ISSN 1977-0677

doi:10.3000/19770677.L_2012.356.eng

Official Journal

of the European Union

L 356

European flag  

English edition

Legislation

Volume 55
22 December 2012


Contents

 

II   Non-legislative acts

page

 

 

INTERNATIONAL AGREEMENTS

 

 

2012/828/EU

 

*

Council Decision of 13 November 2012 on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand

1

Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand

2

 

 

REGULATIONS

 

*

Council Regulation (EU) No 1261/2012 of 20 December 2012 fixing for 2013 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Black Sea

19

 

*

Council Regulation (EU) No 1262/2012 of 20 December 2012 fixing for 2013 and 2014 the fishing opportunities for EU vessels for certain deep-sea fish stocks

22

 

*

Council Regulation (EU) No 1263/2012 of 21 December 2012 amending Regulation (EU) No 267/2012 concerning restrictive measures against Iran

34

 

*

Council Implementing Regulation (EU) No 1264/2012 of 21 December 2012 implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran

55

 

*

Commission Implementing Regulation (EU) No 1265/2012 of 17 December 2012 amending Implementing Regulation (EU) No 837/2012 as regards the minimum activity of a preparation of 6-phytase produced by Aspergillus oryzae (DSM 22594) as feed additive for poultry, weaned piglets, pigs for fattening and sows (holder of authorisation DSM Nutritional Products) ( 1 )

61

 

 

Commission Implementing Regulation (EU) No 1266/2012 of 21 December 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

63

 

 

Commission Implementing Regulation (EU) No 1267/2012 of 21 December 2012 fixing the import duties in the cereals sector applicable from 1 January 2013

65

 

 

DIRECTIVES

 

*

Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State ( 1 )

68

 

 

DECISIONS

 

*

Council Decision 2012/829/CFSP of 21 December 2012 amending Decision 2010/413/CFSP concerning restrictive measures against Iran

71

 

 

2012/830/EU

 

*

Commission Implementing Decision of 7 December 2012 on an additional financial contribution towards Member States’ fisheries control, inspection and surveillance programmes for 2012 (notified under document C(2012) 8967)

78

 

 

2012/831/EU

 

*

Commission Decision of 20 December 2012 authorising Spain to extend the temporary suspension of the application of Articles 1 to 6 of Regulation (EU) No 492/2011 of the European Parliament and of the Council on freedom of movement for workers within the Union with regard to Romanian workers

90

 

 

2012/832/EU

 

*

Decision of the European Central Bank of 10 December 2012 amending Decision ECB/2010/21 on the annual accounts of the European Central Bank (ECB/2012/30)

93

 

 

GUIDELINES

 

 

2012/833/EU

 

*

Guideline of the European Central Bank of 10 December 2012 amending Guideline ECB/2010/20 on the legal framework for accounting and financial reporting in the European System of Central Banks (ECB/2012/29)

94

 

 

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

 

 

2012/834/EU

 

*

Decision No 2/2012 of the Joint European Union/Switzerland Air Transport Committee set up under the Agreement between the European Community and the Swiss Confederation on Air Transport of 30 November 2012 replacing the Annex to the Agreement between the European Community and the Swiss Confederation on Air Transport

109

 


 

(1)   Text with EEA relevance

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


II Non-legislative acts

INTERNATIONAL AGREEMENTS

22.12.2012   

EN

Official Journal of the European Union

L 356/1


COUNCIL DECISION

of 13 November 2012

on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand

(2012/828/EU)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4), in conjunction with Article 218(6)(a)(v) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament,

Whereas:

(1)

The Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (1) entered into force on 1 January 1999 (2).

(2)

In accordance with Council Decision 2011/464/EU (3), the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (‘the Agreement’) was signed by the Commission on 23 February 2012, subject to its conclusion.

(3)

As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community.

(4)

The Agreement should be concluded,

HAS ADOPTED THIS DECISION:

Article 1

The Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (‘the Agreement’) is hereby approved on behalf of the Union.

The text of the Agreement is attached to this Decision.

Article 2

The President of the Council shall designate the person empowered to proceed, on behalf of the Union, to transmitting the diplomatic notes provided for in Article 2 of the Agreement, in order to express the consent of the Union to be bound by the Agreement (4).

Article 3

This Decision shall enter into force on the day of its adoption.

Done at Brussels, 13 November 2012.

For the Council

The President

V. SHIARLY


(1)  OJ L 229, 17.8.1998, p. 62.

(2)  OJ L 5, 9.1.1999, p. 74.

(3)  OJ L 195, 27.7.2011, p. 1.

(4)  The date of entry into force of the Agreement will be published in the Official Journal of the European Union by the General Secretariat of the Council.


AGREEMENT

between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand

THE EUROPEAN UNION

and

NEW ZEALAND,

hereinafter ‘the Parties’,

HAVING concluded the Agreement on mutual recognition in relation to conformity assessment (1), done at Wellington on 25 June 1998 (hereinafter ‘the Agreement on Mutual Recognition’);

NOTING the need to simplify the operation of the Agreement on Mutual Recognition;

WHEREAS Article 3 of the Agreement on Mutual Recognition sets out the form of the Sectoral Annexes in detail, and, specifically, provides that Section II of each Sectoral Annex to the Agreement shall contain a list of the designated conformity assessment bodies;

WHEREAS Article 4 of the Agreement on Mutual Recognition restricts the application of the Agreement to products that originate in the Parties according to non-preferential rules of origin;

WHEREAS Article 12 of the Agreement on Mutual Recognition establishes a Joint Committee that, inter alia, gives effect to decisions on the inclusion of conformity assessment bodies in, and their removal from, the Sectoral Annexes and sets out a procedure for such inclusion and removal;

WHEREAS Articles 8 and 12 of the Agreement on Mutual Recognition refer to the Chair of the Joint Committee;

WHEREAS Article 12 of the Agreement on Mutual Recognition does not explicitly empower the Joint Committee to amend the Sectoral Annexes, except to give effect to the decision by a designating authority to designate or to withdraw designation of a particular conformity assessment body;

CONSIDERING that Article 3 of the Agreement on Mutual Recognition should be amended, both to reflect the changes proposed to Article 12 thereof to limit the requirement for the Joint Committee to take action on the recognition or withdrawal of recognition of conformity assessment bodies to cases that have been contested by the other Party under Article 8 of the Agreement on Mutual Recognition, and to allow greater flexibility in the structure of Sectoral Annexes to the Agreement;

CONSIDERING that in order that trade between the Parties is not unnecessarily restricted, the origin restriction in Article 4 of the Agreement on Mutual Recognition should be deleted;

CONSIDERING that in order to reflect the fact that the Joint Committee is co-chaired by the Parties, the references to the Chair of the Joint Committee should be deleted from Articles 8 and 12 of the Agreement on Mutual Recognition;

CONSIDERING that enhanced exchange of information between the Parties regarding the operation of the Agreement on Mutual Recognition will facilitate its operation;

CONSIDERING that in order to make timely adaptations to the Sectoral Annexes so as to take account of technical progress, and other factors such as enlargement of the European Union, the Joint Committee should be explicitly empowered in Article 12 of the Agreement on Mutual Recognition to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or to withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes;

CONSIDERING that in order to simplify the operation of the Agreement on Mutual Recognition, the need for the Joint Committee to take decisions on the recognition or withdrawal of recognition of conformity assessment bodies should be limited to cases that have been contested by the other Party under Article 8 of the Agreement on Mutual Recognition;

CONSIDERING that in order to simplify the operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition, and suspension of conformity assessment bodies should be set up in Article 12 thereof, and the position regarding conformity assessment carried out by bodies before their designation is suspended or withdrawn should be clarified;

CONSIDERING that the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia is identical in form to the Agreement on Mutual Recognition, and is therefore being amended in parallel in order to retain coherence between the Agreements;

CONSIDERING that the legal references and mode of operation of the Sectoral Annexes on medicinal products GMP inspection and batch certification and on medical devices are outdated, and the opportunity has been taken to amend them to reflect the current position,

HAVE AGREED AS FOLLOWS:

Article 1

Amendments to the Agreement on Mutual Recognition

The Agreement on Mutual Recognition is hereby amended as follows:

1.

Article 3(2) is replaced by the following:

‘2.   Each Sectoral Annex shall, in general, contain the following information:

(a)

a statement of its scope and coverage;

(b)

the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures;

(c)

the designating authorities;

(d)

a set of procedures for the designation of conformity assessment bodies, and

(e)

additional provisions as required.’.

2.

Article 4 is replaced by the following:

‘Article 4

Scope and coverage

This Agreement shall apply to products specified in the statement of scope and coverage in each Sectoral Annex.’.

3.

Article 6 is replaced by the following:

‘Article 6

Designating authorities

1.   The Parties shall ensure that the designating authorities responsible for designating conformity assessment bodies have the necessary power and competence to designate, suspend, remove suspension and withdraw the designation of such bodies.

2.   In making such designations, suspensions, removals of suspension and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.’.

4.

Article 7(1) is replaced by the following:

‘1.   The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.’.

5.

Article 8 is amended as follows:

(a)

paragraph 3 is replaced by the following:

‘3.   Such contestation has to be justified in an objective and argued manner and in writing to the other Party and to the Joint Committee.’;

(b)

paragraph 6 is replaced by the following:

‘6.   Except when decided otherwise by the Joint Committee, the contested conformity assessment body shall be suspended by the competent designating authority from the time its technical competence and compliance is contested in accordance with this Article until either agreement is reached in the Joint Committee on the status of that body or the challenging Party notifies the other Party and the Joint Committee that it is satisfied as to the technical competence and compliance of that body.’.

6.

Article 9 is replaced by the following:

‘Article 9

Exchange of information

1.   The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement.

2.   Consistent with their obligations under the World Trade Organization Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except as provided for in paragraph 3 of this Article, notify the other Party of the new provisions at least 60 calendar days before their entry into force.

3.   Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to manage a risk posed by a product covered by a Sectoral Annex, it shall notify immediately the other Party of the measures, with a brief indication of their objective and rationale, or as otherwise specified in the Sectoral Annex.’.

7.

Paragraphs 3 to 7 of Article 12 are replaced by the following:

‘3.   The Joint Committee shall meet at least once a year unless the Joint Committee or the Parties decide otherwise. If required for the effective functioning of this Agreement, or at the request of either Party, an additional meeting or meetings shall be held.

4.   The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for:

(a)

amending the Sectoral Annexes in accordance with this Agreement;

(b)

exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies maintain the necessary level of competence;

(c)

in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements;

(d)

exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes including those which require modification of the Sectoral Annexes;

(e)

resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and

(f)

adopting new Sectoral Annexes in accordance with this Agreement.

5.   Any amendments to the Sectoral Annexes made in accordance with this Agreement and any new Sectoral Annexes adopted in accordance with this Agreement shall be notified promptly in writing by the Joint Committee to each Party, and shall come into effect as determined by the Joint Committee.

6.   The following procedure shall apply in relation to the designation of a conformity assessment body:

(a)

a Party wishing to designate a conformity assessment body shall forward its proposal to that effect to the other Party in writing, adding supporting documentation, as may be defined by the Joint Committee;

(b)

in the event that the other Party consents to the proposal or upon the expiry of 60 calendar days without an objection having been lodged, in accordance with any applicable procedures established by the Joint Committee, the conformity assessment body shall be considered to be a designated conformity assessment body under the terms of Article 5;

(c)

in the event that, under Article 8, the other Party contests the technical competence or compliance of the proposed conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8;

(d)

in the case of the designation of a new conformity assessment body, conformity assessment carried out by such a body shall be valid from the date on which it becomes a designated conformity assessment body in accordance with this Agreement;

(e)

either Party may suspend, remove the suspension of, or withdraw the designation of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party and the Joint Committee of its decision in writing, together with the date of such decision. The suspension, removal of suspension or withdrawal of the designation shall take effect from the date of the Party’s decision;

(f)

in accordance with Article 8, either Party may, in exceptional circumstances, contest the technical competence of a designated conformity assessment body under the jurisdiction of the other Party. In this case the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8.

7.   In the event that the designation of a conformity assessment body is suspended or withdrawn, conformity assessment carried out by that body before the date of effect of the suspension or withdrawal shall remain valid unless either the responsible Party has limited or cancelled that validity, or the Joint Committee determines otherwise. The Party under whose jurisdiction the suspended or withdrawn conformity assessment body was operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity.’.

8.

Article 15 is amended as follows:

(a)

paragraph 3 is replaced by the following:

‘3.   The Joint Committee may adopt Sectoral Annexes to which Article 2 applies and which will provide the implementing arrangements for this Agreement.’;

(b)

paragraph 4 is replaced by the following:

‘4.   Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee.’.

9.

The Annex is hereby amended as follows:

(a)

paragraph 9 is replaced by the following:

‘9.

Designating authorities shall inform their Party’s representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be designated, suspended or withdrawn. The designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with this Agreement and the rules of procedure of the Joint Committee.’;

(b)

paragraph 10 is replaced by the following:

‘10.

When advising their Party’s representative on the Joint Committee established under this Agreement, of the conformity assessment bodies to be designated, the designating authority shall provide the following details in respect of each conformity assessment body:

(a)

the name;

(b)

the postal address;

(c)

the facsimile (fax) number and e-mail address;

(d)

the range of products, processes, standards or services it is authorised to assess;

(e)

the conformity assessment procedures it is authorised to carry out; and

(f)

the designation procedure used to determine competence.’.

10.

The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following:

‘SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY – NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT

SCOPE AND COVERAGE

1.

The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in New Zealand and in the European Union, and to which Good Manufacturing Practice (GMP) requirements apply.

For medicinal products covered by this Sectoral Annex, each Party will recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.

In addition, the manufacturer’s certification of the conformity of each batch to its specifications will be recognised by the other Party without re-control at import.

‘Medicinal products’ means all products regulated by the pharmaceutical legislation in the European Union and New Zealand referred to in Section I. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homoeopathic medicinal products.

‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled during manufacture to the quality standards appropriate to their intended use and as required by the marketing authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification (equivalent to Qualified Person certification in the European Union).

2.

With respect to medicinal products covered by the legislation of one Party (‘regulating Party’) but not the other, the manufacturing company may request the authority nominated by the relevant contact point of the regulating Party listed in point 12 of Section III, for the purpose of this Agreement, that an inspection be made by the locally competent inspection service. This provision will apply, inter alia, to the manufacture of active pharmaceutical ingredients and intermediate products and products intended for use in clinical trials, as well as jointly determined pre-marketing inspections. Operational arrangements are detailed under point 3(b) of Section III.

Certification of manufacturers

3.

At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products will certify that the manufacturer:

is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation;

is regularly inspected by the authorities, and

complies with the national GMP requirements recognised as equivalent by the two Parties, referred to in Section I. Where different GMP requirements are used as a reference (in line with the provisions in point 3(b) of Section III), this is to be mentioned in the certificate.

The certificates will also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of the certificate will be decided by the Joint Sectoral Group.

Certificates will be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 calendar days.

Batch certification

4.

Each batch exported will be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate will attest that the batch meets its specifications and will be kept by the importer of the batch. It will be made available upon request of the competent authority.

When issuing a certificate, the manufacturer will take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It will contain a statement that the batch processing and packaging records were reviewed and found to be in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the ‘qualified person’ as referred to in relevant European Union legislation. In New Zealand, the responsible person is named on the licence to manufacture issued under the relevant New Zealand legislation.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS

Subject to Section III, general GMP inspections will be carried out against the GMP requirements of the exporting Party. The applicable legislative, regulatory and administrative provisions related to this Sectoral Annex are set out in the Table.

However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, will be those of the relevant product marketing authorisation granted by the importing Party.

Applicable legislative, regulatory and administrative provisions for the European Union

Applicable legislative, regulatory and administrative provisions for New Zealand

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products, as amended

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended

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, as amended

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as amended

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, as amended

Guide to Good Distribution Practice (94/C 63/03)

Volume 4 — Guidelines for good manufacturing practices for medicinal products for human and veterinary use

Medicines Act, 1981

Medicines Regulations, 1984

New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Parts 1, 2, 4 and 5

Agricultural Compounds and Veterinary Medicines Act, 1997

Agricultural Compounds and Veterinary Medicines Regulations, 2001

Agricultural Compounds and Veterinary Medicines (ACVM) Standard for Good Manufacturing Practice

Agricultural Compounds and Veterinary Medicines (ACVM) Guideline for Good Manufacturing Practice

and any legislation adopted on the basis of, or that amends, the above legislation

SECTION II

OFFICIAL INSPECTION SERVICES

The lists of official inspection services related to this Sectoral Annex have been jointly determined by the Parties and will be maintained by them. If a Party requests from the other Party a copy of its latest lists of official inspection services, the requested Party will provide the requesting Party with a copy of those lists within 30 calendar days of the date of receipt of the request.

SECTION III

OPERATIONAL PROVISIONS

1.   Transmission of inspection reports

Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in the case where analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see point (2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin.

If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

2.   Inspection reports

A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.

3.   Reference GMP

(a)

Manufacturers will be inspected against the applicable GMP of the exporting Party (see Section I).

(b)

With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will inspect against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party.

Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will be determined according to a procedure established by the Joint Sectoral Group.

4.   Nature of inspections

(a)

Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections).

(b)

‘Product- or process-oriented’ inspections (which may be ‘pre-marketing’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

5.   Inspection/establishment fees

The regime of inspection/establishment fees is determined by the manufacturer’s location. Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for products covered by this Sectoral Annex.

6.   Safeguard clause for inspections

Each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an inspection take place, inspection costs may be recovered.

7.   Exchange of information between authorities and approximation of quality requirements

In accordance with the general provisions of this Agreement, the Parties will exchange any relevant information necessary for the ongoing mutual recognition of inspections. For the purposes of demonstration of capability in cases of significant changes to regulatory systems in either of the Parties, additional specific information may be requested by either Party in relation to an official inspection service. Such specific requests may cover information on training, inspection procedures, general information and document exchange, and transparency of agency audits of official inspection services relevant to the operation of this Sectoral Annex. Such requests should be made through and managed by the Joint Sectoral Group as part of an ongoing maintenance programme.

In addition, the relevant authorities in New Zealand and in the European Union will keep each other informed of any new technical guidance or changes to inspection procedures. Each Party will consult the other before their adoption.

8.   Official batch release

The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass this mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party.

For the European Union, the official batch release procedure for medicinal products for human use is published by the European Directorate for the Quality of Medicines & HealthCare. For New Zealand, the official batch release procedure is specified in document ‘WHO Technical Report Series, No 822, 1992’.

9.   Inspectors’ training

In accordance with the general provisions of this Agreement, training sessions for inspectors, organised by the authorities, will be accessible to inspectors of the other Party. The Parties will keep each other informed of these sessions.

