Article 123 
Interbranch organisations 1. mber States shall recognise interbranch organisations which: (a) are made up of representatives of economic activities linked to the production of, trade in, and/or processing of products in the following sectors: (i) the olive oil and table olives sector; (ii) the tobacco sector; (a) are made up of representatives of economic activities linked to the production of, trade in, and/or processing of products in the following sectors: (i) the olive oil and table olives sector; (ii) the tobacco sector; (b) are formed on the initiative of all or some of the organisations or associations which constitute them; (c) pursue a specific aim, which may, in particular relate to: (i) concentrating and coordinating supply and marketing of the produce of the members; (ii) adapting production and processing jointly to the requirements of the market and improving the product; (iii) promoting the rationalisation and improvement of production and processing; (iv) carrying out research into sustainable production methods and market developments. (c) pursue a specific aim, which may, in particular relate to: (i) concentrating and coordinating supply and marketing of the produce of the members; (ii) adapting production and processing jointly to the requirements of the market and improving the product; (iii) promoting the rationalisation and improvement of production and processing; (iv) carrying out research into sustainable production methods and market developments. 2. Where interbranch organisations referred to in paragraph 1 carry out their activities in the territories of several Member States, recognition shall be granted by the Commission without the assistance of the Committee referred to in Article 195(1). 3. Further to paragraph 1, Member States shall, with regard to the fruit and vegetables sector, and may, with regard to the wine sector, also recognise inter-branch organisations which: (a) are made up of representatives of economic activities linked to the production of, trade in, or processing of the products of the sectors referred to in the introductory words; (b) are formed on the initiative of all or some of the representatives referred to in point (a); (c) carry out one, and in the case of the fruit and vegetables sector, two or more, of the following activities in one or more regions of the Community, taking into account the interests of consumers, and, without prejudice to other sectors, in the wine sector taking into account public health and the interests of consumers: (i) improving knowledge and the transparency of production and the market; (ii) helping to coordinate better the way the products of the fruit and vegetables and the wine sectors are placed on the market, in particular by means of research and market studies; (iii) drawing up standard forms of contract compatible with Community rules; (iv) exploiting to a fuller extent the potential of the fruit and vegetables produced, and the potential of production in the wine sector; (v) providing the information and carrying out the research necessary to adjust production towards products more suited to market requirements and consumer tastes and expectations, in particular with regard to product quality and protection of the environment; (vi) seeking ways of restricting the use of plant-health products and other inputs and ensuring product quality and soil and water conservation; (vii) developing methods and instruments for improving product quality at all stages of production and marketing and, as regards the wine sector, also vinification; (viii) exploiting the potential of organic farming and protecting and promoting such farming as well as designations of origin, quality labels and geographical indications; (ix) promoting integrated production or other environmentally sound production methods; (x) with regard to the fruit and vegetables sector, laying down rules, as regards the production and marketing rules referred to in points 2 and 3 of Annex XVIa, which are stricter than Community or national rules; (xi) with regard to the wine sector: — providing information on particular characteristics of wine with a protected designation of origin or a protected geographical indication, — encouraging moderate and responsible consumption of wine and informing on the harm linked to hazardous consumption patterns, — carrying out promotion actions for wine, especially in third countries. (c) carry out one, and in the case of the fruit and vegetables sector, two or more, of the following activities in one or more regions of the Community, taking into account the interests of consumers, and, without prejudice to other sectors, in the wine sector taking into account public health and the interests of consumers: (i) improving knowledge and the transparency of production and the market; (ii) helping to coordinate better the way the products of the fruit and vegetables and the wine sectors are placed on the market, in particular by means of research and market studies; (iii) drawing up standard forms of contract compatible with Community rules; (iv) exploiting to a fuller extent the potential of the fruit and vegetables produced, and the potential of production in the wine sector; (v) providing the information and carrying out the research necessary to adjust production towards products more suited to market requirements and consumer tastes and expectations, in particular with regard to product quality and protection of the environment; (vi) seeking ways of restricting the use of plant-health products and other inputs and ensuring product quality and soil and water conservation; (vii) developing methods and instruments for improving product quality at all stages of production and marketing and, as regards the wine sector, also vinification; (viii) exploiting the potential of organic farming and protecting and promoting such farming as well as designations of origin, quality labels and geographical indications; (ix) promoting integrated production or other environmentally sound production methods; (x) with regard to the fruit and vegetables sector, laying down rules, as regards the production and marketing rules referred to in points 2 and 3 of Annex XVIa, which are stricter than Community or national rules; (xi) with regard to the wine sector: — providing information on particular characteristics of wine with a protected designation of origin or a protected geographical indication, — encouraging moderate and responsible consumption of wine and informing on the harm linked to hazardous consumption patterns, — carrying out promotion actions for wine, especially in third countries. (xi) with regard to the wine sector: — providing information on particular characteristics of wine with a protected designation of origin or a protected geographical indication, — encouraging moderate and responsible consumption of wine and informing on the harm linked to hazardous consumption patterns, — carrying out promotion actions for wine, especially in third countries.
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 123 ):
Interbranch organisations 1. mber States shall recognise interbranch organisations which: (a) are made up of representatives of economic activities linked to the production of, trade in, and/or processing of products in the following sectors: (i) the olive oil and table olives sector; (ii) the tobacco sector; (a) are made up of representatives of economic activities linked to the production of, trade in, and/or processing of products in the following sectors: (i) the olive oil and table olives sector; (ii) the tobacco sector; (b) are formed on the initiative of all or some of the organisations or associations which constitute them; (c) pursue a specific aim, which may, in particular relate to: (i) concentrating and coordinating supply and marketing of the produce of the members; (ii) adapting production and processing jointly to the requirements of the market and improving the product; (iii) promoting the rationalisation and improvement of production and processing; (iv) carrying out research into sustainable production methods and market developments. (c) pursue a specific aim, which may, in particular relate to: (i) concentrating and coordinating supply and marketing of the produce of the members; (ii) adapting production and processing jointly to the requirements of the market and improving the product; (iii) promoting the rationalisation and improvement of production and processing; (iv) carrying out research into sustainable production methods and market developments. 2. Where interbranch organisations referred to in paragraph 1 carry out their activities in the territories of several Member States, recognition shall be granted by the Commission without the assistance of the Committee referred to in Article 195(1). 3. Further to paragraph 1, Member States shall, with regard to the fruit and vegetables sector, and may, with regard to the wine sector, also recognise inter-branch organisations which: (a) are made up of representatives of economic activities linked to the production of, trade in, or processing of the products of the sectors referred to in the introductory words; (b) are formed on the initiative of all or some of the representatives referred to in point (a); (c) carry out one, and in the case of the fruit and vegetables sector, two or more, of the following activities in one or more regions of the Community, taking into account the interests of consumers, and, without prejudice to other sectors, in the wine sector taking into account public health and the interests of consumers: (i) improving knowledge and the transparency of production and the market; (ii) helping to coordinate better the way the products of the fruit and vegetables and the wine sectors are placed on the market, in particular by means of research and market studies; (iii) drawing up standard forms of contract compatible with Community rules; (iv) exploiting to a fuller extent the potential of the fruit and vegetables produced, and the potential of production in the wine sector; (v) providing the information and carrying out the research necessary to adjust production towards products more suited to market requirements and consumer tastes and expectations, in particular with regard to product quality and protection of the environment; (vi) seeking ways of restricting the use of plant-health products and other inputs and ensuring product quality and soil and water conservation; (vii) developing methods and instruments for improving product quality at all stages of production and marketing and, as regards the wine sector, also vinification; (viii) exploiting the potential of organic farming and protecting and promoting such farming as well as designations of origin, quality labels and geographical indications; (ix) promoting integrated production or other environmentally sound production methods; (x) with regard to the fruit and vegetables sector, laying down rules, as regards the production and marketing rules referred to in points 2 and 3 of Annex XVIa, which are stricter than Community or national rules; (xi) with regard to the wine sector: — providing information on particular characteristics of wine with a protected designation of origin or a protected geographical indication, — encouraging moderate and responsible consumption of wine and informing on the harm linked to hazardous consumption patterns, — carrying out promotion actions for wine, especially in third countries. (c) carry out one, and in the case of the fruit and vegetables sector, two or more, of the following activities in one or more regions of the Community, taking into account the interests of consumers, and, without prejudice to other sectors, in the wine sector taking into account public health and the interests of consumers: (i) improving knowledge and the transparency of production and the market; (ii) helping to coordinate better the way the products of the fruit and vegetables and the wine sectors are placed on the market, in particular by means of research and market studies; (iii) drawing up standard forms of contract compatible with Community rules; (iv) exploiting to a fuller extent the potential of the fruit and vegetables produced, and the potential of production in the wine sector; (v) providing the information and carrying out the research necessary to adjust production towards products more suited to market requirements and consumer tastes and expectations, in particular with regard to product quality and protection of the environment; (vi) seeking ways of restricting the use of plant-health products and other inputs and ensuring product quality and soil and water conservation; (vii) developing methods and instruments for improving product quality at all stages of production and marketing and, as regards the wine sector, also vinification; (viii) exploiting the potential of organic farming and protecting and promoting such farming as well as designations of origin, quality labels and geographical indications; (ix) promoting integrated production or other environmentally sound production methods; (x) with regard to the fruit and vegetables sector, laying down rules, as regards the production and marketing rules referred to in points 2 and 3 of Annex XVIa, which are stricter than Community or national rules; (xi) with regard to the wine sector: — providing information on particular characteristics of wine with a protected designation of origin or a protected geographical indication, — encouraging moderate and responsible consumption of wine and informing on the harm linked to hazardous consumption patterns, — carrying out promotion actions for wine, especially in third countries. (xi) with regard to the wine sector: — providing information on particular characteristics of wine with a protected designation of origin or a protected geographical indication, — encouraging moderate and responsible consumption of wine and informing on the harm linked to hazardous consumption patterns, — carrying out promotion actions for wine, especially in third countries. 4. Member States may also recognise interbranch organisations which: (a) have formally requested recognition and are made up of representatives of economic activities linked to the production of raw milk and linked to at least one of the following stages of the supply chain: processing of or trade in, including distribution of, products of the milk and milk products sector; (c) carry out, in one or more regions of the Union, taking into account the interests of the members of those interbranch organisations and of consumers, one or more of the following activities: (i) improving the knowledge and the transparency of production and the market, including by publication of statistical data on the prices, volumes and durations of contracts for the delivery of raw milk which have been previously concluded, and by providing analyses of potential future market developments at regional, national and international level; (ii) helping to coordinate better the way the products of the milk and milk products sector are placed on the market, in particular by means of research and market studies; (iii) promoting consumption of, and providing information on, milk and milk products in both internal and external markets; (iv) exploring potential export markets; (v) drawing up standard forms of contract compatible with Union rules for the sale of raw milk to purchasers and/or the supply of processed products to distributors and retailers, taking into account the need to achieve fair competitive conditions and to avoid market distortions; (vi) providing the information and carrying out the research necessary to adjust production in favour of products more suited to market requirements and consumer tastes and expectations, in particular with regard to product quality and protection of the environment; (vii) maintaining and developing the production potential of the dairy sector, inter alia, by promoting innovation and supporting programmes for applied research and development in order to exploit the full potential of milk and milk products, especially in order to create value-added products which are more attractive to the consumer; (viii) seeking ways of restricting the use of animal-health products, improving the management of other inputs and enhancing food safety and animal health; (ix) developing methods and instruments for improving product quality at all stages of production and marketing; (x) exploiting the potential of organic farming and protecting and promoting such farming as well as the production of products with designations of origin, quality labels and geographical indications; and (xi) promoting integrated production or other environmentally sound production methods. (c) carry out, in one or more regions of the Union, taking into account the interests of the members of those interbranch organisations and of consumers, one or more of the following activities: (i) improving the knowledge and the transparency of production and the market, including by publication of statistical data on the prices, volumes and durations of contracts for the delivery of raw milk which have been previously concluded, and by providing analyses of potential future market developments at regional, national and international level; (ii) helping to coordinate better the way the products of the milk and milk products sector are placed on the market, in particular by means of research and market studies; (iii) promoting consumption of, and providing information on, milk and milk products in both internal and external markets; (iv) exploring potential export markets; (v) drawing up standard forms of contract compatible with Union rules for the sale of raw milk to purchasers and/or the supply of processed products to distributors and retailers, taking into account the need to achieve fair competitive conditions and to avoid market distortions; (vi) providing the information and carrying out the research necessary to adjust production in favour of products more suited to market requirements and consumer tastes and expectations, in particular with regard to product quality and protection of the environment; (vii) maintaining and developing the production potential of the dairy sector, inter alia, by promoting innovation and supporting programmes for applied research and development in order to exploit the full potential of milk and milk products, especially in order to create value-added products which are more attractive to the consumer; (viii) seeking ways of restricting the use of animal-health products, improving the management of other inputs and enhancing food safety and animal health; (ix) developing methods and instruments for improving product quality at all stages of production and marketing; (x) exploiting the potential of organic farming and protecting and promoting such farming as well as the production of products with designations of origin, quality labels and geographical indications; and
Article 124 
Common provisions concerning producer and interbranch organisations 1. Article 122 and Article 123(1) shall apply without prejudice to the recognition, decided by Member States on the basis of national law and in compliance with Community law, of producer organisations or interbranch organisations respectively, in any sector referred to in Article 1 except for the sectors referred to in point (a) of the first paragraph of Article 122 and in Article 123(1). 2. Producer organisations recognised or approved in accordance with Regulations (EC) No 865/2004, (EC) No 1952/2005 and (EC) No 1544/2006 shall be considered as recognised producer organisations under Article 122 of this Regulation. Interbranch organisations recognised or approved in accordance with Regulations (EEC) 2077/92 and (EC) No 865/2004 shall be considered recognised interbranch organisations under Article 123 of this Regulation.
