27.10.2012   

EN

Official Journal of the European Union

L 299/1

(1)

Recent pharmacovigilance incidents in the Union have shown the need for an automatic procedure at Union level in cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The scope of different Union procedures concerning products authorised at national level, as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), should be clarified.

(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 relevant competent authorities and 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)

It is appropriate to further clarify and strengthen the Normal Procedure and the Urgent Union Procedure in order to ensure coordination, swift assessment in case of urgency and the possibility to take immediate action, where necessary to protect public health, before a decision is taken at Union level. The Normal Procedure should be initiated for matters concerning quality, safety or efficacy of medicinal products where the interests of the Union are involved. The Urgent Union Procedure should be initiated when there is a need to swiftly assess concerns resulting from the evaluation of data from pharmacovigilance activities. Regardless of whether the Urgent Union Procedure or the Normal Procedure is applied, and regardless of the procedure by means of which the medicinal product was authorised, be it centralised or otherwise, the Pharmacovigilance Risk Assessment Committee should always give its recommendation when the reason for taking action is based on pharmacovigilance data. It is appropriate that the coordination group and the Committee for Medicinal Products for Human Use rely on that recommendation when carrying out the assessment of the issue.

(4)

It is appropriate that Member States bring cases concerning new contraindications, reductions in the recommended dose or restrictions to the indication for medicinal products authorised in accordance with the decentralised procedure and the mutual recognition procedure to the attention of the coordination group when the Urgent Union Procedure is not initiated. In order to ensure harmonisation for those products, the coordination group may discuss whether any action is necessary in the event that no Member State has triggered the Normal Procedure.

(5)

Since the objective of this Directive, namely to harmonise the rules on pharmacovigilance across the Union, 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 Directive does not go beyond what is necessary in order to achieve that objective.

(6)

Directive 2001/83/EC should therefore be amended accordingly,

(1)

in Article 23a, the second paragraph is replaced by the following:

‘If the product ceases to be placed on the market of a Member State, either temporarily or permanently, the marketing authorisation holder shall notify the competent authority of that Member State. 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 competent authority of the reasons for such action in accordance with Article 123(2).’;

(2)

Article 31 is amended as follows:

(3)

in Article 34(3), the following subparagraph is added:

‘Where the scope of the procedure initiated under Article 31 includes medicinal products authorised in accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of Article 31(2) of this Directive, the Commission shall, where necessary, adopt decisions to vary, suspend or revoke the marketing authorisations or to refuse the renewal of the marketing authorisations concerned.’;

(4)

in Article 37, the words ‘Articles 35 and 36 shall apply’ are replaced by the words ‘Article 35 shall apply’;

(5)

Article 63 is amended as follows:

(6)

Article 85a is replaced by the following:

‘Article 85a

In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of the first paragraph of Article 80 shall not apply. Moreover, points (b) and (ca) of the first paragraph of Article 80 shall not apply where a product is directly received from a third country but not imported. However, in that case wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned. Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned. The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.’;

(7)

in Article 107i, paragraph 1 is replaced by the following:

‘1.   A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, initiate the procedure provided for in this section by informing the other Member States, the Agency and the Commission where:

1a.   A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, inform the other Member States, the Agency and the Commission where it considers that a new contraindication, a reduction in the recommended dose or a restriction to the indications of a medicinal product is necessary. The information shall outline the action considered and the reasons therefor.

Any Member State or the Commission, as appropriate, shall, when urgent action is considered necessary, initiate the procedure provided for in this section in any of the cases referred to in this paragraph.

Where the procedure provided for in this section is not initiated, for medicinal products authorised in accordance with the procedures laid down in Chapter 4 of Title III, the case shall be brought to the attention of the coordination group.

Article 31 shall be applicable where the interests of the Union are involved.

1b.   Where the procedure provided for in this section is initiated, the Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class.

Where the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the procedure of the outcome of this verification, and the procedures laid down in Articles 107j and 107k shall apply. Otherwise, the safety concern shall be addressed by the Member State concerned. The Agency or the Member State, as applicable, shall make the information that the procedure has been initiated available to marketing authorisation holders.’;

(8)

in Article 107i(2) the words ‘paragraph 1 of this Article’ are replaced by the words ‘paragraphs 1 and 1a of this Article’;

(9)

in the second subparagraph of Article 107i(3) the words ‘in accordance with paragraph 1’ are replaced by the words ‘in accordance with paragraphs 1 and 1a’;

(10)

in Article 107i(5) the words ‘in paragraph 1’ are replaced by the words ‘in paragraphs 1 and 1a’;

(11)

in the first subparagraph of Article 107j(1) the words ‘in Article 107i(1)’ are replaced by the words ‘in paragraphs 1 and 1a of Article 107i’;

(12)

Article 123 is amended as follows:

27.10.2012   

EN

Official Journal of the European Union

L 299/5

(1)

Publicly accessible libraries, educational establishments and museums, as well as archives, film or audio heritage institutions and public-service broadcasting organisations, established in the Member States, are engaged in large-scale digitisation of their collections or archives in order to create European Digital Libraries. They contribute to the preservation and dissemination of European cultural heritage, which is also important for the creation of European Digital Libraries, such as Europeana. Technologies for mass digitisation of print materials and for search and indexing enhance the research value of the libraries' collections. Creating large online libraries facilitates electronic search and discovery tools which open up new sources of discovery for researchers and academics who would otherwise have to content themselves with more traditional and analogue search methods.

