Article 90 
Implementing rules The Commission shall adopt the detailed rules for the implementation of this Subsection which may, in particular, include rules concerning: (a) declarations to be submitted by undertakings when applying for aid; (b) conditions to be complied with for the determination of the eligibility for the aid, in particular as regards the keeping of stock records and other supporting documents; (c) the granting of the aid provided for in this Subsection and the advance, as well as the release of the securities, provided for in Article 87(1); (d) the conditions and criteria to be fulfilled by the undertakings referred to in Article 86 and, in the case where undertakings obtain their supplies from natural or legal persons, rules concerning the guarantees to be provided by those persons; (e) the terms of approvals of buyers of fodder for drying, to be applied by the Member States; (f) the criteria for determining the requirements laid down in Article 86(2); (g) the criteria to be fulfilled for the conclusion of contracts and information which they shall contain; (h) the application of the maximum guaranteed quantity laid down in Article 89; (i) further requirements to those laid down in Article 86, in particular as regards carotene and fibre content. Subsection II Flax and hemp grown for fibre
Amendment rationale: CONTEXT OF THE PROPOSAL The Commission proposal for the Multiannual Financial Framework (MFF) for 2014-2020 (the MFF proposal)[1] sets the budgetary framework and main orientations for the Common Agricultural Policy (CAP). On this basis, the Commission presents a set of regulations laying down the legislative framework for the CAP in the period 2014-2020, together with an impact assessment of alternative scenarios for the evolution of the policy. The current reform proposals are based on the Communication on the CAP towards 2020[2] that outlined broad policy options in order to respond to the future challenges for agriculture and rural areas and to meet the objectives set for the CAP, namely 1) viable food production; 2) sustainable management of natural resources and climate action; and 3) balanced territorial development. The reform orientations in the Communication have since been broadly supported both in the inter-institutional debate[3] and in the stakeholder consultation that took place in the framework of the

|52011PC0631Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers /* COM/2011/0631 final - 2011/0285 (COD) */EXPLANATORY MEMORANDUM1.           CONTEXT OF THE PROPOSALThe Commission proposal for the Multiannual Financial Framework (MFF) for 2014-2020 (the MFF proposal)[1] sets the budgetary framework and main orientations for the Common Agricultural Policy (CAP). On this basis, the Commission presents a set of regulations laying down the legislative framework for the CAP in the period 2014-2020, together with an impact assessment of alternative scenarios for the evolution of the policy.The current reform proposals are based on the Communication on the CAP towards 2020[2] that outlined broad policy options in order to respond to the future challenges for agriculture and rural areas and to meet the objectives set for the CAP, namely 1) viable food production; 2) sustainable management of natural resources and climate action; and 3) balanced territorial development. The reform orientations in the Communication have since been broadly supported both in the inter-institutional debate[3] and in the stakeholder consultation that took place in the framework of the impact assessment.A common theme that has emerged throughout this process is the need to promote resource efficiency with a view to smart, sustainable and inclusive growth for EU agriculture and rural areas in line with the Europe 2020 strategy, keeping the structure of the CAP around two pillars that use complementary instruments in pursuit of the same objectives. Pillar I covers direct payments and market measures providing a basic annual income support to EU farmers and support in case of specific market disturbances, while Pillar II covers rural development where Member States draw up and co-finance multiannual programmes under a common framework.[4]Through successive reforms the CAP has increased market orientation for agriculture while providing income support to producers, improved the integration of environmental requirements and reinforced support for rural development as an integrated policy for the development of rural areas across the EU. However, the same reform process has raised demands for a better distribution of support among and within Member States, as well as calls for a better targeting of measures aiming at addressing environmental challenges and better addressing increased market volatility.In the past, reforms mainly responded to endogenous challenges, from huge surpluses to food safety crises; they have served the EU well both on the domestic and the international front. However, most of today's challenges are driven by factors that are external to agriculture and would thus require a broader policy response.The pressure on agricultural income is expected to continue as farmers are facing more risks, a slowdown in productivity and a margin squeeze due to rising input prices; there is therefore a need to maintain income support and to reinforce instruments to better manage risks and respond to crisis situations. A strong agriculture is vital for the EU food industry and global food security.At the same time, agriculture and rural areas are being called upon to step up their efforts to meet the ambitious climate and energy targets and biodiversity strategy that are part of the Europe 2020 agenda. Farmers, who are together with foresters the main land managers, will need to be supported in adopting and maintaining farming systems and practices that are particularly favourable to environmental and climate objectives because market prices do not reflect the provision of such public goods. It will also be essential to best harness the diverse potential of rural areas and thus contribute to inclusive growth and cohesion.The future CAP will not, therefore, be a policy that caters only for a small, albeit essential, part of the EU economy, but also a policy of strategic importance for food security, the environment and territorial balance. Therein lies the EU added value of a truly common policy that makes the most efficient use of limited budgetary resources in maintaining a sustainable agriculture throughout the EU, addressing important cross-border issues such as climate change and reinforcing solidarity among Member States, while also allowing flexibility in implementation to cater for local needs.The framework set out in the MFF proposal foresees that the CAP should maintain its two-pillar structure with the budget for each pillar maintained in nominal terms at its 2013 level and with a clear focus on delivering results on the key EU priorities. Direct payments should promote sustainable production by assigning 30 % of their budgetary envelope to mandatory measures that are beneficial to climate and the environment. Payment levels should progressively converge and payments to large beneficiaries be subject to progressive capping. Rural development should be included in a Common Strategic Framework with other EU shared management funds with a reinforced outcome-orientated approach and subject to clearer, improved ex-ante conditionalities. Finally, on market measures the financing of the CAP should be reinforced with two instruments outside the MFF: 1) an emergency reserve to react to crisis situations; and 2) the extension of the scope of the European Globalization Adjustment Fund.On this basis, the main elements of the legislative framework for the CAP during the period 2014-2020 are set out in the following regulations:–                         Proposal for a Regulation of the European Parliament and of the Council establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy ('the direct payments regulation');–                         Proposal for a Regulation of the European Parliament and of the Council establishing a common organisation of the markets in agricultural products (Single CMO Regulation) ('the Single CMO regulation');–                         Proposal for a Regulation of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) ('the rural development regulation');–                         Proposal for a Regulation of the European Parliament and of the Council on the financing, management and monitoring of the common agricultural policy ('the horizontal regulation');–                         Proposal for a Council regulation determining measures on fixing certain aids and refunds related to the common organisation of the markets in agricultural products;–                         Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 73/2009 as regards the application of direct payments to farmers in respect of the year 2013;–                         Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers.The rural development regulation builds on the proposal presented by the Commission on 6 October 2011 that sets out common rules for all funds operating under a Common Strategic Framework[5]. A regulation will follow on the scheme for most deprived persons, for which funding is now placed under a different heading of the MFF.In addition, new rules on the publication of information on beneficiaries taking account of the objections expressed by the Court of Justice of the European Union are also under preparation with a view to finding the most appropriate way to reconcile beneficiaries' right to protection of personal data with the principle of transparency.

|52012PC0051Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 as regards pharmacovigilance /* COM/2012/051 final - 2012/0023 (COD) */EXPLANATORY MEMORANDUMThe Commission presents a proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmamacovigilance, Regulation (EC) No 726/2004. It is complemented by parallel changes to Directive 2001/83/EC.1.           CONTEXT OF THE PROPOSALOn 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012.The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns.However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system.Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed.In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level.Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns.Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance.2.           OBJECTIVE OF THE COMMISSION'S PROPOSALSThe general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens. Following this line, the proposals aim specifically to address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified.3.           BUDGETARY IMPLICATIONThe proposals have no implication for the budget of the Union.The proposals only make minor changes to the system set forth by the 2010 pharmacovigilance legislation. They do not require additional human or administrative resources for the functioning of the pharmacovigilance system.2012/0023 (COD)Proposal for aREGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILamending Regulation (EC) No 726/2004 as regards pharmacovigilance(Text with EEA relevance)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 Article 114 and Article 168(4)(c) thereof,Having regard to the proposal from the European Commission[1],Having regard to the opinion of the European Economic and Social Committee[2],Having regard to the opinion of the Committee of the Regions[3],Acting in accordance with the ordinary legislative procedure,Whereas:(1)       In order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency[4], as amended by Regulation (EU) No 1235/2010[5], should systematically include medicinal products that are subject to post-authorisation safety conditions.(2)       In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provisions should be made for the marketing authorisation holder to inform the Agency of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation.(3)       Regulation (EC) No 726/2004 should therefore be amended accordingly.(4)       Since the objective of this Regulation, namely to provide for specific rules on pharmacovigilance and improve the safety of medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member States and can 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. 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 this objective,
Article 91 
Eligibility 1. Aid for processing the straw of long flax grown for fibre and the straw of short flax and hemp grown for fibre shall be granted for the 2009/2010 to 2011/2012 marketing years to authorised primary processors on the basis of the quantity of fibre actually obtained from straw for which a contract of sale has been concluded with a farmer. However, in cases where farmers retain ownership of the straw which they are having processed under contract by an authorised primary processor and prove that they have placed the fibres obtained on the market, the aid shall be granted to the farmers. In cases where the authorised primary processor and the farmer are one and the same person, the contract of sale shall be replaced by a commitment by the party concerned to carry out the processing itself. 2. For the purposes of this Subsection, ‘authorised primary processor’ shall mean a natural or legal person or a group of natural or legal persons, irrespective of its legal status under national law, or that of its members, that has been authorised by the competent authority of the Member State in the territory of which are located its facilities for producing flax or hemp fibre.
Article 92 
Aid rate 1. The amount of processing aid provided for in Article 91 shall be fixed: (a) for long flax fibre: — at EUR 160 per tonne for the 2008/2009 marketing year, — at EUR 200 per tonne for the 2009/2010 marketing year; and — at EUR 160 per tonne for the 2010/2011 and 2011/2012 marketing years. (a) for long flax fibre: — at EUR 160 per tonne for the 2008/2009 marketing year, — at EUR 200 per tonne for the 2009/2010 marketing year; and — at EUR 160 per tonne for the 2010/2011 and 2011/2012 marketing years. (b) at EUR 90 per tonne for the 2009/2010, 2010/2011 and 2011/2012 marketing years for short flax and hemp fibre containing not more than 7,5 % impurities and shives. However, the Member State may, with reference to traditional outlets, also decide to grant aid: (a) for short flax fibre containing a percentage of impurities and shives of between 7,5 % and 15 %; (b) for hemp fibre containing a percentage of impurities and shives of between 7,5 % and 25 %. In the cases provided for in the second subparagraph, the Member State shall grant the aid in respect of a quantity which amounts to not more than the quantity produced, on the basis of 7,5 % of impurities and shives. 2. The quantities of fibre eligible for aid shall be limited on the basis of the areas which were the subject of one of the contracts or commitments referred to in Article 91. The limits referred to in the first subparagraph shall be fixed by the Member States so as to comply with the national guaranteed quantities referred to in Article 94.
Article 93 
Advance payment At the request of authorised primary processors, an advance shall be paid on the aid referred to in Article 91 on the basis of the quantity of fibre obtained.
Article 94 
Guaranteed quantity 1. A maximum guaranteed quantity of 80 878 tonnes for each of the 2009/2010 to 2011/2012 marketing years shall be established for long flax fibre in respect of which aid may be granted. That quantity shall be apportioned among certain Member States as national guaranteed quantities in accordance with point A.I. of Annex XI. 1 a . A maximum guaranteed quantity of 147 265 tonnes for each of the 2009/2010 to 2011/2012 marketing years shall be established for short flax fibre and hemp fibre in respect of which aid may be granted. That quantity shall be apportioned as national guaranteed quantities among certain Member States in accordance with point A.II. of Annex XI. 2. In cases where the fibre obtained in one Member State originates from straw produced in another Member State, the quantities of fibre concerned shall be offset against the national guaranteed quantity of the Member State in which the straw was harvested. The aid shall be paid by the Member State against whose national guaranteed quantity such an offset is made. 3. Each Member State may transfer part of its national guaranteed quantity as referred to in paragraph 1 to its national guaranteed quantity as referred to in paragraph 1a and vice versa . Transfers as referred to in the first subparagraph shall be carried out on the basis of an equivalence of one tonne of long flax fibre to 2,2 tonnes of short flax fibre and hemp fibre. Processing aid shall be granted only in respect of the quantities referred to in paragraphs 1 and 1a, respectively, adjusted in accordance with the first two subparagraphs of this paragraph.
Article 94a Additional aid
During the 2008/2009 marketing year, additional aid shall be granted to the authorised primary processor in respect of areas under flax in zones I and II as described in point A.III. of Annex XI and the straw production of which has been the subject of: (a) a sale/purchase contract or a commitment as referred to in Article 91(1); and (b) aid for processing into long fibre. The amount of additional aid shall be EUR 120 per hectare in zone I and EUR 50 per hectare in zone II.
Article 95 
Implementing rules The Commission shall adopt the detailed rules for the implementation of this Subsection which may, in particular, include rules concerning: (a) the conditions for authorisation of primary processors referred to in Article 91; (b) the conditions to be met by approved primary processors as regards the contracts of sale and commitments referred to in Article 91(1); (c) the requirements to be complied with by farmers in the case referred to in the second subparagraph of Article 91(1); (d) the criteria to be met by long flax fibre; (e) the conditions for the grant of aid and the advance payment, and in particular proof of the processing of straw; (f) the conditions to be met for fixing the limits referred to in Article 92(2). Subsection III Potato starch
Article 95a Potato starch premium
1. A premium of EUR 22,25 per tonne of starch produced shall be paid for the 2009/2010, 2010/2011 and 2011/2012 marketing years to potato starch manufacturers for the quantity of potato starch up to the quota limit referred to in Article 84 a (2), provided that they have paid to potato producers a minimum price for all the potatoes necessary to produce starch up to that quota limit. 2. The minimum price of potatoes intended for the manufacture of potato starch shall be set at EUR 178,31 per tonne for the marketing years concerned. This price applies to the quantity of potatoes, delivered to the factory, which is needed to make one tonne of starch. The minimum price shall be adjusted according to the starch content of the potatoes. 3. The Commission shall adopt the detailed rules for the implementation of this Subsection.
Article 97 
Production refund in the sugar sector 1. A production refund may be granted on the products of the sugar-sector listed in points (b) to (e) of Part III of Annex I if surplus sugar or imported sugar, surplus isoglucose or surplus inulin syrup is not available at a price corresponding to the world price for the manufacturing of the products referred to in Article 62(2)(b) and (c). 2. The production refund referred to in paragraph 1 shall be fixed taking into account in particular the costs arising from the use of imported sugar which the industry would have to bear in the event of supply on the world market and the price of the surplus sugar available on the Community market or the reference price if there is no surplus sugar.
Article 98 
Conditions for granting The Commission shall adopt the conditions for the granting of the production refunds referred to in this Section, as well as the amount of such refunds and, as regards the production refund for sugar provided for in Article 97, the eligible quantities.
Article 99 Aid for skimmed milk and skimmed milk powder for use as feedingstuffs
1. When surpluses of milk products build up or are likely to occur, creating or likely to create a serious imbalance in the market, the Commission may decide that aid shall be granted for Community-produced skimmed milk and skimmed-milk powder intended for use as feedingstuffs, according to conditions and product standards to be determined by the Commission. The aid may be fixed in advance or by means of tendering procedures. For the purposes of this Article, buttermilk and buttermilk powder shall be regarded as skimmed milk and skimmed-milk powder. 2. Aid amounts shall be fixed by the Commission taking into account the reference price fixed in point (e)(ii) of Article 8(1) for skimmed-milk powder, and the development of the market situation as regards skimmed milk and skimmed-milk powder.
Article 100 Aid for skimmed milk processed into casein and caseinates
1. When surpluses of milk products build up or are likely to occur, creating or likely to create a serious imbalance in the market, the Commission may decide that aid shall be granted for Community-produced skimmed milk processed into casein and caseinates, according to conditions and product standards of such milk and the casein or caseinates produced from it to be determined by the Commission. The aid may be fixed in advance or by means of tendering procedures. 2. Aid shall be fixed by the Commission taking into account the development of the market situation for skimmed-milk powder and the reference price for skimmed-milk powder, fixed in point (e)(ii) of Article 8(1). The aid may vary, according to whether the skimmed milk is processed into casein or caseinates and according to the quality of those products.
