# EUR-Lex - 52014PC0180 - EN

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# 52014PC0180

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on organic production and labelling of organic products, amending Regulation (EU) No XXX/XXX of the European Parliament and of the Council [Official controls Regulation] and repealing Council Regulation (EC) No 834/2007 /* COM/2014/0180 final - 2014/0100 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

1.1.        Grounds
for and objectives of the proposal

Over the last 10 years the organic market
has been characterised by dynamic development driven by strong growth in
demand. The global world market for organic food has expanded fourfold since
1999. The area under organic production in the European Union (the Union) has doubled. Each year 500000 ha of land are converted to organic farming. However,
neither internal supply nor the legislative framework has kept up with this
market expansion. Production rules do not sufficiently take into account
evolving consumer and citizen concerns and expectations; labelling rules are
complicated; weaknesses in the control system and in the trade regime have been
identified. The legislation is complex and entails a
high level of administrative burden which is stopping small farmers from
joining the Union's organic scheme. Some of the exemptions that were needed
for the development of the sector seem no longer to be justified.

The proposal aims at improving the
legislation on organic production with the objectives of:

(1)
removing obstacles to the sustainable
development of organic production in the Union,

(2)
guaranteeing fair competition for farmers and
operators and allowing the internal market to function more efficiently,

(3)
maintaining or improving consumer confidence in
organic products.

1.2.        General
context

When adopting Council Regulation (EC)
No 834/2007 on organic production and labelling of organic products[1], the Council earmarked
a series of issues on which the Commission was required to submit a report to
the European Parliament and the Council, after having reviewed the experience
gained from the application of Regulation (EC) No 834/2007.

The Council adopted conclusions on the
Commission's report[2]
at its Agriculture and Fisheries meeting of 13-14 May 2013[3] and called on the
Member States and on the Commission to develop the organic production sector at
an ambitious level by reviewing the current legal framework, with a view to
improving its usability while providing for a period of stability and
certainty, aiming at further clarification and simplification, and addressing
the current outstanding issues requiring further development.

The review of the organic production
legislation is part of the Commission's Regulatory Fitness and Performance
Programme[4].

The review provides an opportunity to align
the Commission implementing powers in Council Regulation (EC) No 834/2007 to
the differentiation between delegated and implementing powers of the Commission
introduced by Articles 290 and 291 of the Treaty on the Functioning of the
European Union (TFEU).

1.3.        Existing
provisions in this area

The first piece of Union legislation on
organic production was adopted in 1991. Council Regulation (EEC)
No 2092/91 provided a legal definition of organic production through
production rules, and set out control and labelling requirements and rules for
importing organic products. This provided a basis for protecting consumers and
organic producers against false and misleading organic claims.

That legislation was revised with the
adoption of Council Regulation (EC) No 834/2007 in June 2007, which in
particular:

–
defined organic production further by describing
its objectives and principles,

–
improved the harmonisation of the organic
production rules within the Union, by putting an end to national rules for
animal products,

–
introduced the possibility of exceptions to the
rules under the responsibility of Member States (MS) but with strict
limitations and for a limited period of time,

–
linked the organic control system to the
official food and feed controls system provided for in Regulation (EC) No
882/2004[5]
and made the accreditation of private control bodies obligatory,

–
restructured the import regime: in addition to
the recognition of third countries for the purpose of equivalence,  the
European Union recognises control bodies (CBs) active in third countries for
the purpose of equivalence or compliance. The previous system of individual
authorisations granted by MS consignment by consignment was removed from the
basic Regulation and is now being phased out.

1.4.        Consistency
with other policies

This initiative pursues the objectives of
the Communication on Smart Regulation in the European Union. One of the aims of
the review is to simplify legislative burdens.

It is in line with the general framework of
the Europe 2020 Strategy, in particular regarding the sustainable growth
priority and the promotion of a more resource-efficient, greener and more
competitive economy.

It is consistent with the reform of the
Common Agricultural Policy (CAP), which shapes the overall framework for the
development of agriculture in the Union for the period 2014-2020[6]. The new provisions aim
at sustainable competitiveness to achieve an economically viable food
production sector, together with sustainable management of the Union's natural land-based resources, in which organic production has been identified as a
key-element.

The proposal takes into account 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 a context of growing global
aquatic food demand.

It is also consistent with the Commission's
proposal for a new Council and Parliament regulation on official controls[7], which aims at
consolidating the integrated approach in all areas related to the food chain by
rationalising and simplifying the overall legislative framework whilst
simultaneously pursuing the objective of better regulation. In particular,
definitions are aligned and/or clarified as appropriate, and the necessary
specific control provisions are proposed to be integrated into the single
legislative framework for official controls.

Finally, the organic production scheme
forms part of the Union's agricultural product quality schemes together with
geographical indications, traditional specialities guaranteed, and products of
the EU's outermost regions and mountain areas as underlined in the
Communication from the Commission to the European Parliament and to the
Council, the European Economic and Social Committee and the Committee of the
Regions on agricultural product quality policy and indicated in Regulation (EU)
No 1151/2012 of the European Parliament and of the Council on quality
schemes[8].

2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

2.1.        Consultations

The current situation was analysed in depth
on the basis of the information collected during a series of stakeholder
hearings to which the Commission
invited over 70 experts and academics to discuss fully the current and
future challenges facing the organic sector.

The Commission launched an on-line
consultation at the beginning of 2013. Around 45 000 replies were
submitted in response to the questionnaire and almost 1 400 free
contributions were received. The majority (96%) of responses were submitted by
citizens of the European Union, while the remaining 4% were sent by
stakeholders.

In addition, stakeholders of the sector
were informed and consulted on the review in several meetings of the Advisory
Group on Organic Farming.

Member States, as competent authorities in
charge of implementing the legislation, were kept informed and were consulted
on technical aspects of the review.

2.2.        Main
outcome of the consultations

The respondents to the public consultation
are concerned mainly with environmental and quality issues. They would like the
European organic rules to be strengthened and wish to have uniformity of
organic rules for farmers and other operators throughout the Union. Therefore
the majority are in favour of putting an end to the exceptions to the rules.
High expectations were expressed as regards residues of products and substances
that are not authorised for use in organic production. The organic logo of the
European Union was ranked equal to national logos as a means of recognising
organic products. The majority of citizens and stakeholders trust the organic
control system while considering that it could be improved, mainly by
introducing electronic certification. They are also in favour of group
certification for small farmers.

The need to improve the legislation on
organic production is widely acknowledged in the organic sector. There is also
broad agreement that organic production should remain close to its principles
and objectives and that exceptions to the rules should be ended.

2.3.        Impact
assessment

The impact assessment compared three
alternative policy scenarios:

–
The improved status quo, based on improvements and better enforcement of the current
legislation.

–
The market-driven option, which aims at providing the conditions needed to respond
dynamically to further market developments with more flexible rules.
Long-standing exceptional rules would be integrated in the production rules.

–
The principle-driven option aiming at
re-focusing organic production on its principles, which would be better
reflected in the production rules. Exceptional rules would be ended.

The three policy options have been assessed
against their potential to achieve the CAP 2020 objectives, specific policy
objectives and operational objectives for the review, and in terms of
effectiveness and efficiency. The principle-driven option performs better according
to all criteria evaluated, followed by the market-driven option and lastly the
improved status quo.

The principle-driven option is expected to
produce the following results:

–
A positive market outlook, thanks to greater
consumer confidence, which is likely to support organic product prices and to
attract newcomers,

–
The removal of exceptions to the rules should
contribute to the development of organic inputs, notably seeds,

–
Clearer and simpler production rules will make
the sector more attractive,

–
Competition will become fairer as a result of
stronger harmonisation, simpler and clearer rules and the move from equivalence
to compliance for the recognition of control bodies in third countries,

–
Consumer confidence will rise with an improved
control system and harmonised production rules taking account of evolving
societal concerns (environmental management system for processors and traders,
animal welfare),

–
A risk-based approach is expected to improve the
effectiveness and efficiency of controls and contribute, together with a more
reliable import regime, to fraud prevention,

–
Positive environmental impacts associated with
organic production will be stressed by ending exceptional rules,

–
Animal welfare conditions will be improved
through the removal of exceptions.

The impact assessment concluded that the
preferred option was the principle-driven option, together with the inclusion
of the improvements proposed in the improved status quo, and with some
sub-options.

Particular attention has been paid to
simplification during the whole process. The preferred option will:

–
clarify the provisions on scope, production
rules, labelling and controls,

–
remove ineffective provisions,

–
limit the MS' scope for granting exceptions to
the rules,

–
simplify the import regime,

–
simplify requirements for small farmers, in
particular with the introduction of group certification.

As regards administrative costs, the
current proposal will lead to the removal of 37 out of the 135 existing
information obligations imposed on organic operators and administrations.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

3.1.        Summary
of the proposed action

Organic production must continue to adhere
to a set of principles that reflect closely the expectations of consumers.

Specific production rules are brought
together in an Annex to the proposed Regulation, thus addressing the issue of
readability.

Production rules are strengthened and
harmonised by removing exceptions, except where temporary measures are
necessary in order to allow organic production to continue or recommence in the
case of catastrophic circumstances. Organic agricultural holdings have to be
entirely managed in compliance with the requirements applicable to organic
production and retroactive acknowledgement of the conversion period is in
principle not possible any more. The agricultural ingredients used in the
composition of organic processed products have to be exclusively organic. With
the exceptions of micro-enterprises, organic operators other than farmers or
operators producing seaweed or aquaculture animals are required to develop a
system for improving their environmental performance.

The control system is improved by
integrating all control-related provisions into a single legislative text under
the Commission proposal for a Regulation on official controls and other
official activities in food and feed. Consequently, operators, competent
authorities, control authorities and control bodies will no longer need to rely
on two different legislative texts for the provisions related to controls.

Controllability is enhanced by
clarification, simplification and harmonisation of the production rules and the
removal of a series of possible exceptions to such rules.

The proposal seeks to do away with the
possibility to exempt certain types of retailers provided for in Regulation
(EC) No 834/2007, which has led to different interpretations and practices
across Member States and has made management, supervision and control more
difficult.

The risk-based approach to official
controls is reinforced by removing the requirement for mandatory annual
verification of compliance of all operators provided for in Regulation (EC)
No 834/2007. This will make it possible to adapt the control frequency,
through delegated acts to be adopted in accordance with Regulation (EU) No XX/XXX
(Official Controls Regulation, so that operators with a low risk profile may be
physically inspected less than annually and/or subject to reduced annual
physical inspections, while higher risk operators would be more closely
targeted. There will thus be a fairer balance of the control pressure on
operators, with a reduced burden on those with a proven track record of
compliance with the rules, and more effective and efficient use of resources by
the competent authorities, control authorities and control bodies.

Specific provisions are introduced in order
to increase transparency with regard to fees that may be collected for the
controls, and the provisions related to publication of operators together with
information on their certification status are reinforced.

A system of group certification is
introduced for small-scale farmers in the Union with a view to reducing
inspection and certification costs and the associated administrative burden,
strengthening local networks, contributing to better market outlets, and
ensuring a level playing field with operators in third countries.

Specific provisions are introduced for
purposes of enhanced traceability and fraud prevention: operators may not be
controlled by different control authorities or bodies for the same groups of
products across different stages of the organic chain.

Specific provisions are also introduced to
harmonise action to be taken when non-authorised products or substances are
detected. In this context, there may be instances where farmers are prevented
from marketing their products as organic due to the unintentional presence of
non-authorised products or substances. Member States may be authorised by the
Commission to grant national payments to compensate for the losses incurred in
such instances. In addition, Member States may use the instruments of the
Common Agricultural Policy to cover totally or partially such losses.

Lastly, the proposal sets out action to be
taken throughout the Union on the same broad categories of non-compliance so as
to ensure a level playing field in the treatment of operators, a properly
functioning  internal market and maintenance of consumers' trust, while not
prejudging the  determination of sanctions that is within  Member States'
competence.

The trade regime is adapted to improve the
level playing for the organic operators of the European Union and in Third
Countries and to better ensure consumer confidence. The possibility of
equivalence agreements with Third Countries remains while the system of
unilateral equivalency is phased out. The recognition of control bodies is
proposed to be progressively shifted to a compliance regime.

3.2.        Legal
basis

Treaty on the Functioning of the European
Union, the first paragraph of Article 42 and Article 43(2) thereof.

3.3.        Subsidiarity
and proportionality principles

The proposal revises an existing quality
scheme set within the CAP. Production of and trade in agricultural products and
foodstuffs on the market of the European Union and ensuring that the internal
market in organic products functions properly, are matters of Union competence
shared with MS.

As part of the overall CAP, to ensure
smooth development of the single market, a Union-wide organic scheme is more
efficient than 28 different schemes. In addition, it allows for a stronger
and more consistent trade policy vis-à-vis global trading partners, in
particular by enhancing the bargaining power of the Union.

The proposal leads to further harmonisation
in the following areas:

–          The current scope offered to Member States for granting
exceptions to the rules, which leads to unfair competition among operators,
risk of loss of consumer confidence, complexity in the legislation and trade
issues (difficulties in enforcing compliance), is reduced.

–          The fact that the response to the same non-compliance
with EU organic legislation can vary between Member States is an issue leading
to unfair competition and ineffective functioning of the single market.

3.4.        Choice
of instruments

The proposed instrument is a regulation,
since the existing provisions have been proven to provide an appropriate
framework for Member States; no other type of measure would be appropriate. A
directive would lay down more flexible rules, which could entail unfair
competition among operators and lead to confusion and deception of consumers. A
regulation provides a consistent approach for Member States to follow and
reduces the administrative burden because operators are required to comply with
a single set of rules. Soft law instruments such as guidelines are considered
inadequate to tackle differences in the interpretation and implementation of
the rules and in view of the international context.

4.           BUDGETARY IMPLICATIONS

The proposal allocates a budget for
technical assistance measures. Details of the budgetary implications can be
found in the legislative financial statement.

5.           OPTIONAL ELEMENTS:
SIMPLIFICATION

The proposal provides for simplifications
and clarifications and fills several gaps in the legislation. It involves the
removal of 37 of the 135 existing obligations in the organic farming
legislation. The proposal involves significant reduction of the administrative
burden. Delegated acts stemming from the proposal will be drafted according to
the same principles.

On production rules, the proposal greatly
simplifies things for operators and national administrations with a limitation
on the Member States' scope for granting exceptions. Several ineffective
provisions are removed, particularly through reinforcement of the risk-based
approach to controls. On the import side, the compliance regime for control
bodies will be easier to manage for the producers, the control bodies and the
Commission.

A significant simplification for small
farmers is brought about by group certification, which entails more proportionate
inspection and record-keeping requirements.

The proposal intends to make the
legislation more user-friendly. In particular, while the general production
rules remain in the text of the Regulation, the specific organic production
rules are contained in an Annex to the Regulation.

6.           ALIGNMENT

In 2010, the Commission adopted COM
(2010)759 concerning the alignment to the Treaty of Lisbon of Council
Regulation (EC) No 834/2007. A detailed discussion in trialogues in 2011 and
2012 lead in practice to a standstill on the alignment proposal. The current
proposal incorporates the necessary elements of the alignment proposal,
including architecture of legal provisions in basic act, delegated acts and
implementing acts.  . COM (2010) 759 will therefore be withdrawn as obsolete.

2014/0100 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on organic production and labelling of
organic products, amending Regulation (EU) No XXX/XXX of the European
Parliament and of the Council [Official controls Regulation] and repealing
Council Regulation (EC) No 834/2007

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular the first paragraph of
Article 42 and 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[9],

Having regard to the opinion of the
Committee of the Regions[10],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Organic production is an
overall system of farm management and food production that combines best
environmental and climate action practices, a high level of biodiversity, the
preservation of natural resources, the application of high animal welfare
standards and 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 it, on the one hand,
provides for a specific market responding to consumer demand for organic
products and, on the other hand, delivers publicly available goods contributing
to the protection of the environment and animal welfare, as well as to rural
development.

(2)       The observance of high
health, environmental and animal welfare standards in the production of organic
products is intrinsic to the high quality of those products. As underlined in
the Communication from the Commission to the European Parliament and to the
Council, the European Economic and Social Committee and the Committee of the
Regions on agricultural product quality policy[11],
organic production forms part of the Union's agricultural product quality
schemes together with geographical indications, traditional specialties
guaranteed and products of the outermost regions of the Union, as laid down in
Regulation (EU) No 1151/2012 of the European Parliament and of the Council[12] and Regulation (EU) No
228/2013 of the European Parliament and of the Council[13], respectively. In this
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.

(4)       Furthermore, organic
production is a system that contributes to the integration of environmental
protection requirements into the CAP, and promotes sustainable agricultural
production. That is why, measures financially supporting organic production
have been introduced under the CAP, most recently under Regulation (EU) No
1307/2013 of the European Parliament and of the Council[14], and in particular
strengthened in the recent reform of the legal framework for rural development
policy as established by Regulation (EU) No 1305/2013 of the European Parliament
and of the Council[15].

(5)       Organic production also
contributes to the achievements of the Union environmental policy objectives,
in particular those of the 2020 Biodiversity Strategy[16], the Green
Infrastructure Communication[17],
the Soil Thematic Strategy[18]
and environmental legislation such as the Birds[19] and Habits[20] Directives, the
Nitrates Directive[21],
the Water Framework Directive[22],
the National Emissions Ceiling Directive[23]
and the Directive on the sustainable use of pesticides[24].

(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 a proper
functioning of the internal market in organic products, and at maintaining and
justifying consumer confidence in products labelled as organic. It should
further aim 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 as set out in the Commission Communication entitled
‘Europe 2020: A strategy for smart, sustainable and inclusive growth’[25] include the aims of
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)       Given the dynamic
evolution of the organic sector, Council Regulation (EC) No 834/2007[26] 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. Therefore, Regulation (EC)
No 834/2007 should be repealed and replaced by a new Regulation.

(9)       Experience gained so far
with the application of Regulation (EC) No 834/2007 shows a need to clarify the
products to which this Regulation applies. Primarily, it should cover
agricultural products, including aquaculture products, listed in Annex I to the
Treaty on the Functioning of the European Union (‘the Treaty’). Moreover, it
should cover processed agricultural products for use as food or feed because
the placing on the market of such products as organic provides a major outlet
for agricultural products and ensures visibility to the consumer of the organic
nature of the agricultural products from which they are processed. Likewise,
this Regulation should cover certain other products which are linked to
agricultural products in a similarly close way as processed agricultural
products because those other products either constitute a major outlet for
agricultural products or form an integral part of the production process.
Finally, sea salt should be included in the scope of this Regulation because it
is produced by applying natural production techniques and its production
contributes to the development of rural areas, and thus falls within the
objectives of this Regulation. For reasons of clarity, those other products,
not listed in Annex I to the Treaty, should be listed in an Annex to this
Regulation.

(10)     In order to supplement or
amend certain non-essential elements of this Regulation, the power to adopt
acts in accordance with Article 290 of the Treaty should be delegated to the
Commission. It is of particular importance that the Commission carry out
appropriate consultations during its preparatory work, including at expert
level. The Commission, when preparing and drawing-up delegated acts, should
ensure a simultaneous, timely and appropriate transmission of relevant
documents to the European Parliament and to the Council.

(11)     In order to take into
account new production methods or material or international committments, the
power to adopt certain acts should be delegated to the Commission in respect of
the amendment of the list of other products falling within the scope of this
Regulation. Only products which are closely linked to agricultural products
should be eligible for inclusion in that list.

(12)     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. Equally, products of hunting and
fishing of wild animals should not be covered by this Regulation since the
production process cannot be fully controlled.

(13)     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. In addition, those
production rules should meet operators' and consumers' expectations regarding
the quality of organic products and the compliance with the principles and
rules laid down in this Regulation.

(14)     This Regulation should
apply without prejudice to related legislation, such as in the field of safety
of the food chain, animal health and welfare, plant health, plant reproductive
material, labelling and the environment. More specifically, as regards the
authorisation of products and substances that may be used for the production of
organic products, it is important to highlight that such products and
substances have to be authorised at Union level first. Therefore this
Regulation should apply without prejudice to other specific Union provisions
relating to the authorisation and placing on the market of those products and
susbstances.

(15)     As a matter of principle,
the general production rules of this Regulation should include a prohibition on
the use of ionising radiation and genetically modified organisms (GMOs) and
products produced from or by GMOs. Since consumers are more and more concerned
about environmental impacts of food processing and transportation, organic
operators other than farmers and operators producing seaweed or aquaculture
animals should be required to manage their environmental performance according
to a harmonised system. With the objective of minimising the regulatory burden
of micro-enterprises as defined in Commission Recommendation 2003/361/EC[27] involved in organic
production, it is appropriate to exempt them from this requirement. In order to
ensure the correct application of the general production rules, the power to
adopt certain acts should be delegated to the Commission in respect of
establishing the criteria to which the environmental management system is to
correspond.

(16)     The
risk of non-compliance with the organic production rules is considered higher
in agricultural holdings which include units not managed under organic
production 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. Organic agricultural
holdings should undergo the same conversion period in all Member States,
irrespective of whether they have previously adhered to agri-environmental
measures supported by Union funds. However, no conversion period is necessary in
the case of fallow land.  In order to ensure quality, traceability and
compliance with this Regulation and adaptation to technical developments, the
power to adopt certain acts should be delegated to the Commission in respect of
establishing rules supplementing the general conversion rules or supplementing
and amending the specific conversion rules.

(17)     Specific
production rules should be established with regard to plant, livestock and
aquaculture production, including rules for the collection of wild plants and
seaweeds, and with regard to the production of processed food and feed, as well
as of wine and yeast to ensure harmonisation and respect of the objectives and
principles of organic production.

(18)     As organic plant production
is based on nourishing the plants primarily through the soil ecosystem,
hydroponic production should not be allowed. In addition, organic plant
production should involve the use of production techniques that prevent or
minimise any contribution to the contamination of the environment.

(19)     Concerning soil management
and fertilisation, conditions should be laid down for the use of cultivation
practices allowed in organic plant production and for the use of fertilisers
and conditioners.

(20)     The use of pesticides, 
should be significantly restricted. Preference should be given to the
application of measures that prevent any damage by pests and weeds through
techniques which do not involve the use of plant protection products such as
crop rotation. Presence of pests and weeds should be monitored to decide
whether any intervention is economically and ecologically justified. The use of
certain plant protection products should be allowed if such techniques do not provide
adequate protection and only if those plant protection products have been
authorised in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council[28], after having been assessed to be compatible
with objectives and principles of organic production, including with
restrictive  conditions of use, and consequently authorised in accordance with
this Regulation.

(21)     In order to ensure quality,
traceability and compliance with this Regulation and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of establishing rules amending or supplementing the
specific plant production rules as regards cultivation practices, soil
management and fertilisation, plant health and management of pests and weeds,
management of mushroom production and other specific plants and plant
production systems, the production origin of plant reproductive material and
the collection of wild plants.

(22)     As livestock production
naturally involves the management of agricultural land, where the manure is
used to nourish crop production, landless livestock production should be
prohibited. The choice of breeds should take account of their capacity to adapt
to local conditions, their vitality and their resistance to disease, and a wide
biological diversity should be encouraged.

(23)     Organic livestock and
aquaculture production housing, including where relevant the aquatic medium,
should satisfy the behavioural needs of the animals. Specific housing
conditions and husbandry practices should be laid down with regard to certain
animals, including bees. Those conditions and practices should ensure a high
level of animal welfare, which in certain aspects 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 grazing and
such open air areas should in principle be organised under an appropriate
system of rotation.

(24)     In order to avoid environmental
pollution of natural resources such as soil and water by nutrients, an upper
limit for the use of manure per hectare and for keeping livestock per hectare
should be set. That limit should be related to the nitrogen content of the
manure.

(25)     Mutilations which lead to
stress, harm, disease or suffering of animals should be prohibited.

(26)     Livestock should be fed on
feed materials produced in accordance with the rules of organic production, and
preferably coming from the own holding, taking their physiological needs into
account. In addition, in order to provide for the basic nutritional
requirements of livestock, certain minerals, trace elements and vitamins may
need to be used under well-defined conditions.

(27)     Animal health management
should mainly be based on prevention of disease. In addition, specific cleaning
and disinfection measures should be applied. The preventive use of
chemically-synthesised allopathic medicinal products should not be permitted in
organic production, except in the event of sickness or injury of an animal
requiring immediate treatment and limited to the minimum necessary to
re-establish the well-being of the animal. In such cases, in order to guarantee
the integrity of organic production for consumers, it should be possible to
take restrictive measures such as doubling the official withdrawal period after
use of such medicinal products as specified in the relevant Union legislation.
Regarding beekeeping, it is necessary to lay down specific rules for disease
prevention and veterinary treatment.

(28)     In order to ensure quality,
traceability and compliance with this Regulation and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of establishing rules amending or supplementing the
specific livestock production rules as regards the origin of animals, livestock
housing, including minimum surface areas indoors and outdoors and the maximum
number of animals per hectare, husbandry practices, breeding, feed and feeding,
disease prevention and veterinary treatment.

(29)     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 a context
of growing global aquatic food demand. The 2013 Communication from the
Commission to the Council and the European Parliament on Strategic Guidelines
for the sustainable development of European aquaculture[29] highlights the main
challenges faced by the Union aquaculture and its potential for growth. It
identifies organic aquaculture as a particularly promising sector, and
highlights the competitive advantages deriving from organic certification.