(2)

The need to promote free movement of knowledge and innovation in the internal market is an important component of the Europe 2020 Strategy, as set out in the Communication from the Commission entitled ‧Europe 2020: A strategy for smart, sustainable and inclusive growth‧, which includes as one of its flagship initiatives the development of a Digital Agenda for Europe.

(3)

Creating a legal framework to facilitate the digitisation and dissemination of works and other subject-matter which are protected by copyright or related rights and for which no rightholder is identified or for which the rightholder, even if identified, is not located — so-called orphan works — is a key action of the Digital Agenda for Europe, as set out in the Communication from the Commission entitled ‧A Digital Agenda for Europe‧. This Directive targets the specific problem of the legal determination of orphan work status and its consequences in terms of the permitted users and permitted uses of works or phonograms considered to be orphan works.

(4)

This Directive is without prejudice to specific solutions being developed in the Member States to address larger mass digitisation issues, such as in the case of so-called ‧out-of-commerce‧ works. Such solutions take into account the specificities of different types of content and different users and build upon the consensus of the relevant stakeholders. This approach has also been followed in the Memorandum of Understanding on key principles on the digitisation and making available of out-of-commerce works, signed on 20 September 2011 by representatives of European libraries, authors, publishers and collecting societies and witnessed by the Commission. This Directive is without prejudice to that Memorandum of Understanding, which calls on Member States and the Commission to ensure that voluntary agreements concluded between users, rightholders and collective rights management organisations to licence the use of out-of-commerce works on the basis of the principles contained therein benefit from the requisite legal certainty in a national and cross-border context.

(5)

Copyright is the economic foundation for the creative industry, since it stimulates innovation, creation, investment and production. Mass digitisation and dissemination of works is therefore a means of protecting Europe's cultural heritage. Copyright is an important tool for ensuring that the creative sector is rewarded for its work.

(6)

The rightholders' exclusive rights of reproduction of their works and other protected subject-matter and of making them available to the public, as harmonised under Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (3), necessitate the prior consent of rightholders to the digitisation and the making available to the public of a work or other protected subject-matter.

(7)

In the case of orphan works, it is not possible to obtain such prior consent to the carrying-out of acts of reproduction or of making available to the public.

(8)

Different approaches in the Member States to the recognition of orphan work status can present obstacles to the functioning of the internal market and the use of, and cross-border access to, orphan works. Such different approaches can also result in restrictions on the free movement of goods and services which incorporate cultural content. Therefore, ensuring the mutual recognition of such status is appropriate, since it will allow access to orphan works in all Member States.

(9)

In particular, a common approach to determining the orphan work status and the permitted uses of orphan works is necessary in order to ensure legal certainty in the internal market with respect to the use of orphan works by publicly accessible libraries, educational establishments and museums, as well as by archives, film or audio heritage institutions and public-service broadcasting organisations.

(10)

Cinematographic or audiovisual works and phonograms in the archives of public-service broadcasting organisations and produced by them include orphan works. Taking into account the special position of broadcasters as producers of phonograms and audiovisual material and the need to adopt measures to limit the phenomenon of orphan works in the future, it is appropriate to set a cut-off date for the application of this Directive to works and phonograms in the archives of broadcasting organisations.

(11)

Cinematographic and audiovisual works and phonograms contained in the archives of public-service broadcasting organisations and produced by them, should for the purposes of this Directive be regarded as including cinematographic and audiovisual works and phonograms which are commissioned by such organisations for the exclusive exploitation by them or other co-producing public-service broadcasting organisations. Cinematographic and audiovisual works and phonograms contained in the archives of public-service broadcasting organisations which have not been produced or commissioned by such organisations, but which those organisations have been authorised to use under a licensing agreement, should not fall within the scope of this Directive.

(12)

For reasons of international comity, this Directive should apply only to works and phonograms that are first published in the territory of a Member State or, in the absence of publication, first broadcast in the territory of a Member State or, in the absence of publication or broadcast, made publicly accessible by the beneficiaries of this Directive with the consent of the rightholders. In the latter case, this Directive should only apply provided that it is reasonable to assume that the rightholders would not oppose the use allowed by this Directive.

(13)

Before a work or phonogram can be considered an orphan work, a diligent search for the rightholders in the work or phonogram, including rightholders in works and other protected subject-matter that are embedded or incorporated in the work or phonogram, should be carried out in good faith. Member States should be permitted to provide that such diligent search may be carried out by the organisations referred to in this Directive or by other organisations. Such other organisations may charge for the service of carrying out a diligent search.

(14)

It is appropriate to provide for a harmonised approach concerning such diligent search in order to ensure a high level of protection of copyright and related rights in the Union. A diligent search should involve the consultation of sources that supply information on the works and other protected subject-matter as determined, in accordance with this Directive, by the Member State where the diligent search has to be carried out. In so doing, Member States could refer to the diligent search guidelines agreed in the context of the High Level Working Group on Digital Libraries established as part of the i2010 digital library initiative.

(15)

In order to avoid duplication of search efforts, a diligent search should be carried out in the Member State where the work or phonogram was first published or, in cases where no publication has taken place, where it was first broadcast. The diligent search in respect of cinematographic or audiovisual works the producer of which has his headquarters or habitual residence in a Member State should be carried out in that Member State. In the case of cinematographic or audiovisual works which are co-produced by producers established in different Member States, the diligent search should be carried out in each of those Member States. With regard to works and phonograms which have neither been published nor broadcast but which have been made publicly accessible by the beneficiaries of this Directive with the consent of the rightholders, the diligent search should be carried out in the Member State where the organisation that made the work or phonogram publicly accessible with the consent of the rightholder is established. Diligent searches for the rightholders in works and other protected subject-matter that are embedded or incorporated in a work or phonogram should be carried out in the Member State where the diligent search for the work or phonogram containing the embedded or incorporated work or other protected subject-matter is carried out. Sources of information available in other countries should also be consulted if there is evidence to suggest that relevant information on rightholders is to be found in those other countries. The carrying-out of diligent searches may generate various kinds of information, such as a search record and the result of the search. The search record should be kept on file in order for the relevant organisation to be able to substantiate that the search was diligent.