Article 102 
Aid for the supply of milk products to pupils 1. Under conditions to be determined by the Commission, Community aid shall be granted for supplying to pupils in educational establishments certain processed milk products to be determined by the Commission falling within CN codes 0401, 0403, 0404 90 and 0406 or CN code 2202 90. 2. Member States may, in addition to Community aid, grant national aid for supplying the products referred to in paragraph 1 to pupils in educational establishments. Member States may finance their national aid by means of a levy on the dairy sector or by any other contribution from the dairy sector. 3. The Community aid shall be EUR 18,15/100 kg for all milk. The amounts of aid for other eligible milk products shall be determined taking into account the milk components of the product concerned. 4. The aid referred to in paragraph 1 shall be granted on a maximum quantity of 0,25 litre of milk equivalent per pupil and per day.
Article 103 
Aids to operator organisations 1. The Community shall finance three-year work programmes to be drawn up by the operator organisations referred to in Article 125 in one or more of the following areas. 1a. The Community financing per year of the work programmes shall be: (a) EUR 11 098 000 for Greece, (b) EUR 576 000 for France, and (c) EUR 35 991 000 for Italy. 2. The maximum Community funding for the work programmes referred to in paragraph 1 shall be equal to the part of the amounts withheld by the Member States. This funding shall concern the eligible cost with a maximum of: (a) 100 % for activities in the areas referred to in points (a) and (b) of paragraph 1; (b) 100 % for fixed assets investments and 75 % for other activities in the area referred to in point (c) of paragraph 1; (c) 75 % for the work programmes carried out in at least three third countries or non-producing Member States by approved operator organisations from at least two producer Member States in the areas referred to in points (d) and (e) of paragraph 1, and 50 % for the other activities in these areas. Complementary financing shall be ensured by the Member State up to 50 % of the costs not covered by the Community funding. The Commission shall establish the detailed rules for the application of this Article and in particular the procedures for the approval of the work programmes by the Member States and the types of activities eligible under such programmes. 3. Without prejudice to any specific provisions which may be adopted by the Commission in accordance with Article 194, Member States shall verify that the conditions for granting Community funding are met. To that end, they shall carry out an audit of work programmes and a control plan involving a sample determined on the basis of a risk analysis and comprising at least 30 % per year of producer organisations and all the other operators' organisations in receipt of Community funding under this Article.
Article 103a Aid to producer groups
1. During the transitional period allowed pursuant to Article 125e, Member States may grant to producer groups in the fruit and vegetables sector which have been formed in view of being recognised as a producer organisation: (a) aid to encourage their formation and facilitate their administrative operation; (b) aid, provided either directly or through credit institutions, to cover part of the investments required to attain recognition and set out in the recognition plan referred to in the third subparagraph of Article 125e(1). 2. The aid referred to in paragraph 1 shall be reimbursed by the Community in accordance with rules to be adopted by the Commission on the financing of such measures, including the thresholds and ceilings and the degree of Community financing. 3. The aid referred to in paragraph 1(a) shall be determined for each producer group on the basis of its marketed production and shall amount, for the first, second, third, fourth and fifth years, to: (a) 10 %, 10 %, 8 %, 6 % and 4 % respectively of the value of marketed production in the Member States which acceded to the European Union on 1 May 2004 or thereafter; and (b) 5 %, 5 %, 4 %, 3 % and 2 %, respectively of the value of marketed production in the outermost regions of the Community as referred to in Article 299(2) of the Treaty or in the smaller Aegean Islands as referred to in Article 1(2) of Regulation (EC) No 1405/2006 of 18 September 2006 laying down specific measures for agriculture in favour of the smaller Aegean Islands ( 62 ). Those percentage rates may be reduced in relation to the value of marketed production which exceeds a threshold. A ceiling may be applied to the aid payable in any given year to a producer group. Subsection II Operational funds and operational programmes
Article 103b Operational funds
1. Producer organisations in the fruit and vegetables sector may set up an operational fund. The fund shall be financed by: (a) financial contributions of members or of the producer organisation itself; (b) Community financial assistance which may be granted to producer organisations. 2. Operational funds shall be used only to finance operational programmes approved by Member States in accordance with Article 103g.
Article 103c Operational programmes
1. Operational programmes in the fruit and vegetables sector shall have two or more of the objectives referred to in Article 122(c) or of the following objectives: (a) planning of production; (b) improvement of product quality; (c) boosting products’ commercial value; (d) promotion of the products, whether in a fresh or processed form; (e) environmental measures and methods of production respecting the environment, including organic farming; (f) crisis prevention and management. 2. Crisis prevention and management shall be related to avoiding and dealing with crises on the fruit and vegetable markets and shall cover in this context: (a) market withdrawal; (b) green harvesting or non-harvesting of fruit and vegetables; (c) promotion and communication; (d) training measures; (e) harvest insurance; (f) support for the administrative costs of setting up mutual funds. Crisis prevention and management measures, including any repayment of capital and interest as referred to in the third subparagraph, shall not comprise more than one-third of the expenditure under the operational programme. In order to finance crisis prevention and management measures, producer organisations may take out loans on commercial terms. In this case, the repayment of the capital and interest on those loans may form part of the operational programme and so may be eligible for Community financial assistance under Article 103d. Any specific action under crisis prevention and management shall be financed either by such loans, or directly, but not both. 3. Member States shall provide that: (a) operational programmes include two or more environmental actions; or (b) at least 10 % of the expenditure under operational programmes covers environmental actions. Environmental actions shall respect the requirements for agri-environment payments set out in the first subparagraph of Article 39(3) of Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) ( 63 ). Where at least 80 % of the producer members of a producer organisation are subject to one or more identical agri-environment commitments under that provision then each one of those commitments shall count as an environmental action as referred to in point (a) of the first subparagraph. Support for the environmental actions referred to in the first subparagraph shall cover additional costs and income foregone resulting from the action. 4. Paragraph 3 shall only apply in Bulgaria and Romania from 1 January 2011. 5. Investments which increase environmental pressure shall only be permitted in situations where effective safeguards to protect the environment from these pressures are in place.
Article 103d Community financial assistance
1. The Community financial assistance shall be equal to the amount of the financial contributions referred to in Article 103b(1)(a) as actually paid but limited to 50 % of the actual expenditure incurred. 2. The Community financial assistance shall be capped at 4,1 % of the value of the marketed production of each producer organisation. However, that percentage may be increased to 4,6 % of the value of the marketed production provided that the amount in excess of 4,1 % of the value of the marketed production is used solely for crisis prevention and management measures. 3. At the request of a producer organisation, the percentage provided for in paragraph 1 shall be 60 % for an operational programme or part of an operational programme where it meets at least one of the following conditions: (a) it is submitted by several Community producer organisations operating in different Member States on transnational schemes; (b) it is submitted by one or more producer organisations engaged in schemes operated on an interbranch basis; (c) it covers solely specific support for the production of organic products covered until 31 December 2008, by Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs ( 64 ) and, from 1 January 2009, by Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products ( 65 ); (d) it is submitted by a producer organisation in one of the Member States which acceded to the European Union on 1 May 2004 or thereafter for measures running no later than the end of 2013; (e) it is the first to be submitted by a recognised producer organisation which has merged with another recognised producer organisation; (f) it is the first to be submitted by a recognised association of producer organisations; (g) it is submitted by producer organisations in Member States where producer organisations market less than 20 % of fruit and vegetables production; (h) it is submitted by a producer organisation in one of the outermost regions of the Community; (i) it covers solely specific support for actions to promote the consumption of fruit and vegetables targeted at children in educational establishments. 4. The percentage provided for in paragraph 1 shall be 100 % in the case of market withdrawals of fruit and vegetables which shall not exceed 5 % of the volume of marketed production of each producer organisation and which are disposed of by way of: (a) free distribution to charitable organisations and foundations, approved to that effect by the Member States, for use in their activities to assist persons whose right to public assistance is recognised in national law, in particular because they lack the necessary means of subsistence; (b) free distribution to penal institutions, schools and public education institutions and to children’s holiday camps as well as to hospitals and old people’s homes designated by the Member States, which shall take all necessary steps to ensure that the quantities thus distributed are additional to the quantities normally bought in by such establishments.
Article 103e National financial assistance
1. In regions of the Member States where the degree of organisation of producers in the fruit and vegetables sector is particularly low, Member States may be authorised by the Commission, on a duly substantiated request, to pay producer organisations national financial assistance equal to a maximum of 80 % of the financial contributions referred to in Article 103b(1)(a). This assistance shall be additional to the operational fund. In regions of Member States where producer organisations market less than 15 % of the value of fruit and vegetable production and whose fruit and vegetable production represents at least 15 % of their total agricultural output, the assistance referred to in the first subparagraph may be reimbursed by the Community at the request of the Member State concerned.
Article 103f National framework and national strategy for operational programmes
1. Member States shall establish a national framework for drawing up the general conditions relating to the actions referred to in Article 103c(3). This framework shall provide in particular that such actions shall meet the appropriate requirements of Regulation (EC) No 1698/2005 including those in its Article 5 on complementarity, consistency and conformity. Member States shall submit their proposed framework to the Commission which may require modifications within three months if it finds that the proposal does not enable the attainment of the objectives set out in Article 174 of the Treaty and in the sixth Community environment action programme ( 66 ). Investments on individual holdings supported by operational programmes shall also respect those objectives. 2. Member States shall establish a national strategy for sustainable operational programmes in the fruit and vegetable market. Such a strategy shall provide for the following elements: (a) an analysis of the situation in terms of strengths and weaknesses and the potential for development; (b) justification of the priorities chosen; (c) the objectives of operational programmes and instruments, performance indicators; (d) assessment of operational programmes; (e) reporting obligations for producer organisations. The national strategy shall also integrate the national framework referred to in paragraph 1. 3. Paragraphs 1 and 2 shall not apply to Member States which have no recognised producer organisations.
Article 103g Approval of operational programmes
1. Draft operational programmes shall be submitted to the competent national authorities, who shall approve or reject them or request their modification in line with the provisions of this subsection. 2. Producer organisations shall communicate to the Member State the estimated amount of the operational fund for each year and shall submit appropriate reasons therefore based on operational programme estimates, expenditure for the current year and possibly expenditure for previous years and, if necessary, on estimated production quantities for the next year. 3. The Member State shall notify the producer organisation or association of producer organisations of the estimated amount of Community financial assistance in line with the limits set out in Article 103d. 4. Community financial assistance payments shall be made on the basis of expenditure incurred for the schemes covered by the operational programme. Advances may be made in respect of the same schemes subject to the provision of a guarantee or security. 5. The producer organisation shall notify the Member State of the final amount of expenditure for the previous year, accompanied by the necessary supporting documents, so that it may receive the balance of the Community financial assistance. 6. Operational programmes and their financing by producers and producer organisations on the one hand and by Community funds on the other shall have a minimum duration of three and a maximum duration of five years. Subsection IIa School Fruit Scheme
Article 103ga Aid for the supply of fruit and vegetable, processed fruit and vegetable and banana products to children
1. Under conditions to be determined by the Commission, from the 2009-2010 school year onwards, Community aid shall be granted for: (a) the supply to children in educational establishments, including nurseries, other pre-school establishments, primary and secondary schools, of products of the fruit and vegetables, processed fruit and vegetables, and bananas sectors; and (b) certain related costs of logistics and distribution, equipment, communication, monitoring and evaluation. 2. Member States, at national or regional level, wishing to participate in the scheme shall draw up a prior strategy for its implementation containing, in particular, the budget of their scheme including: the Community and national contributions, the duration, the target group, the eligible products and the involvement of relevant stakeholders. They shall also provide for the accompanying measures necessary to make the scheme effective. 3. When drawing up their strategies, Member States shall draw up a list of products of the fruit and vegetables, processed fruit and vegetables, and bananas sectors that will be eligible under their respective schemes. This list, however, shall not include products excluded by a measure adopted by the Commission under Article 103h(f). They shall choose their products on the basis of objective criteria which may include seasonality, availability of produce or environmental concerns. In this connection, Member States may give preference to products of Community origin. 4. The Community aid referred to in paragraph 1 shall neither: (a) exceed EUR 90 million per school year; nor (b) exceed 50 % of the costs of supply and related costs referred to in paragraph 1, or 75 % of such costs in the regions eligible under the Convergence Objective in accordance with Article 5(1) of Council Regulation (EC) No 1083/2006 of 11 July 2006 laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund ( 67 ), and in the outermost regions referred to in Article 299(2) of the Treaty; nor (c) cover costs other than the costs of supply and related costs referred to in paragraph 1. 5. The Community aid referred to in paragraph 1 shall be allocated to each Member State on the basis of objective criteria based on their proportion of six to ten year old children. However, Member States participating in the scheme shall each receive at least EUR 175 000 of Community aid. Member States participating in the scheme shall apply every year for Community aid on the basis of their strategy. Following the requests of the Member States, the Commission shall decide on definitive allocations, within the appropriations available in the budget. 6. Community aid referred to in paragraph 1 shall not be used to replace funding for any existing national school fruit schemes or other school distribution schemes that include fruit. However, if a Member State already has a scheme in place that would be eligible for Community aid under this Article and intends to extend it or make it more effective, including as regards the target group of the scheme, its duration or eligible products, Community aid may be granted provided that the limits of paragraph 4(b) are abided by as regards the proportion of Community aid to the total national contribution. In this case, the Member State shall indicate in its strategy how it intends to extend its scheme or make it more effective. 7. Member States may, in addition to Community aid, grant national aid for the supply of products and related costs referred to in paragraph 1. These costs may also be covered by contributions from the private sector. Member States may also grant national aid for financing the accompanying measures referred to in paragraph 2. 8. The Community School Fruit Scheme shall be without prejudice to any separate national school fruit schemes which are compatible with Community law. 9. The Community may also finance, under Article 5 of Regulation (EC) No 1290/2005, information, monitoring and evaluation measures relating to the School Fruit Scheme, including raising public awareness of it, and related networking measures. Subsection III Procedural provisions
Article 103h Implementing rules
The Commission shall establish the detailed rules for the application of this section, in particular: (a) rules on financing of the measures referred to in Article 103a, including the thresholds and ceilings for aid and the degree of Community co-financing of the aid; (b) the proportion of and rules on the reimbursement of the measures referred to in Article 103e(1); (c) rules on investments on individual holdings; (d) the dates for the communications and notifications referred to in Article 103g; (e) provision for partial payments of the Community financial assistance referred to in Article 103g; (f) provisions concerning the School Fruit Scheme referred to in Article 103ga, including: a list of products or ingredients that should be excluded from the School Fruit Scheme, the definitive allocation of aid between Member States, financial and budgetary management, and the related costs, the strategies of the Member States, accompanying measures and information, monitoring and evaluation and networking measures.
Article 103i Scope
This Section lays down the rules governing the attribution of Community funds to Member States and the use of those funds by Member States through national support programmes (hereinafter referred to as support programmes) to finance specific support measures to assist the wine sector.
