(1)

The application of certain Union acts governing the free movement of goods, persons, services and capital in the internal market requires Member States to cooperate more effectively and exchange information with one another and with the Commission. As practical means to implement such information exchange are often not specified in those acts, appropriate practical arrangements need to be made.

(2)

The Internal Market Information System (‘IMI’) is a software application accessible via the internet, developed by the Commission in cooperation with the Member States, in order to assist Member States with the practical implementation of information exchange requirements laid down in Union acts by providing a centralised communication mechanism to facilitate cross-border exchange of information and mutual assistance. In particular, IMI helps competent authorities to identify their counterpart in another Member State, to manage the exchange of information, including personal data, on the basis of simple and unified procedures and to overcome language barriers on the basis of pre-defined and pre-translated workflows. Where available, the Commission should provide IMI users with any existing additional translation functionality that meets their needs, is compatible with the security and confidentiality requirements for the exchange of information in IMI and can be offered at a reasonable cost.

(3)

In order to overcome language barriers, IMI should in principle be available in all official Union languages.

(4)

The purpose of IMI should be to improve the functioning of the internal market by providing an effective, user-friendly tool for the implementation of administrative cooperation between Member States and between Member States and the Commission, thus facilitating the application of Union acts listed in the Annex to this Regulation.

(5)

The Commission Communication of 21 February 2011 entitled ‘Better governance of the Single Market through greater administrative cooperation: A strategy for expanding and developing the Internal Market Information System (“IMI”)’ sets out plans for the possible expansion of IMI to other Union acts. The Commission Communication of 13 April 2011 entitled ‘Single Market Act: Twelve Levers to boost growth and strengthen confidence — “Working together to create new growth”’ stresses the importance of IMI for strengthening cooperation among the actors involved, including at local level, thus contributing to better governance of the single market. It is therefore necessary to establish a sound legal framework for IMI and a set of common rules to ensure that IMI functions efficiently.

(6)

Where the application of a provision of a Union act requires Member States to exchange personal data and provides for the purpose of this processing, such a provision should be considered an adequate legal basis for the processing of personal data, subject to the conditions set out in Articles 8 and 52 of the Charter of Fundamental Rights of the European Union. IMI should be seen primarily as a tool used for the exchange of information, including personal data, which would otherwise take place via other means, including regular mail, fax or electronic mail on the basis of a legal obligation imposed on Member States’ authorities and bodies in Union acts. Personal data exchanged via IMI should only be collected, processed and used for purposes in line with those for which it was originally collected and should be subject to all relevant safeguards.

(7)

Following the privacy-by-design principle, IMI has been developed with the requirements of data protection legislation in mind and has been data protection-friendly from its inception, in particular because of the restrictions imposed on access to personal data exchanged in IMI. Therefore, IMI offers a considerably higher level of protection and security than other methods of information exchange such as regular mail, telephone, fax or electronic mail.

(8)

Administrative cooperation by electronic means between Member States and between Member States and the Commission should comply with the rules on the protection of personal data laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) and in Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (4). The definitions used in Directive 95/46/EC and Regulation (EC) No 45/2001 should also apply for the purposes of this Regulation.

(9)

The Commission supplies and manages the software and IT infrastructure for IMI, ensures the security of IMI, manages the network of national IMI coordinators and is involved in the training of and technical assistance to the IMI users. To that end, the Commission should only have access to such personal data that are strictly necessary to carry out its tasks within the responsibilities set out in this Regulation, such as the registration of national IMI coordinators. The Commission should also have access to personal data when retrieving, upon a request by another IMI actor, such data that have been blocked in IMI and to which the data subject has requested access. The Commission should not have access to personal data exchanged as part of administrative cooperation within IMI, unless a Union act provides for a role for the Commission in such cooperation.

(10)

In order to ensure transparency, in particular for data subjects, the provisions of Union acts for which IMI is to be used should be listed in the Annex to this Regulation.

(11)

IMI may be expanded in the future to new areas, where it can help to ensure effective implementation of a Union act in a cost-efficient, user-friendly way, taking account of technical feasibility and overall impact on IMI. The Commission should conduct the necessary tests to verify the technical readiness of IMI for any envisaged expansion. Decisions to expand IMI to further Union acts should be taken by means of the ordinary legislative procedure.

(12)

Pilot projects are a useful tool for testing whether the expansion of IMI is justified and for adapting technical functionality and procedural arrangements to the requirements of IMI users before a decision on the expansion of IMI is taken. Member States should be fully involved in deciding which Union acts should be subject to a pilot project and on the modalities of that pilot project, in order to ensure that the pilot project reflects the needs of IMI users and that the provisions on processing of personal data are fully complied with. Such modalities should be defined separately for each pilot project.

(13)

Nothing in this Regulation should preclude Member States and the Commission from deciding to use IMI for the exchange of information which does not involve the processing of personal data.

(14)

This Regulation should set out the rules for using IMI for the purposes of administrative cooperation, which may cover, inter alia, the one-to-one exchange of information, notification procedures, alert mechanisms, mutual assistance arrangements and problem-solving.

(15)

The right of the Member States to decide which national authorities carry out the obligations resulting from this Regulation should remain unaffected by this Regulation. Member States should be able to adapt functions and responsibilities in relation to IMI to their internal administrative structures, as well as to implement the needs of a specific IMI workflow. Member States should be able to appoint additional IMI coordinators to carry out the tasks of national IMI coordinators, alone or jointly with others, for a particular area of the internal market, a division of the administration, a geographic region, or according to another criterion. Member States should inform the Commission of the IMI coordinators they have appointed, but they should not be obliged to indicate additional IMI coordinators in IMI, where this is not required for its proper functioning.

