EUR-Lex - 22001A1029(01) - EN Avis juridique important | 22001A1029(01) Agreement on mutual recognition between the European Community and Japan - Annexes - Final Act - Joint Declarations - Exchange of letters Official Journal L 284 , 29/10/2001 P. 0003 - 0032 Agreementon mutual recognition between the European Community and JapanTHE EUROPEAN COMMUNITY and JAPAN (hereinafter referred to as "the parties");CONSIDERING the traditional friendly relations that exist between the European Community and Japan;RECOGNISING the significance of mutual recognition of the results of conformity assessment procedures in facilitating market access and promoting trade between the parties;CONSIDERING the common interest in enhancing product quality, with a view to ensuring the health and safety of the public and protecting the environment;RECOGNISING the OECD principles of good laboratory practice (GLP);RECALLING that long and fruitful cooperative activities of the European Community and Japan have made contributions to international development and harmonisation of good manufacturing practice (GMP) requirements;BEING AWARE of the positive contribution that mutual recognition agreements can make to encouraging international harmonisation of standards, andBEARING IN MIND the obligations of the parties as Members of the World Trade Organisation, and being conscious, inter alia, of their obligations under the Agreement on Technical Barriers to Trade (hereinafter referred to as the "WTO Agreement on Technical Barriers to Trade") included in Annex1A, and the Agreement on Trade-related Aspects of Intellectual Property Rights (hereinafter referred to as the "WTO Agreement on Trade-related Aspects of Intellectual Property Rights") included in Annex1C of the Marrakesh Agreement Establishing the World Trade Organisation (hereinafter referred to as the "WTO Agreement"),HAVE AGREED AS FOLLOWS:Article 11. For the purposes of this Agreement:(a) the term "conformity assessment procedure" means any procedure to determine, directly or indirectly, whether products or processes fulfil relevant technical requirements set out in the applicable laws, regulations and administrative provisions of a party;(b) the term "conformity assessment body" means a body which conducts conformity assessment procedure, and the term "registered conformity assessment body" means the conformity assessment body registered pursuant to Article 9 of this Agreement;(c) the term "designation" means the designation of conformity assessment bodies by a designating authority of a party pursuant to the applicable laws, regulations and administrative provisions of that party;(d) the term "designating authority" means an authority of a party with the power to designate, monitor, withdraw the designation of, suspend the designation of, and withdraw the suspension of the designation of the conformity assessment bodies in its territory that conduct conformity assessment procedures based upon requirements set out in the applicable laws, regulations and administrative provisions of the other party;(e) the term "criteria for designation" means the criteria which conformity assessment bodies of a party are required to fulfil in order to be designated by the designating authority of that party, and other relevant conditions which designated conformity assessment bodies are required to continuously fulfil after the designation, as set out in the applicable laws, regulations and administrative provisions of the other party specified in the relevant Sectoral Annex;(f) the term "confirmation" means the confirmation of the compliance of manufacturing facilities or test facilities (hereinafter referred to as "facilities") with the criteria for confirmation by a competent authority of a party pursuant to the applicable laws, regulations and administrative provisions of that party;(g) the term "competent authority" means an authority of a party with the power to conduct inspection or study audits on facilities in its territory to confirm their compliance with the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party;(h) the term "criteria for confirmation" means the criteria which a facility of a party is required to continuously fulfil in order to be confirmed by the cauthority of the party, as set out in the applicable laws, regulations and administrative provisions of that party specified in the relevant Sectoral Annex, and(i) the term "verification" means an action to verify in the territories of the parties, by such means as audits or inspections, compliance with the criteria for designation or the criteria for confirmation by a conformity assessment body or a facility respectively.2. Any term used in this Agreement, unless otherwise defined herein, has the meaning assigned to it in the ISO/IEC Guide 2: 1996 Edition, "Standardisation and related activities - General vocabulary".Article 21. Each party shall accept, in accordance with the provisions of this Agreement, the results of conformity assessment procedures required by the applicable laws, regulations and administrative provisions of that party specified in the relevant Sectoral Annex, including certificates and marks of conformity, that are conducted by the registered conformity assessment bodies of the other party.2. Each party shall accept, in accordance with the provisions of this Agreement:(a) the confirmation of facilities conducted by the competent authorities of the other party based on the results of verification and in accordance with the criteria for confirmation stipulated in the laws, regulations and administrative provisions of that other party as specified in the relevant Sectoral Annex, and(b) the data generated by confirmed facilities of the other party.Article 31. This Agreement applies to designation of conformity assessment bodies, conformity assessment procedures for products or processes, and to confirmation of facilities and data generated by them, covered by its Sectoral Annexes. Sectoral Annexes may consist of Part A and Part B.2. Part A of Sectoral Annexes shall include, inter alia, provisions on scope and coverage.3. Part B of Sectoral Annexes shall set out the following matters:(a) the applicable laws, regulations and administrative provisions of each party concerning the scope and coverage;(b) the applicable laws, regulations and administrative provisions of each party stipulating the requirements covered by this Agreement, all the conformity assessment procedures covered by this Agreement to satisfy such requirements and the criteria for designation of conformity assessment bodies, or the applicable laws, regulations and administrative provisions of each party stipulating the criteria for confirmation of the facilities covered by this Agreement, and(c) the list of designating authorities or competent authorities.Article 41. Each party shall ensure that designating authorities have the necessary power to designate, monitor (including verification), withdraw the designation of, suspend the designation of and withdraw the suspension of the designation of the conformity