Article 103j Compatibility and consistency
1. Support programmes shall be compatible with Community law and consistent with the activities, policies and priorities of the Community. 2. Member States shall be responsible for the support programmes and ensure that they are internally consistent and drawn up and implemented in an objective manner, taking into account the economic situation of the producers concerned and the need to avoid unjustified unequal treatment between producers. Member States shall be responsible for providing for and carrying out the necessary controls and penalties in case of non-compliance with the support programmes. 3. No support shall be granted: (a) for research projects and measures to support research projects; (b) for measures which are contained in Member States’ rural development programmes under Regulation (EC) No 1698/2005. Subsection II Submission and content of support programmes
Article 103k Submission of support programmes
1. Each producer Member State referred to in Annex Xb shall submit to the Commission a draft five-year support programme containing measures in accordance with this Section. Support programmes that became applicable in accordance with the first subparagraph of Article 5(1) of Regulation (EC) No 479/2008 shall continue to apply under this Regulation. The support measures in the support programmes shall be drawn up at the geographical level which the Member States deem most appropriate. Before being submitted to the Commission, the support programme shall be subject to consultation with the competent authorities and organisations at the appropriate territorial level. Each Member State shall submit one single draft support programme which may accommodate regional particularities. 2. Support programmes shall become applicable three months after their submission to the Commission. However, if the submitted support programme does not comply with the conditions laid down in this Section, the Commission shall inform the Member State thereof. In such a case, the Member State shall submit a revised support programme to the Commission. The revised support programme shall become applicable two months after its notification unless an incompatibility persists in which case this subparagraph shall apply. 3. Paragraph 2 shall apply mutatis mutandis to changes in respect of support programmes submitted by Member States. 4. Article 103l shall not apply where a Member State’s only measure in a support programme consists of the transfer to the Single Payment Scheme referred to in Article 103o. In such case, Article 188a(5) shall apply only in relation to the year in which the transfer takes place and Article 188a(6) shall not apply.
Amendment rationale: CONTEXT OF THE PROPOSAL The proposal for a Council Regulation is necessitated by the upcoming accession of the Republic of Croatia to the European Union. The Treaty concerning the accession of the Republic of Croatia to the European Union[1] was signed by all Member States of the European Union and the Republic of Croatia at Brussels on 9 December 2011. Article 3 (3) of the Treaty of Accession provides that it shall enter into force on 1 July 2013 provided that all the instruments of ratification have been deposited before that date. Article 3(4) of the Treaty of Accession enables the institutions of the Union to adopt before accession measures referred to, inter alia, in Article 50 of the Act concerning the conditions of accession of the Republic of Croatia[2]. These measures shall enter into force only subject to and on the date of the entry into force of the Treaty of Accession. Article 50 of the Act of Accession provides that where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in this Act or its Annexes, the Council or the Commission (if the original acts were adopted by the Commission) shall adopt the necessary acts. Point 2 of the Final Act[3] refers to the political agreement on a set of adaptations to acts adopted by the institutions which was reached between the Member States and Croatia in the context of the approval of the Treaty of Accession; the High Contracting Parties of the Treaty of Accession invited the Council and the Commission to adopt these adaptations before accession in accordance with Article 50 of the Act of Accession, completed and updated where necessary to take account of the evolution of the law of the Union. The present proposal regroups the technical adaptations to all Council regulations and decisions as well as to all European Parliament and Council regulations and decisions which require technical adaptation by reason of the accession of Croatia, into a single Council regulation. Alongside this proposal for a Council Regulation, the Commission transmits a series of separate proposals for several Council directives to the Council which cover technical adaptations to Council directives as well as to European Parliament and Council directives which also need technical adaptation by reason of the accession of Croatia. Each of these separate proposals for Council directives regroups the technical adaptations which correspond to different negotiation chapters. This structure is designed to facilitate the transposition of the directives by Member States into their respective legal orders, and is in line with the approach which was taken in view of the accession of Bulgaria and Romania[4]. It is foreseen that all the legal acts included in this package will be published in the Official Journal of the European Union at the same date. The present proposal and the other proposals included in this package will take into account technical adaptations to the acquis which were published in the Official Journal of the European Union until 1 September 2012. The reasons for this are to provide sufficient time for the legislative processes involved on the one hand, and for the fulfilment of the ensuing transposition and notification obligations by Member States as regards directives on the other hand. Adaptations which may be necessary to the acquis published in the Official Journal of the European Union after 1 September 2012 will be foreseen in the relevant acts themselves or done at a later stage through the appropriate procedure. In addition, the Commission intends to informally provide a list of such legislation to Member States in early July 2013.
Revised version (Article 103k Submission of support programmes):
1. Each producer Member State referred to in Annex Xb shall submit to the Commission a draft five-year support programme containing measures in accordance with this Section. Support programmes that became applicable in accordance with the first subparagraph of Article 5(1) of Regulation (EC) No 479/2008 shall continue to apply under this Regulation. The support measures in the support programmes shall be drawn up at the geographical level which the Member States deem most appropriate. Before being submitted to the Commission, the support programme shall be subject to consultation with the competent authorities and organisations at the appropriate territorial level. Each Member State shall submit one single draft support programme which may accommodate regional particularities. This paragraph shall not apply to Croatia for the financial year 2013. Croatia shall submit to the Commission a draft five-year support programme for the 2014-2018 programme period. 2. Support programmes shall become applicable three months after their submission to the Commission. However, if the submitted support programme does not comply with the conditions laid down in this Section, the Commission shall inform the Member State thereof. In such a case, the Member State shall submit a revised support programme to the Commission. The revised support programme shall become applicable two months after its notification unless an incompatibility persists in which case this subparagraph shall apply. 3. Paragraph 2 shall apply mutatis mutandis to changes in respect of support programmes submitted by Member States. 4. Article 103l shall not apply where a Member State’s only measure in a support programme consists of the transfer to the Single Payment Scheme referred to in Article 103o. In such case, Article 188a(5) shall apply only in relation to the year in which the transfer takes place and Article 188a(6) shall not apply.
Article 103l Content of support programmes
Support programmes shall consist of the following elements: (a) a detailed description of the measures proposed as well as their quantified objectives; (b) the results of consultations held; (c) an appraisal showing the expected technical, economic, environmental and social impact; (d) a schedule for implementing the measures; (e) a general financing table showing the resources to be deployed and the envisaged indicative allocation of the resources between the measures in accordance with ceilings provided for in Annex Xb; (f) the criteria and quantitative indicators to be used for monitoring and evaluation as well as the steps taken to ensure that the support programmes are implemented appropriately and effectively; and (g) the designation of competent authorities and bodies responsible for implementing the support programme.
Article 103m Eligible measures
1. Support programmes shall contain one or more of the following measures: (a) Single Payment Scheme support in accordance with Article 103o; (b) promotion in accordance with Article 103p; (c) restructuring and conversion of vineyards in accordance with Article 103q; (d) green harvesting in accordance with Article 103r; (e) mutual funds in accordance with Article 103s; (f) harvest insurance in accordance with Article 103t; (g) investments in accordance with Article 103u; (h) by-product distillation in accordance with Article 103v; (i) potable alcohol distillation in accordance with Article 103w; (j) crisis distillation in accordance with Article 103x; (k) use of concentrated grape must in accordance with Article 103y. 2. Support programmes shall not contain other measures than the ones listed in Articles 103o to 103y.
Article 103n General rules concerning support programmes
1. The allocation of the available Community funds as well as the budgetary limits are provided for in Annex Xb. 2. Community support shall only relate to eligible expenditure incurred after the submission of the relevant support programme as referred to in Article 103k(1). 3. Member States shall not contribute to the costs of measures financed by the Community under the support programmes. 4. By way of derogation from paragraph 3, Member States may grant national aid in accordance with the relevant Community rules on State aid for the measures referred to in Articles 103p, 103t and 103u. The maximum aid rate as laid down in the relevant Community rules on State aids shall apply to the global public financing, including both Community and national funds. Subsection III Specific support measures
Amendment rationale: CONTEXT OF THE PROPOSAL The proposal for a Council Regulation is necessitated by the upcoming accession of the Republic of Croatia to the European Union. The Treaty concerning the accession of the Republic of Croatia to the European Union[1] was signed by all Member States of the European Union and the Republic of Croatia at Brussels on 9 December 2011. Article 3 (3) of the Treaty of Accession provides that it shall enter into force on 1 July 2013 provided that all the instruments of ratification have been deposited before that date. Article 3(4) of the Treaty of Accession enables the institutions of the Union to adopt before accession measures referred to, inter alia, in Article 50 of the Act concerning the conditions of accession of the Republic of Croatia[2]. These measures shall enter into force only subject to and on the date of the entry into force of the Treaty of Accession. Article 50 of the Act of Accession provides that where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in this Act or its Annexes, the Council or the Commission (if the original acts were adopted by the Commission) shall adopt the necessary acts. Point 2 of the Final Act[3] refers to the political agreement on a set of adaptations to acts adopted by the institutions which was reached between the Member States and Croatia in the context of the approval of the Treaty of Accession; the High Contracting Parties of the Treaty of Accession invited the Council and the Commission to adopt these adaptations before accession in accordance with Article 50 of the Act of Accession, completed and updated where necessary to take account of the evolution of the law of the Union. The present proposal regroups the technical adaptations to all Council regulations and decisions as well as to all European Parliament and Council regulations and decisions which require technical adaptation by reason of the accession of Croatia, into a single Council regulation. Alongside this proposal for a Council Regulation, the Commission transmits a series of separate proposals for several Council directives to the Council which cover technical adaptations to Council directives as well as to European Parliament and Council directives which also need technical adaptation by reason of the accession of Croatia. Each of these separate proposals for Council directives regroups the technical adaptations which correspond to different negotiation chapters. This structure is designed to facilitate the transposition of the directives by Member States into their respective legal orders, and is in line with the approach which was taken in view of the accession of Bulgaria and Romania[4]. It is foreseen that all the legal acts included in this package will be published in the Official Journal of the European Union at the same date. The present proposal and the other proposals included in this package will take into account technical adaptations to the acquis which were published in the Official Journal of the European Union until 1 September 2012. The reasons for this are to provide sufficient time for the legislative processes involved on the one hand, and for the fulfilment of the ensuing transposition and notification obligations by Member States as regards directives on the other hand. Adaptations which may be necessary to the acquis published in the Official Journal of the European Union after 1 September 2012 will be foreseen in the relevant acts themselves or done at a later stage through the appropriate procedure. In addition, the Commission intends to informally provide a list of such legislation to Member States in early July 2013.
Revised version (Article 103n General rules concerning support programmes):
1. The allocation of the available Community funds as well as the budgetary limits are provided for in Annex Xb. 1a. By 1 August 2013, Member States may decide to reduce, from 2015, the amount available for the support programmes referred to in Annex Xb, in order to increase their national ceilings for direct payments referred to in Article 40 of Regulation (EC) No 73/2009. The amount resulting from the decrease referred to in the first subparagraph shall definitively remain in the national ceilings for direct payments referred to in Article 40 of Regulation (EC) No 73/2009 and shall no longer be available for the measures listed in Articles 103p to 103y. 2. Community support shall only relate to eligible expenditure incurred after the submission of the relevant support programme as referred to in Article 103k(1). 3. Member States shall not contribute to the costs of measures financed by the Community under the support programmes. 4. By way of derogation from paragraph 3, Member States may grant national aid in accordance with the relevant Community rules on State aid for the measures referred to in Articles 103p, 103t and 103u. The maximum aid rate as laid down in the relevant Community rules on State aids shall apply to the global public financing, including both Community and national funds. Subsection III Specific support measures
Article 103o Single Payment Scheme and support to vine-growers
1. Member States may provide support to vine-growers by allocating to them payment entitlements within the meaning of Chapter 3 of Title III of Regulation (EC) No 1782/2003 in accordance with point O of Annex VII to that Regulation. 2. Member States intending to make use of the possibility referred to in paragraph 1 shall foresee such support in their support programmes, including, as regards subsequent transfers of funds to the Single Payment Scheme, by way of changes to those programmes in accordance with Article 103k(3). 3. Once effective, support as referred to in paragraph 1 shall: (a) remain in the Single Payment Scheme and no longer be available, or be made available under Article 103k(3), for the measures listed in Articles 103p to 103y in subsequent years of the operation of the support programmes; (b) commensurately reduce the amount of funds available for measures listed in Articles 103p to 103y in the support programmes.
Amendment rationale: CONTEXT OF THE PROPOSAL The proposal for a Council Regulation is necessitated by the upcoming accession of the Republic of Croatia to the European Union. The Treaty concerning the accession of the Republic of Croatia to the European Union[1] was signed by all Member States of the European Union and the Republic of Croatia at Brussels on 9 December 2011. Article 3 (3) of the Treaty of Accession provides that it shall enter into force on 1 July 2013 provided that all the instruments of ratification have been deposited before that date. Article 3(4) of the Treaty of Accession enables the institutions of the Union to adopt before accession measures referred to, inter alia, in Article 50 of the Act concerning the conditions of accession of the Republic of Croatia[2]. These measures shall enter into force only subject to and on the date of the entry into force of the Treaty of Accession. Article 50 of the Act of Accession provides that where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in this Act or its Annexes, the Council or the Commission (if the original acts were adopted by the Commission) shall adopt the necessary acts. Point 2 of the Final Act[3] refers to the political agreement on a set of adaptations to acts adopted by the institutions which was reached between the Member States and Croatia in the context of the approval of the Treaty of Accession; the High Contracting Parties of the Treaty of Accession invited the Council and the Commission to adopt these adaptations before accession in accordance with Article 50 of the Act of Accession, completed and updated where necessary to take account of the evolution of the law of the Union. The present proposal regroups the technical adaptations to all Council regulations and decisions as well as to all European Parliament and Council regulations and decisions which require technical adaptation by reason of the accession of Croatia, into a single Council regulation. Alongside this proposal for a Council Regulation, the Commission transmits a series of separate proposals for several Council directives to the Council which cover technical adaptations to Council directives as well as to European Parliament and Council directives which also need technical adaptation by reason of the accession of Croatia. Each of these separate proposals for Council directives regroups the technical adaptations which correspond to different negotiation chapters. This structure is designed to facilitate the transposition of the directives by Member States into their respective legal orders, and is in line with the approach which was taken in view of the accession of Bulgaria and Romania[4]. It is foreseen that all the legal acts included in this package will be published in the Official Journal of the European Union at the same date. The present proposal and the other proposals included in this package will take into account technical adaptations to the acquis which were published in the Official Journal of the European Union until 1 September 2012. The reasons for this are to provide sufficient time for the legislative processes involved on the one hand, and for the fulfilment of the ensuing transposition and notification obligations by Member States as regards directives on the other hand. Adaptations which may be necessary to the acquis published in the Official Journal of the European Union after 1 September 2012 will be foreseen in the relevant acts themselves or done at a later stage through the appropriate procedure. In addition, the Commission intends to informally provide a list of such legislation to Member States in early July 2013.
Revised version (Article 103o Single payment scheme and support to vine-growers):
1. Member States may decide, by 1 December 2012, to provide support to vine-growers for 2014 by allocating payment entitlements within the meaning of Chapter 1 of Title III of Regulation (EC) No 73/2009. If the amount of the support referred to in the first subparagraph is greater than the amount of support that was provided for 2013, the Member State concerned shall use the difference to allocate payment entitlements within the meaning of Chapter 1 of Title III of Regulation (EC) No 73/2009 to vine-growers in accordance with point C of Annex IX to that Regulation. 2. Member States intending to provide support referred to in paragraph 1 shall make provision for such support in their support programmes in accordance with Article 103k(3). 3. The support for 2014 referred to in paragraph 1 shall: (a) remain in the single payment scheme and no longer be available under Article 103k(3) for the measures listed in Articles 103p to 103y; (b) reduce proportionately the amount of funds available for measures listed in Articles 103p to 103y in the support programmes.
Article 103p Promotion on third-country markets
1. Support under this Article shall cover information or promotion measures concerning Community wines in third countries, thereby improving their competitiveness in those countries. 2. The measures referred to in paragraph 1 shall relate to wines with a protected designation of origin or a protected geographical indication or wines with an indication of the wine grape variety. 3. The measures referred to in paragraph 1 may consist only of: (a) public relations, promotion or advertisement measures, in particular highlighting the advantages of the Community products, especially in terms of quality, food safety or environmental friendliness; (b) participation at events, fairs or exhibitions of international importance; (c) information campaigns, in particular on the Community systems covering designations of origin, geographical indications and organic production; (d) studies of new markets, necessary for the expansion of market outlets; (e) studies to evaluate the results of the information and promotion measures. 4. The Community contribution to promotion activities shall not exceed 50 % of the eligible expenditure.