Article 125 
Operator organisations For the purposes of this Regulation, operator organisations shall comprise recognised producer organisations, recognised interbranch organisations or recognised organisations of other operators in the olive oil and table olives sector or their associations.
Article 125a Rules of association of producer organisations
1. The rules of association of a producer organisation in the fruit and vegetables sector shall require its producer 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) belong to only one producer organisation in respect of a given holding's production of any given product referred to in Article 122(a)(iii); (c) market their entire production concerned through the producer organisation; (d) provide the information requested by the producer organisation for statistical purposes, in particular on growing areas, quantities cropped, yields and direct sales; (e) pay the financial contributions provided for in its rules of association for the establishment and replenishment of the operational fund provided for in Article 103b. 2. Notwithstanding paragraph 1(c), where the producer organisation so authorises and where this is in compliance with the terms and conditions laid down by the producer organisation, the producer members may: (a) sell no more than a fixed percentage of their production and/or products directly on their holdings and/or outside their holdings to consumers for their personal needs, such percentages being fixed by Member States at not less than 10 %; (b) market themselves or through another producer organisation designated by their own organisation, quantities of products which are marginal in relation to the volume of marketable production of their organisation; (c) market themselves or through another producer organisation designated by their own organisation products which, because of their characteristics, are not normally covered by the commercial activities of the producer organisation concerned. 3. The rules of association of a producer organisation shall also provide for: (a) procedures for determining, adopting and amending the rules referred to in paragraph 1; (b) the imposition on members of financial contributions needed to finance the producer organisation; (c) rules enabling the producer members to scrutinise democratically their organisation and its decisions; (d) penalties for infringement of obligations under the rules of association, particularly non-payment of financial contributions, or of the rules laid down by the producer organisation; (e) rules on the admission of new members, particularly a minimum membership period; (f) the accounting and budgetary rules necessary for the operation of the organisation. 4. Producer organisations in the fruit and vegetables sector shall be deemed as acting in the name of, and on behalf of, their members in economic matters.
Article 125b Recognition
1. Member States shall recognise as producer organisations in the fruit and vegetables sector all legal entities or clearly defined parts of legal entities applying for such recognition, provided that: (a) they have the objective of the use of environmentally sound cultivation practices, production techniques and waste management practices in particular to protect the quality of water, soil and landscape and preserve or encourage biodiversity and meet the requirements laid down in Articles 122 and 125a and provide the relevant evidence therefore; (b) they have a minimum number of members and cover a minimum volume or value of marketable production to be laid down by Member States, and provide the relevant evidence therefore; (c) there is sufficient evidence that they can carry out their activities properly, both over time and in terms of effectiveness and concentration of supply, to which end Member States may decide which of the products, or groups of products referred to in Article 122(a)(iii) should be covered by the producer organisation; (d) they effectively enable their members to obtain technical assistance in using environmentally-sound cultivation practices; (e) they effectively provide their members, where necessary, with the technical means for collecting, storing, packaging and marketing their produce; (f) they ensure proper commercial and accounting management of their activities; and (g) they do not hold a dominant position on a given market unless this is necessary in pursuance of the objectives of Article 33 of the Treaty. 2. Member States shall: (a) decide whether to grant recognition to a producer organisation within three months of the lodging of an application accompanied by all the relevant evidence; (b) carry out checks at regular intervals to ascertain that producer organisations comply with this Chapter, impose the penalties on such organisations in the event of non-compliance or irregularities concerning the provisions of this Regulation and decide, where necessary, to withdraw recognition; (c) notify the Commission, once per year, of every decision to grant, refuse or withdraw recognition. Subsection II Association of producer organisations and producer groups
Article 125c Association of producer organisations in the fruit and vegetables sector
An association of producer organisations in the fruit and vegetables sector shall be formed on the initiative of recognised producer organisations and may carry out any of the activities of a producer organisation referred to in this Regulation. To this end, Member States may recognise, on request, an association of producer organisations where: (a) the Member State considers that the association is capable of effectively carrying out those activities; and (b) the association does not hold a dominant position on a given market unless this is necessary in pursuance of the objectives of Article 33 of the Treaty. Article 125a(4) shall apply mutatis mutandis .
Article 125d Outsourcing
Member States may permit a recognised producer organisation in the fruit and vegetables sector or a recognised association of producer organisations in that sector to outsource any of its activities, including to subsidiaries, provided that it provides sufficient evidence to the Member State that doing so is an appropriate way to achieve the objectives of the producer organisation or association of producer organisations concerned.
Article 125e Producer groups in the fruit and vegetables sector
1. In Member States which acceded to the European Union on 1 May 2004 or thereafter, or 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, producer groups may be formed as a legal entity or clearly defined part of a legal entity, on the initiative of farmers who are growers of one or more products of the fruit and vegetables sector and/or of such products solely intended for processing, with a view to being recognised as a producer organisation. Such producer groups may be allowed a transitional period in which to meet the conditions for recognition as a producer organisation in accordance with Article 122. In order to qualify, those producer groups shall present a phased recognition plan to the relevant Member State, acceptance of which shall signal the start of the transitional period referred to in the second subparagraph and shall constitute a preliminary recognition. The transitional period shall be no more than five years long. 2. Before acceptance of the recognition plan, Member States shall inform the Commission of their intentions and the likely financial implications thereof. Subsection III Extension of rules to producers in an economic area
Article 125f Extension of rules
1. In cases where a producer organisation in the fruit and vegetables sector which operates in a specific economic area is considered, in respect of a specific product, to be representative of production and producers in that area, the Member State concerned may, at the request of the producer organisation, make the following rules binding on producers established in that economic area who do not belong to the producer organisation: (a) the rules referred to in Article 125a(1)(a); (b) the rules required to implement the measures referred to in Article 103c(2)(c). The first subparagraph shall apply on condition that those rules: (a) have been in force for at least one marketing year; (b) are included in the exhaustive list in Annex XVIa; (c) are made binding for no more than three marketing years. However, the condition referred to in point (a) of the second subparagraph shall not apply if the rules concerned are those listed in points 1, 3 and 5 of Annex XVIa. In this case, the extension of rules may not apply for more than one marketing year. (b) the rules required to implement the measures referred to in Article 103c(2)(c). The first subparagraph shall apply on condition that those rules: (a) have been in force for at least one marketing year; (b) are included in the exhaustive list in Annex XVIa; (c) are made binding for no more than three marketing years. However, the condition referred to in point (a) of the second subparagraph shall not apply if the rules concerned are those listed in points 1, 3 and 5 of Annex XVIa. In this case, the extension of rules may not apply for more than one marketing year. 2. For the purposes of this subsection, ‘economic area’ means a geographical zone made up of adjoining or neighbouring production regions in which production and marketing conditions are homogeneous. Member States shall notify a list of economic areas to the Commission. Within one month of notification, the Commission shall approve the list or shall, after consultation with the Member State concerned, decide on the amendments which the latter must make to it. The Commission shall make the approved list publicly available by the methods it considers appropriate. 3. A producer organisation shall be deemed representative within the meaning of paragraph 1 where its members account for at least 50 % of the producers in the economic area in which it operates and it covers at least 60 % of the volume of production of that area. Without prejudice to paragraph 5, in calculating these percentages account shall not be taken of producers or production of organic products covered, until 31 December 2008, by Regulation (EEC) No 2092/91 and, from 1 January 2009, by Regulation (EC) No 834/2007. 4. The rules which are made binding on all producers in a specific economic area: (a) shall not cause any damage to other producers in the Member State concerned or in the Community; (b) shall not apply, unless they expressly cover them, to products delivered for processing under a contract signed before the beginning of the marketing year, with the exception of the rules on production reporting referred to in Article 125a(1)(a); (c) shall not be incompatible with Community and national rules in force. 5. Rules may not be made binding on producers of organic products covered, until 31 December 2008, by Regulation (EEC) No 2092/91 and, from 1 January 2009, by Regulation (EC) No 834/2007 unless such a measure has been agreed to by at least 50 % of such producers in the economic area in which the producer organisation operates and that organisation covers at least 60 % of such production of that area.
Article 125g Notification
Member States shall notify the Commission forthwith of the rules which they have made binding on all producers in a specific economic area pursuant to Article 125f(1). The Commission shall make these rules publicly available by the methods it considers appropriate.
Article 125h Repeal of the extension of rules
The Commission shall decide that a Member State shall repeal an extension of the rules decided on by that Member State pursuant to Article 125f(1): (a) where it finds that the extension in question to other producers excludes competition in a substantial part of the internal market or jeopardises free trade, or that the objectives of Article 33 of the Treaty are endangered; (b) where it finds that Article 81(1) of the Treaty applies to the rules extended to other producers. The Commission’s decision with regard to those rules shall apply only from the date of such a finding; (c) where it finds after checks that this subsection has not been complied with.
Article 125i Financial contributions of non-member producers
Where Article 125f(1) is applied, the Member State concerned may decide, on scrutiny of evidence presented, that non-member producers shall be liable to the producer organisation for the part of the financial contributions paid by the producer members, insofar as these are used to cover: (a) administrative costs resulting from applying the rules referred to in Article 125f(1); (b) the cost of research, market studies and sales promotion undertaken by the organisation or association and benefiting all producers in the area.
Article 125j Extension of rules of associations of producer organisations
For the purposes of this subsection, any reference to producer organisations shall also be construed as a reference to recognised associations of producer organisations. Subsection IV Interbranch organisations in the fruit and vegetables sector
Article 125k Recognition and withdrawal of recognition
1. If warranted by the Member State’s structures, Member States may recognise as interbranch organisations in the fruit and vegetables sector all legal entities established on their territory which make an appropriate application, on condition that: (a) they carry out their activity in one or more regions in the Member State concerned; (b) they represent a significant share of the production of, trade in and/or processing of fruit and vegetables and products processed from fruit and vegetables in the region or regions in question and, where more than one region is involved, they can demonstrate a minimum level of representativeness in each region for each of the branches that they group; (c) they carry out two or more of the activities referred to in Article 123(3)(c); (d) they are not themselves engaged in the production or processing or marketing of fruit and vegetables or products processed from fruit and vegetables; (e) they do not engage in any of the agreements, decisions and concerted practices referred to in Article 176a(4). 2. Before granting recognition Member States shall notify the Commission of the interbranch organisations which have applied for recognition, providing all relevant information about their representativeness and their various activities, together with all other information needed for an assessment. The Commission may object to recognition within a time limit of two months after notification. 3. Member States shall: (a) decide whether to grant recognition within three months of the lodging of an application with all relevant supporting documents; (b) carry out checks at regular intervals to ascertain that interbranch organisations comply with the terms and conditions for recognition, impose the penalties on such organisations in the event of non-compliance or irregularities concerning the provisions of this Regulation and decide, where necessary, to withdraw recognition; (c) withdraw recognition if: (i) the requirements and conditions for recognition laid down in this subsection are no longer met; (ii) the interbranch organisation engages in any of the agreements, decisions and concerted practices referred to in Article 176a(4), without prejudice to any other penalties to be imposed pursuant to national law; (iii) the interbranch organisation fails to comply with the notification obligation referred to in Article 176a(2); (c) withdraw recognition if: (i) the requirements and conditions for recognition laid down in this subsection are no longer met; (ii) the interbranch organisation engages in any of the agreements, decisions and concerted practices referred to in Article 176a(4), without prejudice to any other penalties to be imposed pursuant to national law; (iii) the interbranch organisation fails to comply with the notification obligation referred to in Article 176a(2); (d) notify the Commission, within two months, of any decision to grant, refuse or withdraw recognition. 4. The Commission shall lay down the terms and conditions on which and the frequency with which the Member States are to report to the Commission on the activities of interbranch organisations. The Commission may, as a result of checks, request a Member State to withdraw recognition. 5. Recognition shall constitute an authorisation to carry out the activities listed in Article 123(3)(c), subject to the terms of this Regulation. 6. The Commission shall make publicly available a list of recognised interbranch organisations, by the methods it considers appropriate, indicating the economic sphere or the area of their activities and the activities carried out within the meaning of Article 125l. Withdrawals of recognition shall also be made publicly available.
Article 125l Extension of rules
1. In cases where an interbranch organisation operating in a specific region or regions of a Member State is considered to be representative of the production of or trade in or processing of a given product, the Member State concerned may, at the request of that interbranch organisation, make binding some of the agreements, decisions or concerted practices agreed on within that organisation for a limited period on other operators operating in the region or regions in question, whether individuals or groups, who do not belong to the organisation. 2. An interbranch organisation shall be deemed representative within the meaning of paragraph 1 where it accounts for at least two thirds of the production or trade in or processing of the product or products concerned in the region or regions concerned of a Member State. Where the application for extension of its rules to other operators covers more than one region, the interbranch organisation must demonstrate a minimum level of representativeness for each of the branches it groups in each of the regions concerned. 3. The rules for which extension to other operators may be requested: (a) shall have one of the following aims: (i) production and market reporting; (ii) stricter production rules than those laid down in Community or national rules; (iii) drawing up of standard contracts which are compatible with Community rules; (iv) rules on marketing; (v) rules on protecting the environment; (vi) measures to promote and exploit the potential of products; (vii) measures to protect organic farming as well as designations of origin, quality labels and geographical indications; (a) shall have one of the following aims: (i) production and market reporting; (ii) stricter production rules than those laid down in Community or national rules; (iii) drawing up of standard contracts which are compatible with Community rules; (iv) rules on marketing; (v) rules on protecting the environment; (vi) measures to promote and exploit the potential of products; (vii) measures to protect organic farming as well as designations of origin, quality labels and geographical indications; (b) shall have been in force for at least one marketing year; (c) may be made binding for no more than three marketing years; (d) shall not cause any damage to other operators in the Member State concerned or the Community. However, the condition referred to in point (b) of the first subparagraph shall not apply if the rules concerned are those listed in points 1, 3 and 5 of Annex XVIa. In this case, the extension of rules may not apply for more than one marketing year. 4. The rules referred to in points (a)(ii), (iv) and (v) of paragraph 3 shall not be other than those set out in Annex XVIa. The rules referred to in point (a)(ii) of paragraph 3 shall not apply to products which were produced outside the specific region or regions referred to in paragraph 1.