assessment bodies that conduct conformity assessment procedures based on the requirements set out in the applicable laws, regulations and administrative provisions of the other party specified in the relevant Sectoral Annex.2. Each party shall ensure that competent authorities have the necessary power to conduct, in accordance with its applicable laws, regulations and administrative provisions, verification of facilities to confirm their compliance with the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party specified in the relevant Sectoral Annex.Article 51. Each party shall ensure, through appropriate means such as audits, inspections or monitoring, that the registered conformity assessment bodies fulfil the criteria for designation set out in the applicable laws, regulations and administrative provisions of the other party specified in the relevant Sectoral Annex. When applying the criteria for designation of the conformity assessment bodies, designating authorities of a party should take into account the bodies' understanding of and experience relevant to the requirements set out in the applicable laws, regulations and administrative provisions of the other party.2. Each party shall, in accordance with its applicable laws, regulations and administrative provisions and through appropriate means such as study audits, inspections or monitoring, ensure that the confirmed facilities fulfil the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party specified in the relevant Sectoral Annex.3. Each party may request the other party, by indicating in writing a reasoned doubt on whether a registered conformity assessment body or a confirmed facility complies with the criteria for designation or the criteria for confirmation set out in the applicable laws, regulations and administrative provisions specified in the relevant Sectoral Annex, respectively, to conduct verification of the conformity assessment body or the facility in accordance with the laws, regulations and administrative provisions of that other party.4. Each party may, on request, participate as an observer in the verification of conformity assessment bodies conducted by the designating authorities or the verification of facilities conducted by the competent authorities of the other party, with the prior consent of such conformity assessment bodies or such facilities respectively, in order to maintain a continuing understanding of that other party's procedures for verification.5. The parties shall, in accordance with the procedures to be determined by the Joint Committee to be established pursuant to Article 8, exchange information on methods, including accreditation systems, used to designate the conformity assessment bodies and to ensure that the registered conformity assessment bodies fulfil the criteria for designation and on methods to ensure that the confirmed facilities fulfil the criteria for confirmation.6. Each party should encourage its registered conformity assessment bodies to cooperate with the conformity assessment bodies of the other party.Article 61. In case of suspension of the designation of a registered conformity assessment body, the party whose designating authority has suspended the designation shall immediately notify the other party and the Joint Committee to that effect. The registration of that conformity assessment body shall be suspended from the time of receipt of the notification by the co-chairman of that other party on the Joint Committee. The other party shall accept the results of the conformity assessment procedures conducted by that conformity assessment body prior to the suspension of the designation.2. In case of lifting of the suspension of the designation of a registered conformity assessment body, the party whose designating authority has lifted the suspension of the designation shall immediately notify the other party and the Joint Committee to that effect. The suspension of the registration of that conformity assessment body shall be lifted from the time of receipt of the notification by the co-chairman of that other party on the Joint Committee. The other party shall accept the results of the conformity assessment procedures conducted by that conformity assessment body from the time of lifting of the suspension of the registration.Article 71. Each party may contest the compliance with the criteria for designation or the criteria for confirmation set out in the applicable laws, regulations and administrative provisions specified in the relevant Sectoral Annex by a registered conformity assessment body or a confirmed facility of the other party, respectively. Such contestation shall be notified to the Joint Committee and to that other party in writing with an objective explanation of the reason for the contestation. The Joint Committee shall discuss such contestation within 20 days of the date on which such notification is made.2. Where the Joint Committee decides to conduct a joint verification, it will be conducted in a timely manner by the parties with the participation of the designating authority that designated the contested conformity assessment body and with the prior consent of the conformity assessment body. The result of such joint verification shall be discussed in the Joint Committee with a view to resolving the issue as soon as possible.3. The registration of the contested conformity assessment body shall be suspended 15 days after the date on which the notification is made or on the date on which the Joint Committee decides to suspend the registration, whichever is the sooner. The registration of the contested conformity assessment body shall remain suspended until the Joint Committee decides to lift the suspension of the registration of the conformity assessment body. In the event of such suspension, the contesting party shall accept the results of conformity assessment procedures conducted by that conformity assessment body prior to the date of suspension.4. The Joint Committee will decide on the actions to be taken by a party or parties with a view to resolving issues concerning the contestation of facilities as soon as possible.5. The contesting party shall not be obliged to accept the confirmation of and the data generated by the contested facility from the date on which the co-chairman of the other party on the Joint Committee receives the notification referred to in paragraph 1 until the date on which the Joint Committee decides otherwise.Article 81. A Joint Committee made up of representatives of both parties shall be established on the date of the entry into force of this Agreement, as a body responsible for the effective functioning of this Agreement.2. The Joint Committee shall take decisions and adopt recommendations by consensus. It shall meet at the request of either party under the co-chairmanship of both parties. The Joint Committee may establish subcommittees and delegate specific tasks to such subcommittees. It shall adopt its rules of procedure.3. The Joint Committee may consider any matter related to the operation of this