10.   Joint inspections

In accordance with the general provisions of this Agreement, and by mutual arrangement between the Parties, joint inspections may be authorised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form will be established through procedures approved by the Joint Sectoral Group.

11.   Alert system

Contact points will be designated by the Parties to permit competent authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defects, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure will be jointly established.

The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, is communicated to the other Party with the appropriate degree of urgency.

12.   Contact points

For the purpose of this Sectoral Annex, the contact points for any technical question, such as exchange of inspection reports, inspector training sessions, technical requirements, will be:

FOR NEW ZEALAND:

For medicinal products for human use:

Group Manager

Medicines and Medical Devices Safety Authority (Medsafe)

PO Box 5013

Wellington

New Zealand

Tel. 64-4-819 6874

Fax 64-4-819 6806

For medicinal products for use in animals:

Director, Approvals and ACVM Standards

Ministry of Agriculture and Forestry

(MAF) PO Box 2526

Wellington 6140

New Zealand

Tel. 64-4-894 2541

Fax 64-4-894 2501

FOR THE EUROPEAN UNION:

The Director of the European Medicines Agency

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Tel. 44-171-418 8400

Fax 44-171-418 8416

13.   Joint Sectoral Group

A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the Joint Committee will determine.

The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.

14.   Divergence of views

Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

SECTION IV

CHANGES TO THE LIST OF OFFICIAL INSPECTION SERVICES

The Parties recognise the need for this Sectoral Annex to accommodate change, particularly with regard to the entry of new official inspection services or changes in the nature or role of established competent authorities. Where significant changes have occurred with regard to official inspection services, the Joint Sectoral Group will consider what, if any, additional information is required to verify programmes and establish or maintain mutual recognition of inspections, in accordance with point 7 of Section III.’.

11.

The Sectoral Annex on medical devices is replaced by the following:

SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY — NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT

SCOPE AND COVERAGE

The provisions of this Sectoral Annex will apply to the following products:

Products for export to the European Union

Products for export to New Zealand

(1)

All medical devices:

(a)

manufactured in New Zealand; and

(b)

subject to third party conformity assessment procedures, both product and quality systems-related; and

(c)

provided for in Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; and

(d)

provided for in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended.

(1)

All medical devices:

(a)

manufactured in the European Union; and

(b)

subject to third party conformity assessment procedures, both product and quality systems-related, or subject to other requirements under the legislation listed in Section I, as amended.

(2)

For the purposes of paragraph 1:

(a)

medical devices provided for in the Appendix are excluded; and

(b)

unless otherwise provided for or by mutual arrangement by the Parties, ‘manufacture’ of a medical device does not include:

(i)

restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or

(ii)

operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or

(iii)

quality control inspections alone; or

(iv)

sterilisation alone.

(2)

For the purposes of paragraph 1:

(a)

medical devices provided for in the Appendix are excluded; and

(b)

unless otherwise provided for or by mutual arrangement by the Parties, ‘manufacture’ of a medical device does not include:

(i)

restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or

(ii)

operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or

(iii)

quality control inspections alone; or

(iv)

sterilisation alone.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS

The legislative, regulatory and administrative requirements of the European Union with which New Zealand-designated conformity assessment bodies will assess compliance

The legislative, regulatory and administrative requirements of New Zealand with which European Union-designated conformity assessment bodies will assess compliance

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended

and any European Union legislation adopted on the basis of these Directives

Radiocommunications Act 1989 and Regulations made pursuant to that Act

Electricity Act 1992 and Regulations made pursuant to that Act

Medicines Act 1981

Medicines Regulations 1984

Medicines (Database of Medical Devices) Regulations 2003

and any legislation adopted on the basis of, or that amends, the above legislation

SECTION II

THE AUTHORITIES RESPONSIBLE FOR DESIGNATING CONFORMITY ASSESSMENT BODIES UNDER THIS SECTORAL ANNEX

For the conformity assessment bodies designated by New Zealand

For the conformity assessment bodies designated by the European Union

Ministry of Health

Belgium

Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale

Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie

Agence Fédérale des Médicaments et des Produits de Santé – Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten

Bulgaria

Държавна агенция за метрологичен и технически надзор

Czech Republic

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví

Denmark

Indenrigs- og Sundhedsministeriet

Lægemiddelstyrelsen

Germany

ZLG — Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Bonn

ZLS — Zentralstelle der Länder für Sicherheitstechnik, München

Estonia

Majandus- ja Kommunikatsiooniministeerium

Ireland

Department of Health

Irish Medicines Board

Greece

Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης

Εθνικός Οργανισμός Φαρμάκων

Spain

Ministerio de Sanidad, Política Social e Igualdad

Agencia Española de Medicamentos y Productos Sanitarios

France

Ministère de la Santé

Agence Française de Sécurité Sanitaire des produits de Santé

Agence Nationale du Médicament Vétérinaire

Italy

Ministero della Salute – Dipartimento dell’ Innovazione – Direzione Generale Farmaci e Dispositivi Medici

Cyprus

The Drugs Council, Pharmaceutical Services (Ministry of Health)

Veterinary Services (Ministry of Agriculture)

Latvia

Zāļu valsts aģentūra

Veselības ministrija

Lithuania

Lietuvos Respublikos sveikatos apsaugos ministerija

Luxembourg

Ministère de la Santé

Division de la Pharmacie et des Médicaments

Hungary

Országos Gyógyszerészeti Intézet

Malta

Direttorat tal-Affarijiet Regolatorji, Awtorità Maltija dwar l-iStandards

Netherlands

Ministerie van Volksgezondheid, Welzijn en Sport

Inspectie voor de Gezondheidszorg

Austria

Bundesministerium für Gesundheit

Bundesamt für Sicherheit im Gesundheitswesen

Poland

Ministerstwo Zdrowia

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Portugal

INFARMED:I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.)

Romania

Ministerul Sănătății – Departament Dispozitive Medicale

Slovenia

Ministrstvo za zdravje

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Slovakia

Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky

Finland

Sosiaali- ja terveysministeriö

Sosiaali- ja terveysalan lupa- ja valvontavirasto (Valvira)

Sweden

Styrelsen för ackreditering och teknisk kontroll (SWEDAC)

United Kingdom

Medicines and Healthcare products Regulatory Agency

SECTION III

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES

The procedures to be followed by New Zealand in designating conformity assessment bodies to assess products against the European Union’s requirements

The procedures to be followed by the European Union in designating conformity assessment bodies to assess products against New Zealand’s requirements

Conformity assessment bodies to be designated for the purposes of this Sectoral Annex will meet the requirements of the Directives listed in Section I, taking into account Annex II to 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, as amended, and be designated on the basis of the procedures defined in the Annex to this Agreement. This may be demonstrated through:

(a)

Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either:

accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), or

able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.

(b)

Quality System certification bodies operating according to the requirements of EN 45012 or ISO Guide 62, and either:

accredited by JAS-ANZ, or

able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.

(c)

Inspection bodies operating according to the requirements of ISO/IEC 17020, and either:

accredited by the Testing Laboratory Registration Council of New Zealand or any other body established by law in New Zealand which replaces it and which has the same functions, or

able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.

Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

1.

The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to this Agreement.

2.

The following procedures are deemed to be consistent with those set out in the Annex to this Agreement:

(a)

Certification bodies:

accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement (MLA) for certification of products,

members of the Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE) CB Scheme,

accredited by an accreditation body with which JAS-ANZ has a mutual recognition agreement, or

able to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.

(b)

Testing laboratories:

accredited by accreditation bodies which are signatories to the EA MLA for calibration and testing laboratories,

recognised within the IECEE CB Scheme, or

able to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.

Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

SECTION IV

ADDITIONAL PROVISIONS

1.   New legislation

The Parties note New Zealand’s intention to introduce new legislation concerning medical devices, and jointly decide that the provisions of this Sectoral Annex will apply to this legislation upon its entry into force in New Zealand.

The Parties jointly declare their intention to extend the scope of this Sectoral Annex to in vitro diagnostic devices as soon as New Zealand’s new legislation concerning medical devices is in place.

2.   Exchange of information

The Parties will inform each other of incidents in the context of the medical device vigilance procedure, or with regard to matters concerning product safety. The Parties will also inform each other of:

certificates withdrawn, suspended, restricted or revoked, and

any legislation or amendment to existing legislation adopted on the basis of the legal texts listed in Section I.

The contact points through which the information can be passed are:

New Zealand:

The Manager

Medicines and Medical Devices Safety Authority (Medsafe)

PO Box 5013

Wellington

New Zealand

Tel. 64-4-819 6874

Fax 64-4-819 6806

and

Group Manager

Energy Safety and Radio Spectrum Management

Ministry of Economic Development (MED)

P.O. Box 1473

Wellington

New Zealand

Tel. 64-4-472-0030

Fax 64-4-471-0500

European Union

European Commission

Directorate-General for Health and Consumers

Rue de la Loi/Wetstraat 200

B-1049 Brussels

Tel. 32-2-299 11 11

The Parties may exchange information on the consequences of the establishment of the European Database on Medical Devices (Eudamed).

In addition, the Medicines and Medical Devices Safety Authority will advise of any certificates issued.

3.   Subcontracting

Where required by New Zealand legislative, regulatory and administrative provisions, European Union conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with point 2 of Section III.

4.   Recording of approvals granted

In addition to the requirements imposed by the Annex to this Agreement on the designation of a conformity assessment body, the relevant European Union designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of the method that such conformity assessment body intends to adopt to record the fact that an approval required by the Secretary under the Electricity Act 1992 (and Regulations made pursuant to that Act) for fittings or appliances to be sold or offered for sale in New Zealand has been granted.

5.   Confidence-building with respect to high-risk devices

5.1.

A confidence-building process for the purpose of strengthening confidence in the designating systems of each of the Parties will apply for the following medical devices:

active implantable devices as defined in the legislation referred to in Section I;

devices that are classified as class III devices under the legislation referred to in Section I;

medical devices that are implantable intra-ocular lenses;

medical devices that are intra-ocular visco elastic fluids, and

medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease.

5.2.

The Parties will establish a detailed programme to this effect involving the Medicines and Medical Devices Safety Authority and the European Union’s competent authorities.

5.3.

The confidence-building period will be reviewed after two years commencing from the date this Sectoral Annex, as amended, becomes effective.

5.4.

Additional specific requirements for regulatory progress:

5.4.1.

In pursuance of Articles 2, 7(1), 8(1) and 9(1) of this Agreement, either Party may request additional specific requirements in relation to the conformity assessment bodies for the purposes of demonstration of experience in the evolving regulatory systems.

5.4.2.

These specific requirements may include training, observed conformity assessment body audits, visits and information and document exchange, including audit reports.

5.4.3.

These requirements may likewise be applicable in relation to the designation of a conformity assessment body in accordance with this Agreement.

6.   Joint Sectoral Group

A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the latter will determine.

The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.

7.   Divergence of views

Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of conformity assessment reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

Appendix

The provisions of this Sectoral Annex will not apply to the following devices:

medical devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;

medical devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;

medical devices incorporating tissues or tissue derivatives of human origin;

medical devices incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;

medical devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device, and

medical devices that are intended by the manufacturer specifically to be used for chemical disinfection of another medical device, except for sterilisers using dry heat, moist heat or ethylene oxide.

Both Parties may decide by common arrangement to extend the application of this Sectoral Annex to the aforementioned medical devices.

’.

Article 2

Entry into force

This Agreement shall enter into force on the first day of the second month following the date on which the Parties have exchanged diplomatic notes confirming the completion of their respective procedures for entry into force of this Agreement

Done at Brussels, in duplicate, on 23 February 2012 in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages, each text being equally authentic.

За Европейския съюз

Por la Unión Europea

Za Evropskou unii

For Den Europæiske Union

Für die Europäische Union

Euroopa Liidu nimel

Για την Ευρωπαϊκή Ένωση

For the European Union

Pour l'Union européenne

Per l'Unione europea

Eiropas Savienības vārdā –

Europos Sąjungos vardu

Az Európai Unió részéről

Għall-Unjoni Ewropea

Voor de Europese Unie

W imieniu Unii Europejskiej

Pela União Europeia

Pentru Uniunea Europeană

Za Európsku úniu

Za Evropsko unijo

Euroopan unionin puolesta

För Europeiska unionen

Image

За Нοва Зeлaндия

Por Nueva Zelanda

Za Nový Zéland

For New Zealand

Für Neuseeland

Uus-Meremaa nimel

Για τη Nέα Ζηλανδία

For New Zealand

Pour la Nouvelle-Zélande

Per la Nuova Zelanda

Jaunzēlandes vārdā –

Naujosios Zelandijos vardu

Uj-Zéland részéről

Gћal New Zealand

Voor Nieuw-Zeeland

W imieniu Nowej Zelandii

Pela Nova Zelândia

Pentru Noua Zeelandă

Za Nový Zéland

Za Novo Zelandijo

Unden-Seelannin puolesta

För Nya Zeeland

Image


(1)  OJ L 229, 17.8.1998, p. 62.


REGULATIONS

22.12.2012   

EN

Official Journal of the European Union

L 356/19


COUNCIL REGULATION (EU) No 1261/2012

of 20 December 2012

fixing for 2013 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Black Sea

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

Article 43(3) of the Treaty provides that the Council, on a proposal from the Commission, is to adopt measures on the fixing and allocation of fishing opportunities.

(2)

Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (1) requires that measures governing access to waters and resources and the sustainable pursuit of fishing activities be established taking into account available scientific advice and, in particular, the report drawn up by the Scientific, Technical and Economic Committee for Fisheries (STECF).

(3)

It is incumbent upon the Council to adopt measures on the fixing and allocation of fishing opportunities by fishery or group of fisheries, including certain conditions functionally linked thereto, as appropriate. Fishing opportunities should be distributed among Member States in such a way as to assure each Member State relative stability of fishing activities for each stock or fishery and having due regard to the objectives of the common fisheries policy established in Regulation (EC) No 2371/2002.

(4)

The total allowable catch (TACs) should be established on the basis of the available scientific advice, taking into account biological and socioeconomic aspects whilst ensuring fair treatment between fishing sectors, as well as in the light of the opinions expressed during the consultation of stakeholders.

(5)

The use of fishing opportunities set out in this Regulation should be subject to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (2) and in particular to Articles 33 and 34 thereof concerning respectively the recording of catches and fishing effort and the notification of data on the exhaustion of fishing opportunities. It is therefore necessary to specify the codes to be used by the Member States when sending data to the Commission relating to landings of stocks subject to this Regulation.

(6)

In accordance with Article 2 of Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (3), the stocks that are subject to the various measures referred to therein must be identified.

(7)

In order to avoid interruption of fishing activities and to ensure the livelihood of Union fishermen, it is important to open these fisheries on 1 January 2013. For reasons of urgency, this Regulation should enter into force immediately after its publication,

HAS ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation fixes the fishing opportunities for 2013 for certain fish stocks and groups of fish stocks in the Black Sea.

Article 2

Scope

This Regulation shall apply to EU vessels operating in the Black Sea.

Article 3

Definitions

For the purposes of this Regulation the following definitions shall apply:

(a)

‘GFCM’ means General Fisheries Commission for the Mediterranean;

(b)

‘Black Sea’ means geographical sub-area 29 as defined in Annex I to Regulation (EU) No 1343/2011 of the European Parliament and of the Council of 13 December 2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area (4) and in the resolution GFCM/33/2009/2;

(c)

‘EU vessel’ means a fishing vessel flying the flag of a Member State and registered in the Union;

(d)

‘total allowable catch (TAC)’ means the quantity that can be taken from each stock each year;

(e)

‘quota’ means a proportion of the TAC allocated to the Union, a Member State or a third country.

CHAPTER II

FISHING OPPORTUNITIES

Article 4

TACs and allocations

The TACs, the allocation of such TACs among Member States, and conditions functionally linked thereto, where appropriate, are set out in the Annex.

Article 5

Special provisions on allocations

The allocation of fishing opportunities among Member States as set out in this Regulation shall be without prejudice to:

(a)

exchanges made pursuant to Article 20(5) of Regulation (EC) No 2371/2002;

(b)

deductions and reallocations made pursuant to Article 37 of Regulation (EC) No 1224/2009;

(c)

additional landings allowed pursuant to Article 3 of Regulation (EC) No 847/96;

(d)

quantities withheld in accordance with Article 4 of Regulation (EC) No 847/96;

(e)

deductions made pursuant to Articles 105 and 107 of Regulation (EC) No 1224/2009.

Article 6

Conditions for landing catches and by-catches

Fish from stocks for which fishing opportunities are fixed by this Regulation shall be retained on board or landed only if:

(a)

the catches have been taken by vessels of a Member State having a quota and that quota is not exhausted; or

(b)

the catches consist of a share in a Union quota which has not been allocated by quota among Member States, and that Union quota has not been exhausted.

CHAPTER III

FINAL PROVISIONS

Article 7

Data transmission

When, pursuant to Articles 33 and 34 of Regulation (EC) No 1224/2009, Member States send the Commission data relating to landings of quantities of stocks caught, they shall use the stock codes set out in the Annex to this Regulation.

Article 8

Entry into force

This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.

It shall apply from 1 January 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 December 2012.

For the Council

The President

A. D. MAVROYIANNIS


(1)  OJ L 358, 31.12.2002, p. 59.

(2)  OJ L 343, 22.12.2009, p. 1.

(3)  OJ L 115, 9.5.1996, p. 3.

(4)  OJ L 347, 30.12.2011, p. 44.


ANNEX

TACs applicable to EU vessels in areas where TACs exist by species and by area

The following tables set out the TACs and quotas (in tonnes live weight, except where otherwise specified) by stock, and conditions functionally linked thereto, where appropriate.

Fish stocks are referred to following the alphabetical order of the Latin names of the species. For the purposes of this Regulation, the following comparative table of Latin names and common names is provided:

Scientific name

Alpha-3 code

Common name

Psetta maxima

TUR

Turbot

Sprattus sprattus

SPR

Sprat


Species

:

Turbot

Psetta maxima

Zone

:

EU waters in the Black Sea

TUR/F37.4.2.C.

Bulgaria

43,2

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Romania

43,2

Union

86,4 (1)

TAC

Not relevant


Species

:

Sprat

Sprattus sprattus

Zone

:

EU waters in the Black Sea

SPR/F37.4.2.C

Bulgaria

8 032,5

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Romania

3 442,5

Union

11 475

TAC

Not relevant


(1)  No fishing activity, including transhipment, taking on board, landing and first sale shall be permitted from 15 April to 15 June 2013.