(16)

Member States should ensure that the organisations concerned keep records of their diligent searches and that the results of such searches, consisting in particular of any finding that a work or phonogram is to be considered an orphan work within the meaning of this Directive, as well as information on the change of status and on the use which those organisations make of orphan works, are collected and made available to the public at large, in particular through the recording of the relevant information in an online database. Considering in particular the pan-European dimension, and in order to avoid duplication of efforts, it is appropriate to make provision for the creation of a single online database for the Union containing such information and for making it available to the public at large in a transparent manner. This can enable both the organisations which are carrying out diligent searches and the rightholders easily to access such information. The database could also play an important role in preventing and bringing to an end possible copyright infringements, particularly in the case of changes to the orphan work status of the works and phonograms. Under Regulation (EU) No 386/2012 (4), the Office for Harmonization in the Internal Market (‧the Office‧) is entrusted with certain tasks and activities, financed by making use of its own budgetary means, aimed at facilitating and supporting the activities of national authorities, the private sector and the Union institutions in the fight against, including the prevention of, infringement of intellectual property rights.

In particular, pursuant to point (g) of Article 2(1) of that Regulation, those tasks include providing mechanisms which help to improve the online exchange of relevant information between the Member States' authorities concerned and fostering cooperation between those authorities. It is therefore appropriate to rely on the Office to establish and manage the European database containing information related to orphan works referred to in this Directive.

(17)

There can be several rightholders in respect of a particular work or phonogram, and works and phonograms can themselves include other works or protected subject-matter. This Directive should not affect the rights of identified and located rightholders. If at least one rightholder has been identified and located, a work or phonogram should not be considered an orphan work. The beneficiaries of this Directive should only be permitted to use a work or phonogram one or more of the rightholders in which are not identified or not located, if they are authorised to carry out the acts of reproduction and of making available to the public covered by Articles 2 and 3 respectively of Directive 2001/29/EC by those rightholders that have been identified and located, including the rightholders of works and other protected subject-matter which are embedded or incorporated in the works or phonograms. Rightholders that have been identified and located can give this authorisation only in relation to the rights that they themselves hold, either because the rights are their own rights or because the rights were transferred to them, and should not be able to authorise under this Directive any use on behalf of rightholders that have not been identified and located. Correspondingly, when previously non-identified or non-located rightholders come forward in order to claim their rights in the work or phonogram, the lawful use of the work or phonogram by the beneficiaries can continue only if those rightholders give their authorisation to do so under Directive 2001/29/EC in relation to the rights that they hold.

(18)

Rightholders should be entitled to put an end to the orphan work status in the event that they come forward to claim their rights in the work or other protected subject-matter. Rightholders that put an end to the orphan work status of a work or other protected subject-matter should receive fair compensation for the use that has been made of their works or other protected subject-matter under this Directive, to be determined by the Member State where the organisation that uses an orphan work is established. Member States should be free to determine the circumstances under which the payment of such compensation may be organised, including the point in time at which the payment is due. For the purposes of determining the possible level of fair compensation, due account should be taken, inter alia, of Member States' cultural promotion objectives, of the non-commercial nature of the use made by the organisations in question in order to achieve aims related to their public-interest missions, such as promoting learning and disseminating culture, and of the possible harm to rightholders.

(19)

If a work or phonogram has been wrongly found to be an orphan work, following a search which was not diligent, the remedies for copyright infringement in Member States' legislation, provided for in accordance with the relevant national provisions and Union law, remain available.

(20)

In order to promote learning and the dissemination of culture, Member States should provide for an exception or limitation in addition to those provided for in Article 5 of Directive 2001/29/EC. That exception or limitation should permit certain organisations, as referred to in point (c) of Article 5(2) of Directive 2001/29/EC and film or audio heritage institutions which operate on a non-profit making basis, as well as public-service broadcasting organisations, to reproduce and make available to the public, within the meaning of that Directive, orphan works, provided that such use fulfils their public interest missions, in particular the preservation of, the restoration of, and the provision of cultural and educational access to, their collections, including their digital collections. Film or audio heritage institutions should, for the purposes of this Directive, cover organisations designated by Member States to collect, catalogue, preserve and restore films and other audiovisual works or phonograms forming part of their cultural heritage. Public-service broadcasters should, for the purposes of this Directive, cover broadcasters with a public-service remit as conferred, defined and organised by each Member State. The exception or limitation established by this Directive to permit the use of orphan works is without prejudice to the exceptions and limitations provided for in Article 5 of Directive 2001/29/EC. It can be applied only in certain special cases which do not conflict with the normal exploitation of the work or other protected subject-matter and do not unreasonably prejudice the legitimate interests of the rightholder.

(21)

In order to incentivise digitisation, the beneficiaries of this Directive should be allowed to generate revenues in relation to their use of orphan works under this Directive in order to achieve aims related to their public-interest missions, including in the context of public-private partnership agreements.