Agreement. In particular, it shall be responsible for and/or decide on:(a) registration of a conformity assessment body, suspension of registration of a conformity assessment body, lifting of suspension of registration of a conformity assessment body, and termination of registration of a conformity assessment body;(b) establishment and, unless otherwise decided, publication on a sector-by-sector basis of lists of the registered conformity assessment bodies and the confirmed facilities;(c) establishment of appropriate modalities of information exchange referred to in this Agreement, and(d) appointment of experts from each party for the joint verification referred to in Article 7(2) and (c) and Article 9(1)(c).4. If any problem arises to the interpretation or application of this Agreement, the parties shall seek an amicable solution through the Joint Committee.5. The Joint Committee is responsible for coordinating and facilitating the negotiation of additional Sectoral Annexes.6. Each party shall provide the other party and the Joint Committee, at least annually, with a list of the confirmed facilities.7. Any decision made by the Joint Committee will be notified promptly in writing to each party.8. The parties shall, through the Joint Committee:(a) specify and communicate to each other the applicable articles or annexes contained in the laws, regulations and administrative provisions set out in the Sectoral Annexes;(b) exchange information concerning the implementation of the applicable laws, regulations and administrative provisions specified in the Sectoral Annexes;(c) notify each other of any scheduled changes in the laws, regulations and administrative provisions related to this Agreement prior to their entry into force, and(d) notify each other of any scheduled changes concerning their designating authorities, competent authorities, the registered conformity assessment bodies and the confirmed facilities.Article 91. The following procedure shall apply to the registration of a conformity assessment body:(a) each party shall make a proposal that a conformity assessment body of that party designated by its designating authority be registered under this Agreement, by presenting its proposal in writing, supported by necessary documents, to the other party and the Joint Committee;(b) the other party shall consider whether the proposed conformity assessment body complies with the criteria for designation set out in the applicable laws, regulations and administrative provisions of that other party specified in the relevant Sectoral Annex and indicate its position regarding the registration of that conformity assessment body within 90 days of receipt of the proposal referred to in subparagraph (a). In such consideration, such other party should assume that the proposed conformity assessment body complies with the aforementioned criteria. The Joint Committee shall take a decision whether to register the proposed conformity assessment body within 90 days of the receipt of the proposal;(c) in the event that the Joint Committee cannot decide to register the proposed conformity assessment body, the Joint Committee may decide to conduct a joint verification or to request the proposing party to conduct a verification of the proposed body with the prior consent of such body. After the completion of such verification, the Joint Committee may reconsider the proposal.2. The proposing party shall provide the following information in its proposal for registration of a conformity assessment body and keep such information up to date:(a) the name and address of the conformity assessment body;(b) the products or processes the conformity assessment body is authorised to assess;(c) the conformity assessment procedures the conformity assessment body is authorised to conduct, and(d) the designation procedure and necessary information used to determine the compliance of the conformity assessment body with the criteria for designation.3. Each party shall ensure that its designating authority withdraws the designation of a registered conformity assessment body when the designating authority considers that the conformity assessment body no longer complies with the criteria for designation set out in the applicable laws, regulations and administrative provisions of the other party specified in the relevant Sectoral Annex.4. Each party shall propose the termination of the registration of its conformity assessment body when that party considers that the conformity assessment body no longer complies with the criteria for designation set out in the applicable laws, regulations and administrative provisions of the other party specified in the relevant Sectoral Annex, or the designating authority of that party withdraws the designation of a conformity assessment body. Proposals for terminating the registration of that conformity assessment body shall be made to the Joint Committee and the other party. The registration of that conformity assessment body shall be terminated on receipt of the proposal by the co-chairman of that other party on the Joint Committee, unless otherwise determined by the Joint Committee.5. In the case of the registration of a new conformity assessment body, the other party shall accept the results of conformity assessment procedures conducted by that conformity assessment body from the date of the registration. In the event that the registration of a conformity assessment body is terminated, the other party shall accept the results of the conformity assessment procedures conducted by that conformity assessment body prior to the termination, without prejudice to 6(1) and Article 7(3).Article 101. Nothing in this Agreement shall be construed to limit the authority of a party to take measures it considers appropriate, for protecting health, safety or the environment or prevention of deceptive practices.2. (a) The competent authority of a party may visit manufacturing facilities of the other party on the condition that such other party and the manufacturing facilities concerned consent to such visit and, if such other party so requests, officials of the competent authority of such other party join the visit, for the purpose of deciding whether to continue to accept the confirmation of the manufacturing facilities concerned and the data generated by them pursuant to Article 2(2), where an emergency as defined in subparagraph (b) of this paragraph takes place. Such visit shall be carried out in a manner not inconsistent with the laws and regulations of that other party and in accordance with the modalities to be decided pursuant to subparagraph (b) of this paragraph. The party shall use the information obtained by its competent authority in connection with such visit only for the purpose above.