Article 103q Restructuring and conversion of vineyards
1. The objective of measures relating to the restructuring and conversion of vineyards shall be to increase the competitiveness of wine producers. 2. The restructuring and conversion of vineyards shall be supported in accordance with this Article only if Member States submit the inventory of their production potential in accordance with Article 185a(3). 3. Support for the restructuring and conversion of vineyards may only cover one or more of the following activities: (a) varietal conversion, including by means of grafting-on; (b) relocation of vineyards; (c) improvements to vineyard management techniques. The normal renewal of vineyards which have come to the end of their natural life shall not be supported. 4. Support for the restructuring and conversion of vineyards may only take the following forms: (a) compensation to producers for the loss of revenue due to the implementation of the measure; (b) contribution to the costs of restructuring and conversion. 5. Compensation to producers for the loss of revenue as referred to in paragraph 4(a) may cover up to 100 % of the relevant loss and take either of the following forms: (a) notwithstanding Subsection II of Section IVa of Chapter III of Title I of Part II setting out the transitional planting right regime, the permission for both old and new vines to coexist for a fixed period which shall not exceed three years, until the end of the transitional regime concerning planting rights; (b) financial compensation. 6. The Community contribution to the actual costs of the restructuring and conversion of vineyards shall not exceed 50 %. In regions classified as convergence regions in accordance with Council Regulation (EC) No 1083/2006 of 11 July 2006 laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund ( 68 ), the Community contribution to the costs of restructuring and conversion shall not exceed 75 %.
Article 103r Green harvesting
1. For the purposes of this Article, green harvesting means the total destruction or removal of grape bunches while still in their immature stage, thereby reducing the yield of the relevant area to zero. 2. Support for green harvesting shall contribute to restoring the balance of supply and demand in the market in wine in the Community in order to prevent market crises. 3. Support for green harvesting may be granted as compensation in the form of a flat rate payment per hectare to be determined by the Member State concerned. The payment shall not exceed 50 % of the sum of the direct costs of the destruction or removal of grape bunches and the loss of revenue related to such destruction or removal. 4. The Member States concerned shall establish a system based on objective criteria to ensure that the green harvesting measure does not lead to compensation of individual wine producers in excess of the ceiling referred to in the second subparagraph of paragraph 3.
Article 103s Mutual funds
1. Support for the setting up of mutual funds shall provide assistance to producers seeking to insure themselves against market fluctuations. 2. Support for the setting up of mutual funds may be granted in the form of temporary and degressive aid to cover the administrative costs of the funds.
Article 103t Harvest insurance
1. Support for harvest insurance shall contribute to safeguarding producers’ incomes where these are affected by natural disasters, adverse climatic events, diseases or pest infestations. 2. Support for harvest insurance may be granted in the form of a financial Community contribution which must not exceed: (a) 80 % of the cost of the insurance premiums paid for by producers for insurance against losses resulting from adverse climatic events which can be assimilated to natural disasters; (b) 50 % of the cost of the insurance premiums paid for by producers for insurance against: (i) losses referred to in point (a) and against other losses caused by adverse climatic events; (ii) losses caused by animals, plant diseases or pest infestations. (b) 50 % of the cost of the insurance premiums paid for by producers for insurance against: (i) losses referred to in point (a) and against other losses caused by adverse climatic events; (ii) losses caused by animals, plant diseases or pest infestations. 3. Support for harvest insurance may only be granted if the insurance payments concerned do not compensate producers for more than 100 % of the income loss suffered, taking into account any compensation the producers may have obtained from other support schemes related to the insured risk. 4. Support for harvest insurance shall not distort competition in the insurance market.
Article 103u Investments
1. Support may be granted for tangible or intangible investments in processing facilities, winery infrastructure and marketing of wine which improve the overall performance of the enterprise and concern one or more of the following: (a) the production or marketing of products referred to in Annex XIb; (b) the development of new products, processes and technologies related to the products referred to in Annex XIb. 2. Support under paragraph 1 at its maximum rate shall be limited to micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 69 ). For the territories of the Azores, Madeira, the Canary Islands, the smaller Aegean islands within the meaning of Regulation (EC) No 1405/2006 and the French overseas departments, no size limits shall apply for the maximum rate. For enterprises that are not covered by Article 2(1) of Title I of the Annex to Recommendation 2003/361/EC with less than 750 employees or with a turnover of less than EUR 200 million, the maximum aid intensity shall be halved. Support shall not be granted to enterprises in difficulty within the meaning of the Community guidelines on State aid for rescuing and restructuring firms in difficulty. 3. The eligible expenditure shall exclude the elements referred to in Article 71(3)(a), (b) and (c) of Regulation (EC) No 1698/2005. 4. The following maximum aid rates in relation to the eligible investment costs shall apply to the Community contribution: (a) 50 % in regions classified as convergence regions in accordance with Regulation (EC) No 1083/2006; (b) 40 % in regions other than convergence regions; (c) 75 % in the outermost regions in accordance with Regulation (EC) No 247/2006; (d) 65 % in the smaller Aegean islands within the meaning of Regulation (EC) No 1405/2006. 5. Article 72 of Regulation (EC) No 1698/2005 shall apply mutatis mutandis to support referred to in paragraph 1 of this Article.
Article 103v By-product distillation
1. Support may be granted for the voluntary or obligatory distillation of by-products of wine making which has been carried out in accordance with the conditions laid down in point D of Annex XVb. The amount of aid shall be fixed per % volume and per hectolitre of alcohol produced. No aid shall be paid for the volume of alcohol contained in the by-products to be distilled which exceeds 10 % in relation to the volume of alcohol contained in the wine produced. 2. The maximum applicable aid levels shall be based on collection and processing costs and fixed by the Commission. 3. The alcohol resulting from the supported distillation referred to in paragraph 1 shall be used exclusively for industrial or energy purposes so as to avoid distortion of competition.
Article 103w Potable alcohol distillation
1. Support may be granted, in the form of a per-hectare aid, until 31 July 2012 to producers, for wine which is distilled into potable alcohol. 2. The relevant contracts concerning the distillation of wine as well as the relevant proofs of delivery for distillation shall be submitted before support is granted.
Article 103x Crisis distillation
1. Support may be granted until 31 July 2012 for voluntary or obligatory distillation of surplus wine decided upon by Member States in justified cases of crisis so as to reduce or eliminate the surplus and at the same time ensure supply continuity from one harvest to the next. 2. The maximum applicable aid levels shall be fixed by the Commission. 3. The alcohol resulting from the supported distillation referred to in paragraph 1 shall be used exclusively for industrial or energy purposes so as to avoid distortion of competition. 4. The share of the available budget used for the crisis distillation measure shall not exceed the following percentage shares as calculated against the globally available funds laid down in Annex Xb per Member State in the respective budget year: — 20 % in 2009, — 15 % in 2010, — 10 % in 2011, — 5 % in 2012. 5. Member States may increase the available funds for the crisis distillation measure beyond the annual ceilings given in paragraph 4 by way of contributing national funds in accordance with the following limits (expressed in terms of percentage of the respective annual ceiling given in paragraph 4): — 5 % in the wine year 2010, — 10 % in the wine year 2011, — 15 % in the wine year 2012. Member States shall, where applicable, notify the Commission of the addition of national funds referred to in the first subparagraph and the Commission shall approve the transaction before such funds are made available.
Article 103y Use of concentrated grape must
1. Support may be granted until 31 July 2012 to wine producers who use concentrated grape must, including rectified concentrated grape must, to increase the natural alcoholic strength of products in accordance with the conditions laid down in Annex XVa. 2. The amount of the aid shall be fixed per % volume potential alcoholic strength and per hectolitre of the must used for enrichment. 3. The maximum applicable aid levels for this measure in the different wine growing zones shall be fixed by the Commission.
Article 103z Cross-compliance
Where farmers are found not to have complied on their holding, at any time during three years from payment under the support programmes for restructuring and conversion or at any time during one year from payment under the support programmes for green harvesting, with the statutory management requirements and the good agricultural and environmental condition referred to in Articles 3 to 7 of Regulation (EC) No 1782/2003, the amount of the payment shall, where non-compliance is the result of an action or omission directly imputable to the farmer, be reduced or cancelled, partially or wholly depending on the severity, extent, permanence and repetition of the non-compliance, and the farmer shall, where applicable, be ordered to reimburse it in accordance with the conditions set out in those provisions. Subsection IV Procedural provisions
Article 103za Implementing measures
The measures necessary for the implementation of this Section shall be adopted by the Commission. Those measures may include, in particular: (a) the format of presentation of the support programmes; (b) rules concerning changes to support programmes after they have become applicable; (c) detailed rules for the implementation of the measures provided for in Articles 103p to 103y; (d) the conditions under which assistance through Community funds is to be communicated and publicised.
Article 104 
Tobacco Fund 1. A Community Tobacco Fund (hereinafter referred to as the Fund) shall be set up to finance measures in the following areas: (a) improving public awareness of the harmful effects of all forms of tobacco consumption, in particular through information and education, support for the collection of data to establish tobacco consumption patterns and to conduct epidemiological studies on nicotinism in the Community, and a study on preventing nicotinism; (b) specific measures to help tobacco growers to switch to other crops or other economic activities that create employment and studies of the possibilities for tobacco growers to do so. 2. The Fund shall be financed: (a) for the 2002 harvest by a deduction of 2 % and for the 2003, 2004 and 2005 harvests, of 3 % of the premium provided for in Title I of Regulation (EEC) No 2075/92 as applicable until and including the 2005 harvest for the financing of any kind of measures provided for in paragraph 1; (b) for the calendar years 2006 to 2009, in accordance with Article 110m of Regulation (EC) No 1782/2003. 3. Detailed rules for the application of this Article shall be adopted by the Commission.
Article 105 
Scope 1. With a view to improving general conditions for the production and marketing of apiculture products, Member States may draw up a national programme for a period of three years (hereinafter referred to as the ‘apiculture programme’). 2. Member States may pay specific national aids for the protection of apiaries disadvantaged by structural or natural conditions or under economic development programmes, except for those allocated for production or trade. These aids shall be notified to the Commission by Member States together with the communication of the apiculture programme in accordance with Article 109.
Article 106 
Measures eligible for aid The measures which may be included in the apiculture programme shall be the following: (a) technical assistance to beekeepers and groupings of beekeepers; (b) control of varroasis; (c) rationalisation of transhumance; (d) measures to support laboratories carrying out analyses of the physico-chemical properties of honey; (e) measures to support the restocking of hives in the Community; (f) cooperation with specialised bodies for the implementation of applied research programmes in the field of beekeeping and apiculture products. Measures financed from the EAFRD in accordance with Council Regulation (EC) No 1698/2005 ( 70 ) shall be excluded from the apiculture programme.
Article 107 
Study of the production and marketing structure in the beekeeping sector To be eligible for the part-financing provided for in Article 108(1), Member States shall carry out a study of the production and marketing structure in the beekeeping sector in their territory.
Article 108 
Financing 1. The Community shall provide part-financing for the apiculture programmes equivalent to 50 % of the expenditure borne by Member States. 2. Expenditure relating to the measures taken under the apiculture programmes shall be made by the Member States by 15 October each year.
Article 109 
Consultation The apiculture programme shall be drawn up in close collaboration with the representative organisations and beekeeping cooperatives. It shall be submitted to the Commission for approval.
Article 110 
Implementing rules The Commission shall establish the detailed rules for the application of this Section.
Article 111 
Aid to be granted to silkworm rearers 1. Aid shall be granted for silkworms falling within CN-code ex010690 00 and for silkworm eggs falling within CN-code ex051199 85 reared within the Community. 2. The aid shall be granted to silkworm rearers for each box of silkworm eggs used, on condition that the boxes contain a minimum quantity of eggs, to be determined, and that the worms have been successfully reared. 3. The aid per box of silkworm eggs used shall be EUR 133,26.
Article 112 
Implementing rules Detailed rules for the application of this Section shall be adopted by the Commission which shall cover, in particular, the minimum quantity of eggs referred to in Article 111(2).
Article 113 
Marketing standards 1. Provision may be made by the Commission for marketing standards for one or more of the products of the following sectors: (a) olive oil and table olives in respect of the products referred to in point (a) of Part VII of Annex I; (b) fruit and vegetables; (c) processed fruit and vegetables; (d) bananas; (e) live plants. 2. The standards referred to in paragraph 1: (a) shall be established taking into account, in particular: (i) the specificities of the products concerned; (ii) the need to ensure the conditions for a smooth disposal of those products on the market; (iii) the interest of consumers to receive adequate and transparent product information including, in particular for products of the fruit and vegetables and processed fruit and vegetables sectors, the country of origin, the class and, where appropriate, the variety (or the commercial type) of the product; (iv) as concerns the olive oils referred to in point (a) of Part VII of Annex I, changes in the methods used for determining their physical, chemical and organoleptic characteristics; (v) as regards the fruit and vegetables and the processed fruit and vegetables sectors, the Standard recommendations adopted by the UN-Economic Commission for Europe (UN/ECE); (a) shall be established taking into account, in particular: (i) the specificities of the products concerned; (ii) the need to ensure the conditions for a smooth disposal of those products on the market; (iii) the interest of consumers to receive adequate and transparent product information including, in particular for products of the fruit and vegetables and processed fruit and vegetables sectors, the country of origin, the class and, where appropriate, the variety (or the commercial type) of the product; (iv) as concerns the olive oils referred to in point (a) of Part VII of Annex I, changes in the methods used for determining their physical, chemical and organoleptic characteristics; (v) as regards the fruit and vegetables and the processed fruit and vegetables sectors, the Standard recommendations adopted by the UN-Economic Commission for Europe (UN/ECE); (b) may in particular relate to quality, grading into classes, weight, sizing, packaging, wrapping, storage, transport, presentation, marketing, origin and labelling. 3. Save as otherwise provided for by the Commission in accordance with the criteria referred to in point (a) of paragraph 2, the products for which marketing standards have been laid down may be marketed in the Community only in accordance with such standards. Without prejudice to any specific provisions which may be adopted by the Commission in accordance with Article 194, Member States shall check whether those products conform to those standards and shall apply penalties as appropriate.
Article 113a Additional requirements for the marketing of the products of the fruit and vegetables sector
1. The products of the fruit and vegetables sector which are intended to be sold fresh to the consumer, may only be marketed if they are sound, fair and of marketable quality and if the country of origin is indicated. 2. The marketing standards referred to in paragraph 1 of this Article and in points (b) and (c) of Article 113(1) shall apply at all marketing stages including import and export unless otherwise provided for by the Commission. 3. The holder of products of the fruit and vegetables and processed fruit and vegetables sector covered by marketing standards may not display such products or offer them for sale or deliver or market them in any manner within the Community other than in conformity with those standards and shall be responsible for ensuring such conformity. 4. Further to the second subparagraph of Article 113(3) and without prejudice to any specific provisions which may be adopted by the Commission in accordance with Article 194, in particular on the consistent application in the Member States of the conformity checks, Member States shall, in respect of the fruit and vegetables and the processed fruit and vegetables sectors, check selectively, based on a risk analysis, whether the products concerned conform to the respective marketing standards. These checks shall be focused on the stage prior to dispatch from the production areas when the products are being packed or loaded. For products from third countries, checks shall be done prior to release for free circulation.
Article 113b Marketing of the meat of bovine animals aged 12 months or less
1. Without prejudice to the provisions laid down in Article 42(1)(a) and (2) and point A of Annex V, the conditions laid down in Annex XIa, in particular the sales descriptions to be used set out in point III thereof, shall apply to the meat of bovine animals aged 12 months or less slaughtered on or after 1 July 2008, whether produced in the Community or imported from third countries. However, the meat from animals aged 12 months or less and slaughtered before 1 July 2008 may continue to be marketed without meeting the conditions laid down in Annex XIa. 2. The conditions referred to in paragraph 1 shall not apply to the meat of bovine animals for which a protected designation of origin or geographical indication has been registered in accordance with Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs ( 71 ), before 29 June 2007.