(22)

Contractual arrangements may play a role in fostering the digitisation of European cultural heritage, it being understood that publicly accessible libraries, educational establishments and museums, as well as archives, film or audio heritage institutions and public-service broadcasting organisations, should be allowed, with a view to undertaking the uses permitted under this Directive, to conclude agreements with commercial partners for the digitisation and making available to the public of orphan works. Those agreements may include financial contributions by such partners. Such agreements should not impose any restrictions on the beneficiaries of this Directive as to their use of orphan works and should not grant the commercial partner any rights to use, or control the use of, the orphan works.

(23)

In order to foster access by the Union's citizens to Europe's cultural heritage, it is also necessary to ensure that orphan works which have been digitised and made available to the public in one Member State may also be made available to the public in other Member States. Publicly accessible libraries, educational establishments and museums, as well as archives, film or audio heritage institutions and public-service broadcasting organisations that use an orphan work in order to achieve their public-interest missions should be able to make the orphan work available to the public in other Member States.

(24)

This Directive is without prejudice to the arrangements in the Member States concerning the management of rights such as extended collective licences, legal presumptions of representation or transfer, collective management or similar arrangements or a combination of them, including for mass digitisation.

(25)

Since the objective of this Directive, namely ensuring legal certainty with respect to the use of orphan works, cannot be sufficiently achieved by the Member States and can therefore, by reason of the need for uniformity of the rules governing the use of orphan works, 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 Directive does not go beyond what is necessary in order to achieve that objective,

(a)

works published in the form of books, journals, newspapers, magazines or other writings contained in the collections of publicly accessible libraries, educational establishments or museums as well as in the collections of archives or of film or audio heritage institutions;

(b)

cinematographic or audiovisual works and phonograms contained in the collections of publicly accessible libraries, educational establishments or museums as well as in the collections of archives or of film or audio heritage institutions; and

(c)

cinematographic or audiovisual works and phonograms produced by public-service broadcasting organisations up to and including 31 December 2002 and contained in their archives;

(a)

the results of the diligent searches that the organisations have carried out and which have led to the conclusion that a work or a phonogram is considered an orphan work;

(b)

the use that the organisations make of orphan works in accordance with this Directive;

(c)

any change, pursuant to Article 5, of the orphan work status of works and phonograms that the organisations use;

(d)

the relevant contact information of the organisation concerned.

(a)

by making the orphan work available to the public, within the meaning of Article 3 of Directive 2001/29/EC;

(b)

by acts of reproduction, within the meaning of Article 2 of Directive 2001/29/EC, for the purposes of digitisation, making available, indexing, cataloguing, preservation or restoration.

27.10.2012   

EN

Official Journal of the European Union

L 299/13

(1)

The European Council has asked Member States to inform the Commission as of 1 January 2012 of all their new and existing bilateral agreements with third countries in the field of energy. The Commission should make this information available to all other Member States in an appropriate form, having regard to the need for protection of commercially sensitive information.

(2)

Article 4 of the Treaty on European Union (TEU) requires Member States to take all appropriate measures to ensure fulfilment of the obligations arising out of the Treaties or resulting from the acts of the Union institutions. Member States should therefore avoid or eliminate any incompatibility between Union law and international agreements concluded between Member States and third countries.

(3)

The proper functioning of the internal energy market requires that the energy imported into the Union be fully governed by the rules establishing the internal energy market. An internal energy market that does not function properly puts the Union in a vulnerable and disadvantageous position with regard to security of energy supply, and undermines its potential benefits to European consumers and industry. A high degree of transparency with regard to agreements between Member States and third countries in the field of energy would allow the Union to take coordinated action, in the spirit of solidarity, in order to ensure that such agreements comply with Union law and effectively secure energy supply. Such transparency would also be of benefit in achieving both closer intra-Union cooperation in the field of external energy relations and the Union’s long-term policy objectives relating to energy, climate and security of energy supply.

(4)

A new information exchange mechanism should therefore be established. It should cover only intergovernmental agreements having an impact on the internal energy market or on the security of energy supply in the Union as the two issues are intrinsically linked. The initial assessment as to whether an intergovernmental agreement, or another text to which an intergovernmental agreement refers explicitly, has an impact on the internal energy market or the security of energy supply in the Union, should be the responsibility of Member States; in case of doubt, Member States should consult the Commission. In principle, agreements that are no longer in force or are no longer applied do not have an impact on the internal energy market or on the security of energy supply in the Union and should therefore not be covered by this information exchange mechanism. The information exchange mechanism should comprise in particular all intergovernmental agreements which have an impact on the supply of gas, oil or electricity through fixed infrastructure or which have an impact on the amount of energy imported into the Union.

(5)

Intergovernmental agreements which must be notified in their entirety to the Commission on the basis of other Union acts should be excluded from the information exchange mechanism. However, that exemption should not apply to intergovernmental agreements with third countries which have an impact on the development and use of gas infrastructure and gas supplies and which must be communicated to the Commission in accordance with point (a) of Article 13(6) of Regulation (EU) No 994/2010 of the European Parliament and of the Council of 20 October 2010 concerning measures to safeguard security of gas supply (3). Such agreements should be notified according to the rules laid down in this Decision. To avoid duplication, a notification submitted in accordance with this Decision should be considered to fulfil the obligation set out in point (a) of Article 13(6) of Regulation (EU) No 994/2010.

(6)

Intergovernmental agreements concerning matters within the purview of the Treaty establishing the European Atomic Energy Community should not be covered by this Decision.