(30)     Organic
aquaculture is a relatively new field of organic production compared to organic
agriculture where long experience exists at the farm level. Given consumers’
growing interest in organic aquaculture products, further growth in the
conversion of aquaculture units to organic production is likely. This is
leading to increased experience, technical knowledge and development, with
improvements in organic aquaculture that should be reflected in the production
rules.

(31)     In order to ensure common
understanding,  avoid ambiguities and guarantee uniform application of the
organic aquaculture animal and seaweed production rules, certain definitions
relating to aquaculture should accompany those production rules.

(32)     In order to ensure quality,
traceability and compliance with this Regulation and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of establishing rules amending or supplementing the
specific seaweed production rules as regards the suitability of the aquatic
medium and the sustainable management plan, the harvesting of wild seaweed,
seaweed cultivation, and antifouling measures and cleaning of production
equipment and facilities, and in respect of the establishment of rules supplementing
the specific production rules for aquaculture animals as regards the
suitability of the aquatic medium and the sustainable management plan, the
origin of aquaculture animals, aquaculture husbandry, including aquatic
containment systems, production systems and maximum stocking density, breeding,
management of aquaculture animals, feed and feeding, and disease prevention and
veterinary treatment.

(33)     Operators producing organic
food or feed should follow appropriate procedures based on systematic
identification of critical processing steps in order to ensure that processed
products comply with the organic production rules. Organic processed products
should be produced by means of processing methods which guarantee that the
organic integrity and vital qualities of the products are maintained through
all stages of organic production.

(34)     Provisions concerning the
composition of organic processed food should be laid down. In particular, such
food should be produced mainly from agricultural ingredients that are organic
with a limited possibility to use certain non-organic agricultural ingredients
specified in this Regulation. In addition, only certain substances authorised
in accordance with this Regulation should be allowed for use in the production of
organic processed food.

(35)     Processed food should be
labelled as organic only where all or almost all the ingredients of
agricultural origin are organic. However, special labelling provisions should
be laid down for processed foods which include agricultural ingredients that
cannot be obtained organically, as is the case for products of hunting and
fishing. Moreover, for the purposes of consumer information and transparency in
the market, and to encourage the use of organic ingredients, it should also be
made possible to refer to organic production in the ingredients list under
certain conditions.

(36)     Provisions concerning the
composition of organic processed feed and the use of certain substances and
techniques in the production of that feed should be laid down.

(37)     In order to ensure quality,
traceability and compliance with this Regulation and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of establishing rules amending or supplementing the
specific production rules for processed food and feed as regards the procedures
to be followed, preventive measures to be taken, the composition of processed
food and feed, cleaning measures, the placing on the market of processed
products including their labelling and identification, separation of organic
products, agricultural ingredients and feed materials from non-organic
products, agricultural ingredients and feed materials, the list of non-organic
agricultural ingredients which may exceptionally be used in the production of
organic processed products, calculation of the percentage of agricultural
ingredients, and the techniques used in food or feed processing.

(38)     Organic wine should be
produced entirely from organic raw material and only certain substances
authorised in accordance with this Regulation should be allowed to be added.
Certain oenological practices, processes and treatments should be prohibited in
the production of organic wine. Other practices, processes and treatments should
be permitted under well-defined conditions.

(39)     In order to ensure quality,
traceability and compliance with this Regulation and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of establishing rules amending or supplementing the
specific wine production rules as regards oenological practices and
restrictions.

(40)     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[30] introduced the
obligatory calculation of yeast and yeast products as agricultural ingredients
for the purposes of organic production as of 31 December 2013, which gave the
industry sufficient time to adjust to that rule. Accordingly, only organically
produced substrates should be used in the production of organic yeast and only
certain substances should be allowed for use in its production, confection and
formulation. In addition, organic yeast should not be present in organic food
or feed together with non-organic yeast.

(41)     In order to ensure quality,
traceability and compliance with this Regulation and adaptation to technical
developments, the power to adopt certain acts should be delegated to the
Commission in respect of establishing rules amending or supplementing the
specific production rules for organic yeast as regards the processing and the
substrates used in its production.

(42)     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
and 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 establishing specific production rules for such
products, including amendments or supplements thereof.

(43)     Regulation (EC) No 834/2007
provided for different exceptions from organic production rules. The experience
gained from the application of those provisions has shown that such exceptions
have a negative impact on organic production. In particular, it has been found
that the very existence of such exceptions impedes the production of inputs in
organic form and that the high level of animal welfare associated with organic
production is not ensured. In addition, the management and control of
exceptions entail considerable administrative burden, both for the national
administrations and operators. Finally, the existence of exceptions has created
conditions for distortions in competition and has threatened to undermine
consumer confidence. Accordingly, the scope for allowing exceptions from
organic production rules should be further restricted and limited to cases of
catastrophic circumstances.

(44)     In order to allow organic
production to continue or recommence in cases of catastrophic circumstances,
the power to adopt certain acts should be delegated to the Commission in
respect of establishing the criteria for qualifying cases of catastrophic
circumstances and to lay down specific rules for addressing such cases and for
the necessary monitoring and reporting requirements.

(45)     Under certain conditions
organic products and non-organic products can be collected and transported
simultaneously. In order to duly separate organic from non-organic products
during handling and to avoid any commingling, specific provisions should be
laid down.

(46)     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
establishing rules amending or supplementing the specific rules on collection,
packaging, transport and storage of organic products.

(47)     The use in organic
production of products and substances such as plant protection products,
fertilisers, soil conditioners, nutrients, components of animal nutrition, feed
or food additives, processing aids and products for cleaning and disinfection
should be limited to the minimum and under the specific conditions laid down in
this Regulation. The same approach should be followed regarding the use of
products and substances as food additives and processing aids in the production
of organic processed food. Therefore,  provisions should be laid down to define
any possible use of such products and substances in organic production in
general and in the production of organic processed food in particular, subject
to the principles laid down in this Regulation and to certain criteria.

(48)     In order to ensure quality,
traceability and compliance with this Regulation as regards organic production in
general and the production of organic processed food in particular, and
adaptation to technical developments, the power to adopt certain acts should be
delegated to the Commission to provide for additional criteria for the
authorisation or withdrawal of the authorisation of products and substances for
use in organic production in general and in the production of organic processed
food in particular, and other requirements for the use of such authorised
products and substances.

(49)     In the absence of specific
Union rules on the measures to take when non-authorised substances or products
are present in organic products, different approaches have been developed and
implemented across the Union. This situation creates uncertainties for
operators, control authorities and control bodies. It may also entail a
different treatment of operators in the Union and affect consumers' confidence
in organic products. It is therefore appropriate to lay down clear and uniform
provisions to prohibit marketing as organic those products in which any
non-authorised products or substances are present beyond given levels. Those
levels should be established taking account in
particular of Commission Directive 2006/125/EC[31]
on processed cereal-based foods and baby foods for infants and young
children.

(50)     In order to ensure the
effectiveness, efficiency and transparency of the organic production and
labelling system, the power to adopt certain acts should be delegated to the
Commission  in respect of specific criteria and conditions for the
establishment and application of the levels of presence of non-authorised
products and substances beyond which products shall not be marketed as organic
and with respect to the establishment of those levels and their adaptation in
the light of technical developments.

(51)     Organic production is based
on the general principle of restriction of the use of external inputs. Farmers
are required to take measures to prevent the risk of contamination by
non-authorised products or substances. Despite such measures, there may be
instances where farmers are prevented from marketing their agricultural
products as organic due to the unintentional presence of non-authorised
products or substances. It is therefore appropriate to provide for the
possibility whereby Member States may, in accordance with Article 42 of the
Treaty, be authorised by the Commission to grant national payments to
compensate for the losses incurred in such instances. Member States may also
use the instruments of the Common Agricultural Policy to cover totally or
partially such losses.

(52)     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[32], and in particular the provisions aimed at preventing labelling
that may confuse or mislead consumers. In addition, specific provisions
relating to the labelling of organic 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 enjoying conditions of fair
competition, and those of consumers in enabling them to make informed choices.

(53)     Accordingly,
the terms used to indicate organic products should be protected from being used
in the labelling of non-organic products throughout the Union and independently
of the language used. The protection should also apply to the usual derivatives
or diminutives of those terms, whether they are used alone or combined.

(54)     In
order to create clarity for consumers throughout the Union market, the use of
the organic production logo of the European Union should be made obligatory for
all organic pre-packed food produced within the Union. It should otherwise be
possible to use that logo on a voluntary basis in the case of non pre-packed
organic products produced within the Union or any organic products imported
from third countries. The model of the organic production logo of the European
Union should be set out in this Regulation.

(55)     However,
in order not to mislead consumers as to the organic nature of the entire
product, it is considered 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 % of their ingredients of agricultural
origin are organic.

(56)     For
the sake of avoiding any possible confusion amongst 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 this context, it should be allowed to refer to aquaculture in the label of
products from organic aquaculture instead of referring to agriculture.

(57)     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 adapting the list of terms referring
to organic production set out in this Regulation, establishing the specific
labelling and composition requirements applicable to feed and ingredients
thereof, laying down further rules on labelling and the use of the indications,
other than the organic production logo of the European Union, set out in this
Regulation, and amending the organic production logo of the European Union and
the rules relating thereto.

(58)     Organic
production is only credible if accompanied by effective verification and
controls at all stages of production, processing and distribution. Organic
production should be subject to official controls or other official activities
carried out in accordance with Regulation (EU) No (XXX/XXXX) of the European
Parliament and of the Council[33]
to verify compliance with the rules on organic production and labelling of
organic products.

(59)     Specific
requirements should be laid down to ensure compliance with the rules that are
peculiar to organic production. In particular, provisions should be made for notification
of the activities of the operators and for a certification system to identify
the operators that comply with the rules governing organic production and labelling
of organic products. Those provisions should also apply to any subcontractors
of the operators concerned. The transparency of the certification system should
be ensured by requiring Member States to make public the list of operators that
have notified their activities and any fees that may be collected in relation
to the controls for verifying compliance with the organic production rules.

(60)     Small
farmers in the Union face, individually, relatively high inspection costs and
administrative burden linked to organic certification. A system of group
certification should be allowed with a view to reducing the inspection and
certification costs and the associated administrative burden, strengthening
local networks, contributing to better market outlets and ensuring a level
playing field with operators in third countries. For that reason, the concept
of ‘group of operators’ should be introduced and
defined.

(61)     In
order to ensure the effectiveness, efficiency and transparency of the organic
production and labelling system, the power to adopt certain acts should be
delegated to the Commission in respect of the requirements for keeping of
records by operators or groups of operators, the requirements for publication
of the list of operators, the requirements and procedures to be applied for 
publication of the fees that may be collected in relation to the controls for
verifying compliance with the organic production rules and for supervision by
the competent authorities of the application of those fees, as well as the
criteria for defining the groups of products in respect of which operators
should be entitled to have only one organic certificate issued by the control
authority or control body concerned.

(62)     In
order to ensure that the certification of a group of operators is done
effectively and efficiently, the
power to adopt certain acts should be delegated to the Commission in respect of
the responsibilities of the individual members of a group of operators, the
composition and size of that group, the categories of products to be produced
by a group of operators, the conditions for participation in the group, and the
set up and functioning of the group's system for internal controls, including
the scope, content and frequency of the controls to be carried out.

(63)     The
experience with the arrangements for import of organic products 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 rules as high as those of the Union, as well as to better
ensure the access of Union organic products to the international market. In
addition, it is necessary to provide for clarity regarding the rules applicable
to export of organic products, in particular by establishing a certificate of
export and laying down provisions for export to third countries recognised for
the purpose of equivalence under Regulation (EC) No 834/2007.

(64)     The
provisions governing the import of products that comply with the Union
production and labelling rules and in respect of which operators have been
subject to the control of control authorities and control bodies recognised by
the Commission as competent to carry out controls and certification in the
field of organic production in third countries, 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, aiming at ensuring 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.

(65)     The
possibility for organic products to get 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 should be preserved. However,
the recognition of equivalence of third countries, as laid down in Regulation
(EC) No 834/2007, should only be granted through an international
agreement between the Union and those third countries, where a reciprocal
recognition of equivalence would be also pursued for the Union.

(66)     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 of time necessary to ensure a smooth transition
to the scheme of recognition through an international agreement, provided that they continue to ensure the equivalence of their organic
production and control rules 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 the third countries send to the Commission.

(67)     The
experience with the scheme of control authorities and control bodies recognised
as competent to carry out controls and issue certificates in third countries
for the purpose of import of products providing equivalent guarantees shows
that the rules applied by those authorities and bodies are different and could
be difficult to be considered as equivalent to the respective Union rules.
Furthermore, multiplication of control authorities and control bodies standards
hampers adequate supervision by the Commission. Therefore that scheme of
recognition of equivalence should be abolished. However, sufficient time should
be given to those control authorities and control bodies so that they can
prepare themselves for obtaining recognition for the purposes of import of
products complying with Union rules.

(68)     The placing on the market 
as organic of any organic product 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.

(69)     In order to ensure fair
competition among operators, the traceability of the imported products intended
to be placed on the market within the Union as organic or the transparency of
the recognition and supervision procedure for control authorities and control
bodies within the context of import of compliant organic products, and in order
to ensure the management of the list of third countries 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 documents
intended for customs authorities in third countries, in particular an organic
export certificate, in electronic form wherever possible, the documents
necessary for the purposes of import, also in electronic form wherever possible,
the criteria for recognition or withdrawal of the recognition of control
authorities and control bodies in the context of import of compliant organic
products, and in respect of the information to be sent by third countries
recognised under that Regulation necessary for the supervision of their
recognition and the exercise of that supervision by the Commission, including
on-the-spot examination.

(70)     Provision should be made to
ensure that the movement of organic products that have been subject to a
control in one Member State and which comply with this Regulation cannot be
restricted in another Member State. In order to ensure the proper functioning
of the single market and trade between Member States, the power to adopt
certain acts should be delegated to the Commission to lay down rules relating
to the free movement of organic products.

(71)     For the purpose of obtainaing
reliable information needed for the implementation of this Regulation, Member
States should provide the Commission annually 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 annually published by the Commission.

(72)     It is necessary to lay down
measures to ensure a smooth transition to some modifications of the legal
framework governing the import of organic products into the Union, as
introduced by this Regulation. In particular, in order to ensure a smooth
transition from the old to the new legal framework, the power to adopt certain
acts should be delegated to the Commission in respect of the rules relating to
conversion periods starting under Regulation (EC) No 834/2007, by way of
derogation from the general rule that no previous periods may be recognised
retroactively as being part of the conversion period.

(73)     Furthermore, a date for the
expiration of the recognition of control authorities and control bodies for the
purpose of equivalence should be set and provisions to address the situation
until the expiration of their recognition should be laid down. Provisions
should also be laid down regarding applications from third countries for the
purpose of equivalence which have been submitted under Regulation (EC) No 834/2007
and which are pending at the time of entry into force of this Regulation.

(74)     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 and to facilitate
the completion of the examination of applications from third countries for
recognition for the purpose of equivalence that are pending at the date of
entry into force of this Regulation, the power to adopt certain acts should be
delegated to the Commission in respect of the information to be sent by those
control authorities and control bodies that is necessary for the supervision of
their recognition and in respect of the exercise of that supervision by the
Commission, as well as in respect of any procedural rules necessary for the
examination of the pending applications from third countries.

(75)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission as regards the technical details for the
establishment of the database for the listing of the varieties for which plant
reproductive material obtained by the organic production method is available,
as regards the authorisation or the withdrawal of the authorisation of the
products and substances that may be used in organic production in general and
in the production of processed organic food in particular, including the
procedures to be followed for the authorisation and the lists of those products
and substances and, where appropriate, their description, compositional
requirement and conditions for use, as regards the specific and practical
modalities regarding the presentation, composition and size of the indications
referring to the code numbers of control authorities and control bodies and of the indication of the place where the agricultural raw materials
have been farmed, the assignment of code numbers to
control authorities and control bodies and the indication of the place
where the agricultural raw materials have been farmed, as regards the details
and specifications regarding the content, form and way of notification of the
notifications by operators and groups of operators of their activity to the
competent authorities and the form of publication of the fees that may be
collected for the controls, as regards  the exchange of
information between groups of operators and competent authorities, control
authorities and control bodies and between Member States and the Commission, as
regards the recognition or withdrawal of the recognition of control authorities
and control bodies which are competent to carry out controls in third countries
and the establishment of the list of those control authorities and control
bodies and rules to ensure the application of measures in relation to cases of
non-compliance, or suspicion thereof, affecting the integrity of imported
organic products, as regards the establishment of a
list of third countries recognised under Article 33(2) of Regulation (EC) No
834/2007 and the amendment of that list as well as
rules to ensure the application of measures in relation to cases of
non-compliance, or suspicion thereof, affecting the integrity of organic
products imported from those countries, as regards the system to be used to
transmit the information necessary for the implementation and monitoring of
this Regulation, and as regards the establishment of the list of control
authorities and control bodies recognised under Article 33(3) of Regulation
(EC) No 834/2007 and the amendment of that list. Those powers should be exercised in accordance with Regulation (EU)
No 182/2011 of the European Parliament and of the Council[34].

(76)     The Commission should be
empowered to adopt immediately applicable implementing acts where, in duly
justified cases relating to the protection against unfair practices or
practices which are incompatible with the principles and rules on organic
production, the protection of consumers' confidence or the protection of fair
competition between operators, imperative grounds of urgency so require to
ensure the application of measures in relation to cases of non-compliance, or
the suspicion thereof, affecting the integrity of imported organic products
under the control of recognised control authorities or control bodies.

(77)     In order to ensure a smooth
transition between on the one hand the rules on the organic origin of plant
reproductive material and on animals for breeding purposes provided for in
Regulation (EC) No 834/2007 and the exception to production rules adopted
pursuant to Article 22 of that Regulation, and on the other hand the new
production rules for plants and plant products and livestock provided for in
this Regulation, the power to adopt certain acts should be delegated to the
Commission in respect of the granting of exceptions where exceptions are deemed
necessary, in order to ensure access to plant reproductive material and live
animals for breeding purposes that may be used in organic production. Since
those acts are transitional in nature, they should apply for a limited period
of time.

(78)     The Commission should
consider the situation of the availability of organic plant reproductive
material and animals for breeding purposes and present a report to this end to
the European Parliament and the Council in 2021.

(79)     Provision should be made to
allow the exhaustion of stocks of products which have been produced in
accordance with Regulation (EC) No 834/2007 and placed on the market before
this Regulation starts to apply.

(80)     The review of the
legislative framework for organic production and labelling of organic products
showed that the specific needs relating to the official controls and other
official activities carried out in accordance with Regulation (EU) No XXX/XXX
(Official controls Regulation) require provisions to better address instances
of non-compliance. In addition, the provisions of Regulation (EU) No XXX/XXX
[official controls Regulation] relating to the tasks and responsibilities of
competent authorities, the approval and supervision of delegated bodies,
official certification,  reporting obligations and administrative assistance
should be adapted to the specific needs of the organic production sector.
Regulation (EU) No XXX/XXX [official controls Regulation] should therefore be
amended accordingly.

(81)     Since the objectives of
this Regulation, in particular fair competition and 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 instead,
because 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.

(82)     It is appropriate to
provide for a date of application of this Regulation that would give the
possibility to operators to adapt to the new requirements introduced.

HAVE ADOPTED THIS REGULATION:

Chapter I

Subject matter, scope and definitions

Article 1

Subject
matter

This Regulation establishes the principles
of organic production and lays down the rules concerning organic production and
the use of indications referring thereto in labelling and advertising.

Article 2

Scope

1.           This Regulation shall
apply to agricultural products listed in Annex I to the Treaty on the
Functioning of the European Union (‘the Treaty’) and to some other products
listed in Annex I to this Regulation, insofar as those agricultural products
and those other products are intended to be produced, prepared, distributed,
placed on the market, imported or exported as
organic.

The products of hunting and fishing of wild
animals shall not be considered as organic products.

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

Mass catering operations carried out by a mass
caterer as defined in point (d) of Article 2(2) of Regulation (EU)
No 1169/2011 of the European Parliament and of the Council[35] shall not be subject
to this Regulation.

Member States may apply national rules or, in
the absence thereof, private standards on labelling and control of products
originating from mass-catering operations.

3.           This Regulation shall apply
without prejudice to related Union legislation in the fields of inter alia
safety of the food chain, animal health and welfare, plant health, and plant
reproductive material, and in particular to Regulation (EU) No XX/XXX of the
European Parliament and of the Council[36]
(plant reproductive material) and Regulation (EU) No XX/XXXX of the European
Parliament and of the Council[37]
(protective measures against pests of plants).

4.           This Regulation shall
apply without prejudice to other specific Union provisions relating to the placing of products on the market and, in particular, to
Regulation (EU) No 1308/2013 of the European Parliament and of the Council[38], and to Regulation
(EU) No 1169/2011.

5.           In order to take into
account new information on production methods or material or international
commitments, the Commission shall be empowered to adopt delegated acts in
accordance with Article 36 amending the list of products set out in Annex I.
Only products which are closely linked to agricultural products shall be
eligible for inclusion in that list.

Article 3

Definitions

For the purposes of this Regulation, the
following definitions shall apply:

(1)
‘organic production’ means the use of production
methods compliant with this Regulation, at all stages of production, preparation
and distribution;

(2)
‘organic’ means coming from or related to
organic production;

(3)
‘agricultural raw material’ means an
agricultural product that has not been subjected to any operation of
preservation or processing;

(4)
‘preventive measures’ means measures to be taken
in order to ensure soil quality as well as prevention and control of pests and
weeds, and to prevent contamination with products or substances that are not
authorised under this Regulation;

(5)
‘conversion’ means the transition from non-organic
to organic production within a given period of time;

(6)
‘operator’ means the natural or legal person
responsible for ensuring that this Regulation is complied with at all stages of
production, preparation and distribution under their control;

(7)
‘group of operators’ means a group in which each
operator is a farmer who has a holding of up to 5 hectares of utilised
agricultural area and who may, in addition to producing food or feed, be
engaged in processing of food or feed;

(8)
‘farmer’ means a natural or legal person, or a
group of natural or legal persons, regardless of the legal status granted to
such group and its members by national law, who exercises an
agricultural activity.

(9)
 ‘agricultural area’ means agricultural area as
defined in point (e) of Article 4(1) of Regulation (EU) No 1307/2013;

(10)
‘plants’ means plants as defined in point 5 of
Article 3 of Regulation (EC) No 1107/2009;

(11)
‘plant production’ means production of
agricultural crop products including harvesting of wild plant products for
commercial purposes;

(12)
‘plant products’ means plant products as defined
in point 6 of Article 3 of Regulation (EC) No 1107/2009;

(13)
‘pest’ means a pest as defined in Article 1(1)
of Regulation (EU) No XX/XXXX (protective measures against pests of plants);

(14)
‘plant protection products’ means the products
referred to in Article 2 of Regulation (EC) No 1107/2009;

(15)
‘livestock production’ means the production of
domestic or domesticated terrestrial animals, including insects;

(16)
‘veranda’ means an additional, roofed,
uninsulated, outdoor part of a livestock building, the longest side being
usually equipped with wire fencing or netting with outdoor climate, natural and
artificial illumination and a littered floor;

(17)
‘aquaculture’ means aquaculture as defined in
point (25) of Article 4(1) of Regulation (EU) No 1380/2013 of the European
Parliament and of the Council[39];

(18)
‘veterinary treatment’ means all courses of a
curative or preventive treatment against one occurrence of a specific disease;

(19)
‘veterinary medicinal products’ means veterinary
medicinal products as defined in point 2 of Article 1 of Directive 2001/82/EC
of the European Parliament and of the Council[40];

(20)
‘preparation’ means the operations of preserving
or processing of organic products, including slaughter and cutting for
livestock products, packaging, labelling or alterations made to the labelling
relating to organic production;

(21)
‘food’ means food as defined in Article 2 of
Regulation (EC) No 178/2002 of the European Parliament and of the Council[41];

(22)
‘feed’ means feed as defined in point 4 of
Article 3 of Regulation (EC) No 178/2002;

(23)
‘feed material’ means feed material as defined
in point (g) of Article 3(2) of Regulation (EC) No 767/2009 of the European
Parliament and of the Council[42];

(24)
‘in-conversion feed’ means feed produced during
the conversion period, with the exclusion of those harvested in the 12 months
following the beginning of the conversion;

(25)
‘placing on the market’ means placing on the
market as defined in point 8 of Article 3 of Regulation (EC) No 178/2002;

(26)
‘traceability’ means traceability as defined in
point 15 of Article 3 of Regulation (EC) No 178/2002;

(27)
‘stages of production, preparation and
distribution’ means any stage from and including the primary production of an
organic product up to and including its storage, processing, transport, sale or
supply to the final consumer, and where relevant labelling, advertising,
import, export and subcontracting activities;

(28)
‘catastrophic circumstances’ means circumstances
deriving from an ‘adverse climatic event’, an ‘environmental incident’, a
‘natural disaster’ or a ‘catastrophic event’ as defined respectively in points
(h), (j), (k) and (l) of Article 2(1) of Regulation (EU) No 1305/2013;

(29)
‘ingredient’ means an ingredient as defined in
point (f) of Article 2(2) of Regulation (EU) No 1169/2011;

(30)
‘labelling’ means labelling as defined in point
(j) of Article 2(2) of Regulation (EU) No 1169/2011;

(31)
‘advertising’ means any presentation of organic
products to the public, by any means other than a label, that is intended or is
likely to influence and shape attitude, beliefs and behaviours in order to
promote directly or indirectly the sale of organic products;

(32)
‘competent authorities’ means competent
authorities as defined in point 5 of Article 2 of Regulation (EU) No XXX/XXXX [Official
controls Regulation];

(33)
‘control authority’ means control authority for
organic production and labelling of organic products as defined in point 39 of
Article 2 of Regulation (EU) No XXX/XXXX [Official controls Regulation];

(34)
‘control body’ means a delegated body as defined
in point 38 of Article 2 of Regulation (EU) No XXX/XXXX [Official controls
Regulation], as well as a body recognised by the Commission or by a third
country recognised by the Commission to carry out controls in third countries
for the import of organic products into the Union;

(35)
‘non-compliance’ means non-compliance with this
Regulation;

(36)
‘genetically modified organism’ means a
genetically modified organism as defined in point (2) of Article 2 of Directive
2001/18/EC of the European Parliament and of the Council[43] which is not obtained
through the techniques of genetic modifications listed in Annex I.B to that
Directive, hereinafter referred to as ‘GMO’;

(37)
‘produced from GMOs’ means derived in whole or
in part from GMOs but not containing or consisting of GMOs;

(38)
‘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;

(39)
 ‘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[44] ;

(40)
‘feed additive’ means a feed additive as defined
in point (a) of Article 2(2) of Regulation (EC) No 1831/2003 of the European
Parliament and of the Council[45];

(41)
‘equivalence’ means meeting the same objectives
and principles by applying rules which ensure the same level of assurance of
conformity; ‘processing aid’ means processing aid as defined in point (b) of
Article 3(2) of Regulation (EC) No 1333/2008;

(42)
‘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[46];

(43)
‘ionising radiation’ means ionising radiation as
defined in Article 1 of Council Directive 96/29/Euratom[47].