Article 113c Marketing rules to improve and stabilise the operation of the common market in wines
1. In order to improve and stabilise the operation of the common market in wines, including the grapes, musts and wines from which they derive, producer Member States may lay down marketing rules to regulate supply, particularly by way of implementing decisions taken by the inter-branch organisations referred to in Articles 123(3) and 125o. Such rules shall be proportionate to the objective pursued and shall not: (a) relate to any transaction after the first marketing of the produce concerned; (b) allow for price fixing, including where prices are set for guidance or recommendation; (c) render unavailable an excessive proportion of the vintage that would otherwise be available; (d) provide scope for refusing to issue the national and Community certificates required for the circulation and marketing of wines where such marketing is in accordance with those rules. 2. The rules referred to in paragraph 1 must be brought to the attention of operators by publication in extenso in an official publication of the Member State concerned. 3. The reporting obligation referred to in Article 125o(3) shall also apply in respect of the decisions or actions taken by the Member States in accordance with this Article.
Article 113d Specific provisions for the marketing of wine
1. A designation for a category of a grapevine product as provided for in Annex XIb may be used in the Community only for the marketing of a product which conforms to the corresponding conditions laid down in that Annex. However, notwithstanding Article 118y(1)(a), Member States may allow the use of the term ‘wine’ if: (a) it is accompanied by the name of a fruit in the form of a composite name to market products obtained by the fermentation of fruit other than grapes; or (b) it is part of a composite name. Any confusion with products corresponding to the wine categories in Annex XIb shall be avoided. 2. Categories of grapevine products listed in Annex XIb may be modified by the Commission in accordance with the procedure referred to in Article 195(4). 3. Except for bottled wine in respect of which there is evidence that bottling was performed before 1 September 1971, wine produced from wine grape varieties listed in the classifications drawn up in accordance with the first subparagraph of Article 120a(2) but not conforming to one of the categories laid down in Annex XIb, shall be used only for consumption by individual wine-producers’ households, for the production of wine vinegar or for distillation.
Article 114 
Marketing standards for milk and milk products 1. Foodstuffs intended for human consumption may be marketed as milk and milk products only if they comply with the definitions and designations laid down in Annex XII. 2. Without prejudice to exemptions provided for in Community law and to measures for the protection of public health, milk falling within CN code 0401 intended for human consumption may only be marketed within the Community in accordance with Annex XIII and, in particular, with the definitions set out in point I thereof.
Article 115 
Marketing standards for fats Without prejudice to Article 114(1) or to any provisions adopted in the veterinary and foodstuffs sectors to ensure that products comply with hygiene and health standards and to protect animal and human health, the standards laid down in Annex XV shall apply to the following products having a fat content of at least 10 % but less than 90 % by weight, intended for human consumption: (a) milk fats falling within CN codes 0405 and ex21 06; (b) fats falling within CN code ex15 17; (c) fats composed of plant and/or animal products falling within CN codes ex15 17 and ex21 06. The fat content excluding salt shall be at least two-thirds of the dry matter. However, those standards shall only apply to products which remain solid at a temperature of 20 o C, and which are suitable for use as spreads.
Article 116 
Marketing standards for products of the eggs and poultrymeat sectors Products of the eggs and poultrymeat sectors shall be marketed in accordance with the provisions set out in Annex XIV.
Article 117 
Certification for hops 1. Products of the hops sector, harvested or prepared within the Community, shall be subject to a certification procedure. 2. Certificates may be issued only for products having the minimum quality characteristics appropriate to a specific stage of marketing. In the case of hop powder, hop powder with higher lupulin content, extract of hops and mixed hop products, the certificate may only be issued if the alpha acid content of these products is not lower than that of the hops from which they have been prepared. 3. The certificates shall indicate at least: (a) the place(s) of production of the hops; (b) the year(s) of harvesting; (c) the variety or varieties. 4. Products of the hops sector may be marketed or exported only if a certificate as referred to in paragraphs 1, 2 and 3 has been issued. In the case of imported products of the hops sector, the attestation provided for in Article 158(2) shall be deemed to be equivalent to the certificate. 5. Measures derogating from paragraph 4 may be adopted by the Commission: (a) in order to satisfy the trade requirements of certain third countries; or (b) for products intended for special uses. The measures referred to in the first subparagraph shall: (a) not prejudice the normal marketing of products for which the certificate has been issued; (b) be accompanied by guarantees intended to avoid any confusion with those products.
Article 118 
Marketing standards for olive oils and olive-pomace oils 1. The use of the descriptions and definitions of olive oils and olive-pomace oils set out in Annex XVI shall be compulsory as regards the marketing of the products concerned within the Community and, insofar as compatible with international compulsory rules, in trade with third countries. 2. Only oils referred to in points 1(a) and (b), 3 and 6 of Annex XVI may be marketed at the retail stage.
Article 118a Scope
1. Rules relating to designations of origin, geographical indications and traditional terms laid down in this Section shall apply to the products referred to in paragraphs 1, 3 to 6, 8, 9, 11, 15 and 16 of Annex XIb. 2. The rules referred to in paragraph 1 shall be based on: (a) protecting of legitimate interests of: (i) consumers; and (ii) producers; (a) protecting of legitimate interests of: (i) consumers; and (ii) producers; (b) ensuring the smooth operation of the common market in the products concerned; and (c) promoting the production of quality products, whilst allowing national quality policy measures. Subsection I Designations of origin and geographical indications
Article 118b Definitions
1. For the purposes of this Subsection, the following definitions shall apply: (a) ‘designation of origin’ means the name of a region, a specific place or, in exceptional cases, a country used to describe a product referred to in Article 118a(1) that complies with the following requirements: (i) its quality and characteristics are essentially or exclusively due to a particular geographical environment with its inherent natural and human factors; (ii) the grapes from which it is produced come exclusively from this geographical area; (iii) its production takes place in this geographical area; and (iv) it is obtained from vine varieties belonging to Vitis vinifera; (a) ‘designation of origin’ means the name of a region, a specific place or, in exceptional cases, a country used to describe a product referred to in Article 118a(1) that complies with the following requirements: (i) its quality and characteristics are essentially or exclusively due to a particular geographical environment with its inherent natural and human factors; (ii) the grapes from which it is produced come exclusively from this geographical area; (iii) its production takes place in this geographical area; and (iv) it is obtained from vine varieties belonging to Vitis vinifera; (b) ‘geographical indication’ means an indication referring to a region, a specific place or, in exceptional cases, a country, used to describe a product referred to in Article 118a(1) which complies with the following requirements: (i) it possesses a specific quality, reputation or other characteristics attributable to that geographical origin; (ii) at least 85 % of the grapes used for its production come exclusively from this geographical area; (iii) its production takes place in this geographical area; and (iv) it is obtained from vine varieties belonging to Vitis vinifera or a cross between the Vitis vinifera species and other species of the genus Vitis. (b) ‘geographical indication’ means an indication referring to a region, a specific place or, in exceptional cases, a country, used to describe a product referred to in Article 118a(1) which complies with the following requirements: (i) it possesses a specific quality, reputation or other characteristics attributable to that geographical origin; (ii) at least 85 % of the grapes used for its production come exclusively from this geographical area; (iv) it is obtained from vine varieties belonging to Vitis vinifera or a cross between the Vitis vinifera species and other species of the genus Vitis. 2. Certain traditionally used names shall constitute a designation of origin where they: (a) designate a wine; (b) refer to a geographical name; (c) meet the requirements referred to in paragraph 1(a)(i) to (iv); and (d) undergo the procedure conferring protection on designations of origin and geographical indications laid down in this Subsection. 3. Designations of origin and geographical indications, including those relating to geographical areas in third countries, shall be eligible for protection in the Community in accordance with the rules laid down in this Subsection.
Article 118c Content of applications for protection
1. Applications for protection of names as designations of origin or geographical indications shall include a technical file containing: (a) the name to be protected; (b) the name and address of the applicant; (c) a product specification as referred to in paragraph 2; and (d) a single document summarising the product specification referred to in paragraph 2. 2. The product specification shall enable interested parties to verify the relevant conditions of production of the designation of origin or geographical indication. It shall consist at least of: (b) a description of the wine(s): (i) for wines with a designation of origin, its principal analytical and organoleptic characteristics; (ii) for wines with a geographical indication, its principal analytical characteristics as well as an evaluation or indication of its organoleptic characteristics; (b) a description of the wine(s): (i) for wines with a designation of origin, its principal analytical and organoleptic characteristics; (ii) for wines with a geographical indication, its principal analytical characteristics as well as an evaluation or indication of its organoleptic characteristics; (c) where applicable, the specific oenological practices used to make the wine(s) as well as the relevant restrictions on making the wine(s); (d) the demarcation of the geographical area concerned; (e) the maximum yields per hectare; (f) an indication of the wine grape variety or varieties the wine(s) is obtained from; (g) the details bearing out the link referred to in Article 118b(1)(a)(i) or, as the case may be, in Article 118b(1)(b)(i); (h) applicable requirements laid down in Community or national legislation or, where foreseen by Member States, by an organisation which manages the protected designation of origin or the protected geographical indication, having regard to the fact that such requirements shall be objective, and non-discriminatory and compatible with Community law; (i) the name and address of the authorities or bodies verifying compliance with the provisions of the product specification and their specific tasks.
Article 118d Application for protection relating to a geographical area in a third country
1. Where the application for protection concerns a geographical area in a third country, it shall contain in addition to the elements provided for in Article 118c, proof that the name in question is protected in its country of origin. 2. The application shall be sent to the Commission, either directly from the applicant or via the authorities of the third country concerned. 3. The application for protection shall be filed in one of the official languages of the Community or accompanied by a certified translation into one of those languages.
Article 118e Applicants
1. Any interested group of producers, or in exceptional cases a single producer, may apply for the protection of a designation of origin or geographical indication. Other interested parties may participate in the application. 2. Producers may lodge an application for protection only for wines which they produce. 3. In the case of a name designating a trans-border geographical area or a traditional name connected to a trans-border geographical area, a joint application may be lodged.
Article 118f Preliminary national procedure
1. Applications for protection of a designation of origin or a geographical indication of wines in accordance with Article 118b originating in the Community shall be subject to a preliminary national procedure in accordance with this Article. 2. The application for protection shall be filed with the Member State in which territory the designation of origin or geographical indication originates. 3. The Member State shall examine the application for protection in order to verify whether it meets the conditions set out in this Subsection. The Member State shall carry out a national procedure ensuring adequate publication of the application and providing for a period of at least two months from the date of publication within which any natural or legal person having a legitimate interest and resident or established on its territory may object to the proposed protection by lodging a duly substantiated statement with the Member State. 4. If the Member State considers that the designation of origin or geographical indication does not meet the relevant requirements or is incompatible with Community law in general, it shall reject the application. 5. If the Member State considers that the relevant requirements are met, it shall: (a) publish the single document and the product specification at least on the Internet; and (b) forward to the Commission an application for protection containing the following information: (i) the name and address of the applicant; (ii) the single document referred to in Article 118c(1)(d); (iii) a declaration by the Member State that it considers that the application lodged by the applicant meets the conditions required; and (iv) the reference to publication, as referred to in point (a). (b) forward to the Commission an application for protection containing the following information: (i) the name and address of the applicant; (ii) the single document referred to in Article 118c(1)(d); (iii) a declaration by the Member State that it considers that the application lodged by the applicant meets the conditions required; and (iv) the reference to publication, as referred to in point (a). This information shall be forwarded in one of the official languages of the Community or accompanied by a certified translation into one of those languages. 6. Member States shall introduce the laws, regulations or administrative provisions necessary to comply with this Article by 1 August 2009. 7. Where a Member State has no national legislation concerning the protection of designations of origin and geographical indications, it may, on a transitional basis only, grant protection to the name in accordance with the terms of this Subsection at national level with effect from the day the application is lodged with the Commission. Such transitional national protection shall cease on the date on which a decision on registration or refusal under this Subsection is taken.
Article 118g Scrutiny by the Commission
1. The Commission shall make the date of submission of the application for protection of the designation of origin or geographical indication public. 2. The Commission shall examine whether the applications for protection referred to in Article 118f(5) meet the conditions laid down in this Subsection. 3. Where the Commission considers that the conditions laid down in this Subsection are met, it shall publish in the Official Journal of the European Union the single document referred to in Article 118c(1)(d) and the reference to the publication of the product specification referred to in Article 118f(5). Where this is not the case, the Commission shall decide, in accordance with the procedure referred to in Article 195(4), to reject the application.
Article 118h Objection procedure
Within two months from the date of publication provided for in the first subparagraph of Article 118g(3), any Member State or third country, or any natural or legal person having a legitimate interest, resident or established in a Member State other than that applying for the protection or in a third country, may object to the proposed protection by lodging a duly substantiated statement relating to the conditions of eligibility as laid down in this Subsection with the Commission. In the case of natural or legal persons resident or established in a third country, such statement shall be lodged, either directly or via the authorities of the third country concerned, within the time limit of two months referred to in the first paragraph.
Article 118i Decision on protection
On the basis of the information available to the Commission, the Commission shall decide, in accordance with the procedure referred to in Article 195(4), either to confer protection on the designation of origin or geographical indication which meets the conditions laid down in this Subsection and is compatible with Community law, or to reject the application where those conditions are not satisfied.
Article 118j Homonyms
1. A name, for which an application is lodged, and which is wholly or partially homonymous with that of a name already registered under this Regulation concerning the wine sector, shall be registered with due regard for local and traditional usage and for any risk of confusion. A homonymous name which misleads the consumer into believing that products come from another territory shall not be registered even if the name is accurate as far as the actual territory, region or place of origin of the products in question is concerned. The use of a registered homonymous name shall be subject to there being a sufficient distinction in practice between the homonym registered subsequently and the name already on the register, having regard to the need to treat the producers concerned in an equitable manner and the need not to mislead the consumer. 2. Paragraph 1 shall apply mutatis mutandis if a name, for which an application is lodged, is wholly or partially homonymous with a geographical indication protected as such under the legislation of Member States. Member States shall not register non-identical geographical indications for protection under their respective legislation on geographical indications if a designation of origin or geographical indication is protected in the Community by virtue of the Community law relevant to designations of origin and geographical indications. 3. Save as otherwise provided for in Commission implementing measures, where the name of a wine grape variety contains or consists of a protected designation of origin or a protected geographical indication, that name shall not be used for the purposes of labelling the products covered by this Regulation. 4. The protection of designations of origin and geographical indications for products covered in Article 118b shall be without prejudice to protected geographical indications applying in relation to spirit drinks within the meaning of Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks ( 72 ) and vice versa.
Article 118k Grounds for refusal of protection
1. Names that have become generic shall not be protected as a designation of origin or geographical indication. For the purposes of this Subsection, a ‘name that has become generic’ means the name of a wine which, although it relates to the place or the region where this product was originally produced or marketed, has become the common name of a wine in the Community. To establish whether or not a name has become generic, account shall be taken of all relevant factors, in particular: (a) the existing situation in the Community, notably in areas of consumption; (b) the relevant Community or national legislation. 2. A name shall not be protected as a designation of origin or geographical indication where, in the light of a trademark’s reputation and renown, protection is liable to mislead the consumer as to the true identity of the wine.
Article 118l Relationship with trademarks
1. Where a designation of origin or a geographical indication is protected under this Regulation, the registration of a trademark corresponding to one of the situations referred to in Article 118m(2) and relating to a product falling under one of the categories listed in Annex XIb shall be refused if the application for registration of the trademark is submitted after the date of submission of the application for protection of the designation of origin or geographical indication to the Commission and the designation of origin or geographical indication is subsequently protected. Trademarks registered in breach of the first subparagraph shall be invalidated. 2. Without prejudice to Article 118k(2), a trademark the use of which corresponds to one of the situations referred to in Article 118m(2), which has been applied for, registered or established by use, if that possibility is provided for by the legislation concerned, in the territory of the Community before the date on which the application for protection of the designation of origin or geographical indication is submitted to the Commission, may continue to be used and renewed notwithstanding the protection of a designation of origin or geographical indication, provided that no grounds for the trademark’s invalidity or revocation exist as specified by the First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks ( 73 ) or by Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade ( 74 ). In such cases the use of the designation of origin or geographical indication shall be permitted alongside the relevant trademarks.