Article 125m Notification and repeal of the extension of rules
1. Member States shall notify the Commission forthwith of the rules which they have made binding on all operators in one or more specific regions pursuant to Article 125l(1). The Commission shall make those rules publicly available by the methods it considers appropriate. 2. Before the rules are made publicly available, the Commission shall inform the Committee set up by Article 195 of any notification of the extension of interbranch agreements. 3. The Commission shall decide that a Member State must repeal an extension of the rules decided on by that Member State in the cases referred to in Article 125h.
Article 125n Financial contributions of non-members
In cases where rules for one or more products are extended and where one or more of the activities referred to in Article 125l(3)(a) are pursued by a recognised interbranch organisation and are in the general economic interest of those persons whose activities relate to one or more of the products concerned, the Member State which has granted recognition may decide that individuals or groups which are not members of the interbranch organisation but which benefit from those activities shall pay the organisation all or part of the financial contributions paid by its members to the extent that such contributions are intended to cover costs directly incurred as a result of pursuing the activities in question.
Article 125o Recognition
1. Member States may recognise producer and inter-branch organisations which have lodged an application for recognition with the Member State concerned and the application contains evidence that the entity: (a) as regards producer organisations: (i) meets the requirements laid down in Article 122; (ii) has a minimum number of members, to be laid down by the Member State concerned; (iii) covers a minimum volume of marketable production, to be laid down by the Member State concerned, in the area where the organisation operates; (iv) can carry out its activities properly, both over time and in terms of effectiveness and concentration of supply; (v) effectively enables its members to obtain technical assistance in using environmentally sound cultivation practices; (a) as regards producer organisations: (i) meets the requirements laid down in Article 122; (ii) has a minimum number of members, to be laid down by the Member State concerned; (iii) covers a minimum volume of marketable production, to be laid down by the Member State concerned, in the area where the organisation operates; (iv) can carry out its activities properly, both over time and in terms of effectiveness and concentration of supply; (v) effectively enables its members to obtain technical assistance in using environmentally sound cultivation practices; (b) as regards inter-branch organisations: (i) meets the requirements laid down in Article 123(3); (ii) carries out its activities in one or more regions in the territory concerned; (iii) represents a significant share of the production of, or trade in, products covered by this Regulation; (iv) does not engage in the production, processing or marketing of products of the wine sector. (b) as regards inter-branch organisations: (i) meets the requirements laid down in Article 123(3); (ii) carries out its activities in one or more regions in the territory concerned; (iii) represents a significant share of the production of, or trade in, products covered by this Regulation; (iv) does not engage in the production, processing or marketing of products of the wine sector. 2. Producer organisations recognised in accordance with Regulation (EC) No 1493/1999 shall be considered as recognised producer organisations under this Article. Organisations meeting the criteria set out in Article 123(3) and of paragraph (1)(b) of this Article, which have been recognised by Member States, shall be considered as recognised interbranch organisations under those provisions. 3. Articles 125b(2) and 125k(3) shall apply mutatis mutandis to producer and inter-branch organisations respectively in the wine sector. However: (a) the periods referred to in Articles 125b(2)(a) and 125k(3)(c) respectively shall be four months; (b) the applications for recognition referred to in Articles 125b(2)(a) and 125k(3)(c) shall be lodged with the Member State where the organisation has its headquarters; (c) the annual notifications referred to in Articles 125b(2)(c) and 125k(3)(d) respectively shall be made by 1 March each year.
Article 126 
Payment of subscription by non-members 1. Where one or more of the activities referred to in paragraph 2 is pursued by a recognised interbranch organisation in the tobacco sector and is in the general economic interest of those persons whose activities relate to one or more of the products concerned, the Member State which has granted recognition, or the Commission, without the assistance of the Committee referred to in Article 195(1), where recognition has been granted by the Commission, may decide that individuals or groups which are not members of the organisation but which benefit from those activities shall pay the organisation all or part of the subscriptions paid by its members to the extent that such subscriptions are intended to cover costs, other than administrative costs of any description, directly incurred as a result of pursuing the activities in question. 2. The activities referred to in paragraph 1 shall relate to one of the following objectives: (a) research to add value to the products, in particular through new uses which do not pose a threat to public health; (b) studies to improve the quality of leaf or baled tobacco; (c) research into methods of cultivation permitting reduced use of plant health products and guaranteeing conservation of the soil and the environment. 3. The Member States concerned shall notify the Commission of decisions which they intend to take under paragraph 1. Such decisions may not apply before the expiry of a three month period starting from the date of notification to the Commission. Within that three month period the Commission may call for the rejection of all or part of the draft decision if the general economic interest put forward does not appear to be well founded. 4. Where the activities of an interbranch organisation recognised by the Commission in accordance with this Chapter are in the general economic interest, the Commission shall notify its draft decision to the Member States concerned, who shall then have two months to make their comments.
Article 127 
Implementing rules The Commission shall adopt the detailed rules for the application of this Chapter, in particular the conditions and procedures for the recognition of producer, interbranch and operator organisations in individual sectors, including: (a) the specific aims to be pursued by such organisations; (b) the rules of association of such organisations; (c) the activities of such organisations; (d) derogations from the requirements laid down in Articles 122, 123 and 125; (da) as the case may be, the rules on transnational producer organisations and transnational associations of producer organisations including administrative assistance to be given by the relevant competent authorities in the case of transnational cooperation; (e) as the case may be, any effects deriving from the recognition as an interbranch organisation.
Article 128 
General principles Unless otherwise provided for in this Regulation or in provisions adopted pursuant thereto, the following shall be prohibited in trade with third countries: (a) the levying of any charge having equivalent effect to a customs duty; (b) the application of any quantitative restriction or measure having equivalent effect.
Article 129 
Combined nomenclature The general rules for interpreting the Combined Nomenclature, provided for in Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( 80 ) (hereinafter referred to as ‘Combined Nomenclature’'), and the special rules for its application shall apply to the tariff classification of products covered by this Regulation. The tariff nomenclature resulting from the application of this Regulation, including, as the case may be, the definitions in Annex III and Annex XIb shall be included in the Common Customs Tariff.
Article 130 
Import licences 1. Without prejudice to cases where import licences are required in accordance with this Regulation, the Commission may make imports of one or more products of the following sectors into the Community subject to presentation of an import licence: (a) cereals; (b) rice; (c) sugar; (d) seeds; (e) olive oil and table olives, with regard to products falling within CN codes 1509, 1510 00, 0709 90 39, 0711 20 90, 2306 90 19, 1522 00 31 and 1522 00 39; (f) flax and hemp, as far as hemp is concerned; (fa) fruit and vegetables; (fb) processed fruit and vegetables; (g) bananas; (ga) wine; (h) live plants; (i) beef and veal; (j) milk and milk products; (k) pigmeat; (l) sheepmeat and goatmeat; (m) eggs; (n) poultrymeat; (o) agricultural ethyl alcohol. 2. When applying paragraph 1, the Commission shall take account of the need for import licences for the management of the markets concerned and, in particular, for monitoring the imports of the products in question.
Article 131 
Issue of licences Import licences shall be issued by Member States to any applicant, irrespective of its place of establishment in the Community, unless a Council Regulation or any other act of the Council provides otherwise, and without prejudice to measures taken for the application of this Chapter.
Article 132 
Validity Import licences shall be valid throughout the Community.
Article 133 
Security 1. Save as otherwise provided for by the Commission, licences shall be issued subject to the lodging of a security guaranteeing that the products are imported during the term of validity of the licence. 2. Except in cases of force majeure , the security shall be forfeited in whole or in part if the import is not carried out, or is carried out only partially, within the period of validity of the licence.
Article 133a Special security in the wine sector
1. For juice and musts falling under CN codes 2009 61, 2009 69 and 2204 30 for which the application of the Common Customs Tariff duties depends on the import price of the product, the actual amount of that price shall be verified either by checking every consignment or by using a flat-rate import value calculated by the Commission on the basis of price quotations for the same products in the countries of origin. Should the declared entry price of the consignment be higher than the flat-rate import value, if such applies, increased by a margin adopted by the Commission that may not exceed the flat-rate value by more than 10 %, a security must be lodged equal to the import duties determined on the basis of the flat-rate import value. If the entry price of the consignment is not declared, the application of Common Customs Tariff shall be dependent on the flat-rate import value or on the application, under conditions to be determined by the Commission, of the relevant provisions of customs legislation. 2. Should derogations by the Council referred to in points B.5 or C of Annex XVb be applied to imported products, importers shall lodge a security for those products with the designated customs authorities at the time of release for free circulation. The security shall be released on presentation by the importer of proof, to the satisfaction of the customs authorities of the Member State of release for free circulation, that the musts were made into grape juice, used in other products outside the wine sector or, if vinified, have been appropriately labelled.
Article 134 
Implementing rules The Commission shall adopt the detailed rules for the application of this Section, including the terms of validity of the licences and the rate of security.
Article 135 
Import duties Save as otherwise provided for pursuant to this Regulation, the rates of import duty in the Common Customs Tariff shall apply to the products referred to in Article 1.
Article 136 
Calculation of import duties for cereals 1. Notwithstanding Article 135, the import duty on products covered by CN codes 1001 10 00, 1001 90 91, ex100190 99 (high quality common wheat), 1002 00 00, 1005 10 90, 1005 90 00 and 1007 00 90 other than hybrid for sowing, shall be equal to the intervention price valid for such products on importation increased by 55 %, minus the c.i.f. import price applicable to the consignment in question. However, that duty may not exceed the conventional rate of duty as determined on the basis of the Combined Nomenclature. 2. For the purposes of calculating the import duty referred to in paragraph 1, representative c.i.f. import prices shall be established on a regular basis for the products referred to in that paragraph.
Article 137 
Calculation of import duties for husked rice 1. Notwithstanding Article 135, the import duty on husked rice falling within CN code 1006 20 shall be fixed by the Commission without the assistance of the Committee referred to in Article 195(1) within 10 days of the end of the reference period concerned in accordance with point 1 of Annex XVII. The Commission, without the assistance of the Committee referred to in Article 195(1), shall fix a new applicable duty if the calculations performed under that Annex indicate a need to change the duty. Until such time as a new applicable duty is fixed, the duty previously fixed shall apply. 2. In order to calculate the imports referred to in point 1 of Annex XVII, account shall be taken of the quantities for which import licences for husked rice falling within CN code 1006 20 were issued in the corresponding reference period, excluding the import licences for Basmati rice referred to in Article 138. 3. The annual reference quantity shall be 449 678 tonnes. The partial reference quantity for each marketing year shall correspond to half the annual reference quantity.
Article 138 
Calculation of import duties for husked basmati rice Notwithstanding Article 135, the husked Basmati rice varieties falling within CN codes 1006 20 17 and 1006 20 98 listed in Annex XVIII shall qualify for a zero rate of import duty under the conditions fixed by the Commission.
Article 139 
Calculation of import duties for milled rice 1. Notwithstanding Article 135, the import duty for semi-milled or wholly milled rice falling within CN code 1006 30 shall be fixed by the Commission, without the assistance of the Committee referred to in Article 195(1), within ten days after the end of the reference period concerned in accordance with point 2 of Annex XVII. The Commission, without the assistance of the Committee referred to in Article 195(1), shall fix a new applicable duty if the calculations performed under that Annex indicate a need to change the duty. Until such time as a new applicable duty is fixed, the duty previously fixed shall apply. 2. In order to calculate imports referred to in point 2 of Annex XVII, account shall be taken of the quantities for which import licences for semi-milled or wholly milled rice falling within CN code 1006 30 were issued in the corresponding reference period.
Article 140 
Calculation of import duties for broken rice Notwithstanding Article 135, the import duty on broken rice falling within CN code 1006 40 00 shall be EUR 65 per tonne.
Article 140a Entry price system for the fruit and vegetables and the processed fruit and vegetables sectors
1. Should application of the common customs tariff duty rate depend on the entry price of the imported consignment, the veracity of this price shall be checked using a flat-rate import value calculated by the Commission, by product and by origin, on the basis of the weighted average of prices for the product on Member States’ representative import markets or on other markets, where appropriate. Specific provisions may, however, be adopted by the Commission for verifying the entry price of products imported primarily for processing. 2. Where the declared entry price of the consignment in question is higher than the flat-rate import value, increased by a margin set by the Commission which may not exceed the flat-rate value by more than 10 %, the lodging of a security equal to the import duty determined on the basis of the flat-rate import value shall be required. 3. If the entry price of the consignment in question is not declared at the time of customs clearance, the common customs tariff duty rate to be applied shall depend on the flat-rate import value or be arrived at by application of the relevant customs legislation provisions under conditions to be determined by the Commission.
