0848 en
32018R0848 en
Having regard to the Treaty on the Functioning of the European Union, and in
particular Article 43(2) thereof, Having regard to the proposal from the European
Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee ( 1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3), Whereas:
(1) Organic production is an overall system of farm management and food
production that combines best environ mental and climate action practices, a
high level of biodiversity, the preservation of natural resources and the
application of high animal welfare standards and high production standards in
line with the demand of a growing number of consumers for products produced
using natural substances and processes. Organic production thus plays a dual
societal role, where, on the one hand, it provides for a specific market
responding to consumer demand for organic products and, on the other hand, it
delivers publicly available goods that contribute to the protection of the
environment and animal welfare, as well as to rural development.
(2) The observance of high standards for health, the environment and animal
welfare in the production of organic products is intrinsic to the high quality of
those products. As underlined in the communication of the Commission of 28
May 2009 on agricultural product quality policy, organic production forms part
of the Union’s agricultural product quality schemes, together with geographical
indications and traditional specialities guaranteed in accordance with Regulation
(EU) No 1151/2012 of the European Parliament and of the Council ( 4) and
products of the outermost regions of the Union in accordance with Regulation
(EU) No 228/2013 of the European Parliament and of the Council ( 5). In this
1
OJ C 12, 15.1.2015, p. 75.
2
OJ C 19, 21.1.2015, p. 84.
3
Position of the European Parliament of 19 April 2018 (not yet published in the Official Journal) and
decision of the Council of 22 May 2018.
4
Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012
on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1).
5
Regulation (EU) No 228/2013 of the European Parliament and of the Council of 13 March 2013
laying down specific measures for agriculture in the outermost regions of the Union and repealing
sense, organic production pursues the same objectives within the common
agricultural policy (‘CAP’), which are inherent to all the agricultural product
quality schemes of the Union.
(3) In particular, the objectives of the organic production policy are embedded in
the objectives of the CAP by ensuring that farmers receive a fair return for
complying with the organic production rules. In addition, the growing consumer
demand for organic products creates conditions for further development and
expansion of the market in those products and thus for an increase in the return
of farmers engaged in organic production.
(5) Organic production also contributes to the achievement of the objectives of the
Union’s environmental policy, in particular those set out in the communications
of the Commission of 22 September 2006 entitled ‘Thematic Strategy for Soil
Protection’, of 3 May 2011 entitled ‘Our life insurance, our natural capital: an
EU biodiversity strategy to 2020’ and of 6 May 2013 entitled ‘Green
Infrastructure (GI) — Enhancing Europe’s Natural Capital’, and in
environmental legislation such as Directives 2000/60/EC ( 3), 2001/81/EC (4),
2009/128/EC (5) and 2009/147/EC (6) of the European Parliament and of the
Council and Council Directives 91/676/EEC (7) and 92/43/EEC (8).
(6) In view of the objectives of the Union’s organic production policy, the legal
framework established for implementing that policy should aim at ensuring fair
competition and the proper functioning of the internal market in organic
products, at maintaining and justifying consumer confidence in products
labelled as organic, and at providing conditions under which the policy can
progress in line with production and market developments.
(7) The policy priorities of the Europe 2020 strategy, set out in the communication
of the Commission of 3 March 2010 entitled ‘Europe 2020: A strategy for
smart, sustainable and inclusive growth’, include achieving a competitive
economy based on knowledge and innovation, fostering a high-employment
economy delivering social and territorial cohesion, and supporting the shift
towards a resource-efficient and low-carbon economy. The organic production
policy should therefore provide operators with the right tools to better identify
and promote their products while protecting them against unfair practices.
(8) The organic farming sector in the Union has developed rapidly in the past years,
in terms not only of the area used for organic farming but also of the number of
holdings and the overall number of organic operators registered in the Union.
(9) Given the dynamic evolution of the organic sector, Council Regulation (EC) No
834/2007 (19) identified the need for a future review of the Union rules on
organic production, taking into account the experience gained from the
application of those rules. The results of that review carried out by the
Commission show that the Union legal framework governing organic
production should be improved to provide for rules that correspond to the high
expectations of consumers and that guarantee sufficient clarity for those to
whom they are addressed. Regulation (EC) No 834/2007 should be therefore
repealed and replaced by a new Regulation.
(10) Experience gained so far with the application of Regulation (EC) No 834/2007
shows the need to make clear to which products this Regulation applies.
Primarily, it should cover products originating from agriculture, including
aquaculture and beekeeping, as listed in Annex I to the Treaty on the
Functioning of the European Union (TFEU). Moreover, it should cover
processed agricultural products for use as food or feed because the placing of
such products on the market as organic products provides a major outlet for
agricultural products and ensures that the organic nature of the agricultural
products from which they are processed is visible to the consumer. Likewise,
this Regulation should cover certain other products which are linked to
agricultural products in a similarly close way as processed agricultural products
for use as food and feed because those other products either constitute a major
outlet for agricultural products or form an integral part of the production
1
Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of
organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).
process. Finally, sea salt and other salts used for food and feed should be
included in the scope of this Regulation because they may be produced by
applying natural production techniques, and because their production
contributes to the development of rural areas, and thus falls within the
objectives of this Regulation. For reasons of clarity, such other products not
listed in Annex I to the TFEU should be listed in an Annex to this Regulation.
(12) In order to take into account new production methods, new materials or
international commitments, the power to adopt certain acts should be delegated
to the Commission in respect of enlarging the list of other products closely
linked to agriculture falling within the scope of this Regulation.
(13) Products covered by this Regulation but originating from hunting or fishing of
wild animals should not be considered organic since their production process
cannot be fully controlled.
(14) Because of the local nature of mass catering operations, measures taken by
Member States and private schemes in this area are considered adequate to
ensure the functioning of the single market. Therefore, food prepared by mass
caterers on their premises should not be subject to this Regulation and should
therefore not be labelled or advertised with the organic production logo of the
European Union.
(15) Research projects have demonstrated that consumer confidence is crucial in the
market for organic food. In the long run, rules that are not trustworthy can
jeopardise public confidence and lead to market failure. Therefore, the
sustainable development of organic production in the Union should be based on
sound production rules which are harmonised at Union level and which meet
operators’ and consumers’ expectations regarding the quality of organic
products and compliance with the principles and rules laid down in this
Regulation.
1
OJ L 123, 12.5.2016, p. 1.
32018R0848R(02), 03, 04, 05 08
(17) This Regulation should provide the basis for the sustainable development of
organic production and its positive effects on the environment, while ensuring
the effective functioning of the internal market in organic products and fair
competition, thereby helping farmers to achieve a fair income, ensuring
consumer confidence, protecting consumer interest and encouraging short
distribution channels and local production. Those objectives should be achieved
through compliance with general and specific principles and general and
detailed production rules applicable to organic production.
(18) Having regard to the particularities of the organic production systems, the
choice of plant varieties should focus on agronomic performance, genetic
diversity, disease resistance, longevity, and adaptation to diverse local soil and
climate conditions, and should respect the natural crossing barriers.
(19) The risk of non-compliance with organic production rules is considered higher
in agricultural holdings which include units that are not managed under those
rules. Therefore, after an appropriate conversion period, all agricultural holdings
in the Union which aim to become organic should be entirely managed in
compliance with the requirements applicable to organic production. However,
holdings including both units managed under organic production rules and units
managed under non-organic production rules should be allowed under certain
conditions, including in particular the condition of clear and effective separation
between organic, in-conversion and non-organic production units and between
the products produced by those units.
(20) Since the use of external inputs should be restricted in organic production,
certain objectives should be identified for which products and substances are
often used in the production of agricultural products or processed agricultural
products. When normally used for those objectives, the use of products or
substances should only be allowed when they have been authorised in
accordance with this Regulation. However, such authorisation should only be
valid as long as the use of such external inputs in non-organic production is not
prohibited by Union law or by national law that is based on Union law. The use
of products or substances which plant protection products contain or consist of,
other than active substances, should be allowed in organic production as long as
their use is authorised in accordance with Regulation (EC) No 1107/2009 of the
European Parliament and of the Council ( 1) and as long as neither the placing of
those plant protection products on the market nor use of those plant protection
products is prohibited by Member States in accordance with that Regulation.
1
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
(21) When the entire holding or parts of the holding are intended to produce organic
products, they should be subject to a conversion period during which they are
managed under organic production rules, but cannot produce organic products.
Products should only be allowed to be placed on the market as organic products
once the conversion period has elapsed. That period should not start before the
farmer or operator producing algae or aquaculture animals has notified that
conversion to organic production to the competent authorities of the Member
State where the holding is situated, and is therefore subject to the control system
that is to be set up by Member States in accordance with Regulation (EU)
2017/625 of the European Parliament and of the Council ( 1) and this Regulation.
Competent authorities should only be able retroactively to recognise periods
before the date of notification as conversion periods where the holding or the
relevant parts thereof have been subject to agri-environmental measures
supported by Union funds or are natural or agricultural areas which for a period
of at least three years have not been treated with products or substances not
authorised for use in organic production.
(23) The use of ionising radiation, animal cloning and artificially induced polyploid
animals or genetically modified organisms (‘GMOs’), as well as products
produced from or by GMOs, is incompatible with the concept of organic
production and consumers’ perception of organic products. Such use should
therefore be prohibited in organic production.
(24) In order to support and facilitate compliance with this Regulation, operators
should take preventive measures at every stage of production, preparation and
distribution, where appropriate, to ensure the preservation of biodiversity and
soil quality, to prevent and control pests and diseases and to avoid negative
effects on the environment, animal health and plant health. They should also
take, where appropriate, proportionate precautionary measures which are under
their control to avoid contamination with products or substances that are not
authorised for use in organic production in accordance with this Regulation and
1
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on
official controls and other official activities performed to ensure the application of food and feed law,
rules on animal health and welfare, plant health and plant protection products, amending Regulations
(EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012,
(EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the
Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives
98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC)
No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives
89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council
Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
32018R0848R(02), 03, 04, 05 08
(25) Products produced during the conversion period should not be placed on the
market as organic products. To avoid the risk of confusing and misleading
consumers, those products also should not be marketed as in-conversion
products, except in the cases of plant reproductive material, food products of
plant origin and feed products of plant origin that have only one agricultural
crop ingredient, in all cases subject to the condition that a conversion period of
at least 12 months before the harvest has been complied with.
(26) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of conversion rules for further animal
species.
(27) Detailed production rules should be established with regard to plant, livestock
and aquaculture production, including rules for the collection of wild plants and
algae, and with regard to the production of processed food and feed, as well as
of wine and yeast used as food or feed, to ensure harmonisation of and
compliance with the objectives and principles of organic production.
(28) As organic plant production is based on nourishing the plants primarily through
the soil ecosystem, plants should be produced on and in living soil in connection
with the subsoil and bedrock. Consequently, hydroponic production should not
be allowed, nor growing plants in containers, bags or beds where the roots are
not in contact with the living soil.
(29) However, certain cultivation practices which are not soil-related, such as the
production of sprouted seeds or chicory heads and the production of
ornamentals and herbs in pots that are sold in pots to the consumers, for which
the principle of soil-related crop cultivation is not adapted or for which no risk
exists that the consumer is misled regarding the production method, should be
allowed. In order to facilitate organic production at an earlier growing stage of
plants, growing seedlings or transplants in containers for further transplanting
should also be permitted.
(30) The principle of land-related crop cultivation and the nourishing of plants
primarily through the soil ecosystem was established by Regulation (EC) No
834/2007. Some operators have, however, developed an economic activity by
growing plants in ‘demarcated beds’ and have been certified as organic under
Regulation (EC) No 834/2007 by their national authorities. An agreement has
been reached within the ordinary legislative procedure on 28 June 2017 that the
organic production should be based on nourishing the plants primarily through
the soil ecosystem and be soil-related, and that growing plants in demarcated
beds should not be allowed anymore from that date. In order to give the
operators who have developed such economic activity until that date the
possibility to adapt, they should be allowed to maintain their production
surfaces, if they were certified as organic under Regulation (EC) No 834/2007
before that date by their national authorities, for further 10 years after the date
of application of this Regulation. On the basis of the information provided by
Member States to the Commission, such activity had only been authorised in the
Union before 28 June 2017 in Finland, Sweden and Denmark. The use of
demarcated beds in organic agriculture should be subject to a report of the
Commission which is to be published five years after the date of application of
this Regulation.
(31) Organic plant production should involve the use of production techniques that
prevent or minimise any contribution to the contamination of the environment.
(32) While non-organic agriculture has more external means to adapt to the
environment to achieve optimal crop growth, organic plant production systems
need plant reproductive material which is able to adapt to disease resistance,
diverse local soil and climate conditions and to the specific cultivation practices
of organic agriculture contributing to the development of the organic sector.
Therefore, it is important to develop organic plant reproductive material suitable
for organic agriculture.
(35) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of certain derogations, the use of in-
conversion or non-organic plant reproductive material, agreements between
operators of agricultural holdings, further pest and weed management measures,
and further detailed rules and cultivation practices for specific plants and plant
production.