Chapter II

Principles of organic production

Article 4

General
principles

Organic production is
a sustainable management system for agriculture that is based on the following
general principles:

(a)
respect for nature's systems and cycles and
sustainment and enhancement of the state of soil, water, air and biodiversity,
of the health of plants and animals and of the balance between them;

(b)
contribution to a high level of biodiversity;

(c)
responsible use of energy and natural resources,
such as water, soil, organic matter and air;

(d)
respect of high animal welfare standards and, in
particular, fulfilment of animals’ species-specific behavioural needs;

(e)
appropriate design and management of biological
processes based on ecological systems using natural resources which are
internal to the system by methods that:

(i)      use living organisms and mechanical
production methods;

(ii)     practice land-related crop cultivation
and livestock production or practice aquaculture which complies with the
principle of sustainable exploitation of fisheries;

(iii)    exclude the use of GMOs and products
produced from or by GMOs with the exception of veterinary medicinal products;

(iv)    are based on the use of preventive
measures, when appropriate;

(f)
restriction of the use of external inputs. Where
external inputs are required or the appropriate management practices and
methods referred to in point (e) do not exist, these shall be limited to:

(i)      inputs from organic production;

(ii)     natural or naturally-derived substances;

(iii)    low solubility mineral fertilisers;

(g)
adaptation, where necessary, and within the
framework of this Regulation, of the production process, taking account of the
sanitary status, regional differences in ecological balance, climate and local
conditions, stages of development and specific husbandry practices.

Article 5

Specific
principles applicable to agricultural activities and aquaculture

In the framework of agricultural activities
and aquaculture, organic production shall in particular be based on the
following specific principles:

(a)
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)
limitation of the use of non-renewable resources
and external inputs to a minimum;

(c)
recycling of wastes and by-products of plant and
animal origin as input in plant and livestock production;

(d)
maintenance of plant health by preventive
measures, in particular the choice of appropriate species, varieties or
heterogeneous material resistant to pests and diseases, appropriate crop
rotations, mechanical and physical methods and protection of the natural
enemies of pests;

(e)
choice of breeds having regard to the capacity
of animals to adapt to local conditions, their vitality and their resistance to
disease or health problems; the practice of site-adapted and land-related
livestock production; the application of animal husbandry practices, which
enhance the immune system and strengthen the natural defence against diseases,
in particular including regular exercise and access to open air areas and
pastureland, where appropriate;

(f)
observance of a high level of animal welfare
respecting species-specific needs;

(g)
feeding of livestock with organic feed composed
of agricultural ingredients from organic production and of natural
non-agricultural substances;

(h)
exclusion of genetic engineering, animal
cloning, artificially induced polyploidy and ionising radiation from the whole
organic food chain;

(i)
continuing health of the aquatic environment and
the quality of surrounding aquatic and terrestrial ecosystems;

(j)
feeding of aquatic organisms with feed from
sustainable exploitation of fisheries in accordance with Regulation (EU) No
1380/2013 or with organic feed composed of agricultural ingredients from
organic production, including organic aquaculture, and of natural
non-agricultural substances.

Article 6

Specific
principles applicable to the processing of organic food and feed

Production of processed organic food and feed
shall in particular be based on the following specific principles:

(a)
production of organic food from organic
agricultural ingredients;

(b)
production of organic feed from organic feed
materials;

(c)
limitation 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;

(d)
limitation of the use of feed additives and
processing aids to a minimum extent and only in cases of essential
technological or zootechnical needs or for particular nutritional purposes;

(e)
exclusion of substances and processing methods
that might be misleading as regards the true nature of the product;

(f)
processing of food or feed with care, preferably
through the use of biological, mechanical and physical methods.

Chapter III

Production rules

Article 7

General
production rules

1.           Operators shall comply
with the following general production rules:

(a)
the entire agricultural holding or aquaculture
operation shall be managed in compliance with the requirements applicable to
organic production;

(b)
save as otherwise provided in point 2.2 of Part
IV and point 1.3 of Part VI of Annex II, only products and substances
authorised pursuant to Article 19 may be used in organic agriculture and
aquaculture, provided that the product or substance in question has been
authorised for use in agriculture and aquaculture, in accordance with the
relevant provisions of Union law and, where necessary, in the Member States
concerned, in accordance with national provisions based on Union law;

(c)
the use of ionising radiation for the treatment
of organic food or feed, or of raw materials used in organic food or feed shall
be prohibited;

(d)
organic operators other than micro-enterprises,
farmers and operators producing seaweed or aquaculture animals, shall put in
place an environmental management system with a view to improving their
environmental performance.

2.           In order to ensure the correct
application of the general production rules, the Commission shall be empowered
to adopt delegated acts in accordance with Article 36 providing the criteria to
which the environmental management system referred to in point (d) of paragraph
1 is to correspond. Those criteria shall take into account the specificities of
small and medium size enterprises.

Article 8

Conversion

1.           Farmers and operators
producing seaweed or aquaculture animals shall respect a conversion period.
During the whole conversion period they shall apply the rules on organic
production laid down in this Regulation and, in particular, the specific rules
on conversion set out in Annex II.

2.           The conversion period
shall start at the earliest when the farmer or the operator producing seaweed
or aquaculture animals has notified his activity to the competent authorities
in accordance with this Regulation.

(2a) By way of derogation from paragraph 2, in
cases where the land has been left fallow before the notification referred to
in Article 24(1) for at least the time period required for conversion and
provided that other necessary requirements are fulfilled, no conversion period shall
be necessary for this fallow land

3.           No previous period may be
recognised retroactively as being part of the conversion period.

4.           Products produced during
the conversion period shall not be marketed as organic.

5.           By way of derogation from
Article 7(1)(a), during the conversion period, the agricultural holding may be
split into clearly separated units which are not all managed under organic
production. As regards livestock, different species shall be involved in
organic production during the conversion period.  As regards aquaculture, the
same species may be involved, provided that there is adequate separation
between the production sites. As regards plants, different varieties that can
easily be distinguished shall be involved in organic production during the
conversion period.

6.           In order to ensure
quality, traceability and compliance with this Regulation as regards organic
production and adaptation to technical developments, the Commission shall be
empowered to adopt delegated acts in accordance with Article 36 supplementing
the rules laid down in this Article or supplementing and amending the rules set
out in Annex II as regards conversion.

Article 9

Prohibition
of the use of GMOs

1.           GMOs and products produced
from or 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 and animals in organic production.

2.           For the purposes of
paragraph 1, with regard to GMOs or products produced from or by GMOs for food
and feed, operators may rely on the labels of a product or any other
accompanying document, affixed or provided pursuant to Directive 2001/18/EC,
Regulation (EC) No 1829/2003 of the European Parliament and of the Council[48] or Regulation (EC)
No 1830/2003 of the European Parliament and of the Council[49].

3.           Operators may assume that
no GMOs or products produced from or by GMOs have been used in the manufacture
of purchased food and feed when such products are not labelled, or accompanied
by a document, pursuant to the Regulations referred to in paragraph 2, unless
they have obtained other information indicating that the labelling of the
products concerned is not in conformity with those Regulations.

Article 10

Plant
production rules

1.           Operators producing plants
or plant products shall in particular comply with the specific production rules
set out in Part I of Annex II.

2.           Each Member State shall
ensure that a computerised database is established for listing the varieties and
heterogeneous material, according to Regulation (EU) No XX/XXX (PRM law) for
which plant reproductive material obtained by the organic production method is
available on its territory.

3.           In order to ensure quality, traceability and compliance with this
Regulation as regards organic plant production and adaptation to technical developments,
the Commission shall be empowered to adopt delegated acts in accordance with
Article 36 amending or supplementing the specific plant production rules as
regards:

(a)
cultivation practices;

(b)
soil management and fertilisation;

(c)
plant health and management of pests and weeds;

(d)
management of mushroom production and other
specific plant and plant production systems;

(e)
the origin of plant reproductive material;

(f)
the collection of wild plants.

4.           The Commission shall adopt
implementing acts laying down the technical details for establishing the
database referred to in paragraph 2. Those implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 37(2).

Article 11

Livestock
production rules

1.           Livestock
operators shall in particular
comply with the specific production rules set out in Part II of Annex II.

2.           In order to ensure
quality, traceability and compliance with this Regulation as regards organic
livestock production and adaptation to technical developments, the Commission
shall be empowered to adopt delegated acts in accordance with Article 36
amending or supplementing the specific livestock production rules as regards:

(a)
the origin of animals;

(b)
livestock housing, including minimum surface
areas indoors and outdoors and the maximum number of animals per hectare;

(c)
husbandry practices;

(d)
breeding;

(e)
feed and feeding;

(f)
disease prevention and veterinary treatment.

Article 12

Production
rules for seaweed and aquaculture animals

1.           Operators producing
seaweed and aquaculture animals shall in particular comply with the specific
production rules set out in Part III of Annex II.

2.           In
order to ensure quality,
traceability and compliance with this Regulation as regards organic seaweed
production and adaptation to technical developments, the Commission shall be
empowered to adopt delegated acts in accordance with Article 36 amending or
supplementing the specific seaweed production rules as regards:

(a)
the suitability of the aquatic medium and the
sustainable management plan;

(b)
the harvesting of wild seaweed;

(c)
seaweed cultivation;

(d)
antifouling measures and cleaning of production
equipment and facilities.

3.           In order to ensure
quality, traceability and compliance with this Regulation as regards organic
aquaculture animals production and adaptation to technical developments, the
Commission shall be empowered to adopt delegated acts in accordance with
Article 36 amending or supplementing the specific production rules for
aquaculture animals as regards:

(a)
the suitability of the aquatic medium and the
sustainable management plan;

(b)
the origin of aquaculture animals;

(c)
aquaculture husbandry, including aquatic
containment systems, production systems, maximum stocking density and, where
appropriate, minimum stocking density;

(d)
breeding;

(e)
management of aquaculture animals;

(f)
feed and feeding;

(g)
disease prevention and veterinary treatment.

Article 13

Production
rules for processed food and feed

1.           Operators producing
processed food and feed shall in particular comply with the specific production
rules set out in Part IV of Annex II.

2.           In
order to ensure quality,
traceability and compliance with this Regulation as regards organic processed
food and feed production and adaptation to technical developments, the
Commission shall be empowered to adopt delegated acts in accordance with
Article 36 amending or supplementing the specific production rules for processed food and feed as regards:

(a)
procedures to be followed;

(b)
preventive measures to be taken;

(c)
the composition and conditions of use of
processed food and feed, including products and substances allowed for use in
processed food and feed;

(d)
cleaning measures;

(e)
the placing on the market of processed products
including their labelling and identification;

(f)
separation of organic products, agricultural
ingredients and feed materials from non-organic products, agricultural
ingredients and feed materials;

(g)
the list of non-organic agricultural ingredients
which may exceptionally be used for the production of organic processed
products;

(h)
calculation of the percentage of agricultural
ingredients referred to in Article 21(3)(a)(ii) and (b);

(i)
techniques used in food or feed processing.

Article 14

Production
rules for wine

1.           Operators producing products of the wine sector shall in particular comply
with the specific production rules set out in Part V of Annex II.

2.           In order to ensure quality, traceability and
compliance with this Regulation as regards organic wine production and
adaptation to technical developments, the Commission shall be empowered to
adopt delegated acts in accordance with Article 36 amending or supplementing
the specific wine production rules as regards oenological
practices and restrictions.

Article 15

Production
rules for yeast used as food or feed

1.           Operators producing yeast to be used as food or feed shall in particular
comply with the specific production rules set out in Part VI of Annex II.

2.           In order to ensure
quality, traceability and compliance with this Regulation as regards organic
yeast production and adaptation to technical developments, the Commission shall
be empowered to adopt delegated acts in accordance with Article 36 amending or
supplementing the specific yeast production rules as regards the processing and
the substrates used.

Article 16

Production
rules for other products

In order to take account of any future need
to have specific production rules for products other than those referred to in
Articles 10 to 15, and in order to ensure quality, traceability and compliance
with this Regulation as regards organic production of those additional other
products and adaptation to technical developments, the Commission shall be
empowered to adopt delegated acts in accordance with Article 36 amending or
supplementing Annex II with regard to specific production rules for those
products.

Article 17

Adoption
of exceptional production rules

In order to allow organic production to
continue or recommence in the event of catastrophic circumstances and subject
to the principles laid down in Chapter II, the Commission shall be empowered to
adopt delegated acts in accordance with Article 36 providing for the criteria
to qualify such situations as catastrophic and laying down specific rules on
how to deal with them, on monitoring and on reporting requirements.

Article 18

Collection,
packaging, transport and storage

1.  Organic products shall be collected,
packaged, transported and stored in accordance with the rules set out in Annex
III.

2. In order to ensure the integrity of
organic production and adaptation to technical developments, the Commission
shall be empowered to adopt delegated acts in accordance with Article 36 amending
or supplementing the rules set out in Annex III.

Article 19

Authorisation
of products and substances used in organic production

1.           The
Commission may authorise certain products and substances for use in organic production and include them in
restricted lists, for the following purposes:

(a)
as plant protection products;

(b)
as fertilisers, soil conditioners and nutrients;

(c)
as feed materials;

(d)
as feed additives and processing aids;

(e)
as products for cleaning and disinfection of
ponds, cages, tanks, raceways, buildings and installations used for animal
production;

(f)
as products for cleaning and disinfection of
buildings and installations used for plant production, including storage on an
agricultural holding.

In particular, the Commission may authorise certain products and
substances for use in the production of organic processed food and include them in restricted lists, for
the following purposes:

(a)
as food additives, food enzymes and processing
aids;

(b)
as processing aids for the production of yeast
and yeast products.

2.           The
authorisation of the products and substances referred to in the first
subparagraph of paragraph 1 for use in organic production shall be subject to
the principles laid down in Chapter II and to the following criteria which
shall be evaluated as a whole:

(a)
their use is necessary for sustained production
and essential for its intended use;

(b)
all products and substances are of plant,
animal, microbial or mineral origin, except where products or substances from
such sources are not available in sufficient quantities or qualities or if
alternatives are not available;

(c)
in the case of products referred to in point (a)
of the first subparagraph of paragraph 1, the following shall apply:

(i)      their use
is essential for the control of a pest for which other biological, physical or
breeding alternatives or cultivation practices or other effective management
practices are not available;

(ii)     if
products are not of plant, animal, microbial or mineral origin and are not
identical to their natural form, they may be authorised only if their
conditions for use preclude any direct contact with the edible parts of the
crop;

(d)
in the case of products referred to in point (b)
of the first subparagraph of paragraph 1, their use is essential for obtaining
or maintaining the fertility of the soil or to fulfil specific nutrition
requirements of crops, or for specific soil-conditioning purposes;

(e)
in the case of products referred to in points
(c) and (d) of the first subparagraph of paragraph 1, the following shall
apply:

(i)      their use
is necessary to maintain animal health, animal welfare and vitality and
contribute to an appropriate diet fulfilling the physiological and behavioral
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;

(ii)     feed of
mineral origin, trace elements, vitamins or provitamins shall be of natural
origin, except where products or substances from such sources are not available
in sufficient quantities or qualities or if alternatives are not available.

The authorisation of the products and substances referred to in the second
subparagraph of paragraph 1 for use in the production of organic processed food
shall be subject to the principles laid down in Chapter II and to the following
criteria which shall be evaluated as a whole:

(a)
alternatives authorised in accordance with this
Article are not available;

(b)
it would be impossible to produce or preserve
the food or to fulfil given dietary requirements provided for on the basis of
the Union legislation, without having recourse to those products and
substances;

(c)
they are to be found in nature and may have
undergone only mechanical, physical, biological, enzymatic or microbial
processes, except where products and substances from such sources are not
available in sufficient quantities or qualities.

The authorisation of the use of chemically
synthesised products or substances shall be strictly limited to cases where the
use of external inputs referred to in Article 4(f) would contribute to
unacceptable environmental impacts.

3.           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, and adaptation to technical developments, the Commission
shall be empowered to adopt delegated acts in accordance with Article 36
providing for additional criteria for the authorisation or withdrawal of the
authorisation of products and substances referred to in paragraph 1 for use in
organic production in general and in the production of organic processed food in
particular, and other requirements and conditions for the use of such
authorised products and substances.

4.           Where
a Member State considers that a product or substance should be added to, or
withdrawn from the lists of authorised products and substances referred to in
paragraph 1, or that the specifications of use mentioned in the production
rules should be amended, the Member State concerned shall ensure that a dossier
giving the reasons for the inclusion, withdrawal or amendments is sent
officially to the Commission and to the other Member States.

Requests for amendment or withdrawal shall be published by Member
States.

5.           The
Commission shall adopt implementing acts authorising or withdrawing the
authorisation of products and substances that may be used in organic production
in general and products and substances that may be used in the production of processed
organic food in particular, and establishing the procedures to be followed for
the authorisation and the lists of those products and substances and, where
appropriate, their description, compositional requirements and conditions for
use. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 37(2).

Article 20

Presence
of non-authorised products or substances

1.           Products in which the
presence of products or substances that have not been authorised in accordance
with Article 19 is detected beyond the levels established taking account in
particular of Directive 2006/125/EC, shall not be marketed as organic.

2.           In
order to ensure the effectiveness, efficiency and transparency of the organic
production and labelling system, the Commission shall be empowered to adopt
delegated acts in accordance with Article 36 regarding the specific criteria and conditions for the application
of the levels referred to in paragraph 1 and regarding the establishment of those
levels and their adaptation in the light of technical developments.

3.           By
way of derogation from Article 211(1) of Regulation (EU) No 1308/2013, and
subject to an authorization by the Commission adopted without applying the
procedure referred to in Article 37(2) or (3) of this Regulation, Member States
may grant national payments to
compensate farmers for the losses they have incurred due to the contamination
of their agricultural products by non-authorised products or substances which
prevents them from marketing those products as organic provided that the
farmers have taken all appropriate measures to prevent the risk of such
contamination. Member States may also use the instruments of the Common
Agricultural Policy to cover totally or partially such losses.

Chapter IV

Labelling

Article 21

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 are described in terms suggesting to the purchaser that the
product, its ingredients or feed materials have been obtained in accordance
with this Regulation. In particular, the terms listed in Annex IV, their
derivatives or diminutives, such as ‘bio’ and ‘eco’, alone or combined, may be
used throughout the Union and in any language listed in that Annex for the
labelling and advertising of products which comply with this Regulation.

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

Furthermore, any terms, including terms used in trademarks, or
practices used in labelling or advertising liable to mislead the consumer or
user by suggesting that a product or its ingredients comply with this
Regulation shall not be used.

3.           As
regards processed food, the
terms referred to in paragraph 1 may be used:

(a)
in the sales description, provided that:

(i)      the processed food complies with the
production rules set out in Part IV of Annex II;

(ii)     at least 95% by weight of its
agricultural ingredients are organic;

(b)
only in the list of ingredients, where less than
95% of agricultural ingredients are organic and provided that those ingredients
comply with the production rules set out in this Regulation.

The list of ingredients referred to in point (b) of the first
subparagraph shall indicate which ingredients are organic. The references to
organic production may only appear in relation to the organic ingredients. That
list of ingredients 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 and the indication of the
percentage referred to in point (b) of the first 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.

4.           In
order to provide clarity for
consumers and to ensure that the appropriate information is communicated to
them, the Commission shall be empowered to adopt delegated acts in accordance
with Article 36 concerning adaptation of the list of terms set out in Annex IV,
taking into account linguistic developments within the Member States and
concerning the establishment of specific labelling and compositional
requirements applicable to feed and ingredients thereof.

Article 22

Compulsory
indications

1.           Where terms as referred to in Article 21(1) are used:

(a)
the code number of the control authority or
control body to which the operator who has carried out the last production or
preparation operation is subject, shall also appear in the labelling;

(b)
the organic production logo of the European
Union referred to in Article 23 as regards pre-packed food as defined in point
(e) of Article 2(2) of Regulation (EU) No 1169/2011 shall also appear on the
packaging.

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 also 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.

The word ‘Agriculture’ may be replaced by ‘Aquaculture’ where
appropriate.

The indication ‘EU’ or ‘non-EU’ may be replaced or supplemented by
the name of a country if all agricultural raw materials of which the product is
composed have been farmed in that country.

For the indication ‘EU’ or ‘non-EU’ 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 indication ‘EU’ or ‘non-EU’ shall not appear in a colour, size
and style of lettering more prominent than the name of the food.

3.           The
indications referred to in paragraphs 1 and 2 of this Article and in Article
23(3) shall be marked in a conspicuous place in such a way as to be easily
visible, clearly legible and indelible.

4.           In
order to provide clarity for
consumers and to ensure that the appropriate information is communicated to
them, the Commission shall be empowered to adopt delegated acts in accordance
with Article 36 laying down further rules on labelling and the use of the
indications referred to in point (a) of paragraph 1 and in paragraph 2 of this
Article and in Article 23(3).

5.           The
Commission shall adopt implementing acts relating to the following:

(a)
specific and practical modalities as regards the
presentation, composition and size of the indications referred to in point (a)
of paragraph 1 and in paragraph 2 of this Article and in Article 23(3);

(b)
the assignment of code numbers to control authorities and control bodies;

(c)
the indication of the place where
the agricultural raw materials have been farmed, in accordance with paragraph 2
of this Article and Article 232(3).

Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 37(2).

Article 23

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.

2.           The organic production
logo of the European Union is an official attestation in accordance with Articles
85 and 90 of Regulation (EU) No XXX/XXXX [Official controls Regulation].

3.           The use of the organic
production logo of the European Union shall be optional for products imported
from third countries. In addition, where that logo appears in the labelling,
the indication referred to in Article 22(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 and private logos
may be used in the labelling, presentation and advertising of products which
comply with this Regulation.

6.           In order to provide
clarity for consumers and to ensure that the appropriate information is
communicated to them, the Commission shall be empowered to adopt delegated acts
in accordance with Article 36 amending the organic production logo of the
European Union and the rules relating thereto set out in Annex V.

Chapter V

Organic certification

Article 24

Organic
certification system

1.           Operators or groups of
operators that produce, prepare or store organic products, who import such
products from a third country or export such products to a third country or who
place such products on the market shall, prior to the placing on the market as
organic or prior to conversion, notify their activity to the competent
authorities of the Member State(s) where the activity is carried out.

2.           Where operators or groups
of operators subcontract any of their activities to a third party, both the
operators and groups of operators and the third party to whom activities have
been subcontracted shall comply with paragraph 1.

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

4.           Competent authorities
shall keep an updated list containing the names and addresses of operators and
groups of operators that have notified their activities in accordance with
paragraph 1 and shall make that list public, together with the information
relating to their organic certificates as referred to in Article 25(1). The
competent authorities shall respect the requirements of the protection of
personal data under Directive 95/46/EC of the European Parliament and of the
Council[50].

5.           Member States shall ensure
that the fees that may be collected by the competent authorities, control
authorities or control bodies in accordance with Article 76 of Regulation (EU)
No XX/XXXX (official controls Regulation) are made public.

6.           In order to ensure the
effectiveness, efficiency and transparency of the organic production and
labelling system, the Commission shall be empowered to adopt delegated acts in
accordance with Article 36 concerning the requirements for keeping records, the
requirements for publication of the list referred to in paragraph 4 of this
Article and the requirements and procedures to be applied for publication of
the fees referred to in paragraph 5 of this Article and for supervision by the
competent authorities of the application of those fees.