Article 141 
Additional import duties 1. An additional import duty shall apply to imports, subject to the rate of duty laid down in Articles 135 to 140a of one or more products of the cereals, rice, sugar, fruit and vegetables, processed fruit and vegetables, beef and veal, milk and milk products, pig meat, sheep meat and goat meat, eggs, poultry and bananas sectors, as well as of grape juice and grape must, in order to prevent or counteract adverse effects on the Community market which may result from those imports, if: (a) the imports are made at a price below the level notified by the Community to the WTO (the trigger price); or (b) the volume of imports in any year exceeds a certain level (the trigger volume). The trigger volume shall be based on market access opportunities defined, where applicable, as imports as a percentage of the corresponding domestic consumption during the three previous years. 2. Additional import duties shall not be imposed where the imports are unlikely to disturb the Community market, or where the effects would be disproportionate to the intended objective. 3. For the purposes of paragraph 1(a), import prices shall be determined on the basis of the c.i.f. import prices of the consignment under consideration. C.i.f. import prices shall be checked against the representative prices for the product on the world market or on the Community import market for that product.
Article 142 
Suspension of import duties in the sugar sector The Commission may suspend import duties in whole or in part for certain quantities in respect of the following products to guarantee the supply necessary for the manufacturing of products referred to in Article 62(2): (a) sugar falling within CN code 1701; (b) isoglucose falling within CN codes 1702 30 10, 1702 40 10, 1702 60 10 and 1702 90 30.
Article 143 
Implementing rules The Commission shall adopt the detailed rules for the application of this Section, in particular specifying: (a) as regards Article 136: (i) the minimum requirements for high quality common wheat; (ii) the price quotations to be taken into consideration; (iii) the possibility, where appropriate in specific cases, of giving operators the opportunity to know the duty applicable before the arrival of the consignments concerned. (a) as regards Article 136: (i) the minimum requirements for high quality common wheat; (ii) the price quotations to be taken into consideration; (iii) the possibility, where appropriate in specific cases, of giving operators the opportunity to know the duty applicable before the arrival of the consignments concerned. (b) as regards Article 141, the products to which additional import duties shall be applied and the other criteria necessary to ensure the application of paragraph 1 of that Article.
Article 144 
Tariff quotas 1. Tariff quotas for imports of products referred to in Article 1 resulting from agreements concluded in accordance with Article 300 of the Treaty or from any other act of the Council shall be opened and administered by the Commission under detailed rules adopted by the Commission. 2. Tariff quotas shall be administered in a manner which avoids any discrimination between the operators concerned, by applying one of the following methods or a combination of them or another appropriate method: (a) a method based on the chronological order of the lodging of applications (‘first come, first served’ principle); (b) a method of distribution in proportion to the quantities requested when the applications were lodged (using the ‘simultaneous examination method’); (c) a method based on taking traditional trade patterns into account (using the ‘traditional/newcomers method’). 3. The method of administration adopted shall, where appropriate, give due weight to the supply requirements of the Community market and the need to safeguard the equilibrium of that market.
Article 145 
Opening of tariff quotas The Commission shall provide for the annual tariff quotas, if necessary suitably phased over the year and shall determine the administrative method to be used.
Article 146 
Specific rules 1. With regard to the import quota of 54 703 tonnes of frozen beef and veal meat falling within CN codes 0202 20 30, 0202 30 and 0206 29 91 and intended for processing, the Council, acting in accordance with the procedure laid down in Article 37(2) of the Treaty, may lay down that all or part of the quota shall cover equivalent quantities of quality meat, applying a conversion rate of 4,375. 2. In the case of tariff quota for import into Spain of 2 000 000 tonnes of maize and 300 000 tonnes of sorghum and tariff quota for import into Portugal of 500 000 tonnes of maize, the detailed rules referred to in Article 148 shall also include the provisions necessary for carrying out the tariff quota imports and, where appropriate, the public storage of the quantities imported by the paying agencies of the Member States concerned and their disposal on the markets of those Member States.
Article 147 
Tariff rates for bananas This Chapter shall apply without prejudice to Council Regulation (EC) No 1964/2005 ( 81 ).
Article 148 
Implementing rules The Commission shall adopt detailed rules for the implementation of this Section, in particular on: (a) guarantees covering the nature, provenance and origin of the product; (b) recognition of the document used for verifying the guarantees referred to in point (a); (c) the conditions under which import licences shall be issued and their term of validity.
Article 149 
Imports of mixtures of different cereals The import duty applicable to mixtures composed of cereals falling within points (a) and (b) of Part I of Annex I shall be established as follows: (a) in the case where the mixture is composed of two of such cereals, the import duty shall be that applicable: (i) to the component cereal predominating by weight, when the cereal represents at least 90 % of the weight of the mixture; (ii) to the component cereal liable to the higher import duty, when neither of the two component cereals represents at least 90 % of the weight of the mixture; (a) in the case where the mixture is composed of two of such cereals, the import duty shall be that applicable: (i) to the component cereal predominating by weight, when the cereal represents at least 90 % of the weight of the mixture; (ii) to the component cereal liable to the higher import duty, when neither of the two component cereals represents at least 90 % of the weight of the mixture; (b) in the case where the mixture is composed of more than two of such cereals, and where several cereals each represent more than 10 % by weight of the mixture, the import duty applicable to the mixture shall be the highest of the import duties applicable to such cereals, even when the amount of the import duty is the same for two or more of the cereals. Where only one cereal represents more than 10 % of the weight of the mixture, the import duty to be applied shall be that applicable to this cereal. (b) in the case where the mixture is composed of more than two of such cereals, and where several cereals each represent more than 10 % by weight of the mixture, the import duty applicable to the mixture shall be the highest of the import duties applicable to such cereals, even when the amount of the import duty is the same for two or more of the cereals. Where only one cereal represents more than 10 % of the weight of the mixture, the import duty to be applied shall be that applicable to this cereal. (c) in all cases not covered by points (a) and (b), the import duty shall be the highest of the import duties applicable to the cereals composing the mixture concerned, even when the amount of the import duty is the same for two or more of the cereals.
Article 150 
Imports of mixtures between cereals and rice The import duty applicable to mixtures composed of one or more of the cereals falling within points (a) and (b) of Part I of Annex I, on the one hand, and of one or more of the products falling within points (a) and (b) of Part II of Annex I, on the other, shall be that applicable to the component cereal or product liable to the highest import duty.
Article 151 
Imports of mixtures of rice The import duty applicable to mixtures composed either of rice classifiable under several different processing groups or stages or of rice classifiable under one or more different processing groups or stages on the one hand and of broken rice on the other shall be that applicable: (a) to the component predominating by weight, when that component represents at least 90 % of the weight of the mixture; (b) the component liable to the highest import duty, when no component represents at least 90 % of the weight of the mixture.
Article 152 
Applicability of the tariff classification Where the method for fixing the import duty set out in Articles 149 to 151 cannot be applied, the duty to be applied to the mixtures referred to in those Articles shall be that determined by the tariff classification of sthe mixtures. Subsection II Preferential import arrangements for sugar
Article 153 
Traditional supply need for refining 1. A traditional supply need of sugar for refining is fixed for the Community at 2 424 735 tonnes per marketing year, expressed in white sugar. During the marketing year 2008/2009, the traditional supply need shall be distributed as follows: (a) 198 748 tonnes for Bulgaria; (b) 296 627 tonnes for France; (c) 100 000 tonnes for Italy; (d) 291 633 tonnes for Portugal; (e) 329 636 tonnes for Romania; (f) 19 585 tonnes for Slovenia; (g) 59 925 tonnes for Finland; (h) 1 128 581 tonnes for the United Kingdom. 2. The traditional supply need referred to in the first subparagraph of paragraph 1 shall be increased by 65 000 tonnes. This quantity shall concern raw cane sugar and shall be reserved for the marketing year 2008/2009 for the sole sugar beet processing plant at work in 2005 in Portugal. That processing plant is deemed to be a full time refiner. 3. Import licences for sugar for refining shall be issued only to full-time refiners provided that the quantities concerned do not exceed the quantities that may be imported in the framework of the traditional supply need referred to in paragraph 1. The licences may be transferred only between full-time refiners and their validity expires at the end of the marketing year for which they have been issued. This paragraph shall apply for the marketing year 2008/2009, and for the first three months of each of the following marketing years. 4. The application of import duties on cane sugar for refining falling within CN code 1701 11 10 originating in the States referred to in Annex XIX shall be suspended for the complementary quantity which is needed to allow an adequate supply of the full-time refiners for the marketing year 2008/2009. The complementary quantity shall be fixed by the Commission, based on the balance between the traditional supply need referred to in paragraph 1 and the forecast supply of sugar for refining for the marketing year concerned. This balance may be revised by the Commission during the marketing year and may be based on historic flat-rate estimates of raw sugar intended for consumption.
Article 154 
Guaranteed price 1. The guaranteed prices fixed for the ACP/Indian sugar shall apply for import of standard quality raw and white sugar from: (a) the least developed countries under the arrangements referred to in Articles 12 and 13 of Council Regulation (EC) No 980/2005 ( 82 ); (b) the States listed in Annex XIX for the complementary quantity referred to in Article 153(4). 2. Applications for import licences for sugar benefiting from a guaranteed price shall be accompanied by an export licence issued by the authorities of the exporting country certifying the compliance of the sugar with the rules provided for in the agreements concerned.
Article 155 
Sugar Protocol commitments The Commission may adopt measures to ensure that the ACP/Indian sugar is imported into the Community under the conditions set out in Protocol 3 to Annex V to the ACP-EC Partnership Agreement and the Agreement on cane sugar between the European Community and the Republic of India. Those measures may, if necessary, derogate from Article 153 of this Regulation.
Article 156 
Implementing rules Detailed rules for the application of this Subsection shall be adopted by the Commission, in particular to comply with international agreements. They may include amendments to Annex XIX. Subsection III Special provisions for imports of hemp
Article 157 
Imports of hemp 1. The following products may be imported into the Community only if the following conditions are met: (a) raw true hemp falling within CN code 5302 10 00 meeting the conditions laid down in Article 52 of Regulation (EC) No 1782/2003; (b) seeds of varieties of hemp falling within CN code ex120799 15 for sowing accompanied by proof that the tetrahydrocannabinol level does not exceed that fixed in accordance with Article 52 of Regulation (EC) No 1782/2003; (c) hemp seeds other than for sowing, falling within CN code 1207 99 91 imported only by importers authorised by the Member State in order to ensure that such seeds are not intended for sowing. 2. Without prejudice to any specific provisions which may be adopted by the Commission in accordance with Article 194, imports into the Community of the products specified in paragraph 1(a) and (b) of this Article shall be subject to checks to determine whether the conditions provided for in paragraph 1 of this Article are met. 3. This Article shall apply without prejudice to more restrictive provisions adopted by Member States in compliance with the Treaty and the obligations arising under the WTO Agreement on Agriculture. Subsection IV Special provisions for imports of hops
Article 158 
Imports of hops 1. Products of the hops sector may be imported from third countries only if their quality standards are at least equivalent to those adopted for like products harvested within the Community or made from such products. 2. Products shall be considered as being of the standard referred to in paragraph 1 if they are accompanied by an attestation issued by the authorities of the country of origin and recognised as equivalent to the certificate referred to in Article 117. In the case of hop powder, hop powder with higher lupulin content, extract of hops and mixed hop products, the attestation may be recognised as being equivalent to the certificate only if the alpha acid content of these products is not lower than that of the hops from which they have been prepared. The equivalence of those attestations shall be verified in accordance with detailed rules adopted by the Commission. Subsection V Special provisions for imports of wine
Article 158a Special import requirements for wine
1. Save as otherwise provided for, in particular in agreements concluded pursuant to Article 300 of the Treaty, the provisions concerning designations of origin and geographical indications and labelling set out in Subsection I of Section Ia of Chapter I of Title II of Part II, as well as Article 113d(1) of this Regulation shall apply to products falling under CN codes 2009 61, 2009 69 and 2204 which are imported into the Community. 2. Save as otherwise provided for in agreements concluded pursuant to Article 300 of the Treaty, products referred to in paragraph 1 of this Article shall be produced in accordance with oenological practices recommended and published by the OIV or authorised by the Community pursuant to this Regulation and its implementing measures. 3. The importation of the products referred to in paragraph 1 shall be subject to the presentation of: (a) a certificate evincing compliance with the provisions referred to in paragraphs 1 and 2, to be drawn up by a competent body, included on a list to be made public by the Commission, in the product’s country of origin; (b) an analysis report drawn up by a body or department designated by the product’s country of origin, in so far as the product is intended for direct human consumption. 4. Detailed rules for the application of this Article shall be adopted by the Commission.
Article 159 
Safeguard measures 1. Safeguard measures against imports into the Community shall be taken by the Commission, subject to paragraph 3 of this Article, in accordance with Council Regulations (EC) No 519/94 ( 83 ) and (EC) No 3285/94 ( 84 ). 2. Save as otherwise provided for pursuant to any other act of the Council, safeguard measures against imports into the Community provided for in international agreements concluded in accordance with Article 300 of the Treaty shall be taken by the Commission in accordance with paragraph 3 of this Article. 3. Measures referred to in paragraphs 1 and 2 may be taken by the Commission, without the assistance of the Committee referred to in Article 195(1), at the request of a Member State or on its own initiative. If the Commission receives a request from a Member State, it shall take a decision thereon within five working days following receipt of the request. The Member States shall be notified of such measures, which shall be immediately applicable. Decisions taken by the Commission pursuant to paragraphs 1 and 2 may be referred to the Council by any Member State within five working days of the date on which they were notified. The Council shall meet without delay. It may, acting by qualified majority, amend or repeal the decision in question within one month following the date on which it was referred to the Council. 4. Where the Commission considers that any safeguard measure taken in accordance with paragraphs 1 or 2 should be revoked or amended, it shall proceed as follows: (a) where the measure was enacted by the Council, the Commission shall propose to the Council that it be revoked or amended. The Council shall act by a qualified majority; (b) in all other cases, Community safeguard measures shall be revoked or amended by the Commission without the assistance of the Committee referred to in Article 195(1).