Article 118m Protection
1. Protected designations of origins and protected geographical indications may be used by any operator marketing a wine which has been produced in conformity with the corresponding product specification. 2. Protected designations of origins and protected geographical indications and the wines using those protected names in conformity with the product specification shall be protected against: (a) any direct or indirect commercial use of a protected name: (i) by comparable products not complying with the product specification of the protected name; or (ii) in so far as such use exploits the reputation of a designation of origin or a geographical indication; (a) any direct or indirect commercial use of a protected name: (i) by comparable products not complying with the product specification of the protected name; or (ii) in so far as such use exploits the reputation of a designation of origin or a geographical indication; (b) any misuse, imitation or evocation, even if the true origin of the product or service is indicated or if the protected name is translated or accompanied by an expression such as ‘style’, ‘type’, ‘method’, ‘as produced in’, ‘imitation’, ‘flavour’, ‘like’ or similar; (c) any other false or misleading indication as to the provenance, origin, nature or essential qualities of the product, on the inner or outer packaging, advertising material or documents relating to the wine product concerned, and the packing of the product in a container liable to convey a false impression as to its origin; (d) any other practice liable to mislead the consumer as to the true origin of the product. 3. Protected designations of origin or protected geographical indications shall not become generic in the Community within the meaning of Article 118k(1). 4. Member States shall take the steps necessary to stop unlawful use of protected designations of origin and protected geographical indications as referred to in paragraph 2.
Amendment rationale: CONTEXT OF THE PROPOSAL The proposal for a Council Regulation is necessitated by the upcoming accession of the Republic of Croatia to the European Union. The Treaty concerning the accession of the Republic of Croatia to the European Union[1] was signed by all Member States of the European Union and the Republic of Croatia at Brussels on 9 December 2011. Article 3 (3) of the Treaty of Accession provides that it shall enter into force on 1 July 2013 provided that all the instruments of ratification have been deposited before that date. Article 3(4) of the Treaty of Accession enables the institutions of the Union to adopt before accession measures referred to, inter alia, in Article 50 of the Act concerning the conditions of accession of the Republic of Croatia[2]. These measures shall enter into force only subject to and on the date of the entry into force of the Treaty of Accession. Article 50 of the Act of Accession provides that where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in this Act or its Annexes, the Council or the Commission (if the original acts were adopted by the Commission) shall adopt the necessary acts. Point 2 of the Final Act[3] refers to the political agreement on a set of adaptations to acts adopted by the institutions which was reached between the Member States and Croatia in the context of the approval of the Treaty of Accession; the High Contracting Parties of the Treaty of Accession invited the Council and the Commission to adopt these adaptations before accession in accordance with Article 50 of the Act of Accession, completed and updated where necessary to take account of the evolution of the law of the Union. The present proposal regroups the technical adaptations to all Council regulations and decisions as well as to all European Parliament and Council regulations and decisions which require technical adaptation by reason of the accession of Croatia, into a single Council regulation. Alongside this proposal for a Council Regulation, the Commission transmits a series of separate proposals for several Council directives to the Council which cover technical adaptations to Council directives as well as to European Parliament and Council directives which also need technical adaptation by reason of the accession of Croatia. Each of these separate proposals for Council directives regroups the technical adaptations which correspond to different negotiation chapters. This structure is designed to facilitate the transposition of the directives by Member States into their respective legal orders, and is in line with the approach which was taken in view of the accession of Bulgaria and Romania[4]. It is foreseen that all the legal acts included in this package will be published in the Official Journal of the European Union at the same date. The present proposal and the other proposals included in this package will take into account technical adaptations to the acquis which were published in the Official Journal of the European Union until 1 September 2012. The reasons for this are to provide sufficient time for the legislative processes involved on the one hand, and for the fulfilment of the ensuing transposition and notification obligations by Member States as regards directives on the other hand. Adaptations which may be necessary to the acquis published in the Official Journal of the European Union after 1 September 2012 will be foreseen in the relevant acts themselves or done at a later stage through the appropriate procedure. In addition, the Commission intends to informally provide a list of such legislation to Member States in early July 2013.
Revised version (Article 118m Protection):
1. Protected designations of origins and protected geographical indications may be used by any operator marketing a wine which has been produced in conformity with the corresponding product specification. 2. Protected designations of origins and protected geographical indications and the wines using those protected names in conformity with the product specification shall be protected against: (a) any direct or indirect commercial use of a protected name: (i) by comparable products not complying with the product specification of the protected name; or (ii) in so far as such use exploits the reputation of a designation of origin or a geographical indication; (a) any direct or indirect commercial use of a protected name: (i) by comparable products not complying with the product specification of the protected name; or (ii) in so far as such use exploits the reputation of a designation of origin or a geographical indication; (b) any misuse, imitation or evocation, even if the true origin of the product or service is indicated or if the protected name is translated or accompanied by an expression such as ‘style’, ‘type’, ‘method’, ‘as produced in’, ‘imitation’, ‘flavour’, ‘like’ or similar; (c) any other false or misleading indication as to the provenance, origin, nature or essential qualities of the product, on the inner or outer packaging, advertising material or documents relating to the wine product concerned, and the packing of the product in a container liable to convey a false impression as to its origin; (d) any other practice liable to mislead the consumer as to the true origin of the product. 3. Protected designations of origin or protected geographical indications shall not become generic in the Community within the meaning of Article 118k(1). 4. Member States shall take the steps necessary to stop unlawful use of protected designations of origin and protected geographical indications as referred to in paragraph 2. 5. By way of derogation from paragraphs 1 to 4, Croatia shall be allowed to place on the market in Croatia or export to third countries, wines with the denomination ‘Mlado vino portugizac’, until clearance of the stocks existing at the date of accession. Croatia shall set up a computerised databank with information on the stocks existing at the date of accession, and shall ensure that these stocks are verified and declared to the Commission.
Article 118n Register
The Commission shall establish and maintain an electronic register of protected designations of origin and protected geographical indications for wine which shall be publicly accessible.
Article 118o Designation of competent control authority
1. Member States shall designate the competent authority or authorities responsible for controls in respect of the obligations established by this Chapter in accordance with the criteria laid down in Article 4 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on the official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules ( 75 ). 2. Member States shall ensure that any operator complying with this Subsection is entitled to be covered by a system of controls. 3. Member States shall inform the Commission of the competent authority or authorities referred to in paragraph 1. The Commission shall make their names and addresses public and update them periodically.
Article 118p Verification of compliance with specifications
1. In respect of protected designations of origin and protected geographical indications relating to a geographical area within the Community, annual verification of compliance with the product specification, during the production and during or after conditioning of the wine, shall be ensured by: (a) the competent authority or authorities referred to in Article 118o(1); or (b) one or more control bodies within the meaning of point 5 of the second subparagraph of Article 2 of Regulation (EC) No 882/2004 operating as a product certification body in accordance with the criteria laid down in Article 5 of that Regulation. The costs of such verification shall be borne by the operators subject to it. 2. In respect of protected designations of origin and protected geographical indications relating to a geographical area in a third country, annual verification of compliance with the product specification, during the production and during or after conditioning of the wine, shall be ensured by: (a) one or more public authorities designated by the third country; or (b) one or more certification bodies. 3. The certification bodies referred to in paragraphs 1(b) and 2(b) shall comply with, and from 1 May 2010 be accredited in accordance with, the European standard EN 45011 or ISO/IEC Guide 65 (General requirements for bodies operating product certification systems). 4. Where the authority or authorities referred to in paragraphs 1(a) and 2(a) verify compliance with the product specification, they shall offer adequate guarantees of objectivity and impartiality, and have at their disposal the qualified staff and resources needed to carry out their tasks.
Article 118q Amendments to product specifications
1. An applicant satisfying the conditions of Article 118e may apply for approval of an amendment to the product specification of a protected designation of origin or a protected geographical indication, in particular to take account of developments in scientific and technical knowledge or to redefine the geographical area referred to in point (d) of the second subparagraph of Article 118c(2). Applications shall describe and give reasons for the amendments requested. 2. Where the proposed amendment involves one or more amendments to the single document referred to in Article 118c(1)(d), Articles 118f to 118i shall apply mutatis mutandis to the amendment application. However, if the proposed amendment is only minor, the Commission shall decide, in accordance with the procedure referred to in Article 195(4), whether to approve the application without following the procedure laid down in Article 118g(2) and Article 118h and in the case of approval, the Commission shall proceed to the publication of the elements referred to in Article 118g(3). 3. Where the proposed amendment does not involve any change to the single document, the following rules shall apply: (a) where the geographical area is in a given Member State, that Member State shall express its position on the amendment and, if it is in favour, shall publish the amended product specification and inform the Commission of the amendments approved and the reasons for them; (b) where the geographical area is in a third country, the Commission shall determine whether to approve the proposed amendment.
Article 118r Cancellation
The Commission may decide, in accordance with the procedure referred to in Article 195(4), at its own initiative or at the duly substantiated request of a Member State, of a third country or of a natural or legal person having a legitimate interest, to cancel the protection of a designation of origin or a geographical indication if compliance with the corresponding product specification is no longer ensured. Articles 118f to 118i shall apply mutatis mutandis .
Article 118s Existing protected wine names
1. Wine names, which are protected in accordance with Articles 51 and 54 of Regulation (EC) No 1493/1999 and Article 28 of Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products ( 76 ), shall automatically be protected under this Regulation. The Commission shall list them in the register provided for in Article 118n of this Regulation. 2. Member States shall, in respect of existing protected wine names referred to in paragraph 1, transmit to the Commission: (a) the technical files as provided for in Article 118c(1); (b) the national decisions of approval. 3. Wine names referred to in paragraph 1, for which the information referred to in paragraph 2 is not submitted by 31 December 2011, shall lose protection under this Regulation. The Commission shall take the corresponding formal step of removing such names from the register provided for in Article 118n. 4. Article 118r shall not apply in respect of existing protected wine names referred to in paragraph 1. The Commission may decide, until 31 December 2014, at its own initiative and in accordance with the procedure referred to in Article 195(4), to cancel protection of existing protected wine names referred to in paragraph 1 if they do not meet the conditions laid down in Article 118b.
Amendment rationale: CONTEXT OF THE PROPOSAL The proposal for a Council Regulation is necessitated by the upcoming accession of the Republic of Croatia to the European Union. The Treaty concerning the accession of the Republic of Croatia to the European Union[1] was signed by all Member States of the European Union and the Republic of Croatia at Brussels on 9 December 2011. Article 3 (3) of the Treaty of Accession provides that it shall enter into force on 1 July 2013 provided that all the instruments of ratification have been deposited before that date. Article 3(4) of the Treaty of Accession enables the institutions of the Union to adopt before accession measures referred to, inter alia, in Article 50 of the Act concerning the conditions of accession of the Republic of Croatia[2]. These measures shall enter into force only subject to and on the date of the entry into force of the Treaty of Accession. Article 50 of the Act of Accession provides that where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in this Act or its Annexes, the Council or the Commission (if the original acts were adopted by the Commission) shall adopt the necessary acts. Point 2 of the Final Act[3] refers to the political agreement on a set of adaptations to acts adopted by the institutions which was reached between the Member States and Croatia in the context of the approval of the Treaty of Accession; the High Contracting Parties of the Treaty of Accession invited the Council and the Commission to adopt these adaptations before accession in accordance with Article 50 of the Act of Accession, completed and updated where necessary to take account of the evolution of the law of the Union. The present proposal regroups the technical adaptations to all Council regulations and decisions as well as to all European Parliament and Council regulations and decisions which require technical adaptation by reason of the accession of Croatia, into a single Council regulation. Alongside this proposal for a Council Regulation, the Commission transmits a series of separate proposals for several Council directives to the Council which cover technical adaptations to Council directives as well as to European Parliament and Council directives which also need technical adaptation by reason of the accession of Croatia. Each of these separate proposals for Council directives regroups the technical adaptations which correspond to different negotiation chapters. This structure is designed to facilitate the transposition of the directives by Member States into their respective legal orders, and is in line with the approach which was taken in view of the accession of Bulgaria and Romania[4]. It is foreseen that all the legal acts included in this package will be published in the Official Journal of the European Union at the same date. The present proposal and the other proposals included in this package will take into account technical adaptations to the acquis which were published in the Official Journal of the European Union until 1 September 2012. The reasons for this are to provide sufficient time for the legislative processes involved on the one hand, and for the fulfilment of the ensuing transposition and notification obligations by Member States as regards directives on the other hand. Adaptations which may be necessary to the acquis published in the Official Journal of the European Union after 1 September 2012 will be foreseen in the relevant acts themselves or done at a later stage through the appropriate procedure. In addition, the Commission intends to informally provide a list of such legislation to Member States in early July 2013.
Revised version (Article 118s Existing protected wine names):
1. Wine names, which are protected in accordance with Articles 51 and 54 of Regulation (EC) No 1493/1999 and Article 28 of Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products ( 76 ), shall automatically be protected under this Regulation. The Commission shall list them in the register provided for in Article 118n of this Regulation. 2. Member States shall, in respect of existing protected wine names referred to in paragraph 1, transmit to the Commission: (a) the technical files as provided for in Article 118c(1); (b) the national decisions of approval. 3. Wine names referred to in paragraph 1, for which the information referred to in paragraph 2 is not submitted by 31 December 2011, shall lose protection under this Regulation. The Commission shall take the corresponding formal step of removing such names from the register provided for in Article 118n. 4. Article 118r shall not apply in respect of existing protected wine names referred to in paragraph 1. The Commission may decide, until 31 December 2014, at its own initiative and in accordance with the procedure referred to in Article 195(4), to cancel protection of existing protected wine names referred to in paragraph 1 if they do not meet the conditions laid down in Article 118b. 5. For Croatia, the wine names published in OJ C 116 of 14 April 2011 shall be protected under this Regulation, subject to a favourable outcome of the objection procedure. The Commission shall list them in the register provided for in Article 118n. Paragraphs 2 to 4 of this Article shall apply, subject to the following: the deadline referred to in paragraph 3 shall be one year from the date of accession of Croatia. The deadline referred to in paragraph 4 shall be four years from the date of accession of Croatia.
Article 118t Fees
Member States may charge a fee to cover their costs, including those incurred in examining applications for protection, statements of objections, applications for amendments and requests for cancellations under this Subsection. Subsection II Traditional terms
Article 118u Definitions
1. ‘Traditional term’ means a term traditionally used in Member States for products referred to in Article 118a(1) to designate: (a) that the product has a protected designation of origin or a protected geographical indication under Community or national law; (b) the production or ageing method or the quality, colour, type of place, or a particular event linked to the history of the product with a protected designation of origin or a protected geographical indication. 2. Traditional terms shall be recognised, defined and protected by the Commission.
Article 118v Protection
1. A protected traditional term may only be used for a product which has been produced in conformity with the definition referred to in Article 118u(1). Traditional terms shall be protected against unlawful use. Member States shall take the steps necessary to stop the unlawful use of protected traditional terms. 2. Traditional terms shall not become generic in the Community.
Article 118w Definition
For the purposes of this Section: (a) ‘labelling’ means any words, particulars, trademarks, brand name, pictorial matter or symbol placed on any packaging, document, notice, label, ring or collar accompanying or referring to a given product; (b) ‘presentation’ means any information conveyed to consumers by virtue of the packaging of the product concerned, including the form and type of bottles.
Article 118x Applicability of horizontal rules
Save as otherwise provided for in this Regulation, Directive 89/104/EEC, Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs ( 77 ), Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling presentation and adversity of foodstuffs ( 78 ) and Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products ( 79 ) shall apply to the labelling and presentation of products falling within their scopes.
Article 118y Compulsory particulars
1. Labelling and presentation of the products referred to in paragraphs 1 to 11, 13, 15 and 16 of Annex XIb marketed in the Community or for export shall contain the following compulsory particulars: (a) the designation for the category of the grapevine product in accordance with Annex XIb; (b) for wines with a protected designation of origin or a protected geographical indication: (i) the term ‘protected designation of origin’ or ‘protected geographical indication’; and (ii) the name of the protected designation of origin or the protected geographical indication; (b) for wines with a protected designation of origin or a protected geographical indication: (i) the term ‘protected designation of origin’ or ‘protected geographical indication’; and (ii) the name of the protected designation of origin or the protected geographical indication; (c) the actual alcoholic strength by volume; (d) an indication of provenance; (e) an indication of the bottler or, in the case of sparkling wine, aerated sparkling wine, quality sparkling wine or quality aromatic sparkling wine, the name of the producer or vendor; (f) an indication of the importer in the case of imported wines; and (g) in the case of sparkling wine, aerated sparkling wine, quality sparkling wine or quality aromatic sparkling wine, an indication of the sugar content. 2. By way of derogation from paragraph 1(a) the reference to the category of the grapevine product may be omitted for wines whose labels include the name of a protected designation of origin or a protected geographical indication. 3. By way of derogation from paragraph 1(b) the reference to the terms ‘protected designation of origin’ or ‘protected geographical indication’ may be omitted in the following cases: (a) where a traditional term as referred to in Article 118u(1)(a) is displayed on the label; (b) where, in exceptional circumstances to be determined by the Commission, the name of the protected designation of origin or protected geographical indication is displayed on the label.