7.           The Commission may adopt
implementing acts to provide details and specifications regarding the content,
form and way of notification referred to in paragraph 1 and the form of
publication of the fees referred to in paragraph 5. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 37(2).

Article 25

Organic
certificate

1.           Operators and groups of
operators that have notified their activity in accordance with Article 24(1)
and comply with this Regulation shall be entitled to be provided with an
organic certificate. The organic certificate, issued in electronic form
wherever possible, shall at least allow the identification of the operator or
group of operators, the type or range of products covered by the certificate
and its period of validity.

2.           The organic certificate is
an official certification within the meaning of Articles 85 and 86 of
Regulation (EU) No XXX/XXX (Official controls Regulation).

3.           Operators and groups of
operators shall not be entitled to be provided with an organic certificate by
different control authorities or control bodies for the same group of products,
including when those operators and groups of operators engage in different
stages of production, preparation and distribution.

4.           Members of a group of
operators shall not be entitled to be provided with an individual organic
certificate for any of the activities covered by the certification of the
group.

5.           Operators shall
systematically verify the organic certificate of operators that are their suppliers.

6.           In order to ensure the
effectiveness, efficiency and transparency of the organic production and
labelling system, the Commission shall be empowered to adopt delegated acts in
accordance with Article 36 concerning the criteria for defining the groups of
products referred to in paragraph 3.

Article 26

Group of
operators

1.           Each group of operators
shall establish a system for internal controls. That system shall consist of a
documented set of control activities and procedures, in accordance with which
an identified person or body is responsible for verifying compliance with this
Regulation of each member of the group.

2.           Deficiencies in the set-up
or functioning of the system for internal controls referred in to paragraph 1,
in particular as regards failures to detect or address non-compliance by
individual members of the group of operators that affect the integrity of
organic products, may result in the withdrawal of the organic certification for
the whole group.

3.           In order to ensure the
effective and efficient functioning of the certification of a group of
operators, the Commission shall be empowered to adopt delegated acts in
accordance with Article 36 concerning the responsibilities of the individual
members of a group of operators, the composition and dimension of a group of
operators, the categories of products to be produced by a group of operators,
the conditions for participation in a group of operators, the set-up and
functioning of the group's system for internal controls, including the scope,
content and frequency of the controls to be carried out.

4.           The Commission may adopt
implementing acts concerning the exchange of information between a group of
operators and the competent authority or authorities, control authorities or
control bodies, and between the Member States and the Commission. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 37 (2).

Chapter VI

Trade with third countries

Article 27

Export of
organic products

1.           A product may be exported
from the Union as organic and bear the organic production logo of the European
Union if it complies with this Regulation.

However, a product intended to be exported as
organic to a third country which is recognised in accordance with Article 31
may be exported to that third country if it complies with that third country’s
requirements to be placed on the market in that third country as organic.

2.           In
order to avoid creating unequal
conditions for operators when exporting to third countries, the Commission
shall be empowered to adopt delegated acts in accordance with Article 36
concerning specific rules for exports of organic products to a third country
which is recognised in accordance with Article 31.

3.           In order to ensure fair
competition among operators, the Commission shall be empowered to adopt
delegated acts in accordance with Article 36 concerning documents intended for
customs authorities in third countries, in particular as regards an organic
export certificate issued in electronic form wherever possible and providing
assurance that exported organic products comply with this Regulation.

Article 28

Import of
organic products

1.           A product may be imported
from a third country in order to be placed on the market within the Union as organic if the following conditions are met:

(a)
the product is an organic product as referred to in Article 2(1);

(b)
the product:

(i)      complies with Chapters II, III and IV
and all operators, including the exporters in the third country concerned, have
been subject to the control of control authorities or control bodies recognised in accordance with Article 29; or

(ii)     comes from a third country which is recognised in accordance with:

–
Article 30; or

–
Article 31;

(c)
the operators in third countries are able to
provide at any time, to the importers or the national authorities information
allowing the identification of the operator who carried out the last operation
with a view to ensuring the traceability of the organic product.

2.           In order to ensure the traceability
of the imported products intended to be placed on the market within the Union
as organic, the Commission shall be empowered to adopt delegated acts in
accordance with Article 36 concerning documents, issued in electronic form
wherever possible, that are necessary for the purposes of import.

3.           The respect of the
conditions and measures for the import of organic products into the Union shall be ascertained at border control posts, in accordance with Article 45(1) of
Regulation (EU) No XXX/XXX (Official controls regulation). The physical checks
referred to in Article 47(3) of that Regulation shall be performed at a
frequency dependent on the risk of non-compliance with this Regulation.

Article 29

Recognition
of control authorities and control bodies

1.           The Commission may adopt
implementing acts recognising, or withdrawing the recognition of control
authorities and control bodies which fulfil the criteria set out in a delegated
act adopted pursuant to paragraph 7 and which are competent to carry out
controls in third countries, and establishing a list of those control
authorities and control bodies. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 37(2).

2.           The control bodies shall
be accredited to the relevant harmonised standard for ‘Conformity assessment –
Requirements for bodies certifying products, processes and services’, the
reference of which has been published in the Official Journal of the
European Union.

3.           The accreditation referred
to in paragraph 2 may only be granted by:

(a)
a national accreditation body
in the Union in accordance with Regulation (EC) No 765/2008 of the
European Parliament and of the Council[51];
or

(b)
an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of
the International Accreditation Forum.

4.           When examining requests
for recognition, the Commission shall invite the control authority or control
body to supply all the necessary information.

The recognised control bodies or control authorities
shall provide the certificate issued by the accreditation body or respectively
the assessment report issued by the competent authority, and, as appropriate, reports
on the regular on-the-spot evaluation, surveillance and multiannual
re-assessment of their activities.

5.           Based on the information
referred to under paragraph 4, the Commission shall ensure appropriate
supervision of the recognised control authorities and control bodies by
regularly reviewing their recognition. For the purposes of that supervision,
the Commission may request additional information from the accreditation bodies
or, as appropriate, the competent authorities.

6.           The nature of the
supervision shall be determined on the basis of an assessment of the risk of
non-compliance.

7.           In order to ensure the transparency
of the recognition and supervision procedures, the Commission shall be
empowered to adopt delegated acts in accordance with Article 36 concerning the
criteria to be applied to the recognition, or the withdrawal of the
recognition, of the control authorities and control bodies referred to in
paragraph 1,
as well as concerning the exercise of the supervision
by the Commission, including through on-the-spot examination.

8.           The Commission may adopt
implementing acts to ensure the application of measures in relation to cases of
non-compliance affecting the integrity of organic products imported under the
recognition provided for in this Article or suspicion of such cases. Such
measures may consist in particular in the verification of the integrity of the
organic products before placing the products on the market within the Union
and, where appropriate, the suspension of the authorisation of placing on the
market within the Union of such products as organic. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 37(2).

9.           On
duly justified imperative grounds of urgency relating to the protection against
unfair practices or practices which are incompatible with the principles and
rules on organic production, the protection of consumers' confidence or the
protection of fair competition between operators, the Commission shall adopt
immediately applicable implementing acts in accordance with the procedure
referred to in Article 37(3) to take the measures referred to in paragraph 8 of
this Article or to decide on the withdrawal of the recognition of the control
authorities and control bodies referred to in paragraph 1 of this Article.

Article 30

Equivalence
under a trade agreement

A recognised third country referred to in
the first indent of Article 28(1)(b)(ii) 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 31

Equivalence
under Regulation (EC) No 834/2007

1.           A recognised third country referred to in the second indent of Article 28(1)(b)(ii)
is a third country which has been recognised for the purpose of equivalence
under Article 33(2) of Regulation (EC) No 834/2007, including those recognised
under the transitional measure provided for in Article 40.

The recognition of the third countries referred
to in the first subparagraph shall expire on [a date to be inserted which
corresponds to 5 years following the date of application of the Regulation].

2.           On the basis of annual reports to be sent to the
Commission, by 31 March of each year, by the third countries referred to in
paragraph 1 regarding the implementation and enforcement of the control
measures established by them, the Commission assisted by the Member States
shall ensure appropriate supervision of the recognised third countries by
regularly reviewing their recognition. The nature of the supervision shall be
determined on the basis of an assessment of the risk of non-compliance.

3.           The control bodies performing controls in the
third countries referred to in paragraph 1 shall be accredited to the relevant
harmonised standard for ‘Conformity assessment – Requirements for bodies
certifying products, processes and services’, the reference of which has been
published in the Official Journal of the European Union. If the
accreditation is not granted by a national accreditation body in the Union in
accordance with Regulation (EC) No 765/2008, it may only be granted by an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of
the International Accreditation Forum.

4.           The Commission shall, by
means of an implementing act, establish a list of the third countries referred
to in paragraph 1 and may amend that list by means of implementing acts. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 37(2).

5.           In order to ensure the management of the list
of third countries referred to in paragraph 4, the Commission shall be
empowered to adopt delegated acts in accordance with Article 36 concerning the
information to be sent by those third countries necessary for the supervision
of their recognition by the Commission, as well as the exercise of that
supervision by the Commission, including through on-the-spot examination.

6.           The Commission may adopt implementing acts to
ensure the application of measures in relation to cases of non-compliance
affecting the integrity of organic products imported from third countries
referred to in this Article or suspicion of such cases. Such measures may consist
in particular in the verification of the integrity of the organic products
before placing the products on the market within the Union and, where
appropriate, the suspension of the authorisation of placing on the market
within the Union of such products as organic. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 37(2).

Chapter VII

General provisions

Section 1

Free movement of organic products

Article 32

Non-prohibition
and non-restriction of the marketing of organic products

1.           Competent authorities,
control authorities and control bodies may not, on grounds relating to the
production, to the labelling or to the presentation of the products, prohibit
or restrict the marketing of organic products controlled by another competent
authority, control authority or control body located in another Member State,
if those products comply with this Regulation. In particular, no official
controls and other official activities other than those under Regulation (EU)
No XXX/XXX (Official controls Regulation) may be performed and no fees for
official controls and other official activities other than those under Article
76 of that Regulation may be collected.

2.           In order to ensure the
proper functioning of the single market and trade between Member States, the
Commission shall be empowered to adopt delegated acts in accordance with
Article 36 laying down rules relating to the free movement of organic products
for the purposes of paragraph 1 of this Article.

Section 2

information and reporting

Article 33

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.

2.           The
Commission shall adopt
implementing acts as regards the system to be used for
transmitting the information referred to in paragraph
1, the details of information to be transmitted, and
the date by which that information is to be transmitted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
37(2).

Article 34

Information
relating to the competent authorities, control authorities and control bodies

1.           Members
States shall keep a regularly updated
list containing:

(a)
the names and addresses of the competent
authorities;

(b)
the names and addresses of the control authorities and control bodies, and
their code numbers.

Member States shall make public the list
referred to in point (b) of the first subparagraph.

2.           The Commission shall
publish annually on the internet the list of control authorities and control
bodies referred to in point (b) of paragraph 1.

Article 35

Report

By 31 December 2021, the Commission shall
present a report to the European Parliament and the Council on the availability
of organic plant reproductive material and animals for breeding purposes.

Chapter VIII

Procedural, transitional and final
provisions

Section 1

Procedural provisions

Article 36

Exercise
of the delegation

1.           The
power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

2.           The delegation of power
referred to in [..........] 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.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the
European Parliament and to the Council.

4.           A delegated act adopted
pursuant to [.....] shall enter into force only if no 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 37

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.

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

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

Section 2

Repeal, amendments, transitional and
final provisions

Article 38

Repeal

Regulation (EC) No 834/2007 is repealed.

However, Regulation (EC) No 834/2007 shall
continue to apply for the purposes of completing the examination of pending
applications from third countries, as provided for in Article 42 of this
Regulation.

Article 39

Transitional
measures relating to conversion to organic farming

In order to ensure a smooth transition from
the old to the new legal framework, the Commission shall be empowered to adopt
delegated acts in accordance with Article 36 concerning rules providing for a
derogation from Article 8(3) in relation to conversion periods for farmers
initiating conversion before the entry into force of this Regulation.

Article 40

Transitional
measures relating to the origin of plant reproductive material, animals for
breeding purposes and young stock of aquaculture animals

In order to ensure a smooth transition
between the rules on organic origin of plant reproductive material provided for
in Article 12(1)(i) of Regulation (EC) No 834/2007 and on animals for
breeding purposes provided for in Article 14(1)(a)(ii) of that Regulation and
on young stock of aquaculture animals provided for in Article 15(1)(a)(ii) of
that Regulation and the exception to production rules that the Commission
adopted pursuant to Article 22 of Regulation (EC) No 834/2007, and the new
production rules for plants and plant products and livestock and seaweed and
aquaculture animals provided for in Articles 10(1) and 11(1), respectively, of
this Regulation, the Commission shall be empowered to adopt delegated acts in
accordance with Article 36 providing for exceptions where granting exceptions
is deemed necessary in order to ensure access to plant reproductive material
and live animals for breeding purposes and young stock of aquaculture animals, that
may be used in organic production. The delegated acts adopted under this
Article shall cease to apply on 31 December 2021.

Article 41

Transitional measures relating
to control authorities and control bodies recognised under Article 33(3) of
Regulation (EC) No 834/2007

1.           The recognition of control
authorities and control bodies granted under Article 33(3) of Regulation (EC)
No 834/2007 shall expire on [31 December 2018] at the latest.

2.           The Commission shall, by
means of an implementing act, establish a list of the control authorities and
control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007
and may amend that list by means of implementing acts. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 37(2).

3.           In order to ensure the management
of the list of control authorities and control bodies referred to in paragraph
2, the Commission shall be empowered to adopt delegated acts in accordance with
Article 36 concerning the information to be sent by those control authorities
and control bodies necessary for the supervision of their recognition by the
Commission, as well as the exercise of that supervision by the Commission,
including through on-the-spot examination.

Article 42

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 submitted under
Article 33(2) of Regulation (EC) No 834/2007 which are pending at the date of
entry into force of this Regulation. Regulation (EC) No 834/2007 shall apply to
the examination of such applications.

2.           In order to facilitate the
completion of the examination of the applications referred to in paragraph 1,
the Commission shall be empowered to adopt delegated acts in accordance with
Article 36 concerning the procedural rules necessary for the examination,
including on the information to be submitted by the third countries.

Article 43

Transitional
measures for stocks of organic products produced in accordance with Regulation
(EC) No 834/2007

Products produced in accordance with
Regulation (EC) No 834/2007 and placed on the market before 1 July 2017 may
continue to be marketed after that date until stocks are exhausted.

Article 44

Amendments
to Regulation (EU) No [...][on official controls]

Regulation (EU)
No XXX/XXXX (Official controls Regulation) is amended as follows:

1.           In Article 2, points 38
and 39 are replaced by the following:

"38. 'delegated body' means a third party
to which the competent authorities have delegated specific official control
tasks or other official activities;

39. 'control authority for organic production
and labelling of organic products' means a public administrative organisation
of a Member State to which the competent authorities have conferred, in whole
or in part, their competences in relation to the application of the Union
legislation in the area referred to in Article 1(2)(j), including, where appropriate,
the corresponding authority of a third country or operating in a third country;";

2.           Article 3 is amended as
follows:

(a) Paragraph 3 is replaced by the following:

"3. Competent authorities responsible for
the verification of compliance with the rules referred to in point (j) of
Article 1(2) may confer official control tasks or other official activities to
one or more control authorities for organic production and labelling of organic
products. In such cases, they shall allocate a code number to each of
them.";

(b)     In paragraph 4, point (c) is replaced
by the following:

" (c) the control authorities for organic
production and labelling of organic products referred to in paragraph 3;";

3.           Article 23 is replaced by
the following:

“Article
23

Specific rules on official controls and on
action to be taken by the competent authorities in relation to organic products
and to protected designations of origin, protected geographical indications and
traditional specialties guaranteed

1. In relation to the rules referred to in
point (j) of Article 1(2), competent authorities shall:

(a) in the event of non-compliance that affects
the integrity of organic products throughout any of the stages of production,
preparation and distribution and export, in particular due to the use of
prohibited or non-authorised substances and techniques or commingling with
non-organic products, ensure that no reference is made to organic production in
the labelling and advertising of the entire lot or production run concerned;

(b) in the event of repetitive or continued non-compliance,
ensure that the operators or the group of operators concerned, as defined in
points (6) and (7) of Article 3 of Regulation (EU) No [organic production] of
the European Parliament and of the Council*, in addition to the measures
referred to in point (a) of this paragraph, are prohibited from marketing
products which refer to organic production, and that their organic certificate
be suspended or withdrawn as appropriate.

2. The Commission shall be empowered to adopt
delegated acts in accordance with Article 139 concerning rules for the
performance of official controls and other official activities to verify
compliance with the rules referred to in points (j) and (k) of Article 1(2),
and on action to be taken by the competent authorities following such official
controls and other official activities.

3. In relation to the rules referred to in
point (j) of Article 1(2), the delegated acts referred to in paragraph 2 of
this Article shall lay down rules on:

(a) the specific responsibilities and tasks of
the competent authorities, in addition to those provided for in Articles 4, 8,
9, 10(1), 11 to 13, 34(1) and (2), and 36, and in addition to Articles 25, 26,
28, 29, 30 and 32 for the approval and supervision of delegated bodies, and to
Articles 85 to 90 concerning official certification;

(b) requirements additional to those referred
to in Article 8(1) for risk assessment and for establishing the frequency of
official controls, and of sampling as appropriate, taking into account the risk
of the occurrence of non-compliance;

(c) the frequency of official controls on
operators, and the cases where and conditions under which certain such
operators are to be exempted from certain official controls;

(d) methods and techniques for official
controls additional to those referred to in Article 13 and Article 33(1) to
(5), and specific requirements for the performance of official controls aimed
at ensuring the traceability of organic products at all stages of production,
preparation and distribution, and at providing assurances as to compliance with
the rules referred to in point (j) of Article 1(2);

(e) actions and measures additional to those
provided for in Article 134(2) and (3) in case of suspicion of non-compliance,
criteria additional to those referred to in the second subparagraph of Article
135(1), and criteria and measures additional to those provided for in Article
135(2) and in paragraph 1 of this Article in the event of non-compliance;

(f) requirements additional to those provided
for in point (f) of Article 4(1) in relation to the facilities and equipment
necessary to carry out official controls and specific and additional conditions
and obligations to those referred to in Articles 25, 26, 28, 29, and 30 to 32
for the delegation of official control tasks and other official activities to
delegated bodies;

(g)  reporting obligations additional to those
referred to in Articles 12, 28 and 31 for the competent authorities, the
control authorities  and the delegated bodies in charge of official controls
and other official activities;

(h) specific criteria and conditions for the
activation and the functioning of the mechanisms of administrative assistance
provided for in Title IV, including  the exchange of information concerning
instances of non-compliance or the likelihood of non-compliance between
competent authorities, control authorities and delegated bodies.

4. In relation to the rules referred to in
point (k) of Article 1(2), the delegated acts referred to in paragraph 3 of
this Article shall lay down rules on:

(a) requirements, methods and techniques additional
to those referred to in Articles 11 and 13 for official controls performed to
verify compliance with product specifications and labelling requirements;

(b) methods and techniques additional to those
referred to in Article 13 for the performance of official controls aimed at
ensuring the traceability of products falling within the scope of the rules
referred to in point (k) of Article 1(2) at all stages of production,
preparation and distribution, and at providing assurances as to compliance with
those rules;

(c) specific criteria and content additional to
those provided for in Article 108, for the preparation of the relevant parts of
the multi-annual national control plan provided for in Article 107(1), and
specific additional content of the report provided for in Article 112;

(d) specific criteria and conditions for
activating the mechanisms of administrative assistance provided for in Title
IV;

(e) specific measures to be taken, in addition
to those referred to in Article 135(2) in the event of non-compliance and of
serious or recurrent non-compliance.

5. Where appropriate, the delegated acts
referred to in paragraphs 3 and 4 shall derogate from the provisions of this
Regulation referred to in those paragraphs.

- OJ L ..., p. ...”

4.           In Article 128, paragraph
1 is replaced by the following:

"1. In the areas governed by the
rules referred to in Article 1(2), with the exclusion of points (d), (e), (g),
(h) and (j) of Article 1(2), the Commission may, by means of implementing acts,
recognise that measures applied in a third country, or regions thereof, are
equivalent to the requirements laid down in those rules, on the basis of:

(a) a thorough examination of information and
data provided by the third country concerned pursuant to Article 124(1);

(b) where appropriate, the satisfactory outcome
of a control performed in accordance with Article 119(1);

Those implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 141(2)."

5.           In Article 141, paragraph
1 is replaced by the following:

"1. The Commission shall be assisted by
the Standing Committee on Plants, Animals, Food and Feed established by Article
58(1) of Regulation (EC) No 178/2002. That Committee shall be a Committee within
the meaning of Regulation (EU) No 182/2011. For measures falling within the area
referred to in Article 1(2)(j) of this Regulation, the Commission shall be
assisted by the Organic production Committee established by Article 37(1) of Regulation
(EU) No  [organic production]."

Article 45

Entry into
force and application

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
July 2017[52].

This Regulation shall be binding
in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament                        For
the Council

The President                                                 The
President
[...]                                                                [...]

Legislative financial statement

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
mode(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of estimated impact on expenditure

3.2.2. Estimated
impact on operational appropriations

3.2.3. Estimated
impact on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
contributions

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

1.1.        Title of the proposal/initiative

Regulation of the European Parliament and of
the Council on organic production and labelling of organic products, amending
Regulation (EU) No XXX/XXX of the European Parliament and of the Council
[Official controls Regulation] and repealing Regulation (EC) No 834/2007

1.2.        Policy area(s) concerned
in the ABM/ABB structure[53]

1.3.        Nature of the
proposal/initiative

 ̈ The proposal/initiative relates to a new action

 ̈ The proposal/initiative relates to a new action
following a pilot project/preparatory action[54]

 ̈ The proposal/initiative relates to the extension of
an existing action

X The
proposal/initiative relates to an action redirected towards a new action

1.4.        Objective(s)

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

The proposal targets how rules concerning organic production
contribute to the realisation of the policy priorities of the Europe 2020
strategy for smart, sustainable and inclusive growth, in particular 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. Specific
objective(s) and ABM/ABB activity(ies) concerned

The specific objectives of the proposal are  :

- to remove the obstacles to the development of organic production 
in the Union,

- to guarantee fair competition for farmers and operators and to
improve the functioning of the internal market,

- to maintain or improve consumer confidence in organic products.

In accordance with the 2014-2020 Common Monitoring and Evaluation
Framework (CMEF) for the Common Agricultural Policy (CAP)[55], the proposal
contributes to the general objectives: "Sustainable management of natural
resources and climate action" by providing public goods (mostly
environmental) and by pursuing "climate change mitigation and
adaptation" and "Viable food production" by "meeting
consumers expectations" and by "improving the competitiveness of the
agricultural sector and enhancing the  share in food-chain", under the
first Pillar of the CAP.

In addition, the proposal contributes to the general objective
"sustainable management of natural resources and climate action"  by
restoring, preserving and enhancing ecosystems (priority 4) under Pillar II of
the CAP.

The proposal is related to measures supported under both Pillar I
(direct payments and markets) and  Pillar II of the CAP.

ABB activity concerned: 05 04 Rural Development (and 05 02
Interventions in agricultural markets and 05 03 Direct aids).

1.4.2.     Expected result(s) and
impact

Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.

A positive market
outlook, thanks to improved consumer confidence, is expected to support organic
products prices and to attract newcomers.

The removal of
exceptions to the rules  is expected to contribute to the development of
organic inputs, notably seeds.

Clearer and simpler
production rules will make the sector more attractive.

Fair competition will
be improved notably by stronger harmonisation,  simpler and clearer rules and
the move from equivalence to compliance for the recognition of control bodies
in third countries.

Consumer confidence
will be addressed with harmonised production rules taking into account evolving
societal concerns (animal welfare, environmental management system for
processors and traders).

A risk-based approach
is expected to improve the effectiveness and efficiency of controls and
contribute, together with a more reliable import regime, to fraud prevention

Specify the
indicators for monitoring implementation of the proposal/initiative.

The main result indicators in the Common Monitoring and
Evaluation Framework are:

- Share of organic area in total utilised agricultural
area (UAA);

-  Share of organic livestock in total livestock.

And the main output indicators are:

- Organic land area (in conversion and fully converted);

- Number of certified organic operators.

The following complementary indicators will also be
monitored within the context of this Regulation:

- Livestock (number of organic animals and products of
animal origin);

- Crop production and processing (number of operators and
value/volume of production by type of economic activity);

- Number of exceptions used and number of exceptions
removed,

- Knowledge of, and confidence in, the Union organic logo
(Eurobarometer survey).

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

The overall objective of the legislative framework, which is the
sustainable development of organic production, is currently not fully met. It
leads to lost opportunities for farmers and operators in the Union (the organic
land area in the Union has only doubled in the last 10 years, while the market
has increased fourfold), a risk of limitation to the organic market expansion
and a risk of limitation to the environmental benefits associated with organic production.