(16)

In order to achieve efficient administrative cooperation through IMI, Member States and the Commission should ensure that their IMI actors have the necessary resources to carry out their obligations in accordance with this Regulation.

(17)

While IMI is in essence a communication tool for administrative cooperation between competent authorities, which is not open to the general public, technical means may need to be developed to allow external actors such as citizens, enterprises and organisations to interact with the competent authorities in order to supply information or retrieve data, or to exercise their rights as data subjects. Such technical means should include appropriate safeguards for data protection. In order to ensure a high level of security, any such public interface should be developed in such a way as to be technically fully separate from IMI, to which only IMI users should have access.

(18)

The use of IMI for the technical support of the SOLVIT network should be without prejudice to the informal character of the SOLVIT procedure which is based on a voluntary commitment of the Member States, in accordance with the Commission Recommendation of 7 December 2001 on principles for using ‘SOLVIT’ — the Internal Market Problem Solving Network (5) (‘the SOLVIT Recommendation’). To continue the functioning of the SOLVIT network on the basis of existing work arrangements, one or more tasks of the national IMI coordinator may be assigned to SOLVIT centres within the remit of their work, so that they can function independently from the national IMI coordinator. The processing of personal data and of confidential information as part of SOLVIT procedures should benefit from all guarantees set out in this Regulation, without prejudice to the non-binding character of the SOLVIT Recommendation.

(19)

While IMI includes an internet-based interface for its users, in certain cases and at the request of the Member State concerned, it may be appropriate to consider technical solutions for the direct transfer of data from national systems to IMI, where such national systems have already been developed, notably for notification procedures. The implementation of such technical solutions should depend on the outcome of an assessment of their feasibility, costs and expected benefits. Those solutions should not affect the existing structures and the national order of competencies.

(20)

Where Member States have fulfilled the obligation to notify under Article 15(7) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (6) by using the procedure in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (7), they should not also be required to make the same notification through IMI.

(21)

The exchange of information through IMI follows from the legal obligation on Member States’ authorities to give mutual assistance. To ensure that the internal market functions properly, information received by a competent authority through IMI from another Member State should not be deprived of its value as evidence in administrative proceedings solely on the ground that it originated in another Member State or was received by electronic means, and it should be treated by that competent authority in the same way as similar documents originating in its Member State.

(22)

In order to guarantee a high level of data protection, maximum retention periods for personal data in IMI need to be established. However, those periods should be well-balanced taking into due consideration the need for IMI to function properly, as well as the rights of the data subjects to fully exercise their rights, for instance by obtaining evidence that an information exchange took place in order to appeal against a decision. In particular, retention periods should not go beyond what is necessary to achieve the objectives of this Regulation.

(23)

It should be possible to process the name and contact details of IMI users for purposes compatible with the objectives of this Regulation, including monitoring of the use of the system by IMI coordinators and the Commission, communication, training and awareness-raising initiatives, and gathering information on administrative cooperation or mutual assistance in the internal market.

(24)

The European Data Protection Supervisor should monitor and seek to ensure the application of this Regulation, inter alia by maintaining contacts with national data protection authorities, including the relevant provisions on data security.

(25)

In order to ensure the effective monitoring of, and reporting on, the functioning of IMI and the application of this Regulation, Member States should make relevant information available to the Commission.

(26)

Data subjects should be informed about the processing of their personal data in IMI and of the fact that they have the right of access to the data relating to them and the right to have inaccurate data corrected and illegally processed data erased, in accordance with this Regulation and national legislation implementing Directive 95/46/EC.

(27)

In order to make it possible for the competent authorities of the Member States to implement legal provisions for administrative cooperation and efficiently exchange information by means of IMI, it may be necessary to lay down practical arrangements for such an exchange. Those arrangements should be adopted by the Commission in the form of a separate implementing act for each Union act listed in the Annex or for each type of administrative cooperation procedure and should cover the essential technical functionality and procedural arrangements required to implement the relevant administrative cooperation procedures via IMI. The Commission should ensure the maintenance and development of the software and IT infrastructure for IMI.

(28)

In order to ensure sufficient transparency for data subjects, the predefined workflows, question and answer sets, forms and other arrangements relating to administrative cooperation procedures in IMI should be made public.

(29)

Where Member States apply, in accordance with Article 13 of Directive 95/46/EC, any limitations on or exceptions to the rights of data subjects, information about such limitations or exceptions should be made public in order to ensure full transparency for data subjects. Such exceptions or limitations should be necessary and proportionate to the intended purpose and subject to adequate safeguards.

(30)

Where international agreements are concluded between the Union and third countries that also cover the application of provisions of Union acts listed in the Annex to this Regulation, it should be possible to include the counterparts of IMI actors in such third countries in the administrative cooperation procedures supported by IMI, provided that it has been established that the third country concerned offers an adequate level of protection of personal data in accordance with Directive 95/46/EC.

(31)

Commission Decision 2008/49/EC of 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data (8) should be repealed. Commission Decision 2009/739/EC of 2 October 2009 setting out the practical arrangements for the exchange of information by electronic means between the Member States under Chapter VI of Directive 2006/123/EC of the European Parliament and of the Council on services in the internal market (9) should continue to apply to issues relating to the exchange of information under Directive 2006/123/EC.

(32)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (10).

(33)

The performance of the Member States regarding the effective application of this Regulation should be monitored in the annual report on the functioning of IMI based on statistical data from IMI and any other relevant data. The performance of Member States should be evaluated, inter alia, based on average reply times with the aim of ensuring rapid replies of good quality.