(b) The definition of the emergency and the modalities of such visit referred to in subparagraph (a) of this paragraph will be decided by the Joint Committee as part of the preparatory work to be done in accordance with the provisions of the relevant Sectoral Annex.Article 111. Without prejudice to Article 2(2), nothing in this Agreement shall entail mutual acceptance of the standards or technical regulations of the parties.2. Nothing in this Agreement shall be construed to entail an obligation on a party to accept the result of the conformity assessment procedures of any non-member country.3. Nothing in this Agreement shall be construed so as to affect the rights and obligations that either party has as a member of the WTO Agreement, including the WTO Agreement on Technical Barriers to Trade and the WTO Agreement on Trade-related Aspects of Intellectual Property Rights.Article 12This Agreement shall apply to the territories in which the Treaty establishing the European Community is applied under the conditions laid down in that Treaty and to the territory of Japan.Article 13Neither party shall disclose any information obtained under this Agreement as confidential, unless otherwise required under the laws or regulations of each party.Article 141. This Agreement shall enter into force on the first day of the second month following the date on which the parties exchange diplomatic notes informing each other that their respective internal procedures necessary to give effect to this Agreement have been completed.2. Either party may terminate this Agreement by giving the other party six months written notice.Article 151. The Sectoral Annexes to this Agreement are an integral part of this Agreement.2. In case of conflict between the provisions of Part A of a Sectoral Annex and Articles 1 to 15 of this Agreement, the provisions of Part A of the Sectoral Annex shall prevail.3. (a) The provisions concerning the scope and coverage of paragraph 1 of Part A of each Sectoral Annex shall not be changed unless the parties amend this Agreement in accordance with the first sentence of subparagraph (b) of this paragraph.(b) This Agreement may be amended by agreement between the parties. However, if the amendments relate only to changes of laws, regulations and administrative provisions, designating authorities or competent authorities specified in Part B of the Sectoral Annexes, the amendments may be made by exchange of diplomatic notes between the European Community and the Government of Japan, in conformity with their applicable domestic procedures.4. If a party introduces new or additional conformity assessment procedures within the same product coverage to satisfy the requirements set out in the applicable laws, regulations and administrative provisions specified in the relevant Sectoral Annex, Part B of the Sectoral Annex shall be amended to set out the applicable laws, regulations and administrative provisions stipulating such new or additional conformity assessment procedures, in accordance with the procedures set out in the second sentence of subparagraph (b) of paragraph 3 of this Article.This Agreement and its Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish, Swedish and Japanese languages. In case of divergence the English and Japanese versions shall prevail over the other language versions.IN WITNESS WHEREOF, the undersigned, being duly authorised, have signed this Agreement.Done at Brussels, on the fourth day of April in the year two thousand and one.For the European Community>PIC FILE= "L_2001284EN.000801.TIF">>PIC FILE= "L_2001284EN.000802.TIF">For Japan>PIC FILE= "L_2001284EN.000803.TIF">SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT AND RADIO EQUIPMENTPART AScope and coverage1. This Sectoral Annex applies to conformity assessment procedures for all telecommunications terminal equipment and radio equipment, which in the European Community and Japan respectively are subject to conformity assessment procedures conducted by the conformity assessment body, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex.2. It is understood that the term "amendment" referred to in Part B of this Sectoral Annex includes the following cases:(a) a party entirely or partially changes its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex, whether or not those names are changed;(b) a party repeals its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex and adopts new laws, regulations and/or administrative provisions substituting for the previous laws, regulations and/or administrative provisions, whether or not the previous names are changed, and(c) a party incorporates the whole or a relevant part of its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations and/or administrative provisions.PART BSection I: The applicable laws, regulations and administrative provisions stipulating telecommunications terminal equipment and radio equipment>TABLE>Section II: The applicable laws, regulations and administrative provisions stipulating the requirements and the conformity assessment procedures>TABLE>Section III: Designating authorities>TABLE>Section IV: The applicable laws, regulations and administrative provisions stipulating the criteria for designation>TABLE>SECTORAL ANNEX ON ELECTRICAL PRODUCTSPART AScope and coverage1. This Sectoral Annex applies to conformity assessment procedures for all electrical products, which in the European Community and Japan respectively are subject to conformity assessment procedures conducted by the conformity assessment body, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex.2. It is understood that the term "amendment" referred to in Part B of this Sectoral Annex includes the following cases:(a) a party entirely or partially changes its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex, whether or not those names are changed;(b) a party repeals its applicable laws, regulations and /or administrative provisions listed in Part B of this Sectoral Annex and adopts new laws, regulations and/or administrative provisions substituting for the previous laws, regulations and/or administrative provisions, whether or not the previous names are changed; and(c) a party incorporates the whole or a relevant part of its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations and/or administrative provisions.PART BSection I: The applicable laws, regulations and administrative provisions stipulating electrical products>TABLE>Section II: The applicable laws, regulations and administrative provisions stipulating the requirements and the conformity assessment procedures>TABLE>Section III: Designating authorities>TABLE>Section IV: The applicable laws, regulations and administrative provisions stipulating the criteria for designation>TABLE>SECTORAL ANNEX ON GOOD LABORATORY PRACTICE (GLP) FOR CHEMICALSPART A1. This Sectoral Annex applies to:(a) the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex; and,(b) the acceptance of the data generated by confirmed test facilities.2. (a) For the purpose of this Sectoral Annex:(i) "criteria for confirmation" are the principles of GLP as stipulated in the laws, regulations and administrative provisions of each party specified in Section III of Part B of this Sectoral Annex and that are consistent with Annex II of the OECD Council Decision of 12 May 1981 (C(81)30 (final)) as amended by the OECD Council Decision of 26 November 1997 (C(97) 186 (final)), and(ii) "verification" means the monitoring of the compliance of a test facility with the principles of GLP by procedures such as study audits and inspections that are set out in the laws, regulations and administrative provisions of each party specified in Section III of Part B of this Sectoral Annex and that are consistent with the OECD Council Decision - Recommendation of 2 October 1989 (C(89) 87(final)), and in particular its Annexes I and II, as amended by the OECD Council Decision of 9 March 1995 (C(95)8(final)).