Article 160 
Suspension of inward processing arrangements 1. Where the Community market is disturbed or is liable to be disturbed by inward processing arrangements, the Commission may, at the request of a Member State or on its own initiative, fully or partially suspend the use of inward processing arrangements for the products of the cereals, rice, sugar, olive oil and table olives, fruit and vegetables, processed fruit and vegetables, wine, beef and veal, milk and milk products, pigmeat, sheepmeat and goatmeat, eggs, poultrymeat and agricultural ethyl alcohol sectors. If the Commission receives a request from a Member State, it shall take a decision thereon within five working days following receipt of the request. The Member States shall be notified of such measures, which shall be immediately applicable. Measures decided on by the Commission pursuant to the first subparagraph may be referred to the Council by any Member State within five working days of the date on which they were notified. The Council shall meet without delay. It may, acting by qualified majority, amend or repeal the measures in question within one month following the date on which they were referred to the Council. 2. To the extent necessary for the proper functioning of the CMO, the use of inward processing arrangements for the products referred to in paragraph 1 may be fully or partially prohibited by the Council, acting in accordance with the procedure laid down in Article 37(2) of the Treaty.
Article 161 
Export licences 1. Without prejudice to cases where export licences are required in accordance with this Regulation, the Commission may make exports of one or more products of the following sectors from the Community subject to presentation of an export licence: (a) cereals; (b) rice; (c) sugar; (d) olive oil and table olives, with regard to olive oil referred to in point (a) of Part VII of Annex I; (da) fruit and vegetables; (db) processed fruit and vegetables; (dc) wine; (e) beef and veal; (f) milk and milk products; (g) pigmeat; (h) sheepmeat and goatmeat; (i) eggs; (j) poultrymeat; (k) agricultural ethyl alcohol. When applying the first subparagraph, the Commission shall take account of the need for export licences for the management of the markets concerned and, in particular, for monitoring the exports of the products in question. 2. Articles 131 to 133 shall apply mutatis mutandis . 3. The Commission shall adopt detailed rules for the application of paragraphs 1 and 2, including the terms of validity of the licences and the rate of security.
Article 162 
Scope of export refunds 1. To the extent necessary to enable exports on the basis of world market quotations or prices and within the limits resulting from agreements concluded in accordance with Article 300 of the Treaty, the difference between those quotations or prices and prices in the Community may be covered by export refunds for: (a) the products of the following sectors to be exported without further processing: (i) cereals; (ii) rice; (iii) sugar, with regard to the products listed in points (b), (c), (d) and (g) of Part III of Annex I; (iv) beef and veal; (v) milk and milk products; (vi) pigmeat; (vii) eggs; (viii) poultrymeat; (a) the products of the following sectors to be exported without further processing: (i) cereals; (ii) rice; (iii) sugar, with regard to the products listed in points (b), (c), (d) and (g) of Part III of Annex I; (iv) beef and veal; (v) milk and milk products; (vi) pigmeat; (vii) eggs; (viii) poultrymeat; (b) the products listed in point (a)(i), (ii), (iii), (v) and (vii) to be exported in the form of goods listed in Annexes XX and XXI. In the case of the milk and milk products exported in the form of products listed in Part IV of Annex XX, export refunds may only be granted for products listed in points (a) to (e) and (g) of Part XVI of Annex I. 2. Export refunds on products exported in the form of processed goods listed in Annexes XX and XXI may not be higher than those applicable to the same products exported without further processing. 3. Insofar as is necessary to take account of the features of production peculiar to certain spirit drinks obtained from cereals, the criteria for granting export refunds referred to in paragraphs 1 and 2, and the procedure for verification, may be adapted by the Commission to suit this particular situation.
Article 163 
Export refund distribution The quantities which may be exported with an export refund shall be allocated by the method which: (a) is most suited to the nature of the product and the situation on the market in question, allowing the most efficient possible use of the resources available, account being taken of the efficiency and structure of Community exports without creating discrimination between the operators concerned and in particular between large and small operators; (b) is least cumbersome administratively for operators, account being taken of administrative requirements; (c) avoids any discrimination between the operators concerned.
Article 164 
Export refund fixation 1. Export refunds shall be the same for the whole Community. They may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary. 2. Refunds shall be fixed by the Commission. Refunds may be fixed: (a) at regular intervals; (b) by invitation to tender for products in respect of which provision was made for that procedure before the date of application of this Regulation in accordance with Article 204(2). Except where fixed by tender, the list of products on which an export refund is granted and the amount of export refunds shall be fixed at least once every three months. The amount of the refund may, however, remain at the same level for more than three months and may, where necessary, be adjusted in the intervening period by the Commission, without the assistance of the Committee referred to in Article 195(1), either at the request of a Member State or on its own initiative. 3. One or more of the following aspects shall be taken into account when refunds for a certain product are being fixed: (a) the existing situation and the future trend with regard to: — prices and availabilities of that product on the Community market, — prices for that product on the world market. (a) the existing situation and the future trend with regard to: — prices and availabilities of that product on the Community market, — prices for that product on the world market. (b) the aims of the common market organisation which are to ensure equilibrium and the natural development of prices and trade on this market; (c) the need to avoid disturbances likely to cause a prolonged imbalance between supply and demand on the Community market; (d) the economic aspect of the proposed exports; (e) the limits resulting from agreements concluded in accordance with Article 300 of the Treaty; (f) the need to establish a balance between the use of Community basic products in the manufacture of processed goods for export to third countries, and the use of third-country products brought in under processing arrangements; (g) the most favourable marketing costs and transport costs from Community markets to Community ports or other places of export together with forwarding costs to the countries of destination; (h) demand on the Community market; (i) in respect of the pigmeat, eggs and poultrymeat sectors, the difference between prices within the Community and prices on the world market for the quantity of feed grain input required for the production in the Community of the products of those sectors. 4. A corrective amount applicable to the export refunds may be set by the Commission in respect of the cereals and rice sectors. However, where necessary, the Commission, without the assistance of the Committee referred to in Article 195(1), may amend the corrective amounts. The first subparagraph may also be applied to products that are exported in the form of goods listed in Annex XX.
Article 165 
Export refund for malt in storage For the first three months of the marketing year, the refund applicable to exports of malt in storage at the end of the previous marketing year or made from barley in stock at that time shall be that which would have been applied in respect of the export licence in question to exports during the last month of the preceding marketing year.
Article 166 
Export refund adjustment for cereals Unless otherwise provided for by the Commission, the refund on products listed in points (a) and (b) of Part I of Annex I, established in accordance with Article 167(2), shall be adjusted by the Commission in line with the level of the monthly increases applicable to the intervention price and, where appropriate, changes in that price. The first paragraph may be applied, in whole or in part, to products listed in points (c) and (d) of Part I of Annex I as well as to products referred to in Part I of Annex I and exported in the form of goods referred to in Part I of Annex XX. In that case, the adjustment referred to in the first subparagraph shall be corrected by applying to the monthly increase a coefficient expressing the ratio between the quantity of basic product and the quantity thereof contained in the processed product exported or used in the goods exported.
Article 167 
Granting of export refund 1. Refunds on products listed in Article 162(1)(a) exported as such without further processing shall only be granted on application and on presentation of an export licence. 2. The refund applicable to products referred to in paragraph 1 shall be that applicable on the day of application for the licence or, as the case may be, that resulting from the tender procedure concerned and, in the case of a differentiated refund, that applicable on the same day: (a) for the destination indicated on the licence, or (b) where appropriate, for the actual destination if this differs from the destination indicated on the licence, in which case the amount applicable shall not exceed the amount applicable to the destination indicated on the licence. Appropriate measures may be taken by the Commission to prevent abuse of the flexibility provided for in this paragraph. 3. By way of derogation from paragraph 1, the Commission may decide that in the case of eggs for hatching and of day-old chicks export licences may be granted ex post . 4. It may be decided, in accordance with the procedure referred to in Article 16(2) of Council Regulation (EC) No 3448/93 ( 85 ), to apply paragraphs 1 and 2 to the goods referred to in Article 162(1)(b) of this Regulation. 5. Derogations from paragraph 1 and 2 may be granted by the Commission in the case of products on which export refunds are paid under food-aid operations. 6. The refund shall be paid upon submission of proof that: (a) the products have been exported from the Community; (b) in the case of a differentiated refund, the products have reached the destination indicated on the licence or another destination for which a refund was fixed, without prejudice to point (b) of paragraph 2. However, exceptions may be allowed by the Commission provided that conditions are laid down which offer equivalent guarantees. 7. Further conditions for the granting of export refunds may be established by the Commission for one or more products. They may include: (a) that refunds are only paid for products of Community origin; (b) that the amount of refunds for imported products shall be limited to the duties collected on importation where those duties are lower than the refund applicable.
Article 168 
Export refunds for live animals in the beef and veal sector With regard to products of the beef and veal sector, the granting and the payment of the refund for exports of live animals shall be subject to compliance with the provisions established in Community legislation concerning animal welfare and, in particular, the protection of animals during transport.
Article 169 
Export limits Observance of the volume commitments resulting from the agreements concluded in accordance with Article 300 of the Treaty shall be ensured on the basis of export licences issued for the reference periods which apply to the products concerned. With regard to compliance with the obligations arising under the WTO Agreement on Agriculture, the ending of a reference period shall not affect the validity of export licences.
Article 170 
Implementing rules Detailed rules for the application of this Section shall be adopted by the Commission, in particular: (a) on the redistribution of exportable quantities which have not been allocated or utilised; (b) governing the quality and other specific requirements and conditions of the products eligible for an export refund; (c) for monitoring whether operations conferring entitlement to the payment of refunds and all other amounts in respect of export transactions have actually been carried out and executed correctly, including physical checks and document scrutiny. Any necessary amendments to Annex XX shall be made by the Commission taking into account the criteria referred to in the first subparagraph of Article 8(2) of Regulation (EC) No 3448/93. However, the detailed rules for the application of Article 167 for products referred to in Article 162(1)(b) shall be adopted in accordance with the procedure referred to in Article 16(2) of Regulation (EC) No 3448/93.
Article 171 
Management of tariff quotas opened by third countries 1. With regard to milk and milk products, where an agreement concluded in accordance with Article 300 of the Treaty provides for the total or partial management of a tariff quota opened by a third country, the management method to be applied and detailed rules relating to that method shall be adopted by the Commission. 2. The tariff quotas referred to in paragraph 1 shall be administered in a manner which avoids any discrimination between the operators concerned and which guarantees the full use of the possibilities available under the quota concerned, by applying one of the following methods or a combination of them or another appropriate method: (a) a method based on the chronological order of the lodging of applications (‘first come, first served’ principle); (b) a method of distribution in proportion to the quantities requested when the applications were lodged (using the ‘simultaneous examination method’); (c) a method based on taking traditional trade patterns into account (using the ‘traditional/new arrival method’).
Article 172 
Certificates for products benefiting from a special import treatment in a third country 1. When products are exported which may, in accordance with agreements concluded by the Community in accordance with Article 300 of the Treaty, benefit from a special treatment on importation into a third country if certain conditions are respected, the competent authorities of the Member States shall, on request and after appropriate checks, issue a document certifying that the conditions are met. 2. Detailed rules for the application of this Article shall be adopted by the Commission.
Article 173 
Minimum export prices 1. For each of the products of the live plants sector falling within CN code 0601 10, one or more minimum prices for exports to third countries may be fixed by the Commission each year in good time before the marketing season. Exportation of such products shall be permitted only at a price equal to or above the minimum price fixed for the product in question. 2. Detailed rules for the application of paragraph 1 shall be adopted by the Commission having regard to the obligations arising from agreements concluded in accordance with Article 300(2) of the Treaty.
Article 174 
Suspension of outward processing arrangements 1. Where the Community market is disturbed or is liable to be disturbed by outward processing arrangements, the Commission may, at the request of a Member State or on its own initiative, fully or partially suspend the use of outward processing arrangements for the products of the cereals, rice, fruit and vegetables, processed fruit and vegetables, wine, beef and veal, pigmeat, sheepmeat and goatmeat and poultrymeat sectors. If the Commission receives a request from a Member State, it shall take a decision thereon within five working days following receipt of the request. The Member States shall be notified of such measures, which shall be immediately applicable. Measures decided on by the Commission pursuant to the first subparagraph may be referred to the Council by any Member State within five working days of the date on which they were notified. The Council shall meet without delay. It may, acting by qualified majority, amend or repeal the measures in question within one month following the date on which they were referred to the Council. 2. To the extent necessary for the proper functioning of the CMO, the use of outward processing arrangements for the products referred to in paragraph 1 may be fully or partially prohibited by the Council, acting in accordance with the procedure laid down in Article 37(2) of the Treaty.
Article 175 Application of Articles 81 to 86 of the Treaty
Save as otherwise provided for in this Regulation, Articles 81 to 86 of the Treaty and implementation provisions thereof shall, subject to Articles 176 to 177 of this Regulation, apply to all agreements, decisions and practices referred to in Articles 81(1) and 82 of the Treaty which relate to the production of, or trade in, the products covered by this Regulation.