(34)

Since the objective of this Regulation, namely laying down the rules for the use of IMI for administrative cooperation, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(35)

The European Data Protection Supervisor has been consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 22 November 2011 (11),

(1)

The primary objective of standardisation is the definition of voluntary technical or quality specifications with which current or future products, production processes or services may comply. Standardisation can cover various issues, such as standardisation of different grades or sizes of a particular product or technical specifications in product or services markets where compatibility and interoperability with other products or systems are essential.

(2)

European standardisation is organised by and for the stakeholders concerned based on national representation (the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec)) and direct participation (the European Telecommunications Standards Institute (ETSI)), and is founded on the principles recognised by the World Trade Organisation (WTO) in the field of standardisation, namely coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency (‘the founding principles’). In accordance with the founding principles, it is important that all relevant interested parties, including public authorities and small and medium-sized enterprises (SMEs), are appropriately involved in the national and European standardisation process. National standardisation bodies should also encourage and facilitate the participation of stakeholders.

(3)

European standardisation also helps to boost the competitiveness of enterprises by facilitating in particular the free movement of goods and services, network interoperability, means of communication, technological development and innovation. European standardisation reinforces the global competitiveness of European industry especially when established in coordination with the international standardisation bodies, namely the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU). Standards produce significant positive economic effects, for example by promoting economic interpenetration on the internal market and encouraging the development of new and improved products or markets and improved supply conditions. Standards thus normally increase competition and lower output and sales costs, benefiting economies as a whole and consumers in particular. Standards may maintain and enhance quality, provide information and ensure interoperability and compatibility, thereby increasing safety and value for consumers.

(4)

European standards are adopted by the European standardisation organisations, namely CEN, Cenelec and ETSI.

(5)

European standards play a very important role within the internal market, for instance through the use of harmonised standards in the presumption of conformity of products to be made available on the market with the essential requirements relating to those products laid down in the relevant Union harmonisation legislation. Those requirements should be precisely defined in order to avoid misinterpretation on the part of the European standardisation organisations.

(6)

Standardisation plays an increasingly important role in international trade and the opening-up of markets. The Union should seek to promote cooperation between European standardisation organisations and international standardisation bodies. The Union should also promote bilateral approaches with third countries to coordinate standardisation efforts and promote European standards, for instance when negotiating agreements or by seconding standardisation experts to third countries. Furthermore the Union should encourage contact between European standardisation organisations and private forums and consortia, while maintaining the primacy of European standardisation.

(7)

European standardisation is governed by a specific legal framework consisting of three different legal acts, namely Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (3), Decision No 1673/2006/EC of the European Parliament and of the Council of 24 October 2006 on the financing of European standardisation (4) and Council Decision 87/95/EEC of 22 December 1986 on standardisation in the field of information technology and telecommunications (5). However, the current legal framework is no longer up to date with developments in European standardisation over recent decades. Therefore, the current legal framework should be simplified and adapted in order to cover new aspects of standardisation to reflect those latest developments and future challenges in European standardisation. That relates in particular to the increased development of standards for services and the evolution of standardisation deliverables other than formal standards.

(8)

The European Parliament’s Resolution of 21 October 2010 on the future of European standardisation (6), as well as the report of the Expert Panel for the Review of the European Standardization System (Express) of February 2010 entitled ‘Standardization for a competitive and innovative Europe: a vision for 2020’, have set out an important number of strategic recommendations regarding the review of the European standardisation system.

(9)

In order to ensure the effectiveness of standards and standardisation as policy tools for the Union, it is necessary to have an effective and efficient standardisation system which provides a flexible and transparent platform for consensus building between all participants and which is financially viable.

(10)

Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (7) establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services. It obliges the Member States to encourage, in cooperation with the Commission, the development of voluntary European standards with the aim of facilitating compatibility between services supplied by providers in different Member States, the provision of information to the recipient and the quality of service provision. However, Directive 98/34/EC only applies to standards for products while standards for services are not expressly covered by it. Furthermore, the delineation between services and goods is becoming less relevant in the reality of the internal market. In practice, it is not always possible to clearly distinguish standards for products from standards for services. Many standards for products have a service component while standards for services often also partly relate to products. Thus, it is necessary to adapt the current legal framework to these new circumstances by extending its scope to standards for services.

(11)

Like other standards, standards for services are voluntary and should be market-driven, whereby the needs of the economic operators and stakeholders directly or indirectly affected by such standards prevail, and should take into account the public interest and be based on the founding principles, including consensus. They should primarily focus on services linked to products and processes.

(12)

The legal framework allowing the Commission to request one or several European standardisation organisations to draft a European standard or European standardisation deliverable for services should be applied while fully respecting the distribution of competences between the Union and the Member States as laid down in the Treaties. This concerns in particular Articles 14, 151, 152, 153, 165, 166 and 168 of the Treaty on the Functioning of the European Union (TFEU) and Protocol (No 26) on Services of General Interest annexed to the Treaty on European Union (TEU) and to the TFEU in accordance with which it remains the exclusive competence of the Member States to define the fundamental principles of their social security, vocational training and health systems and to shape the framework conditions for the management, financing, organisation and delivery of the services supplied within those systems, including - without prejudice to Article 168(4) TFEU and to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (8) - the definition of requirements, quality and safety standards applicable to them. The Commission should not, by means of such a request, affect the right to negotiate, conclude and enforce collective agreements and to take industrial action in accordance with national law and practices which respect Union law.

(13)

The European standardisation organisations are subject to competition law to the extent that they can be considered to be an undertaking or an association of undertakings within the meaning of Articles 101 and 102 TFEU.