(7)

This Decision does not create obligations as regards agreements between commercial entities. However, it does not prevent Member States from communicating to the Commission, on a voluntary basis, commercial agreements that are referred to explicitly in intergovernmental agreements. Furthermore, as it is possible that commercial agreements contain regulatory provisions, commercial operators negotiating commercial agreements with operators from third countries should have the possibility to seek guidance from the Commission in order to avoid potential conflicts with Union law.

(8)

Member States should submit to the Commission all existing intergovernmental agreements, whether they have entered into force or are being applied provisionally within the meaning of Article 25 of the Vienna Convention on the Law of Treaties, and all new intergovernmental agreements.

(9)

More transparency with regard to future intergovernmental agreements that will be negotiated or that are being negotiated between Member States and third countries in the field of energy could contribute to consistency in Member States’ approaches to such agreements, to compliance with Union law, and to the security of energy supply in the Union. Therefore, Member States should have the option of informing the Commission of negotiations with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements. Where Member States choose that option, the Commission should be kept informed regularly of the progress of the negotiations. Member States should have the possibility to invite the Commission to participate in the negotiations as an observer.

The Commission should also have the possibility to participate as an observer at its own request, subject to the approval of the Member State concerned. Member States should also have the possibility to request the Commission to assist them during their negotiations with third countries. In that case, the Commission should have the possibility to provide advice on how to avoid incompatibility with Union law, and to draw attention to the Union’s energy policy objectives and the principle of solidarity between Member States.

(10)

The Commission should assess the compatibility of existing intergovernmental agreements with Union law. In the event of incompatibility, Member States should take all necessary steps to find a suitable solution to eliminate the incompatibility identified.

(11)

In order to ensure more transparency and to avoid potential conflicts with Union law, Member States should have the option of informing the Commission of a new intergovernmental agreement with a third country before or during the negotiations thereof. Where a Member State, which has negotiated an intergovernmental agreement, has informed the Commission before the closure of negotiations accordingly and has submitted the draft intergovernmental agreement to it, the Commission should have the possibility to inform that Member State of its opinion on the compatibility of the negotiated agreement with Union law. The Commission has the right to launch infringement proceedings in accordance with Article 258 of the Treaty on the Functioning of the European Union (TFEU), where it considers that a Member State has failed to fulfil its obligations under the TFEU.

(12)

All final, ratified intergovernmental agreements covered by this Decision should be transmitted to the Commission in order to enable all other Member States to be informed.

(13)

The Commission should make all information it receives available to all other Member States in secure electronic form. The Commission should respect requests from Member States to treat information submitted to it as confidential. Requests for confidentiality should, however, not restrict access of the Commission itself to confidential information, as the Commission needs to have comprehensive information for its own assessments. The Commission should be responsible for guaranteeing the application of the confidentiality clause. Requests for confidentiality should be without prejudice to the right of access to documents as provided for in Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (4).

(14)

If a Member State considers an intergovernmental agreement to be confidential, it should provide the Commission with a summary of it for the purposes of sharing that summary with the other Member States.

(15)

A permanent exchange of information on intergovernmental agreements at Union level should enable best practices to be developed. On the basis of those best practices, the Commission, where appropriate in cooperation with the European External Action Service (EEAS) as regards the Union’s external policies, should develop optional model clauses to be used in intergovernmental agreements between Member States and third countries. The use of such model clauses should aim to avoid conflicts of intergovernmental agreements with Union law, in particular competition law and internal energy market rules, and conflicts with international agreements concluded by the Union. Their use should be optional, and it should be possible to adapt their content to any particular circumstance.

(16)

Given the existence of the internal energy market and the objectives of Union energy policy, Member States should take due account of those objectives when negotiating intergovernmental agreements in the field of energy that have an impact on Union energy policy.

(17)

The improved mutual knowledge of existing and new intergovernmental agreements should allow for better coordination in energy matters between Member States and between Member States and the Commission. Such improved coordination should enable Member States to benefit fully from the political and economic weight of the Union and enable the Commission to propose solutions for problems identified in the area of intergovernmental agreements.

(18)

The Commission should facilitate and encourage coordination between Member States with a view to enhancing the overall strategic role of the Union through a strong and effective coordinated approach to producer, transit, and consumer countries.

(19)

The information exchange mechanism, including assessments to be made by Member States in implementing it, is without prejudice to the application of the Union rules on infringements, State aid and competition.

(20)

The Commission should assess whether this Decision is sufficient and effective in ensuring compliance of intergovernmental agreements with Union law and a high level of coordination between Member States with regard to intergovernmental agreements in the field of energy.

(21)

Since the objective of this Decision, namely the exchange of information between Member States and the Commission with regard to intergovernmental agreements in the field of energy, cannot be sufficiently achieved by the Member States but can rather, by reason of the effects of this Decision, be better achieved at 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 Decision does not go beyond what is necessary in order to achieve this objective,

(1)

‘intergovernmental agreement’ means any legally binding agreement between one or more Member States and one or more third countries having an impact on the operation or the functioning of the internal energy market or on the security of energy supply in the Union; however, where such a legally binding agreement also covers other issues, only those provisions that relate to energy, including general provisions applicable to those energy-related provisions, shall constitute an ‘intergovernmental agreement’;

(2)

‘existing intergovernmental agreement’ means an intergovernmental agreement which entered into force or is applied provisionally prior to the entry into force of this Decision.

(a)

the subject matter;

(b)

the aim and the scope;

(c)

the duration;

(d)

the contracting parties;

(e)

information on the main elements.