22.12.2012   

EN

Official Journal of the European Union

L 356/22


COUNCIL REGULATION (EU) No 1262/2012

of 20 December 2012

fixing for 2013 and 2014 the fishing opportunities for EU vessels for certain deep-sea fish stocks

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

Article 43(3) of the Treaty provides that the Council, on a proposal from the Commission, is to adopt measures on the fixing and allocation of fishing opportunities.

(2)

Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (1) requires that measures governing access to waters and resources and the sustainable pursuit of fishing activities be established taking into account available scientific, technical and economic advice and in particular reports drawn up by the Scientific, Technical and Economic Committee for Fisheries (STECF), as well as in the light of any advice received from Regional Advisory Councils.

(3)

It is incumbent upon the Council to adopt measures on the fixing and allocation of fishing opportunities by fishery or group of fisheries, including certain conditions functionally linked thereto, as appropriate. Fishing opportunities should be distributed among Member States in such a way as to assure each Member State relative stability of fishing activities for each stock or fishery and having due regard to the objectives of the Common Fisheries Policy established by Regulation (EC) No 2371/2002.

(4)

The total allowable catches (TACs) should be established on the basis of available scientific advice, taking into account biological and socioeconomic aspects whilst ensuring fair treatment between fishing sectors, as well as in the light of the opinions expressed during the consultation of stakeholders, in particular at the meetings with the Advisory Committee for Fisheries and Aquaculture and the Regional Advisory Councils concerned.

(5)

Fishing opportunities should be in accordance with international agreements and principles, such as the 1995 United Nations agreement concerning the conservation and management of straddling stocks and highly migratory fish stocks (2), and the detailed management principles laid down in the 2008 Inter-national Guidelines for the Management of Deep-sea Fisheries in the High Seas of the Food and Agriculture Organisation of the United Nations, according to which, in particular, a regulator should be more cautious when information is uncertain, unreliable or inadequate. The absence of adequate scientific information should not be used as a reason for postponing or failing to take conservation and management measures.

(6)

The latest scientific advice from the International Council for the Exploration of the Sea (ICES) and from the STECF indicates that most deep-sea stocks are harvested unsustainably and that fishing opportunities for those stocks, in order to assure their sustainability, should be reduced until the evolution of the stock sizes show a positive trend. The ICES has further advised that no directed fishery should be allowed for orange roughy in all areas and for certain stocks of blue ling and red seabream.

(7)

Concerning deep sea sharks, the main commercial species are considered depleted and, therefore, no directed fishing should take place.

(8)

The fishing opportunities for deep-sea species as defined in Article 2(a) of Council Regulation (EC) No 2347/2002 of 16 December 2002 establishing specific access requirements and associated conditions applicable to fishing for deep-sea stocks (3) are decided on a bi-annual basis. Nevertheless, an exception is made for the stocks of greater silver smelt and the main fishery of blue ling for which the fishing opportunities depend on the outcome of the annual negotiations with Norway. The fishing opportunities for those stocks should be established in another relevant annual regulation fixing fishing opportunities.

(9)

In the interest of simplification, blue ling TACs autonomously decided by the Union should be regulated in the same legal instrument. Therefore, TACs for blue ling in international waters of II, III and IV should be included, together with the TACs for blue ling in international waters of XII, in the Regulation fixing the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements.

(10)

In accordance with Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (4) the stocks that are subject to various measures referred to therein should be identified. Precautionary TACs should apply for stocks for which no scientifically-based evaluation of fishing opportunities is available specifically for the year in which the TACs are to be set; analytical TACs should apply otherwise. In view of ICES and STECF advice for deep-sea stocks, those for which a science-based evaluation of the relevant fishing opportunities is not available should be subject to precautionary TACs in this Regulation.

(11)

In light of the scientific advice, the biological distribution of some stocks of roundnose grenadier does not necessarily correspond to the TAC areas in this Regulation. In order to facilitate the sustainable exploitation of these stocks, it is appropriate to allow for increased flexibility between TAC area Vb, VI, VII, on one hand, and TAC area VIII, IX, X, XII and XIV, on the other.

(12)

In order to avoid the interruption of fishing activities and to ensure the livelihood of the fishermen of the Union, this Regulation should apply from 1 January 2013. For reasons of urgency, this Regulation should enter into force immediately after its publication,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation fixes for the years 2013 and 2014 the annual fishing opportunities available to EU vessels for fish stocks of certain deep-sea species in EU waters and in certain non-EU waters where catch limits are required.

Article 2

Definitions

1.   For the purposes of this Regulation, the following definitions shall apply:

(a)

‘EU vessel’ means a fishing vessel flying the flag of a Member State and registered in the Union;

(b)

‘EU waters’ means the waters under the sovereignty or jurisdiction of the Member States with the exception of waters adjacent to the territories mentioned in Annex II to the Treaty;

(c)

‘total allowable catch’ (TAC) means the quantity that can be taken and landed from each fish stock each year;

(d)

‘quota’ means a proportion of the TAC allocated to the Union, a Member State or a third country;

(e)

‘international waters’ means waters falling outside the sovereignty or jurisdiction of any State.

2.   For the purposes of this Regulation, the following zone definitions shall apply:

(a)

ICES (International Council for the Exploration of the Sea) zones are the geographical areas specified in Annex III to Regulation (EC) No 218/2009 of the European Parliament and of the Council (5);

(b)

CECAF (Committee for Eastern Central Atlantic Fisheries) zones are the geographical areas specified in Annex II to Regulation (EC) No 216/2009 of the European Parliament and of the Council (6).

Article 3

TACs and allocations

The TACs for deep-sea species caught by EU vessels in EU waters or in certain non-EU waters, the allocation of such TACs among Member States and the conditions functionally linked thereto, where appropriate, are set out in the Annex to this Regulation.

Article 4

Special provisions on allocations of fishing opportunities

1.   The allocation of fishing opportunities among Member States as set out in this Regulation shall be without prejudice to:

(a)

exchanges made pursuant to Article 20(5) of Regulation (EC) No 2371/2002;

(b)

deductions and reallocations made pursuant to Article 37 of Council Regulation (EC) No 1224/2009 (7) or pursuant to Article 10(4) of Council Regulation (EC) No 1006/2008 (8);

(c)

additional landings allowed pursuant to Article 3 of Regulation (EC) No 847/96;

(d)

quantities withheld pursuant to Article 4 of Regulation (EC) No 847/96;

(e)

deductions made pursuant to Articles 105, 106 and 107 of Regulation (EC) No 1224/2009.

2.   Article 3 of Regulation (EC) No 847/96 shall apply to stocks subject to precautionary TAC whereas Article 3(2) and (3) and Article 4 of that Regulation shall apply to stocks subject to analytical TAC, except where otherwise specified in the Annex to this Regulation.

Article 5

Conditions for landing catches and by-catches

Fish from stocks for which TACs are established shall be retained on board or landed only if the catches have been taken by vessels flying the flag of a Member State having a quota and that quota is not exhausted.

Article 6

Entry into force

This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.

It shall apply from 1 January 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 December 2012.

For the Council

The President

S. ALETRARIS


(1)  OJ L 358, 31.12.2002, p. 59.

(2)  Agreement on 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 (OJ L 189, 3.7.1998, p. 16).

(3)  OJ L 351, 28.12.2002, p. 6.

(4)  OJ L 115, 9.5.1996, p. 3.

(5)  Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (OJ L 87, 31.3.2009, p. 70).

(6)  Regulation (EC) No 216/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in certain areas other than those of the North Atlantic (OJ L 87, 31.3.2009, p. 1).

(7)  Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (OJ L 343, 22.12.2009, p. 1).

(8)  Council Regulation (EC) No 1006/2008 of 29 September 2008 concerning authorisations for fishing activities of Community fishing vessels outside Community waters and the access of third country vessels to Community waters (OJ L 286, 29.10.2008, p. 33).


ANNEX

The references to fishing zones are references to ICES zones, unless otherwise specified.

PART 1

Definition of species and species groups

1.

In the list set out in Part 2 of this Annex, fish stocks are referred to following the alphabetical order of the Latin names of the species. However, deep-sea sharks are placed at the beginning of that list. For the purposes of this Regulation, the following comparative table of common names and Latin names is provided:

Common name

Alpha-3 code

Scientific name

Black scabbardfish

BSF

Aphanopus carbo

Alfonsinos

ALF

Beryx spp.

Roundnose grenadier

RNG

Coryphaenoides rupestris

Orange roughy

ORY

Hoplostethus atlanticus

Red seabream

SBR

Pagellus bogaraveo

Greater Forkbeard

GFB

Phycis blennoides

2.

For the purposes of this Regulation, ‘deep-sea sharks’ means the following list of species:

Common name

Alpha-3 code

Scientific name

Deep-water catsharks

API

Apristurus spp.

Frilled shark

HXC

Chlamydoselachus anguineus

Gulper shark

GUP

Centrophorus granulosus

Leafscale gulper shark

GUQ

Centrophorus squamosus

Portuguese dogfish

CYO

Centroscymnus coelolepis

Longnose velvet dogfish

CYP

Centroscymnus crepidater

Black dogfish

CFB

Centroscyllium fabricii

Birdbeak dogfish

DCA

Deania calcea

Kitefin shark

SCK

Dalatias licha

Greater lanternshark

ETR

Etmopterus princeps

Velvet belly

ETX

Etmopterus spinax

Blackmouth catshark (Blackmouth dogfish)

SHO

Galeus melastomus

Mouse catshark

GAM

Galeus murinus

Bluntnose six-gill shark

SBL

Hexanchus griseus

Sailfin roughshark (Sharpback shark)

OXN

Oxynotus paradoxus

Knifetooth dogfish

SYR

Scymnodon ringens

Greenland shark

GSK

Somniosus microcephalus

PART 2

Annual fishing opportunities applicable for EU vessels in areas where TACs exist by species and by area (in tonnes live weight)

Species

:

Deep-sea sharks

Zone

:

EU and international waters of V, VI, VII, VIII and IX (DWS/56789-)

Year

2013

2014

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Germany

0

0

Estonia

0

0

Ireland

0

0

Spain

0

0

France

0

0

Lithuania

0

0

Poland

0

0

Portugal

0

0

United Kingdom

0

0

Union

0

0

TAC

0

0


Species

:

Deep-sea sharks

Zone

:

EU and international waters of X (DWS/10-)

Year

2013

2014

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Portugal

0

0

Union

0

0

TAC

0

0


Species

:

Deep-sea sharks, Deania hystricosa and Deania profundorum

Zone

:

International waters of XII (DWS/12INT-)

Year

2013

2014

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Ireland

0

0

Spain

0

0

France

0

0

United Kingdom

0

0

Union

0

0

TAC

0

0


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

EU and international waters of I, II, III and IV (BSF/1234-)

Year

2013

2014

Precautionary TAC

Germany

3

3

France

3

3

United Kingdom

3

3

Union

9

9

TAC

9

9


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

EU and international waters of V, VI, VII and XII (BSF/56712-)

Year

2013

2014

Analytical TAC

Germany

35

46

Estonia

17

22

Ireland

87

113

Spain

174

226

France

2 440

3 172

Latvia

113

147

Lithuania

1

1

Poland

1

1

United Kingdom

174

226

Others (1)

9

12

Union

3 051

3 966

TAC

3 051

3 966


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

EU and international waters of VIII, IX and X (BSF/8910-)

Year

2013

2014

Analytical TAC

Spain

12

12

France

29

29

Portugal

3 659

3 659

Union

3 700

3 700

TAC

3 700

3 700


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

EU and international waters of CECAF 34.1.2. (BSF/C3412-)

Year

2013

2014

Precautionary TAC

Portugal

3 674

3 490

Union

3 674

3 490

TAC

3 674

3 490


Species

:

Alfonsinos

Beryx spp.

Zone

:

EU and international waters of III, IV, V, VI, VII, VIII, IX, X, XII and XIV (ALF/3X14-)

Year

2013

2014

Analytical TAC

Ireland

10

9

Spain

70

67

France

19

18

Portugal

203

193

United Kingdom

10

9

Union

312

296

TAC

312

296


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

EU and international waters of I, II and IV (RNG/124-)

Year

2013

2014

Precautionary TAC

Denmark

1

1

Germany

1

1

France

10

10

United Kingdom

1

1

Union

13

13

TAC

13

13


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

EU and international waters of III (RNG/03-) (2)

Year

2013

2014

Precautionary TAC

Denmark

643

515

Germany

4

3

Sweden

33

26

Union

680

544

TAC

680

544


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

EU and international waters of Vb, VI, VII (RNG/5B67-)

Year

2013 (3)

2014 (3)

Analytical TAC

Germany

8

8

Estonia

63

63

Ireland

279

279

Spain

70

70

France

3 539

3 539

Lithuania

81

81

Poland

41

41

United Kingdom

208

208

Others (4)

8

8

Union

4 297

4 297

TAC

4 297

4 297


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

EU and international waters of VIII, IX, X, XII and XIV (RNG/8X14-)

Year

2013 (5)

2014 (5)

Analytical TAC

Germany

23

21

Ireland

5

4

Spain

2 573

2 317

France

119

107

Latvia

41

37

Lithuania

5

4

Poland

805

724

United Kingdom

10

9

Union

3 581

3 223

TAC

3 581

3 223


Species

:

Orange roughy

Hoplostethus atlanticus

Zone

:

EU and international waters of VI (ORY/06-)

Year

2013

2014

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Ireland

0

0

Spain

0

0

France

0

0

United Kingdom

0

0

Union

0

0

TAC

0

0


Species

:

Orange roughy

Hoplostethus atlanticus

Zone

:

EU and international waters of VII (ORY/07-)

Year

2013

2014

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Ireland

0

0

Spain

0

0

France

0

0

United Kingdom

0

0

Others

0

0

Union

0

0

TAC

0

0


Species

:

Orange roughy

Hoplostethus atlanticus

Zone

:

EU and international waters of I, II, III, IV, V, VIII, IX, X, XII and XIV (ORY/1CX14)

Year

2013

2014

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Ireland

0

0

Spain

0

0

France

0

0

Portugal

0

0

United Kingdom

0

0

Union

0

0

TAC

0

0


Species

:

Red seabream

Pagellus bogaraveo

Zone

:

EU and international waters of VI, VII and VIII (SBR/678-)

Year

2013

2014

Analytical TAC

Ireland

6

5

Spain

156

143

France

8

7

United Kingdom

20

18

Others (6)

6

5

Union

196

178

TAC

196

178


Species

:

Red seabream

Pagellus bogaraveo

Zone

:

EU and international waters of IX (SBR/09-)

Year

2013 (7)

2014 (7)

Analytical TAC

Spain

614

614

Portugal

166

166

Union

780

780

TAC

780

780


Species

:

Red seabream

Pagellus bogaraveo

Zone

:

EU and international waters of X (SBR/10-)

Year

2013

2014

Analytical TAC

Spain

9

8

Portugal

1 004

904

United Kingdom

9

8

Union

1 022

920

TAC

1 022

920


Species

:

Greater Forkbeard

Phycis blennoides

Zone

:

EU and international waters of I, II, III and IV (GFB/1234-)

Year

2013

2014

Analytical TAC

Germany

9

9

France

9

9

United Kingdom

13

13

Union

31

31

TAC

31

31


Species

:

Greater Forkbeard

Phycis blennoides

Zone

:

EU and international waters of V, VI and VII (GFB/567-)

Year

2013 (8)

2014 (8)

Analytical TAC

Germany

10

10

Ireland

260

260

Spain

588

588

France

356

356

United Kingdom

814

814

Union

2 028

2 028

TAC

2 028

2 028


Species

:

Greater Forkbeard

Phycis blennoides

Zone

:

EU and international waters of VIII and IX (GFB/89-)

Year

2013 (9)

2014 (9)

Analytical TAC

Spain

242

242

France

15

15

Portugal

10

10

Union

267

267

TAC

267

267


Species

:

Greater Forkbeard

Phycis blennoides

Zone

:

EU and international waters of X and XII (GFB/1012-)

Year

2013

2014

Analytical TAC

France

9

9

Portugal

36

36

United Kingdom

9

9

Union

54

54

TAC

54

54


(1)  Exclusively for by-catches. No directed fisheries are permitted under this quota.

(2)  No directed fishery for roundnose grenadier shall be conducted in ICES zone IIIa pending consultations between the European Union and Norway.

(3)  A maximum of 10 % of each quota may be fished in EU and international waters of VIII, IX, X, XII and XIV (RNG/*8X14-).

(4)  Exclusively for by-catches. No directed fisheries are permitted under this quota.

(5)  A maximum of 10 % of each quota may be fished in EU and international waters of Vb, VI, VII (RNG/*5B67-).

(6)  Exclusively for by-catches. No directed fisheries are permitted under this quota.

(7)  A maximum of 8 % of each quota may be fished in EU and international waters of VI, VII and VIII (SBR/*678-).

(8)  A maximum of 8 % of each quota may be fished in EU and international waters of VIII and IX (GFB/*89-).

(9)  A maximum of 8 % of each quota may be fished in EU and international waters of V, VI, VII (GFB/*567-).


22.12.2012   

EN

Official Journal of the European Union

L 356/34


COUNCIL REGULATION (EU) No 1263/2012

of 21 December 2012

amending Regulation (EU) No 267/2012 concerning restrictive measures against Iran

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 215 thereof,

Having regard to Council Decision 2010/413/CFSP of 26 July 2010 concerning restrictive measures against Iran (1),

Having regard to the joint proposals from the High Representative of the Union for Foreign Affairs and Security Policy and the European Commission,

Whereas:

(1)

Regulation (EU) No 267/2012 (2) gives effect to the measures provided for in Decision 2010/413/CFSP. On 15 October 2012, the Council adopted Decision 2012/635/CFSP (3) which amends Decision 2010/413/CFSP and provides for additional restrictive measures against Iran.

(2)

Those additional restrictive measures comprise, in particular, an export prohibition on key naval equipment and technology for ship-building, maintenance or refit. Moreover, trade in graphite, raw or semi-finished metals, such as aluminium and steel, and software for certain industrial processes should be prohibited.

(3)

The additional restrictive measures also include a ban on the import, purchase or transport of Iranian natural gas. Effective implementation of this prohibition requires that measures be taken to prohibit swaps of natural gas that are known to increase the export of natural gas from Iran in circumvention of the prohibition, or there is reasonable cause to suspect this. The contracts satisfied by use of a pipeline directly connected to the natural gas transmission grid of the Union without any inlet point intended to facilitate the purchase or increase export of natural gas originating in Iran should not be affected by the prohibition on natural gas imports.

(4)

Decision 2012/635/CFSP called for the review of restrictive measures concerning dual-use goods and technology set out in Annex I to Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items (4), with a view to including certain items in Part 2 of category 5 thereof which might be relevant to industries controlled directly or indirectly by the Islamic Revolutionary Guard Corps or which might be relevant to Iran's nuclear, military or ballistic missile programme while taking into account the need to avoid unintended effects on the civilian population in Iran.