(14)

Within the Union, national standards are adopted by national standardisation bodies which could lead to conflicting standards and technical impediments in the internal market. Therefore, it is necessary for the internal market and for the effectiveness of standardisation within the Union to confirm the existing regular exchange of information between the national standardisation bodies, the European standardisation organisations and the Commission, about their current and future standardisation activities as well as the standstill principle applicable to the national standardisation bodies within the framework of the European standardisation organisations which provides for the withdrawal of national standards after the publication of a new European standard. The national standardisation bodies and European standardisation organisations should also observe the provisions on exchange of information in Annex 3 to the Agreement on Technical Barriers to Trade (9).

(15)

The Member States’ obligation to notify the Commission of their national standardisation bodies should not require the adoption of a specific national legislation for the purposes of recognition of those bodies.

(16)

The regular exchange of information between the national standardisation bodies, the European standardisation organisations and the Commission should not prevent national standardisation bodies from complying with other obligations and commitments, and in particular with Annex 3 to the Agreement on Technical Barriers to Trade.

(17)

The representation of societal interests and societal stakeholders in European standardisation activities refers to the activities of organisations and parties representing interests of greater societal relevance, for instance environmental, consumer interests or employee interests. However, the representation of social interests and social stakeholders in European standardisation activities refers particularly to the activities of organisations and parties representing employees and workers’ basic rights, for instance trade unions.

(18)

In order to speed up the decision-making process, national standardisation bodies and European standardisation organisations should facilitate accessible information on their activities through the promotion of the use of information and communication technologies (ICT) in their respective standardisation systems, for example by providing to all relevant stakeholders an easy-to-use online consultation mechanism for the submission of comments on draft standards and by organising virtual meetings, including by means of web conferencing or video conferencing, of technical committees.

(19)

Standards can contribute to helping Union policy address the major societal challenges such as climate change, sustainable resource use, innovation, ageing population, integration of people with disabilities, consumer protection, workers’ safety and working conditions. By driving the development of European or international standards for goods and technologies in the expanding markets in those areas, the Union could create a competitive advantage for its enterprises and facilitate trade, in particular for SMEs, which account for a large part of European enterprises.

(20)

Standards are important tools for the competitiveness of undertakings and especially SMEs, whose participation in the standardisation process is important for technological progress in the Union. Therefore it is necessary that the standardisation framework encourage SMEs to actively participate in and provide their innovative technology solutions to standardisation efforts. This includes improving their participation at national level where they can be more effective due to lower costs and lack of linguistic barriers. Consequently this Regulation should improve representation and participation of SMEs in both national and European technical committees and should facilitate their effective access to and awareness of standards.

(21)

European standards are of vital interest for the competitiveness of SMEs which, however, are in some cases under-represented in European standardisation activities. Thus, this Regulation should encourage and facilitate appropriate representation and participation of SMEs in the European standardisation process by an entity that is effectively in contact with, and duly representative of, SMEs and organisations representing SMEs at national level.

(22)

Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, workers’ safety and working conditions, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the development of standards are strengthened, through the reinforced support of organisations representing consumers and environmental and social interests.

(23)

The obligation of the European standardisation organisations to encourage and facilitate representation and effective participation of all relevant stakeholders does not entail any voting rights for these stakeholders unless such voting rights are prescribed by the internal rules of procedure of the European standardisation organisations.

(24)

The European standardisation system should also fully take into account the United Nations Convention on the Rights of Persons with Disabilities (10). It is therefore important that organisations representing the interests of consumers sufficiently represent and include the interests of people with disabilities. In addition, the participation of people with disabilities in the standardisation process should be facilitated by all available means.

(25)

Due to the importance of standardisation as a tool to support Union legislation and policies and in order to avoid ex-post objections to and modifications of harmonised standards, it is important that public authorities participate in standardisation at all stages of the development of those standards where they may be involved and especially in the areas covered by Union harmonisation legislation for products.

(26)

Standards should take into account environmental impacts throughout the life cycle of products and services. Important and publicly available tools for evaluating such impacts throughout the life cycle have been developed by the Commission’s Joint Research Centre (JRC). Thus, this Regulation should ensure that the JRC can play an active role in the European standardisation system.

(27)

The viability of the cooperation between the Commission and the European standardisation system depends on careful planning of future requests for the development of standards. This planning could be improved, in particular through the input of interested parties, including national market surveillance authorities, by introducing mechanisms for collecting opinions and facilitating the exchange of information among all interested parties. Since Directive 98/34/EC already provides for the possibility to request the European standardisation organisations to develop European standards, it is appropriate to put in place a better and more transparent planning in an annual work programme which should contain an overview of all requests for standards which the Commission intends to submit to European standardisation organisations. It is necessary to ensure a high level of cooperation between the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation and the Commission in the establishment of its annual Union work programme for standardisation and in the preparation of requests for standards in order to analyse the market relevance of the proposed subject matter and the policy objectives set by the legislator, and to allow the European standardisation organisations to respond more quickly to the requested standardisation activities.

(28)

Before bringing a matter regarding requests for European standards or European standardisation deliverables, or objections to a harmonised standard before the committee set up by this Regulation, the Commission should consult experts of the Member States, for instance through the involvement of committees set up by the corresponding Union legislation or by other forms of consultation of sectoral experts, where such committees do not exist.

(29)

Several directives harmonising the conditions for the marketing of products specify that the Commission may request the adoption, by the European standardisation organisations, of harmonised standards on the basis of which conformity with the applicable essential requirements is presumed. However, many of those directives contain a wide variety of provisions on objections to these standards when the latter do not, or do not entirely, cover all applicable requirements. Diverging provisions which lead to uncertainty for economic operators and European standardisation organisations are in particular contained in Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (11), Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses (12), Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (13), Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (14), European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (15), Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (16), Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (17), Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles (18), Directive 2009/23/EC of the European Parliament and of the Council of23 April 2009 on non-automatic weighing instruments (19) and Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels (20). Therefore, it is necessary to include in this Regulation the uniform procedure provided for in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (21), delete the relevant provisions in those Directives and extend to the European Parliament the right to object to a harmonised standard in accordance with this Regulation.