The main drivers are: regulatory and non-regulatory obstacles to the
development of organic production in the Union; a risk of erosion of consumer
confidence, notably because of the many exceptions that are watering down
organic production rules and because of the fraud cases that have developed in connection
with shortcomings in the control system and in the import regime; unfair
competition among operators in the Union and in Third Countries; and issues in
the design and the enforcement of the legal provisions, notably issues with the
functioning of the internal market, because of gaps in the legislation and
different approaches in implementation.

1.5.2.     Added value of EU
involvement

The current proposal is an updating of an existing quality scheme
set within the Common Agricultural Policy.

Production and trade of agricultural products and foodstuffs on the
internal market and ensuring the functioning of the internal market are matters
of Union competence. Both are competences shared with MS.

A Union wide scheme is more efficient than 28 different schemes and
allows for a stronger and more consistent trade policy vis-à-vis global trading
partners, most notably by enhancing the Union's bargaining power.

The organic logo of the European Union should cover products
complying with a common set of rules that are applied across the whole Union.

Areas where further harmonisation is needed include: exceptions to
the rules and action to preserve the integrity of organic production, including
a common approach to address the presence of non-authorised substance residues
in organic products.

1.5.3.     Lessons learned from
similar experiences in the past

An external evaluation of the Union legislation on organic farming
was completed in 2013[56].
In particular, it analysed the adequacy of the production rules and of the
rules on controls, imports and labelling of organic products. The evaluation
concluded that most of the rules laid down in the organic legislative framework
are in general adequate for achieving its global objectives. Yet, it also
identified a number of shortcomings and proposed recommendations for
improvement. These recommendations have been given due consideration in the
present proposal.

The European Court of Auditors audited the effectiveness of the
control system governing the production, processing, distribution and imports
of organic products as provided in Council Regulation (EC) No 834/2007. The
results, published in ECA Special Report No 9/2012, show a number of weaknesses
and include recommendations for improvement that have been taken into account
in the present proposal.

1.5.4.     Compatibility and possible
synergy with other appropriate instruments

The proposal is consistent with the new CAP, e.g. with the new
Regulation on Direct Payments[57],
under which organic farms benefit ipso facto from the new "green"
payment, and with the new Regulation on Rural Development[58], providing for
specific measures benefitting  organic farming, and the new Common Fisheries
Policy.

The proposal is also consistent with the proposal for a new
Regulation on official controls in Food and Feed and with smart Regulation principles.

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited
duration

–
 ̈  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

–
 ̈  Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited
duration

–
Implementation with a start-up period from YYYY
to YYYY,

–
followed by full-scale operation.

1.7.        Management mode(s) planned[59]

Direct management by the Commission

–
X by its
departments, including by its staff in the Union delegations;

–
 ̈  by the executive agencies;

X Shared management with the Member
States

 ̈ Indirect management by delegating implementation tasks to:

–
 ̈ third countries or the bodies they have designated;

–
 ̈ international organisations and their agencies (to be specified);

–
 ̈the EIB and the European Investment Fund;

–
 ̈ bodies referred to in Articles 208 and 209 of the Financial
Regulation;

–
 ̈ public law bodies;

–
 ̈ bodies governed by private law with a public service mission to the
extent that they provide adequate financial guarantees;

–
 ̈ bodies governed by the private law of a Member State that are entrusted with the implementation of a public-private partnership and that
provide adequate financial guarantees;

–
 ̈ persons entrusted with the implementation of specific actions in
the CFSP pursuant to Title V of the TEU, and identified in the relevant basic
act.

– If more than one management mode is
indicated, please provide details in the "Comments" section.

Comments

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

Member States shall provide the Commission annually with the
information necessary for implementation and monitoring of application of this
Regulation. Member States shall also provide the Commission with annual
information on the controls carried out to ensure compliance with the
requirements on organic production, as part of their Multi-annual national
control plans and Annual Reports referred to under the Official Controls
Regulation.

Third Countries recognised as equivalent, and Control Bodies or
Control Authorities recognised as compliant for the import of organic products
into the Union shall submit to the Commission annual reports with the necessary
information for implementation of the requirements under this Regulation.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

The general risks as regards to the rules in the proposal that can
be identified relate to the effectiveness of the proposal, and not as regards
to the EU expenditure given the relatively insignificant amounts which are
involved:

Harmonised production rules that remove exceptions may, in an
initial stage, create problems for some operators and discourage uptake of the
organic scheme.

The transition period for the move from the equivalency to the
compliance system, as concerns imports of organic products into the Union, may not fully ensure a level-playing field.

The replacement of the annual physical inspection of all operators,
regardless of their risk profile, by a fully risk-based approach to controls
may be considered as inappropriate by some stakeholders and/or control
authorities or bodies in Member States.

Other risks may be linked to shortcomings in enforcement: namely,
implementation by the competent authorities and control authorities or control
bodies in Member States and Third Countries, and supervision by the Commission.

Experience gained with implementation of Regulation (EC) No 834/2007
- including through the results of audits, stakeholders' input in the framework
of the impact assessment, and the recommendations from external studies and the
external evaluation have been duly taken into account in the design of the
proposal so as to mitigate these risks. Particular attention has also been paid
to mitigate the risk linked to possible shortcomings in enforcement through
efforts for clearer rules, simpler to manage and control

2.2.2.     Information concerning the
internal control system set up

Expenditure entailed by this proposal shall be implemented by the
Commission under direct management, in accordance with the principles set out in
article 32 of Regulation (EU, Euratom) No 966/2012 on the financial rules
applicable to the general budget of the Union – the Financial Regulation.

As required by the Financial Regulation, the Director General for
Agriculture and Rural Development has put in place the organisational structure
and the internal control processes suited to the achievement of the policy and
control objectives, in accordance with the internal control standards adopted
by the Commission and having regard to the risks associated with the
environment in which the policy operates.

2.2.3.     Estimate of the costs and
benefits of the controls and assessment of the expected level of risk of error

Expenditure entailed by this proposal will not lead to an increase in
the error rate for the European Agricultural Rural Development Fund (EARDF),
taking into account the relatively insignificant amounts involved.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

The Commission shall take appropriate measures ensuring that, when
actions financed under this Regulation are implemented, the financial interests
of the  Union are protected by the application of preventive measures against
fraud, corruption and any other illegal activities, by the performance of
effective checks and, if irregularities are detected, by the recovery of the
amounts wrongly paid as well as, where appropriate, by effective, proportional and
deterrent penalties, in accordance with Article 325 of the Treaty on the
Functioning of the European Union, with Council Regulation (EC) No 2988/95 on
the protection of the European Communities’ financial interests, and with title
IV of the Financial Regulation applicable to the general budget of the  Union.

The Commission or its representatives and the Court of Auditors
shall have the power of audit, on the basis of documents and on-the-spot, over all
contractors and subcontractors who have received Union funds. OLAF shall be
authorised to carry out on-the spot checks and inspections on economic
operators concerned directly or indirectly by such funding in accordance with
the procedures laid down in Council Regulation No 2185/96 of 11 November 1996
with a view to establishing that there has been fraud. Decisions, agreements
and contracts resulting from the implementation of the Regulation shall
expressly entitle the Commission, including OLAF, and the Court of Auditors to
conduct such audits, on-the-spot checks and inspections.

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing budget lines

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [...]Heading..........................................................] || Diff./non-diff. ([60]) || from EFTA countries[61] || from candidate countries[62] || from third countries || within the meaning of Article 21(2)(b) of the Financial Regulation

2 || 05 04 60 02 Assistance technique opérationnelle || Diff. || /NO || /NO || NO || NO

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million

Heading of multiannual financial framework || 2 || Sustainable growth : natural resources

DG: AGRI || || || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

Ÿ Operational appropriations || || || || || || ||

05 04  60 02 Assistance technique opérationnelle * || Commitments || (1) || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

Payments || (2) || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

Appropriations of an administrative nature financed from the envelope of specific programmes[63] || || || || || || ||

|| || (3) || || || || || || ||

TOTAL appropriations ** for DG AGRI || Commitments || =1+1a +3 || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

Payments || =2+2a +3 || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

- Currently the control of imports of organic products
takes place via TRACES which is partly financed from this line and the proposal
is not expected to increase the needs for this measure. Furthermore to the
already existing tool for the imports, the Regulation foresees that all organic
production put in the market in the EU be subject to an e-certificate, it is
therefore necessary to extend the e-certificate for import to cover products
within the Union. An IT tool within Traces' architecture estimated at EUR 500
000 will have to be developed for the e-certificate for internal organic
production foreseen in Article 23 of the Commission proposal in order to ensure
it will be operational as from 01.01.2016.The maintenance is estimated at EUR
110 000 per year.

- Furthermore harmonisation of the database for
organic seeds is foreseen in Article 10 of the proposal: To ensure the
development of this separate seeds database, technical assistance from the Union estimated at EUR 300 000 is to be financed from this line outside TRACES. The maintenance is estimated to EUR 120 000 the
first year after the development and to EUR 60 000  for the subsequent years.

|| || || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || Total

Ÿ TOTAL operational appropriations || Commitments || (4) || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

Payments || (5) || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || ||

TOTAL appropriations for HEADING 2 of the multiannual financial framework || Commitments || =4+ 6 || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

Payments || =5+ 6 || 0,800 || 0,230 || 0,170 || 0,170 || 0,170 || 0,170 || 1,710

**  The IT tools will be financed  by the technical
assistance  for the Commission  in accordance with Article 58(2) of the
Regulation (EU) N°XXX/2013 of the European Parliament and of the Council on
support for rural development by the European Agricultural Fund for Rural
Development (EARFD) and repealing Council Regulation (EC) N° 1698/2005. These
amounts are already foreseen in the MultiAnnual Financial framework for
2014-2020.

Heading of multiannual financial framework || 5 || Administration

EUR million

|| || ||  2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

DG: AGRI ||

Ÿ Human resources || - || - || - || - || - || - || -

Ÿ Other administrative expenditure || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

TOTAL DG AGRI || Appropriations || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

TOTAL appropriations for HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

TOTAL appropriations for HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

EUR million

|| || || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 0,927 || 0,357 || 0,225 || 0,225 || 0,225 || 0,225 || 2.184

Payments || 0,927 || 0,357 || 0,225 || 0,225 || 0,225 || 0,225 || 2.184

3.2.2.     Estimated impact on
operational appropriations

–
 ̈  The proposal/initiative does not require the use of operational
appropriations

–
 ̈  The proposal/initiative requires the use of operational
appropriations, as explained below:

Commitment appropriations in EUR million

Indicate objectives and outputs || || || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

REALISATIONS (outputs) ||

Type[64] || Average cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost

SPECIFIC OBJECTIVE[65] ||  To provide the conditions for the sustainable management of natural resources  supporting the shift towards a resource efficient and low-carbon economy ||

Output || Area under organic farming              (Number of hectares) || || || || || || || || || || || || ||

Output || Area under conversion (Number of hectares) || || || || || || || || || || || || ||

Output || Number of certified organic operatorsl || || || || || || || || || || || || ||

Output || Number of certified organic producers || || || || || || || || || || || || ||

TOTAL COST || || || || || || || || || || || ||

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

–
 ̈  The proposal/initiative does not require the use of appropriations
of an administrative nature

–
x   The proposal/initiative requires the use of
appropriations of an administrative nature, as explained below:

EUR million (to
three decimal places)

|| 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || ||

Human resources || - || - || - || - || - || - || -

Other administrative expenditure || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

Subtotal HEADING 5 of the multiannual financial framework || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

Outside HEADING 5[66] of the multiannual financial framework || || || || || || ||

Human resources || || || || || || ||

Other expenditure of an administrative nature || || || || || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

TOTAL || 0,127 || 0,127 || 0,055 || 0,055 || 0,055 || 0,055 || 0,474

The human resources
appropriations required will be met by appropriations from the DG that are
already assigned to management of the action and/or have been redeployed within
the DG, together if necessary with any additional allocation which may be
granted to the managing DG under the annual allocation procedure and taking
account of budgetary constraints.

3.2.3.2.  Estimated
requirements of human resources

–
 ̈  The proposal/initiative does not require the use of human
resources.

–
X  The proposal/initiative requires the use of
human resources, as explained below:

Estimate to be expressed in full time
equivalent units

|| 2015 || 2016 || 2017 || 2018 || 2019 || 2020

XX 01 01 01 (headquarters and Commission's representatives) || 18 || 18 || 18 || 18 || 18 || 18

XX 01 01 02 (Delegations) || || || || || ||

XX 01 05 01 (Indirect research) || || || || || ||

10 01 05 01 (Direct reserach) || || || || || ||

XX 01 02 01 (CA, SNE, INT from the "global envelope") || 3 || 3 || 3 || 3 || 3 || 3

XX 01 02 02 (CA, LA,SNE, INT and JED  in the delegations) || || || || || ||

XX 01 04 yy || - at headquarters || || || || || ||

-  delegations || || || || || ||

XX 01 05 02 (CA,SNE, INT – indirect research) || || || || || ||

10 01 05 02 (CA,SNE, INT – direct research) || || || || || ||

Other budget lignes ( specify) || || || || || ||

TOTAL (*) || 21 || 21 || 21 || 21 || 21 || 21

XX is the policy
area or budget title concerned.

The human resources
required will be met by staff from the DG who are already assigned to
management of the action and/or have been redeployed within the DG, together if
necessary with any additional allocation which may be granted to the managing
DG under the annual allocation procedure and in the light of budgetary
constraints.

Description of
tasks to be carried out:

Officials and temporary staff || Policy development Policy implementation Planning, programming, monitoring and supervision Relations with Member States and stakeholders Negotiation, and representation of the Commission, with Third Countries Relations with other Union institutions and bodies

External staff || Assisting in policy implementation, monitoring and contacts with Member States and stakeholders

3.2.4.     Compatibility with the
current multiannual financial framework

–
X  Proposal/initiative
is compatible with the current multiannual financial framework.

–
 ̈  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

–
 ̈  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework.

3.2.5.     Third-party contributions

–
X  The
proposal/initiative does not provide for co-financing by third parties.

–
The proposal/initiative provides for the
co-financing estimated below

3.3.        Estimated impact on
revenue

–
X  Proposal/initiative
has no financial impact on revenue.

–
 ̈  Proposal/initiative has the following financial impact:

–
 ̈  on own resources

–
 ̈  on miscellaneous revenue

[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 L189, 20.7.2007, p. 1).

[2]               COM (2012) 212 final of 11 May 2012 Report from the
Commission to the European Parliament and to the Council on the application of
Council Regulation (EC) No 834/2007 on organic production and labelling of
organic products.

[3]               8906/13 AGRILEG 56 – Organic Production: Application
of the regulatory framework and development of the sector.

[4]               Commission Communication on EU Regulatory Fitness of
12 December 2012 – COM(2012)746.

[5]               Regulation
(EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004
on official controls performed to ensure the verification of compliance with
feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004,
p. 1).

[6]               Regulation (EU) No 1307/2013 of the European
Parliament and of the Council of 17 December 2013 establishing rules for direct
payments to farmers under support schemes within the framework of the common
agricultural policy and repealing Council Regulation (EC) No 637/2008 and
Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608); 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); Regulation (EU) No 1305/2013 of
the European Parliament and of the Council of 17 December 2013 on support for
rural development by the European Agricultural Fund for Rural Development
(EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347,
20.12.2013, p. 487); 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).

[7]               Proposal for a Regulation of the European Parliament
and of the Council 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, plant reproductive material, plant protection products
and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005,
396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No
1151/2012, [....]/2013 [Office of Publications, please insert number of
Regulation laying down provisions for the management of expenditure relating to
the food chain, animal health and animal welfare, and relating to plant health
and plant reproductive material], and Directives 98/58/EC, 1999/74/EC,
2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls
Regulation), COM(2013)265 final of 6.5.2013.

[8]               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).

[9]               OJ C , , p. .

[10]             OJ C , , p. .

[11]             COM (2009) 234 final.

[12]             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).

[13]             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 Council
Regulation (EC) No 247/2006 (OJ L 78, 20.3.2013, p. 23).

[14]             Regulation (EU) No 1307/2013 of the European Parliament
and of the Council of 17 December 2013 establishing rules for direct payments
to farmers under support schemes within the framework of the common
agricultural policy and repealing Council Regulation (EC) No 637/2008 and
Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608).

[15]             Regulation (EU) No 1305/2013 of the European Parliament
and of the Council of 17 December 2013 on support for rural development by the
European Agricultural Fund for Rural Development (EAFRD) and repealing Council
Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487).

[16]             COM(2011) 244 final, ‘Our life insurance, our natural
capital: an EU biodiversity strategy to 2020’.

[17]             SWD(2013) 155 final, ‘Green Infrastructure (GI) –
Enhancing Europe's Natural Capital’.

[18]             COM(2006) 231 final, ‘Thematic Strategy for Soil
Protection’.

[19]             Directive 2009/147/EC of the European Parliament and of
the Council of 30 November 2009 on the conservation of wild birds (OJ L 20,
26.1.2010, p.7).

[20]             Council Directive 92/43/EEC of 21 May 1992 on the
conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992,
p.7).

[21]             Council Directive 91/676/EEC of 12 December 1991
concerning the protection of waters against pollution caused by nitrates from
agricultural sources (OJ L 375, 31.12.1991, p.1).

[22]             Directive 2000/60/EC of the European Parliament and of
the Council of 23 October 2000 establishing a framework for Community action in
the field of water policy (OJ L 327, 22.12.2000, p.1).

[23]             Directive 2001/81/EC of the European Parliament and of
the Council of 23 October 2001 on national emission ceilings for certain
atmospheric pollutants (OJ L 309, 27.11.2001, p. 22).

[24]             Directive 2009/18/EC of the European Parliament and of
the Council of 21 October 2009 establishing a framework for Community action to
achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71)

[25]             COM(2010)2020 final.

[26]             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).

[27]             Commission Recommendation 2003/361/EC of 6 May 2003
concerning the definition of micro, small and medium-sized enterprises (OJ L
124,  of 20.05.2003, p. 36).

[28]             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).

[29]             COM(2013) 229 of 29.4.2013.

[30]             Commission Regulation (EC) No
889/2008 of 5 September 2008 laying down detailed rules for 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).

[31]             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).

[32]             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).–

[33]             Regulation (EU) No XX/XXX of the European Parliament
and of the Council of [...] 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, plant reproductive material, plant protection
products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003,
1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU)
No 1151/2012, [....]/2013 [Office of Publications, please insert number of
Regulation laying down provisions for the management of expenditure relating to
the food chain, animal health and animal welfare, and relating to plant health
and plant reproductive material], and Directives 98/58/EC, 1999/74/EC,
2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls
Regulation)  (OJ L ...).

[34]             Regulation (EU) No 182/2011 of
the European Parliament and of the Council of 16 February 2011 laying down
the rules and general principles concerning mechanisms for control by the
Member States of Commission's exercise of implementing powers (OJ L 55, 28.2.2011,
p. 13).

[35]             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).

[36]             [full title] (OJ L,...).

[37]             [full title] (OJ L,...).

[38]             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).

[39]             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).

[40]             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).

[41]             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).

[42]             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).

[43]             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).

[44]             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).

[45]             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).

[46]             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)

[47]             Council Directive 96/29/Euratom of 13 May 1996 laying
down basic safety standards for the   protection of the health of workers and
the general public against the dangers arising from ionizing radiation (OJ L
159, 29.6.1996, p. 1).

[48]             Regulation (EC) 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).

[49]             Regulation (EC) 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).

[50]             Directive 95/46/EC of the European
Parliament and of the Council of 24 October 1995 on the protection of
individuals with regard to the processing of personal data and on the free
movement of such data (OJ L 281, 23.11.1995, p. 31).

[51]             Regulation (EC) No 765/2008 of the European Parliament
and of the Council of 9 July 2008 setting out the requirements for
accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

[52]             At least 6 months after enter into force.

[53]             ABM: activity-based management – ABB: activity-based
budgeting.

[54]             As referred to in Article 54(2)(a) or (b) of the
Financial Regulation.

[55]             Article 110 of Regulation (EU) No 1306/2013 of the
European Parliament and of the Council on the financing, management and
monitoring of the common agricultural policy.

[56]             Sanders, J (ed.) 2013: Evaluation of the EU legislation
on organic farming, Thünen Institute of Farm Economics http://ec.europa.eu/agriculture/evaluation/market-and-income-reports/organic-farming-2013_en.htm

[57]             Regulation EU
No  1307/2013 of the European Parliament and of the Council establishing rules
for direct payments to farmers under support schemes within the framework of
the common agricultural policy and repealing Council Regulation (EC) No
637/2008 and Council Regulation (EC) No 73/2009.

[58]             Regulation (EU) No 1305/2013 of the European Parliament
and of the Council on support for rural development by the European
Agricultural Fund for Rural Development (EARFD) and repealing Council
Regulation (EC) No 1698/2005.

[59]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site:http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[60]             Diff. = Differentiated appropriations / Non-Diff. =
Non-differentiated appropriations.

[61]             EFTA: European Free Trade Association.

[62]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[63]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[64]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[65]             In line with the Common Monitoring and Evaluation
framework of the CAP, a common monitoring and evaluation framework will be
established  as from 2014 onwards and indicators tables will therefore be duly
completed at a later stage

[66]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

ANNEX I

OTHER PRODUCTS REFERRED TO IN ARTICLE 2(1)

–
yeasts used as food or feed,

–
beer,

–
maté,

–
extracts, essences and concentrates of coffee,
tea and maté and preparations with a basis of those products or with a basis of
coffee, tea and maté; roasted chicory and other roasted coffee subsitutes, and
extracts, essences and concentrates thereof,

–
fruit nectars,

–
cocao paste, butter, fat, oil and powder;
chocolate, and other food preparations containing cocoa,

–
sugar confectionery,

–
preparations of cereals, flour, starch or milk;
pastrycooks' products,

–
soups,

–
sauces,

–
cooked meals,

–
ice cream,

–
flavoured yoghurts, yoghurts containing added
fruits, nuts or cocoa,

–
sea salt,

–
natural gums and resins,

–
pollen,

–
beeswax,

–
essential oils,

–
spirit drinks, provided that the ethyl alcohol
used for the production of the spirit drinks is exclusively of agricultural
origin.

ANNEX II

SPECIFIC PRODUCTION RULES REFERRED TO IN CHAPTER III

Part
I: Plant production rules

In addition to the production rules laid
down in Articles 7 to 10, the rules set out in this Part shall apply to organic
plant production.

1.
General requirements

1.1.
Hydroponic production, which is a method of
growing plants with their roots in a nutrient solution only or in an inert
medium to which a nutrient solution is added, is prohibited.

1.2.
All plant production techniques used shall
prevent or minimise any contribution to the contamination of the environment.

1.3.
Conversion

1.3.1.
For plants and plant products to be considered
organic, the production rules laid down in this Regulation must have been
applied on the parcels during a conversion period of at least two years before
sowing, or, in the case of grassland or perennial forage, at least two years
before its use as feed from organic production, or, in the case of perennial
crops other than forage, at least three years before the first harvest of
organic products.

1.3.2.
The competent authority may decide, in the cases
where the land has been contaminated with products not authorised for organic
production, to extend the conversion period beyond the period referred to in
point 1.3.1.

1.3.3.
In the case of treatment with a product not
authorised for organic production, the competent authority shall require a new
conversion period in accordance with point 1.3.1.

That period may
be shortened in the following two cases:

(a)
treatment with a product not authorised for
organic production as part of a compulsory control measure for pests or weeds,
including quarantine organisms or invasive species, imposed by the competent
authority of the Member State;

(b)
treatment with a product not authorised for
organic production as part of scientific tests approved by the competent
authority of the Member State.

1.3.4.
In the cases referred to in points 1.3.2. and
1.3.3., the length of the conversion period shall be fixed taking into account
the following factors:

(a)
the process of degradation of the product
concerned shall guarantee, at the end of the conversion period, an
insignificant level of residues in the soil and, in the case of a perennial
crop, in the plant;

(b)
the harvest following the treatment may not be
sold with reference to organic production.

1.3.5.
The specific conversion rules for land associated with organic livestock production should
be as follows:

1.3.5.1.
The conversion rules shall apply to the whole
area of the production unit on which animal feed is produced.

1.3.5.2.
Notwithstanding point 1.3.5.1., the conversion
period may be reduced to one year for pasturages and open air areas used by
non-herbivore species.

1.4.
Origin of plants
including plant reproductive material

1.4.1.
For the production of plants and plant products
only organically produced plant reproductive material shall be used. To this end, the plant intended for plant
reproductive material production and, where relevant, the mother plant 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.

1.4.2.
Use of plant
reproductive material not obtained from organic
production

Plant reproductive material not obtained from
organic production may be used only when it comes from a production unit in
conversion to organic production or where it is justified for use in research,
test in small-scale field trials or for genetic resources conservation purposes
agreed by the competent authority of the Member State.

1.5.
Soil management and fertilisation

1.5.1.
Organic plant production shall use tillage and
cultivation practices that maintain or increase soil organic matter, enhance
soil stability and soil biodiversity, and prevent soil compaction and soil
erosion.

1.5.2.
The fertility and biological activity of the
soil shall be maintained and increased by multiannual crop rotation including
legumes and other green manure crops, and by the application of livestock
manure or organic material, both preferably composted, from organic production.