32018R0848R(02), 03, 04, 05 08
(36) Research in the Union on plant reproductive material that does not fulfil the
variety definition as regards uniformity shows that there could be benefits of
using such diverse material, in particular with regard to organic production, for
example to reduce the spread of diseases, to improve resilience and to increase
biodiversity.
(37) Therefore, plant reproductive material that does not belong to a variety, but
rather belongs to a plant grouping within a single botanical taxon with a high
level of genetic and phenotypic diversity between individual reproductive units,
should be available for use in organic production.
(38) In order to ensure quality, traceability, compliance with this Regulation and
1
Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ 125,
11.7.1966, p. 2298).
2
Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p.
2309).
3
Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative
propagation of the vine (OJ L 93, 17.4.1968, p. 15).
4
Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental
plants (OJ L 226, 13.8.1998, p. 16).
5
Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural
plant species (OJ L 193, 20.7.2002, p. 1).
6
Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (OJ L 193, 20.7.2002, p.
12).
7
Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 193,
20.7.2002, p. 33).
8
Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193,
20.7.2002, p. 60).
9
Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L
193, 20.7.2002, p. 74).
10
Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and
planting material, other than seed (OJ L 205, 1.8.2008, p. 28).
11
Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating
material and fruit plants intended for fruit production (OJ L 267, 8.10.2008, p. 8).
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of setting out certain rules for the
production and marketing of plant reproductive material of organic
heterogeneous material of particular genera or species.
(39) In order to meet the needs of organic producers, to foster research and to
develop organic varieties suitable for organic production, taking into account
the specific needs and objectives of organic agriculture such as enhanced
genetic diversity, disease resistance or tolerance and adaptation to diverse local
soil and climate conditions, a temporary experiment should be organised in
accordance with Directives 66/401/EEC, 66/402/EEC, 68/193/EEC,
2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC
and 2008/90/EC. That temporary experiment should be for a term of seven
years, should involve sufficient quantities of plant reproductive material and
should be subject to yearly reporting. It should help to establish the criteria for
the description of the characteristics of that material and to determine the
production and marketing conditions for that material.
(41) Organic animals are not always available in sufficient quantity and quality to
meet the needs of farmers who wish to constitute a herd or a flock for the first
time or to increase or renew their livestock. Under certain conditions, it should
therefore be possible to bring non-organically raised animals to an organic
production unit.
(42) Livestock should be fed on feed materials produced in accordance with the rules
of organic production, and preferably coming from the farmer’s own holding,
taking into account the physiological needs of the livestock. However, farmers
should be given the possibility to use also in-conversion feed coming from their
own holdings, under certain conditions. In addition, in order to provide for the
basic nutritional requirements of livestock, farmers should be allowed to use
certain feed material of microbial or of mineral origin or certain feed additives
and processing aids under well-defined conditions.
establish the well-being of the animal. In such cases, in order to guarantee the
integrity of organic production for consumers, the official withdrawal period
after use of such medicinal products as specified in the relevant Union
legislation should be double the normal withdrawal period and have a minimum
duration of 48 hours.
(44) Organic livestock housing conditions and husbandry practices should satisfy the
behavioural needs of the animals and should ensure a high level of animal
welfare, certain aspects of which should go beyond the Union animal welfare
standards applicable to livestock production in general. In most cases, livestock
should have permanent access to open-air areas for exercise. Any suffering, pain
or distress should be avoided, or should be kept to a minimum at all stages of
the animals’ lives. Tethering and mutilation, such as tail-docking for sheep,
beak trimming in the first three days of life and disbudding, should only be
possible if allowed by competent authorities, and only under certain conditions.
(45) Since organic production is the most developed for bovine animals, ovine
animals, caprine animals, equine animals, cervine animals and porcine animals,
as well as for poultry, rabbits and bees, additional detailed production rules
should apply to those species. For those species it is necessary for the
Commission to lay down certain requirements that are important for the
production of those animals, such as requirements for stocking density,
minimum surfaces and characteristics, as well as technical requirements for
housing. For other species, such requirements should be laid down once
additional detailed production rules apply to those species.
(46) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of the reduction of the derogations
concerning the origin of animals, limits on organic nitrogen linked to the total
stocking density, the feeding of bee colonies, acceptable treatments for the
disinfection of apiaries, methods and treatments to fight against Varroa
destructor, and detailed livestock production rules for further species.
(47) This Regulation reflects the objectives of the new Common Fisheries Policy as
regards aquaculture, which plays a key role in ensuring sustainable, long-term
food security as well as growth and employment, while reducing pressure on
wild fish stocks, in the context of growing global aquatic food demand. The
communication of the Commission of 29 April 2013 on Strategic Guidelines for
the sustainable development of EU aquaculture high lights the main challenges
faced by aquaculture in the Union and its potential for growth. That
communication identifies organic aquaculture as a particularly promising sector,
and highlights the competitive advantages that derive from organic certification.
(49) Organic aquaculture should be based on the rearing of young stock originating
from organic production units. Organic aquaculture animals for breeding or on-
growing purposes are not always available in sufficient quantity and quality to
meet the needs of operators that produce aquaculture animals. Under certain
conditions, it should be possible to bring wild caught or non-organic aquaculture
animals to an organic production unit.
(50) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of feed for aquaculture animals and the
veterinary treatment of those animals, and in respect of detailed conditions for
broodstock management, breeding and juvenile production.
(51) Operators producing organic food or feed should follow appropriate procedures
based on the systematic identification of critical processing steps, in order to
ensure that processed products comply with the organic production rules.
Processed organic products should be produced using processing methods
which guarantee that the organic characteristics and qualities of the products are
maintained through all stages of organic production.
(52) Provisions concerning the composition of processed organic food and feed
should be laid down. In particular, such food should be produced mainly from
organic agricultural ingredients or from other ingredients falling within the
scope of this Regulation that are organic, with the limited possibility of using
certain non-organic agricultural ingredients specified in this Regulation. In
addition, only certain products and substances authorised in accordance with
this Regulation should be allowed for use in the production of processed organic
food and feed.
(53) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of precautionary and preventive
measures to be taken by operators producing processed food or feed, in respect
of the type and composition of products and substances that are allowed for use
in processed food, as well as conditions under which they may be used, and in
respect of the calculation of the percentage of agricultural ingredients, including
the specification of the additives allowed for use in organic production that are
considered as agricultural ingredients for the purpose of calculating the
percentage that needs to be achieved in order to describe the product as organic
in the sales description.
32018R0848R(02), 03, 04, 05 08
(54) Organic wine should be subject to the relevant rules on processed organic food.
However, since wine is a specific and important category of organic products,
additional detailed production rules should be laid down specifically for organic
wine. Organic wine should be produced entirely from organic raw material, and
only certain products and substances authorised in accordance with this
Regulation should be allowed to be added. The use of certain oenological
practices, processes and treatments in the production of organic wine should be
prohibited. Other practices, processes and treatments should be permitted under
well-defined conditions.
(55) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of specifying additional prohibited
oenological practices, processes and treatments and in respect of amending the
list of permitted oenological practices, processes and treatments.
(56) Initially, yeast was not considered an agricultural ingredient under Regulation
(EC) No 834/2007 and therefore it did not count for the agricultural
composition of organic products. However, Commission Regulation (EC) No
889/2008 (1) introduced the obligation to consider yeast and yeast products as
agricultural ingredients for the purposes of organic production from 31
December 2013. Accordingly, from 1 January 2021, only organically produced
substrates should be used in the production of organic yeast for use as food and
feed. In addition, only certain products and substances should be allowed for
use in its production, confection and formulation.
(57) In order to ensure quality, traceability, compliance with this Regulation and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of additional detailed yeast production
rules.
(58) While this Regulation should harmonise the organic production rules in the
Union for all products falling within its scope, and should lay down detailed
production rules for different categories of products, it will only be possible at a
later stage to adopt certain production rules, such as additional detailed
production rules for further animal species or for products that do not fall within
the categories for which detailed production rules have been laid down in this
Regulation. In the absence of such production rules at Union level, Member
States should still have the possibility to lay down national rules for their own
national production, provided that those rules are not contrary to this
Regulation. However, Member States should not apply those national rules to
products produced or marketed in other Member States where those products
1
Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the
implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of
organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).
comply with this Regulation. In the absence of such national detailed production
rules, operators should at least comply with the general production rules and
with the principles for organic production, insofar as those rules and principles
could apply to the products concerned, when placing such products on the
market with terms referring to organic production.
(59) In order to take account of any future need to have specific production rules for
products whose production does not fall within any of the categories of specific
production rules laid down in this Regulation, as well as in order to ensure
quality, traceability, compliance with this Regulation and, subsequently,
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission in respect of laying down detailed production
rules, as well as rules on the obligation to convert, for such products.
(60) Exceptions from organic production rules should be provided for only in the
event of catastrophic circumstances. In order to allow organic production to
continue or recommence in such cases, the power to adopt certain acts should be
delegated to the Commission in respect of laying down the criteria to determine
whether a situation qualifies as catastrophic circumstances as well as specific
rules, including possible derogation from this Regulation, on how Member
States are to deal with such catastrophic circumstances and on the necessary
monitoring and reporting requirements in such cases.
(61) Under certain conditions organic products, in-conversion products and non-
organic products can be collected and transported simultaneously. In order to
duly separate organic, in-conversion and non-organic products during their
handling and to avoid any commingling, specific provisions should be laid
down.
(62) In order to ensure the integrity of organic production and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of rules on packaging and transport of organic products.
(64) In order to ensure quality, traceability, and compliance with this Regulation as
regards organic production in general and the production of processed organic
food in particular, as well as to ensure adaptation to technical developments, the
power to adopt certain acts should be delegated to the Commission in respect of
additional criteria for the authorisation of products and substances for use in
organic production in general, and in the production of processed organic food
in particular, as well as criteria for the withdrawal of such authorisations.
(65) In order to ensure access to agricultural ingredients, where such ingredients are
not available in organic form in sufficient quantity for the production of
processed organic food, Member States should also have the possibility to allow
the use of non-organic agricultural ingredients under certain conditions and for a
limited period.
(66) In order to foster organic production and address the need for reliable data,
information and data on the availability on the market for organic and in-
conversion plant reproductive material, for organic animals and for organic
aquaculture juveniles needs to be collected and disseminated to farmers and
operators. For that purpose, Member States should ensure that regularly updated
databases and systems with such information are established on their territories,
and the Commission should make such information public.
(67) In order to ensure compliance with the requirements for organic production and
to ensure consumer trust in this production method, it is necessary that operators
inform competent authorities, or, where appropriate, control authorities or
control bodies, of cases of suspicion of non-compliance with this Regulation,
which is substantiated or cannot be eliminated, concerning products they
produce, prepare, import or receive from other operators. Such suspicion may,
inter alia, arise due to the presence of a product or substance that is not
authorised for use in the production of a product that is intended to be used or
marketed as an organic or in-conversion product. Operators should inform
competent authorities where they are in position to substantiate a suspicion of
non-compliance or where they cannot eliminate such a suspicion. In such cases,
the products concerned should not be placed on the market as organic or in-
conversion products for as long as the suspicion cannot be eliminated. Operators
should cooperate with the competent authorities, and, where appropriate, with
the control authorities or control bodies, in identifying and verifying the reasons
for such non-compliance.
(70) The occurrence of the presence of products or substances that are not authorised
for use in organic production in products that are marketed as organic or in-
conversion products, as well as the measures taken in that respect, should be
subject to further observation by Member States and the Commission. The
Commission should therefore present a report to the European Parliament and
the Council four years after the date of application of this Regulation, based on
the information collected by Member States about the cases where non-
authorised products and substances in organic production have been
investigated. Such report could be accompanied, if appropriate, by a legislative
proposal for further harmonisation.
(71) In the absence of such further harmonisation, Member States that have
developed approaches to avoid products that contain a certain level of products
or substances not authorised for use in organic production for certain purposes
being marketed as organic or in-conversion products should have the possibility
to keep applying those approaches. However, in order to ensure the free
movement of organic and in-conversion products in the internal market of the
Union, such approaches should not prohibit, restrict or impede the placing of
products produced in other Member States in compliance with this Regulation
on the market. Such approaches should therefore only be applied to products
produced on the territory of the Member State that has chosen to continue to
apply that approach. Member States that decide to use this possibility should
32018R0848R(02), 03, 04, 05 08
(73) The labelling of agricultural products and foodstuffs should be subject to the
general rules laid down in Regulation (EU) No 1169/2011 of the European
Parliament and of the Council (1), and in particular to the provisions aimed at
preventing labelling that might confuse or mislead consumers. In addition,
specific provisions relating to the labelling of organic and in-conversion
products should be laid down in this Regulation. They should protect both the
interests of operators in having their products correctly identified on the market
and in enjoying conditions of fair competition, and the interests of consumers in
being able to make informed choices.
(74) Accordingly, the terms used to indicate organic products should be protected
throughout the Union against their use in the labelling of non-organic products,
independently of the language used. That protection should also apply to the
usual derivatives or diminutives of those terms, whether they are used alone or
combined.