Article 118z Optional particulars
1. Labelling and presentation of the products referred to in Article 118y(1) may in particular contain the following optional particulars: (a) the vintage year; (b) the name of one or more wine grape varieties; (c) in the case of wines other than those referred to in Article 118y(1)(g), terms indicating the sugar content; (d) for wines with a protected designation of origin or a protected geographical indication, traditional terms as referred to in Article 118u(1)(b); (e) the Community symbol indicating the protected designation of origin or the protected geographical indication; (f) terms referring to certain production methods; (g) for wines bearing a protected designation of origin or a protected geographical indication, the name of another geographical unit that is smaller or larger than the area underlying the designation of origin or geographical indication. 2. Without prejudice to Article 118j(3), as regards the use of particulars referred to in paragraph 1(a) and (b) for wines without a protected designation of origin or a protected geographical indication: (a) Member States shall introduce laws, regulations or administrative provisions to ensure certification, approval and control procedures so as to guarantee the veracity of the information concerned; (b) Member States may, on the basis of non-discriminatory and objective criteria and with due regard to loyal competition, for wine produced from wine grape varieties on their territory, draw up lists of excluded wine grape varieties, in particular if: (i) there is a risk of confusion for consumers as to the true origin of the wine due to the fact that the given wine grape variety forms an integral part of an existing protected designation of origin or a protected geographical indication; (ii) the relevant controls would not be cost effective due to the fact that the given wine grape variety represents a very small part of the Member State vineyard; (b) Member States may, on the basis of non-discriminatory and objective criteria and with due regard to loyal competition, for wine produced from wine grape varieties on their territory, draw up lists of excluded wine grape varieties, in particular if: (i) there is a risk of confusion for consumers as to the true origin of the wine due to the fact that the given wine grape variety forms an integral part of an existing protected designation of origin or a protected geographical indication; (ii) the relevant controls would not be cost effective due to the fact that the given wine grape variety represents a very small part of the Member State vineyard; (c) mixtures of wines from different Member States shall not give rise to labelling of the wine grape variety or varieties unless the Member States concerned agree otherwise and ensure the feasibility of the relevant certification, approval and control procedures.
Article 118za Languages
1. Compulsory and optional particulars referred to in Articles 118y and 118z shall, where expressed in words, appear in one or more of the official languages of the Community. 2. Notwithstanding paragraph 1, the name of a protected designation of origin or a protected geographical indication or a traditional term as referred to in Article 118u(1)(a) shall appear on the label in the language or languages for which the protection applies. In the case of protected designations of origin or protected geographical indications or national specific designations using a non-Latin alphabet, the name may also appear in one or more official languages of the Community.
Article 118zb Enforcement
The competent authorities of the Member States shall take measures to ensure that a product referred to in Article 118y(1) which is not labelled in conformity with this Section is not placed on, or is withdrawn from, the market.
Article 119 Use of casein and caseinate in the manufacture of cheese
Where aid is paid under Article 100, the Commission may make the use of casein and caseinates in the manufacture of cheese subject to prior authorisation which shall be granted only if such use is a necessary condition for the manufacture of the products.
Article 120 
Method of production of agricultural ethyl alcohol The method of production and the characteristics of agricultural ethyl alcohol obtained from a specific agricultural product listed in Annex I to the Treaty may be laid down by the Commission.
Article 120a Classification of wine grape varieties
1. Products listed in Annex XIb and produced in the Community shall be made from wine grape varieties classifiable according to paragraph 2. 2. Subject to paragraph 3, Member States shall classify which wine grape varieties may be planted, replanted or grafted on their territories for the purpose of wine production. Only wine grape varieties meeting the following conditions may be classified by Member States: (a) the variety concerned belongs to the Vitis vinifera or comes from a cross between the species Vitis vinifera and other species of the genus Vitis; (b) the variety is not one of the following: Noah, Othello, Isabelle, Jacquez, Clinton and Herbemont. Where a wine grape variety is deleted from the classification referred to in the first subparagraph, grubbing-up of this variety shall take place within 15 years of its deletion. 3. Member States whose wine production does not exceed 50 000 hectolitres per wine year, calculated on the basis of the average production during the latest five wine years, shall be exempted from the classification obligation referred to in paragraph 2. However, also in the Member States referred to in the first subparagraph, only wine grape varieties complying with paragraph 2(a) and (b) may be planted, replanted or grafted for the purpose of wine production. 4. By way of derogation from the first and second subparagraphs of paragraph 2 and the second subparagraph of paragraph 3, the planting, replanting or grafting of the following wine grape varieties shall be allowed for scientific research and experimental purposes: (a) wine grape varieties which are not classified as far as Member States referred to in paragraph 2 are concerned; (b) wine grape varieties which do not comply with paragraph 2(a) and (b) as far as Member States referred to in paragraph 3 are concerned. 5. Areas planted with wine grape varieties for the purpose of wine production planted in breach of paragraphs 2, 3 and 4 shall be grubbed up. However, there shall be no obligation to grub up such areas where the relevant production is intended exclusively for consumption by the wine-producers’ households. 6. Member States shall take the necessary measures to check compliance by producers with paragraphs 2 to 5. Subsection II Oenological practices and restrictions
Article 120b Scope
This Subsection concerns the authorised oenological practices and the applicable restrictions applying to the production and commercialisation of products of the wine sector as well as the procedure for deciding on those practices and restrictions.
Article 120c Oenological practices and restrictions
1. Only oenological practices authorised under Community law as laid down in Annex XVa or decided upon in accordance with Articles 120d and 120e shall be used in the production and conservation in the Community of products of the wine sector. The first subparagraph shall not apply to: (a) grape juice and concentrated grape juice; (b) grape must and concentrated grape must intended for the preparation of grape juice. 2. Authorised oenological practices shall only be used for the purposes of ensuring proper vinification, proper preservation or proper refinement of the product. 3. Products of the wine sector shall be produced in the Community in accordance with the relevant restrictions laid down in Annex XVb. 4. Products covered by this Regulation, which have undergone unauthorised Community oenological practices or, where applicable, unauthorised national oenological practices or which contravene the restrictions laid down in Annex XVb, shall not be marketed in the Community.
Article 120d Stricter rules decided by Member States
Member States may limit or exclude the use of certain oenological practices and provide for more stringent restrictions for wines authorised under Community law produced in their territory with a view to reinforcing the preservation of the essential characteristics of wines with a protected designation of origin or a protected geographical indication and of sparkling wines and liqueur wines. Member States shall communicate those limitations, exclusions and restrictions to the Commission, which shall bring them to the attention of the other Member States.
Article 120e Authorisation of oenological practices and restrictions
1. Except for the oenological practices concerning enrichment, acidification and de-acidification laid down in Annex XVa for the specific products covered therein as well as the restrictions listed in Annex XVb, the authorisation of oenological practices and restrictions as regards the production and conservation of products of the wine sector shall be decided by the Commission in accordance with the procedure referred to in Article 195(4). 2. Member States may allow the experimental use of unauthorised oenological practices under conditions to be determined by the Commission in accordance with the procedure referred to in Article 195(4).
Article 120f Authorisation criteria
When authorising oenological practices in accordance with the procedure referred to in Article 195(4), the Commission shall: (a) base itself on the oenological practices recommended and published by the International Organisation of Vine and Wine (OIV) as well as on the results of experimental use of as yet unauthorised oenological practices; (b) take into account the protection of human health; (c) take into account the possible risk of consumers being misled due to their established expectations and perceptions, having regard to the availability and feasibility of informational means to exclude such risks; (d) allow the preservation of the natural and essential characteristics of the wine and not cause a substantial change in the composition of the product concerned; (e) ensure an acceptable minimum level of environmental care; (f) respect the general rules concerning oenological practices and restrictions laid down in Annexes XVa and XVb respectively.
Article 120g Methods of analysis
The methods of analysis for determining the composition of the products of the wine sector and the rules whereby it may be established whether these products have undergone processes contrary to the authorised oenological practices shall be those recommended and published by the OIV. Where there are no methods and rules recommended and published by the OIV, corresponding methods and rules shall be adopted by the Commission in accordance with the procedure referred to in Article 195(4). Pending the adoption of such rules, the methods and rules to be used shall be the ones allowed by the Member State concerned.
Article 121 
Adoption of standards, implementing rules and derogations The Commission shall establish the detailed rules for the application of this Chapter, which may in particular relate to: (a) marketing standards referred to in Articles 113 and 113a including rules on: (i) derogations or exemptions from the application of the standards; (ii) presentation of particulars required by the standards as well as on marketing and labelling; (iii) the application of the standards to products imported into, or exported from, the Community; (iv) in respect of Article 113a(1), to define what constitutes a product which is sound, fair and of marketable quality; (a) marketing standards referred to in Articles 113 and 113a including rules on: (i) derogations or exemptions from the application of the standards; (ii) presentation of particulars required by the standards as well as on marketing and labelling; (iii) the application of the standards to products imported into, or exported from, the Community; (iv) in respect of Article 113a(1), to define what constitutes a product which is sound, fair and of marketable quality; (b) as regards the definitions and designations that may be used in the marketing of milk and milk products in accordance with Article 114(1): (i) drawing up and, where necessary, supplementing the list of the products referred to in the second subparagraph of point III(1) of Annex XII, on the basis of the lists sent to it by the Member States; (ii) making additions, where necessary, to the list of designations given in point (a) of the second subparagraph of point II(2) of Annex XII; (b) as regards the definitions and designations that may be used in the marketing of milk and milk products in accordance with Article 114(1): (i) drawing up and, where necessary, supplementing the list of the products referred to in the second subparagraph of point III(1) of Annex XII, on the basis of the lists sent to it by the Member States; (ii) making additions, where necessary, to the list of designations given in point (a) of the second subparagraph of point II(2) of Annex XII; (c) as regards the standards for spreadable fats referred to in Article 115: (i) a list of the products referred to in point (a) of the third subparagraph of point I(2) of Annex XV, on the basis of the lists sent to the Commission by the Member States; (ii) the methods of analysis needed to check the composition and manufacturing characteristics of the products referred to in Article 115; (iii) detailed rules for the taking of samples; (iv) detailed rules for obtaining statistical information on the markets in the products referred to in Article 115; (c) as regards the standards for spreadable fats referred to in Article 115: (i) a list of the products referred to in point (a) of the third subparagraph of point I(2) of Annex XV, on the basis of the lists sent to the Commission by the Member States; (ii) the methods of analysis needed to check the composition and manufacturing characteristics of the products referred to in Article 115; (iii) detailed rules for the taking of samples; (iv) detailed rules for obtaining statistical information on the markets in the products referred to in Article 115; (d) as regards the provisions concerning the marketing of eggs set out in Part A of Annex XIV: (i) definitions; (ii) the frequency of collection, delivery, preservation and handling of eggs; (iii) quality criteria, in particular the appearance of the shell, the consistency of the white and the yolk and the height of the air space; (iv) weight grading, including exceptions; (v) marking of eggs and indications on packs, including exceptions and including the rules to be applied in relation to packing centres; (vi) trade with third countries; (vii) farming methods; (d) as regards the provisions concerning the marketing of eggs set out in Part A of Annex XIV: (i) definitions; (ii) the frequency of collection, delivery, preservation and handling of eggs; (iii) quality criteria, in particular the appearance of the shell, the consistency of the white and the yolk and the height of the air space; (iv) weight grading, including exceptions; (v) marking of eggs and indications on packs, including exceptions and including the rules to be applied in relation to packing centres; (vi) trade with third countries; (vii) farming methods; (e) as regards the provisions concerning the marketing of poultrymeat set out in Part B of Annex XIV: (i) definitions; (ii) the list of poultry carcasses, parts of such carcasses and offals, including foie gras , to which Part B of Annex XIV shall apply; (iii) the criteria for classification within the meaning of point III(1) of Part B of Annex XIV; (iv) the rules concerning further indications to be shown on accompanying commercial documents, the labelling, presentation and advertising of poultrymeat intended for the final consumer and the name under which the product is sold within the meaning of point (1) of Article 3(1) of Directive 2000/13/EC; (v) optional indications of the method of the chilling used and of the type of farming; (vi) derogations that may be applied in case of deliveries to cutting or processing establishments; (vii) the rules to be applied as regards the percentages of water absorption during the preparation of fresh, frozen and quick-frozen carcasses and cuts thereof as well as the indications to be made in that respect; (e) as regards the provisions concerning the marketing of poultrymeat set out in Part B of Annex XIV: (ii) the list of poultry carcasses, parts of such carcasses and offals, including foie gras , to which Part B of Annex XIV shall apply; (iii) the criteria for classification within the meaning of point III(1) of Part B of Annex XIV; (iv) the rules concerning further indications to be shown on accompanying commercial documents, the labelling, presentation and advertising of poultrymeat intended for the final consumer and the name under which the product is sold within the meaning of point (1) of Article 3(1) of Directive 2000/13/EC; (v) optional indications of the method of the chilling used and of the type of farming; (vi) derogations that may be applied in case of deliveries to cutting or processing establishments; (vii) the rules to be applied as regards the percentages of water absorption during the preparation of fresh, frozen and quick-frozen carcasses and cuts thereof as well as the indications to be made in that respect; (f) as regards the provisions concerning the standards for the production and marketing of eggs for hatching and of farmyard poultry chicks set out in Part C of Annex XIV: (i) definitions; (ii) the registration of establishments producing or marketing eggs for hatching or farmyard poultry chicks; (iii) indications to be made on eggs for hatching, including those to be imported from or to be exported to third countries, and on the packings, as well as the rules to be applied in respect of chicks originating in third countries; (iv) registers to be kept by hatcheries; (v) the use, other than for human consumption, that may be made of incubated eggs withdrawn from the incubator; (vi) communications from hatcheries and other establishments to the competent authorities of the Member States; (vii) accompanying documents; (f) as regards the provisions concerning the standards for the production and marketing of eggs for hatching and of farmyard poultry chicks set out in Part C of Annex XIV: (ii) the registration of establishments producing or marketing eggs for hatching or farmyard poultry chicks; (iii) indications to be made on eggs for hatching, including those to be imported from or to be exported to third countries, and on the packings, as well as the rules to be applied in respect of chicks originating in third countries; (iv) registers to be kept by hatcheries; (v) the use, other than for human consumption, that may be made of incubated eggs withdrawn from the incubator; (vi) communications from hatcheries and other establishments to the competent authorities of the Member States; (vii) accompanying documents; (g) the minimum quality characteristics for products of the hops sector referred to in Article 117; (h) the methods of analysis to be used, where applicable; (i) as regards the use of casein and caseinates referred to in Article 119: (i) the conditions according to which the Member States shall grant the authorisations and the maximum percentages to be incorporated, on the basis of objective criteria having regard to what is technologically necessary; (ii) the obligations to be respected by the undertakings authorised in accordance with point (i); (i) as regards the use of casein and caseinates referred to in Article 119: (i) the conditions according to which the Member States shall grant the authorisations and the maximum percentages to be incorporated, on the basis of objective criteria having regard to what is technologically necessary; (ii) the obligations to be respected by the undertakings authorised in accordance with point (i); (j) as regards the conditions that shall be used in the marketing of the meat of bovine animals aged 12 months or less in accordance with Article 113b: (i) the practical methods of indicating the category identification letter as defined in point II of Annex XIa, as regards the location and size of the characters used; (ii) the import of meat from third countries as referred to in point VIII of Annex XIa, as regards the methods of verifying compliance with this Regulation; (j) as regards the conditions that shall be used in the marketing of the meat of bovine animals aged 12 months or less in accordance with Article 113b: (i) the practical methods of indicating the category identification letter as defined in point II of Annex XIa, as regards the location and size of the characters used; (ii) the import of meat from third countries as referred to in point VIII of Annex XIa, as regards the methods of verifying compliance with this Regulation; (k) the rules concerning the designation of origin and geographical indications referred to in Subsection I of Section Ia, in particular derogations from the applicability of the rules and requirements laid down in that Subsection: (i) in so far as pending applications for protection of designations of origin or geographical indications are concerned; (ii) in so far as the production of certain wines with a protected designation of origin or a protected geographical indication in a geographical area in proximity of the geographical area where the grapes originate is concerned; (iii) in so far as traditional production practices of certain wines with a protected designation of origin are concerned; (k) the rules concerning the designation of origin and geographical indications referred to in Subsection I of Section Ia, in particular derogations from the applicability of the rules and requirements laid down in that Subsection: (i) in so far as pending applications for protection of designations of origin or geographical indications are concerned; (ii) in so far as the production of certain wines with a protected designation of origin or a protected geographical indication in a geographical area in proximity of the geographical area where the grapes originate is concerned; (iii) in so far as traditional production practices of certain wines with a protected designation of origin are concerned; (l) the rules concerning traditional terms referred to in Subsection II of Section Ia in particular concerning: (i) the procedure conferring protection; (ii) the specific level of protection; (l) the rules concerning traditional terms referred to in Subsection II of Section Ia in particular concerning: (i) the procedure conferring protection; (ii) the specific level of protection; (m) the rules concerning labelling and presentation referred to in Section Ib, in particular: (i) details on the indication of provenance of the relevant product; (ii) the terms of use of the optional particulars listed in Article 118z; (iii) specific requirements relating to the indications concerning the vintage year and the wine grape variety displayed on labels as referred to in Article 118z(2); (iv) further derogations in addition to those referred to in Article 118y(2) which provide that the reference to the category of the grapevine product may be omitted; (v) rules concerning protection to be conferred in relation to the presentation of a given product. (m) the rules concerning labelling and presentation referred to in Section Ib, in particular: (i) details on the indication of provenance of the relevant product; (ii) the terms of use of the optional particulars listed in Article 118z; (iii) specific requirements relating to the indications concerning the vintage year and the wine grape variety displayed on labels as referred to in Article 118z(2); (iv) further derogations in addition to those referred to in Article 118y(2) which provide that the reference to the category of the grapevine product may be omitted; (v) rules concerning protection to be conferred in relation to the presentation of a given product. The Commission may amend Part B of the table set up in point III(2) of Annex XIa. The measures necessary for the implementation of the provisions concerning oenological practices and restrictions laid down in Subsection II of Section IIa and Annexes XVa and XVb, save as otherwise provided in those Annexes, shall be adopted by the Commission in accordance with the procedure referred to in Article 195(4). The measures referred to in the third paragraph may include, in particular: (a) provisions to the effect that the Community oenological practices listed in Annex IV to Regulation (EC) No 1493/1999 are considered authorised oenological practices; (b) authorised oenological practices and restrictions, including enrichment, acidification and de-acidification concerning sparkling wines, quality sparkling wines and quality aromatic sparkling wines; (c) authorised oenological practices and restrictions concerning liqueur wines; (d) subject to point C of Annex XVb, provisions regulating the blending and coupage of musts and wines; (e) where Community rules on that matter do not exist, the purity and identification, specification of substances used in oenological practices; (f) administrative rules for carrying out the oenological practices authorised; (g) the conditions governing the holding, circulation and use of products not complying with Article 120c and possible exemptions from the requirements of that Article, as well as the establishment of criteria for the purpose of avoiding hardship in individual cases; (h) the conditions under which Member States may authorise the holding, circulation and use of products not complying with Subsection II of Section IIa other than Article 120c, or with provisions implementing that Subsection.