(b) For the purpose of this Sectoral Annex, any term, unless otherwise defined in this Agreement, has the meaning assigned to it in the "OECD Principles of good laboratory practice" as contained in Annex II of the OECD Council Decision of 12 May 1981 (C(81)30(final)), the "Guides for compliance monitoring procedures for good laboratory practice" as contained in Annex I of the OECD Council Decision - Recommendation of 2 October 1989 (C(89)87(final)), the GLP Consensus Document "The Application of the GLP Principles to Field Studies" (OECD Series on Principles of good laboratory practice and compliance monitoring, Number 6), and all amendments made thereto.(c) It is understood that the term "amendment" referred to in Part B of this Sectoral Annex includes the following cases:(i) a party entirely or partially changes its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex, whether or not those names are changed;(ii) a party repeals its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex and adopts new laws, regulations and/or administrative provisions substituting for the previous laws, regulations and/or administrative provisions, whether or not the previous names are changed, and(iii) a party incorporates the whole or a relevant part of its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations and/or administrative provisions.(d) In making amendments to the laws, regulations and administrative provisions specified in Section III of this Sectoral Annex, the parties should take account of the need to maintain consistency with the relevant decisions and recommendations of the OECD.3. With respect to Article 2(2) of this Agreement, each party shall, as a result of the acceptance of the confirmation of test facilities by the competent authorities of the other party, accept the data for a test item generated by the confirmed test facilities as equivalent to the data generated by its own test facilities which are confirmed to be compliant with the principles of GLP, taking into account the equivalence of GLP compliance monitoring programme of both parties, which are consistent with the OECD Council Decision-Recommendation of 2 October 1989 (C(89)87 (final)) as amended by the OECD Council Decision of 9 March 1995 (C (95) 8 (final)), provided that:(a) a certificate or an alternative document on the GLP compliance status of the test facility issued by the competent authority of that other party, in accordance with the applicable laws, regulations and administrative provisions of that other party specified in Section III of Part B of this Sectoral Annex, is attached to the data, and(b) the testing for which the data is generated is covered by the principles of GLP in both parties pursuant to the applicable laws, regulations and administrative provisions of each party;4. (a) The list of the confirmed facilities referred to in Article 8(3) and (6) of this Agreement shall be provided in an appropriate agreed format and include the following information:(i) the name and address of the test facility;(ii) the dates of verification or confirmation;(iii) the GLP compliance status, and(iv) the areas of expertise as listed in point 4 of the Appendix to Annex III of the OECD Council Decision-Recommendation of 2 October 1989 (C (89) 87 (final)).(b) each party shall, to the extent possible, provide the other party with additional information on the confirmed facilities upon a reasoned request by that other party;(c) each party shall transmit to the other party, without delay, information on any withdrawal of the certificate of a confirmed test facility if the facility has been found to be non-compliant with the principles of GLP.5. (a) Each party may request the other party, by indicating in writing a reasoned doubt on whether a study was conducted in accordance with the principles of GLP, to conduct further inspections or study audits on a confirmed test facility, in accordance with the applicable laws, regulations and administrative provisions of that other party;(b) the requested party shall inform the requesting party of the results of the inspections or study audits, or provide an explanation why such an inspection or study audit has not been carried out;(c) the requesting party shall not be obliged to accept the data generated by the test facility concerned from the date on which the request is made, until the results of the further inspection or study audit conducted by the competent authority of the requested party have re-confirmed the compliance of the test facility with the principles of GLP;(d) If, in exceptional cases, doubts persist, and the requesting party can justify a specific concern, that party may contest the compliance of the test facility concerned in accordance with the provisions of Article 7 of this Agreement.PART BSection I: The applicable laws, regulations and administrative provisions stipulating the coverage of chemicals subject to testing in accordance with the principles of GLP>TABLE>Section II: Competent authorities>TABLE>Section III: The applicable laws, regulations and administrative provisions stipulating the principles of GLP, verification and confirmation>TABLE>SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTSPART A1. This Sectoral Annex applies:(a) to the confirmation of the compliance with GMP requirements of manufacturing facilities for medicinal products to which the GMP requirements of both parties are applied in accordance with the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex, and(b) to the acceptance of the data generated by confirmed manufacturing facilities (the certificate issued by confirmed manufacturing facilities in accordance with the provisions of Part A of this Sectoral Annex).2. For the purpose of this Sectoral Annex:(a) the term "medicinal products" means drugs which are industrially manufactured for human use as defined in the laws, regulations and administrative provisions of Japan specified in Section I of Part B of this Sectoral Annex, and medicinal products and intermediate products which are industrially manufactured for human use as defined in the laws, regulations and administrative provisions of the European Community in Section I of Part B of this Sectoral Annex.The definition of medicinal products above may include medicinal products intended for clinical trials, active ingredients, chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma and, where appropriate, vitamins, minerals and herbal medicines.(b) The term "criteria for confirmation" means the GMP requirements.