(75) Processed food should be labelled as organic only where all or almost all of the
ingredients of agricultural origin are organic. To encourage the use of organic
ingredients, it should also be possible to refer to organic production only in the
list of ingredients of processed food where certain conditions are satisfied, in
particular that the food in question complies with certain organic production
rules. Special labelling provisions should also be laid down to allow operators to
identify the organic ingredients that are used in products which consist mainly
of an ingredient that stems from hunting or fishing.
(76) Processed feed should be labelled as organic only where all or almost all the
ingredients of agricultural origin are organic.
1
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on
the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC)
No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive
87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive
2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and
2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).
(77) In order to create clarity for consumers throughout the Union market, the use of
the organic production logo of the European Union should be obligatory for all
organic prepacked food produced within the Union. In addition, it should be
possible to use that logo on a voluntary basis in the case of non-prepacked
organic products that are produced within the Union and in the case of any
organic products imported from third countries, as well as for information and
educational purposes. The model of the organic production logo of the European
Union should be set out.
(78) However, in order not to mislead consumers as to the organic nature of the
entire product, it is appropriate to limit the use of that logo to products which
contain only, or almost only, organic ingredients. It should therefore not be
allowed to use it in the labelling of in-conversion products or processed
products of which less than 95 % by weight of their ingredients of agricultural
origin are organic.
(79) To avoid any possible confusion among consumers about the Union or non-
Union origin of a product, whenever the organic production logo of the
European Union is used, consumers should be informed about the place where
the agricultural raw materials of which the product is composed have been
farmed. In that context, it should be allowed to refer to aquaculture in the label
of products from organic aquaculture instead of referring to agriculture.
(80) In order to provide clarity for consumers, and to ensure that the appropriate
information is communicated to them, the power to adopt certain acts should be
delegated to the Commission in respect of laying down additional rules on the
labelling of organic products and amending the list of terms referring to organic
production set out in this Regulation, the organic production logo of the
European Union, and the rules relating thereto.
(83)[(84)] Small retail shops not selling organic products other than prepacked
organic products present a relatively low risk of non-compliance with organic
production rules, and they should not face disproportionate burdens for selling
organic products. They should therefore not be subject to the notification and
certification obligations, but should remain subject to official controls
performed for the verification of compliance with the rules governing organic
production and the labelling of organic products. Equally, small retail shops
selling unpacked organic products should be subject to official controls, but in
order to facilitate the marketing of organic products, Member States should have
the possibility of exempting such shops from the obligation to certify their
activities.
(84)[(85)] Small farmers and operators that produce algae or aquaculture animals in
the Union individually face relatively high inspection costs and administrative
burdens linked to organic certification. A system of group certification should
be allowed in order to reduce the inspection and certification costs and the
associated administrative burdens, strengthen local networks, contribute to
better market outlets and ensure a level playing field with operators in third
countries. For that reason, the concept of ‘group of operators’ should be
introduced and defined, and rules should be established that reflect the needs
and resource capacity of small farmers and operators.
(90)[(91)] In order to support the performance of official controls and other official
activities to verify compliance with this Regulation, the power to adopt certain
acts should be delegated to the Commission in respect of specific criteria and
conditions for the performance of official controls conducted to ensure the
traceability at all stages of production, preparation and distribution, and
compliance with this Regulation and in respect of additional elements to be
taken into account in the determination, based on practical experience, of the
likelihood of non-compliance.
(91)[(92)] In order to support the performance of official controls and other official
activities to verify compliance with this Regulation, the power to adopt certain
acts should be delegated to the Commission in respect of the conditions for the
delegation of official control tasks and tasks related to other official activities to
control bodies, in addition to the conditions laid down in this Regulation.
(92)[(93)] The experience with the arrangements for the import of organic products
32018R0848R(02), 03, 04, 05 08
into the Union under Regulation (EC) No 834/2007 has shown that there is a
need to revise those arrangements in order to respond to consumer expectations
that imported organic products meet standards as high as those of the Union, as
well as in order to better ensure the access of Union organic products to the
international market. In addition, it is necessary to provide clarity regarding the
rules applicable to export of organic products, in particular by establishing
organic export certificates.
(93)[(94)] The provisions governing the import of products that comply with the
Union production and labelling rules, in respect of which operators have been
subject to the control of control authorities and control bodies recognised by the
Commission to carry out in third countries controls and certification in the field
of organic production, should be further reinforced. In particular, requirements
concerning the accreditation bodies which accredit control bodies for the
purposes of import of compliant organic products into the Union should be laid
down in order to ensure a level playing field for the supervision of the control
bodies by the Commission. Furthermore, it is necessary to provide for the
possibility for the Commission to contact directly the accreditation bodies and
competent authorities in third countries to render the supervision of control
authorities and control bodies respectively more efficient. In the case of
products imported from third countries or the outermost regions of the Union
with specific climatic and local conditions, it is appropriate to provide for the
possibility for the Commission to grant specific authorisations for the use of
products and substances in organic production.
(94)[(95)] It should remain possible for organic products to have access to the Union
market where such products do not comply with the Union rules on organic
production but come from third countries whose organic production and control
systems have been recognised as equivalent to those of the Union. However, the
recognition of equivalence of third countries, as laid down in Regulation (EC)
No 834/2007, should only be granted through international agreements between
the Union and those third countries, where a reciprocal recognition of
equivalence would be also pursued for the Union.
(95)[(96)] Third countries recognised for the purpose of equivalence under Regulation
(EC) No 834/2007 should continue to be recognised as such under this
Regulation, for a limited period necessary to ensure a smooth transition to the
scheme of recognition through an international agreement, provided that they
continue to ensure that their organic production and control rules are equivalent
to the relevant Union rules in force and that they fulfil all requirements relating
to the supervision of their recognition by the Commission. That supervision
should be based in particular on the annual reports those recognised third
countries send to the Commission.
(96)[(97)] The experience with the scheme of control authorities and control bodies
recognised by the Commission to carry out controls and to issue certificates in
third countries for the purpose of importing products, which provides equivalent
guarantees, shows that the rules applied by those authorities and bodies differ,
and it could be difficult to consider such rules as equivalent to the respective
Union rules. Furthermore, the multiplication of standards for control authorities
and control bodies hampers adequate supervision by the Commission.
Therefore, that scheme of recognition of equivalence should be abolished.
However, those control authorities and control bodies should be given sufficient
time so that they can prepare themselves to obtain recognition for the purposes
of import of products that comply with Union rules. Furthermore, the new rules
for the recognition of control authorities and control bodies for the purpose of
importing compliant products should already apply from the date of entry into
force of this Regulation, in order to allow the Commission to prepare for the
recognition of such control authorities and control bodies from the date of
application of this Regulation.
(97)[(98)] The placing of any product on the market as an organic product, where that
product has been imported into the Union under any of the import arrangements
provided for in this Regulation, should be subject to the availability of the
information necessary to ensure the traceability of the product on the food
chain.
(98)[(99)] In order to ensure fair competition among operators, the power to adopt
certain acts should be delegated to the Commission in respect of the documents
intended for customs authorities in third countries, in particular organic export
certificates.
(102)[(103)] Provision should be made for ensuring that the movement of organic
products that comply with this Regulation and have been subject to a control in
one Member State cannot be restricted in another Member State.
(103)[(104)] For the purpose of obtaining reliable information for the implementation
of this Regulation, Member States should regularly provide the Commission
with the necessary information. For reasons of clarity and transparency,
Member States should keep updated lists of competent authorities, control
authorities and control bodies. The lists of control authorities and control bodies
should be made public by the Member States and published by the Commission.
(104)[(105)] In view of the phasing out of the derogations concerning the use of non-
organic plant reproductive material, non- organically reared poultry, and non-
organic livestock for breeding purposes, the Commission should consider the
availability of such material in organic form on the market in the Union. To that
end, and on the basis of the data on the availability of organic material collected
through the database and systems set up by Member States, five years after the
date of application of this Regulation, the Commission should present a report
to the European Parliament and the Council on the availability and reasons of a
possible limited access of organic operators to such material.
(105)[(106)] In view of the phasing out of the derogations concerning the use of non-
organic protein feed for poultry and porcine animals, and on the basis of the
data provided every year by Member States on the availability of such protein
feed in organic form on the market in the Union, five years after the date of
application of this Regulation, the Commission should present a report to the
European Parliament and to the Council on the availability of and reasons for a
possible limited access of organic operators to such organic protein feed.
(106)[(107)] In order to take into account the evolution of availability on the market
of organic plant reproductive material, organic animals and organic protein feed
for poultry and porcine animals, the power to adopt certain acts should be
delegated to the Commission in respect of ending or extending derogations and
authorisations concerning the use of non-organic plant reproduction material,
non-organic animals and non-organic protein feed for poultry and porcine
animals.
(109)[(110)] In order to ensure the management of the list of control authorities and
control bodies recognised for the purpose of equivalence under Regulation (EC)
No 834/2007, the power to adopt certain acts should be delegated to the
Commission in respect of the information that those control authorities and
control bodies should send for the purpose of the supervision of their
recognition and in respect of the exercise of that supervision by the
Commission.
establishing and maintaining the systems for making available data on organic
or in-conversion plant reproductive material or organic animals or organic
aquaculture juveniles and the specifications for the collection of data for that
purpose, as regards the arrangements for operators’ participation in those
systems, and as regards details concerning the information to be provided by
Member State as regards derogations from the use of organic plant reproductive
material, organic animals and organic feed and as regards the availability on the
market of certain organic products.
(121)[(122)] Provision should be made to allow the exhaustion after the date of
application of this Regulation of stocks of products which have been produced
in accordance with Regulation (EC) No 834/2007 before that date.
(122)[(123)] Since the objectives of this Regulation, in particular fair competition and
the proper functioning of the internal market in organic products, as well as
ensuring consumer confidence in those products and in the organic production
logo of the European Union, cannot be sufficiently achieved by the Member
States themselves but can rather, by reason of the required harmonisation of the
rules on organic production, be better achieved at Union level, the Union may
adopt measures, in accordance with the principle of subsidiarity as set out in
Article 5 of the Treaty on European Union. In accordance with the principle of
proportionality, as set out in that Article, this Regulation does not go beyond
what is necessary in order to achieve those objectives.
CHAPTER I
Article 1
Subject matter
This Regulation establishes the principles of organic production and lays down the
rules concerning organic production, related certification and 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.
laying down the rules and general principles concerning mechanisms for control by Member States of
Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Article 2
Scope
1. This Regulation applies to the following products originating from agriculture,
including aquaculture and beekeeping, as listed in Annex I to the TFEU and to
products originating from those products, where such products are, or are intended to
be, produced, prepared, labelled, distributed, placed on the market, imported into or
exported from the Union:
(a) live or unprocessed agricultural products, including seeds and other plant
reproductive material;
(c) feed.
This Regulation also applies to certain other products closely linked to agriculture
listed in Annex I to this Regulation, where they are, or are intended to be, produced,
prepared, labelled, distributed, placed on the market, imported into or exported from
the Union.
3. Mass catering operations carried out by a mass caterer as defined in point (d)
of Article 2(2) of Regulation (EU) No 1169/2011 are not subject to this Regulation
except as set out in this paragraph.
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 logo of the European Union shall not be used in
the labelling, the presentation or the advertising of such products, and shall not be
used to advertise the mass caterer.
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
32018R0848R(02), 03, 04, 05 08
1308/2013 of the European Parliament and of the Council ( 1) and to Regulation (EU)
No 1169/2011.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘organic production’ means the use, including during the conversion 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 fishing of 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;
1
Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013
establishing a common organisation of the markets 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).
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 aquaculture 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 in point (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 is managed in compliance
with the requirements applicable to organic production;
(11) ‘in-conversion production unit’ means a production unit, during the conversion
period referred to in Article 10, which is managed in compliance with the
requirements applicable to organic production; it may be constituted of land
parcels or other 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 to organic 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 agricultural activity;
(15) ‘agricultural area’ means agricultural area as defined in point (e) of Article 4(1)
of Regulation (EU) No 1307/2013;
32018R0848R(02), 03, 04, 05 08
(16) ‘plants’ means plants as defined in point (5) of Article 3 of Regulation (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, and intended for, producing
entire plants;
(c) is not a variety within the meaning of Article 5(2) of Council Regulation
(EC) No 2100/94 (1);
(b) results from organic breeding activities referred to in point 1.8.4 of Part I
of Annex II to this Regulation;
(20) ‘mother plant’ means an identified plant from which plant reproductive
material is taken for the reproduction of new plants;
(21) ‘generation’ means a group of plants constituting a single step in the line of
descent of plants;
1
Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (OJ L 227,
1.9.1994, p. 1).
(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);
(29) ‘pullets’ means young animals of the Gallus gallus species that are of 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 are of 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);
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 1143/2014 of 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 the Council of 11 December 2013
on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No
1224/2009 and repealing 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).