1.5.3.
Where the nutritional needs of plants cannot be
met by measures provided for in points 1.5.1. and 1.5.2. only fertilisers and
soil conditioners authorised for use in organic production pursuant to Article
19 may be used and only to the extent necessary.

1.5.4.
The total amount of livestock manure, as defined
in Council Directive 91/676/EEC[1],
applied on the agricultural holding, shall not exceed 170 kg of nitrogen per
year/hectare of agricultural area used. That limit shall only apply to the use
of farmyard manure, dried farmyard manure and dehydrated poultry manure,
composted animal excrements, including poultry manure, composted farmyard
manure and liquid animal excrements.

1.5.5.
Organic agricultural holdings may establish
written cooperation agreements exclusively with other agricultural holdings and
enterprises which comply with the organic production rules, with the intention
of spreading surplus manure from organic production. The maximum limit as
referred to in point 1.5.4., shall be calculated on the basis of all of the
organic production units involved in such cooperation.

1.5.6.
Preparations of micro-organisms may be used to
improve the overall condition of the soil or the availability of nutrients in
the soil or in the crops.

1.5.7.
For compost activation appropriate plant-based
preparations or preparations of micro-organisms may be used.

1.5.8.
Mineral nitrogen fertilisers shall not be used.

1.6.
Pest and weed management

1.6.1.
The prevention of damage caused by pests and
weeds shall rely primarily on the protection by:

–
natural enemies,

–
the choice of species, varieties and
heterogeneous material,

–
crop rotation,

–
cultivation techniques such as biofumigation,
and

–
thermal processes such as solarisation and
shallow steam treatment of the soil (to a maximum depth of 10 cm).

1.6.2.
Where plants cannot be protected adequately from
pests by measures provided for in point 1.6.1. or in the case of an established
threat to a crop, only products authorised for use in organic production
pursuant to Article 19 may be used and only to the extent necessary.

1.6.3.
The traps or dispensers of products other than
pheromones shall prevent the substances from being released into the
environment and prevent contact between the substances and the crops being
cultivated. The traps shall be collected after use and disposed of safely.

1.7.
Products  used for cleaning and disinfection

With regard to
cleaning and disinfection, only the products for cleaning and disinfection in
plant production authorised for use in organic production pursuant to Article
19 shall be used.

2.
Requirements for specific plants or plant
products

2.1.
Rules on mushroom production

For the
production of mushrooms, substrates may be used, if they are composed only of
the following components:

(a)
farmyard manure and animal excrements:

(i)      either from agricultural holdings
producing according to the organic production rules; or

(ii)     referred to in point 1.5.3., only
when the product referred to in point (i) is not available, provided that these
farmyard manure and animal excrements do not exceed 25 % of the weight of total
components of the substrate, excluding the covering material and any added
water, before composting;

(b)
products of agricultural origin, other than
those referred to in point (a), from agricultural holdings producing according
to the organic production rules;

(c)
peat not chemically treated;

(d)
wood, not treated with chemical products after
felling;

(e)
mineral products referred to in point 1.5.3.,
water and soil.

2.2.
Rules concerning the collection of wild plants

The collection
of wild plants and parts thereof, growing naturally in natural areas, forests
and agricultural areas is considered as organic production provided that:

(a)
those areas have not, for a period of at least
three years before the collection, received treatment with products other than
those authorised for use in organic production pursuant to Article 19;

(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 7, 8, 9 and 11, the rules laid down in this Part shall apply
to livestock production.

1.
General requirements

1.1.
Where the farmer producing livestock does not
manage agricultural land and has not established a written cooperation agreement
with another farmer, landless livestock production shall be prohibited.

1.2.
Conversion

1.2.1.
The conversion period shall start at the
earliest when the farmer has notified his activity to the competent authorities
and subjected his holding to the control system in accordance with this
Regulation.

1.2.2.
Conversion periods specific to the type of
animal production are set out in point 2.

1.2.3.
Animals and animal products produced during the
conversion period shall not be marketed as organic.

1.2.4.
Animals and animal products may be considered
organic at the end of the conversion period if there is simultaneous conversion
of the complete production unit, including livestock, pasturage or any land
used for animal feed.

1.3.
Origin of animals

1.3.1.
Organic livestock shall be born and raised on
organic agriculturalholdings.

1.3.2.
Animals existing on the agricultural holding at
the beginning of the conversion period and their products may be deemed organic
after compliance with the applicable conversion period referred to in point 2.

1.3.3.
With regard to the breeding of organic animals:

(a)
reproduction shall use natural methods; however,
artificial insemination shall be allowed;

(b)
reproduction shall not be induced by treatment
with hormones or similar substances, unless as a form of veterinary therapeutic
treatment in case of an individual animal;

(c)
other forms of artificial reproduction, such as
cloning and embryo transfer, shall not be used;

(d)
the choice of breeds shall be appropriate and
shall contribute to the prevention of any suffering and to avoiding the need for
the mutilation of animals.

1.3.4.
In the choice of breeds or strains, account
shall be taken of the capacity of animals to adapt to local conditions, without
impairment of their welfare, their vitality and their resistance to disease. In
addition, breeds or strains of animals shall be selected to avoid specific
diseases or health problems associated with some breeds or strains used in
intensive production, such as porcine stress syndrome, pale-soft-exudative
(PSE) syndrome, sudden death, spontaneous abortion and difficult births
requiring caesarean operations. Preference shall be given to indigenous breeds
and strains.

1.3.5.
For breeding purposes, non-organically raised
animals may be brought onto an agricultural holding when breeds are in danger
of being lost to farming in accordance with Annex IV to Commission Regulation
(EC) No 1974/2006[2]
and in that case animals of those breeds must not necessarily be nulliparous.

1.4.
Nutrition

1.4.1.
General nutrition requirements

With regard to
nutrition the following rules shall apply:

(a)
feed for livestock shall be obtained primarily
from the agricultural holding where the animals are kept or from other organic
holdings in the same region;

(b)
livestock shall be fed with organic feed that
meets the animal's nutritional requirements at the various stages of its
development. Restricted feeding shall not be permitted in livestock production;

(c)
the keeping of livestock in conditions, or on a
diet which may encourage anaemia, shall be prohibited;

(d)
fattening practices shall be reversible at any
stage of the rearing process. Force-feeding is forbidden;

(e)
with the exception of bees, livestock shall have
permanent access to pasture or roughage;

(f)
growth promoters and synthetic amino-acids shall
not be used;

(g)
suckling animals shall be fed in preference on 
maternal milk for a minimum period;

(h)
feed materials of mineral origin, feed
additives, certain products used in animal nutrition and processing aids shall
be used only if they have been authorised for use in organic production
pursuant to Article 19.

1.4.2.
Grazing of common land and transhumance

1.4.2.1.
Organic animals may be grazed on common land,
provided that:

(a)
the common land is fully managed in accordance
with this Regulation;

(b)
any non-organic animals which use the land
concerned are derived from a production system equivalent to one of those
provided for  in Articles 28 and 30 of Regulation (EU) No 1305/2013[3];

(c)
any livestock products from organic animals,
whilst using this land, is not regarded as being from organic production,
unless adequate segregation from non-organic animals can be proved.

1.4.2.2.
During the period of transhumance animals may
graze on non-organic land when they are being moved on foot from one grazing
area to another. The uptake of non-organic feed, in the form of grass and other
vegetation on which the animals graze, shall be allowed for a maximum of 35
days covering both the outward and return journeys.

1.4.3.
In-conversion feed

1.4.3.1.
For in-conversion agricultural holdings, up to
15 % of the total average amount of feed fed to livestock may originate from
the grazing or harvesting of permanent pastures, perennial forage parcels or
protein crops, sown under organic management on lands in their first year of
conversion, provided that they are part of the holding itself. Feed in their
first year of conversion may not be used for the production of organic
processed feed. When both in-conversion feed and feed from parcels in their
first year of conversion are being used, the total combined percentage of such
feed shall not exceed the maximum percentages fixed in point 1.4.3.2.

1.4.3.2.
For organic agricultural holdings, up to 20 % on
average of the feed formula of rations may comprise in-conversion feed, namely
feed from the second year of conversion. For in-conversion agricultural
holdings, when the in-conversion feed come from the holding itself, this
percentage may be increased to 100.

1.4.3.3.
The figures in points 1.4.3.1. and 1.4.3.2.
shall be calculated annually as a percentage of the dry matter of feed of plant
origin.

1.4.4.
Use of certain feed materials and substances in
feed

Only organic
feed materials of animal origin as well as feed materials and feed additives
authorised for use in organic production pursuant to Article 19 may be used in
the processing of organic feed and in the feeding of organic animals.

1.5.
Health care

1.5.1.
Disease prevention

1.5.1.1.
Disease prevention shall be based on breed and
strain selection, husbandry management practices, high quality feed and
exercise, appropriate stocking density and adequate and appropriate housing
maintained in hygienic conditions.

1.5.1.2.
The use of immunological veterinary medicinal
products shall be allowed.

1.5.1.3.
The use of chemically synthesised allopathic
veterinary medicinal products or antibiotics for preventive treatment shall be
prohibited.

1.5.1.4.
The use of substances to promote growth or
production (including antibiotics, coccidiostatics and other artificial aids
for growth promotion purposes) and the use of hormones or similar substances to
control reproduction or for other purposes (e.g. induction or synchronisation
of oestrus), shall be prohibited.

1.5.1.5.
Where livestock is obtained from non-organic
units, special measures such as screening tests or quarantine periods shall
apply, depending on local circumstances.

1.5.1.6.
With regard to cleaning and disinfection, only
the products for cleaning and disinfection in livestock buildings and installations
authorised for use in organic production pursuant to Article 19 shall be used.

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 the products
authorised for use in organic production pursuant to Article 19 may be used for
the elimination of insects and other pests in buildings and other installations
where livestock is kept.

1.5.2.
Veterinary treatment

1.5.2.1.
Where despite preventive measures to ensure
animal health animals become sick or injured they shall be treated immediately.

1.5.2.2.
Disease shall be treated immediately to avoid
suffering of the animal; chemically synthesised allopathic veterinary medicinal
products including antibiotics may be used where necessary and under strict
conditions and under the responsibility of a veterinarian, when the use of
phytotherapeutic, homeopathic and other products is inappropriate. In
particular restrictions with respect to courses of treatment and withdrawal
periods shall be defined.

1.5.2.3.
Feed materials of mineral origin and nutritional
additives authorised for use in organic production pursuant to Article 19 and
phytotherapeutic and homeopathic products shall be used in preference to
chemically-synthesised allopathic veterinary treatment including antibiotics,
provided that their therapeutic effect is effective for the species of animal,
and the condition for which the treatment is intended.

1.5.2.4.
With the exception of vaccinations, treatments
for parasites and compulsory eradication schemes where an animal or group of
animals receive more than three courses of treatments with
chemically-synthesised allopathic veterinary medicinal products including
antibiotics within 12 months, or more than one course of treatment if their
productive lifecycle is less than one year, the livestock concerned, or produce
derived from them, shall not be sold as organic products, and the livestock
shall undergo the conversion periods referred to in points 1.2 and 2.

1.5.2.5.
The withdrawal period between the last
administration of an allopathic veterinary medicinal product to an animal under
normal conditions of use, and the production of organically produced foodstuffs
from such animals, is to be twice the  withdrawal period as referred to in
Article 11 of Directive 2001/82/EC or, in a case in which this period is not
specified, 48 hours.

1.5.2.6.
Treatments related to the protection of human
and animal health imposed on the basis of Union legislation shall be allowed.

1.6.
Housing conditions and husbandry practices

1.6.1.
Insulation, heating and
ventilation of the building shall ensure that air circulation, dust level,
temperature, relative air humidity and gas concentration, are kept within
limits which ensure the well-being of the animals. The building shall permit
plentiful natural ventilation and light to enter.

1.6.2.
Housing for livestock shall not be mandatory in areas with appropriate climatic
conditions to enable animals to live outdoors. Livestock shall have permanent
access to open air areas, preferably pasture, whenever weather conditions and
the state of the ground allow this, unless restrictions and obligations related
to the protection of human and animal health are imposed on the basis of Union
legislation. 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, the well-being
and the species-specific needs of the animals which, in particular, shall
depend 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,
move, lie down easily, turn round, groom themselves, assume all natural
postures and make all natural movements such as stretching and wing flapping.

1.6.4.
The minimum surface for indoor and outdoor areas, and other characteristics of
housing for different species and categories of animals, shall be as set out in
points 2.1.4., 2.2.4., 2.3.4. and 2.4.5.

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.

1.6.7.
To determine the appropriate density of
livestock referred to in point 1.6.6, the competent authority shall set out the
livestock units equivalent to the limit referred to in point 1.6.6., following
the figures laid down in each of the specific requirement by animal production.

1.7.
Animal welfare

1.7.1.
All persons involved in keeping animals shall possess the necessary basic knowledge and skills as
regards the health and the welfare needs of the
animals.

1.7.2.
Husbandry practices,
including stocking densities and housing conditions shall ensure that the developmental,
physiological and ethological needs of animals are met.

1.7.3.
The livestock shall have permanent access to open air areas, preferably pasture,
whenever weather conditions and the state of the ground allow this unless
restrictions and obligations related to the protection of human and animal
health are imposed on the basis of Union legislation.

1.7.4.
The number of livestock shall be limited with a view to minimising
overgrazing, poaching of soil, erosion, or pollution caused by animals or by
the spreading of their manure.

1.7.5.
Where Article 8(5) and point 1.4.2.2. of this
Part apply, organic livestock shall be kept separate from other livestock.

1.7.6.
Tethering or isolation
of livestock shall be prohibited, unless for individual animals for a limited
period of time, and in so far as this is justified for veterinary reasons.
Competent authorities may authorise cattle in micro-enterprises to be tethered
if it is not possible to keep the cattle in groups appropriate to their
behaviour requirements, provided they have access to pastures during the
grazing period, and at least twice a week access to open air areas when grazing
is not possible.

1.7.7.
Duration of transport of
livestock shall be minimised.

1.7.8.
Any suffering shall be kept to a minimum during the entire life of the animal,
including at the time of slaughter.

1.7.9.
Mutilation of animals shall
be prohibited.

1.7.10.
Any suffering to the animals shall be reduced to a minimum by applying adequate
anaesthesia and/or analgesia and by carrying out the operation only at the most
appropriate age by qualified personnel.

1.7.11.
Physical castration shall
be allowed in order to maintain the quality of products and traditional
production practices but only under adequate anaesthesia or analgesia and by
carrying out the operation only at the most appropriate age by qualified
personnel.

1.7.12.
Loading and unloading of animals shall be carried out without the use of any
type of electrical stimulation to coerce the animals. The use of allopathic
tranquillisers, prior to or during transport, shall be prohibited.

2.
Requirements for specific livestock
species

2.1.
Production of bovine, ovine and caprine animals

2.1.1.
Conversion

For bovine,
ovine and caprine animals and their products to be considered organic, the
production rules set out in this Regulation must have been applied for at
least:

(a)
12 months in the case of bovines animals for
meat production, and in any case at least three quarters of their lifetime;

(b)
six months in the case of ovine and caprine
animals and of animals for milk production.

2.1.2.
Nutrition

With regard to
nutrition the following rules shall apply:

(a)
bovine, ovine and caprine animals shall have
access to pasturage for grazing whenever conditions allow;

(b)
notwithstanding point (a), male bovine animals
over one year old shall have access to pasturage or an open air area;

(c)
in cases where bovine, ovine and caprine animals
have access to pasturage during the grazing period and where the winter-
housing system gives freedom of movement to the animals, the obligation to
provide open air areas during the winter months may be waived;

(d)
except during the period each year when the
animals are under transhumance referred to in point 1.4.2.2., at least 90 % of
the feed shall come from the farm itself or in case this is not feasible, be
produced in cooperation with other organic farms in the same region;

(e)
rearing systems for bovine, ovine and caprine
animals shall be based on maximum use of grazing pasturage according to the
availability of pastures in the different periods of the year. At least 60 % of
the dry matter in daily rations of bovine, ovine and caprine animals shall
consist of roughage, fresh or dried fodder, or silage. A reduction to 50 % for
animals in dairy production for a maximum period of three months in early
lactation shall be allowed;

(f)
all suckling bovine, ovine and caprine animals
shall be fed in preference on maternal milk for a minimum period of three
months for bovine animals and 45 days for ovine and caprine animals.

2.1.3.
Specific housing conditions

With regard to
the housing conditions the following rules shall apply:

(a)
housing of bovine, ovine and caprine animals
shall have smooth, but not slippery floors. At least half of the indoor surface
area as specified in the table on minimum surface areas for bovine, ovine and
caprine animals set out in point 2.1.4., shall be solid, that is, not of
slatted or of grid construction;

(b)
the housing shall be provided with a
comfortable, clean and dry laying/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 as fertiliser or soil conditioner for use in
organic production pursuant to Article 19;

(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[4],
the housing of calves in individual boxes shall be forbidden after the age of
one week, unless for individual animals for a limited period of time, and in so
far as this is justified for veterinary reasons.

2.1.4.
Stocking density

The number of bovine, ovine and caprine animals per
hectare shall respect the following limits:

Class or species || Maximum number of animals per ha equivalent to 170 kg N/ha/year

Calves for fattening || 5

Other bovine animals less than one year old || 5

Male bovine animals from one to less than two years old || 3,3

Female bovine animals from one to less than two years old || 3,3

Male bovine animals two years old or over || 2

Breeding heifers || 2,5

Heifers for fattening || 2,5

Dairy cows || 2

Cull dairy cows || 2

Other cows || 2,5

Goats || 13,3

Ewes || 13,3

The minimum
surface areas indoors and outdoors and other characteristics of housing of
bovine, ovine, and caprine animals shall be as follows:

|| Indoors area (net area available to animals) || Outdoors area (exercise area, excluding pasturage)

|| Live weight minimum (kg) || M2/head || M2/head

Breeding and fattening bovine animals || up to 100 || 1,5 || 1,1

up to 200 || 2,5 || 1,9

up to 350 || 4,0 || 3

over 350 || 5 with a minimum of 1 m2/100 kg || 3,7 with a minimum of 0,75 m2/100 kg

Dairy cows || || 6 || 4,5

Bulls for breeding || || 10 || 30

Ovine and caprine animals || || 1,5 sheep/goat || 2,5

|| 0,35 lamb/kid || 2,5 with 0,5 per lamb/kid

2.2.
Production of equine animals

2.2.1.
Conversion

For equine animals and their products to be
considered organic, the production rules of this Regulation must have been
applied for at least:

(a)
12 months, for meat production, and in any case
at least three quarters of their lifetime;

(b)
six months in the case of animals for milk
production.

2.2.2.
Nutrition

With regard to
nutrition the following rules shall apply:

(a)
equine animals shall have access to pasturage
for grazing whenever conditions allow;

(b)
in cases where equine animals have access to
pasturage during the grazing period and where the winter-housing system gives
freedom of movement to the animals, the obligation to provide open air areas
during the winter months may be waived;

(c)
except during the period each year when the
animals are under transhumance as mentioned in point
1.4.2.2., at least 90 % of the feed shall come from the farm  itself or in case
this is not feasible, be produced in cooperation with other organic farms in
the same region;

(d)
rearing systems for equine animals shall be
based on maximum use of grazing pasturage according to the availability of
pastures in the different periods of the year. At least 60 % of the dry matter
in daily rations of equine animals shall consist of roughage, fresh or dried
fodder, or silage;

(e)
all suckling equine animals shall be fed in
preference on maternal milk, for a minimum period of
three months.

2.2.3.
Specific housing conditions

With regard to
the housing conditions the following rules shall apply:

(a)
housing of equine animals shall have smooth, but
not slippery floors. At least half of the indoor surface area as specified in
the table on minimum surface areas for equine animals set out in point 2.2.4.,
shall be solid, that is, not of slatted or of grid construction;

(b)
the housing shall be provided with a
comfortable, clean and dry laying/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 as fertiliser or soil
conditioner for use in organic production pursuant to Article 19.

2.2.4.
Stocking density

The number of equine
animals per hectare shall respect the following limit:

Class or species || Maximum number of animals per ha equivalent to 170 kg N/ha/year

Equine animals over six months old || 2

The minimum surface areas indoors and outdoors
and other characteristics of housing equine animals shall be as follows:

|| Indoors area (net area available to animals) || Outdoors area (exercise area, excluding pasturage)

|| Live weight minimum (kg) || M2/head || M2/head

Breeding and fattening equine animals || up to 100 || 1,5 || 1,1

up to 200 || 2,5 || 1,9

up to 350 || 4,0 || 3

over 350 || 5 with a minimum of 1 m2/100 kg || 3,7 with a minimum of 0,75 m2/100 kg

2.3.
Production of porcine animals

2.3.1.
Conversion

For porcine animals and their products to be
considered organic, the production rules of this Regulation must have been
applied for at least six months.

2.3.2.
Nutrition

With regard to
nutrition the following rules shall apply:

(a)
at least 60 % of the feed shall come from the
farm itself or in case this is not feasible, be produced in the same region in
cooperation with other organic farms or feed operators;

(b)
all suckling porcine animals shall be fed in
preference on maternal milk, for a minimum period of 40 days;

(c)
roughage, fresh or dried fodder, or silage shall
be added to the daily ration for pigs.

2.3.3.
Specific housing conditions

With regard to
the housing conditions the following rules shall apply:

(a)
housing of porcine animals shall have smooth,
but not slippery floors. At least half of the indoor surface area as specified
in the table on minimum surface areas for porcine animals set out in point
2.3.4., shall be solid, that is, not of slatted or of grid construction;

(b)
the housing of porcine animals shall be provided
with a comfortable, clean and dry laying/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 as fertiliser or soil
conditioner for use in organic production pursuant to Article 19;

(c)
sows shall be kept in groups, except in the last
stages of pregnancy and during the suckling period;

(d)
piglets shall not be kept on flat decks or in
piglet cages;

(e)
exercise areas shall permit dunging and rooting
by porcine animals. For the purposes of rooting different substrates can be used.

2.3.4.
Stocking density

The number of porcine animals per hectare shall respect the following limits:

Class or species || Maximum number of animals per ha equivalent to 170 kg N/ha/year

Piglets || 74

Breeding sows || 6,5

Porcine animals for fattening || 14

Other porcine animals || 14

The minimum
surface areas indoors and outdoors and other characteristics for housing
porcine animals shall be as follows:

|| Indoors area (net area available to animals) || Outdoors area (exercise area, excluding pasturage)

|| Live weight minimum (kg) || M2/head || M2/head

Farrowing sows with piglets up to 40 days || || 7,5 sow || 2,5

Fattening porcine animals || up to 50 || 0,8 || 0,6

up to 85 || 1,1 || 0,8

up to 110 || 1,3 || 1

Piglets || over 40 days and up to 30 kg || 0,6 || 0,4

Brood porcine animals || || 2,5 female || 1,9

|| 6 male If pens are used for natural service: 10 m2/boar || 8,0

2.4.
Production of poultry

2.4.1.
Conversion

For poultry and
their products to be considered organic, the production rules of this Regulation must have been applied for at least:

(a)
10 weeks for poultry for meat production,
brought in before they are three days old;

(b)
six weeks in the case of poultry for egg production.

2.4.2.
Origin of poultry

Poultry shall
either be reared until they reach a minimum age or else shall come from slow-growing
poultry strains as defined by the competent authority. 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;

(b)
150 days for capons;

(c)
49 days for Peking ducks;

(d)
70 days for female Muscovy ducks;

(e)
84 days for male Muscovy ducks;

(f)
92 days for Mallard ducks;

(g)
94 days for guinea fowl;

(h)
140 days for male turkeys and roasting geese;
and

(i)
100 days for female turkeys.

2.4.3.
Nutrition

With regard to
nutrition the following rules
shall apply:

(a)
at least 60 % of the feed shall come from the farm itself or in case this is
not feasible, be produced in the same region in cooperation with other organic
farms or feed operators;

(b)
roughage, fresh or dried fodder, or silage shall
be added to the daily ration.

2.4.4.
Specific housing conditions

With regard to
the housing conditions the following rules shall apply:

(a)
poultry shall not be
kept in cages;

(b)
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, they shall have access to water which enables
them to dip their head therein so as to clean plumage;

(c)
poultry shall have access to an open air area
for at least one third of their life. Open air areas for poultry shall be
mainly covered with vegetation and be provided with protective facilities and
permit fowl to have easy access to adequate numbers of drinking troughs;

(d)
where poultry are kept indoors due to
restrictions or obligations imposed on the basis of Union legislation, they
shall permanently have access to sufficient quantities of roughage and suitable
material in order to meet their ethological needs;

(e)
buildings for all
poultry shall meet the following conditions:

(i)      at least one third of the floor area
shall be solid, that is, not of slatted or of grid construction, and covered
with a litter material such as straw, wood shavings, sand or turf;

(ii)     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;

(iii)    poultry shall have perches of a size
and number commensurate with the size of the group and of the birds as laid
down in the table on the minimum surface areas indoors and outdoors and other
characteristics of housing for poultry production set out in point 2.4.5.;

(iv)    the external boundary of the house,
i.e. including a possible veranda, shall have exit/entry pop-holes of a size
adequate for the birds, and those pop-holes shall have a combined length of at
least 4 m per 100 m2 area of the house available to the birds. Where a veranda
is present, the internal pop-holes between the house and the veranda shall have
a combined length of 2 m per 100 m2 area of the house. Twenty-four hour access
to the veranda must be allowed;

(v)     poultry houses shall be constructed in
a manner allowing all birds easy access to open air area, i.e. the maximum
distance from any point within the house to the nearest external pop-hole shall
not be more than 15 m;

(vi)    multi-layer systems shall have no more
than three levels of usable area including the ground floor. There shall be no
more than 1 m between levels or intermediate areas, such as nesting areas. Higher
tiers shall be capable of having manure removed by an automated system;

(f)
natural light may be supplemented by artificial means to provide a maximum of 16
hours light per day with a continuous nocturnal rest period without artificial
light of at least eight hours;

(g)
buildings shall be
emptied of livestock between each batch of poultry reared. The buildings and
fittings shall be cleaned and disinfected during this time. In addition, when
the rearing of each batch of poultry has been completed, runs shall be left
empty during a period to be established by the Member States in order to allow
vegetation to grow back. These requirements shall not apply where poultry are
not reared in batches, are not kept in runs and are free to roam, throughout
the day.