(a)

reviewing developments in relation to intergovernmental agreements and striving for consistency and coherence in the Union’s external energy relations with producer, transit, and consumer countries;

(b)

identifying common problems in relation to intergovernmental agreements and considering appropriate action to address those problems and, where appropriate, proposing solutions;

(c)

on the basis of best practice and in consultation with Member States, developing optional model clauses, which, if applied, would significantly improve compliance of future intergovernmental agreements with Union law;

(d)

supporting, where appropriate, the development of multilateral intergovernmental agreements involving several Member States or the Union as a whole.

27.10.2012   

EN

Official Journal of the European Union

L 299/18

(1)

In order to take into account the developments in the area of statistics on science and technology, as well as requests for new and more detailed and frequent statistics, new implementing measures of Decision No 1608/2003/EC should be laid down.

(2)

Existing statistical support for decisions in current policy areas should be continued and additional requirements arising from new policy initiatives should be satisfied, with a view to making best use of available resources and minimising the response burden.

(3)

Regulation (EC) No 223/2009 of the European Parliament and of the Council (2) on European statistics provides a reference framework, in particular with regard to rules on access to administrative data sources and statistical confidentiality.

(4)

It is necessary to ensure that European statistics on science and technology are consistent with other international standards. To that end, work carried out by the Organisation for Economic Cooperation and Development (OECD) and other international organisations should be taken into account. In particular, the Frascati Manual on research and development statistics, the Canberra Manual on statistics on human resources devoted to science and technology, the OECD Patent Statistics Manual, published by the OECD, as well as the Oslo Manual on innovation statistics, published jointly by the OECD and the European Commission (Eurostat), should provide a reference framework.

(5)

For the sake of clarity, Commission Regulation (EC) No 753/2004 of 22 April 2004 implementing Decision No 1608/2003/EC of the European Parliament and of the Council as regards statistics on science and technology (3) and Commission Regulation (EC) No 1450/2004 of 13 August 2004 implementing Decision No 1608/2003/EC of the European Parliament and of the Council concerning the production and development of Community statistics on innovation (4) should be repealed.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

(a)

statistics on research and development (R & D);

(b)

statistics on government budget appropriations or outlays on research and development (GBAORD);

(c)

innovation statistics;

(d)

statistics on human resources in science and technology, including gender and mobility statistics, statistics on patents, statistics on high-technology industries and knowledge-based services and other statistics on science and technology.

(a)

research and development (R & D);

(b)

government budget appropriations or outlays on research and development (GBAORD);

(c)

innovation.

27.10.2012   

EN

Official Journal of the European Union

L 299/31

(1)

Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.

(2)

Following the accident at the Fukushima nuclear power station on 11 March 2011, the Commission was informed that radionuclide levels in certain food products originating in Japan exceeded the action levels in food applicable in Japan. Such contamination may constitute a threat to public and animal health in the Union and therefore Commission Implementing Regulation (EU) No 297/2011 of 25 March 2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station (2) was adopted. That Regulation was replaced by Commission Implementing Regulation (EU) No 961/2011 (3) which was later replaced by Commission Implementing Regulation (EU) No 284/2012 (4).

(3)

Implementing Regulation (EU) No 284/2012 has been amended several times to take into account the development of the situation. Since now further amendments are required, it is appropriate to replace Implementing Regulation (EU) No 284/2012 by a new Regulation.

(4)

The existing measures have been reviewed taking into account more than 26 000 occurrence data on radioactivity in feed and food provided by the Japanese authorities concerning the second growing season after the accident.

(5)

It is appropriate to exclude personal consignments from the application of the provisions of this Regulation. For food and feed of animal orgin reference should be made to the provisions provided for in Commission Regulation (EC) No 206/2009 of 5 March 2009 on the introduction into the Community of personal consingments of products of animal origin and amending Regulation (EC) 136/2004 (5). For other feed and food, it should be provided that consignments can only be considered as personal consignments if they are non-commercial and are destined to a private person for personal consumption or use.

(6)

The Japanese authorities have provided extensive information to the Commission that in addition to the already exempted alcoholic beverages (sake, whiskey and shochu) also other alcoholic beverages do not contain measurable levels of radioactivity. The process of polishing and fermentation reduces the radioactivity in the alcoholic beverage to a significant extent. It is therefore appropriate to exclude certain other alcoholic beverages from the scope of this Regulation in order to reduce the administrative burden for the Japanese authorities and the competent authorities of the importing Member States.

(7)

The data submitted by the Japanese authorities provide evidence that it is no longer necessary to require the sampling and analysis of feed and food originating in the prefectures of Yamanashi and Shizuoka on the presence of radioactivity before export to the Union. The requirement for sampling and analyses should only be maintained for tea from Shizuoka and mushrooms from Shizuoka and Yamanashi.

(8)

Since non-compliant or significant levels of radioactivity continue to be found in feed and food originating in the prefecture of Fukushima, it is appropriate to maintain the existing requirement of sampling and analysis before export to the Union for all feed and food originating in that prefecture. However, the general exemptions, such as for alcoholic beverages and personal consignments, should continue to apply in relation to such feed and food.

(9)

As regards the prefectures of Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Iwate, Chiba and Kanagawa for which it is currently required to sample and analyse all feed and food before export to the Union, it is appropriate to limit that requirement to mushrooms, tea, fishery products, certain edible wild plants, certain vegetables, certain fruits, rice and soybeans and the processed and derived products thereof. The same requirements should apply to compound foodstuffs containing more than 50 % of (an) ingredient(s) for which pretesting before export to the Union is required.

(10)

The controls performed at import show that the special conditions provided for by Union law are correctly implemented by the Japanese authorities and non-compliance has not occurred for more than a year. Therefore it is appropriate to reduce the frequency of controls at import and the reporting of the results to the Commission.