32018R0848R(02), 03, 04, 05 08
(35) ‘energy from renewable sources’ means energy from renewable non-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 particular finfish and shellfish;
(39) ‘polyculture’ means the rearing in aquaculture of two or more species, usually
from different trophic levels, in the same culture unit;
(40) ‘production cycle’ means the lifespan of an aquaculture animal or alga, from
the earliest life stage (fertilised eggs, in the case of aquaculture animals) to
harvesting;
(41) ‘locally grown species’ means aquaculture species which are neither alien nor
locally absent species within the meaning of points (6) and (7), respectively, of
Article 3 of Council Regulation (EC) No 708/2007 ( 2), as well as the species
listed in Annex IV to that Regulation;
(46) ‘feed’ means feed as defined in point (4) of Article 3 of Regulation (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
(3);
(48) ‘placing on the market’ means placing on the market as defined in point (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 product referred to in Article 2(1), through
all stages of production, preparation 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;
1
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).
2
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of food law, establishing the European Food
Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
3
Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the
placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No
1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council
Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision
2004/217/EC (OJ L 229, 1.9.2009, p. 1).
32018R0848R(02), 03, 04, 05 08
(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 to directly or indirectly promote the sale of
products;
(55) ‘control authority’ means an organic control authority as defined in point (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 the Commission for the purposes of carrying out
controls in third countries for the import of organic and in-conversion products
into the Union;
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 genetically modified organisms and repealing Council
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
(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
(1);
(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
(2);
(64) ‘equivalence’ means meeting the same objectives and principles by applying
rules which ensure the same level of assurance of conformity;
(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 in point (h) of Article 2(2) of
Regulation (EC) No 1831/2003 for feed;
(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
(4);
(67) ‘ionising radiation’ means ionising radiation as defined in point (46) of Article
4 of Council Directive 2013/59/ Euratom (5);
1
Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008
on food additives (OJ L 354, 31.12.2008, p. 16).
2
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003
on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
3
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on
novel foods, amending Regulation (EU) No 1169/2011 of 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).
4
Regulation (EC) No 1332/2008 of the European Parliament and of the Council 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).
5
Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for
32018R0848R(02), 03, 04, 05 08
(68) ‘prepacked food’ means prepacked food as defined in point (e) of Article 2(2) of
Regulation (EU) No 1169/2011;
(69) ‘poultry house’ means a fixed or mobile building for accommodating flocks of
poultry, which includes all surfaces covered by 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 in soil that is
mixed or fertilised with materials and products that are allowed in organic
production in connection with the subsoil and bedrock;
(74) ‘integrity of organic or in-conversion products’ means the fact that the 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
CHAPTER II
protection against the dangers arising from exposure to ionising 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).
1
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the
hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
OBJECTIVES 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;
(e) contributing to high animal welfare standards and, in particular, to meeting the
species-specific behavioural needs of animals;
(f) encouraging short distribution channels and local production in the various areas
of the Union;
(g) encouraging the preservation of rare and native breeds in danger of extinction;
(h) contributing to the development of the supply of plant genetic material adapted
to the specific needs and objectives of organic agriculture;
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 and enhancement
of the state of the soil, the water and the air, of the health of plants and
32018R0848R(02), 03, 04, 05 08
(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 other agricultural 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;
(e) ensuring the integrity of organic production at all stages of the production,
preparation and distribution of food and feedensuring the integrity of organic
production at all stages of the production, processing and distribution of food
and feed;
(iii) exclude the use of GMOs, products produced from GMOs, and products
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 be limited to:
(i) inputs from organic production; in the case of plant reproductive material,
priority shall be given to varieties selected for their ability to meet the
specific needs and objectives of organic agriculture;
(i) the exclusion from the whole organic food chain of animal cloning, of rearing
artificially induced polyploid animals and of ionising radiation;
Article 6
Specific principles applicable to agricultural activities and
aquaculture
As 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;
(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 particularities of the
specific organic production systems, focussing on agronomic performance,
disease resistance, adaptation to diverse local soil and climate conditions and
32018R0848R(02), 03, 04, 05 08
(g) the use of organic plant reproductive material, such as plant reproductive
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;
(j) in the choosing of animal breeds, having regard to a high degree of genetic
diversity, the capacity of animals to adapt to local conditions, their breeding
value, their longevity, their vitality and their resistance to disease or health
problems;
(l) the application of animal husbandry practices which enhance the immune
system and strengthen the natural defence against diseases, including regular
exercise and access to open air areas and pastures;
(m) the feeding of livestock with organic feed composed of agricultural ingredients
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 of
surrounding aquatic and terrestrial ecosystems;
(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 agricultural ingredients resulting from organic production,
including organic aquaculture, and of natural non-agricultural substances;
(q) avoiding any endangerment of species of conservation interest that might arise
from organic production.
Article 7
Specific principles applicable to the processing of organic food
The production of processed organic food shall be based, in particular, on the
following specific principles:
(b) the restriction of the use of food additives, of non-organic ingredients with
mainly technological and sensory functions, and of micronutrients and
processing aids, so that they are used to a minimum extent and only in cases of
essential technological need or for particular nutritional purposes;
(c) the exclusion of substances and processing methods that might be misleading
as regards the true nature of the product;
(d) the processing of organic food with care, preferably through the use of
biological, mechanical and physical methods;
Article 8
Specific principles applicable to the processing of organic feed
The production of processed organic feed shall be based, in particular, on the
following specific principles:
(b) the restriction of the use of feed additives and processing aids, so that 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 be misleading
as regards the true nature of the product;
(d) the processing of organic feed with care, preferably through the use of
biological, mechanical and physical methods.
32018R0848R(02), 03, 04, 05 08
CHAPTER III
PRODUCTION RULES
Article 9
General production rules
1. Operators shall comply with the general production rules laid down in this
Article.
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 on
Union law.
The following products and substances referred to in Article 2(3) of Regulation (EC)
No 1107/2009 shall be allowed for use in organic production, provided that they are
authorised pursuant to that Regulation:
(a) safeners, synergists and co-formulants as components of plant protection
products;
5. The use of animal cloning, and the rearing of artificially induced polyploid
animals, shall be prohibited.
(b) as regards plants, different varieties that can be easily differentiated are
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 is within the context of a conversion plan, and provided
that the conversion of the last part of the area related to the production in question to
organic production begins as soon as possible and is completed within a maximum
of five years.
In such cases:
(a) the farmer shall notify the competent authority, or, where appropriate, the
control authority or the control body, of the start of harvest of each of the
products concerned at least 48 hours in advance;
(b) upon completion of the harvest, the farmer shall inform the competent
authority, or, where appropriate, the control authority or the control body, of
the exact quantities harvested from the units concerned and of the measures
taken to separate the products;
(c) the conversion plan and the measures to be taken to ensure the effective and
clear separation shall be confirmed each year by the competent 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 and breeding 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 and non-organic
production units separate from each other;
32018R0848R(02), 03, 04, 05 08
(c) keep adequate records to show the effective separation of the production units
and of the products.
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 this Regulation, in particular the applicable
rules on conversion set out in this Article and in Annex II.
2. The conversion period shall start at the earliest when the farmer or the operator
that produces algae or aquaculture animals has notified the activity to the competent
authorities, in accordance with Article 34(1), in the Member State in which the
activity is carried out and in which that farmer or operator’s holding is subject to the
control system.
(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 not been treated with
products or substances that are not authorised for use in organic production.
However, the following products produced during the conversion period and in
compliance with paragraph 1 may be marketed as in-conversion products:
(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.
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 reproductive material, micro- organisms
or animals in organic production.
2. For the purposes of the prohibition laid down in paragraph 1, with regard to
GMOs and products produced from GMOs for food and feed, operators may rely on
the labels of a product that have been affixed or provided pursuant to Directive
2001/18/EC, Regulation (EC) No 1829/2003 of the European Parliament and of the
Council (1) or Regulation (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 and feed 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
1
Regulation (EC) No 1829/2003 of the European Parliament and of the Council 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 the Council of 22 September 2003
concerning the traceability and labelling of genetically 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).
32018R0848R(02), 03, 04, 05 08
4. For the purposes of the prohibition laid down in paragraph 1, with regard to
products not covered by paragraphs 2 and 3, operators using non-organic products
purchased from third parties shall require the vendor to confirm that those products
are not produced from GMOs or produced by GMOs.
Article 12
Plant production rules
1. Operators that produce plants or plant products shall comply, in particular, with
the detailed rules set out in Part I of Annex II.
(b) point 1.8.5 of Part I of Annex II as regards the use of in-conversion and non-
organic plant reproductive material;
(d) point 1.10.1 of Part I of Annex II by adding further pest- and weed-
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 for sprouted seeds, or by
amending those added rules.
Article 13
Specific provisions for the marketing of plant reproductive material of 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 other categories, 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.
(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
Three months after the date shown on the return receipt, provided that no additional
information was requested or that no formal refusal for reasons of incompleteness of
the dossier or non-compliance as defined in Article 3(57) was communicated to the
supplier, the responsible official body shall be deemed to have acknowledged the
notification and its content.
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 in accordance with
Article 54 supplementing this Regulation by setting out rules governing the
production and marketing of plant reproductive material of organic heterogeneous
32018R0848R(02), 03, 04, 05 08
(b) the minimum quality requirements for seeds lots, including identity, specific
purity, germination rates and sanitary quality;
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.
(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 bee colonies;
(d) points 1.9.6.3(b) and (e) of Part II of Annex II as regards the acceptable
treatments for the disinfection of apiaries and the methods 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;
(b) the stocking density and the minimum surface for indoor and outdoor areas
that are to be complied with for specific livestock species to ensure that the
developmental, physiological and ethological needs of animals are met in
accordance with points 1.6.3, 1.6.4 and 1.7.2, the characteristics of and
technical requirements for the minimum surface for indoor and outdoor areas;
(c) the characteristics of and technical requirements for buildings and pens for all
livestock species other than bees, to ensure that the developmental,
physiological and ethological needs of animals are met in accordance with
point 1.7.2;
(d) requirements for vegetation and the characteristics of protected facilities and
open-air areas.
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 55(2).
Article 15
Production rules for algae and aquaculture animals
1. Operators that produce algae and aquaculture animals shall comply, in
particular, with the detailed production rules set out in Part III of Annex II and in
any implementing acts referred to in paragraph 3 of this Article.
(a) point 3.1.3.3 of Part III of Annex II as regards feed for carnivorous aquaculture
animals;
32018R0848R(02), 03, 04, 05 08
(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.
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, in the case of flatfish and shrimp, the weight per
square metre of surface.
Article 16
Production rules for processed food
1. Operators that produce processed food shall comply, in particular, with the
detailed production rules set out in Part IV of Annex II and in any implementing acts
referred to in paragraph 3 of this Article.
(b) point 2.2.2 of Part IV of Annex II as regards the types and composition 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 the percentage
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 are considered as agricultural ingredients for the
purpose of such calculations.
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), nor organic.
3. The Commission may adopt implementing acts laying down the techniques
authorised in the processing of food products.
Article 17
Production rules for processed feed
1. Operators that produce processed feed shall comply, in particular, with the
detailed production rules set out in Part V of Annex II and in any implementing acts
referred to in paragraph 3 of this Article.
3. The Commission may adopt implementing acts laying down the techniques
authorised for use in the processing of feed products.
Article 18
Production rules for wine
1. 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.
1
Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008
on flavourings and certain food ingredients with 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).
32018R0848R(02), 03, 04, 05 08
Article 19
Production rules for yeast used as food or feed
1. Operators that produce yeast to be used as food or feed shall comply, in
particular, with the detailed production rules set out in Part VII of Annex II.
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 those regulated in
point 1.9 of Part II of Annex II in accordance with point (e) of Article 14(2);
(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 or group 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 the elements to be covered by the
measures referred to in points (a), (b) and (c), provided that those national 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 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 in accordance 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 to in Articles 12 to 19, or by amending those added rules.
Those delegated acts shall be based on the objectives and principles of organic
production laid down in Chapter II and shall comply with the general production
rules laid down in Articles 9, 10 and 11 as well as existing detailed production rules
laid down for similar products in Annex II. They shall lay down requirements
concerning, in particular, the treatments, practices and inputs that are allowed or
prohibited, or conversion periods for the products concerned.
2. In the absence of the detailed production rules referred to in paragraph 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 the general production rules laid down in
Articles 9 to 11;
Article 22
Adoption of exceptional production rules
1. The Commission is empowered to adopt delegated acts in accordance with
Article 54 supplementing this Regulation by laying down:
(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 circumstances if they decide
to apply this Article; and
3. Member States may adopt measures in accordance with the delegated 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 accordance
with the rules set out in Annex III.
(b) Sections 3, 4 and 6 of Annex III by adding further special rules for the
transport and reception of the products concerned, or by amending those added
rules.
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;
(c) as non-organic feed material of plant, algal, animal or yeast origin or as feed
material of microbial or mineral origin;
(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 agricultural holding;
(g) as products for cleaning and disinfection in processing and storage facilities.
(c) as processing aids for the production of yeast and yeast products.