(c) The term "good manufacturing practice (GMP)" means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications.(d) The term "inspection" means an on-site evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with GMP requirements including the requirements of the applicable marketing authorisation or product specifications. Such inspection is conducted in accordance with the laws, regulations and administrative provisions specified in Section I of Part B of this Sectoral Annex carried out by a competent authority listed in Section II of Part B of this Sectoral Annex, and may include pre-marketing and post-marketing inspection.(e) It is understood that the term "amendment" referred to in Part B of this Sectoral Annex includes the following cases:(i) a party entirely or partially changes its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex, whether or not those names are changed;(ii) a party repeals its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex and adopts new laws, regulations and/or administrative provisions substituting for the previous laws, regulations and/or administrative provisions, whether or not the previous names are changed, and(iii) a party incorporates the whole or a relevant part of its applicable laws, regulations and/or administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations and/or administrative provisions.3. This Agreement does not cover mutual recognition of batch release (Kentei) referred to in Article 43 of the Pharmaceutical Affairs Law (Law No 145, 1960) of Japan and batch release referred to in Article 4 of Council Directive 89/342/EEC of 3 May 1989 and in Article 4 of Council Directive 89/381/EEC of 14 June 1989.4. With respect to Article 2(2) of this Agreement, each party shall, as a result of the acceptance of confirmation of manufacturing facilities carried out by the competent authorities of the other party, accept, regarding the medicinal products for which its marketing authorisation has been issued or for which product specifications are applicable, the certificate issued by the confirmed manufacturing facilities of the conformity of each batch to the marketing authorisation or product specifications and exempt the importers from the testing of each batch, in accordance with the laws, regulations and administrative provisions of each party specified in the Section I of Part B of this Sectoral Annex, taking into account the equivalence of GMP requirements of both parties, provided that:(a) such certificate is issued by the confirmed manufacturing facilities on the results of a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks;(b) the certificate contains a statement that the product has been manufactured in conformity with GMP requirements, and(c) both parties apply the equivalent GMP requirements for the products to which the certificate is issued.5. In the certificate issued by the confirmed manufacturing facilities and related to each batch to be exported, as referred to in paragraph 4, it will be certified, through the testing which is required for the manufacturing of medicinal products in accordance with the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex, that each batch of medicinal products is manufactured as required by the applicable marketing authorisation or product specifications of the importing party.6. A subcommittee of the Joint Committee will be established in particular to monitor the progress of the preparatory work set out in paragraph 9 of this Sectoral Annex and the operation of this Sectoral Annex. It will report to the Joint Committee.7. (a) The parties will exchange information on, in particular:(i) GMP for specific products or classes of products;(ii) new technical guidance or inspection procedures;(iii) quality defects, batch recalls, counterfeiting and other problems concerning quality;(iv) any suspension or withdrawal of a manufacturing authorisation.(b) The parties will agree detailed alert procedures through the subcommittee of the Joint Committee to fulfil specific objectives of this Sectoral Annex.(c) Equivalence of GMP for specific products or classes of products will be coordinated according to a procedure established by the subcommittee of the Joint Committee.(d) Notwithstanding Article 8(6) of this Agreement, each party shall provide the other party and the Joint Committee with a list of the confirmed manufacturing facilities at the frequency to be decided by the Joint Committee.(e) Each party will, on reasoned request by the other party, provide a copy of the most recent inspection report on a confirmed facility within 30 days of the date of the request. If the requested party conducts an additional inspection, that party will provide a copy of the report of such additional inspection to the requesting party within 60 days of the date of the request. If after the exchange of inspection reports there remains serious cause for concern on whether a manufacturing facility in the other party complies with GMP requirements, each party may request the other party to conduct further inspections of that facility.(f) The competent authority of a party will, on request by an exporter, importer or the competent authority of the other party, confirm that a manufacturing facility in its territory:(i) is appropriately authorised to manufacture medicinal products in accordance with its laws, regulations and administrative provisions specified in Section I of Part B of this Sectoral Annex;(ii) is regularly inspected by the competent authorities;(iii) complies with its GMP requirements that are recognised by both parties as equivalent.8. With regard to Article 5(2), the exporting party shall, in accordance with its applicable laws, regulations and administrative provisions, inspect periodically the manufacturing facilities in order to ensure that the facilities fulfil its GMP requirements set out in the laws, regulations and administrative provisions of that party specified in Section I of Part B of this Sectoral Annex.9. (a) Articles 2, 4, 5, 7 and Article 10(2)(a) relating to this Sectoral Annex and the provisions of this Sectoral Annex other than paragraph 6 and paragraph 7(b) and this paragraph shall not be applied before the 30th day after the date of exchange of diplomatic notes confirming to each other that the preparatory work is completed. Such exchange of diplomatic notes is expected to take place within 18 months of the entry into force of this Agreement.