(30)

Public authorities should make best use of the full range of relevant technical specifications when procuring hardware, software and information technology services, for example by selecting technical specifications which can be implemented by all interested suppliers, allowing for more competition and reduced risk of lock-in. Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (22), Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (23), Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security (24) and Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (25) specify that technical specifications in public procurement should be formulated by reference to national standards transposing European standards, European technical approvals, common technical specifications, international standards, other technical reference systems established by the European standardisation organisations or - when these do not exist - to national standards, national technical approvals or national technical specifications relating to the design, calculation and execution of the works and use of the products, or equivalent. ICT technical specifications, however, are often developed by other standard developing organisations and do not fall in any of the categories of standards and approvals laid down in Directives 2004/17/EC, 2004/18/EC or 2009/81/EC or Regulation (EC, Euratom) No 2342/2002. Therefore, it is necessary to provide for the possibility that technical specifications for public procurement could refer to ICT technical specifications, in order to respond to the fast evolution in the field of ICT, facilitate the provision of cross-border services, encourage competition and promote interoperability and innovation.

(31)

Technical specifications not adopted by European standardisation organisations do not hold an equivalent status to European standards. Some ICT technical specifications are not developed in accordance with the founding principles. Therefore, this Regulation should lay down a procedure for the identification of ICT technical specifications that could be referenced in public procurement, involving a broad consultation of a large spectrum of stakeholders, including the European standardisation organisations, enterprises and public authorities. This Regulation should also lay down requirements, in the form of a list of criteria, for such technical specifications and their associated development processes. The requirements for the identification of ICT technical specifications should ensure that public policy objectives and societal needs are respected, and should be based on the founding principles.

(32)

In order to further innovation and competition, the identification of a particular technical specification should not disqualify a competing technical specification from being identified in accordance with the provisions of this Regulation. Any identification should be subject to the criteria being fulfilled and to the technical specification having achieved a significant level of market acceptance.

(33)

The identified ICT technical specifications could contribute to the implementation of Decision No 922/2009/EC of the European Parliament and of the Council of 16 September 2009 on interoperability solutions for European public administrations (ISA) (26) which establishes, for the period 2010-2015, a programme on interoperability solutions for European public administrations and institutions and bodies of the Union, providing common and shared solutions facilitating interoperability.

(34)

Situations may arise in the field of ICT where it is appropriate to encourage the use of, or require compliance, with relevant standards at Union level in order to ensure interoperability in the single market and to improve freedom of choice for users. In other circumstances, it may also happen that specified European standards no longer meet consumers’ needs or are hampering technological development. For these reasons, Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (27) enables the Commission, where necessary, to request European standardisation organisations to draw up standards, to establish and publish in the Official Journal of the European Union a list of standards or specifications with the view to encourage their use, or to make their implementation compulsory, or to remove standards or specifications from that list.

(35)

This Regulation should not prevent European standardisation organisations from continuing to develop standards in the field of ICT and to increase their cooperation with other standard developing bodies, especially in the field of ICT, in order to ensure coherence and avoid fragmentation or duplication during implementation of standards and specifications.

(36)

The procedure for identification of ICT technical specifications provided for in this Regulation should not undermine the coherence of the European standardisation system. Therefore, this Regulation should also lay down the conditions under which it can be considered that a technical specification does not conflict with other European standards.

(37)

Before identifying ICT technical specifications which may be eligible for referencing in public procurement, the Multi Stakeholder Platform established by the Commission Decision of 28 November 2011 (28) should be used as a forum for consultation of European and national stakeholders, European standardisation organisations and Member States in order to ensure legitimacy of the process.

(38)

Decision No 1673/2006/EC establishes the rules concerning the contribution of the Union to the financing of European standardisation in order to ensure that European standards and other European standardisation deliverables are developed and revised in support of the objectives, legislation and policies of the Union. It is appropriate, for the purpose of administrative and budgetary simplification, to incorporate the provisions of that Decision into this Regulation and to use wherever possible the least burdensome procedures.

(39)

In view of the very broad field of involvement of European standardisation in support of Union legislation and policies and the different types of standardisation activity, it is necessary to provide for different financing arrangements. This mainly concerns grants without calls for proposals to the European standardisation organisations and national standardisation bodies in accordance with the second subparagraph of Article 110(1) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (29) and point (d) of Article 168(1) of Regulation (EC, Euratom) No 2342/2002. Furthermore, the same provisions should apply to those bodies which, whilst not recognised as European standardisation organisations in this Regulation, have been mandated in a basic act and have been entrusted with carrying out preliminary work in support of European standardisation in cooperation with the European standardisation organisations.

(40)

Inasmuch as European standardisation organisations provide ongoing support for Union activities, they should have effective and efficient central secretariats. The Commission should therefore be allowed to provide grants to those organisations that are pursuing an objective of general European interest without applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.

(41)

Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) (30), Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 establishing a programme of Community action in the field of consumer policy (2007-2013) (31) and Regulation (EC) No 614/2007 of the European Parliament and of the Council of 23 May 2007 concerning the Financial Instrument for the Environment (LIFE+) (32) already provide for the possibility of financial support of European organisations representing SMEs, consumers and environmental interests in standardisation, while specific grants are paid to European organisations representing social interests in standardisation. The financing under Decision No 1639/2006/EC, Decision No 1926/2006/EC and Regulation (EC) No 614/2007 will end on 31 December 2013. It is essential for the development of European standardisation to continue fostering and encouraging the active participation of European organisations representing SMEs, consumers and environmental and social interests. Such organisations pursue an aim of general European interest and constitute, by virtue of the specific mandate that national non-profit organisations have given them, a European network representing non-profit organisations active in the Member States and promoting principles and policies consistent with the objectives of the Treaties. Because of the context in which they operate and their statutory objectives, European organisations representing SMEs, consumers and environmental and social interests in European standardisation have a permanent role which is essential for Union objectives and policies. Therefore, the Commission should be in a position to continue providing grants to those organisations without applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.