(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 in sufficient quantities or qualities or where
alternatives are not available;
(i) their use is essential for the control of a pest for which other biological,
physical or breeding alternatives, cultivation practices or other effective
management practices are not available;
(ii) if such products are not of plant, algal, animal, microbial or mineral
origin and are not identical to their natural form, their conditions for use
32018R0848R(02), 03, 04, 05 08
preclude any direct contact with the edible parts of the crop;
(c) in the case of products referred to in point (b) of paragraph 1, their use is
essential for building or maintaining the fertility of the soil or to fulfil specific
nutritional requirements of crops, or for specific soil-conditioning purposes;
(d) in the case of products referred to in points (c) and (d) of paragraph 1:
(i) their use is necessary to maintain animal health, animal welfare and
vitality and contributes to an appropriate diet fulfilling the physiological
and behavioural needs of the species concerned or 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;
(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 and their use is limited
to 1 % of the feed ration for a given species, calculated annually as a
percentage of the dry matter of feed from agricultural origin.
authorisations and the lists of such products and substances and, where
appropriate, their description, compositional requirements and conditions
for use.
Article 25
Authorisation of non-organic agricultural ingredients for processed organic
food by Member States
1. Where it is necessary in order to ensure access to certain agricultural
ingredients, and where such ingredients are not available in organic form
in sufficient quantity, a Member State may, at the request 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 and the
other Member States, via a computer system that enables the electronic
exchange of documents and information made available by the
Commission, of any authorisation granted for its territory in accordance
with paragraph 1.
2. Member States shall have in place systems that allow operators that
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 make public on a
voluntary basis, free of charge, together with their names and contact
details, information on the following:
(a) the organic and in-conversion plant reproductive material, such as plant
reproductive material of organic heterogeneous material or of organic varieties
suitable for organic production, excluding seedlings but including seed
potatoes, which is available; the quantity in weight of that material; and the
period of the year of its availability; such material shall be listed using at least
the Latin scientific name;
(b) the organic animals for which derogation may be provided in accordance with
point 1.3.4.4 of Part II of Annex II; the number of 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 the animals; and any other relevant information;
(c) the organic aquaculture juveniles available on the holding and their health
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 that
market breeds and strains adapted to organic production in accordance
with point 1.3.3 of Part II of Annex II or organic pullets and that are able
to supply those animals in sufficient quantities and within a reasonable
period to make public the relevant information on a voluntary basis, free of
charge, together with names and contact details.
1
Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture
animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
(OJ L 328, 24.11.2006, p. 14).
32018R0848R(02), 03, 04, 05 08
6. The Commission shall make public the link to each of the national
databases or systems on a dedicated website of the Commission, in order
to allow users to have access to such databases or systems throughout the
Union.
(c) not place the product concerned on the market as an organic or in-conversion
product and not use it in organic production, unless the 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, where appropriate,
with the relevant control authority or control body, in verifying and identifying
the reasons for the suspected non-compliance.
Article 28
Precautionary measures to avoid the presence of non-authorised
products and substances
1. In order to avoid contamination with products or substances that are
not authorised in accordance with the first subparagraph of Article 9(3) for
use in organic production, operators shall take the following precautionary
measures at every stage of production, preparation and distribution:
(a) put in place and maintain measures that are proportionate and appropriate to
identify the risks of contamination of organic production and products with
non-authorised products or substances, including systematic identification of
critical procedural steps;
(b) put in place and maintain measures that are proportionate and appropriate to
avoid risks of contamination of organic production and products with non-
authorised products or substances;
(d) comply with other relevant requirements of this Regulation that ensure the
separation of organic, in-conversion and non-organic products.
(c) not place the product concerned on the market as an organic or in-conversion
product and not use it in organic production unless the 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, where appropriate,
with the relevant control authority or control body, in identifying and verifying
the reasons for the presence of non-authorised products or substances.
(a) the procedural steps to be followed by operators in accordance with points (a)
to (e) of paragraph 2 and the relevant documents to be provided by them;
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 the
presence 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 or an in-
conversion product:
(b) it shall provisionally prohibit both the placing on the market of the products
concerned as organic or in-conversion products and their use in organic
production pending the results of the investigation referred to in point (a).
(a) has used products or substances not authorised pursuant to the first
subparagraph 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.
Where required, the operator concerned shall take such corrective measures as
necessary to avoid future contamination.
Member States shall make such information available to the other Member States
and to the Commission via a computer system that enables the electronic exchange
of documents and information made available by the Commission.
(b) the details and format of the information to be made available by Member
States to the Commission and other Member States in accordance with
paragraph 6 of this Article.
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 in terms
suggesting to the purchaser that the product, ingredients or feed materials
have been produced in accordance with this Regulation. In particular, the
terms listed in Annex IV and their derivatives and diminutives, 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.
product for which Union law requires the labelling or advertising to state
that the product contains GMOs, consists of GMOs or is produced from
GMOs.
(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 Regulation (EC) No 1334/2008 and all
of the flavouring components and carriers of flavouring components in
the flavouring concerned are organic;
(b) only in the list of ingredients, provided thatonly in the list of ingredients,
provided that:
[(i)] less than 95 % of the agricultural ingredients of the product by weight are
organic, and provided that those ingredients comply with the production
rules set out in this Regulation; andless than 95 % of the agricultural
ingredients of the product by weight 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 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)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 and with the rules laid down in accordance with Article
16(3);
(c) in the sales description and in the list of ingredients, provided thatin the sales
description and in the list of ingredients, provided that:
[(i)] the main ingredient is a product of hunting or fishingthe main
ingredient is a product of hunting or fishing;
[(iii)] all other agricultural ingredients are organic; andall 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).the food complies with points 1.5, 2.1(a),
2.1(b) and 2.2.1 of Part IV of Annex II and with the rules laid down in
accordance with Article 16(3).
The list of ingredients referred to in points (a), (b) and (c) of the first subparagraph
shall indicate which ingredients are organic. The references to organic production
may only appear in relation to the organic ingredients.
The list of ingredients referred to in points (b) and (c) of the first subparagraph shall
include an indication of the total percentage of organic ingredients in proportion to
the total quantity of agricultural ingredients.
The terms referred to in paragraph 1, when used in the list of ingredients referred to
in points (a), (b), and (c) of the first subparagraph of this paragraph, and the
indication of the percentage referred to in the third subparagraph of this paragraph
shall appear in the same colour, identical size and style of lettering as the other
indications in the list of ingredients.
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:
(a) the processed feed complies with the production rules set out in Parts II, III
and V of Annex II and with the specific rules laid down in accordance with
Article 17(3)the processed feed complies with the production rules set out in
Parts II, III and V of Annex II and with the specific rules laid down in
accordance with Article 16(3);
(b) all of the ingredients of agricultural origin that are contained in the processed
feed are organic; 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.
(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
(b) in the case of prepacked food, the organic production logo of the European
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 same visual 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 that country 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 the first 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 of agricultural raw materials.
The words ‘EU’ or ‘non-EU’ shall not appear in a colour, size and style of lettering
that is more prominent than the name of the product.
(b) the assignment of code numbers to control authorities and control bodies;
(c) the indication of the place where the agricultural raw materials were farmed, in
accordance with paragraph 2 of this Article and with Article 33(3).
Those implementing acts shall be adopted in accordance with the examination
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 used in 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 and advertising of the
logo itself, provided that such use is not liable to mislead the consumer as regards
the organic production of specific products, and provided that the logo is reproduced
32018R0848R(02), 03, 04, 05 08
in accordance with the rules set out in Annex V. In such case, the requirements of
Article 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 of paragraph
1, the organic production logo of the European Union is an official attestation in
accordance with Articles 86 and 91 of Regulation (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 that logo appears in the
labelling of such products, the indication referred to in 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 in that Annex.
5. National logos and private logos may be used in the labelling, presentation and
advertising of products which comply with this Regulation.
CHAPTER V
CERTIFICATION
Article 34
Certification system
1. Prior to placing any products on the market as ‘organic’ or as ‘in-conversion’
or prior to the conversion period, operators and groups of operators referred to in
Article 36 which produce, prepare, distribute or store 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 or delegated
certain official control tasks or certain tasks related to other official activities to
more than one control authority or control body, the operators or groups of operators
shall indicate in the notification referred to in the first subparagraph which control
authority or control body verifies whether their activity complies with this
Regulation and provides 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 obligation referred 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 with the point of sale, or import such products from a third country, or
subcontract such activities to another operator.
6. Member States shall keep updated lists containing the names and addresses of
operators and groups of operators that have notified their activities in accordance
with paragraph 1 and shall make public in an 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 of operators 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 and of the Council (1).
7. Member States shall ensure that any operator or group of operators that
complies with this Regulation and, in cases where a fee is collected in accordance
with Articles 78 and 80 of Regulation (EU) 2017/625, that pays a reasonable fee
covering the cost of controls is entitled to be covered by the control system. Member
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 the processing of personal data and on the free movement
of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119,
4.5.2016, p. 1).
32018R0848R(02), 03, 04, 05 08
States shall ensure that any fees that may be collected are made public.
(b) the arrangements for the publication of the lists referred to in paragraph 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 examination
procedure referred to in Article 55(2).
Article 35
Certificate
1. Competent authorities, or, where appropriate, control authorities or control
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 covered by the certificate and
its period of validity;
(c) certify that the notified activity complies with this Regulation; and
(d) be issued in accordance with the model set out in Annex VI.
6. Operators shall verify the certificates of those operators that are their suppliers.
(e) feed;
(f) wine;
(g) other products listed in Annex I to this Regulation or not covered by the
previous categories.
8. Member States may exempt from the obligation to be in the possession of a
certificate, provided for in paragraph 2, operators that sell 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, and provided 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
32018R0848R(02), 03, 04, 05 08
(c) the potential certification cost of the operator exceeds 2 % of the total turnover
on unpacked organic products sold by that operator.
If a Member State decides to exempt the operators referred to in the first
subparagraph, it may set stricter limits than those set in the first subparagraph.
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 in accordance 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 in paragraph 1 and the
technical means by which it is issued.
Those implementing acts shall be adopted in accordance with the examination
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 be engaged in processing,
preparation or placing on the market of food or feed;
— five hectares,
(f) set up a joint marketing system for the products produced by the group; and
(g) establish a system for internal controls comprising a documented set of control
activities and procedures in accordance with which an identified person or
body is responsible for verifying compliance with this Regulation of each
member of the group.
(b) the criteria to determine the geographical proximity of the members of the
group, such as the sharing of facilities or sites;
(c) the set-up and functioning of the system for internal controls, including the
scope, content and frequency of the controls to be carried out and the criteria
to identify deficiencies in the set-up or functioning of the system for internal
controls.
4. The Commission may adopt implementing acts laying down specific rules
concerning:
(b) the documents and record-keeping systems, the system for internal traceability
32018R0848R(02), 03, 04, 05 08
(c) the exchange of information between a group of operators and the competent
authority or authorities, control authorities or control bodies, and between the
Member States and the Commission.
CHAPTER VI
Article 37
Relationship with Regulation (EU) 2017/625 and additional rules for official
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 for in Article 40(2) of this
Regulation, and in addition to Article 29 of this Regulation, save as otherwise
provided for in Article 41(1) of this Regulation, 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 to in Article 2(1)
of this Regulation have been produced in compliance with 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 Regulation (EU)
2017/625 for the verification of compliance with this Regulation shall include, in
particular:
(a) the verification of the application by operators of preventive and precautionary
measures, as referred to in Article 9(6) and in Article 28 of this Regulation, at
every stage of production, preparation and distribution;
(b) where the holding includes non-organic or in-conversion production units, the
verification of the records and of the measures or procedures or arrangements
in place to ensure the clear and effective separation between organic, in-
conversion and non-organic production units as well as between the respective
products produced by those units, and of the substances and products 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 of the conversion period, and checks on the non-organic
production units;
(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 in accordance
with Article 34(2) of this Regulation or from the obligation to be in the
possession of a certificate in accordance with Article 35(8) of this Regulation,
the verification that the requirements for that exemption have been fulfilled
and the verification of the products sold by those operators.
(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 and distribution;
(c) the results of the controls performed in accordance with this Article;
(d) the point in time relevant for the activities carried out;
(f) the type, quantity and value of products and their development over time;
(i) the critical points for non-compliance and the likelihood of non-compliance at
every stage of production, preparation and distribution;
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.
(a) the previous controls of the operator or group of operators concerned have not
revealed any non-compliance affecting the integrity of organic or in-
conversion products during at least three consecutive 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 Regulation (EU)
2017/625 for the verification of compliance with this Regulation 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;
(c) be carried out by taking a minimum number of the samples that have been
taken in accordance with point (h) of Article 14 of Regulation (EU) 2017/625;
(d) ensure that a minimum number of operators that are members of a group of
operators are controlled in connection with the verification of 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 of compliance referred to in paragraphs 1 to 4
of this Article.
6. The written record to be drawn up regarding each official control that has been
performed to verify compliance with this Regulation in accordance with Article
13(1) of Regulation (EU) 2017/625 shall be countersigned by the operator or groups
of operators as confirmation of their receipt of that written record.
7. Article 13(1) of Regulation (EU) 2017/625 shall not apply to audits and
inspections carried out by competent authorities in the context of their supervisory
activities over control bodies to which certain official control tasks or certain tasks
related to other official activities have been delegated.
(iii) where appropriate, the period within which the controls provided for in
this Regulation, including the physical on-the-spot inspections referred to
in paragraph 3 of this Article, are to be performed and the particular
premises in or area 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 or groups of
operators that are to be carried out without prior notice as referred to in point
(a) of paragraph 4;
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 examination procedure referred to in Article
55(2).
