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 m