(5)

In order to ensure the effective implementation of the prohibition on the sale, supply, transfer or export to Iran of additional key equipment or technology which could be used in the key sectors of the oil, natural gas and petrochemical industries, an additional list of such key equipment and technology should be provided.

(6)

For the same reason, lists of items subject to trade restrictions on natural gas, graphite, raw or semi-finished metals, such as aluminium and steel, and software for certain industrial processes should also be provided.

(7)

Decision 2012/635/CFSP also prohibits transactions between Union and Iranian banks and financial institutions, unless authorised in advance by the relevant Member State.

(8)

Furthermore, Decision 2012/635/CFSP provides for prohibitions on the provision of flagging and classification services to Iranian oil tankers and cargo vessels as well as regarding the supply of vessels designed for the transport or storage of oil and petrochemical products to Iranian persons and entities or to other persons and entities for the purpose of transporting or storing Iranian oil and petrochemical products.

(9)

In order to protect the environment and the health and safety of workers, it is necessary to provide that the competent authorities of Member States may take all action they deem necessary to ensure that legal obligations concerning the health and safety of workers and environment protection are respected. In cases of urgency, a Member State should be allowed to take such action without prior notification provided that it notifies the other Member States and the Commission as soon as possible afterwards.

(10)

Where a Member State had granted a license to engage in the activities of exploitation of hydrocarbons to a designated person, entity or body before that person, entity or body was designated, the competent authority of that Member State may authorise derogation from certain prohibitions provided for in Regulation (EU) No 267/2012 where such derogation is needed to avoid or remediate environmental damage or permanent destruction of the license's value.

(11)

These measures fall within the scope of the Treaty and regulatory action at the level of the Union is therefore necessary in order to implement them, in particular with a view to ensuring their uniform application by economic operators in all Member States.

(12)

Regulation (EU) No 267/2012 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 267/2012 is amended as follows:

(1)

Article 2, is amended as follows:

(a)

paragraph 2 is replaced by the following:

"2.   Annex I shall include goods and technology, including software, which are dual-use items or technology as defined in Regulation (EC) No 428/2009, except for certain goods and technology as specified in part A of Annex I to this Regulation.";

(b)

the following paragraph is inserted:

"2a.   The Member State concerned shall inform the other Member States and the Commission, within four weeks, of authorisations granted in accordance with Regulation (EC) No 428/2009, in respect of the goods and technology as specified in part A of Annex I to this Regulation.".

(2)

In Article 6, the following points are added:

"(d)

the execution, until 15 April 2013, of contracts concluded before 22 December 2012 for the sale, supply, transfer or export of goods and technology as specified in Part C of Annex I to this Regulation or ancillary contracts necessary for the execution of such contracts.

(e)

the execution, until 15 April 2013, of contracts concluded before 22 December 2012 for the provision of technical assistance or financing or financial assistance related to goods and technology as specified in Part C of Annex I to this Regulation."

With regard to point (d), the Member State concerned shall inform the other Member States and the Commission, within four weeks, of authorisations granted in accordance with Regulation (EC) No 428/2009.

(3)

Article 8 is replaced by the following:

"Article 8

1.   It shall be prohibited to sell, supply, transfer or export key equipment or technology listed in Annexes VI and VIA, directly or indirectly, to any Iranian person, entity or body, or for use in Iran.

2.   Annexes VI and VIA shall include key equipment and technology for the following key sectors of the oil and gas industry in Iran:

(a)

exploration of crude oil and natural gas;

(b)

production of crude oil and natural gas;

(c)

refining;

(d)

liquefaction of natural gas.

3.   Annexes VI and VIA shall also include key equipment and technology for the petrochemical industry in Iran.

4.   Annexes VI and VIA shall not include items included in the Common Military List, or in Annex I, II or III.".

(4)

Article 9 is replaced by the following:

"Article 9

It shall be prohibited:

(a)

to provide, directly or indirectly, technical assistance or brokering services related to the key equipment and technology listed in Annexes VI and VIA, or related to the provision, manufacture, maintenance and use of goods listed in Annexes VI and VIA, to any Iranian person, entity or body, or for use in Iran;

(b)

to provide, directly or indirectly, financing or financial assistance related to the key equipment and technology listed in Annexes VI and VIA, to any Iranian person, entity or body, or for use in Iran.".

(5)

Article 10 is replaced be the following:

"Article 10

1.   The prohibitions in Articles 8 and 9 shall not apply to:

(a)

the execution, until 15 April 2013, of transactions required by a trade contract concerning key equipment or technology in the exploration of crude oil and natural gas, production of crude oil and natural gas, refining, liquefaction of natural gas as listed in Annex VI concluded before 27 October 2010, or ancillary contracts necessary for the execution of such contracts, or by a contract or agreement concluded before 26 July 2010 and relating to an investment in Iran made before 26 July 2010, nor shall they prevent the execution of an obligation arising therefrom;

(b)

the execution, until 15 April 2013, of transactions required by a trade contract concerning key equipment or technology for the petrochemical industry as listed in Annex VI concluded before 24 March 2012, or of ancillary contracts necessary for the execution of such contracts, or by a contract or agreement concluded before 23 January 2012 and relating to an investment in Iran made before 23 January 2012, nor shall they prevent the execution of an obligation arising therefrom;

(c)

the execution, until 15 April 2013, of transactions required by a trade contract concerning key equipment or technology in the exploration of crude oil and natural gas, production of crude oil and natural gas, refining, liquefaction of natural gas and for the petrochemical industry as listed in Annex VIA concluded before 16 October 2012 and relating to an investment in Iran in the exploration of crude oil and natural gas, production of crude oil and natural gas, and the refining, liquefaction of natural gas made before 26 July 2010, or relating to an investment in Iran in the petrochemical industry made before 23 January 2012, nor shall they prevent the execution of an obligation arising therefrom; or

(d)

the provision of technical assistance intended solely for the installation of equipment or technology delivered in accordance with points (a), (b) and (c),

provided that the natural or legal person, entity or body seeking to engage in such transactions, or to provide assistance to such transactions, has notified, at least 20 working days in advance, the transaction or assistance to the competent authority of the Member State in which it is established.

2.   Prohibitions in Articles 8 and 9 shall be without prejudice to the execution of obligations arising from contracts referred to in Article 12(1)(b) and 14(1)(b) provided that those obligations arise from service contracts or ancillary contracts necessary for their execution and provided that the execution of those obligations has been authorised in advance by the competent authority concerned and the Member State concerned has informed the other Member States and the Commission of its intention to grant an authorisation."

(6)

The following Articles are inserted:

"Article 10a

1.   It shall be prohibited to sell, supply, transfer or export key naval equipment or technology listed in Annex VIB, directly or indirectly, to any Iranian person, entity or body, or for use in Iran.

2.   Annex VIB shall include key naval equipment or technology for ship building, maintenance or refit, including equipment or technology used in the construction of oil tankers.

Article 10b

1.   It shall be prohibited:

(a)

to provide, directly or indirectly, technical assistance or brokering services related to the key equipment and technology listed in Annex VIB, or related to the provision, manufacture, maintenance and use of goods listed in Annex VIB, to any Iranian person, entity or body, or for use in Iran;

(b)

to provide, directly or indirectly, financing or financial assistance related to the key equipment and technology listed in Annex VIB, to any Iranian person, entity or body, or for use in Iran.

Article 10c

1.   The prohibitions in Articles 10a and 10b shall be without prejudice to the supply of key naval equipment and technology to a vessel which is not owned or controlled by an Iranian person, entity or body and which has been forced into a port in Iran, or into Iranian territorial waters, under force majeure.

2.   The prohibitions in Articles 10a and 10b shall not apply to the execution, until 15 February 2013, of contracts concluded before 22 December 2012 or ancillary contracts necessary for the execution of such contracts.

Article 10d

1.   It shall be prohibited to sell, supply, transfer or export software as listed in Annex VIIA, directly or indirectly, to any Iranian person, entity or body, or for use in Iran.

2.   Annex VIIA shall include software for integrating industrial processes which is relevant to industries controlled directly or indirectly by the Islamic Revolutionary Guard Corps or which is relevant to Iran's nuclear, military or ballistic missile programme.

Article 10e

1.   It shall be prohibited:

(a)

to provide, directly or indirectly, technical assistance or brokering services related to the software listed in Annex VIIA, or related to the provision, manufacture, maintenance and use of goods listed in Annex VIIA, to any Iranian person, entity or body, or for use in Iran;

(b)

to provide, directly or indirectly, financing or financial assistance related to the software listed in Annex VIIA, to any Iranian person, entity or body, or for use in Iran.

Article 10f

1.   The prohibitions in Articles 10d and 10e shall not apply to the execution, until 15 January 2013, of contracts concluded before 22 December 2012 or ancillary contracts necessary for the execution of such contracts."

(7)

Article 12(1) is replaced by the following:

"1.   The prohibitions in Article 11 shall not apply to:

(a)

the execution until 1 July 2012, of trade contracts concluded before 23 January 2012, or of ancillary contracts necessary for the execution of such contracts;

(b)

the execution of contracts concluded before 23 January 2012, or of ancillary contracts, necessary for the execution of such contracts, where such a contract specifically provides that the supply of Iranian crude oil and petroleum products or the proceeds derived from their supply are for the reimbursement of outstanding amounts to persons, entities or bodies under the jurisdiction of Member States;

(c)

crude oil or petroleum products, which had been exported from Iran prior to 23 January 2012, or where the export was made pursuant to point (a) on or prior to 1 July 2012; or where the export was made pursuant to point (b);

(d)

the purchase of bunker oil produced and supplied by a third country other than Iran, intended for the propulsion of the engines of vessels;

(e)

the purchase of bunker oil for the propulsion of the engines of a vessel which has been forced into a port in Iran, or into Iranian territorial waters, under force majeure,

provided that the person, entity or body seeking to perform the contract referred to in points (a), (b) and (c) has notified, at least 20 working days in advance, the activity or transaction to the competent authority of the Member State in which it is established.".

(8)

In Article 14(1), point (c) is replaced by the following:

"(c)

petrochemical products which had been exported from Iran prior to 23 January 2012, or where the export was made pursuant to point (a) on or prior to 1 May 2012, or where the export was made pursuant to point (b),".

(9)

The following Article is inserted:

"Article 14a

1.   It shall be prohibited:

(a)

to purchase, transport, or import into the Union natural gas which originates in Iran or has been exported from Iran;

(b)

to swap natural gas which originates in Iran or has been exported from Iran;

(c)

to provide, directly or indirectly, brokering services, financing or financial assistance, including financial derivatives, as well as insurance and re-insurance and brokering services relating to insurance and re-insurance, in respect of the activities in points (a) or (b).

2.   The prohibitions in paragraph 1 shall not apply to:

(a)

natural gas that has been exported from a State other than Iran when the exported gas has been combined with gas originating from Iran within the infrastructure of a State other than Iran;

(b)

the purchase of natural gas within Iran by nationals of Member States for civilian purposes, including residential heating or power, or for the maintenance of diplomatic missions; or

(c)

the execution of contracts for the delivery of natural gas originating in a State other than Iran into the Union.

3.   "Natural gas" means the products listed in Annex IVA.

4.   For the purpose of paragraph 1, "to swap" means to exchange natural gas streams of different origins.".

(10)

The following Articles are inserted:

"Article 15a

1.   It shall be prohibited to sell, supply, transfer or export graphite and raw or semi-finished metals as listed in Annex VIIB, directly or indirectly, to any Iranian person, entity or body, or for use in Iran.

2.   Annex VIIB shall include graphite and raw or semi-finished metals, such as aluminium and steel, which are relevant to industries controlled directly or indirectly by the Islamic Revolutionary Guard Corps or which are relevant to Iran's nuclear, military or ballistic missile programme.

3.   The prohibition in paragraph 1 shall not apply to the goods listed in Annexes I, II and III.

Article 15b

1.   It shall be prohibited:

(a)

to provide, directly or indirectly, technical assistance or brokering services related to the goods as listed in Annex VIIB, or related to the provision, manufacture, maintenance and use of goods listed in Annex VIIB, to any Iranian person, entity or body, or for use in Iran;

(b)

to provide, directly or indirectly, financing or financial assistance related to the goods listed Annex VIIB, to any Iranian person, entity or body, or for use in Iran.

2.   The prohibitions in paragraph 1 shall not apply in relation to the goods listed in Annexes I, II and III.

Article 15c

The prohibitions in Article 15a shall not apply to the execution, until 15 April 2013, of contracts concluded before 22 December 2012 or ancillary contracts necessary for the execution of such contracts."

(11)

Article 23 is amended as follows:

(a)

in paragraph 2, points (c) and (d) are replaced by the following:

"(c)

being a member of the Islamic Revolutionary Guard Corps or a legal person, entity or body owned or controlled by the Islamic Revolutionary Guard Corps or by one or more of its members, or natural or legal persons acting on their behalf or providing insurance or other essential services to them;

(d)

being other persons, entities or bodies that provide support, such as material, logistical or financial support, to the Government of Iran and entities owned or controlled by them, or persons and entities associated with them;";

(b)

paragraph 4 is replaced by the following:

"4.   Without prejudice to the derogations provided for in Article 24, 25, 26, 27, 28, 28a or 29, it shall be prohibited to supply specialised financial messaging services, which are used to exchange financial data to the natural or legal persons, entities or bodies listed in Annexes VIII and IX.".

(12)

In Article 25, point (a)(ii) is replaced by the following:

"(ii)

the payment will not contribute to an activity prohibited under this Regulation. If the payment serves as consideration for a trade activity that has already been performed and the competent authority of another Member State had given prior confirmation that the activity was not prohibited at the time it was performed, it shall be deemed, prima facie, that the payment will not contribute to a prohibited activity; and".

(13)

In Article 26(1), point (a) is replaced by the following:

"(a)

the competent authority concerned has determined that the funds or economic resources are:

(i)

necessary to satisfy the basic needs of persons listed in Annex VIII or IX and their dependent family members, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;

(ii)

intended exclusively for payment of reasonable professional fees and reimbursement of incurred expenses associated with the provision of legal services;

(iii)

intended exclusively for payment of fees or service charges for routine holding or maintenance of frozen funds or economic resources; or

(iv)

intended exclusively for the payment of fees due in connection with the de-flagging of vessels; and".

(14)

Article 28 is replaced by the following:

"Article 28

By way of derogation from Article 23(2), the competent authorities may also authorise, under such conditions as they deem appropriate:

(a)

the release of certain frozen funds or economic resources of the Central Bank of Iran, after having determined that the funds or economic resources are necessary for the purpose of providing credit or financial institutions with liquidity for the financing of trade, or the servicing of trade loans; or

(b)

the release of certain frozen funds or economic resources held by the Central Bank of Iran, after having determined that the funds or economic resources are necessary for the reimbursement of a claim due under a contract or agreement concluded by an Iranian person, entity or body before 16 October 2012 where such a contract or agreement provides for the reimbursement of outstanding amounts to persons, entities or bodies under the jurisdiction of Member States;

provided that the Member State concerned has notified the other Member States and the Commission of its intention to grant an authorisation at least ten working days prior to the authorisation.".

(15)

Article 30 is replaced by the following Articles:

"Article 30

1.   It shall be prohibited to transfer funds between, on the one hand, financial and credit institutions falling within the scope of this Regulation as defined in Article 49, and, on the other hand:

(a)

credit and financial institutions and bureaux de change domiciled in Iran;

(b)

branches and subsidiaries, where they fall within the scope of this Regulation, of credit and financial institutions and bureaux de change domiciled in Iran;

(c)

branches and subsidiaries, where they do not fall within the scope of this Regulation, of credit and financial institutions and bureaux de change domiciled in Iran; and

(d)

credit and financial institutions and bureaux de change that are not domiciled in Iran but are controlled by persons, entities or bodies domiciled in Iran,

unless such transfers fall within the scope of paragraph 2 and have been processed in accordance with paragraph 3.

2.   The following transfers may be authorised in accordance with paragraph 3:

(a)

transfers regarding foodstuffs, healthcare, medical equipment, or for agricultural or humanitarian purposes;

(b)

transfers regarding personal remittances;

(c)

transfers in connection with a specific trade contract provided that such transfer is not prohibited under this Regulation;

(d)

transfers regarding diplomatic missions or consular posts or international organisations enjoying immunities in accordance with international law, insofar as such transfers are intended to be used for official purposes of the diplomatic missions or consular posts or organisations enjoying immunities in accordance with international law;

(e)

transfers regarding payment to satisfy claims by or against an Iranian person, entity or body, or transfers of similar nature provided that they do not contribute to the activities prohibited under this Regulation, on a case-by-case basis, if the Member State concerned has notified the other Members States and the Commission at least ten days in advance of its intention to grant an authorisation;

(f)

transfers necessary for the execution of the obligations arising from contracts referred to in Article 12(1)(b).

3.   Transfers of funds which may be authorised under paragraph 2 shall be processed as follows:

(a)

transfers due on transactions regarding foodstuffs, healthcare, medical equipment, or for agricultural or humanitarian purposes, below EUR 100 000 or equivalent, and transfers due on transactions regarding personal remittances, below EUR 40 000 or equivalent, shall be carried out without any prior authorisation.

The transfer shall be notified in advance in writing to the competent authority of the Member State concerned if equal to or above EUR 10 000 or equivalent;

(b)

transfers due on transactions regarding foodstuffs, healthcare, medical equipment, or for agricultural or humanitarian purposes, equal to or above EUR 100 000 or equivalent, and transfers due on transactions regarding personal remittances, equal to or above EUR 40 000 or equivalent, shall require prior authorisation of the competent authority of the Member State concerned pursuant to paragraph 2.

Member States shall inform each other of any authorisation granted at three-monthly intervals;

(c)

any other transfer equal to or above EUR 10 000 or equivalent shall require prior authorisation of the competent authority of the Member State concerned pursuant to paragraph 2.

Member States shall inform each other of any authorisation granted at three-monthly intervals.

4.   Transfers of funds below EUR 10 000 or equivalent shall not require any prior authorisation or notification.

5.   Notifications and requests for authorisations relating to the transfer of funds to an entity falling within the scope of paragraph 1(a) to (d) shall be addressed by or on behalf of the payment service provider of the payer to the competent authorities of the Member States where the payment service provider is established.

Notifications and requests for authorisations relating to the transfer of funds from an entity falling within the scope of paragraph 1(a) to (d) shall be addressed by or on behalf of the payment service provider of the payee to the competent authorities of the Member States where the payment service provider is established.

If the payment service provider of the payer or of the payee does not fall under the scope of this Regulation, notifications and requests for authorisation shall be addressed, in the case of a transfer to an entity falling within the scope of paragraph 1(a) to (d), by the payer, and in the case of a transfer from an entity falling within the scope of paragraph 1(a) to (d), by the payee, to the competent authorities of the Member State in which, respectively, the payer or payee is resident.