Article 39
Additional rules on actions to be taken by the operators and groups of operators
1. In addition to the obligations laid down in Article 15 of Regulation (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 this Regulation;
(ii) the relevant practical measures to be taken to ensure compliance with this
Regulation;
(iii) an undertaking:
(b) the declarations and other communications that are necessary for official
controls;
(c) the relevant practical measures for ensuring compliance with this Regulation.
Those implementing acts shall be adopted in accordance with the examination
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 delegated official control
tasks and tasks related to other official activities, including reporting
obligations and other specific obligations, and of 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, in particular, the
basis for the intensity and frequency of the verification of compliance of
the operators and groups of operators, which is to be established on the
basis of the elements 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 of operators;
(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 of suspected 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 operators and the arrangements for reporting on
those tasks.
The control body shall notify subsequent amendment of the elements referred to in
points (i) to (iv) to the competent authority;
(b) those competent authorities have procedures and arrangements in place to
ensure the supervision of control bodies, including to verify that the delegated
tasks are carried out effectively, independently and objectively, in particular as
regards the intensity and 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 the decision 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 compliance with this Regulation which is relevant in
relation to the scope of this Regulation is the most recently notified version of the
international 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.
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 of plant
reproductive material not obtained from organic production;
(d) the assessment of the likelihood of non-compliance with the provisions of this
Regulation that determine the frequency with which physical checks are to be
performed on organic consignments prior to their release for free circulation
into the Union in accordance with Article 54 of Regulation (EU) 2017/625;
5. Competent authorities shall not delegate official control tasks or tasks related
to other official activities to natural persons.
(a) for a period that shall not exceed 12 months, during which the control 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 and control bodies, with competent authorities as well as
with the Commission in accordance with Article 43 of this Regulation; or
(b) for the period during which the accreditation referred to in point (b)(iv) of
Article 29 of Regulation (EU) 2017/625, in connection with Article 40(3) of
this Regulation, is suspended.
Where the delegation of official control tasks or tasks related to other official
activities has been suspended, the control bodies concerned shall not 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
32018R0848R(02), 03, 04, 05 08
remain valid, and shall inform the operators concerned of that decision.
(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 the part on organic production
and labelling of organic products of the annual report referred to in Article 113
of Regulation (EU) 2017/625 by 31 March of each year.
Article 41
Additional rules on actions in case of non-compliance
1. Subject to Article 29, where a competent authority, or, where appropriate, a
control authority or control body, suspects or receives substantiated information,
including information from other competent authorities, or, where appropriate, from
other control authorities or control bodies, that an operator intends to use or to place
on the market a product which may not be in compliance with this Regulation but
which bears terms referring to the organic production, or where such competent
authority, control authority or control body has been informed by an operator of a
suspicion of non-compliance in accordance with Article 27:
(a) it shall immediately carry out an official investigation in accordance with
Regulation (EU) 2017/625 with a view to verifying compliance with this
Regulation; such investigation shall be completed as soon as possible, within a
reasonable period, and shall take into account the 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 their use in organic
production pending the results of the investigation referred to in point (a).
Before taking such a decision, the competent authority, 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 in point (a) of
paragraph 1 do not show any non- compliance affecting the integrity of organic or in-
conversion products, the operator shall be allowed to use the products concerned or
to place them on the market as organic or in-conversion products.
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.
Article 42
Additional rules on measures in the event of non-compliance
1. In the event of non-compliance affecting the integrity of organic or in-
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 appropriate, control authorities and control bodies, shall ensure, in
addition to the measures to be taken in accordance with Article 138 of Regulation
(EU) 2017/625, that no reference is made to organic production in the labelling and
32018R0848R(02), 03, 04, 05 08
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–compliance that affects the integrity of organic or in-
conversion products.
Competent authorities shall share that information with other competent authorities
and the Commission via a computer system that enables the electronic exchanges of
documents and information made available by the Commission.
CHAPTER VII
Article 44
Export of organic products
1. A product may be exported from the Union as an organic product and may
bear the organic production logo of the European Union, provided that it complies
with the rules for organic production under this Regulation.
Article 45
Import of organic and in-conversion products
1. A product may be imported from a third country for the purpose of 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:
1
Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013
on the financing, management and monitoring of 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).
32018R0848R(02), 03, 04, 05 08
(i) the product complies with Chapters II, III and IV of this Regulation, 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 those authorities or bodies have provided all such
operators, groups of operators and exporters with a certificate confirming
that they comply with this Regulation;
(ii) in cases where the product comes from a third country which is
recognised in accordance with Article 47, that product complies with the
conditions laid down in the relevant trade agreement; or
(iii) in cases where the product comes from a third country which is
recognised in accordance with Article 48, that product complies with the
equivalent production and control rules of that third country and is
imported with a certificate of inspection confirming this compliance that
was issued by the competent authorities, control authorities or control
bodies of that third country; and
(c) the operators in third countries are able at any time to provide the importers
and the national authorities in the Union and in those third countries with
information allowing the identification of the operators that are their suppliers
and the control authorities or control bodies of those suppliers, with a view to
ensuring the traceability 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 and substances 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).
3. When providing for the criteria for determining whether a situation qualifies as
catastrophic circumstances, and when laying down specific rules on how to deal with
such circumstances in accordance with Article 22, the Commission shall take into
account differences in the ecological 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 in point (b) of paragraph 1, the
procedure to be followed for their issuance, their verification and the technical means
by which the certificate is issued, in particular as regards the role of competent
authorities, control authorities and control bodies, ensuring the traceability and
compliance of imported products intended to be placed on the Union market as
organic products or as in-conversion products as referred to in paragraph 1.
5. Compliance with the conditions and measures for the import of organic
products and in-conversion products referred to in paragraph 1 into the Union shall
be ascertained at border control posts, in accordance 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 to establish a list of recognised control authorities and
control bodies.
(a) they are legally established in one Member State or third country;
(b) they have the capacity to carry out controls to ensure that the conditions set out
in points (a), (b)(i) and (c) of Article 45(1) and in this Article are met in
relation to organic products and in-conversion products intended for import
into the Union;
(c) they offer adequate guarantees of objectivity and impartiality and are free from
any conflict of interest as regards the exercise of their control tasks;
(d) in the case of control bodies, they are accredited under the relevant harmonised
32018R0848R(02), 03, 04, 05 08
(e) they have the expertise, equipment and infrastructure required to carry out
control tasks, and have a sufficient number of suitable qualified and
experienced staff; and
(f) they meet any additional criteria that may be laid down in a delegated act
adopted pursuant to paragraph 7.
(a) a national accreditation body in the Union in accordance with Regulation (EC)
No 765/2008; or
4. Control authorities and control bodies shall submit a request for recognition to
the Commission. Such request shall consist of a technical dossier containing all
information that is necessary to ensure that the criteria 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 the accreditation certificate
issued by the accreditation body. Where appropriate, control authorities or control
bodies shall also provide latest reports on the regular on-the-spot evaluation,
surveillance and multiannual re- assessment of their activities.
(a) amending paragraph 2 of this Article by adding further criteria to those laid
down therein for the recognition of the control authorities and control bodies
referred to in paragraph 1 of this Article and for the withdrawal of such
recognition, or by amending those added criteria;
(i) the exercise of the supervision of the control authorities and control
bodies recognised by the Commission in accordance with paragraph 1,
including on-the-spot examinations; and
Article 47
Equivalence under a trade agreement
A recognised third country referred to in point (b)(ii) of Article 45(1) is a third
country which the Union has recognised under a trade agreement as having a system
of production meeting the same objectives and principles by applying rules which
ensure the same level of assurance of 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.
CHAPTER VIII
GENERAL PROVISIONS
SECTION 1
Free movement of organic and in-conversion products
Article 50
Non-prohibition and non-restriction of the marketing of organic and 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.
32018R0848R(02), 03, 04, 05 08
SECTION 2
Information, reporting and related derogations
Article 51
Information relating to the organic sector and trade
1. Each year Member States shall transmit to the Commission the information
necessary for the implementation and monitoring of the application of this
Regulation. As far as possible, such information shall be based on established
sources of data. The Commission shall take into account the data needs and synergies
between potential data sources, in particular their use for statistical purposes where
appropriate.
Article 52
Information relating to the competent authorities, control authorities and
control bodies
1. Members States shall keep a regularly updated list of:
(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 the Commission
and make them public, except where such transmission and publication has already
taken place in accordance with Article 4(4) of Regulation (EU) 2017/625.
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 31 December 2035.
(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 31 December 2035 or
extending them beyond that date; or
(b) ending the derogation referred to in point 1.3.4.4.2 of Part II of Annex II.
(a) information provided in the database referred to in Article 26(1) and in the
systems referred to in Article 26(2) and, if relevant, in the systems referred to
32018R0848R(02), 03, 04, 05 08
in Article 26(3);
(b) information on the derogations granted in accordance with point 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 authorisations granted in accordance
with points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II.
(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 and porcine 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, in particular, the
data collected in accordance with Article 26 and the information relating to the
derogations and the authorisations referred to in paragraph 6 of this Article.
CHAPTER IX
SECTION 1
Procedural provisions
Article 54
[2.] 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 from 17 June 2018The 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 from 1 January 2021. The Commission shall draw up a report in respect of
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.
2.[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 time
by the European Parliament or by the Council. A decision to revoke shall put an end
to the delegation of the power specified in that decision. 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
delegated acts already in force.
3.[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.[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
32018R0848R(02), 03, 04, 05 08
objection has been expressed either by the European Parliament or by 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 of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be 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 a committee within the meaning of
Regulation (EU) No 182/2011.
4. Where the Committee delivers no opinion, the Commission shall not 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
Repeal
Regulation (EC) No 834/2007 is repealed.
However, that Regulation shall continue to apply for the purpose of completing the
examination of pending applications from third countries, as provided for in Article
58 of this Regulation.
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) of Regulation (EC) No
834/2007 and which are pending on 17 June 2018. That Regulation shall apply to the
examination of such applications.
This Regulation shall enter into force on the third day following that of its
publication in the Official Journal of the European Union.
It shall apply from 1 January 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member
States. Done at Strasbourg, 30 May 2018.
— maté, sweetcorn, vine leaves, palm hearts, hop shoots, and other similar edible
parts of plants and products produced therefrom,
— beeswax,
— essential oils,
— cork stoppers of natural cork, not agglomerated, and without any binding
substances,
ANNEX II
1. General requirements
1.1. Organic crops, except those which are naturally grown in water, shall be
produced in living soil, or in living soil mixed or fertilised with materials
and products allowed in organic production, in connection with the subsoil
and bedrock.
1.4. By way of derogation from point 1.1, the following practices shall be
allowed:
(a) growing plants for the production of ornamentals and herbs in pots to
be sold together with the pot to the final consumer;
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, the
production rules laid down in this Regulation shall have been applied with
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 at least three years
before the first harvest of organic products.
1.7.2. Where the land or one or more parcels thereof have been contaminated
with products or substances not authorised for use in organic production,
the competent authority may decide to extend the conversion period for the
land or parcels concerned beyond the period referred to in point 1.7.1.
1.7.3. In the case of treatment with a product or a substance not authorised for
use in organic production, the competent authority shall require a new
conversion period in accordance with point 1.7.1.
(b) the harvest following the treatment may not be placed on the market
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.
1.8.1. For the production of plants and plant products other than plant
reproductive 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, the mother plant and,
where relevant, other plants intended for plant reproductive material
production shall have been produced in accordance with 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 shall give
preference to organic plant reproductive material suitable for organic
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 carried out
under certified organic management.
1.8.5. Use of in-conversion and non-organic plant reproductive material
1.8.5.1. By way of derogation from point 1.8.1, where the data collected in the
database referred to in Article 26(1) or the system referred to in point (a)
of Article 26(2) shows that the qualitative or quantitative needs of the
operator regarding relevant organic plant reproductive material, excluding
seedlings, are not met, competent authorities may authorise the use of in-
conversion or non-organic plant reproductive material under the conditions
laid down in points 1.8.5.3, 1.8.5.4 and 1.8.5.5.
Prior to requesting any such derogation, the operator shall consult the
database referred to in Article 26(1) or the system referred to in point (a) of
Article 26(2) in order to verify whether his or her request is justified.
1.8.5.2. Control authorities or control bodies recognised in accordance with Article
46(1) may authorise operators in third countries to use in-conversion or
non-organic plant reproductive material in an organic production unit
when organic plant reproductive material is not available in sufficient
quality or quantity in the territory of the third country in which the
operator is located, under the conditions laid down under points 1.8.5.3,
1.8.5.4 and 1.8.5.5.
1.8.5.3. Non-organic plant reproductive material shall not be treated with plant
protection products other than those authorised for the treatment of seed in
accordance with Article 24(1) of this Regulation, unless chemical
treatment has been prescribed in accordance with Regulation (EU)
2016/2031 for phytosanitary purposes by the competent authority of the
Member State concerned for all varieties of a given species in the area in
which the plant reproductive material is to be used.