Article 176 
Exceptions 1. Article 81(1) of the Treaty shall not apply to the agreements, decisions and practices referred to in Article 175 of this Regulation which are an integral part of a national market organisation or are necessary for the attainment of the objectives set out in Article 33 of the Treaty. In particular, Article 81(1) of the Treaty shall not apply to agreements, decisions and practices of farmers, farmers' associations, or associations of such associations belonging to a single Member State which concern the production or sale of agricultural products or the use of joint facilities for the storage, treatment or processing of agricultural products, and under which there is no obligation to charge identical prices, unless the Commission finds that competition is thereby excluded or that the objectives of Article 33 of the Treaty are jeopardised. 2. After consulting the Member States and hearing the undertakings or associations of undertakings concerned and any other natural or legal person that it considers appropriate, the Commission shall have sole power, subject to review by the Court of Justice, to determine, by a decision which shall be published, which agreements, decisions and practices fulfil the conditions specified in paragraph 1. The Commission shall undertake such determination either on its own initiative or at the request of a competent authority of a Member State or of an interested undertaking or association of undertakings. 3. The publication of the decision referred to in the first subparagraph of paragraph 2 shall state the names of the parties and the main content of the decision. It shall have regard to the legitimate interest of undertakings in the protection of their business secrets.
Article 176a Agreements and concerted practices in the fruit and vegetables sector
1. Article 81(1) of the Treaty shall not apply to the agreements, decisions and concerted practices of recognised interbranch organisations with the object of carrying out the activities referred to in Article 123(3)(c) of this Regulation. 2. Paragraph 1 shall apply only provided that: (a) the agreements, decisions and concerted practices have been notified to the Commission; (b) within two months of receipt of all the details required the Commission has not found that the agreements, decisions or concerted practices are incompatible with Community rules. 3. The agreements, decisions and concerted practices may not be put into effect before the lapse of the period referred to in paragraph 2(b). 4. The following agreements, decisions and concerted practices shall in any case be declared incompatible with Community rules: (a) agreements, decisions and concerted practices which may lead to the partitioning of markets in any form within the Community; (b) agreements, decisions and concerted practices which may affect the sound operation of the market organisation; (c) agreements, decisions and concerted practices which may create distortions of competition which are not essential to achieving the objectives of the common agricultural policy pursued by the interbranch organisation activity; (d) agreements, decisions and concerted practices which entail the fixing of prices, without prejudice to activities carried out by interbranch organisations in the application of specific Community rules; (e) agreements, decisions and concerted practices which may create discrimination or eliminate competition in respect of a substantial proportion of the products in question. 5. If, following expiry of the two-month period referred to in paragraph 2(b), the Commission finds that the conditions for applying paragraph 1 have not been met, it shall take a Decision declaring that Article 81(1) of the Treaty applies to the agreement, decision or concerted practice in question. That Commission Decision shall not apply earlier than the date of its notification to the interbranch organisation concerned, unless that interbranch organisation has given incorrect information or abused the exemption provided for in paragraph 1. 6. In the case of multiannual agreements, the notification for the first year shall be valid for the subsequent years of the agreement. However, in that event, the Commission may, on its own initiative or at the request of another Member State, issue a finding of incompatibility at any time.
Article 177 
Agreements and concerted practices in the tobacco sector 1. Article 81(1) of the Treaty shall not apply to the agreements and concerted practices of recognised interbranch organisations in the tobacco sector, intended to implement the aims referred to in Article 123(c) of this Regulation provided that: (a) the agreements and concerted practices have been notified to the Commission; (b) the Commission, acting within three months of receipt of all the details required, has not found that those agreements or concerted practices are incompatible with Community competition rules. The agreements and concerted practices may not be implemented during that three-month period. 2. Agreements and concerted practices shall be declared contrary to Community competition rules in the following cases where: (a) they may lead to the partitioning of markets in any form within the Community; (b) they may affect the sound operation of the market organisation; (c) they may create distortions of competition which are not essential to achieving the objectives of the common agricultural policy pursued by the interbranch organisation measure; (d) they entail the fixing of prices or quotas, without prejudice to measures taken by interbranch organisations in the application of specific provisions of Community rules; (e) they may create discrimination or eliminate competition in respect of a substantial proportion of the products in question. 3. If, following expiry of the three-month period referred to in point (b) of paragraph 1, the Commission finds that the conditions for applying this Chapter have not been met, it shall without the assistance of the Committee referred to in Article 195(1), take a decision declaring that Article 81(1) of the Treaty applies to the agreement or concerted practice in question. That decision shall not apply earlier than the date of notification to the interbranch organisation concerned, unless that interbranch organisation has given incorrect information or misused the exemption provided for in paragraph 1.
Article 178 
Binding effect of agreements and concerted practices on non-members in the tobacco sector 1. Interbranch organisations in the tobacco sector may request that certain of their agreements or concerted practices be made binding for a limited period on individuals and groups in the economic sector concerned which are not members of the trade branches which they represent, in the areas in which the branches operate. In order for their rules to be extended, interbranch organisations shall represent at least two thirds of the production and/or the trade concerned. Where the proposed extension of the rules is of inter-regional scope, the interbranch organisations shall prove they possess a minimum degree of representativeness, in respect of each of the grouped branches, in each region covered. 2. The rules for which an extension of scope is requested shall have been in force for at least one year and shall relate to one of the following objectives: (a) knowledge of production and the market; (b) definition of minimum qualities; (c) use of cultivation methods compatible with the protection of the environment; (d) definition of minimum standards of packing and presentation; (e) use of certified seed and monitoring of product quality. 3. Extension of the rules shall be subject to approval by the Commission.
Article 179 Implementing rules in respect of agreements and concerted practices in the fruit and vegetables and tobacco sectors
The Commission may adopt the detailed rules for the application of Articles 176a, 177 and 178, including the rules concerning notification and publication.
Article 180 Application of Articles 87, 88 and 89 of the Treaty
Articles 87, 88 and 89 of the Treaty shall apply to the production of, and trade in, the products referred to in Article 1. However, Articles 87, 88 and 89 of the Treaty shall not apply to payments made under Articles 44 to 48, 102, 102a, 103, 103a, 103b, 103e, 103ga, 104, 105, 182 and 182a, Subsection III of Section IVa of Chapter III of Title I of Part II and Section IVb of Chapter IV of Title I of Part II of this Regulation by Member States in conformity with this Regulation. Nevertheless, with regard to Article 103n(4) only Article 88 of the Treaty shall not apply.
Article 181 
Specific provisions for the milk and milk products sector Subject to Article 87(2) of the Treaty, aids the amount of which is fixed on the basis of the price or quantity of products listed in Part XVI of Annex I of this Regulation shall be prohibited. National measures permitting equalisation between the prices of products listed in Part XVI of Annex I of this Regulation shall also be prohibited.
Article 182 
Specific national provisions 1. Subject to Commission authorisation, aids for the production and marketing of reindeer and reindeer products (CN ex02 08 and ex02 10) may be granted by Finland and Sweden insofar as they do not entail any increase in traditional levels of production. 2. Subject to Commission authorisation, Finland may grant aid for certain quantities of seeds, with the exception of Timothy seeds ( Phleum pratense L.), and for certain quantities of cereal seed produced solely in Finland up to and including the 2010 harvest. By 31 December 2008, Finland shall transmit to the Commission a detailed report on the results of the aid authorised. 3. Member States which reduce their sugar quota by more than 50 % of the sugar quota fixed on 20 February 2006 in Annex III to Regulation (EC) No 318/2006 may grant temporary State aid during the period for which the transitional aid for beet growers is being paid in accordance with Chapter 10f of Title IV of Regulation (EC) No 1782/2003. The Commission shall, on the basis of an application by any Member State concerned, decide on the total amount of the State aid available for this measure. For Italy, the temporary aid referred to in the first subparagraph shall not exceed a total of EUR 11 per marketing year per tonne of sugar beet to be granted to sugar beet growers and for the transport of sugar beet. Finland may grant aid up to EUR 350 per hectare per marketing year to sugar beet growers. The Member States concerned shall inform the Commission within 30 days of the end of each marketing year of the amount of State aid actually granted in that marketing year. 4. Without prejudice to the application of Article 88(1) and of the first sentence of Article 88(3) of the Treaty, until 31 December 2010, Germany may grant aid in the framework of the German Alcohol Monopoly for products marketed, after further transformation, by the Monopoly, as ethyl alcohol of agricultural origin listed in Annex I to the Treaty. The total amount of this aid shall not exceed EUR 110 million per year. Germany shall present before 30 June each year, a report to the Commission on the functioning of the system. 5. Member States may continue to pay state aids under any existing schemes in respect of the production of and trade in potatoes, fresh or chilled, of CN code 0701 until 31 December 2011. 6. With regard to the fruit and vegetables sector, Member States may pay a state aid until 31 December 2010 under the following conditions: (a) the state aid is paid only to producers of fruit and vegetables who are not members of a recognised producer organisation and who sign a contract with a recognised producer organisation in which they accept that they shall apply the crisis prevention and management measures of the producer organisation concerned; (b) the amount of aid paid to such producers is no more than 75 % of the Community support received by the members of the producer organisation concerned; and (c) the Member State concerned presents a report to the Commission by 31 December 2010 on the effectiveness and efficiency of the state aid, in particular analysing how much it has supported the organisation of the sector. The Commission will examine the report and decide whether to make any appropriate proposals. 7. Member States may grant until 31 March 2014 state aid of a total annual amount of up to 55 % of the ceiling set out in Article 69(4) and (5) of Regulation (EC) No 73/2009 to farmers in the dairy sector in addition to Community support granted in accordance with Article 68(1)(b) of that Regulation. However, in no case shall the total amount of Community support under the measures referred to in Article 69(4) of that Regulation and State aid exceed the ceiling referred to in Article 69(4) and (5).
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 182 ):
Specific national provisions 1. Subject to Commission authorisation, aids for the production and marketing of reindeer and reindeer products (CN ex02 08 and ex02 10) may be granted by Finland and Sweden insofar as they do not entail any increase in traditional levels of production. 2. Subject to Commission authorisation, Finland may grant aid for certain quantities of seeds, with the exception of Timothy seeds ( Phleum pratense L.), and for certain quantities of cereal seed produced solely in Finland up to and including the 2010 harvest. By 31 December 2008, Finland shall transmit to the Commission a detailed report on the results of the aid authorised. 3. Member States which reduce their sugar quota by more than 50 % of the sugar quota fixed on 20 February 2006 in Annex III to Regulation (EC) No 318/2006 may grant temporary State aid during the period for which the transitional aid for beet growers is being paid in accordance with Chapter 10f of Title IV of Regulation (EC) No 1782/2003. The Commission shall, on the basis of an application by any Member State concerned, decide on the total amount of the State aid available for this measure. For Italy, the temporary aid referred to in the first subparagraph shall not exceed a total of EUR 11 per marketing year per tonne of sugar beet to be granted to sugar beet growers and for the transport of sugar beet. Finland may grant aid up to EUR 350 per hectare per marketing year to sugar beet growers. The Member States concerned shall inform the Commission within 30 days of the end of each marketing year of the amount of State aid actually granted in that marketing year. 4. The derogation contained in the second paragraph of Article 180 of this Regulation shall apply to aid payments granted by Germany in the existing national framework of the German Alcohol Monopoly (‘the Monopoly’) for products marketed after further transformation by the Monopoly as ethyl alcohol of agricultural origin listed in Annex I to the Treaty on the Functioning of the European Union (TFEU). That derogation shall operate only until 31 December 2017, shall be without prejudice to the application of Article 108(1) and the first sentence of Article 108(3) TFEU and shall be conditional upon compliance with the following provisions: (a) the total production of ethyl alcohol under the Monopoly benefiting from the aid shall gradually decrease from the maximum of 600 000 hl in 2011 to 420 000 hl in 2012 and to 240 000 hl in 2013 and may amount to a maximum of 60 000 hl per year from 1 January 2014 until 31 December 2017, on which date the Monopoly shall cease to exist; (b) the production by agricultural bonded distilleries benefiting from the aid shall gradually decrease from 540 000 hl in 2011 to 360 000 hl in 2012 and to 180 000 hl in 2013. By 31 December 2013, all agricultural bonded distilleries shall leave the Monopoly. Upon leaving the Monopoly, each agricultural bonded distillery shall be allowed to receive a compensatory aid of EUR 257,50 per hl of nominal distilling rights within the meaning of the applicable German legislation. This compensatory aid may be granted no later than 31 December 2013. It may, however, be paid in several instalments, of which the last shall be no later than 31 December 2017; (c) the small-scale flat-rate distilleries, distillery users and fruit cooperative distilleries may benefit from the aid granted by the Monopoly until 31 December 2017, on condition that the production benefiting from the aid does not exceed 60 000 hl per year; (d) the total amount of aid paid from 1 January 2011 to 31 December 2013 shall not exceed EUR 269,9 million and the total amount of aid paid from 1 January 2014 to 31 December 2017 shall not exceed EUR 268 million; and (e) before 30 June each year, Germany shall submit a report to the Commission on the functioning of the Monopoly and the aid granted in the framework thereof in the previous year. The Commission shall forward that report to the European Parliament and the Council. Moreover, the annual reports to be submitted in the years 2013 to 2016 shall include an annual phasing-out plan for the following year concerning the small-scale flat-rate distilleries, distillery users and fruit cooperative distilleries. 5. Member States may continue to pay state aids under any existing schemes in respect of the production of and trade in potatoes, fresh or chilled, of CN code 0701 until 31 December 2011. 6. With regard to the fruit and vegetables sector, Member States may pay a state aid until 31 December 2010 under the following conditions: (a) the state aid is paid only to producers of fruit and vegetables who are not members of a recognised producer organisation and who sign a contract with a recognised producer organisation in which they accept that they shall apply the crisis prevention and management measures of the producer organisation concerned; (b) the amount of aid paid to such producers is no more than 75 % of the Community support received by the members of the producer organisation concerned; and (c) the Member State concerned presents a report to the Commission by 31 December 2010 on the effectiveness and efficiency of the state aid, in particular analysing how much it has supported the organisation of the sector. The Commission will examine the report and decide whether to make any appropriate proposals. 7. Member States may grant until 31 March 2014 state aid of a total annual amount of up to 55 % of the ceiling set out in Article 69(4) and (5) of Regulation (EC) No 73/2009 to farmers in the dairy sector in addition to Community support granted in accordance with Article 68(1)(b) of that Regulation. However, in no case shall the total amount of Community support under the measures referred to in Article 69(4) of that Regulation and State aid exceed the ceiling referred to in Article 69(4) and (5).