6.   Credit and financial institutions falling within the scope of this Regulation shall, in their activities with entities referred to in paragraph 1(a) to (d) and in order to prevent infringements of the provisions of this Regulation, conduct enhanced vigilance as follows:

(a)

exercise continuous vigilance over account activity, particularly through their programmes on customer due diligence;

(b)

require that in payment instructions all information fields which relate to the originator and beneficiary of the transaction in question be completed and if that information is not supplied, refuse the transaction;

(c)

maintain all records of transactions for a period of five years and make them available to national authorities on request;

(d)

if they have reasonable grounds to suspect that activities with credit and financial institutions may be in breach of the provisions of this Regulation, report without delay their suspicions to the financial intelligence unit (FIU) or to another competent authority designated by the Member State concerned, without prejudice to Articles 5 and 23. The FIU or such other competent authority will serve as a national centre for receiving and analysing suspicious transaction reports regarding potential breaches of this Regulation. The FIU or such other competent authority shall have access, directly or indirectly, on a timely basis to the financial, administrative and law enforcement information that it requires to properly undertake this function, including the analysis of suspicious transaction reports.

Article 30a

1.   Transfers of funds to and from an Iranian person, entity or body which do not fall within the scope of Article 30(1) shall be processed as follows:

(a)

transfers due on transactions regarding foodstuffs, healthcare, medical equipment, or for agricultural or humanitarian purposes shall be carried out without any prior authorisation.

The transfer shall be notified in advance in writing to the competent authority of the Member State concerned if equal to or above EUR 10 000 or equivalent;

(b)

any other transfer below EUR 40 000 or equivalent shall be carried out without any prior authorisation.

The transfer shall be notified in advance in writing to the competent authority of the Member State concerned if equal to or above EUR 10 000 or equivalent;

(c)

any other transfer equal to or above EUR 40 000 or equivalent shall require a prior authorisation of the competent authority of the Member State concerned.

Member States shall inform each other of any authorisation rejected at three-monthly intervals.

2.   Transfers of funds below EUR 10 000 or equivalent shall not require any prior authorisation or notification.

3.   Notifications and requests for authorisation relating to the transfer of funds shall be processed as follows:

(a)

in the case of electronic transfers of funds processed by credit or financial institutions:

(i)

notifications and requests for authorisation relating to the transfer of funds to an Iranian person, entity or body which is located outside the Union, shall be addressed by or on behalf of the payment service provider of the payer to the competent authorities of the Member State in which the payment service provider is established;

(ii)

notifications and requests for authorisation relating to the transfer of funds from an Iranian person, entity or body which is located outside the Union, shall be addressed by or on behalf of the payment service provider of the payee to the competent authorities of the Member State in which the payment service provider is established;

(iii)

if, in cases (i) and (ii), the payment service provider of the payer or of the payee does not fall under the scope of this Regulation, notifications and requests for authorisation shall be addressed, in the case of a transfer to an Iranian person, entity or body, by the payer, and in the case of a transfer from an Iranian person, entity or body by the payee to the competent authorities of the Member State in which, respectively, the payer or payee is resident;

(iv)

notifications and requests for authorisation relating to the transfer of funds to an Iranian person, entity or body which is located within the Union, shall be addressed by or on behalf of the payment service provider of the payee to the competent authorities of the Member States in which the payment service provider is established;

(v)

notifications and requests for authorisation relating to the transfer of funds from an Iranian person, entity or body which is located within the Union, shall be addressed by or on behalf of the payment service provider of the payer to the competent authorities of the Member States in which the payment service provider is established;

(vi)

if, in cases (iv) and (v), the payment service provider of the payer or of the payee does not fall under the scope of this Regulation, notifications and requests for authorisation shall be addressed, in the case of a transfer to an Iranian person, entity or body, by the payer, and in the case of a transfer from an Iranian person, entity or body by the payee to the competent authorities of the Member State in which, respectively, the payee or payer is resident;

(vii)

in relation to a transfer of funds to or from an Iranian person, entity or body where neither the payer nor the payee, nor their respective payment service providers, fall under the scope of this Regulation but a payment service provider which does fall under the scope of this Regulation acts as an intermediary, then that payment service provider must comply with the obligation to notify or seek authorisation, as applicable, if it knows or has reasonable cause to suspect that the transfer is to or from an Iranian person, entity or body. Where there is more than one payment service provider acting as an intermediary, only the first payment service provider to process the transfer is required to comply with the obligation to notify or seek authorisation, as applicable. Any notification or request for authorisation must be addressed to the competent authorities of the Member State in which the payment service provider is established;

(viii)

where there is more than one payment service provider involved in a series of linked transfers of funds, transfers within the Union shall include a reference to the authorisation granted under this Article;

(b)

in the case of transfers of funds which are made by non-electronic means, notifications and requests for authorisation relating to the transfer of funds shall be processed as follows:

(i)

notifications and requests for authorisation relating to transfers to an Iranian person, entity or body shall be addressed by the payer to the competent authorities of the Member State where the payer is resident;

(ii)

notifications and requests for authorisation relating to the transfers from an Iranian person, entity or body shall be addressed by the payee to the competent authorities of the Member State in which the payee is resident.

Article 30b

1.   Where an authorisation has been granted in accordance with Articles 24, 25, 26, 27, 28 or 28a, Articles 30 and 30a shall not apply.

The requirement for prior authorisation of transfers of funds as provided for in Articles 30(3)(b) and (c), shall be without prejudice to the execution of transfers of funds notified to or authorised by the competent authority in advance before 22 December 2012. Such transfers of funds shall be executed before 15 April 2013.

Articles 30 and 30a shall not apply with regard to transfers of funds provided for in Article 29.

2.   Articles 30(3) and 30a(1) shall apply regardless of whether the transfer of funds is executed in a single operation or in several operations which appear to be linked. For the purpose of this Regulation, "operations which appear to be linked" includes:

(a)

a series of consecutive transfers from or to the same financial or credit institutions within the scope of Article 30(1)(a) to (d) or from or to the same Iranian person, entity or body which are made in connection with a single obligation to a transfer of funds, where each individual transfer falls below the relevant threshold set out in Articles 30 and 30a but which, in the aggregate, meet the criteria for notification or authorisation; or

(b)

a chain of transfers involving different payment service providers or natural or legal persons which effects a single obligation to make a transfer of funds.

3.   For the purposes of Article 30(3)(b) and 30(3)(c) and Article 30a(1)(c), the competent authorities shall grant the authorisation, under such terms and conditions as they deem appropriate, unless they have reasonable grounds to determine that the transfer of funds for which the authorisation is requested could be in breach of any of the prohibitions or obligations in this Regulation.

A competent authority may charge a fee for the assessment of requests for authorisation.

4.   For the purposes of Article 30a(1)(c), an authorisation shall be deemed granted if a competent authority has received a request in writing for authorisation and, within four weeks, the competent authority has not objected in writing to the transfer of funds. If the objection is raised because an investigation is pending, the competent authority shall state this and communicate its decision without delay. The competent authorities shall have access, directly or indirectly, on a timely basis to the financial, administrative and law enforcement related information necessary for carrying out the investigation.

5.   The following persons, entities or bodies do not fall within the scope of Articles 30 and 30a:

(a)

persons, entities or bodies who merely convert paper documents into electronic data and are acting under a contract with a credit institution or a financial institution;

(b)

persons, entities or bodies who provide credit or financial institutions solely with a message or other support system for transmitting funds; or

(c)

persons, entities or bodies who provide credit or financial institutions solely with clearing and settlement systems."

(16)

Article 31 is replaced by the following:

"Article 31

1.   Branches and subsidiaries, falling within the scope of this Regulation as defined in Article 49, of credit and financial institutions domiciled in Iran shall notify the competent authority of the Member State where they are established of all transfers of funds carried out or received by them, the names of the parties and the amount and the date of the transaction, within five working days after carrying out or receiving the transfer of funds concerned. If the information is available, the notification must specify the nature of the transaction and, where appropriate, the nature of the goods covered by the transaction and must, in particular, state whether the goods are covered by Annex I, II, III, IV, IVA, V, VI, VIA, VIB, VII, VIIA or VIIB of this Regulation and, if their export is subject to authorisation, indicate the number of the licence granted.

2.   Subject to and in accordance with the information-sharing arrangements, the notified competent authorities shall without delay transmit the information on notifications referred to in paragraph 1, as necessary, in order to prevent any transaction that could contribute to proliferation-sensitive nuclear activities or to the development of nuclear weapons delivery systems, to the competent authorities of other Member States where the counterparts to such transactions are established.".

(17)

Article 32 is deleted.

(18)

In Articles 33 and 34, references to Article 32(2) are replaced by references to Article 30(1).

(19)

The following Articles are inserted:

"Article 37a

1.   The provision of the following services in respect of oil tankers and cargo vessels flying the flag of the Islamic Republic of Iran or owned, chartered, or operated, directly or indirectly, by an Iranian person, entity or body shall be prohibited:

(a)

the provision of classification services of any kind, including but not limited to:

(i)

the production and application of classification rules or technical specifications concerning the design, construction, equipment and maintenance of ships, as well as shipboard management systems;

(ii)

the carrying out of surveys and inspections in accordance with classification rules and procedures;

(iii)

the assignment of a class notation and the delivery, endorsement or renewal of certificates of compliance with classification rules or specifications;

(b)

the supervision of and participation in the design, construction and repair of ships and their parts including blocks, elements, machinery, electrical installations and control installation, as well as related technical assistance, financing or financial assistance;

(c)

the inspection, testing and certification of marine equipment, materials and components as well as the supervision of the installation on board and the supervision of system integration;

(d)

the carrying out of surveys, inspections, audits and visits and the issuance, renewal or endorsement of the relevant certificates and documents of compliance, on behalf of the flag State administration, in accordance with the International Convention for the Safety of Life at Sea, 1974, as amended (SOLAS 1974) and its 1988 Protocol; the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto, as amended (MARPOL 73/78); the Convention on the International Regulations for Preventing Collisions at Sea, 1972, as amended (COLREG 1972); the International Convention on Load Lines, 1966 (LL 1966) and its 1988 Protocol; the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended (STCW); and the International Convention on Tonnage Measurement of Ships, 1969 (TONNAGE 1969).

2.   The prohibition in paragraph 1 shall apply from 15 January 2013.

Article 37b

1.   It shall be prohibited to make available vessels designed for the transport or storage of oil and petrochemical products:

(i)

to any Iranian person, entity or body; or

(ii)

to any other person, entity or body, unless the providers of vessels have taken appropriate action to prevent the vessel from being used to carry or store oil or petrochemical products that originate in Iran or have been exported from Iran.

2.   The prohibition in paragraph 1 shall be without prejudice to the execution of obligations arising from contracts and ancillary contracts referred to in Article 12(1)(b) and (c) and in Article 14(1)(b) and (c), provided that the import and transport of Iranian crude oil, petroleum or petrochemical products have been notified to the competent authority pursuant to Article 12(1) or 14(1)."

(20)

Article 41 is replaced by the following:

"Article 41

It shall be prohibited to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the measures in Article 2, 5(1), 8, 9, 10a, 10b, 10d, 10e, 11, 13, 14a, 15a, 15b, 17, 22, 23, 30, 30a, 34, 35, 37a or 37b.".

(21)

In Article 43, paragraph 3 is replaced by the following:

"3.   The Member State concerned shall notify the other Member States and the Commission of the determination referred to in paragraph 1 and its intention to grant an authorisation at least ten working days prior to the authorisation. In case of threat to the environment and/or to the health and safety of workers in the Union requiring urgent action, the Member State concerned may grant an authorisation without prior notification and shall notify the other Member States and the Commission within three working days after having granted the authorisation.".

(22)

The following Article is inserted:

"Article 43a

1.   By way of derogation from Articles 8, 9, Article 17(1) as regards an Iranian person, entity or body referred to in Article 17(2)(b), Articles 23(2) and (3) insofar as they refer to persons, entities and bodies listed in Annex IX, Article 30 and 35, the competent authorities of a Member State may authorise, under such conditions as they deem appropriate, activities related to the exploration for, or exploitation of, hydrocarbons within the Union undertaken pursuant to a licence for such exploration or exploitation issued by a Member State to a person, entity or body listed in Annex IX, if the following conditions are met:

(a)

the licence for the exploration for, or exploitation of, hydrocarbons within the Union was issued prior to the date on which the person, entity or body listed in Annex IX was designated; and

(b)

the authorisation is necessary to avoid or remediate environmental damage in the Union or to prevent permanent destruction of the licence's value, including by securing the pipeline and infrastructure used in connection with the licensed activity, on a temporary basis. Such authorisation may include measures taken under national legislation.

2.   The derogation provided for in paragraph 1 shall only be granted for such period as necessary and its validity shall not exceed the validity of the licence issued to the person, entity or body listed in Annex IX. In case the competent authority considers that subrogation to contracts or the provision of indemnities is necessary, the period of validity of the derogation shall not exceed five years.

3.   The Member State concerned shall notify the other Member States and the Commission of its intention to grant an authorisation at least ten working days prior to the authorisation. In case of threat to the environment in the Union requiring urgent action to prevent damage to the environment, the Member State concerned may grant an authorisation without prior notification and shall notify the other Member States and the Commission within three working days after having granted the authorisation.".

(23)

A reference to Article 43a is added in the Title of Annex X.

(24)

In Article 45, point (b) is replaced by the following:

"(b)

amend Annexes III, IV, IVA, V, VI, VIA, VIB, VII, VIIA, VIIB and X on the basis of information supplied by Member States.".

(25)

Annex I is replaced by the text set out in Annex I to this Regulation.

(26)

The text set out in Annex II of this Regulation is inserted as Annex IVA.

(27)

The text set out in Annex III of this Regulation is inserted as Annex VIA.

(28)

The text set out in Annex IV of this Regulation is inserted as Annex VIB.

(29)

The text set out in Annex V of this Regulation is inserted as Annex VIIA.

(30)

The text set out in Annex VI of this Regulation is inserted as Annex VIIB.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 December 2012.

For the Council

The President

A. D. MAVROYIANNIS


(1)  OJ L 195, 27.7.2010. p. 39.

(2)  OJ L 88, 24.3.2012, p. 1.

(3)  OJ L 282, 16.10.2012, p. 58.

(4)  OJ L 134, 29.5.2009, p. 1.


ANNEX I

"ANNEX I

PART A

Goods and technology referred to in Articles 2(1), (2) and (4), 3(3), 5(1), 6, 8(4), 17(2) and 31(1)

This Annex comprises all goods and technology listed in Annex I to Regulation (EC) No 428/2009, as defined therein, with the exception of those specified in Part A as well as with the exception, until 15 April 2013, of those specified in Part C.

 

Description

1.

"Information security" systems and equipment for final use for public telecommunication services and internet service providing or for the protection by the network operator of these services, including components necessary for operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing services related to those systems and equipment as follows:

a.

Systems, equipment, application specific "electronic assemblies", modules and integrated circuits for "information security" related to networks such as wifi, 2G, 3G, 4G or fixed networks (classical, ADSL or optic fiber), as follows, and components therefor specially designed for "information security":

N.B.:

For the control of Global Navigation Satellite Systems (GNSS) receiving equipment containing or employing decryption (i.e., GPS or GLONASS), see 7A005 of Annex I to Regulation (EC) No 428/2009.

1.

Designed or modified to use "cryptography" employing digital techniques performing any cryptographic function other than authentication or digital signature and having any of the following:

1.

Authentication and digital signature functions include their associated key management function.

2.

Authentication includes all aspects of access control where there is no encryption of files or text except as directly related to the protection of passwords, Personal Identification Numbers (PINs) or similar data to prevent unauthorised access.

3.

"Cryptography" does not include "fixed" data compression or coding techniques.

Note:

1.a.1. includes equipment designed or modified to use "cryptography" employing analogue principles when implemented with digital techniques.

a.

A "symmetric algorithm" employing a key length in excess of 56 bits; or

b.

An "asymmetric algorithm" where the security of the algorithm is based on any of the following:

1.

Factorisation of integers in excess of 512 bits (e.g., RSA);

2.

Computation of discrete logarithms in a multiplicative group of a finite field of size greater than 512 bits (e.g., Diffie-Hellman over Z/pZ); or

3.

Discrete logarithms in a group other than mentioned in 1.a.1.b.2. in excess of 112 bits

(e.g., Diffie-Hellman over an elliptic curve);

2.

"Software" as follows, for final use for public telecommunication services, internet service providing or for the protection by the network operator of these services:

a.

"Software" specially designed or modified for the "use" of equipment specified in 1.a.1 or "software" specified in 2.b.1;

b.

Specific "software", as follows:

1.

"Software" having the characteristics, or performing or simulating the functions of the equipment, specified in 5A002.a.1;

3.

"Technology" according to the General Technology Note for the "use" of equipment specified in 1.a.1 or "software" specified in 2.a. or 2.b.1 of this list, for final use for public telecommunication services and internet service providing or for the protection by the network operator of these services.

PART B

Article 6 applies to the following goods:

Item from Annex I to Regulation (EC) No 428/2009

Description

0A001

"Nuclear reactors" and specially designed or prepared equipment and components therefor, as follows:

a.

"Nuclear reactors";

b.

Metal vessels, or major shop-fabricated parts therefor, including the reactor vessel head for a reactor pressure vessel, specially designed or prepared to contain the core of a "nuclear reactor";

c.

Manipulative equipment specially designed or prepared for inserting or removing fuel in a "nuclear reactor";

d.

Control rods specially designed or prepared for the control of the fission process in a "nuclear reactor", support or suspension structures therefor, rod drive mechanisms and rod guide tubes;

e.

Pressure tubes specially designed or prepared to contain fuel elements and the primary coolant in a "nuclear reactor" at an operating pressure in excess of 5.1 MPa;

f.

Zirconium metal and alloys in the form of tubes or assemblies of tubes in which the ratio of hafnium to zirconium is less than 1:500 parts by weight, specially designed or prepared for use in a "nuclear reactor";

g.

Coolant pumps specially designed or prepared for circulating the primary coolant of "nuclear reactors";

h.

‧Nuclear reactor internals‧ specially designed or prepared for use in a "nuclear reactor", including support columns for the core, fuel channels, thermal shields, baffles, core grid plates, and diffuser plates;

Note:

In 0A001.h. ‧nuclear reactor internals‧ means any major structure within a reactor vessel which has one or more functions such as supporting the core, maintaining fuel alignment, directing primary coolant flow, providing radiation shields for the reactor vessel, and guiding in-core instrumentation.

i.

Heat exchangers (steam generators) specially designed or prepared for use in the primary coolant circuit of a "nuclear reactor";

j.