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
32018R0848R(02), 03, 04, 05 08
1.9.2. The fertility and biological activity of the soil shall be maintained and
increased:
(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
1.10.1. The prevention of damage caused by pests and weeds shall rely primarily on
the protection by:
— natural enemies,
— crop rotation,
The collection of wild plants and parts thereof growing naturally in natural
areas, forests and agricultural areas is considered as organic production,
provided that:
(a) for a period of at least three years before the collection, those areas
were not treated with products or substances other than those
authorised pursuant to Articles 9 and 24 for use in organic production;
(b) the collection does not affect the stability of the natural habitat or the
maintenance of the species in the collection area.
Part II: Livestock production rules
In addition to the production rules laid down in Articles 9, 10, 11 and 14, the rules
laid down in this Part shall apply to organic livestock production.
1. General requirements
1.1. Except in the case of beekeeping, landless livestock production, where the
farmer intending to produce organic livestock does not manage
agricultural land and has not established a written cooperation agreement
with a farmer as regards the use of organic production units or in-
conversion production units for that livestock, shall be prohibited.
1.2. Conversion
(d) seven weeks for Peking ducks brought in before they are three days
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;
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 with combs or comb
foundations coming from organic production units. In any case, one swarm
or queen bee may be replaced per year by a non-organic swarm or a queen
bee.
1.3.4.3. By way of derogation from point 1.3.1, where a flock is constituted for the
first time, or is renewed or reconstituted, and where the qualitative and
quantitative needs of farmers cannot be met, the competent authority may
decide that non-organically reared poultry may be brought into an organic
poultry production unit, provided that the pullets 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 the
system referred to in point (b) of Article 26(2) shows that the qualitative 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 the conditions provided
for in points 1.3.4.4.1 to 1.3.4.4.4.
32018R0848R(02), 03, 04, 05 08
Prior to requesting any such derogation, the farmer shall consult the data
collected in the system referred to in point (b) of Article 26(2) in order to
verify whether his or her request is justified.
(b) ovine animals and caprine animals shall be less than 60 days old;
(b) for units with fewer than 10 equine animals, cervine animals or
bovine animals or rabbits, or with fewer than five porcine animals,
ovine animals or caprine animals, any such renewal shall be limited to
a maximum of one animal per year.
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 the conversion
period specified in point 1.2 has been complied with. The conversion
period laid down in point 1.2.2 shall start, at the earliest, once the animals
are introduced into the in- conversion production unit.
1.4. Nutrition
(a) feed for livestock shall be obtained primarily from the agricultural
holding where the animals are kept or shall be obtained from organic
or in-conversion production units belonging to other holdings in the
same region;
(b) livestock shall be fed with organic or in-conversion feed that meets
the 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;
(d) fattening practices shall always respect the normal nutritional patterns
32018R0848R(02), 03, 04, 05 08
for each species and the animals’ welfare at each stage of 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;
(h) feed materials of plant, algal, animal or yeast origin shall be organic;
(i) non-organic feed materials of plant, algal, animal or yeast origin, feed
materials of microbial or of mineral origin, feed additives and
processing 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 land
(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 been
raised 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 segregation from 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, in the 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 agricultural origin.
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).
1.5.1.1. Disease prevention shall be based on breed and strain selection, husbandry
management practices, high-quality feed, exercise, appropriate stocking
density and adequate and appropriate housing maintained in hygienic
conditions.
1.5.1.6. 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.
1.5.1.7. Housing, pens, equipment and utensils shall be properly cleaned and
disinfected to prevent cross-infection and the build-up of disease carrying
organisms. Faeces, urine and uneaten or spilt feed shall be removed as
often as necessary to minimise smell and 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.
1.5.2.3. Feed materials of mineral origin authorised pursuant to Article 24 for use
in organic production, nutritional additives authorised pursuant to Article
24 for use in organic production, and phytotherapeutic and homeopathic
products shall be used in preference to treatment with chemically
synthesised allopathic veterinary medicinal products, including antibiotics,
provided that their therapeutic effect is effective for the species of animal
and for the condition for which the treatment is intended.
1.5.2.6. Treatments related to the protection of human and animal health imposed
on the basis of Union legislation shall be allowed.
1.6.1. 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 and light to
32018R0848R(02), 03, 04, 05 08
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 them from
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 shall depend in particular on
the species, the breed and the age of the animals. It shall also take account
of the behavioural needs of the animals, which depend in particular on the
size of the group and the animals’ sex. The density shall ensure the
animals’ welfare by providing them with sufficient space to stand
naturally, to move, to lie 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 technical
details 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 of organic
nitrogen per year and hectare of agricultural area.
1.6.8. Cages, boxes and flat decks to raise livestock shall not be used for any
livestock species.
1.6.10. Organic livestock may not be reared in a pen on very wet or marshy soil.
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 of the animals and shall
have followed adequate training, as required in particular 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.
1.7.3. Livestock shall have permanent access to open air areas that allow the
animals 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 health have been
imposed on the basis of Union legislation.
1.7.7. Any suffering, pain and distress shall be avoided and shall be kept to a
minimum during the entire life of the animal, including at the time of
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 and 93/119/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 of animals at the
time of killing (OJ L 303, 18.11.2009, p. 1).
32018R0848R(02), 03, 04, 05 08
slaughter.
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 be allowed 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 and justified the operations to that competent authority and where
the operation is to be carried out by qualified personnel.
1.7.11. The loading and unloading of animals shall be carried out without the use
of any type of electrical or other painful stimulation to coerce the animals.
The use of allopathic tranquillisers, prior to or during transport, shall be
prohibited.
1.9.1. For bovine animals, ovine animals, caprine animals and equine animals
1.9.1.1. Nutrition
(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 move freely,
the obligation to provide open air areas during the winter months may
be waived;
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 litter shall 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
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).
32018R0848R(02), 03, 04, 05 08
1.9.2.1. Nutrition
(c) where animals have access to pasturage during the grazing period and
where the winter housing system allows the animals to move freely,
the obligation to provide open air areas during the winter months may
be waived;
(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 to animals 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 and
fences that do not harm animals;
(b) in red deer pens, animals must be able to roll in the mud to ensure
skin 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 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 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 the weather
and accessible both to animals and to persons attending to them. The
soil where feeding places are located shall be consolidated, and the
feeding apparatus shall be equipped with a roof;
1.9.3.1. Nutrition
(a) at least 30 % of the feed shall come from the farm itself or, if this is
not feasible or such feed is not available, shall be produced in
cooperation with other organic or in-conversion production units and
feed operators using feed and feed material from the same region;
32018R0848R(02), 03, 04, 05 08
(b) roughage, fresh or dried fodder, or silage shall be added to the daily
ration;
(c) where farmers are unable to obtain protein feed exclusively from
organic production, and the competent authority has confirmed that
organic protein feed is not available in sufficient quantity, non-
organic protein feed may be used until 31 December 2025 provided
that the following conditions are fulfilled:
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 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 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 suitable material
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 of pregnancy
and during the suckling period, during which time the sow 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 a quantity of
straw or other suitable natural material sufficient to enable them to
build nests;
(f) exercise areas shall permit dunging and rooting by porcine animals.
For the purposes of rooting, different substrates may be used.
Where slow-growing poultry strains are not used by the farmer, the
minimum age at slaughter shall be as follows:
(a) 81 days for chickens;
(h) 140 days for male turkeys and roasting geese; and
(b) roughage, fresh or dried fodder, or silage shall be added to the daily
ration;
(c) where farmers are unable to obtain protein feed exclusively from
organic production for poultry species, and the competent authority
has confirmed that organic protein feed is not available in sufficient
quantity, non-organic protein feed may be used until 31 December
2025, provided that the following conditions are fulfilled:
(i) it is not available in organic form;
(iii) its use is limited to the feeding of young poultry with specific
protein compounds; and
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 of slatted
or of grid construction, and shall be covered with a litter material such
as straw, wood shavings, sand or turf;
(b) in poultry houses for laying hens, a sufficiently large part of the floor
area available to the hens shall be available for the collection of bird
droppings;
(d) poultry shall have access to an open air area for at least one third of
their life. However, laying hens and finisher poultry shall have access
to an open air area for at least one third of their life, except where
temporary restrictions have been imposed on the basis of Union
legislation;
(e) continuous daytime open air access shall be provided from as early an
age as practically possible and whenever physiological and 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 imposed on 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, in such 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 to
adequate numbers of drinking troughs;
(g) open air areas for poultry shall be covered mainly with vegetation;
(i) under conditions where feed availability from the range area is
32018R0848R(02), 03, 04, 05 08
limited, for example, due to long term snow cover or arid weather
conditions, supplementary feeding of roughage shall be included as
part of poultry diets;
(k) water fowl shall have access to a stream, pond, lake or a pool
whenever the weather and hygienic conditions permit, in order to
respect their species-specific needs and animal welfare requirements;
when weather conditions do not permit such access, they shall have
access to water which enables them to dip their head therein so as to
clean plumage;
(m) the total usable surface area for fattening poultry in poultry houses of
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.
1.9.5.1. Nutrition
(a) at least 70 % of the feed shall come from the farm itself or, if this is
not feasible or such feed is not available, shall be produced in
cooperation 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 whenever conditions
allow;
(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 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) rabbit farms shall use robust breeds adapted to outdoor conditions;
(iii) a raised platform on which they can sit, either inside or out;
(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;
(b) bee colonies may only be fed where the survival of the colony is
endangered due to climatic conditions. In such case, bee colonies
shall be fed with organic honey, organic sugar syrups, or organic
sugar.
1.9.6.3. Health care
(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 or
infested, they shall be treated immediately and, if necessary, may be
placed in isolation apiaries;
(e) formic acid, lactic acid, acetic acid and oxalic acid, as well as
menthol, thymol, eucalyptol or camphor, may be used in cases of
infestation with Varroa destructor;
With regard to housing and husbandry practices, the following rules shall
apply:
(a) apiaries shall be placed in areas which ensure the availability of nectar
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 treated with 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 essentially of
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 are dormant;
(d) the hives and materials used in beekeeping shall be made basically of
natural materials presenting no risk of contamination to the
environment 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;
1.6. The plan shall be updated annually and shall detail the environmental
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 the environment (OJ L 26, 28.1.2012,
p. 1).
effects of the operation and the environmental monitoring to be
undertaken, 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 shall record the surveillance and repair of
technical equipment.
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 the
sustainable management plan a waste reduction schedule to be put in place
at the commencement of operations. Where possible, the use of residual
heat shall be limited to energy from renewable sources.
2.1. Conversion
2.1.1. The conversion period for a production unit for algae collection shall be six
months.
2.1.2. The conversion period for a production unit for algae cultivation shall be a
period of six months or one full production cycle, whichever is the longer.
32018R0848R(02), 03, 04, 05 08
2.2.1. The collection of wild algae and parts thereof is considered as organic
production provided that:
(a) the growing areas are suitable from a health point of view and are of
high ecological status as defined by Directive 2000/60/EC, or are of
equivalent quality to:
(b) the collection does not affect significantly the stability of the natural
ecosystem or the maintenance of the species in the collection area.
2.2.2. The cultivation of algae shall take place in areas with environmental and
health characteristics at least equivalent to those outlined in point 2.2.1(a)
in order to be considered organic. In addition the following production
rules shall apply:
(c) fertilisers shall not be used, except in indoor facilities, and only if
they have been authorised pursuant to Article 24 for use in organic
production for this purpose.
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 of animal origin intended for
human consumption (OJ L 139, 30.4.2004, p. 206).
2.3.1. Algae culture at sea shall only utilise nutrients naturally occurring in the
environment, or from organic aquaculture animal production, preferably
located nearby as part of a polyculture system.
2.3.2. In facilities on land where external nutrient sources are used, the nutrient
levels in the effluent water shall be verifiably the same, or lower, than the
inflowing water. Only nutrients of plant or mineral origin authorised
pursuant to Article 24 for use in organic production may be used.
2.3.4. Ropes and other equipment used for growing algae shall be re-used or
recycled where possible.
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 the aquatic 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 that by- catches are prevented.
3.1.1. Conversion
(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, a
conversion period of six months;
(d) for open water facilities, including those producing bivalve molluscs,
a conversion period of three months.
3.1.2.1. With regard to the origin of the aquaculture animals, the following rules
shall apply:
(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 and treatment 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;
(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:
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 juveniles of species that were not
developed as organic in the Union by 1 January 2021, provided that at
least the latter two thirds of the duration of the production cycle are
managed under organic management. Such derogation may be granted
for a maximum period of two years and shall not be renewable.