(11)

It is appropriate to foresee a next review of the provisions when the results of sampling and analysis on the presence of radioactivity of feed and food of the third growing season after the accident will be available, i.e. by 31 March 2014. However, for the products for which the harvest is mainly in the second part of the second growing season and therefore all the data of the second growing season are not yet available, it is appropriate to foresee a review of the provisions for these products by 31 March 2013.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

products which left Japan before 28 March 2011;

(b)

products which have been harvested and/or processed before 11 March 2011;

(c)

alcoholic beverages falling within CN codes 2203 to 2208;

(d)

personal consignments of feed and food of animal origin which are covered by Article 2 of Regulation (EC) 206/2009;

(e)

personal consignments of feed and food other than of animal origin which are not-commercial and destined to a private person for personal consumption and use only. In case of doubt, the burden of proof lies with the recipient of the consignment.

(a)

attest that the products comply with the legislation in force in Japan and

(b)

specify whether the products are falling or not under the transitional measures provided for in the Japanese legislation.

(a)

the product has been harvested and/or processed before 11 March 2011; or

(b)

the product, other than tea and mushrooms originating in the prefecture Shizuoka and other than mushrooms originating in the prefecture Yamanashi, originates in and is consigned from a prefecture other than Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate; or

(c)

the product originates in and is consigned from Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate but is not listed in Annex IV to this Regulation (and consequently no analysis before export is required); or

(d)

the product is consigned from Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate prefectures, but does not originate in one of those prefectures and has not been exposed to radioactivity during transiting; or

(e)

where the product is tea or mushrooms originating in Shizuoka prefecture or mushrooms originating in Yamanashi prefecture, or a derived product thereof or a compound feed or food containing more than 50 % of these products, the product is accompanied by an analytical report containing the results of sampling and analysis; or

(f)

where the product, listed in Annex IV to this Regulation, originates in Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate prefectures, or is a compound feed or food containing more than 50 % of these products, the product is accompanied by an analytical report containing the results of sampling and analysis. The list of products in Annex IV is without prejudice to the requirements of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (7); or

(g)

where the origin of the product or of the ingredients present at more than 50 % is unknown, the product is accompanied by an analytical report containing the results of sampling and analysis.

(a)

documentary checks on all consignments of products referred to in Article 1;

(b)

physical checks and identity checks, including laboratory analysis on the presence of caesium-134 and caesium-137, on 5 % of the consignments.

(a)

has been duly endorsed by the competent authority at the border inspection post or designated point of entry; and

(b)

provides evidence that the official controls referred to in Article 10 have been carried out and that the results of those controls have been favourable.

(a)

the products left Japan before the entry into force of this Regulation; or

(b)

the products are accompanied by a declaration in accordance with Implementing Regulation (EU) No 284/2012 which was issued before 1 November 2012 and the products have left Japan before 1 December 2012.

27.10.2012   

EN

Official Journal of the European Union

L 299/42

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

27.10.2012   

EN

Official Journal of the European Union

L 299/44

(1)

According to the Protocol on Transitional Provisions annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community, the legal effects of the acts of the institutions, bodies, offices and agencies of the Union adopted prior to the entry into force of the Treaty of Lisbon are preserved until those acts are repealed, annulled or amended in implementation of the Treaties.

(2)

Accordingly, Article 25 of Decision 2008/615/JHA is applicable and the Council must unanimously decide whether the Member States have implemented the provisions of Chapter 6 of that Decision.

(3)

Article 20 of Decision 2008/616/JHA provides that decisions referred to in Article 25(2) of Decision 2008/615/JHA are to be taken on the basis of an evaluation report based on a questionnaire. With respect to automated data exchange in accordance with Chapter 2 of Decision 2008/615/JHA, the evaluation report is to be based on an evaluation visit and a pilot run.

(4)

According to Chapter 4, point 1.1, of the Annex to Decision 2008/616/JHA, the questionnaire drawn up by the relevant Council Working Group concerns each of the automated data exchanges and has to be answered by a Member State as soon as it believes it fulfils the prerequisites for sharing data in the relevant data category.

(5)

Sweden has completed the questionnaire on data protection and the questionnaire on Vehicle Registration Data (VRD).

(6)

A successful pilot run has been carried out by Sweden with the Netherlands.

(7)

An evaluation visit has taken place in Sweden and a report on the evaluation visit has been produced by the Belgian/Dutch evaluation team and forwarded to the relevant Council Working Group.

(8)

An overall evaluation report, summarising the results of the questionnaire, the evaluation visit and the pilot run concerning VRD has been presented to the Council,

27.10.2012   

EN

Official Journal of the European Union

L 299/45

(1)

On 25 October 2010, by Decision 2010/638/CFSP (1) the Council imposed restrictive measures against the Republic of Guinea.

(2)

On the basis of a review of Decision 2010/638/CFSP, the restrictive measures should be extended until 27 October 2013.

(3)

It is necessary to amend the measures relating to the arms embargo provided for in Decision 2010/638/CFSP.

(4)

Decision 2010/638/CFSP should therefore be amended accordingly,

(1)

Article 2(1) is amended as follows:

(2)

In Article 8, paragraph 2 is replaced by the following:

‘2.   This Decision shall apply until 27 October 2013. It shall be kept under constant review. It may be renewed or amended, as appropriate, if the Council deems that its objectives have not been met.’.