2.4.5.
Stocking density

The maximum number of animals per hectare shall respect the following limits:

Class or species || Maximum number of animals per ha equivalent to 170 kg N/ha/year

Broilers || 580

Laying hens || 230

The minimum
surface area indoors and outdoors and other characteristics of housing for
birds of the species Gallus gallus shall be as follows:

|| Breeders/ parents || Young stock || Fattening birds || Capons || Layers

Age || Breeding birds || Pullets 0-8 weeks || Pullets 9-18 weeks || Starter 0-21 days || Finisher 22 to 81 days || 22-150 days || Laying hens from 19 weeks

In house stocking rate (birds per m2 of usable area) for fixed and mobile houses || 6 birds || 24 birds with a maximum of 21 kg liveweight/m2 || 15 birds with a maximum of 21 kg liveweight/m2 || 20 birds with a maximum of 21 kg liveweight/m2 || 10 birds with a maximum of 21 kg liveweight/m2 || 10 birds with a maximum of 21 kg liveweight/m2 || 6 birds

Perch space (cm) || || || || || 18

Multi-layer systems additional limits/m2 of ground floor area (including veranda if 24h access) || 9 birds || 36 birds excluding veranda area || 22 birds || Not normally applicable || 9 birds

Flock size limits || 3.000 including males || 10,000* || 3,300 || 10,000* || 4,800 || 2,500 || 3,000

Open-air run stocking rates (m2/bird), provided that the limit of 170 kg of N/ha/year is not exceeded || 4 || 1 || 4 || 1 || 4 || 4 || 4

*    sub-dividable
to produce 3x3000 or 2x4800 batches

The minimum
surface areas indoors and outdoors and other characteristics of housing for
birds of species other than Gallus gallus shall be as follows:

|| Turkeys || Geese || Ducks || Guinea fowl

Type || Male || Female || All || Peking || Male Muscovy || Female Muscovy || Mallard || All

In house stocking rate (birds per m2 of usable area) for fixed and mobile houses || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2 || 10 with a maximum of 21 kg liveweight/m2

Perch space (cm) || 40 || 40 || Not normally applicable || Not normally applicable || 40 || 40 || Not normally applicable || 20

Flock size limits || 2,500 || 2,500 || 2,500 || 4,000 females 3,200 males || 3,200 || 4,000 || 3,200 || 5,200

Open air stocking rate (m2/bird) provided that the limit of 170 kg of N/ha/year is not exceeded || 10 || 10 || 15 || 4.5 || 4.5 || 4.5 || 4.5 || 4

2.4.6.
Access to open air areas

With regard to
access to open air areas the following rules shall apply:

(a)
poultry shall have access to an open air area
for at least one third of their life. In particular, continuous daytime open
air access shall be provided from as early an age as practically possible,
whenever physiological and physical conditions allow, except in the case of
temporary restrictions imposed on the basis of Union legislation;

(b)
open air areas for poultry shall be mainly
covered with vegetation composed of a diverse range of plants and be provided
with protective facilities and permit fowl to have easy access to adequate
numbers of drinking troughs. The vegetation on the open-air area must be
harvested and removed at regular intervals to reduce the potential for nutrient
surpluses. The open air areas shall not extend beyond a radius of 150 m from
the nearest pop-hole of the poultry house. However an extension of up to 350 m
from the nearest pop-hole of the poultry house is permissible provided that a sufficient
number of shelters and drinking troughs are evenly distributed throughout the
whole open-air area with at least four shelters per hectare;

(c)
under conditions where feed availability from
the range area is limited, due for instance to long term snow cover or arid
weather conditions, supplementary feeding of roughage must be included as part
of poultry diets;

(d)
where poultry are kept indoors due to
restrictions or obligations imposed on the basis of Union legislation, they
shall permanently have access to sufficient quantities of roughage and suitable
material in order to meet their ethological needs.

2.4.7.
Animal welfare

Live plucking of poultry shall be prohibited.

2.5.
Beekeeping

2.5.1.
Conversion

Beekeeping products may be sold with references to
organic production only when the organic production rules set out in this
Regulation have been complied with for at least one year.

During the conversion period the wax shall be replaced with wax coming
from organic beekeeping.

2.5.2.
Origin of bees

Preference shall
be given to the use of Apis
mellifera and their local ecotypes.

2.5.3.
Nutrition

With regard to
nutrition the following rules shall apply:

(a)
at the end of the production season hives shall
be left with sufficient reserves of honey and pollen to survive the winter;

(b)
the feeding of bee colonies shall only be
permitted where the survival of the hives is endangered due to climatic
conditions. Feeding shall be with organic honey, organic sugar syrups, or
organic sugar.

2.5.4.
Specific rules on disease prevention and
veterinary treatment in beekeeping

With regard to
disease prevention and veterinary treatment the following rules shall apply:

(a)
for the purposes of protecting frames, hives and
combs, in particular from pests, only rodenticides (to be used only in traps),
and appropriate products authorised for use in organic production pursuant to
Article 19 shall be permitted;

(b)
physical treatments for disinfection of apiaries
such as steam or direct flame shall be permitted;

(c)
the practice of destroying the male brood shall
be permitted only to isolate 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,
the colonies 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;

(f)
if a treatment is applied with chemically
synthesised allopathic products, during such a period, the colonies treated
shall be placed in isolation apiaries and all the wax shall be replaced with
wax coming from organic beekeeping. Subsequently, the conversion period of one
year laid down in point 2.5.1. shall apply to those colonies;

(g)
point (f) shall not apply to products authorised
for use in organic production pursuant to Article 19.

2.5.5.
Specific housing conditions in beekeeping

With regard to
the housing conditions the following rules shall apply:

(a)
apiaries shall be placed in areas which ensure
nectar and pollen sources consisting essentially of organically produced crops
or, as 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 beekeeping 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 as provided
for in Articles 28 and 30 of Regulation (EU) No 1305/2013 which cannot affect
the qualification of beekeeping production as being organic. These requirements
do not apply where flowering is not taking place, or the hives 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;

2.5.6.
Specific rules on practices in beekeeping

With regard to
beekeeping practices the following rules shall apply:

(a)
the beeswax for new foundations shall come from
organic production units;

(b)
only natural products such as propolis, wax and
plant oils may be used in the hives;

(c)
the use of chemical synthetic repellents shall
be prohibited during honey extraction operations;

(d)
the use of brood combs shall be prohibited for
honey extraction;

(e)
beekeeping shall not be considered as organic
when practiced in regions or areas designated by Member States as regions or
areas where organic beekeeping is not practicable.

2.5.7.
Animal welfare

With regard to
animal welfare the following rules shall apply:

(a)
the destruction of bees in the combs as a method
associated with the harvesting of beekeeping products shall be prohibited;

(b)
mutilation such as clipping the wings of queen
bees shall be prohibited.

Part
III: Production rules for seaweed and aquaculture animals

1.
Definitions

For the purposes
of this Part, the following definitions shall apply:

(1)
‘closed recirculation aquaculture facility’
means a facility where aquaculture takes place within an enclosed environment
on land or on a vessel involving the recirculation of water, and depending on
permanent external energy input to stabilise the environment for the
aquaculture animals;

(2)
‘energy from renewable sources’ means renewable
non-fossil energy sources such as wind, solar, geothermal wave, tidal,
hydropower, landfill gas, sewage treatment plant gas and biogases;

(3)
‘hatchery’ means a place of breeding, hatching
and rearing through the early life stages of aquaculture animals, finfish and
shellfish in particular;

(4)
‘nursery’ means
a place where an intermediate production system is
applied between the hatchery and grow-out stages. The nursery stage is completed
within the first third of the production cycle with the exception of species
undergoing a smoltification process;

(5)
‘pollution’ means the direct or indirect
introduction into the aquatic environment of substances or energy as defined in
Directive 2000/60/EC of the European Parliament and of the Council[5] and in Directive
2008/56/EC of the European Parliament and of the Council[6], in the waters to which
those Directives apply, respectively;

(6)
‘polyculture’ means the
rearing of two or more species usually from different trophic levels in the
same culture unit;

(7)
‘production cycle’ means
the lifespan of an aquaculture animal or seaweed from
the earliest life stage (fertilised eggs in the case of aquaculture animals) to
harvesting;

(8)
‘locally grown species’ means species
which are neither alien nor locally absent species under Council Regulation
(EC) No 708/2007[7], as well as the species listed in Annex IV
to that Regulation;

(9)
‘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.

2.
General
requirements

2.1.
Operations shall be situated in locations that
are not subject to contamination by products or substances not authorised for
use in organic production, or pollutants that would compromise the organic
nature of the products.

2.2.
Organic and non-organic production
units shall be separated adequately and in accordance with the minimum
separation distances set by Member States, where such minimum separation
distances have been set. Such separation measures shall be based on the natural
situation, separate water distribution systems, distances, the tidal flow, the
upstream and the downstream location of the organic production unit. Seaweed
production shall not be considered as organic when practiced at locations or in
areas designated by Member State authorities as locations or areas which are
unsuitable for organic aquaculture or seaweed harvesting.

2.3.
An environmental assessment proportionate
to the production unit shall be required for all new operations applying for
organic production and producing more than 20 tonnes of aquaculture products
per year to ascertain the conditions of the production unit and its immediate
environment and likely effects of its operation. The operator shall provide the
environmental assessment to the control authority or control body. The content
of the environmental assessment shall be based on Annex IV to Directive
2011/92/EU of the European Parliament and of the Council[8]. If the unit has
already been subject to an equivalent assessment, then its use shall be
permitted for this purpose.

2.4.
The operator shall provide a sustainable
management plan proportionate to the production unit for aquaculture and
seaweed harvesting.

2.5.
The plan shall be updated annually and shall
detail the environmental effects of the operation, the environmental monitoring
to be undertaken, and list 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.

2.6.
Aquaculture and seaweed 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. For seaweed
harvesting a once-off biomass estimate shall be undertaken at the outset.

3.
Requirements for seaweed

In addition to
the general production rules laid down in Articles 7, 8, 9 and 12, and where
relevant in Section 2, the rules laid down in this Section 3 shall apply to the
collection and production of seaweed. Those rules shall apply mutatis
mutandis to the production of all multi-cellular marine algae or
phytoplankton and micro-algae for further use as feed for aquaculture animals.

3.1.
Conversion

3.1.1.
The conversion period for a seaweed harvesting
site shall be six months.

3.1.2.
The conversion period for a seaweed cultivation
unit shall be a period of six months or one full production cycle, whichever is
the longer.

3.1.3.
During the conversion period, the aquaculture
holding may be split into clearly separated units which are not all managed
under organic production. As regards seaweed production, the same species may
be involved, provided that there is adequate separation between the units.

3.2.
Production rules for seaweed

3.2.1.
The collection of wild seaweeds and parts thereof, growing naturally in the sea, is
considered as organic production provided that:

(a)
the growing areas are of high
ecological status as defined by Directive 2000/60/EC [9], and are not unsuitable
from a health point of view.

(b)
the collection does not affect significantly the
stability of the natural ecosystem or the maintenance of the species in the
collection area.

3.2.2.
The cultivation of seaweeds shall take place in coastal areas with environmental and
health characteristics at least equivalent to those outlined in point 3.2.1(a)
in order to be considered organic. In addition the following production rules
shall apply:

(a)
sustainable practices shall be
used in all stages of production, from collection of juvenile seaweed to
harvesting;

(b)
to ensure that a wide gene-pool is maintained,
the collection of juvenile seaweed in the wild shall take place on a regular
basis to supplement indoor culture stock;

(c)
fertilisers shall not be used except in indoor
facilities and only if they have been authorised for use in organic production
for this purpose.

3.3.
Seaweed cultivation

3.3.1.
Seaweed 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.

3.3.2.
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 for use
in organic production pursuant to Article 19 may be used.

3.3.3.
Culture density or operational intensity shall
be recorded and shall maintain the integrity of the aquatic environment by
ensuring that the maximum quantity of seaweed which can be supported without
negative effects on the environment is not exceeded.

3.3.4.
Ropes and other equipment used for growing
seaweed shall be re-used or recycled where possible.

3.4.
Sustainable harvesting of wild seaweed

3.4.1.
A once-off biomass estimate shall be undertaken
at the outset of seaweed harvesting

3.4.2.
Documentary accounts shall be maintained in the
unit or premises and shall enable the operator to identify and the control
authority or control body to verify that the harvesters have supplied only wild
seaweed produced in accordance with this Regulation.

3.4.3.
Harvesting shall be carried out in such a way
that the amounts harvested do not cause a significant impact on the state of
the aquatic environment. Measures shall be taken to ensure that seaweed can
regenerate and by-catches are prevented, such as harvest technique, minimum sizes,
ages, reproductive cycles or size of remaining seaweed.

3.4.4.
If seaweed is harvested from a shared or common
harvest area, documentary evidence shall be available that the total harvest
complies with this Regulation.

4.
Requirements for aquaculture animals

In addition to
the general production rules laid down in Article 7, 8, 9 and 12, the rules
laid down in this Section 4 shall apply to species of fish, crustaceans,
echinoderms and molluscs, as referred to in point 4.1.5.10. Those rules also
shall apply mutatis mutandis to zooplankton, micro-crustaceans,
rotifers, worms and other aquatic feed animals.

4.1.
General requirements

4.1.1.
Conversion

4.1.1.1.
The following conversion periods for aquaculture
production units shall apply for the following types of aquaculture facilities
including the existing aquaculture animals:

(a)
for facilities that cannot be drained, cleaned
and disinfected, a conversion period of 24 months;

(b)
for facilities that have been drained, or
fallowed, a conversion period of 12 months;

(c)
for facilities that have been drained, cleaned
and disinfected a conversion period of six months;

(d)
for open water facilities including those
producing bivalve molluscs, a conversion period of three months.

4.1.1.2.
During the conversion
period, the aquaculture holding may be split into clearly separated units which
are not all managed under organic production. As regards the production of
aquaculture animals, the same species may be involved provided that there is
adequate separation between the units.

4.1.2.
Origin of aquaculture animals

4.1.2.1.
With regard to the origin of the aquaculture
animals the
following rules shall apply:

(a)
organic aquaculture shall be based on the
rearing of young stock originating from organic broodstock and organic
holdings;

(b)
locally grown species shall be used and breeding
shall aim to give strains which are more 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
control authority or control body;

(c)
species shall be chosen which are robust and can
be produced without causing significant damage to wild stocks;

(d)
wild caught or non-organic aquaculture animals
may be brought into a holding with a view to improving
genetic stock. Such animals shall be kept under organic management for at least
three months before they may be used for breeding.

4.1.2.2.
The following rules shall apply with regard to
breeding:

(a)
the use of hormones and hormone derivates shall
be prohibited;

(b)
artificial production of monosex strains, except
by hand sorting, induction of polyploidy, artificial hybridisation and cloning
shall not be used;

(c)
the appropriate strains shall be chosen;

(d)
where appropriate, species-specific conditions
for broodstock management, breeding and juvenile production shall be
established.

4.1.3.
Nutrition

4.1.3.1.
With regard to feed for fish and crustaceans and
echinoderms: the following rules shall apply:

(a)
animals shall be fed with feed that meets the
animal's nutritional requirements at the various stages of its development;

(b)
feeding regimes shall be designed with the
following priorities:

(i)      animal health and welfare;

(ii)     high product quality, including the
nutritional composition which shall ensure high quality of the final edible
product;

(iii)    low environmental impact;

(c)
the plant fraction of feed shall originate from
organic production and the feed fraction derived from aquatic animals shall
originate from organic aquaculture or sustainable exploitation of fisheries;

(d)
in the case of non-organic feed materials from
plant origin, feed materials from animal and mineral origin, feed additives,
certain products used in animal nutrition and processing aids shall be used
only if they have been authorised for use in organic production under this
Regulation;

(e)
growth promoters and synthetic amino-acids shall
not be used;

(f)
only feed materials of mineral origin authorised
for use in organic production pursuant to Article 19 may be used in organic
aquaculture;

(g)
only feed additives, certain products used in
animal nutrition and processing aids as referred to in point 1.4.4. of Part II
may be used in organic aquaculture.

4.1.3.2.
The following rules shall apply with regard to
bivalve molluscs and other species which are not fed by man but feed on natural
plankton:

(a)
such filter-feeding animals shall receive all
their nutritional requirements from nature except in the case of juveniles
reared in hatcheries and nurseries;

(b)
the growing areas shall be of high ecological status
as defined by Directive 2000/60/EC.

4.1.3.3.
Specific rules on feed for carnivorous
aquaculture animals

Feed for
carnivorous aquaculture animals shall be sourced with the following priorities:

(a)
organic feed of aquaculture origin;

(b)
fish meal and fish oil from organic aquaculture
trimmings sourced from fish, crustaceans or molluscs;

(c)
fish meal and fish oil and ingredients of fish
origin derived from trimmings of fish, crustaceans or molluscs already caught
for human consumption in sustainable fisheries;

(d)
fish meal and fish oil and ingredients 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.

4.1.3.4.
Specific rules on feed for certain aquaculture
animals

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 is not available in
sufficient quantities as referred to in point (a), organic feed of plant
origin, preferably grown on the farm itself or seaweed may be used. Operators
shall keep documentary evidence of the need to use additional feed;

(c)
where natural feed is
supplemented in accordance with point (b) the feed ration of species  as
referred to in point 4.1.5.10. (g) and of siamese catfish (Pangasius spp.)
may comprise a maximum of 10 % fishmeal or fish oil derived from sustainable
fisheries.

4.1.4.
Health care

4.1.4.1.
Disease prevention

With regard to
disease prevention the
following rules shall apply:

(a)
disease prevention shall be based on keeping the
animals in optimal conditions by appropriate siting, taking into account, inter
alia, the species’ requirements as to good water quality, flow and exchange
rate, optimal design of the holdings, the application of good husbandry and
management practices, including regular cleaning and disinfection of premises,
high quality feed, appropriate stocking density, and breed and strain
selection;

(b)
the use of immunological veterinary medicines is
allowed;

(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 and not less than once every two years in the case
of bivalve shellfish;

(d)
holding systems, equipment and utensils shall be
properly cleaned and disinfected;

(e)
bio-fouling organisms shall be removed only by
physical means or by hand and where appropriate returned to the sea at a
distance from the farm;

(f)
only substances for cleaning and disinfection of
equipment and facilities authorised for use in organic production pursuant to
Article 19 may be used.

(g)
with regard to fallowing the following rules
shall apply:

(i)      the competent authority shall
determine whether fallowing is necessary and the appropriate duration which
shall be applied and documented after each production cycle in open water
containment systems at sea;

(ii)     it shall not be mandatory for bivalve
mollusc cultivation;

(iii)    during fallowing the cage or other
structure used for 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, minimise disease risks,
and to avoid attracting insects or rodents;

(i)
ultraviolet light and ozone may be used only in
hatcheries and nurseries;

(j)
for biological control of ectoparasites
preference shall be given to the use of cleaner fish.

4.1.4.2.
Veterinary treatments

The following rules shall apply with regard to veterinary treatments:

(a)
disease shall be treated
immediately to avoid suffering to the animal; chemically synthesised allopathic
veterinary medicinal products including antibiotics may be used where
necessary, under strict conditions and under the responsibility of a
veterinarian, when the use of phytotherapeutic, homeopathic and other products
is inappropriate. Where appropriate, restrictions with respect to courses of
treatment and withdrawal periods shall be defined;

(b)
treatments related to the protection of human
and animal health imposed on the basis of Union legislation shall be allowed;

(c)
when despite preventive measures to ensure
animal health, according to point 4.1.4.1., a health problem arises, veterinary
treatments may be used in the following order of preference:

(i)      substances from plants, animals or
minerals in a homoeopathic dilution;

(ii)     plants and their extracts not having
anaesthetic effects; and

(iii)    substances such as trace elements,
metals, natural immunostimulants or authorised probiotics;

(d)
the use of allopathic treatments shall be
limited to two courses of treatment per year, with the exception of
vaccinations and compulsory eradication schemes. However, in the cases of a
production cycle of less than a year a limit of one allopathic treatment
applies. If the indicated limits for allopathic treatments are exceeded the
aquaculture animals concerned shall not be sold as organic products;

(e)
the use of parasite treatments, not including
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 as referred to in Article 11 of Directive 2001/82/EC or, in a
case in which this period in not specified, 48 hours;

(g)
whenever veterinary medicinal products are used,
such use shall be declared to the control authority or the control body before
the animals are marketed as organic. Treated stock shall be clearly
identifiable.

4.1.5.
Housing conditions and husbandry practices

4.1.5.1.
Closed recirculation aquaculture animal
production facilities shall be prohibited, with the exception of hatcheries and
nurseries or for the production of species used for organic feed organisms.

4.1.5.2.
Artificial heating or
cooling of water shall only be permitted in hatcheries and nurseries. Natural
borehole water may be used to heat or cool water at all stages of production.

4.1.5.3.
The husbandry environment of the aquaculture
animals shall be designed in such a way that, in accordance with their species
specific needs, the aquaculture animals shall:

(a)
have sufficient space for their wellbeing and,
where appropriate, a minimum stocking density;

(b)
be 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)
be kept in temperature and light conditions in
accordance with the requirements of the species and having regard to the
geographic location.

In the case of
freshwater fish, the bottom type shall be as close as possible to natural
conditions.

In the case of
carp, the bottom shall be natural earth.

4.1.5.4.
The design and construction of aquatic
containment systems shall provide flow rates and physiochemical parameters that
safeguard the animals’ health and welfare and provide for their behavioural
needs.

4.1.5.5.
Rearing units on land
shall meet the following conditions:

(a)
for flow-through systems it shall be possible to
monitor and control the flow rate and water quality of both in-flowing and
out-flowing water;

(b)
at least five percent of the perimeter
(“land-water interface”) area shall have natural vegetation.

4.1.5.6.
Containment systems at
sea shall meet the following conditions:

(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.

4.1.5.7.
Containment systems shall be designed, located
and operated to minimise the risk of escape incidents.

4.1.5.8.
If fish or crustaceans escape, appropriate
action shall be taken to reduce the impact on the local ecosystem, including
recapture, where appropriate. Documentary evidence shall be maintained.

4.1.5.9.
For aquaculture animal production in fishponds,
tanks or raceways, farms shall be equipped with either natural-filter beds,
settlement ponds, biological filters or mechanical filters to collect waste
nutrients or use seaweeds or animals (bivalves and algae) which contribute to
improving the quality of the effluent. Effluent monitoring shall be carried out
at regular intervals where appropriate.

4.1.5.10.
Stocking density

In considering the effects of the stocking
density on the welfare of produced fish, the condition of the fish (such as fin
damage, other injuries, growth rate, behaviour expressed and overall health)
and the water quality shall be monitored.

The stocking density shall be as set out by
species or group of species:

(a)
Organic production of salmonids in fresh water:

Species
concerned: brown trout (Salmo trutta) – rainbow
trout (Oncorhynchus mykiss) – American brook trout (Salvelinus
fontinalis) – salmon (Salmo salar) – charr (Salvelinus alpinus) –
grayling (Thymallus thymallus) – American lake trout (or grey trout) (Salvelinus
namaycush) – huchen (Huchohucho)

Production system || Ongrowing farm systems must be fed from open systems. The flow rate must ensure a minimum of 60 % oxygen saturation for stock and must ensure their comfort and the elimination of production effluent.

Maximum stocking density || Salmonid species not listed below 15 kg/m3 Salmon 20 kg/m3 Brown trout and Rainbow trout 25 kg/m3 Arctic charr 20 kg/m3

(b)
Organic production of salmonids in sea water:

Species
concerned: salmon (Salmo salar), brown
trout (Salmo trutta) - rainbow trout (Oncorhynchus mykiss)

Maximum stocking density || 10 kg/m3 in net pens

(c)
Organic production of cod (Gadus morhua) and
other Gadidae, sea bass (Dicentrarchus labrax), sea bream (Sparus
aurata), meagre (Argyrosomus regius), turbot (Psetta maxima [=
Scopthalmus maximux]), red porgy (Pagrus pagrus [= Sparus pagrus]),
red drum (Sciaenops ocellatus) and other Sparidae, and spinefeet (Siganus
spp.)