(42)

The financing of standardisation activities should also be capable of covering preliminary or ancillary activities in connection with the establishment of European standards or European standardisation deliverables for products and for services. This is necessary primarily for work involving research, the preparation of preliminary documents for legislation, inter-laboratory tests and the validation or evaluation of standards. The promotion of standardisation at European and international level should also continue through programmes relating to the technical assistance to, and cooperation with, third countries. With a view to improving market access and boosting the competitiveness of enterprises in the Union, it should be possible to give grants to other bodies through calls for proposals or, where necessary, by awarding contracts.

(43)

Union financing should seek to establish European standards or European standardisation deliverables for products and for services, to facilitate their use by enterprises through the enhanced support for their translation into the various official Union languages, in order to allow SMEs to fully benefit from the understanding and application of the European standards, to strengthen the cohesion of the European standardisation system and to ensure fair and transparent access to European standards for all market players throughout the Union. This is especially important in cases where the use of standards enables compliance with relevant Union legislation.

(44)

In order to ensure the effective application of this Regulation, there should be the possibility of using the requisite expertise, particularly with regard to auditing and financial management, as well as administrative support resources capable of facilitating implementation, and of evaluating on a regular basis the relevance of the activities receiving Union financing in order to ensure their usefulness and impact.

(45)

Appropriate measures should also be taken to avoid fraud and irregularities and to recover funds unduly paid in accordance with Council Regulations (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (33) and (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (34) and Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (35).

(46)

In order to update the list of European standardisation organisations and to adapt the criteria for organisations representing SMEs and societal stakeholders to further developments as regards their non-profit making nature and representativity, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(47)

The committee set up by this Regulation should assist the Commission in all matters related to the implementation of this Regulation, having due regard for the views of sectoral experts.

(48)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (36).

(49)

The advisory procedure should be used for the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have not yet been published in the Official Journal of the European Union, given that the relevant standard has not yet led to the presumption of conformity with the essential requirements set out in the applicable Union harmonisation legislation.

(50)

The examination procedure should be used for each standardisation request submitted to European standardisation organisations and the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have already been published in the Official Journal of the European Union, given that such decision could have consequences on the presumption of conformity with the applicable essential requirements.

(51)

In order to achieve the main objectives of this Regulation and to facilitate speedy decision-making procedures as well as reducing the overall development time for standards, use should be made as far as possible of the procedural measures provided for in Regulation (EU) No 182/2011, which enables the chair of the relevant committee to lay down a time limit within which the committee should deliver its opinion, according to the urgency of the matter. Moreover, where justified, it should be possible for the opinion of the committee to be obtained by written procedure, and silence on the part of the committee member should be regarded as tacit agreement.

(52)

Since the objectives of this Regulation, namely to ensure the effectiveness and efficiency of standards and standardisation as policy tools for the Union through cooperation between European standardisation organisations, national standardisation bodies, Member States and the Commission, the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies, the identification of ICT technical specifications eligible for referencing, the financing of European standardisation and stakeholder participation in European standardisation cannot be sufficiently achieved by the Member States and can, therefore, by reason of their effect, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(53)

Directives 89/686/EEC, 93/15/EEC, 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC should therefore be amended accordingly.

(54)

Decision No 1673/2006/EC and Decision 87/95/EEC should be repealed,

(1)

As provided in the United Nations Convention on the Law of the Sea of 10 December 1982 (‘UNCLOS’) and in the United Nations Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks of 4 August 1995 (‘UNFSA’), the management of certain shared, straddling and highly migratory fish stocks requires the cooperation of all the countries in whose waters the stock occurs (the coastal States) and the countries whose fleets exploit that stock (the fishing States). This cooperation may be established in the framework of regional fisheries management organisations (‘RFMOs’) or, where RFMOs have no competence for the stock in question, by means of ad hoc arrangements among the countries having an interest in the fishery.

(2)

Where a third country with an interest in a fishery involving a stock of common interest to that country and to the Union allows, without due regard to existing fishing patterns or the rights, duties and interests of other countries and the Union, fisheries activities that jeopardise the sustainability of that stock, and fails to cooperate with other countries and the Union in its management, specific measures should be adopted in order to encourage that country to contribute to the conservation of that stock.

(3)

Fish stocks should be considered to be in an unsustainable state when they are not continuously maintained at or above the levels that can produce maximum sustainable yield or, if these levels cannot be estimated, when the stocks are not continuously maintained within safe biological limits.

(4)

It is necessary to define the conditions upon which a country can be considered to be a country allowing non-sustainable fishing and subject to measures under this Regulation, including a process granting the countries concerned the right to be heard and allowing them an opportunity to adopt corrective action.

(5)

In addition, it is necessary to define the type of measures that may be taken with regard to countries allowing non-sustainable fishing and to establish general conditions for the adoption of such measures, so that they are based on objective criteria and are equitable, cost-effective and compatible with international law, in particular with the Agreement establishing the World Trade Organisation.

(6)

Such measures should aim to remove the incentives for countries allowing non-sustainable fishing to fish the stock of common interest. This can be achieved inter alia by restricting the importation of fish products caught by vessels conducting fisheries on a stock of common interest under the control of the country allowing non-sustainable fishing, by restricting the access to ports for those vessels, or by preventing Union fishing vessels or Union fishing equipment from being used for fishing the stock of common interest under the control of the country allowing non-sustainable fishing.