(b) Through the preparatory work, the parties shall reconfirm the equivalence of GMP requirements and their implementation through the Joint Committee. The Joint Committee will decide the detailed procedures for implementing this Sectoral Annex.PART BSection I: The applicable laws, regulations and administrative provisions stipulating medicinal products, GMP requirements for medicinal products, verification and confirmation>TABLE>Section II: Competent authorities>TABLE>Final ActThe undersigned:The representative ofThe EUROPEAN COMMUNITY, hereinafter referred to as the "COMMUNITY",of the one part, andthe representative of JAPAN,of the other part,meeting for the signature of the Agreement on Mutual Recognition between the European Community and Japan, hereinafter referred to as the "Agreement", have signed the following texts:the Agreement including its Sectoral Annexes relating to:1. telecommunications terminal equipment and radio equipment2. electrical products3. good laboratory practice (GLP) for chemicals4. good manufacturing practice (GMP) for medicinal products.The representative of the Community and the representative of Japan have made the Joint Declarations and Exchanges of Letters listed below and annexed to this Final Act:- Joint Declaration on future negotiations on the Agreement on Mutual Recognition between the European Community and Japan- Joint Declaration on international guides or recommendations concerning the technical competence of conformity assessment bodies (CABs)- Joint Declaration on facilitating market access- Exchange of Letters concerning completeness of the Sectoral Annexes- Exchange of Letters on the preparatory work for the Sectoral Annex on GMP for medicinal products and information exchange- Exchange of Letters on the use of languagesHecho en Bruselas, el cuatro de abril de dos mil uno./Udfærdiget i Bruxelles den fjerde april to tusind og en./Geschehen zu Brüssel am vierten April zweitausendundeins./Έγινε στις Βρυξέλλες, στις τέσσερις Απριλίου δύο χιλιάδες ένα./Done at Brussels on the fourth day of April in the year two thousand and one./Fait à Bruxelles, le quatre avril deux mille un./Fatto a Bruxelles, addì quattro aprile duemilauno./Gedaan te Brussel, de vierde april tweeduizendeneen./Feito em Bruxelas, em quatro de Abril de dois mil e um./Tehty Brysselissä neljäntenä päivänä huhtikuuta vuonna kaksituhattayksi./Som skedde i Bryssel den fjärde april tjugohundraett./>PIC FILE= "L_2001284EN.002702.TIF">Por la Comunidad Europea/For Det Europæiske Fællesskab/Für die Europäische Gemeinschaft/Για την Ευρωπαϊκή Κοινότητα/For the European Community/Pour la Communauté européenne/Per la Comunità europea/Voor de Europese Gemeenschap/Pela Comunidade Europeia/Euroopan yhteisön puolesta/På Europeiska gemenskapens vägnar/>PIC FILE= "L_2001284EN.002801.TIF">>PIC FILE= "L_2001284EN.002802.TIF">>PIC FILE= "L_2001284EN.002803.TIF">Por el Japón/For Japan/Für Japan/Για την Ιαπωνία/For Japan/Pour le Japon/Per il Giappone/Voor Japan/Pelo Japão/Japanin puolesta/På Japans vägnar/>PIC FILE= "L_2001284EN.002804.TIF">>PIC FILE= "L_2001284EN.002805.TIF">JOINT DECLARATIONSconcerning the Agreement on Mutual Recognition between the European Community and JapanOn the signing of the Agreement on Mutual Recognition between the European Community and Japan the European Community (EC) and the Government of Japan (GOJ) state the following with regard to the Agreement.1. On future negotiations on the Agreement on Mutual Recognition between the European Community and JapanTo build on this Agreement, the GOJ and the EC will commence the negotiations on the further extension of the sectoral coverage of the Agreement two years from the date on which the Agreement enters into force. In particular, the GOJ and the EC express their intention to commence negotiations on medical devices and on pressure equipment within that period.2. On international guides or recommendations concerning the technical competence of conformity assessment bodies (CABs)The GOJ and the EC express their intention to consider the relevant guides or recommendations issued by international standardisation bodies as an indication of adequate technical competence of CABs with regard to the implementation of the applicable requirements of both parties under the Agreement.3. On facilitating market accessThe GOJ and the EC recognise that the significance of the Agreement lies in promoting trade and facilitating effective market access between Japan and the EC with regard to conformity assessment of products and confirmation of facilities covered under the agreement.EXCHANGE OF LETTERSconcerning the completeness of the Sectoral AnnexesBrussels, 4 April 2001Sir,The European Community confirms that the Sectoral Annexes to the Agreement on Mutual Recognition between the European Community and Japan contain all existing third party conformity assessment or compliance procedures relating to requirements, products or data covered by those Sectoral Annexes.Please accept, Sir, the assurance of my highest consideration.For the European Community>PIC FILE= "L_2001284EN.003002.TIF">>PIC FILE= "L_2001284EN.003003.TIF">Brussels, 4 April 2001Sir,The Government of Japan confirms that the Sectoral Annexes to the Agreement on Mutual Recognition between the European Community and Japan contain all existing third party conformity assessment or compliance procedures relating to requirements, products or data covered by those Sectoral Annexes.Please accept, Sir, the assurance of my highest consideration.For the Government of Japan>PIC FILE= "L_2001284EN.003004.TIF">EXCHANGE OF LETTERSon the preparatory work for the Sectoral Annex on GMP for medicinal products and information exchangeBrussels, 4 April 2001Sir,The European Community underlines its commitment to a thorough and speedy implementation of the preparatory work required by paragraph 9 of the Sectoral Annex on GMP for medicinal products. It will be guided in its task by the need to set out the phases of preparatory work, and the components of a GMP compliance and two-way alert programme against which reconfirmation of equivalence will take place taking into account the previous experiences.The European Community will organise an exchange of information, including at least one seminar which would, inter alia, cover the criteria for designation and the criteria for confirmation in the coming months.Please accept, Sir, the assurance of my highest consideration.For the European Community>PIC FILE= "L_2001284EN.003102.TIF">>PIC FILE= "L_2001284EN.003103.TIF">Brussels, 4 April 2001Sir,The Government of Japan underlines its commitment to a thorough and speedy implementation of the preparatory work required by paragraph 9 of the Sectoral Annex on GMP for medicinal products. It will be guided in its task by the need to set out the phases of preparatory work, and the components of a GMP compliance and two-way alert programme against which reconfirmation of equivalence will take place taking into account the previous experiences.The Government of Japan will organise an exchange of information, including at least one seminar which would, inter alia, cover the criteria for designation and the criteria for confirmation in the coming months.Please accept, Sir, the assurance of my highest consideration.For the Government of Japan>PIC FILE= "L_2001284EN.003104.TIF">EXCHANGE OF LETTERSon the use of languagesBrussels, 4 April 2001Sir,The European Community will in exchanging information, including, for example, GMP inspection reports, under the Agreement use its own languages with a summary in English unless otherwise agreed. It is appropriate that the Joint Committee looks into this matter at an early opportunity.Please accept, Sir, the assurance of my highest consideration.For the European Community>PIC FILE= "L_2001284EN.003202.TIF">>PIC FILE= "L_2001284EN.003203.TIF">Brussels, 4 April 2001Sir,The Government of Japan will in exchanging information, including, for example, GMP inspection reports, under the Agreement use its own language with a summary in English unless otherwise agreed. It is appropriate that the Joint Committee looks into this matter at an early opportunity.Please accept, Sir, the assurance of my highest consideration.For the Government of Japan>PIC FILE= "L_2001284EN.003204.TIF">