3.1.3. Nutrition
3.1.3.1. With regard to feed for fish, crustaceans and echinoderms, the following
rules shall apply:
(a) animals shall be fed with feed that meets the animals’ nutritional
requirements at the various stages of its development;
(c) the plant fraction of feed shall be organic and the feed fraction
derived from aquatic animals shall originate from organic aquaculture
or from fisheries that have been certified as sustainable under a
scheme recognised by the competent authority in line with the
principles laid down in Regulation (EU) No 1380/2013;
(d) non-organic feed materials of plant, animal, algal or yeast origin, feed
materials of mineral or microbial origin, feed additives, and
processing aids shall only be used if they have been authorised under
this Regulation for use in organic production;
3.1.3.2. With regard to bivalve molluscs and other species which are not fed by
man, but instead feed on natural plankton, the following rules shall apply:
(b) the growing areas shall be suitable from a health point of view and
shall either be of high ecological status as defined by Directive
2000/60/EC or of good environmental status as defined by Directive
2008/56/EC or of equivalent quality to:
(b) fish meal and fish oil from organic aquaculture trimmings sourced
from fish, crustaceans or molluscs;
(c) fish meal and fish oil and feed material of fish origin derived from
trimmings of fish, crustaceans or molluscs already caught for human
consumption in sustainable fisheries;
32018R0848R(02), 03, 04, 05 08
(d) fish meal and fish oil and feed material of fish origin derived from
whole fish, crustaceans or molluscs caught in sustainable fisheries and
not used for human consumption;
(e) organic feed materials of plant or animal origin; plant material shall
not exceed 60 % of total ingredients.
In the grow-out phase, fish in inland waters, penaeid shrimps and freshwater
prawns and tropical freshwater fish shall be fed as follows:
(a) they shall be fed with feed naturally available in ponds and lakes;
(b) where natural feed referred to in point (a) is not available in sufficient
quantities, organic feed of plant origin, preferably grown on the farm
itself, or algae may be used. Operators shall keep documentary
evidence of the need to use additional feed;
(ii) the feed ration of siamese catfish (Pangasius spp.) may consist of
a maximum of 10 % fishmeal or fish oil derived from sustainable
fisheries.
(c) an animal health management plan shall detail biosecurity and disease
prevention practices including a written agreement for health
counselling, proportionate to the production unit, with qualified
aquaculture animal health services who shall visit the farm at a
frequency of not less than once per year or, in the case of bivalve
shellfish, not less than once every two years;
(d) holding systems, equipment and utensils shall be properly cleaned and
disinfected;
(iii) during fallowing the cage or other structure used for aquaculture
animal production is emptied, disinfected and left empty before
being used again;
(h) where appropriate, uneaten fish-feed, faeces and dead animals shall be
removed promptly to avoid any risk of significant environmental
damage as regards water status quality, to minimise disease risks, and
to avoid attracting insects or rodents;
32018R0848R(02), 03, 04, 05 08
(i) ultraviolet light and ozone may only be used in hatcheries and
nurseries;
(ii) plants and their extracts not having anaesthetic effects; and
(e) the use of parasite treatments, other than through compulsory control
schemes operated by Member States, shall be limited to twice per
year, or once per year where the production cycle is less than 18
months;
(f) the withdrawal period for allopathic veterinary treatments and parasite
treatments in accordance with point (d), including treatments under
compulsory control and eradication schemes, shall be twice the
withdrawal period referred to in Article 11 of Directive 2001/82/EC
or, where this period is not specified, 48 hours;
(a) have sufficient space for their welfare and have the relevant stocking
density laid down in the implementing acts referred to in Article
15(3);
(b) are kept in water of good quality with, inter alia, an adequate flow and
exchange rate, sufficient oxygen levels and keeping a low level of
metabolites;
(c) are kept in temperature and light conditions in accordance with the
32018R0848R(02), 03, 04, 05 08
In the case of freshwater fish, the bottom type shall be as close as possible
to natural conditions. In the case of carp and similar species:
— the bottom shall be natural earth,
— organic and mineral fertilisation of the ponds and lakes shall be carried
out only with fertilisers and soil conditioners that have been authorised
pursuant to Article 24 for use in organic production, with a maximum
application of 20 kg nitrogen/ha,
3.1.5.4. The design and construction of aquatic containment systems shall provide
flow rates and physiochemical parameters that safeguard the animals’
health and welfare, and that provide for their behavioural needs.
(a) flow-through systems shall allow the monitoring and control of the
flow rate and water quality of both in- flowing and out-flowing water;
(a) they shall be located where water flow, depth and water-body
exchange rates are adequate to minimise the impact on the seabed and
the surrounding water body;
(b) they shall have suitable cage design, construction and maintenance
with regard to their exposure to the operating environment.
3.1.6.1. All persons involved in keeping aquaculture animals shall possess the
necessary basic knowledge and skills as regards the health and the welfare
needs of those animals.
3.1.6.3. The following restrictions shall apply to the use of artificial light:
(a) for prolonging natural day length, it shall not exceed a maximum that
respects the ethological needs, geographical conditions and general
health of the animals; this maximum shall not exceed 14 hours per
day, except where necessary for reproductive purposes;
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, and only
in the following cases:
3.1.6.6. Appropriate measures shall be taken to keep the duration of the transport
of aquaculture animals to a minimum.
3.1.6.7. Any suffering shall be kept to a minimum during the entire life of the
animal, including at the time of slaughter.
3.1.6.8. Eyestalk ablation, including all similar practices such as ligation, incision
and pinching, is prohibited.
With 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 is permitted
by local legislation and provided that the wild seed comes from:
(i) settlement beds which are unlikely to survive winter weather or are
surplus to requirements; or
(b) for the cupped oyster (Crassostrea gigas), preference shall be given to
stock which is selectively bred to reduce spawning in the wild;
(c) records shall be kept of how, where and when wild seed was collected
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 areas
delimited by posts, floats or other clear markers and shall, where
appropriate, be restrained by net bags, cages or other man made
means;
3.2.3. Cultivation
32018R0848R(02), 03, 04, 05 08
3.2.4. Management
(a) production shall use a stocking density not in excess of that used for
non-organic molluscs in the locality. Sorting, thinning and stocking
density adjustments shall be made according to the biomass and to
ensure animal welfare and high product quality;
1.2. Operators producing processed food shall establish and update appropriate
procedures based on a systematic identification of critical processing steps.
1.3. The application of the procedures referred to in point 1.2 shall ensure that
the produced processed products comply with this Regulation at all times.
1.4. Operators shall comply with and implement the procedures referred to in
point 1.2, and, without prejudice to Article 28, shall in particular,:
(c) guarantee that non-organic products are not placed on the market with
an indication referring to organic production.
(a) inform the competent authority, or, where appropriate, the control
authority or control body, accordingly;
(b) carry out the operations continuously until the production run has
been completed, separately in place or time from similar operations
performed on any other kind of product (organic, in-conversion or
non- organic);
1
Good manufacturing practices (GMPs) as defined in Article 3(a) of Commission Regulation (EC) No
2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to
come into contact with food (OJ L 384, 29.12.2006, p. 75).
32018R0848R(02), 03, 04, 05 08
1.6. Products, substances and techniques that reconstitute properties that are
lost in the processing and storage of organic food, that correct the results
of negligence in the processing of organic food, or that otherwise may be
misleading as to the true nature of products intended to be marketed as
organic food, shall not be used.
(b) an organic ingredient shall not be present together with the same
ingredient in non-organic form;
(b) substances and products defined in points (c) and (d)(i) of Article 3(2)
of Regulation (EC) No 1334/2008 that have been labelled 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 the
intention of placing them on the market at a given period of the year;
(e) drinking water and organic or non-organic salt (with sodium chloride
or potassium chloride as basic components) generally used in food
processing;
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.
2.2.4. For the purpose of the calculation referred to in Article 30(5), the following
rules shall apply:
(b) preparations and substances referred to in points (a), (c), (d), (e) and
(f) of point 2.2.2 shall not be calculated as agricultural ingredients;
1.1. Feed additives, processing aids and other substances and ingredients used
for processing feed, and any processing practice used, such as smoking,
shall comply with the principles of good manufacturing practice.
1.2. Operators that produce processed feed shall establish and update
appropriate procedures based on a systematic identification of the critical
1
Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 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).
processing steps.
1.3. The application of the procedures referred to in point 1.2 shall ensure that
the produced processed products comply with this Regulation at all times.
1.4. Operators shall comply with and implement the procedures referred to in
point 1.2, and, without prejudice to Article 28, shall in particular:
(c) guarantee that non-organic products are not placed on the market with
an indication referring to organic production.
(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);
2.1. Organic feed materials, or in-conversion feed materials, shall not enter
simultaneously with the same feed materials produced by non-organic
means into the composition of the organic feed product.
2.2. Any feed materials used or processed in organic production shall not have
been processed with the aid of chemically synthesised solvents.
2.3. Only non-organic feed material of plant, algal, animal or yeast origin, feed
material of mineral origin, and feed additives and processing aids
authorised pursuant to Article 24 for use in organic production may be
used in the processing of feed.
2.4. Only the products for cleaning and disinfection authorised pursuant to
Article 24 for use in processing shall be used for that purpose.
1.1. In addition to the general production rules laid down in Articles 9, 10, 11,
16 and 18, the rules laid down in this Part shall apply to the organic
production of the products of the wine sector as referred to in point (l) of
Article 1(2) of Regulation (EU) No 1308/2013.
1.2. Commission Regulations (EC) No 606/2009 (1) and (EC) No 607/2009 (2)
shall apply, save as explicitly provided otherwise in this Part.
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
1
(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
(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).
organic production may be used for the making of products of the wine
sector, including during the oenological practices, processes and
treatments, subject to the conditions and restrictions laid down in
Regulation (EU) No 1308/2013 and Regulation (EC) No 606/2009, and in
particular in Annex I A to the latter Regulation.
3.2. The use of the following oenological practices, processes and treatments
shall be prohibited:
1.1. For the production of organic yeast, only organically produced substrates
shall be used. However, until 31 December 2023, the addition of up to 5 %
non-organic yeast extract or autolysate to the substrate (calculated in
weight of dry matter) is allowed for the production of organic yeast where
operators are unable 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:
1.4. Only the products for cleaning and disinfection authorised pursuant to
Article 24 for use in processing shall be used for that purpose.
ANNEX III
2.1. Operators shall ensure that organic and in-conversion products are transported
to other operators or units, including wholesalers and retailers, only in
appropriate packaging, containers or vehicles closed in such a manner that
substitution of the content cannot be achieved without manipulation or damage
of the seal and provided with a label stating, without prejudice to any other
indications required by Union law:
(a) the name and address of the operator and, where different, of the owner
or seller of the product;
(c) the name or the code number of the control authority or control body to
which the operator is subject; and
(d) where relevant, the lot identification mark in accordance with a marking
system either approved at national level or agreed with the control
authority or control body and which permits the linking of the lot with
the records referred to in Article 34(5).
transporter.
2.2. The closing of packaging, containers or vehicles shall not be required where:
(a) the transport takes place directly between two operators, both of which
are subject to the organic control system;
(d) both the expediting and the receiving operators keep documentary
records of such transport operations available for the control authority or
control body.
(a) during transport, organically produced feed, in-conversion feed, and non-
organic feed are effectively physically separated;
(d) during transport, the quantity of products at the start and each individual
quantity delivered in the course of a delivery round is recorded.
4.1. Live fish shall be transported in suitable tanks with clean water which meets
their physiological needs in terms of temperature and dissolved oxygen.
4.2. Before transport of organic fish and fish products, tanks shall be thoroughly
cleaned, disinfected and rinsed.
4.3. Precautions shall be taken to reduce stress. During transport, the density shall
not reach a level which is detrimental to the species.
4.4. Records shall be kept for operations referred to in points 4.1, 4.2 and 4.3.
7.1. Areas for the storage of products shall be managed in such a way as to ensure
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.
(a) the organic or in-conversion products shall be kept separate from the
other agricultural products or foodstuffs;
(c) suitable cleaning measures, the effectiveness of which has been checked,
shall have been carried out before the storage of organic or in-conversion
products and the operators shall keep records of those operations.
7.5.Only the products for cleaning and disinfection authorised pursuant to Article
24 for use in organic production shall be used in storage facilities for that
purpose.
32018R0848R(02), 03, 04, 05 08
ANNEX IV
BG: биологичен
DA: økologisk.
EL: βιολογικό.
EN: organic.
FR: biologique.
GA: orgánach.
HR: ekološki.
IT: biologico.
LT: ekologiškas.
HU: ökológiai.
MT: organiku.
NL: biologisch.
PL: ekologiczne.
PT: biológico.
RO: ecologic.
SL: ekološki.
FI: luonnonmukainen.
SV: ekologisk.
32018R0848R(02), 03, 04, 05 08
ANNEX V
1. Logo
1.1. The organic production logo of the European Union shall comply with the
model 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 in black
and white as shown, only where it is not practicable to apply it in colour:
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 or label.
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.
1.7. The organic production logo of the European Union shall have a height of at
least 9 mm and a width of at least 13,5 mm; the proportion ratio height/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 with
graphical or textual elements referring to organic production under the
condition 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
AB-CDE-999
where:
(a) ‘AB’ is the ISO code for the country where the controls take place;
MODEL OF CERTIFICATE
1. Document number:
— unprocessed plants and plant products, Certificate validity period from ............... to
including seeds and other plant reproductive
material
Production method:
— algae and unprocessed aquaculture products Certificate validity period from ............... to
Production method:
This document has been issued in accordance with Regulation (EU) 2018/848 to certify that
the operator or group of operators (choose as appropriate) meets the requirements of that
Regulation.
Date, place:
Signature on behalf of the issuing control authority or control body:
32018R0848R(02), 03, 04, 05 08