Production system || In open water containment systems (net pens/cages) with minimum sea current speed to provide optimum fish welfare or in open systems on land.

Maximum stocking density || For fish other than turbot: 15 kg/m3 For turbot: 25 kg/m2

(d)
Organic production of sea bass, sea bream,
meagre, mullets (Liza, Mugil) and eel (Anguilla spp.) in
earth ponds of tidal areas and costal lagoons

Containment system || Traditional salt pans transformed into aquaculture production units and similar earth ponds in tidal areas

Production system || There shall be adequate renewal of water to ensure the welfare of the species, At least 50 % of the dikes must have plant cover Wetland based depuration ponds required

Maximum stocking density || 4 kg/m3

(e)
Organic production of sturgeon in fresh water:

Species
concerned: Sturgeon family (Acipenseridae)

Production system || Water flow in each rearing unit shall be sufficient to ensure animal welfare Effluent water to be of equivalent quality to incoming water

Maximum stocking density || 30 kg/m3

(f)
Organic production of fish in inland waters:

Species
concerned: carp family (Cyprinidae) and other associated species in the
context of polyculture, including perch, pike, catfish, coregonids, sturgeon

Production system || In fishponds which shall periodically be fully drained and in lakes. Lakes must be devoted exclusively to organic production, including the growing of crops on dry areas. The fishery capture area must be equipped with a clean water inlet and of a size to provide optimal comfort for the fish. The fish must be stored in clean water after harvest. Organic and mineral fertilisation of the ponds and lakes shall be carried out with only fertilisers and soil conditioners authorised for use in organic production pursuant to Article 19 with a maximum application of 20 kg nitrogen/ha. Treatments involving synthetic chemicals for the control of hydrophytes and plant coverage present in production waters shall be prohibited. Areas of natural vegetation shall be maintained around inland water units as a buffer zone for external land areas not involved in the production operation in accordance with the rules of organic aquaculture. For grow-out ‘polyculture’ shall be used on condition that the criteria laid down in the present specifications for the other species of lakes fish are duly adhered to.

Production yield || The total production of species is limited to 1500 kg of fish per hectare per year.

(g)
Organic production of penaeid shrimps and
freshwater prawns (Macrobrachium spp.):

Establishment of production unit/s || Location to be in sterile clay areas to minimise environmental impact of pond construction. Ponds to be built with the natural pre-existing clay. Mangrove destruction shall not be permitted.

Conversion time || Six months per pond, corresponding to the normal lifespan of a produced shrimp.

Broodstock origin || A minimum of half the broodstock shall be domesticated after three years operating The remainder is to be pathogen free wild broodstock originating from sustainable fisheries. A compulsory screening to be implemented on the first and second generation prior to introducing to the farm.

Eyestalk ablation || Is prohibited.

Maximum on farm stocking densities and production limits || Seeding: maximum 22 post larvae/m2 Maximum instantaneous biomass: 240 g/m2

(h)
Molluscs and
echinoderms:

Production systems || Long-lines, rafts, bottom culture, net bags, cages, trays, lantern nets, bouchot poles and other containment systems. For mussel cultivation on rafts the number of drop-ropes shall not exceed one per square meter of surface area. The maximum drop-rope length shall not exceed 20 m. Thinning-out of drop-ropes shall not take place during the production cycle, however sub-division of drop ropes shall be permitted without increasing stocking density at the outset.

(i)
Tropical fresh water fish: milkfish (Chanos
chanos), tilapia (Oreochromis spp.), siamese catfish (Pangasius spp.):

Production systems || Ponds and net cages

Maximum stocking density || Pangasius: 10 kg/m3 Oreochromis: 20 kg/m3

4.1.6.
Animal welfare

4.1.6.1.
All persons involved in keeping aquaculture
animals shall possess the necessary basic knowledge and skills as regards the
health and the welfare needs of the animals

4.1.6.2.
Handling of aquaculture
animals shall be minimised, undertaken with the greatest care and proper equipment
and protocols used to avoid stress and physical damage associated with handling
procedures. Broodstock shall be handled in a manner to minimise physical damage
and stress and under anaesthesia where appropriate. Grading operations shall be
kept to a minimum and as required to ensure fish welfare.

4.1.6.3.
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 produced animals, this maximum shall not exceed 16 hours
per day, except for reproductive purposes;

(b)
abrupt changes in light
intensity shall be avoided at the changeover time by the use of dimmable lights
or background lighting.

4.1.6.4.
Aeration is permitted to
ensure animal welfare and health, under the condition that mechanical aerators
are preferably powered by renewable energy sources.

4.1.6.5.
The use of oxygen is
only permitted for uses linked to animal health and welfare requirements and
critical periods of production or transport, in the following cases:

(a)
exceptional cases of
temperature rise or drop in atmospheric pressure or accidental pollution;

(b)
occasional stock management procedures such as
sampling and sorting;

(c)
in order to assure the
survival of the farm stock.

4.1.6.6.
Appropriate measures shall be taken to keep the
duration of transport of aquaculture animals to a minimum.

4.1.6.7.
Any suffering shall be kept to a minimum during
the entire life of the animal, including at the time of slaughter.

4.1.6.8.
Slaughter techniques
shall render fish immediately unconscious and insensible to pain. Handling
prior to slaughter shall be performed in a way that avoids injuries while
keeping suffering and stress at a minimum. Differences in harvesting sizes,
species, and production sites must be taken into account when considering
optimal slaughtering methods.

4.2.
Specific rules for molluscs

4.2.1.
Origin of seed

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, it is permitted by local
legislation and the wild seed comes from:

(i)      settlement beds which
are unlikely to survive winter weather or are surplus to requirements; or

(ii)     natural settlement of shellfish seed
on collectors;

(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.

4.2.2.
Housing conditions and
husbandry practices

With regard to
the housing conditions and husbandry practices the following rules shall apply:

(a)
production may be carried out in the same area
of water as organic finfish and seaweed production in a polyculture system to
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,
as appropriate, be restrained by net bags, cages or other man made means;

(c)
organic shellfish farms shall minimise risks to
species of conservation interest. If predator nets are used their design shall
not permit diving birds to be harmed.

4.2.3.
Cultivation

With regard to
cultivation the following rules shall apply:

(a)
cultivation on mussel ropes and other methods
listed in point 4.1.5.10 (h) may be eligible for organic production;

(b)
bottom cultivation of molluscs is only permitted
where no significant environmental impact is caused at the collection and
growing sites. The evidence of minimal environmental impact shall be supported
by a survey and report on the exploited area to be provided by the operator to
the control authority or control body. The report shall be added as a separate
chapter to the sustainable management plan.

4.2.4.
Management

With regard to management the following rules
shall apply:

(a)
production shall use a stocking density not in
excess of that used for non-organic molluscs in the locality. Sorting, thinning
and stocking density adjustments shall be made according to the biomass and to
ensure animal welfare and high product quality;

(b)
biofouling organisms shall be removed by
physical means or by hand and where appropriate returned to the sea away from
mollusc farms. Molluscs may be treated once during the production cycle with a
lime solution to control competing fouling organisms.

4.2.5.
Specific cultivation rules for oysters

Cultivation in
bags on trestles shall be permitted. These or other structures in which the
oysters are contained shall be set out so as to avoid the formation of a total
barrier along the shoreline. Stock shall be positioned carefully on the beds in
relation to tidal flow to optimise production. Production shall meet the
requirements set out in point 4.1.5.10. (h).

Part
IV: Processed food and processed feed production rules

In addition to the general production rules
laid down in Articles 7, 9 and 13, the rules laid down in this Part shall apply
to processed food and processed feed.

1.
General requirements for the production
of processed food and feed

1.1.
Food and feed additives, processing aids and
other substances and ingredients used for processing food or feed and any
processing practice applied, such as smoking, shall respect the principles of
good manufacturing practice[10].

1.2.
Operators producing processed food or feed 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 guarantee at all times that the produced processed products
comply with this Regulation.

1.4.
Operators shall comply with and implement the
procedures referred to in point 1.2., and in particular shall:

(a)
take preventive measures to avoid the risk of
contamination by unauthorised substances or products;

(b)
implement suitable cleaning measures, monitor
their effectiveness and record these operations;

(c)
guarantee that non-organic products are not
placed on the market with an indication referring to organic production.

1.5.
The preparation of processed organic products
shall be kept separate in time or space from non-organic products. When
non-organic products are also prepared or stored in the preparation unit
concerned, the operator shall:

(a)
inform the control authority or control body
accordingly;

(b)
carry out the operations continuously until the
complete run has been dealt with, separated by place or time from similar
operations performed on non-organic products;

(c)
store organic products, before and after the
operations, separate by place or time from non-organic products;

(d)
keep available an updated register of all
operations and quantities processed;

(e)
take the necessary measures to ensure
identification of lots and to avoid mixtures or exchanges with non-organic
products;

(f)
carry out operations on organic products only
after suitable cleaning of the production equipment.

1.6.
Products, substances and techniques that
reconstitute properties that are lost in the processing and storage of organic
food, that correct the results of negligence in the processing of organic food
or that otherwise may be misleading as to the true nature of products intended
to be marketed as organic food shall not be used.

2.
Requirements for the production of
processed food

2.1.
The following conditions shall apply to the
composition of organic processed food:

(a)
the product shall be produced mainly from
agricultural ingredients; in order to determine whether a product is produced
mainly from agricultural ingredients, added water and salt shall not be
taken into account;

(b)
only those food additives, processing aids,
flavourings, water, salt, preparations of micro-organisms and food enzymes,
minerals, trace elements, vitamins, as well as amino acids and other
micronutrients in foodstuffs for particular nutritional uses authorised for use
in organic production pursuant to Article 19 may be used;

(c)
an organic ingredient shall not be present
together with the same ingredient in conversion or  in non-organic form;

(d)
food produced from in-conversion crops shall
contain only one crop ingredient of agricultural origin.

2.2.
Use of certain products and substances in
processing of food

2.2.1.
Only the products and substances as referred to
in point 2.1(b) as well as the products and substances referred to in points 2.2.2,
2.2.4. and 2.2.5., may be used in the processing of food, with the exception of
products and substances of the wine sector, for which point 2 of Part V shall
apply, and of yeast for which point 1.3 of Part VI shall apply.

2.2.2.
In the processing of food, the use of the
following products and substances shall be allowed:

(a)
preparations of micro-organisms and food enzymes
normally used in food processing; however food enzymes to be used as food
additives have to be authorised for use in organic production pursuant to
Article 19;

(b)
substances, and products as defined in Article
3(2)(b) and (d) of Regulation (EC) No 1334/2008 of the European Parliament and
of the Council[11]
labelled as natural flavouring substances or natural flavouring preparations,
in accordance with Articles 15(1)(e) and Article 16 of that Regulation;.

(c)
colours for stamping meat and eggshells in
accordance with  Article 17 of Regulation (EC) No 1333/2008 of the European
Parliament and of the Council[12];

(d)
drinking water and salt (with sodium chloride or
potassium chloride as basic components) generally used in food processing;

(e)
minerals (trace elements included), vitamins,
aminoacids, and micronutrients, only authorised as far their use is legally required
in the foodstuffs in which they are incorporated.

2.2.3.
For the purpose of the calculation referred to
in Article 21(3), the following rules shall apply:

(a)
certain food additives authorised for use in
organic production pursuant to Article 19 shall be calculated as agricultural
ingredients;

(b)
preparations and substances referred to in point
2.2.2. shall not be calculated as agricultural ingredients;

(c)
yeast and yeast products shall be calculated as
agricultural ingredients.

2.2.4.
The following non-organic agricultural
ingredients may be used in the processing of organic food:

(a)
animal products:

(i)      aquatic organisms, not originating
from aquaculture, and permitted in non-organic foodstuffs preparation;

(ii)     gelatin;

(iii)   casings;

(b)
unprocessed vegetable products as well as
products derived therefrom by processing:

(i)      edible fruits, nuts and seeds:

– cola nuts                                 Cola acuminata;

(ii)    edible spices
and herbs:

– horseradish seeds                   Armoracia rusticana;

– safflower flowers                   Carthamus tinctorius;

– watercress herb                       Nasturtium officinale;

(iii)    miscellaneous:

– algae, including seaweed;

(c)
processed vegetable products:

(i)      sugars, starches and other products
from cereals and tubers:

– rice paper;

– starch from rice and waxy maize, not chemically modified;

(ii)     miscellaneous:

– rum, only obtained from cane sugar juice.

2.2.5.
Fats and oils whether or not refined, but not
chemically modified, may be used in their non-organic form if they are derived
from plants other than:

– cocoa                                      Theobroma cacao;

– coconut                                   Cocos nucífera;

– olive                                        Olea europaea;

– sunflower                               Helianthus annuus;

– palm                                        Elaeis guineensis;

– rape                                         Brassica napus, rapa;

– safflower                                Carthamus tinctorius;

– sesame                                    Sesamum indicum;

– soya                                        Glycine max.

3.
Requirements for the production of
processed feed

3.1.
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.

3.2.
Any feed materials used or processed in organic
production shall not have been processed with the aid of chemically synthesised
solvents.

Part
V: Wine

1.
Scope

1.1.
In addition to the general production rules laid
down in Articles 7, 8, 9 and 14,  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[13] and (EC) No 607/2009[14] shall apply, save as
explicitly provided otherwise in this Part.

2.
Use of certain products and substances

2.1.
Products of the wine sector shall be produced
from organic raw material.

2.2.
Only products and substances authorised for use
in organic production pursuant to Article 19 may be used for the making of
products of the wine sector, including during the processes and oenological
practices, 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 that Regulation.

3.
Oenological practices and restrictions

3.1.
Without prejudice to Sections 1. and 2. and to
specific prohibitions and restrictions provided for in points 3.2 to 3.5, only
oenological practices, processes and treatments, including the restrictions
provided for in Article 80 and 83(2) of Regulation (EU) No 1308/2013, and in
Article 3, Articles 5 to 9 and Articles 11 to 14 of Regulation (EC) No 606/2009,
and in the Annexes  to those Regulations, used before 1 August 2010, shall be
permitted.

3.2.
The use of the following oenological practices,
processes and treatments shall be prohibited:

(a)
partial concentration through cooling according
to point (c) of Section B.1 of Part I of Annex VIII to Regulation (EU) No 1308/2013;

(b)
elimination of sulphur dioxide by physical
processes according to point 8 of Annex I A to Regulation (EC) No 606/2009;

(c)
electrodialysis treatment to ensure the tartaric
stabilisation of the wine according to point 36 of Annex I A to Regulation (EC)
No 606/2009;

(d)
partial dealcoholisation of wine according to
point 40 of Annex I A to Regulation (EC) No 606/2009;

(e)
treatment with cation exchangers to ensure the
tartaric stabilisation of the wine according to point 43 of Annex I A to
Regulation (EC) No 606/2009.

3.3.
The use of the following oenological practices,
processes and treatments is permitted under the following conditions:

(a)
for heat treatments according to point 2 of
Annex I A to Regulation (EC) No 606/2009, the temperature shall not exceed
70 °C;

(b)
for centrifuging and filtration with or without
an inert filtering agent according to point 3 of Annex I A to Regulation (EC)
No 606/2009, the size of the pores shall be not smaller than 0,2 micrometer.

3.4.
The use of the following oenological practices,
processes and treatments shall be re-examined by the Commission before 1 August
2015 with a view to phase out or to further restrict those practices:

(a)
heat treatments as referred to in point 2 of
Annex I A to Regulation (EC) No 606/2009;

(b)
use of ion exchange resins as referred to in
point 20 of Annex I A to Regulation (EC) No 606/2009;

(c)
reverse osmosis according to point (b) of
Section B.1 of Part I of Annex VIII to Regulation (EU) No 1308/2013.

3.5.
Any amendment introduced after 1 August 2010, as
regards the oenological practice, processes and treatments provided for in
Regulation (EC) No 1234/2007 or Regulation (EC) No 606/2009, may be applicable
in the organic production of wine only after the adoption of the measures
necessary for the implementation of the production rules provided for in this
Section 3 and, if required, an evaluation according to Article 19 of this
Regulation.

Part
VI: Yeast used as food or feed

In addition to the general production rules
laid down in Articles 7, 9 and 15, the rules laid down in this Part shall apply
to organic yeast used as food or feed.

1.
General requirements

1.1.
For the production of organic yeast only
organically produced substrates shall be used.

1.2.
Organic yeast shall not be present in organic
food or feed together with non-organic yeast.

1.3.
The following substances may be used in the
production, confection and formulation of organic yeast:

(a)
processing aids authorised for use in organic
production pursuant to Article 19;

(b)
products and substances referred to in point 2. 2.2.
(a) and (d) of Part IV.

ANNEX III

COLLECTION, PACKAGING, TRANSPORT AND STORAGE OF PRODUCTS

1.
Collection of products and transport to
preparation units

Operators may carry out simultaneous
collection of organic and non-organic products only where appropriate measures
are taken to prevent any possible mixture or exchange with non-organic products
and to ensure the identification of the organic products. The operator shall
keep the information relating to collection days, hours, circuit and date and
time of reception of the products available to the control authority or control
body.

2.
Packaging and transport of products to
other operators or units

2.1.
Operators shall ensure that organic 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;

(b)
the name of the product or a description of the
compound feedingstuff accompanied by a reference to organic production;

(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
according to a marking system either approved at national level or agreed with
the control authority or control body and which permits to link the lot with
the records referred to in Article 24.

The information referred to in points (a) to
(d) may also be presented on an accompanying document, if such a document can
be undeniably linked with the packaging, container or vehicular transport of
the product. This accompanying document shall include information on the
supplier or the transporter.

2.2.
The closing of packaging, containers or vehicles
shall not be required where:

(a)
transportation is direct between an operator and
another operator who are both subject to the organic control system;

(b)
the products are accompanied by a document
giving the information required under point 2.1; and

(c)
both the expediting and the receiving operators
keep documentary records of such transport operations available for the control
authority or control body.

3.
Special rules for transporting feed to
other production or preparation units or storage premises

When transporting feed to other production
or preparation units or storage premises, operators shall ensure that the
following conditions are met:

(a)
during transport, organically produced feed,
in-conversion feed, and non-organic feed shall be effectively physically
separated;

(b)
vehicles or containers which have transported
non-organic products may only be used to transport organic products if:

(i)      suitable cleaning measures, the
effectiveness of which has been checked, have been carried out before
commencing the transport of organic products and the operators record these
operations;

(ii)     all appropriate measures are
implemented, depending on the risks evaluated in accordance with control
arrangements and, where necessary, operators shall guarantee that non-organic
products cannot be placed on the market with an indication referring to organic
production;

(iii)    the operator keep documentary records
of such transport operations available for the control authority or control
body;

(c)
the transport of finished organic feed shall be
separated physically or in time from the transport of other finished products;

(d)
during transport, the quantity of products at
the start and each individual quantity delivered in the course of a delivery
round shall be recorded.

4.
Transport of live fish

4.1.
Live fish shall be transported in suitable tanks
with clean water which meets their physiological needs in terms of temperature
and dissolved oxygen.

4.2.
Before transport of organic fish and fish
products, tanks shall be thoroughly cleaned, disinfected and rinsed.

4.3.
Precautions shall be taken to reduce stress.
During transport, the density shall not reach a level which is detrimental to
the species.

4.4.
Documentary evidence shall be maintained for
operations referred to in points 4.1, 4.2 and 4.3.

5.
Reception of products from other
operators of units

On receipt of an organic product, the
operator shall check the closing of the packaging or container where it is
required and the presence of the indications provided for in Section 2.

The operator shall crosscheck the
information on the label referred to in Section 2 with the information on the
accompanying documents. The result of those verifications shall be explicitly
mentioned in the records referred to in Article 24.

6.
Special rules for the reception of
products from a third country

Where organic products are imported from a
third country, they shall be transported in appropriate packaging or
containers, closed in a manner preventing substitution of the content and
provided with identification of the exporter and with any other marks and
numbers serving to identify the lot and with the certificate of control for
import from third countries as appropriate.

On receipt of an organic product imported
from a third country, the natural or legal person to whom the imported
consignment is delivered and who receives it for further preparation or
marketing, shall check the closing of the packaging or container and, in the
case of products imported in accordance with Article 28(1)(b)(ii), shall check
that the certificate of inspection referred to in that Articlecovers the type
of product contained in the consignment. The result of this verification shall
be explicitly mentioned in the records referred to in Article 24.

7.
Storage of products

7.1.
For the storage of products, areas shall be
managed in such a way as to ensure identification of lots and to avoid any
mixing with or contamination by products or substances not in compliance with
the organic production rules. Organic products shall be clearly identifiable at
all times.

7.2.
In case of organic plant and livestock
production units, storage of input products other than those authorised for use
in organic production pursuant to Article 19 is prohibited in the production
unit.

7.3.
The storage of allopathic veterinary medicinal
products and antibiotics is permitted on agricultural and aquaculture holdings
provided that they have been prescribed by a veterinarian in connection with
treatment as referred to in points 1.5.2.2 of Part II and 4.1.4.2(a) of Part
III of Annex II, that they are stored in a supervised location and that they
are entered in the livestock record as referred to in Article 24.

7.4.
Where operators handle both non-organic products
and organic products and the latter are stored in storage facilities in which
also other agricultural products or foodstuffs are stored:

(a)
the organic products shall be kept separate from
the other agricultural products or foodstuffs;

(b)
every measure shall be taken to ensure
identification of consignments and to avoid mixtures or exchanges with
non-organic products;

(c)
suitable cleaning measures, the effectiveness of
which has been checked, have been carried out before the storage of organic
products and the operators shall record these operations.

ANNEX IV

TERMS REFERRED TO IN ARTICLE 21

BG: биологичен.

ES: ecológico, biológico.

CS: ekologické, biologické.

DA: økologisk.

DE: ökologisch, biologisch.

ET: mahe, ökoloogiline.

EL: βιολογικό.

EN: organic.

FR: biologique.

GA: orgánach.

HR: ekološki.

IT: biologico.

LV: bioloģisks, ekoloģisks.

LT: ekologiškas.

LU: biologësch.

HU: ökológiai.

MT: organiku.

NL: biologisch.

PL: ekologiczne.

PT: biológico.

RO: ecologic.

SK: ekologické, biologické.

SL: ekološki.

FI: luonnonmukainen.

SV: ekologisk.

--------------------------------------------------

ANNEX V

ORGANIC PRODUCTION LOGO OF THE EUROPEAN UNION AND CODE NUMBERS

1.
Logo

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

LOGO to be inserted

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:

LOGO to be inserted

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.

1.5.
If a logo is used in colour on a coloured
background, which makes it difficult to see, a delimiting outer line around the
logo can be used to improve contrast with the background colours.

1.6.
In certain specific situations 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 must 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 22. When associated to national or private
logos using a green colour different from the reference colour provided for in
point 2, the organic production logo of the European Union may be used in that
non-reference colour.

2.
Code numbers

The general format of the code numbers
shall be as follows:

AB-CDE-999

Where:

(a)
‘AB’ is the ISO code for the country where the
controls take place;

(b)
‘CDE’ is a term, indicated in three letters to
be decided by the Commission or each Member State, like “bio” or “öko” or “org”
or “eko” establishing a link with organic production; and

(c)
‘999’ is the reference number, indicated in
maximum three digits, to be assigned by:

(i)      each Member State’s competent
authority to the control authorities or control bodies to which they have
delegated control tasks;

(ii)     the Commission, to:

– the control authorities and control bodies recognised by the
Commission pursuant to of Article 29;

– to the competent authorities of third countries recognised by the
Commission pursuant to of Article 31.

[1]               Council Directive 91/676/EEC of
12 December 1991 concerning the protection of waters against pollution caused
by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).

[2]               Commission Regulation (EC) No 1974/2006 of 15
December 2006 laying down detailed rules for the application of Council
Regulation (EC) No 1698/2005 on support for rural development by the European
Agricultural Fund for Rural Development (EAFRD) (OJ L 368, 23.12.2006, p. 15).

[3]               Regulation (EU) No 1305/2013 of the European
Parliament and of the Council of 17 December 2013 on support for rural
development by the European Agricultural Fund for Rural Development (EAFRD) and
repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487).

[4]               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).

[5]               Directive 2000/60/EC of the European Parliament and
of the Council of 23 October 2000 establishing a framework for Community action
in the field of water policy (OJ L 327, 22.12.2000, p. 1).

[6]               Directive 2008/56/EC of the European Parliament and
of the Council of 17 June 2008 establishing a framework for Community action in
the field of marine environmental policy (Marine Strategy Framework Directive) (OJ
L 164, 25.6.2008, p. 19).

[7]               Council Regulation (EC) No 708/2007 of 11 June 2007
concerning use of alien and locally absent species in aquaculture (OJ L 168,
28.6.2007, p. 1).

[8]               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).

[9]               Directive 2006/113/EC of the European Parliament and
of the Council of 12 December 2006 on the quality required of shellfish waters
(OJ L 376, 27.12.2006, p. 14).

[10]             Good manufacturing practices (GMPs) as defined  in
Article 3(a) of Commission Regulation (EC) N° 2023/2006 of 22 December 2006 on
good manufacturing practice for materials and articles intended to come into
contact with food (O.J. L 384, 29.12.2006, p. 75)

[11]             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).

[12]             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).

[13]             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).

[14]             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).