Neutron detection and measuring instruments specially designed or prepared for determining neutron flux levels within the core of a "nuclear reactor".

0C002

Low enriched uranium covered by 0C002 when it is incorporated in assembled nuclear fuels elements


PART C

Item from Annex I to Regulation (EC) No 428/2009

Description

5A002

"Information security" systems, equipment and components therefor, as follows:

a.

Systems, equipment, application specific "electronic assemblies", modules and integrated circuits for "information security", as follows and other specially designed components therefor:

N.B.:

For the control of Global Navigation Satellite Systems (GNSS) receiving equipment containing or employing decryption (i.e., GPS or GLONASS), see 7A005.

1.

Designed or modified to use "cryptography" employing digital techniques performing any cryptographic function other than authentication or digital signature and having any of the following:

1.

Authentication and digital signature functions include their associated key management function.

2.

Authentication includes all aspects of access control where there is no encryption of files or text except as directly related to the protection of passwords, Personal Identification Numbers (PINs) or similar data to prevent unauthorised access.

3.

"Cryptography" does not include "fixed" data compression or coding techniques.

Note:

5A002.a.1. includes equipment designed or modified to use "cryptography" employing analogue principles when implemented with digital techniques.

a.

A "symmetric algorithm" employing a key length in excess of 56 bits; or

b.

An "asymmetric algorithm" where the security of the algorithm is based on any of the following:

1.

Factorisation of integers in excess of 512 bits (e.g., RSA);

2.

Computation of discrete logarithms in a multiplicative group of a finite field of size greater than 512 bits (e.g., Diffie-Hellman over Z/pZ); or

3.

Discrete logarithms in a group other than mentioned in 5A002.a.1.b.2. in excess of 112 bits

(e.g., Diffie-Hellman over an elliptic curve);

5D002

"Software" as follows:

a.

"Software" specially designed or modified for the "use" of equipment specified in 5A002.a.1 or "software" specified in 5D002.c.1;

c.

Specific "software", as follows:

1.

"Software" having the characteristics, or performing or simulating the functions of the equipment, specified in 5A002.a.1;

Note:

5D002 does not control "software" as follows:

a.

"Software" required for the "use" of equipment excluded from control by the Note to 5A002;

b.

"Software" providing any of the functions of equipment excluded from control by the Note to 5A002.

5E002

"Technology" according to the General Technology Note for the "use" of equipment specified in 5A002.a.1 or "software" specified in 5D002.a. or 5D002.c.1 of this list.".


ANNEX II

"ANNEX IVA

Products referred to in Articles 14a and 31(1)

Natural gas and other gaseous hydrocarbons

HS code

Description

2709 00 10

Natural gas condensates

2711 11 00

Natural Gas – in liquefied state

2711 21 00

Natural Gas – in gaseous state

2711 12

Propane

2711 13

Butanes

2711 19 00

Other".


ANNEX III

"ANNEX VIA

Key equipment and technology referred to Articles 8, 10(1)(c) and 31(1)

HS code

Description

 

– Casing, tubing and drill pipe, of a kind used in drilling for oil or gas:

7304 22

– Drill pipe of stainless steel

7304 23

– – Other drill pipe

7304 24

– – Other, of stainless steel

7304 29

– – Other

ex ex 7305

Other tubes and pipes (for example, welded, riveted or similarly closed), having circular cross-sections, the external diameter of which exceeds 406,4 mm, of iron or steel, with a chrome content of 1 % or more and with a cold resistance that can go below -120°C

 

– Line pipe of a kind used for oil or gas pipelines:

7306 11

– – Welded, of stainless steel

7306 19

– – Other

 

– Casing and tubing of a kind used in drilling for oil or gas:

7306 21 00

– – Welded, of stainless steel

7306 29 00

– – Other

 

Containers for compressed or liquefied gas, of iron or steel:

7311 00 99

– Other, of a capacity of 1 000 l or more

ex ex 7613

Aluminium containers for compressed or liquefied gas, of a capacity of 1 000 l or more".


ANNEX IV

"ANNEX VIB

Key equipment and technology referred to in Articles 10a, 10b, 10c and 31(1)

HS code

Description

8406 10 00

Steam turbines for marine propulsion

ex ex 8406 90

Parts of steam turbines for marine propulsion

8407 21

Marine propulsion engines, outboard motors

ex ex 8407 29

Marine propulsion engines, other

8408 10

Marine propulsion engines

ex ex 8409 91 00

Parts suitable for use solely or principally with machines of subheadings 8407 21 or 8407 29

ex ex 8409 99 00

Parts suitable for use solely or principally with machines of subheading 8408 10

ex ex 8411 81

Other gas turbine of a power not exceeding 5 000 kW, for marine propulsion

ex ex 8411 82

Other gas turbines of a power exceeding 5 000 kW, for marine propulsion

ex ex 8468

Machinery and apparatus for soldering, brazing or welding whether or not capable of cutting, other than those of heading 8515; gas-operated surface tempering machines and appliances:

ex ex 8483

Transmission shafts (including cam shafts and crank shafts) and cranks; bearing housings and plain shaft bearings; gears and gearing; ball or roller screws; gear boxes and other speed changers, including torque converters; flywheels and pulleys, including pulley blocks; clutches and shaft couplings (including universal joints), designed for the propulsion of vessels at the maximum possible deadweight tonnage at scantling draught of 55 000 dwt or more

8487 10

Ships' or boats' propellers and blades therefor

ex ex 8515

Electric (including electrically heated gas), laser or other light or photon beam, ultrasonic, electron beam, magnetic pulse or plasma arc soldering, brazing or welding machines and apparatus, whether or not capable of cutting; electric machines and apparatus for hot spraying of metals or cermets:

ex ex 9014 10 00

Direction finding compasses, solely for the maritime industry

ex ex 9014 80 00

Other navigational instruments and appliances, solely for the maritime industry

ex ex 9014 90 00

Parts and accessories of subheadings 9014 10 00 and 9014 80 00, solely for the maritime industry

ex ex 9015

Surveying (including photogram metrical surveying), hydro graphic, oceanographic, hydrological, meteorological or geophysical instruments and appliances, excluding compasses; rangefinders, solely for the maritime industry ".


ANNEX V

"ANNEX VIIA

Software for integrating industrial processes referred to in Article 10d, 10e, 10f and 31(1)

1.

Enterprise Resource Planning software, designed specifically for use in nuclear, military, gas, oil, navy, aviation, financial and construction industries.

Explanatory note: Enterprise Resource Planning software is software used for financial accounting, management accounting, human resources, manufacturing, supply chain management, project management, customer relationship management, data services, or access control.".


ANNEX VI

"ANNEX VIIB

Graphite and raw or semi-finished metals referred to in Articles 15a, 15b, 15c and 31(1)

Introductory note: The inclusion of goods in this Annex is without prejudice to the rules applicable to the goods included in Annexes I, II and III.

1.   Graphite

HS code

Description

2504

Natural graphite

3801

Artificial graphite; colloidal or semi-colloidal graphite; preparations based on graphite or other carbon in the form of pastes, blocks, plates or other semi-manufactures

6815 10

Non-electrical articles of graphite or other carbon, incl. carbon fibres

6903 10

Retorts, crucibles, mufflers, nozzles, plugs, supports, cupels, tubes, pipes, sheaths, rods and other refractory ceramic goods. Other than those of siliceous fossil meals or of similar siliceous earths, containing, by weight, more than 50 % of graphite, or other carbon or of a mixture of these products

8545

Carbon electrodes, carbon brushes, lamp carbons, battery carbons and other articles of graphite or other carbon, with or without metal, of a kind used for electrical purposes


2.   Iron and Steel

HS code

Description

7201

Pig iron and spiegeleisen in pigs, blocks or other primary forms

7202

Ferro-alloys

7203

Ferrous products obtained by direct reduction of iron ore and other spongy ferrous products, in lumps, pellets or similar forms; iron having a minimum purity by weight of 99,94 %, in lumps, pellets or similar forms

7204

Ferrous waste and scrap; remelting scrap ingots of iron or steel

7205

Granules and powders, of pig iron, spiegeleisen, iron or steel

7206

Iron and non-alloy steel in ingots or other primary forms

7207

Semi-finished products of iron or non-alloy steel

7218

Stainless steel in ingots or other primary forms; semi-finished products of stainless steel

7224

Other alloy steel in ingots or other primary forms; semi-finished products of other alloy steel


3.   Copper and articles thereof

HS code

Description

7401 00 00

Copper mattes; cement copper (precipitated copper)

7402 00 00

Unrefined copper; copper anodes for electrolytic refining

7403

Refined copper and copper alloys, unwrought

7404 00

Copper waste and scrap

7405 00 00

Master alloys of copper

7406

Copper powders and flakes

7407

Copper bars, rods and profiles

7410

Copper foil (whether or not printed or backed with paper, paperboard, plastics or similar backing materials) of a thickness (excluding any backing) not exceeding 0,15 mm

7413 00 00

Stranded wire, cables, plaited bands and the like, of copper, not electrically insulated


4.   Nickel and articles thereof

HS code

Description

7501

Nickel mattes, nickel oxide sinters and other intermediate products of nickel metallurgy

7502

Unwrought nickel

7503 00

Nickel waste and scrap

7504 00 00

Nickel powders and flakes

7505

Nickel bars, rods, profiles and wire

7506

Nickel plates, sheets, strip and foil

7507

Nickel tubes, pipes and tube or pipe fittings (for example, couplings, elbows, sleeves)


5.   Aluminium

HS code

Description

7601

Unwrought aluminium

7602

Aluminium waste and scrap

7603

Aluminium powders and flakes

7605

Aluminium wire

7606

Aluminium plates, sheets and strip, of a thickness exceeding 0,2 mm

7609 00 00

Aluminium tube or pipe fittings (for example, couplings, elbows, sleeves)

7614

Stranded wire, cables, plaited bands and the like, of aluminium, not electrically insulated


6.   Lead

HS code

Description

7801

Unwrought lead

7802 00 00

Lead waste and scrap

7804

Lead plates, sheets, strip and foil; lead powders and flakes


7.   Zinc

HS code

Description

7901

Unwrought zinc

7902 00 00

Zinc waste and scrap

7903

Zinc dust, powders and flakes

7904 00 00

Zinc bars, rods, profiles and wire

7905 00 00

Zinc plates, sheets, strip and foil


8.   Tin

HS code

Description

8001

Unwrought tin

8002 00 00

Tin waste and scrap

8003 00 00

Tin bars, rods, profiles and wire


9.   Other base metals, cermets, articles thereof

HS code

Description

ex ex 8101

Tungsten (wolfram) and articles thereof, including waste and scrap, other than anti-cathodes for x-ray tubes

ex ex 8102

Molybdenum and articles thereof, including waste and scrap, other than articles specifically designed for use in dentistry

ex ex 8103

Tantalum and articles thereof, including waste and scrap, other than dental instruments and surgical tools and articles specially designed for orthopaedic and surgical purposes

8104

Magnesium and articles thereof, including waste and scrap

8105

Cobalt mattes and other intermediate products of cobalt metallurgy; cobalt and articles thereof, including waste and scrap

ex ex 8106 00

Bismuth and articles thereof, including waste and scrap, other than that specially prepared for the preparation of chemical compounds for pharmaceutical use

8107

Cadmium and articles thereof, including waste and scrap

8108

Titanium and articles thereof, including waste and scrap

8109

Zirconium and articles thereof, including waste and scrap

8110

Antimony and articles thereof, including waste and scrap

8111 00

Manganese and articles thereof, including waste and scrap

ex ex 8112

Beryllium, chromium, germanium, vanadium, gallium, hafnium, indium, niobium (columbium), rhenium and thallium, and articles of these metals, including waste and scrap, other than windows for X-ray tubes

8113 00

Cermets and articles thereof, including waste and scrap".


22.12.2012   

EN

Official Journal of the European Union

L 356/55


COUNCIL IMPLEMENTING REGULATION (EU) No 1264/2012

of 21 December 2012

implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EU) No 267/2012 of 23 March 2012 concerning restrictive measures against Iran (1), and in particular Article 46(2) thereof,

Whereas:

(1)

On 23 March 2012, the Council adopted Regulation (EU) No 267/2012.

(2)

In view of the situation in Iran, and in accordance with Decision 2012/829/CFSP (2), additional persons and entities should be included in the list of natural and legal persons, entities and bodies subject to restrictive measures set out in Annex IX to Regulation (EU) No 267/2012.

(3)

Furthermore, certain entities should be removed from the list of natural and legal persons, entities and bodies subject to restrictive measures as set out in Annex IX to Regulation (EU) No 267/2012, while the entries for certain entities should be amended.

(4)

In order to ensure that the measures provided for in this Regulation are effective, it should enter into force on the day of its publication,

HAS ADOPTED THIS REGULATION:

Article 1

Annex IX to Regulation (EU) No 267/2012 shall be amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 December 2012.

For the Council

The President

A. D. MAVROYIANNIS


(1)  OJ L 88, 24.3.2012, p. 1.

(2)  See page 71 of this Official Journal.


ANNEX

I.

The person and entities listed below shall be added to the list set out in Annex IX to Regulation (EU) No 267/2012:

"I.   Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran

Person

 

Name

Identifying information

Reasons

Date of listing

1.

Babak Zanjani

Date of birth: 12 March 1971

Babak Zanjani is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. Zanjani is a key facilitator for Iranian oil deals and transferring oil-related money. Zanjani owns and operates the UAE-based Sorinet Group, and some of its companies are used by Zanjani to channel oil-related payments.

22.12.2012


Entities

 

Name

Identifying information

Reasons

Date of listing

1.

National Iranian Oil Products Distribution Company (NIOPDC)

No.1, Tehran, Iranshahr Ave.Shadab.St,

P.O.Box: 79145/3184

Tel: +98-21-77606030

Website: www.niopdc.ir

Subsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)

22.12.2012

2.

Iranian Oil Pipelines and Telecommunications Company (IOPTC)

No.194, Tehran, Sepahbod Gharani Ave.

Tel: +98-21-88801960/+98-21-66152223

Fax: +98-21-66154351

Website: www.ioptc.com

Subsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)

22.12.2012

3.

National Iranian Oil Engineering and Construction Company (NIOEC)

No.263, Tehran, Ostad Nejatollahi Ave.

P.O.Box: 11365/6714

Tel: +98-21-88907472

Fax: +98-21-88907472

Website: www.nioec.org

Subsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)

22.12.2012

4.

Iran Composites Institute

Iran Composites Institute,

Iranian University of Science and Technology,

16845-188, Tehran, Iran,

Telephone: 98 217 3912858

Fax: 98 217 7491206

E-mail: ici@iust.ac.ir

Website: http://www.irancomposites.org

Iranian Composites Institute (ICI, aka Composite Institute of Iran) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of 2011 ICI had been contracted to provide EU-designated Iran Centrifuge Technology Company (TESA) with IR-2M centrifuge rotors.

22.12.2012

5.

Jelvesazan Company

22 Bahman St., Bozorgmehr Ave, 84155666, Esfahan, Iran

Tel: 98 0311 2658311 15

Fax: 98 0311 2679097

Jelvesazan Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2012 Jelvesazan intended to supply controlled vacuum pumps to EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

6.

Iran Aluminium Company

Arak Road Km 5, Tehran Road, 38189-8116, Arak, Iran

Tel: 98 861 4130430

Fax: 98 861 413023

Website: www.iralco.net

The Iran Aluminium Company (aka IRALCO, Iranian Aluminium Company) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of mid-2012 IRALCO had a contract to supply aluminium to EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

7.

Simatec Development Company

 

Simatec Development Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2010 Simatec was contracted by UN-designated Kalaye Electric Company (KEC) to procure Vacon inverters to power uranium enrichment centrifuges. As of mid-2012 Simatec was attempting to procure EU-controlled inverters.

22.12.2012

8.

Aluminat

1.

Parcham St, 13th Km of Qom Rd 38135 Arak (Factory)

2.

Unit 38, 5th Fl, Bldg No 60, Golfam St, Jordan, 19395-5716, Tehran

Tel: 98 212 2049216 / 22049928 / 22045237

Fax: 98 21 22057127

Website: www.aluminat.com

Aluminat is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. In early 2012 Aluminat had a contract to supply 6061-T6 aluminium to EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

9.

Organisation of Defensive Innovation and Research

 

The Organisation of Defensive Innovation and Research (SPND) is assisting designated persons and entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. The IAEA has identified SPND with their concerns over possible military dimensions (PMD) to Iran's nuclear programme over which Iran continues to refuse to co-operate. SPND is run by UN-designated Mohsen Fakhrizadeh and is part of the Ministry of Defence For Armed Forces Logistics (MODAFL, designatedby the EU in May 2011). Davoud Babaei was designated by the EU in December 2011 in his role as SPND's head of security, in which he is responsible for preventing the disclosure of information including to the IAEA.

22.12.2012

10.

First Islamic Investment Bank

Branch: 19A-31-3A, Level 31 Business Suite, Wisma UOA, Jalan Pinang 50450, Kuala Lumpur; Kuala Lumpur; Wilayah Persekutuan; 50450

Tel: 603-21620361/2/3/4, +6087417049/ 417050, +622157948110

Branch: Unit 13 (C), Main Office Tower, Financial Park Labuan Complex, Jalan Merdeka, 87000 Federal Territory of Labuan, Malaysia; Labuan F.T; 87000

Investor Relations: Menara Prima 17th floor Jalan Lingkar, Mega Kuningan Blok 6.2 Jakarta 12950 – Indonesia; South Jakarta; Jakarta; 12950

First Islamic Investment Bank (FIIB) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. FIIB is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.

22.12.2012

11.

International Safe Oil

 

International Safe Oil (ISO) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. ISO is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.

22.12.2012

12.

Sorinet Commercial Trust

SCT Bankers Company

Branch: No.1808, 18th Floor, Grosvenor House Commercial Tower, Sheik Zayed Road, Dubai, UAE, P.O.Box 31988

Tel: 0097 14 3257022-99

E-mail: INFO@SCTBankers.com

Dubai SWIFT Code: SCTSAEA1

Branch: No.301, 3rd Floor Sadaf Building Kish Island, Iran, P.O.Box 1618

Tel: +98 764 444 32 341-2

Fax: +98 764 444 50 390-1

Sorinet Commercial Trust (SCT) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. SCT is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.

22.12.2012

13.

Hong Kong Intertrade Company Ltd

Hong Kong Intertrade Company, Hong Kong

Hong Kong Intertrade Company Ltd (HKICO) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. HKICO is a front company controlled by EU-designated National Iranian OilCompany (NIOC). In mid-2012 HKICO was scheduled to receive millions of dollars from NIOC oil sales.

22.12.2012

14.