(7)

In order to ensure that Union action for the conservation of fish stocks is effective and coherent, it is important that the measures set out in Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (3) are taken into consideration.

(8)

In order to guarantee that measures adopted against a country under this Regulation are environmentally sound, effective, proportionate and compatible with international rules, it is necessary for their adoption to be preceded by an evaluation of their expected environmental, trade, economic and social effects.

(9)

If measures adopted against a country under this Regulation are ineffective and that country continues to be considered to be a country allowing non-sustainable fishing, further measures may be adopted in accordance with this Regulation.

(10)

The measures adopted against a country under this Regulation should cease to apply when the country allowing non-sustainable fishing has adopted the measures necessary for its contribution to the conservation of the stock of common interest.

(11)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission with regard to identifying a country allowing non-sustainable fishing, to adopting measures in respect of such country and to deciding that such measures should cease to apply. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (4).

(12)

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the end of application of measures taken pursuant to this Regulation, imperative grounds of urgency so require,

(a)

‘stock of common interest’ means a fish stock the geographical distribution of which makes it available to both the Union and third countries and the management of which requires the cooperation between such countries and the Union, in either bilateral or multilateral settings;

(b)

‘associated species’ means any fish that belongs to the same ecosystem as the stock of common interest and that preys upon that stock, is preyed on by it, competes with it for food and living space or co-occurs with it in the same fishing area, and that is exploited or accidentally taken in the same fishery or fisheries;

(c)

‘regional fisheries management organisation’ or ‘RFMO’ means a sub-regional, regional or a similar organisation with competence under international law to establish conservation and management measures for living marine resources placed under its responsibility by virtue of the convention or agreement by which it was established;

(d)

‘importation’ means the introduction of fish or fishery products into the territory of the Union, including for transhipment purposes at ports in its territory;

(e)

‘transhipment’ means the unloading of all or any fish or fishery products on board a fishing vessel to another fishing vessel;

(f)

‘unsustainable state’ means the condition where the stock is not continuously maintained at or above the levels that can produce maximum sustainable yield or, if these levels cannot be estimated, where the stock is not continuously maintained within safe biological limits; the stock levels determining whether the stock is in an unsustainable state are to be determined on the basis of best available scientific advice;

(g)

‘safe biological limits’ means the boundaries of the size of a stock within which the stock can replenish itself with high probability while allowing high yield fisheries on it;

(h)

‘country’ means a third country, including territories enjoying self-governing status and endowed with competencies in the area of conservation and management of living marine resources.

(a)

it fails to cooperate in the management of a stock of common interest in full compliance with the provisions of the UNCLOS and the UNFSA, or any other international agreement or norm of international law; and

(b)

either:

(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 (3), should systematically include medicinal products that are subject to certain post-authorisation safety conditions.

(2)

In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, the marketing authorisation holder should be obliged to inform the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation.

(3)

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 the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(4)

Regulation (EC) No 726/2004 should therefore be amended accordingly,

(1)

in Article 13(4), the second subparagraph is replaced by the following:

‘The marketing authorisation holder shall notify the Agency if the product ceases to be placed on the market of a Member State, either temporarily or permanently. Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The marketing authorisation holder shall inform the Agency of the reasons for such action in accordance with Article 14b.’;

(2)

the following Article is inserted:

(3)

in Article 20, paragraph 8 is replaced by the following:

(4)

Article 23 is replaced by the following:

(5)

Article 57 is amended as follows:

(1)

Article 103o of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (4) provides for a possibility for Member States to grant decoupled aid under the single payment scheme to vine-growers. Several Member States have used this specific support measure.

(2)

However, the fact that Member States may modify transfers to the single payment scheme from the support programmes once a year and that support programmes have a five-year duration whilst payment entitlements giving rise to direct payments are granted for an indeterminate period of time has resulted in administrative and budgetary burdens.

(3)

In order to simplify the management of this specific support measure and to ensure its consistency with the objectives of the rules for direct support schemes for farmers, it is appropriate to convert it into the possibility for Member States to definitively decrease the funds allocated to the support programmes in the wine sector and thereby increase the national ceilings for direct payments.

(4)

It is appropriate to allow Member States to continue applying the support provided for in Article 103o of Regulation (EC) No 1234/2007 for 2014.

(5)

Regulation (EC) No 1234/2007 should therefore be amended accordingly,

(1)

in Article 103n, the following paragraph is inserted:

(2)

Article 103o is replaced by the following:

(1)

The relationship between the European Union (hereinafter referred to as ‘the Union’) and the Islamic Republic of Pakistan (hereinafter referred to as ‘Pakistan’) builds on the Cooperation Agreement which entered into force on 1 September 2004 (2). One of its main objectives is to secure the conditions for, and to promote the increase and development of, trade between the Parties to the Cooperation Agreement. Respect for human rights, including core labour rights, and democratic principles are also an essential element of that Agreement.

(2)

In July and August 2010, following heavy monsoon rains, devastating floods affected extensive regions of Pakistan, notably the areas of Balochistan, Khyber Pakhtunkhwa, Punjab, Sindh and Gilgit-Baltistan. According to United Nations sources, the flooding affected some 20 million people and 20 per cent of Pakistan's land, equivalent to at least 160 000 square kilometres, and leaving up to 12 million people in need of urgent humanitarian aid.

(3)

Humanitarian aid is of course the primary instrument in this kind of situation and the Union has been at the forefront in this field since the beginning of the emergency, committing in excess of EUR 423 million in emergency aid to Pakistan.

(4)

It will be important to use all available means to support Pakistan's recovery from this emergency including the proposed exceptional trade measures to boost Pakistan's exports in order to contribute to its future economic development, while ensuring that consistency and coherence is maintained at all levels with a view to developing a sustainable long-term strategy.