27.10.2012   

EN

Official Journal of the European Union

L 299/46

(1)

Commission Decision 2008/855/EC of 3 November 2008 concerning animal health control measures relating to classical swine fever in certain Member States (3) lays down certain control measures in relation to classical swine fever in the Member States or regions thereof listed in the Annex thereto. That list includes the county of Nógrád in Hungary.

(2)

Hungary has informed the Commission about recent developments with regard to classical swine fever in the territory of the county of Nógrád listed in the Annex to Decision 2008/855/EC.

(3)

That information indicates that classical swine fever has been eradicated in the territory of the county of Nógrád. Accordingly, the measures provided for in Decision 2008/855/EC should no longer apply to that county and the reference to the county of Nógrád in the list set out in Part I of the Annex thereto should be deleted.

(4)

Decision 2008/855/EC should therefore be amended accordingly.

(5)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

27.10.2012   

EN

Official Journal of the European Union

L 299/47

(1)

In accordance with Article 75 of the Financial Regulation and Article 90(1) of the Implementing Rules, the commitment of expenditure from the Union budget shall be preceded by a financing decision setting out the essential elements of the action involving expenditure and adopted by the institution or the authorities to which powers have been delegated by the institution.

(2)

Decision 2009/470/EC lays down the procedures governing the financial contribution from the Union towards specific veterinary measures, including emergency measures. With a view to helping to eradicate avian influenza as rapidly as possible the Union should contribute financially to eligible expenditure borne by the Member States. Article 4(3) first and second indents of that Decision lays down rules on the percentage that must be applied to the costs incurred by the Member States.

(3)

Article 3 of Commission Regulation (EC) No 349/2005 of 28 February 2005 laying down rules on the Community financing of emergency measures and of the campaign to combat certain animal diseases under Council Decision 90/424/EEC (2) sets rules on the expenditure eligible for Union financial support.

(4)

Commission Implementing Decision 2012/132/EU of 15 February 2012 on a financial contribution from the Union towards emergency measures to combat avian influenza in Germany, Italy and the Netherlands in 2011 (3) granted a financial contribution by the Union towards emergency measures to combat avian influenza in the Netherlands in 2011. An official request for reimbursement was submitted by the Netherlands on 13 April 2012, as set out in Article 7(1) and 7(2) of Regulation (EC) No 349/2005.

(5)

The payment of the financial contribution from the Union is to be subject to the condition that the planned activities were actually implemented and that the authorities provided all the necessary information within the set deadlines.

(6)

The Netherlands have in accordance with Article 3(4) of Decision 2009/470/EC without delay informed the Commission and the other Member States of the measures applied in accordance with Union legislation on notification and eradication and the results thereof. The request for reimbursement was, as required in Article 7 of Regulation (EC) No 349/2005, accompanied by a financial report, supporting documents, an epidemiological report on each holding where the animals have been slaughtered or destroyed and the results of respective audits.

(7)

The Commission’s observations, method of calculating the eligible expenditure and final conclusions were communicated to the Netherlands on 25 April 2012 and 4 June 2012. The Netherlands agreed by e-mail dated 11 June 2012.

(8)

Consequently the total amount of the financial support from the Union to the eligible expenditure incurred in connection with the eradication of avian influenza in the Netherlands in 2011 can now be fixed.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

27.10.2012   

EN

Official Journal of the European Union

L 299/49

(1)

In accordance with Article 75 of the Financial Regulation and Article 90(1) of the Implementing Rules, the commitment of expenditure from the Union budget shall be preceded by a financing decision setting out the essential elements of the action involving expenditure and adopted by the institution or the authorities to which powers have been delegated by the institution.

(2)

Decision 2009/470/EC lays down the procedures governing the financial contribution from the Union towards specific veterinary measures, including emergency measures. With a view to helping to eradicate foot-and-mouth disease as rapidly as possible the Union should contribute financially to eligible expenditure borne by the Member States. Article 14(4) of that Decision lays down rules on the percentage that must be applied to the costs incurred by the Member States.

(3)

Article 3 of Commission Regulation (EC) No 349/2005 of 28 February 2005 laying down rules on the Community financing of emergency measures and of the campaign to combat certain animal diseases under Council Decision 90/424/EEC (2) sets rules on the expenditure eligible for Union financial support.

(4)

Commission Implementing Decision 2011/730/EU of 9 November 2011 on a financial contribution from the Union towards emergency measures to combat foot-and-mouth disease in Bulgaria in 2011 (3) granted a financial contribution by the Union towards emergency measures to combat foot-and-mouth disease in Bulgaria in 2011. An official request for reimbursement was submitted by Bulgaria on 9 December 2011 and 24 January 2012, as set out in Articles 7(1) and 7(2) of Regulation (EC) No 349/2005.

(5)

The payment of the financial contribution from the Union is to be subject to the condition that the planned activities were actually implemented and that the authorities provided all the necessary information within the set deadlines.

(6)

Bulgaria has in accordance with Article 14(3) of Decision 2009/470/EC without delay informed the Commission and the other Member States of the measures applied in accordance with Union legislation on notification and eradication and the results thereof. The request for reimbursement was, as required in Article 7 of Regulation (EC) No 349/2005, accompanied by a financial report, supporting documents, an epidemiological report on each holding where the animals have been slaughtered or destroyed and the results of respective audits.

(7)

The Commission’s observations, method of calculating the eligible expenditure and final conclusions were communicated to Bulgaria on 19 June 2012. Bulgaria agreed by e-mail dated 20 June 2012.

(8)

Consequently the total amount of the financial support from the Union to the eligible expenditure incurred in connection with the eradication of foot-and-mouth disease in Bulgaria in 2011 can now be fixed.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,