Article 122 
Producer organisations Member States shall recognise producer organisations, which: (a) are constituted by producers of one of the following sectors: (i) hops; (ii) olive oil and table olives; (iii) fruit and vegetables in respect of farmers growing one or more products of that sector and/or of such products solely intended for processing; (iv) silkworm; (a) are constituted by producers of one of the following sectors: (i) hops; (ii) olive oil and table olives; (iii) fruit and vegetables in respect of farmers growing one or more products of that sector and/or of such products solely intended for processing; (iv) silkworm; (b) are formed on the initiative of the producers; (c) pursue a specific aim which may in particular, or as regards the fruit and vegetables sector shall, include one or more of the following objectives: (i) ensuring that production is planned and adjusted to demand, particularly in terms of quality and quantity; (ii) concentration of supply and the placing on the market of the products produced by its members; (iii) optimising production costs and stabilising producer prices.; (c) pursue a specific aim which may in particular, or as regards the fruit and vegetables sector shall, include one or more of the following objectives: (i) ensuring that production is planned and adjusted to demand, particularly in terms of quality and quantity; (ii) concentration of supply and the placing on the market of the products produced by its members; (iii) optimising production costs and stabilising producer prices.; Member States may also recognise producer organisations constituted by producers in any sector referred to in Article 1, other than those sectors referred to in point (a) of the first paragraph, on the conditions set out in points (b) and (c) of that paragraph. Member States may, as regards the wine sector, recognise producer organisations under the same conditions as those set out in points (b) and (c) of the first paragraph and which apply rules of association which require their members, in particular, to: (a) apply the rules adopted by the producer organisation relating to production reporting, production, marketing and protection of the environment; (b) provide the information requested by the producer organisation for statistical purposes, in particular on growing areas and market evolution; (c) pay penalties for infringement of obligations under the rules of association. The following specific aims within the meaning of point (c) of the first paragraph may be pursued, in particular, in the wine sector: (a) promoting and providing technical assistance for the use of environmentally sound cultivation practices and production techniques; (b) promoting initiatives for the management of by-products of wine making and the management of waste in particular to protect the quality of water, soil and landscape and preserving or encouraging biodiversity; (c) carrying out research into sustainable production methods and market developments; (d) contributing to the achievement of support programmes as referred to in Section IVb of Chapter IV of Title I of Part II.
Amendment rationale: CONTEXT OF THE PROPOSAL The Commission proposal for the Multiannual Financial Framework (MFF) for 2014-2020 (the MFF proposal)[1] sets the budgetary framework and main orientations for the Common Agricultural Policy (CAP). On this basis, the Commission presents a set of regulations laying down the legislative framework for the CAP in the period 2014-2020, together with an impact assessment of alternative scenarios for the evolution of the policy. The current reform proposals are based on the Communication on the CAP towards 2020[2] that outlined broad policy options in order to respond to the future challenges for agriculture and rural areas and to meet the objectives set for the CAP, namely 1) viable food production; 2) sustainable management of natural resources and climate action; and 3) balanced territorial development. The reform orientations in the Communication have since been broadly supported both in the inter-institutional debate[3] and in the stakeholder consultation that took place in the framework of the

|52011PC0631Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers /* COM/2011/0631 final - 2011/0285 (COD) */EXPLANATORY MEMORANDUM1.           CONTEXT OF THE PROPOSALThe Commission proposal for the Multiannual Financial Framework (MFF) for 2014-2020 (the MFF proposal)[1] sets the budgetary framework and main orientations for the Common Agricultural Policy (CAP). On this basis, the Commission presents a set of regulations laying down the legislative framework for the CAP in the period 2014-2020, together with an impact assessment of alternative scenarios for the evolution of the policy.The current reform proposals are based on the Communication on the CAP towards 2020[2] that outlined broad policy options in order to respond to the future challenges for agriculture and rural areas and to meet the objectives set for the CAP, namely 1) viable food production; 2) sustainable management of natural resources and climate action; and 3) balanced territorial development. The reform orientations in the Communication have since been broadly supported both in the inter-institutional debate[3] and in the stakeholder consultation that took place in the framework of the impact assessment.A common theme that has emerged throughout this process is the need to promote resource efficiency with a view to smart, sustainable and inclusive growth for EU agriculture and rural areas in line with the Europe 2020 strategy, keeping the structure of the CAP around two pillars that use complementary instruments in pursuit of the same objectives. Pillar I covers direct payments and market measures providing a basic annual income support to EU farmers and support in case of specific market disturbances, while Pillar II covers rural development where Member States draw up and co-finance multiannual programmes under a common framework.[4]Through successive reforms the CAP has increased market orientation for agriculture while providing income support to producers, improved the integration of environmental requirements and reinforced support for rural development as an integrated policy for the development of rural areas across the EU. However, the same reform process has raised demands for a better distribution of support among and within Member States, as well as calls for a better targeting of measures aiming at addressing environmental challenges and better addressing increased market volatility.In the past, reforms mainly responded to endogenous challenges, from huge surpluses to food safety crises; they have served the EU well both on the domestic and the international front. However, most of today's challenges are driven by factors that are external to agriculture and would thus require a broader policy response.The pressure on agricultural income is expected to continue as farmers are facing more risks, a slowdown in productivity and a margin squeeze due to rising input prices; there is therefore a need to maintain income support and to reinforce instruments to better manage risks and respond to crisis situations. A strong agriculture is vital for the EU food industry and global food security.At the same time, agriculture and rural areas are being called upon to step up their efforts to meet the ambitious climate and energy targets and biodiversity strategy that are part of the Europe 2020 agenda. Farmers, who are together with foresters the main land managers, will need to be supported in adopting and maintaining farming systems and practices that are particularly favourable to environmental and climate objectives because market prices do not reflect the provision of such public goods. It will also be essential to best harness the diverse potential of rural areas and thus contribute to inclusive growth and cohesion.The future CAP will not, therefore, be a policy that caters only for a small, albeit essential, part of the EU economy, but also a policy of strategic importance for food security, the environment and territorial balance. Therein lies the EU added value of a truly common policy that makes the most efficient use of limited budgetary resources in maintaining a sustainable agriculture throughout the EU, addressing important cross-border issues such as climate change and reinforcing solidarity among Member States, while also allowing flexibility in implementation to cater for local needs.The framework set out in the MFF proposal foresees that the CAP should maintain its two-pillar structure with the budget for each pillar maintained in nominal terms at its 2013 level and with a clear focus on delivering results on the key EU priorities. Direct payments should promote sustainable production by assigning 30 % of their budgetary envelope to mandatory measures that are beneficial to climate and the environment. Payment levels should progressively converge and payments to large beneficiaries be subject to progressive capping. Rural development should be included in a Common Strategic Framework with other EU shared management funds with a reinforced outcome-orientated approach and subject to clearer, improved ex-ante conditionalities. Finally, on market measures the financing of the CAP should be reinforced with two instruments outside the MFF: 1) an emergency reserve to react to crisis situations; and 2) the extension of the scope of the European Globalization Adjustment Fund.On this basis, the main elements of the legislative framework for the CAP during the period 2014-2020 are set out in the following regulations:–                         Proposal for a Regulation of the European Parliament and of the Council establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy ('the direct payments regulation');–                         Proposal for a Regulation of the European Parliament and of the Council establishing a common organisation of the markets in agricultural products (Single CMO Regulation) ('the Single CMO regulation');–                         Proposal for a Regulation of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) ('the rural development regulation');–                         Proposal for a Regulation of the European Parliament and of the Council on the financing, management and monitoring of the common agricultural policy ('the horizontal regulation');–                         Proposal for a Council regulation determining measures on fixing certain aids and refunds related to the common organisation of the markets in agricultural products;–                         Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 73/2009 as regards the application of direct payments to farmers in respect of the year 2013;–                         Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers.The rural development regulation builds on the proposal presented by the Commission on 6 October 2011 that sets out common rules for all funds operating under a Common Strategic Framework[5]. A regulation will follow on the scheme for most deprived persons, for which funding is now placed under a different heading of the MFF.In addition, new rules on the publication of information on beneficiaries taking account of the objections expressed by the Court of Justice of the European Union are also under preparation with a view to finding the most appropriate way to reconcile beneficiaries' right to protection of personal data with the principle of transparency.

|52012PC0051Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 as regards pharmacovigilance /* COM/2012/051 final - 2012/0023 (COD) */EXPLANATORY MEMORANDUMThe Commission presents a proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmamacovigilance, Regulation (EC) No 726/2004. It is complemented by parallel changes to Directive 2001/83/EC.1.           CONTEXT OF THE PROPOSALOn 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012.The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns.However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system.Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed.In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level.Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns.Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance.2.           OBJECTIVE OF THE COMMISSION'S PROPOSALSThe general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens. Following this line, the proposals aim specifically to address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified.3.           BUDGETARY IMPLICATIONThe proposals have no implication for the budget of the Union.The proposals only make minor changes to the system set forth by the 2010 pharmacovigilance legislation. They do not require additional human or administrative resources for the functioning of the pharmacovigilance system.2012/0023 (COD)Proposal for aREGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILamending Regulation (EC) No 726/2004 as regards pharmacovigilance(Text with EEA relevance)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 Article 114 and Article 168(4)(c) thereof,Having regard to the proposal from the European Commission[1],Having regard to the opinion of the European Economic and Social Committee[2],Having regard to the opinion of the Committee of the Regions[3],Acting in accordance with the ordinary legislative procedure,Whereas:(1)       In order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency[4], as amended by Regulation (EU) No 1235/2010[5], should systematically include medicinal products that are subject to post-authorisation safety conditions.(2)       In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provisions should be made for the marketing authorisation holder to inform the Agency of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation.(3)       Regulation (EC) No 726/2004 should therefore be amended accordingly.(4)       Since the objective of this Regulation, namely to provide for specific rules on pharmacovigilance and improve the safety of medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member States and can 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. 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 this objective,
Revised version (Article 122 ):
Producer organisations Member States shall recognise producer organisations, which: (a) are constituted by producers of one of the following sectors: (i) hops; (ii) olive oil and table olives; (iii) fruit and vegetables in respect of farmers growing one or more products of that sector and/or of such products solely intended for processing; (iiia) milk and milk products; (iv) silkworm; (a) are constituted by producers of one of the following sectors: (i) hops; (ii) olive oil and table olives; (iii) fruit and vegetables in respect of farmers growing one or more products of that sector and/or of such products solely intended for processing; (iiia) milk and milk products; (iv) silkworm; (b) are formed on the initiative of the producers; (c) pursue a specific aim which may in particular, or as regards the fruit and vegetables sector shall, include one or more of the following objectives: (i) ensuring that production is planned and adjusted to demand, particularly in terms of quality and quantity; (ii) concentration of supply and the placing on the market of the products produced by its members; (iii) optimising production costs and stabilising producer prices.; (c) pursue a specific aim which may in particular, or as regards the fruit and vegetables sector shall, include one or more of the following objectives: (i) ensuring that production is planned and adjusted to demand, particularly in terms of quality and quantity; (ii) concentration of supply and the placing on the market of the products produced by its members; (iii) optimising production costs and stabilising producer prices.; Member States may also recognise producer organisations constituted by producers in any sector referred to in Article 1, other than those sectors referred to in point (a) of the first paragraph, on the conditions set out in points (b) and (c) of that paragraph. Member States may, as regards the wine sector, recognise producer organisations under the same conditions as those set out in points (b) and (c) of the first paragraph and which apply rules of association which require their members, in particular, to: (a) apply the rules adopted by the producer organisation relating to production reporting, production, marketing and protection of the environment; (b) provide the information requested by the producer organisation for statistical purposes, in particular on growing areas and market evolution; (c) pay penalties for infringement of obligations under the rules of association. The following specific aims within the meaning of point (c) of the first paragraph may be pursued, in particular, in the wine sector: (a) promoting and providing technical assistance for the use of environmentally sound cultivation practices and production techniques; (b) promoting initiatives for the management of by-products of wine making and the management of waste in particular to protect the quality of water, soil and landscape and preserving or encouraging biodiversity; (c) carrying out research into sustainable production methods and market developments; (d) contributing to the achievement of support programmes as referred to in Section IVb of Chapter IV of Title I of Part II.