Article 182a National aid for distillation of wine in cases of crisis
1. From 1 August 2012, Member States may grant national aid to wine producers for the voluntary or mandatory distillation of wine in justified cases of crisis. 2. The aid referred to in paragraph 1 shall be proportionate and allow this crisis to be addressed. 3. The overall amount of aid available in a Member State in any given year for such aid shall not exceed 15 % of the globally available funds per Member State laid down in Annex Xb for that year. 4. Member States which wish to make use of the aid referred to in paragraph 1 shall submit a duly substantiated notification to the Commission. The Commission shall decide whether the measure is approved and aid may be granted. 5. The alcohol resulting from distillation referred to in paragraph 1 shall be used exclusively for industrial or energy purposes so as to avoid distortion of competition. 6. Detailed rules for the application of this Article may be adopted by the Commission.
Article 183 
Promotional levy in the milk and milk products sector Without prejudice to the application of Articles 87, 88 and 89 of the Treaty as provided for in Article 180 of this Regulation, a Member State may impose a promotional levy on its milk producers in respect of marketed quantities of milk or milk equivalent in order to finance the measures on promoting consumption in the Community, expanding the markets for milk and milk products and improving quality.
Article 184 
Reporting in respect of certain sectors The Commission shall present a report: 1) to the Council before 30 September 2008 on the dried fodder sector, on the basis of an evaluation of the provisions contained in this Regulation, dealing in particular with the development of areas of leguminous and other green fodder, the production of dried fodder and the savings of fossil fuels achieved. The report shall be accompanied, if necessary, by appropriate proposals; 2) every three years and for the first time by 31 December 2010 to the European Parliament and the Council on the implementation of the measures concerning the apiculture sector set out in Section VI of Chapter IV of Title I of Part II; 3) before 31 December 2009 to the European Parliament and the Council on the application of the derogation provided for in Article 182(4) in respect of the German Alcohol Monopoly, including an evaluation of the aids granted in the framework of that Monopoly, together with any appropriate proposals; 4) to the European Parliament and the Council by 31 December 2013 on the implementation of the provisions set out in Section IVa of Chapter IV of Title I of Part II and Chapter II of Title II of Part II as regards producer organisations, operational funds and operational programmes in the fruit and vegetables sector; 5) before 31 August 2012 to the European Parliament and the Council on the application of the School Fruit Scheme provided for in Article 103ga, accompanied, if necessary, by appropriate proposals. The report shall in particular address the issues of the extent to which the scheme has promoted the establishment of well functioning School Fruit Schemes in Member States and the impact of the Scheme on the improvement of children’s eating habits; 6) before 31 December 2010 and 31 December 2012 to the European Parliament and Council regarding the evolution of the market situation and the consequent conditions for smoothly phasing out the milk quota system, accompanied if necessary by appropriate proposals. Furthermore, a report will study the consequences for producers of cheeses with a protected designation of origin in accordance with Regulation (EC) No 510/2006; 7) to the European Parliament and the Council by 31 December 2011 on the implementation of the promotion measures in the wine sector referred to in Article 103p; 8) by the end of 2012 concerning the wine sector, in particular taking into account the experience gained with the implementation of the reform.
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 184 ):
Reporting in respect of certain sectors The Commission shall present a report: 1) to the Council before 30 September 2008 on the dried fodder sector, on the basis of an evaluation of the provisions contained in this Regulation, dealing in particular with the development of areas of leguminous and other green fodder, the production of dried fodder and the savings of fossil fuels achieved. The report shall be accompanied, if necessary, by appropriate proposals; 2) every three years and for the first time by 31 December 2010 to the European Parliament and the Council on the implementation of the measures concerning the apiculture sector set out in Section VI of Chapter IV of Title I of Part II; 3) before 31 December 2009 to the European Parliament and the Council on the application of the derogation provided for in Article 182(4) in respect of the German Alcohol Monopoly, including an evaluation of the aids granted in the framework of that Monopoly, together with any appropriate proposals; 4) to the European Parliament and the Council by 31 December 2013 on the implementation of the provisions set out in Section IVa of Chapter IV of Title I of Part II and Chapter II of Title II of Part II as regards producer organisations, operational funds and operational programmes in the fruit and vegetables sector; 5) before 31 August 2012 to the European Parliament and the Council on the application of the School Fruit Scheme provided for in Article 103ga, accompanied, if necessary, by appropriate proposals. The report shall in particular address the issues of the extent to which the scheme has promoted the establishment of well functioning School Fruit Schemes in Member States and the impact of the Scheme on the improvement of children’s eating habits; 6) before 31 December 2010 and 31 December 2012 to the European Parliament and Council regarding the evolution of the market situation and the consequent conditions for smoothly phasing out the milk quota system, accompanied, if necessary, by appropriate proposals; 7) to the European Parliament and the Council by 31 December 2011 on the implementation of the promotion measures in the wine sector referred to in Article 103p; 8) by the end of 2012 concerning the wine sector, in particular taking into account the experience gained with the implementation of the reform; 9) by 30 June 2014 and by 31 December 2018 to the European Parliament and the Council regarding the development of the market situation in the milk and milk products sector and in particular on the operation of point (iiia) of point (a) of the first paragraph of Article 122, of Article 123(4) and of Articles 126c, 126d, 177a, 185e and 185f, assessing, in particular, the effects on milk producers and milk production in disadvantaged regions in connection with the general objective of maintaining production in such regions, and covering potential incentives to encourage farmers to enter into joint production agreements together with any appropriate proposals.
Article 185 
Registration of contracts in the hops sector 1. Any contract to supply hops produced within the Community concluded between a producer or producer organisation on the one hand and a buyer on the other shall be registered by the bodies designated for that purpose by each producer Member State concerned. 2. Contracts relating to the supply of specific quantities at agreed prices for a period covering one or more harvests and concluded before 1 August of the year of the first harvest concerned shall be known as ‘contracts concluded in advance’. They shall be registered separately. 3. The data on which registration is based may be used only for the purposes of this Regulation. 4. The Commission shall lay down the detailed rules concerning the registration of contracts to supply hops.
Article 185a Vineyard register and inventory
1. Member States shall maintain a vineyard register which contains updated information on the production potential. 2. Member States in which the total area planted with vines of wine grape varieties classifiable according to Article 120a(2) is less than 500 hectares shall not be subject to the obligation laid down in paragraph 1. 3. Member States, which provide for the measure ‘restructuring and conversion of vineyards’ in their support programmes in accordance with Article 103q, shall, on the basis of the vineyard register, submit to the Commission by 1 March each year an updated inventory of their production potential. 4. Detailed rules concerning the vineyard register and the inventory shall be adopted by the Commission, in particular with regard to their use concerning monitoring and control of the production potential and concerning the measurement of areas. Any time after 1 January 2016, the Commission may decide that paragraphs 1 to 3 no longer apply.
Article 185b Compulsory declarations in the wine sector
1. Producers of grapes for wine making and producers of must and wine shall declare to the competent national authorities each year the quantities produced from the last harvest. 2. Member States may require merchants of grapes for wine making to declare each year the quantities marketed from the last harvest. 3. Producers of must and wine, and merchants other than retailers, shall declare to the competent national authorities each year their stocks of must and wine, whether from the harvest of the current year or from the harvest of preceding years. Must and wine imported from third countries shall be stated separately. 4. Detailed rules for the application of this Article may be adopted by the Commission and may, in particular, include rules on penalties to be applied in case of non-compliance with the communication requirements.
Article 185c Accompanying documents and register in the wine sector
1. The products of the wine sector shall be put into circulation within the Community only with an officially authorised accompanying document. 2. Natural or legal persons or groups of persons who hold products covered by the wine sector in the exercise of their trade, in particular producers, bottlers and processors, as well as merchants to be determined by the Commission, shall keep inwards and outwards registers in respect of those products. 3. Detailed rules for the application of this Article may be adopted by the Commission.
Article 185d Designation of responsible national authorities for the wine sector
1. Without prejudice to any other provisions of this Regulation concerning the determination of competent national authorities, Member States shall designate one or more authorities which shall be responsible for ensuring compliance with Community rules in the wine sector. In particular, Member States shall designate the laboratories authorised to carry out official analyses in the wine sector. The designated laboratories shall meet the general criteria for the operation of testing laboratories set out in ISO/IEC 17025. 2. Member States shall inform the Commission of the names and addresses of the authorities and laboratories referred to in paragraph 1. The Commission, without the assistance of the Committee referred to in Article 195(1), shall make this information public.
Article 186 
Disturbances as regards internal market prices The Commission may take the necessary measures in the case of the following situations, when those situations are likely to continue, thereby disturbing or threatening to disturb the markets: (a) with regard to the products of the sugar, hops, beef and veal, milk and milk products, sheepmeat and goatmeat sectors, where the prices on the Community market for any of those products rise or fall significantly; (b) with regard to the products of the pigmeat, eggs and poultrymeat sectors and, with regard to olive oil, where the prices on the Community market for any of those products rise significantly.
Article 187 
Disturbances caused by quotations or prices on the world market Where, with regard to the products of the cereals, rice, sugar and milk and milk products sectors, the quotations or prices on the world market of one or more products reach a level that disrupts or threatens to disrupt the availability of supply on the Community market and where that situation is likely to continue or to deteriorate, the Commission may take the necessary measures for the sector concerned. It may in particular suspend import duties in whole or in part for certain quantities.
Article 188 
Conditions for measures to be applied in cases of disturbances and implementing rules 1. The measures provided for in Articles 186 and 187 may be adopted: (a) provided that any other measures available under this Regulation appear insufficient; (b) having regard to the obligations arising from agreements concluded in accordance with Article 300(2) of the Treaty. 2. Detailed rules for the application of Articles 186 and 187 may be adopted by the Commission.
Article 188a Reporting and evaluation in the wine sector
1. As concerns unlawful plantings planted after 31 August 1998, referred to in Article 85a, Member States shall communicate to the Commission by 1 March each year the areas which were planted with vines without a corresponding planting right after 31 August 1998, as well as the areas grubbed up in accordance with paragraph 1 of that Article. 2. As concerns the obligatory regularisation of unlawful plantings planted before 1 September 1998 referred to in Article 85b, Member States shall communicate to the Commission by 1 March of each of the relevant years: (a) the areas planted with vines without a corresponding planting right before 1 September 1998; (b) the areas regularised in accordance with paragraph 1 of that Article, the fees as provided for in that paragraph as well as the average value of the regional planting rights as provided for in paragraph 2 of that Article. Member States shall, for the first time by 1 March 2010, communicate to the Commission the areas grubbed up in accordance with the first subparagraph of Article 85b(4). The end of the transitional ban on new plantings on 31 December 2015 as provided for in Article 85g(1), shall not affect the obligations provided for in this paragraph. 3. As concerns aid applications in the context of the grubbing-up scheme set up in Subsection III of Section IVa of Chapter III of Title I of Part II, Member States shall notify the Commission by 1 March each year of the applications accepted, split by regions and by yield ranges, and the total amount of grubbing-up premiums paid by region. For the preceding wine year, Member States shall notify the Commission by 1 December each year of: (a) the areas grubbed up, split by regions and by yield ranges; (b) the total amount of grubbing-up premiums paid by region. 4. As concerns exemptions from the eligibility for the participation in the grubbing-up scheme in accordance with Article 85u, Member States deciding to make use of the possibility provided for in paragraphs 4 to 6 of that Article shall communicate to the Commission by 1 August each year, concerning the grubbing-up measure to be implemented: (a) the areas declared ineligible; (b) the justification for ineligibility in accordance with Article 85u(4) and (5). 5. Member States shall submit to the Commission by 1 March each year, and for the first time by 1 March 2010, a report on the implementation of the measures provided for in their support programmes referred to in Section IVb of Chapter IV of Title I of Part II during the previous financial year. Those reports shall list and describe the measures for which Community assistance under the support programmes was granted and shall, in particular, provide details on the implementation of the promotion measures referred to in Article 103p. 6. Member States shall, by 1 March 2011 and, a second time, by 1 March 2014, submit to the Commission an evaluation of the costs and benefits of the support programmes as well as an indication of how to increase their efficiency. 7. Detailed rules for the application of this Article shall be adopted by the Commission.