Petro Suisse

Petro Suisse

Avenue De la Tour-Halimand 6, 1009 Pully, Switzerland

Petro Suisse is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. It is a front company controlled by EU-designated NIOC. NIOC set up Petro Suisse as a company and would use Petro Suisse accounts to make and receive payments. Petro Suisse continued to be in contact with NIOC in 2012.

22.12.2012

15.

Oil Industry Pension Fund Investment Company

No 234, Taleghani St, Tehran Iran

Iran's Oil Industry Pension Fund Investment Company (OPIC, aka the Oil Pension Fund, NIOC Pension Fund, Petroleum Ministry Pension Fund) is providing financial support to the government of Iran. OPIC operates under the Iranian Ministry of Petroleum and the National Iranian Oil Company (NIOC), both of which are EU-designated. It holds shares in a number of EU-designated entities.

22.12.2012

16.

CF Sharp and Company Private Limited

 

This entity has been assisting the Irano-Hind Shipping Company (IHSC) (designated by the United Nations on 9 June 2010) in circumventing the sanctions adopted against it. Following its designation, IHSC has tried to conceal its ownership of three tankers, by placing them under the management of Noah Ship Management and then Marian Ship Management. CF Sharp and Co. has contributed to this arrangement by concluding a personnel management contract with IHSC covering the crew of those three tankers. That contract was performed by Noah Ship Management and Marian Ship Management.

22.12.2012

17.

Sharif University of Technology

Azadi Ave, 11365-8639, Tehran, Iran

Tel: 98 21 66022727

Fax: 98 21 66036005

Website: www.sharif.ir

Sharif University of Technology (SUT) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is providing support to Iran's proliferation sensitive nuclear activities. As of late 2011 SUT had provided laboratories for use by UN-designated Iraniannuclear entity Kalaye Electric Company (KEC) and EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

18.

Moallem Insurance Company (also known as:

Moallem Insurance; Moallem Insurance Co.; M.I.C; Export and Investment Insurance Co.)

No. 56, Haghani Boulevard, Vanak Square, Tehran 1517973511, Iran PO Box 19395-6314, 11/1 Sharif Ave, Vanaq Square, Tehran 19699, Iran

Phone: (98-21) 886776789, 887950512, 887791835

Fax: (98-21) 88771245

Website: www.mic-ir.com

Main insurer of IRISL

22.12.2012"

II.

The entries for the entities set out in Annex IX to Regulation (EU) No 267/2012 listed below shall be replaced by the entries below:

"B.   Entities

 

Name

Identifying information

Reasons

Date of listing

1.

Technology Cooperation Office (TCO) of the Iranian President's Office (a.k.a.

Center for Innovation and Technology (CITC))

Tehran, Iran

Responsible for Iran's technological advancement through relevant foreign procurement and training links. Supports the nuclear and missile programmes.

26.07.2010

2.

Sureh (a.k.a. Soreh) Nuclear Reactors Fuel Company (a.k.a. Nuclear Fuel Reactor Company; Sookht Atomi Reactorhaye Iran; Soukht Atomi Reactorha-ye Iran)

Head Office: 61 Shahid Abtahi St, Karegar e Shomali, Tehran

Complex: Persian Gulf Boulevard, Km20 SW Esfahan Road, Esfahan

A company subordinate to the UN-sanctioned Atomic Energy Organisation of Iran (AEOI) consisting of the Uranium Conversion Facility, the Fuel Manufacturing Plant and the Zirconium Production Plant.

23.05.2011

3.

Tidewater (a.k.a. Tidewater Middle East Co; Faraz Royal Qeshm Company LLC)

Postal address: No 80, Tidewater Building, Vozara Street, Next to Saie Park, Tehran, Iran

Owned or controlled by IRGC

23.01.2012"

III.

The entities listed below shall be deleted from the list set out in Annex IX to Regulation (EU) No 267/2012:

1.

CF Sharp Shipping Agencies Pte Ltd

2.

Soreh (Nuclear Fuel Reactor Company).


22.12.2012   

EN

Official Journal of the European Union

L 356/61


COMMISSION IMPLEMENTING REGULATION (EU) No 1265/2012

of 17 December 2012

amending Implementing Regulation (EU) No 837/2012 as regards the minimum activity of a preparation of 6-phytase produced by Aspergillus oryzae (DSM 22594) as feed additive for poultry, weaned piglets, pigs for fattening and sows (holder of authorisation DSM Nutritional Products)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 13(3) thereof,

Whereas:

(1)

The use of a preparation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 22594), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for use on poultry, weaned piglets, pigs for fattening and sows by Commission Implementing Regulation (EU) No 837/2012 (2).

(2)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of the preparation concerned by adding a new solid formulation with a minimum activity of 10 000 FYT/g. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter ‘the Authority’).

(3)

The Authority concluded in its opinion of 24 May 2012 (3) that the new enzyme solid formulation is not expected to introduce hazards to the target species, consumers, users or the environment not already considered and it is efficacious at the minimum activity of 10 000 FYT/g. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(4)

The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

(5)

Implementing Regulation (EU) No 837/2012 should therefore be amended accordingly.

(6)

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) No 837/2012 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 December 2012.

For the Commission

The President

José Manuel BARROSO


(1)  OJ L 268, 18.10.2003, p. 29.

(2)  OJ L 252, 19.9.2012, p. 7.

(3)  EFSA Journal 2012; 10(6):2730.


ANNEX

The Annex to Implementing Regulation (EU) No 837/2012 is replaced by the following:

‘ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a18

DSM Nutritional Products

6-phytase (EC 3.1.3.26)

 

Additive composition

Preparation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae

(DSM 22594) with a minimum activity of:

 

10 000 FYT (1)/g in solid form

 

20 000 FYT/g in liquid form

 

Characterisation of the active substance

6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 22594)

 

Analytical method  (2)

For quantification of 6-phytase in feed:

Colorimetric method measuring the inorganic phosphate released by the 6-phytase from phytate (ISO 30024:2009)

Poultry

Pigs for fattening

Piglets

(weaned)

500 FYT

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2.

Recommended dose per kilogram of complete feed for:

poultry, piglets (weaned) and pigs for fattening: 500-4 000 FYT,

sows: 1 000-4 000 FYT.

3.

For use in feed containing more than 0,23 % phytin-bound phosphorus.

4.

For safety: breathing protection, glasses and gloves shall be used during handling.

5.

For use in weaned piglets up to 35 kg.

9 October 2022

Sows

1 000 FYT


(1)  1 FYT is the amount of enzyme which liberates 1 μmol of inorganic phosphate from phytate per minute under reaction conditions with a phytate concentration of 5,0 mM at pH 5,5 and 37 °C.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx’


22.12.2012   

EN

Official Journal of the European Union

L 356/63


COMMISSION IMPLEMENTING REGULATION (EU) No 1266/2012

of 21 December 2012

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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) (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 December 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 157, 15.6.2011, p. 1.


ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

56,9

MA

79,5

TN

111,9

TR

123,6

ZZ

93,0

0707 00 05

AL

87,0

TR

136,9

ZZ

112,0

0709 93 10

MA

110,2

TR

137,7

ZZ

124,0

0805 10 20

MA

61,3

TR

63,0

ZA

51,2

ZZ

58,5

0805 20 10

MA

69,9

ZZ

69,9

0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

IL

86,6

JM

129,1

MA

98,7

TR

84,1

ZZ

99,6

0805 50 10

TR

79,2

ZZ

79,2

0808 10 80

BA

56,8

CA

156,3

CN

174,8

MK

40,0

US

132,7

ZA

123,7

ZZ

114,4

0808 30 90

CN

72,9

TR

135,1

US

182,0

ZZ

130,0


(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


22.12.2012   

EN

Official Journal of the European Union

L 356/65


COMMISSION IMPLEMENTING REGULATION (EU) No 1267/2012

of 21 December 2012

fixing the import duties in the cereals sector applicable from 1 January 2013

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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) (1),

Having regard to Commission Regulation (EU) No 642/2010 of 20 July 2010 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,

Whereas:

(1)

Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

(2)

Article 136(2) of Regulation (EC) No 1234/2007 lays down that, in order to calculate the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

(3)

Under Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is the daily cif representative import price determined as specified in Article 5 of that Regulation.

(4)

Import duties should be fixed for the period from 1 January 2013 and should apply until new import duties are fixed and enter into force.

(5)

Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

HAS ADOPTED THIS REGULATION:

Article 1

From 1 January 2013, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 December 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 187, 21.7.2010, p. 5.


ANNEX I

Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 1 January 2013

CN code

Description

Import duties (1)

(EUR/t)

1001 19 00

1001 11 00

Durum wheat, high quality

0,00

medium quality

0,00

low quality

0,00

ex 1001 91 20

Common wheat seed

0,00

ex 1001 99 00

High quality common wheat other than for sowing

0,00

1002 10 00

1002 90 00

Rye

0,00

1005 10 90

Maize seed other than hybrid

0,00

1005 90 00

Maize other than seed (2)

0,00

1007 10 90

1007 90 00

Grain sorghum other than hybrids for sowing

0,00


(1)  The importer may benefit, under Article 2(4) of Regulation (EU) No 642/2010, from a reduction in the duty of:

EUR 3/t, where the port of unloading is located on the Mediterranean Sea (beyond the Strait of Gibraltar) or on the Black Sea, for goods arriving in the Union via the Atlantic Ocean or the Suez Canal,

EUR 2/t, where the port of unloading is located in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or on the Atlantic coast of the Iberian Peninsula, for goods arriving in the Union via the Atlantic Ocean.

(2)  The importer may benefit from a flat-rate reduction of EUR 24/t where the conditions laid down in Article 3 of Regulation (EU) No 642/2010 are met.


ANNEX II

Factors for calculating the duties laid down in Annex I

14.12.2012-20.12.2012

1.

Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

(EUR/t)

 

Common wheat (1)

Maize

Durum wheat, high quality

Durum wheat, medium quality (2)

Durum wheat, low quality (3)

Exchange

Minnéapolis

Chicago

Quotation

263,55

213,34

Fob price USA

259,19

249,19

229,19

Gulf of Mexico premium

18,17

Great Lakes premium

25,89

2.

Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

Freight costs: Gulf of Mexico-Rotterdam:

14,52 EUR/t

Freight costs: Great Lakes-Rotterdam:

46,05 EUR/t


(1)  Premium of EUR 14/t incorporated (Article 5(3) of Regulation (EU) No 642/2010).

(2)  Discount of EUR 10/t (Article 5(3) of Regulation (EU) No 642/2010).

(3)  Discount of EUR 30/t (Article 5(3) of Regulation (EU) No 642/2010).


DIRECTIVES

22.12.2012   

EN

Official Journal of the European Union

L 356/68


COMMISSION IMPLEMENTING DIRECTIVE 2012/52/EU

of 20 December 2012

laying down measures to facilitate the recognition of medical prescriptions issued in another Member State

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (1), and in particular points (a), (c) and (d) of Article 11(2) thereof,

Whereas:

(1)

Pursuant to Article 11(2) of Directive 2011/24/EU, the Commission has an obligation to adopt measures to facilitate the recognition of medical prescriptions issued in a Member State other than the Member State where the prescriptions are dispensed.

(2)

Pursuant to point (a) of Article 11(2) of Directive 2011/24/EU, the Commission is to adopt a non-exhaustive list of elements to be included in those prescriptions. That list should enable the dispensing health professional to verify the authenticity of the prescription and whether it was issued by a member of a regulated health profession who is legally entitled to do so.

(3)

The elements to be included in the prescriptions should facilitate the correct identification of medicinal products or medical devices as referred to in point (c) of Article 11 (2) of Directive 2011/24/EU.

(4)

Medicinal products should therefore be indicated using the common name in order to facilitate the correct identification of products which are marketed under different brand names across the Union and of products that are not marketed in all Member States. That common name to be used should be either the International Non-proprietary name recommended by the World Health Organisation or, if such name does not exist, the usual common name. In contrast, the brand name of a medicinal product should only be used to ensure clear identification of biological medicinal products as defined in point 3.2.1.1.(b) of Annex I to 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 (2), because of the special characteristics of those products, or of other medicinal products in cases where the prescribing professional considers it medically necessary.

(5)

Medical devices do not have common names as medicinal products. Therefore the prescription should also include direct contact details of the prescriber which enable the dispensing professional, where necessary, to enquire about the prescribed medical device and correctly identify it.

(6)

The non-exhaustive list of elements to appear on the prescriptions should facilitate the comprehensibility of the information to patients concerning the prescription and the instructions included on the use of the product, as referred to in point (d) of Article 11(2) of Directive 2011/24/EU. The Commission will regularly review the situation in order to assess whether additional measures are necessary to help patients understand the instructions concerning the use of the product.

(7)

To enable patients to request appropriate prescriptions, it is important that national contact points referred to in Article 6 of Directive 2011/24/EU provide patients with adequate information on the content and purpose of the non-exhaustive list of elements that should appear in those prescriptions.

(8)

As the overall impact of cross-border healthcare is limited, the non-exhaustive list of elements should apply only to prescriptions intended to be used in another Member State.

(9)

As the principle of mutual recognition of prescriptions derives from Article 56 of the Treaty on the Functioning of the European Union, this Directive does not preclude the Member States from applying the principle of mutual recognition to prescriptions that do not contain the elements set out in the non-exhaustive list. At the same time, nothing in this Directive prevents the Member States from providing that prescriptions drafted on their territory, with a view to be used in another Member State, contain additional elements that are provided for under the rules applicable on their territory, as long as these rules are compatible with Union law.

(10)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 16(1) of Directive 2011/24/EU

HAS ADOPTED THIS DIRECTIVE:

Article 1

Subject matter

This Directive lays down measures for the uniform implementation of Article 11(1) of Directive 2011/24/EU concerning the recognition of medical prescriptions issued in another Member State.

Article 2

Scope

This Directive shall apply to prescriptions, as defined in point (k) of Article 3 of Directive 2011/24/EU, which are issued further to a request of a patient who intends to use them in another Member State.

Article 3

Content of prescriptions

Member States shall ensure that prescriptions contain at least the elements set out in the Annex.

Article 4

Information requirements

Member States shall ensure that the national contact points referred to in Article 6 of Directive 2011/24/EU inform patients about the elements to be included, pursuant to this Directive, in prescriptions issued in a Member State other than the Member State where they are dispensed.

Article 5

Transposition

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 October 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 6

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 7

Addressees

This Directive is addressed to the Member States.

Done at Brussels, 20 December 2012.

For the Commission

The President

José Manuel BARROSO


(1)  OJ L 88, 4.4.2011, p. 45–65

(2)  OJ L 311, 28.11.2001, p. 67.


ANNEX

Non-exhaustive list of elements to be included in medical prescriptions

Headings appearing in bold in this Annex are not required to feature in prescriptions

Identification of the patient

Surname(s)

First name(s) (written out in full, i.e. no initials)

Date of Birth

Authentication of the prescription

Issue date

Identification of the prescribing health professional

Surname(s)

First name(s) (written out in full, i.e. no initials)

Professional qualification

Details for direct contact (email and telephone or fax, the latter both with international prefix)

Work address (including the name of the relevant Member State)

Signature (written or digital, depending on the medium chosen for issuing the prescription)

Identification of the prescribed product, where applicable

‘Common name’ as defined by Article 1 of 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

The brand name if:

(a)

the prescribed product is a biological medicinal product, as defined in point 3.2.1.1.(b) of Annex I (Part I) to Directive 2001/83; or

(b)

the prescribing health professional deems it medically necessary; in that case the prescription shall shortly state the reasons justifying the use of the brand name

Pharmaceutical formulation (tablet, solution, etc.)

Quantity

Strength, as defined in Article 1 of Directive 2001/83/EC

Dosage regimen


DECISIONS

22.12.2012   

EN

Official Journal of the European Union

L 356/71


COUNCIL DECISION 2012/829/CFSP

of 21 December 2012

amending Decision 2010/413/CFSP concerning restrictive measures against Iran

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Whereas:

(1)

On 26 July 2010, the Council adopted Decision 2010/413/CFSP (1).

(2)

A provision concerning enhanced monitoring over all activities of financial institutions within the Union with Iranian financial institutions should be inserted in Decision 2010/413/CFSP.

(3)

In addition, a provision in Decision 2010/413/CFSP concerning the freezing of funds and economic resources should also be amended.

(4)

Furthermore, additional persons and entities should be included in the list of persons and entities subject to restrictive measures as set out in Annex II to Decision 2010/413/CFSP, certain entities should be removed from that list and the entries concerning certain entities should be amended.

(5)

Decision 2010/413/CFSP should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2010/413/CFSP is hereby amended as follows:

(1)

In Article 10, the following paragraph is inserted:

"3a.   Financial institutions shall be required, in their activities with banks and financial institutions as set out in paragraph 1, to:

(a)

exercise continuous vigilance over account activity including through their programmes on customer due diligence and under their obligations relating to money-laundering and financing of terrorism;

(b)

require that all information fields of payment instructions which relate to the originator and beneficiary of the transaction in question be completed and, if that information is not supplied, refuse the transaction;

(c)

maintain all records of transactions for a period of five years and make them available to national authorities on request;

(d)

if they suspect, or have reasonable grounds to suspect, that funds are related to proliferation financing, promptly report their suspicions to the FIU or another competent authority designated by the Member State concerned. The FIU or such other competent authority shall have access, directly or indirectly, on a timely basis to the financial, administrative and law enforcement information that it requires to properly undertake this function, including the analysis of suspicious transaction reports.".

(2)

Article 20(1)(b) is replaced by the following:

"(b)

persons and entities not covered by Annex I that are engaged in, directly associated with, or providing support for, Iran's proliferation-sensitive nuclear activities or for the development of nuclear weapon delivery systems, including through the involvement in procurement of the prohibited items, goods, equipment, materials and technology, or persons or entities acting on their behalf or at their direction, or entities owned or controlled by them, including through illicit means, or persons and entities that have assisted designated persons or entities in evading or violating the provisions of UNSCR 1737 (2006), UNSCR 1747 (2007), UNSCR 1803 (2008) and UNSCR 1929 (2010) or this Decision, as well as other members and entities of IRGC and IRISL and entities owned or controlled by them or acting on their behalf or providing insurance or other essential services to them, as listed in Annex II.".

Article 2

Annex II to Decision 2010/413/CFSP shall be amended as set out in the Annex to this Decision.

Article 3

This Decision shall enter into force on the date of its publication in the Official Journal of the European Union.

Done at Brussels, 21 December 2012.

For the Council

The President

A. D. MAVROYIANNIS


(1)  OJ L 195, 27.7.2010, p. 39.


ANNEX

I.

The person and entities listed below shall be added to the list set out in Annex II to Decision 2010/413/CFSP:

"I.   Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of Iran

Person

 

Name

Identifying information

Reasons

Date of listing

1.