(5)

The severity of this natural disaster demands an immediate and substantial response, which would take into account the geostrategic importance of Pakistan's partnership with the Union, mainly through Pakistan's key role in the fight against terrorism, while contributing to the overall development, security and stability of the region.

(6)

The effects of the autonomous trade preferences should be able to be measured concretely in terms of job creation, poverty eradication and the sustainable development of Pakistan's working population and poor.

(7)

The European Council, in a Declaration on Pakistan attached to its Conclusions of 16 September 2010, resolved to mandate Ministers to agree urgently on a comprehensive package of short, medium and longer term measures which will help underpin Pakistan's recovery and future development, comprising inter alia ambitious trade measures essential for economic recovery and growth.

(8)

In particular, the European Council underlined its firm commitment to grant exclusively to Pakistan increased market access to the Union through the immediate and time limited reduction of duties on key imports from Pakistan. In the light of that Declaration, the Commission proposed a package identifying 75 tariff lines specific to Pakistan's core export sectors in those areas worst hit by the floods, asserting that an increase in Pakistani exports to the Union of EUR 100 million or more a year would provide real, substantial and worthwhile assistance to the region.

(9)

Pakistan's trade with the Union is mainly composed of textiles and clothing products which accounted for 73,7 % of Pakistani exports to the Union in 2009. Pakistan also exports ethanol and leather, which are in addition to textiles and clothing, sensitive industrial products in certain Member States where jobs in the industry have already been impacted to varying degrees by the global recession. Those industries are struggling to adapt to a new global trading environment.

(10)

The textiles sector is of key importance to the Pakistani economy, accounting for 8,5 % of gross domestic product and employing 38 % of the labour force, about half of which is made up of women.

(11)

Given the hardship being suffered by the Pakistani people due to the devastating floods, it is therefore appropriate to extend exceptional autonomous trade preferences to Pakistan by suspending for a limited period of time all tariffs for certain products of export interest to Pakistan. The provision of such trade preferences should only cause limited adverse effects on the domestic market of the Union and should not affect negatively least developed Members of the World Trade Organisation (WTO).

(12)

Those measures are proposed as part of an exceptional package, in response to the specific situation in Pakistan. Under no circumstances should they constitute a precedent for the Union's trade policy with other countries.

(13)

The autonomous trade preferences will be either in the form of an exemption from customs duties upon import in the Union or in the form of tariff-rate quotas.

(14)

Entitlement to benefit from the exceptional autonomous trade preferences is conditional on Pakistan's compliance with the relevant rules of origin of products and the procedures related thereto as well as involvement in effective administrative cooperation with the Union in order to prevent any risk of fraud. Serious and systematic violations of the conditions for the entitlement to the preferential arrangement, fraud or failure to provide administrative cooperation for the verification of origin of goods should constitute reasons for a temporary suspension of the preferences.

(15)

For the purposes of defining the concept of originating products, certification of origin and administrative cooperation procedures, Part I, Title IV, Chapter 2, Section 1 and Section 1A of Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (3), with the exception of Articles 68 to 71, 90 to 97i and 97j(2) of those Sections, should apply. However, as regards cumulation of origin, only materials originating in the Union should be allowed to be used for such purposes. Regional cumulation and other types of cumulation except that with the materials originating in the Union should not apply in relation to the determination of the originating status of products covered by the autonomous trade preferences established pursuant to this Regulation in order to ensure that sufficient transformation takes place in Pakistan.

(16)

Extending autonomous trade preferences to Pakistan requires a waiver from the obligations of the Union under Articles I and XIII of the General Agreement on Tariffs and Trade 1994 (GATT) pursuant to Article IX of the Agreement establishing the WTO. The WTO General Council granted such a waiver on 14 February 2012.

(17)

In order to ensure an immediate and sustainable impact on the economic recovery of Pakistan in the aftermath of the floods and in accordance with the WTO waiver, it is recommended to limit the duration of the autonomous trade preferences until 31 December 2013.

(18)

In order to react swiftly and ensure the integrity and orderly functioning of the autonomous trade preferences for Pakistan and in order to ensure uniform conditions for the implementation of this Regulation concerning temporary suspension due to non-compliance with customs-related procedures and obligations, due to serious and systematic violations of the fundamental principles of human rights, democracy and the rule of law by Pakistan, or due to Pakistan not respecting the condition that it abstain from 1 July 2012 from introducing new or increasing existing export duties or charges having equivalent effect or any other restriction or prohibition on the export or sale for export of any materials used in the production of the products covered by this Regulation, powers should be conferred on the Commission to adopt immediately applicable implementing acts, where imperative grounds of urgency so require. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (4).

(19)

In order to make the necessary technical adaptations to the list of goods for which the autonomous trade preferences apply and to remove products from the scope of this Regulation where volumes of imports covered by this Regulation increase beyond certain levels, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes I and II to reflect changes in the combined nomenclature and to remove products from the scope of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(20)

In order to address without delay significantly increased imports of the products exempted from customs duties when imported into the Union and which may have an adverse impact upon Union producers, the Commission should adopt delegated acts removing products from the scope of this Regulation under the urgency procedure.

(21)

No later than two years after the expiry of this Regulation, the Commission should submit a report to the European Parliament and to the Council on the effects of these autonomous trade preferences. That report should include a detailed analysis of the effects of these preferences on the economy of Pakistan and their impact on trade and the Union's tariff income as well as on the Union economy and jobs. In reporting, the Commission should take into account in particular the effects of the autonomous trade preferences in terms of job creation, poverty eradication and the sustainable development of Pakistan's working population and poor,