Article 189 
Communications in the ethyl alcohol sector 1. As regards the products of the ethyl alcohol sector, the Member States shall communicate to the Commission the following information: (a) the production of ethyl alcohol of agricultural origin expressed as hectolitres of pure alcohol, broken down by alcohol-producing product used; (b) the volume of ethyl alcohol of agricultural origin disposed of, expressed as hectolitres of pure alcohol, broken down by sector of destination; (c) the stocks of ethyl alcohol of agricultural origin available in the Member State at the end of the previous year; (d) forecast production for the current year. Rules for communicating this information and, in particular, the frequency of communication and the definition of the sectors of destination shall be adopted by the Commission. 2. On the basis of the information referred to in paragraph 1 and of any other information available, the Commission without the assistance of the Committee referred to in Article 195(1), shall draw up a Community balance for the market in ethyl alcohol of agricultural origin for the previous year and an estimated balance for the current year. The Community balance shall also contain information on ethyl alcohol of non-agricultural origin. The precise content and means of collecting such information shall be laid down by the Commission. For the purposes of this paragraph, ‘ethyl alcohol of non-agricultural origin’ shall mean products falling within CN codes 2207, 2208 90 91 and 2208 90 99 not obtained from a specific agricultural product listed in Annex I to the Treaty. 3. The Commission shall notify the Member States of the balances referred to in paragraph 2.
Article 190 
Financial provisions Regulation (EC) No 1290/2005 and the provisions adopted for the implementation thereof shall apply to the expenditure incurred by the Member States in carrying out obligations under this Regulation.
Article 190a Transfer of amounts available in the wine sector to rural development
1. The amounts fixed in paragraph 2, based on historical expenditure under Regulation (EC) No 1493/1999 for intervention measures to regulate agricultural markets as referred to in Article 3(1)(b) of Regulation (EC) No 1290/2005, shall be available as additional Community funds for measures in wine-producing regions under the rural development programming financed under Regulation (EC) No 1698/2005. 2. The following amounts shall be available in the given calendar years: — 2009: EUR 40 660 000, — 2010: EUR 82 110 000, — from 2011 onwards: EUR 122 610 000. 3. The amounts set in paragraph 2 shall be allocated among Member States in accordance with Annex Xc.
Article 191 
Emergency The Commission shall adopt the measures which are both necessary and justifiable in an emergency, in order to resolve specific practical problems. Such measures may derogate from provisions of this Regulation, but only to the extent that, and for such a period, as is strictly necessary.
Article 192 
Exchange of information between the Member States and the Commission 1. Member States and the Commission shall provide each other with any information necessary for the application of this Regulation or for market monitoring and analysis and for complying with the international obligations concerning the products referred to in Article 1. 2. The Commission shall adopt detailed rules to determine what information is necessary for the application of paragraph 1, as well as those on its form, content, timing and deadlines and on arrangements for transmitting or making available information and documents.
Article 193 
Circumvention clause Without prejudice to any specific provisions, no advantage provided for under this Regulation shall be granted in favour of a natural or legal person in respect of whom it is established that the conditions required for obtaining such advantages were created artificially, contrary to the objectives of this Regulation.
Article 194 
Controls and administrative measures and administrative penalties and their reporting The Commission shall determine: (a) the rules concerning administrative and physical controls to be conducted by the Member States with regard to the respect of obligations resulting from the application of this Regulation; (b) a system for the application of administrative measures and administrative penalties where non-compliance with any of the obligations resulting from the application of this Regulation is found; (c) the rules regarding the recovery of undue payments resulting from the application of this Regulation; (d) the rules on the reporting of the controls carried out and their results. The administrative penalties referred to in point (b) shall be graduated according to the severity, extent, permanence and repetition of the non-compliance found. The Commission may also determine the rules on the measurement of areas in the wine sector ensuring uniform application of Community provisions as laid down in this Regulation. Such rules may, in particular, relate to controls and rules governing the specific financial procedures for the improvement of controls.
Article 194a Compatibility with the integrated administration and control system
For the purposes of applying this Regulation in the wine sector, Member States shall ensure that the administration and control procedures, referred to in the first and the third paragraph of Article 194, which relate to areas, are compatible with the integrated administration control system (IACS) as regards the following elements: (a) the computerised database; (b) the identification systems for agricultural parcels referred to in Article 20(1) of Regulation (EC) No 1782/2003; (c) the administrative checks. The procedures shall allow, without any problems or conflicts, a common functioning or the exchange of data with the IACS.
Article 195 
Committee 1. The Commission shall be assisted by the Management Committee for the Common Organisation of Agricultural Markets (hereinafter referred to as the Management Committee). 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 3. The Commission shall also be assisted by a Regulatory Committee. 4. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 196 Organisation of the Management Committee
The organisation of the meetings of the Management Committee referred to in Article 195(1) shall take into account, in particular, the scope of its responsibilities, the specificities of the subject to be dealt with, and the need to involve appropriate expertise.
Article 197 
Amendments to Regulation (EC) No 1493/1999 Articles 74 to 76 of Regulation (EC) No 1493/1999 shall be deleted.
Article 198 
Amendments to Regulation (EC) No 2200/96 Articles 46 and 47 of Regulation (EC) No 2200/96 shall be deleted.
Article 199 
Amendments to Regulation (EC) No 2201/96 Articles 29 and 30 of Regulation (EC) No 2201/96 shall be deleted.
Article 200 
Amendments to Regulation (EC) No 1184/2006 Regulation (EC) No 1184/2006 shall be amended as follows: 1. The title shall be replaced by the following: ‘Council Regulation (EC) No 1184/2006 of 24 July 2006 applying certain rules of competition to the production of and trade in certain agricultural products’; 2. Article 1 shall be replaced by the following: ‘Article 1 This Regulation shall lay down the rules to be applied as regards the applicability of Articles 81 to 86 and certain provisions of Article 88 of the Treaty in relation to production of, or trade in, the products listed in Annex I to the Treaty with the exception of the products referred to in points (a) to (h), point (k) and points (m) to (u) of Article 1(1) and in Article 1(3) of Council Regulation (EC) No 1234/2007 ( 86 ). Article 1a Articles 81 to 86 of the Treaty and provisions made for their implementation shall, subject to Article 2 of this Regulation, apply to all agreements, decisions and practices referred to in Articles 81(1) and 82 of the Treaty which relate to the production of, or trade in, the products referred to in Article 1. 2. Article 1 shall be replaced by the following: 
‘Article 1
This Regulation shall lay down the rules to be applied as regards the applicability of Articles 81 to 86 and certain provisions of Article 88 of the Treaty in relation to production of, or trade in, the products listed in Annex I to the Treaty with the exception of the products referred to in points (a) to (h), point (k) and points (m) to (u) of Article 1(1) and in Article 1(3) of Council Regulation (EC) No 1234/2007 ( 86 ). 
‘Article 1a
Articles 81 to 86 of the Treaty and provisions made for their implementation shall, subject to Article 2 of this Regulation, apply to all agreements, decisions and practices referred to in Articles 81(1) and 82 of the Treaty which relate to the production of, or trade in, the products referred to in Article 1. 3. The first subparagraph of Article 2(1) shall be replaced by the following: ‘1. Article 81(1) of the Treaty shall not apply to those agreements, decisions and practices referred to in Article 1a of this Regulation which form an integral part of a national market organisation or are necessary for attainment of the objectives set out in Article 33 of the Treaty.’; 4. Article 3 shall be replaced by the following: ‘Article 3 Article 88(1) and of the first sentence of Article 88(3) of the Treaty shall apply to aid granted for the production of, or trade in, the products referred to in Article 1.’. 4. Article 3 shall be replaced by the following: 
‘Article 3
Article 88(1) and of the first sentence of Article 88(3) of the Treaty shall apply to aid granted for the production of, or trade in, the products referred to in Article 1.’.
Article 201 
Repeals 1. Subject to paragraph 3, the following Regulations shall be repealed: (a) Regulations (EEC) No 234/68, (EEC) No 827/68, (EEC) No 2517/69, (EEC) No 2728/75, (EEC) No 1055/77, (EEC) No 2931/79, (EEC) No 1358/80, (EEC) No 3730/87, (EEC) No 4088/87, (EEC) No 404/93, (EC) No 670/2003 and (EC) No 797/2004, as from 1 January 2008; (b) Regulations (EEC) No 707/76, (EC) No 1786/2003, (EC) No 1788/2003 and (EC) No 1544/2006 as from 1 April 2008; (c) Regulations (EEC) No 315/68, (EEC) No 316/68, (EEC) No 2729/75, (EEC) No 2759/75, (EEC) No 2763/75, (EEC) No 2771/75, (EEC) No 2777/75, (EEC) No 2782/75, (EEC) No 1898/87, (EEC) No 1906/90, (EEC) No 2204/90, (EEC) No 2075/92, (EEC) No 2077/92, (EEC) No 2991/94, (EC) No 2597/97, (EC) No 1254/1999, (EC) No 1255/1999, (EC) No 2250/1999, (EC) No 1673/2000, (EC) No 2529/2001, (EC) No 1784/2003, (EC) No 865/2004 and (EC) No 1947/2005 (EC) No 1952/2005 and (EC) No 1028/2006, as from 1 July 2008; (d) Regulation (EC) No 1785/2003 as from 1 September 2008; (e) Regulation (EC) No 318/2006 as from 1 October 2008; (f) Regulations (EEC) No 3220/84, (EEC) No 386/90, (EEC) No 1186/90, (EEC) No 2137/92, and (EC) No 1183/2006 as from 1 January 2009. 2. Decision 74/583/EEC shall be repealed as from 1 January 2008. 3. The repeal of the Regulations referred to in paragraph 1 shall be without prejudice to: (a) the maintenance in force of Community acts adopted on the basis of those Regulations; and (b) the continuing validity of amendments made by those Regulations to other acts of Community law that are not repealed by this Regulation.
Article 202 
Construction of references References to the provisions and Regulations which are amended or repealed by Articles 197 to 201 shall be construed as references to this Regulation and shall be read in accordance with the correlation tables set out in Annex XXII.
Article 203 
Transitional rules The Commission may adopt the measures required to facilitate the transition from the arrangements provided for in the Regulations which are amended or repealed by Articles 197 to 201 to those established by this Regulation.
Article 203a Transitional rules in the fruit and vegetables and the processed fruit and vegetables sectors
1. The aid schemes set out in Regulations (EC) No 2201/96 and (EC) No 2202/96 of 28 October 1996 introducing a Community aid scheme for producers of certain citrus fruit ( 87 ) and abolished by Regulation (EC) No 1182/2007 shall remain applicable in respect of each of the products concerned for the marketing year for that product ending in 2008. 2. Producer organisations and associations of producer organisations already recognised under Regulation (EC) No 2200/96 before the date of entry into force of this Regulation shall continue to be recognised under this Regulation. Where necessary, they shall make adaptations to the requirements of this Regulation by 31 December 2010. Producer organisations and associations of producer organisations already recognised under Regulation (EC) No 1182/2007 shall continue to be recognised under this Regulation. 3. At the request of a producer organisation, an operational programme approved under Regulation (EC) No 2200/96 before the date of application of Regulation (EC) No 1182/2007: (a) may continue to run until its end; or (b) be modified to meet the requirements of this Regulation; or (c) be replaced by a new operational programme approved under this Regulation. Article 103d(3)(e) and (f) shall apply to operational programmes submitted in 2007 but not yet approved at the date of application of this Regulation which otherwise meet the criteria of those points. 4. Producer groups which were granted preliminary recognition under Regulation (EC) No 2200/96 shall continue to benefit from that preliminary recognition under this Regulation. Recognition plans accepted under Regulation (EC) No 2200/96 shall continue to benefit from that acceptance under this Regulation. However the plans shall be modified, if necessary, so as to permit the producer group to be able to meet the criteria for recognition as a producer organisation laid down in Article 125b of this Regulation. As concerns such producer groups in Member States which acceded to the European Union on 1 May 2004 or thereafter, the aid rates set out in Article 103a(3)(a) shall apply to recognition plans from the date of application of this Regulation. 5. The contracts referred to in Article 3(2) of Regulation (EC) No 2202/96 covering more than one marketing year of the aid scheme for processing citrus fruits which relate to the marketing year beginning on 1 October 2008 or to subsequent marketing years may, with the agreement of both parties, be amended or terminated to take into account the repeal of that Regulation by Regulation (EC) No 1182/2007 and the consequential abolition of the aid. No penalties shall be applied under that Regulation or its implementing rules to the parties concerned as a result of such an amendment or termination. 6. Where a Member State makes use of the transitional arrangement under Article 68b or Article 143bc of Regulation (EC) No 1782/2003, the rules adopted pursuant to Article 6 of Regulation (EC) No 2201/96 or Article 6 of Regulation (EC) No 2202/96 on the minimum characteristics of the raw material supplied for processing and minimum quality requirements for finished products shall remain applicable in respect of the raw materials harvested in its territory. 7. Until new marketing standards are adopted in respect of fruit and vegetables and processed fruit and vegetables in accordance with Articles 113 and 113a, the marketing standards drawn up pursuant to Regulations (EC) No 2200/96 and (EC) No 2201/96 shall continue to apply. 8. The Commission may adopt the measures required to facilitate the transition from the arrangements provided for in Regulations (EC) No 2200/96, (EC) No 2201/96, (EC) No 2202/96 and (EC) No 1182/2007 to those laid down in this Regulation including those provided for in paragraphs 1 to 7 of this Article.
Article 203b Transitional rules in the wine sector
The Commission may adopt the measures required to facilitate the transition from the arrangements provided for in Regulations (EC) No 1493/1999 and (EC) No 479/2008 to those laid down in this Regulation.