Babak Zanjani

Date of birth: 12 March 1971

Babak Zanjani is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. Zanjani is a key facilitator for Iranian oil deals and transferring oil-related money. Zanjani owns and operates the UAE-based Sorinet Group, and some of its companies are used by Zanjani to channel oil-related payments.

22.12.2012


Entities

 

Name

Identifying information

Reasons

Date of listing

1.

National Iranian Oil Products Distribution Company (NIOPDC)

No.1, Tehran, Iranshahr Ave.Shadab.St,

P.O.Box: 79145/3184

Tel: +98-21-77606030

Website: www.niopdc.ir

Subsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)

22.12.2012

2.

Iranian Oil Pipelines and Telecommunications Company (IOPTC)

No.194, Tehran, Sepahbod Gharani Ave.

Tel: +98-21-88801960/+98-21-66152223

Fax: +98-21-66154351

Website: www.ioptc.com

Subsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)

22.12.2012

3.

National Iranian Oil Engineering and Construction Company (NIOEC)

No.263, Tehran, Ostad Nejatollahi Ave.

P.O.Box: 11365/6714

Tel: +98-21-88907472

Fax: +98-21-88907472

Website: www.nioec.org

Subsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)

22.12.2012

4.

Iran Composites Institute

Iran Composites Institute,

Iranian University of Science and Technology,

16845-188, Tehran, Iran,

Telephone: 98 217 3912858

Fax: 98 217 7491206

E-mail: ici@iust.ac.ir

Website: http://www.irancomposites.org

Iranian Composites Institute (ICI, aka Composite Institute of Iran) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of 2011 ICI had been contracted to provide EU-designated Iran Centrifuge Technology Company (TESA) with IR-2M centrifuge rotors.

22.12.2012

5.

Jelvesazan Company

22 Bahman St., Bozorgmehr Ave, 84155666, Esfahan, Iran

Tel: 98 0311 2658311 15

Fax: 98 0311 2679097

Jelvesazan Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2012 Jelvesazan intended to supply controlled vacuum pumps to EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

6.

Iran Aluminium Company

Arak Road Km 5, Tehran Road, 38189-8116, Arak, Iran

Tel: 98 861 4130430

Fax: 98 861 413023

Website: www.iralco.net

The Iran Aluminium Company (aka IRALCO, Iranian Aluminium Company) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of mid-2012 IRALCO had a contract to supply aluminium to EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

7.

Simatec Development Company

 

Simatec Development Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2010 Simatec was contracted by UN-designated Kalaye Electric Company (KEC) to procure Vacon inverters to power uranium enrichment centrifuges. As of mid-2012 Simatec was attempting to procure EU-controlled inverters.

22.12.2012

8.

Aluminat

1.

Parcham St, 13th Km of Qom Rd 38135 Arak (Factory)

2.

Unit 38, 5th Fl, Bldg No 60, Golfam St, Jordan, 19395-5716, Tehran

Tel: 98 212 2049216 / 22049928 / 22045237

Fax: 98 21 22057127

Website: www.aluminat.com

Aluminat is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. In early 2012 Aluminat had a contract to supply 6061-T6 aluminium to EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

9.

Organisation of Defensive Innovation and Research

 

The Organisation of Defensive Innovation and Research (SPND) is assisting designated persons and entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. The IAEA has identified SPND with their concerns over possible military dimensions (PMD) to Iran's nuclear programme over which Iran continues to refuse to co-operate. SPND is run by UN-designated Mohsen Fakhrizadeh and is part of the Ministry of Defence For Armed Forces Logistics (MODAFL, designatedby the EU in May 2011). Davoud Babaei was designated by the EU in December 2011 in his role as SPND's head of security, in which he is responsible for preventing the disclosure of information including to the IAEA.

22.12.2012

10.

First Islamic Investment Bank

Branch: 19A-31-3A, Level 31 Business Suite, Wisma UOA, Jalan Pinang 50450, Kuala Lumpur; Kuala Lumpur; Wilayah Persekutuan; 50450

Tel: 603-21620361/2/3/4, +6087417049/ 417050, +622157948110

Branch: Unit 13 (C), Main Office Tower, Financial Park Labuan Complex, Jalan Merdeka, 87000 Federal Territory of Labuan, Malaysia; Labuan F.T; 87000

Investor Relations: Menara Prima 17th floor Jalan Lingkar, Mega Kuningan Blok 6.2 Jakarta 12950 – Indonesia; South Jakarta; Jakarta; 12950

First Islamic Investment Bank (FIIB) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. FIIB is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.

22.12.2012

11.

International Safe Oil

 

International Safe Oil (ISO) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. ISO is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.

22.12.2012

12.

Sorinet Commercial Trust

SCT Bankers Company

Branch: No.1808, 18th Floor, Grosvenor House Commercial Tower, Sheik Zayed Road, Dubai, UAE, P.O.Box 31988

Tel: 0097 14 3257022-99

E-mail: INFO@SCTBankers.com

Dubai SWIFT Code: SCTSAEA1

Branch: No.301, 3rd Floor Sadaf Building Kish Island, Iran, P.O.Box 1618

Tel: +98 764 444 32 341-2

Fax: +98 764 444 50 390-1

Sorinet Commercial Trust (SCT) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. SCT is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.

22.12.2012

13.

Hong Kong Intertrade Company Ltd

Hong Kong Intertrade Company, Hong Kong

Hong Kong Intertrade Company Ltd (HKICO) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. HKICO is a front company controlled by EU-designated National Iranian OilCompany (NIOC). In mid-2012 HKICO was scheduled to receive millions of dollars from NIOC oil sales.

22.12.2012

14.

Petro Suisse

Petro Suisse

Avenue De la Tour-Halimand 6, 1009 Pully, Switzerland

Petro Suisse is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. It is a front company controlled by EU-designated NIOC. NIOC set up Petro Suisse as a company and would use Petro Suisse accounts to make and receive payments. Petro Suisse continued to be in contact with NIOC in 2012.

22.12.2012

15.

Oil Industry Pension Fund Investment Company

No 234, Taleghani St, Tehran Iran

Iran's Oil Industry Pension Fund Investment Company (OPIC, aka the Oil Pension Fund, NIOC Pension Fund, Petroleum Ministry Pension Fund) is providing financial support to the government of Iran. OPIC operates under the Iranian Ministry of Petroleum and the National Iranian Oil Company (NIOC), both of which are EU-designated. It holds shares in a number of EU-designated entities.

22.12.2012

16.

CF Sharp and Company Private Limited

 

This entity has been assisting the Irano-Hind Shipping Company (IHSC) (designated by the United Nations on 9 June 2010) in circumventing the sanctions adopted against it. Following its designation, IHSC has tried to conceal its ownership of three tankers, by placing them under the management of Noah Ship Management and then Marian Ship Management. CF Sharp and Co. has contributed to this arrangement by concluding a personnel management contract with IHSC covering the crew of those three tankers. That contract was performed by Noah Ship Management and Marian Ship Management.

22.12.2012

17.

Sharif University of Technology

Azadi Ave, 11365-8639, Tehran, Iran

Tel: 98 21 66022727

Fax: 98 21 66036005

Website: www.sharif.ir

Sharif University of Technology (SUT) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is providing support to Iran's proliferation sensitive nuclear activities. As of late 2011 SUT had provided laboratories for use by UN-designated Iraniannuclear entity Kalaye Electric Company (KEC) and EU-designated Iran Centrifuge Technology Company (TESA).

22.12.2012

18.

Moallem Insurance Company (also known as:

Moallem Insurance; Moallem Insurance Co.; M.I.C; Export and Investment Insurance Co.)

No. 56, Haghani Boulevard, Vanak Square, Tehran 1517973511, Iran PO Box 19395-6314, 11/1 Sharif Ave, Vanaq Square, Tehran 19699, Iran

Phone: (98-21) 886776789, 887950512, 887791835

Fax: (98-21) 88771245

Website: www.mic-ir.com

Main insurer of IRISL

22.12.2012"

II.

The entries for entities set out in Annex II to Decision 2010/413/CFSP listed below shall be replaced by the entries below:

"B.   Entities

 

Name

Identifying information

Reasons

Date of listing

1.

Technology Cooperation Office (TCO) of the Iranian President's Office (a.k.a.

Center for Innovation and Technology (CITC))

Tehran, Iran

Responsible for Iran's technological advancement through relevant foreign procurement and training links. Supports the nuclear and missile programmes.

26.07.2010

2.

Sureh (a.k.a. Soreh) Nuclear Reactors Fuel Company (a.k.a. Nuclear Fuel Reactor Company; Sookht Atomi Reactorhaye Iran; Soukht Atomi Reactorha-ye Iran)

Head Office: 61 Shahid Abtahi St, Karegar e Shomali, Tehran

Complex: Persian Gulf Boulevard, Km20 SW Esfahan Road, Esfahan

A company subordinate to the UN-sanctioned Atomic Energy Organisation of Iran (AEOI) consisting of the Uranium Conversion Facility, the Fuel Manufacturing Plant and the Zirconium Production Plant.

23.05.2011

3.

Tidewater (a.k.a. Tidewater Middle East Co.; Faraz Royal Qeshm Company LLC)

Postal address: No 80, Tidewater Building, Vozara Street, next to Saie Park, Tehran, Iran

Owned or controlled by IRGC

23.01.2012"

III.

The entities listed below shall be deleted from the list set out in Annex II to Decision 2010/413/CFSP:

1.

CF Sharp Shipping Agencies Pte Ltd

2.

Soreh (Nuclear Fuel Reactor Company).


22.12.2012   

EN

Official Journal of the European Union

L 356/78


COMMISSION IMPLEMENTING DECISION

of 7 December 2012

on an additional financial contribution towards Member States’ fisheries control, inspection and surveillance programmes for 2012

(notified under document C(2012) 8967)

(Only the Bulgarian, Danish, Dutch, English, Finnish, French, German, Greek, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Spanish and Swedish texts are authentic)

(2012/830/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 861/2006 of 22 May 2006 establishing Community financial measures for the implementation of the common fisheries policy and in the area of the Law of the Sea (1), and in particular Article 21 thereof,

Whereas:

(1)

Based upon the requests for Union co-financing that have been submitted by Member States in their fisheries control programmes for 2012, the Commission has adopted Implementing Decision 2012/294/EU of 25 May 2012 on a Union financial contribution towards Member States’ fisheries control, inspection and surveillance programmes for 2012 (2), which has left some of the 2012 budget available unused.

(2)

That unused part of the 2012 budget should now be allocated by a new Decision.

(3)

In conformity with Article 21(2) of Regulation (EC) No 861/2006, Member States have been asked to submit programmes related to additional funding in the priority areas defined by the Commission in its letter to Member States of 25 April 2012, i.e. projects aiming at improvements in the control system of a Member State as jointly identified by the Member State and the Commission, measurement of engine power, and traceability of fishery products. Requirements to be met by operators and/or Member States carrying out investments in traceability projects were defined by the Commission in its letter of 14 May 2012.

(4)

On that basis and given budgetary constraints, requests in the programmes for Union funding related to actions such as pilot projects, the construction or modernisation of patrol vessels and aircrafts, and those training projects having no link with improvements to be brought in the control systems of Member States have been rejected since they were not dedicated to the priority areas defined above. Within the priority areas indicated by the Commission, not all the projects in the programmes could be retained, due to budgetary restraints. The Commission had to select the projects to be co-financed on the basis of the improvements to be brought in the control systems of Member States and of the requirements defined by the Commission for traceability. Applications concerning actions listed in Article 8(1)(a) of Regulation (EC) No 861/2006 may qualify for Union funding.

(5)

As to traceability projects, it is important to ensure that they are developed on the basis of internationally recognised standards, as required by Article 67(8) of Commission Implementing Regulation (EU) No 404/2011 (3).

(6)

The applications for Union funding have been assessed with regard to their compliance with the rules set out in Commission Regulation (EC) No 391/2007 of 11 April 2007 laying down detailed rules for the implementation of Council Regulation (EC) No 861/2006 as regards the expenditure incurred by Member States in implementing the monitoring and control systems applicable to the Common Fisheries Policy (4).

(7)

The Commission has assessed the projects whose cost does not exceed EUR 40 000 VAT excluded, and has retained those for which it is justified to provide for Union co-financing in the light of the improvements they are likely to bring to the control system of the applicant Member States.

(8)

It is appropriate to fix the maximum amounts and the rate of the Union financial contribution within the limits set by Article 15 of Regulation (EC) No 861/2006 and to lay down the conditions under which such contribution may be granted.

(9)

In order to encourage investment in the priority actions defined by the Commission and in view of the negative impact of the financial crisis on Member States’ budgets, expenditure related to the abovementioned priority areas should benefit from a high co-financing rate, within the limits laid down in Article 15 of Regulation (EC) No 861/2006.

(10)

In order to qualify for the contribution, projects co-financed on the basis of this Regulation should comply with all the relevant provision of Union legislation and, in particular with Implementing Regulation (EU) No 404/2011.

(11)

The measures provided for in this Decision are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

This Decision provides for an additional Union financial contribution towards expenditure incurred by Member States for 2012 in implementing monitoring and control systems applicable to the common fisheries policy (CFP), as referred to in Article 8(1)(a) of Regulation (EC) No 861/2006. It establishes the amount of the Union financial contribution for each Member State, the rate of the Union financial contribution and the conditions on which such contribution may be granted.

Article 2

Closure of outstanding commitments

All payments in respect of which a reimbursement is claimed shall be made by the Member State concerned by 30 June 2016. Payments made by a Member State after that deadline shall not be eligible for reimbursement. Unused budgetary appropriations related to this Decision shall be de-committed at the latest by 31 December 2017.

Article 3

New technologies & IT networks

1.   Expenditure incurred, in respect of projects referred to in Annex I, on the setting up of new technologies and IT networks in order to allow efficient and secure collection and management of data in connection with monitoring, control and surveillance of fisheries activities, shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits laid down in that Annex.

2.   As far as traceability projects are concerned, the EU contribution shall be limited to EUR 1 000 000 in case of investments carried out by Member State authorities, and to EUR 250 000 in case of private investments. The total number of traceability projects carried out by private operators shall be limited to 8 per Member State and per financing decision.

3.   In order to qualify for the financial contribution referred to in paragraph 2, all projects co-financed according to this Decision shall satisfy the applicable requirements laid down in Council Regulation (EC) No 1224/2009 (5) and Implementing Regulation (EU) No 404/2011.

Article 4

Automatic localisation devices

1.   Expenditure incurred, in respect of projects referred to in Annex II, on the purchase and fitting on board of fishing vessels of automatic localisation devices enabling vessels to be monitored at a distance by a fisheries monitoring centre through a vessel monitoring system (VMS) shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits established in that Annex.

2.   The financial contribution referred to in paragraph 1 shall be calculated on the basis of a price capped at EUR 2 500 per vessel.

3.   In order to qualify for the financial contribution referred to in paragraph 1, automatic localisation devices shall satisfy the requirements laid down in Implementing Regulation (EU) No 404/2011.

Article 5

Electronic recording and reporting systems

Expenditure incurred, in respect of projects referred to in Annex III, on the development, purchase, and installation of, as well as technical assistance for, the components necessary for electronic recording and reporting systems (ERS), in order to allow efficient and secure data exchange related to monitoring, control and surveillance of fisheries activities, shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits laid down in that Annex.

Article 6

Electronic recording and reporting devices

1.   Expenditure incurred, in respect of projects referred to in Annex IV, on the purchase and fitting on board of fishing vessels of ERS devices enabling vessels to record and report electronically to a Fisheries Monitoring Centre data on fisheries activities, shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits established in that Annex.

2.   The financial contribution referred to in paragraph 1 shall be calculated on the basis of a price capped at EUR 3 000 per vessel, without prejudice of paragraph 4.

3.   In order to qualify for a financial contribution, ERS devices shall satisfy the requirements established in Implementing Regulation (EU) No 404/2011.

4.   In case of devices combining ERS and VMS functions and fulfilling the requirements laid down in Implementing Regulation (EU) No 404/2011 the financial contribution referred to in paragraph 1 of this Article shall be calculated on the basis of a price capped at EUR 4 500 per vessel.

Article 7

Total maximum Union contribution per Member State

The planned expenditure, the eligible share thereof, and the maximum Union contribution per Member State are as follows:

(EUR)

Member State

Expenditure planned in the national fisheries control additional programme

Expenditure for projects selected under this Decision

Maximum Union contribution

Belgium

194 250

94 250

84 825

Bulgaria

30 678

30 678

27 610

Denmark

5 055 113

3 522 171

2 941 347

Germany

4 511 100

425 000

382 500

Ireland

52 005 000

1 000 000

900 000

Greece

1 246 750

1 246 750

1 122 075

Spain

10 528 653

7 029 087

6 326 179

France

4 815 437

3 349 587

3 014 628

Italy

9 299 000

2 880 000

2 592 000

Latvia

76 355

76 355

68 719

Lithuania

150 462

150 462

135 416

Malta

1 098 060

951 860

856 674

Netherlands

2 639 439

250 000

225 000

Austria

409 102

128 179

115 361

Poland

4 771 695

1 516 741

1 365 067

Portugal

2 013 500

1 863 500

1 677 150

Finland

2 560 000

2 280 000

2 052 000

Sweden

2 980 000

2 900 000

2 610 000

United Kingdom

1 284 738

545 284

490 755

Total

105 669 332

30 239 904

26 987 307

Article 8

Addressees

This Decision is addressed to the Kingdom of Belgium, the Republic of Bulgaria, the Kingdom of Denmark, the Federal Republic of Germany, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Latvia, the Republic of Lithuania, the Republic of Malta, the Kingdom of the Netherlands, the Repubic of Austria, the Republic of Poland, the Portuguese Republic, the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.

Done at Brussels, 7 December 2012.

For the Commission

Maria DAMANAKI

Member of the Commission


(1)  OJ L 160, 14.6.2006, p. 1.

(2)  OJ L 150, 9.6.2012, p. 86.

(3)  OJ L 112, 30.4.2011, p. 1.

(4)  OJ L 97, 12.4.2007, p. 30.

(5)  OJ L 343, 22.12.2009, p. 1.


ANNEX I

NEW TECHNOLOGIES & IT NETWORKS

(EUR)

Member State & project code

Expenditure planned in the national fisheries control additional programme

Expenditure for projects selected under this Decision

Maximum Union contribution

Belgium:

BE/12/08

30 000

30 000

27 000

BE/12/09

4 250

4 250

3 825

BE/12/10

100 000

0

0

Subtotal

134 250

34 250

30 825

Bulgaria:

BG/12/02

30 678

30 678

27 610

Subtotal

30 678

30 678

27 610

Denmark:

DK/12/20

336 419

0

0

DK/12/22

269 136