Summary: EU-Japan mutual recognition agreement (MRA) EU-Japan mutual recognition agreement (MRA) SUMMARY OF: Agreement on mutual recognition between the European Community and Japan Decision 2001/747/EC concluding the mutual recognition agreement between the European Community and Japan WHAT IS THE AIM OF THE AGREEMENT AND OF THE DECISION? The mutual recognition agreement (MRA)* aims to promote trade in goods between the EU and Japan by removing technical barriers. Under the bilateral agreement EU governments approved on 27 September 2001, the EU and Japan accept the conformity assessments* each carries out for specified industrial products. The decision adopts the MRA with Japan on behalf of the EU. KEY POINTS The agreement covers the following sectors: telecommunications terminal and radio equipment; electrical products; good laboratory practice for chemicals; good manufacturing practice for medicines. The agreement: enables EU companies to have their products — which must comply with Japanese requirements — tested and certified in the EU and then they can export them to the Japanese market and vice versa; lists the legislation, regulations and administrative rules the agreement covers for each sector; lays down the conditions for reciprocal acceptance of conformity assessment results; provides procedures for designating EU and Japanese conformity assessment bodies* for each sector; requires the EU and Japanese authorities to audit, inspect and monitor the designated conformity assessment bodies to ensure they carry out their work correctly; provides for the suspension of a designated conformity assessment body; establishes a joint committee of EU and Japanese representatives to deal with any issues that might arise under the agreement. FROM WHEN DOES THE AGREEMENT APPLY? It has applied since 1 January 2002. BACKGROUND For more information, see: Mutual Recognition Agreements (European Commission). KEY TERMS Mutual recognition agreement: an international agreement where 2 or more countries recognise each other’s conformity assessment results. Conformity assessment: the procedure in which a product, before it can be marketed, is tested, inspected and certified to ensure it complies with the relevant legislation. Conformity assessment bodies: these assess whether a product meets the relevant regulatory or legislative requirements. MAIN DOCUMENTS Agreement on mutual recognition between the European Community and Japan (OJ L 284, 29.10.2001, pp. 3-32) Council Decision 2001/747/EC of 27 September 2001 concerning the conclusion of the Agreement on Mutual Recognition between the European Community and Japan (OJ L 284, 29.10.2001, pp. 1-2) Successive amendments to Decision 2001/747/EC have been incorporated in the original text. This consolidated version is of documentary value only. last update 17.07.2018


3.10.2001 EN Official Journal of the European Communities L 263/1 COUNCIL REGULATION (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas: (1) The Community has since 14 November 1997 been a Contracting Party to the International Convention for the Conservation of Atlantic Tunas (3) (hereinafter referred to as the ICCAT Convention). (2) The ICCAT Convention provides a framework for regional cooperation on the conservation and management of resources of tuna and tuna-like fish in the Atlantic ocean and adjacent seas through an International Commission for the Conservation of Atlantic Tunas (hereinafter referred to as ICCAT), and the adoption of recommendations on conservation and management in the Convention area that become obligatory for Contracting Parties. (3) ICCAT has adopted a number of recommendations creating control and surveillance obligations, notably on the establishment and transmission of statistics, inspection in port, vessel surveillance by satellite, vessel observations and transhipments, and checks on non-contracting parties and on stateless vessels. These recommendations have become obligatory for the Community and should therefore be implemented. (4) Certain obligations have been transposed by Council Regulation (EC) No 1351/1999 of 21 June 1999 laying down certain control measures to ensure compliance with the measures adopted by ICCAT (4) and into Article 22(1) of Council Regulation (EC) No 2742/1999 of 17 December 1999 fixing for 2000 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks applicable in Community waters and, for Community vessels, in waters where limitations in catch are required and amending Regulation (EC) No 66/98 (5). For reasons of clarity these measures should be incorporated in a single Regulation, repealing and replacing former Regulations. (5) For scientific research purposes masters of Community fishing vessels should be required to comply with the instructions of the ‘Operational manual for statistics and sampling of tuna and tuna-like fish in the Atlantic Ocean’ published by ICCAT. (6) The Community has approved the Agreement for the establishment of the Indian Ocean Tuna Commission (6), (hereinafter referred to as IOTC). The Agreement provides a useful framework for strengthening international cooperation for the purpose of conserving and rationally utilising Indian Ocean tuna and related species, through creation of the IOTC and the adoption of recommendations on conservation and management in its area of competence that become binding on Contracting Parties. The Community should apply the control measures adopted by the IOTC. (7) The IOTC has adopted a recommendation on the recording and exchange of information on tropical tuna. This is binding on the Community, which should therefore implement it. (8) The Community has fishing interests in the Eastern Pacific and has initiated the procedure for accession to the Inter-American Tropical Tuna Commission, (hereinafter referred to as IATTC). Pending accession and in line with its cooperation requirement arising under the United Nations Convention on the Law of the Sea, it should apply the control measures adopted by the IATTC. (9) The Community, which has signed the Agreement on the International Dolphin Conservation Programme (7), has decided by Decision 1999/386/EC (8) to apply it provisionally pending its approval, and should therefore apply its control measures. (10) In order to ensure the respect of the applicable control measures of the IOTC, IATTC and of the Agreement on the International Dolphin Conservation Programme, Member States should take the necessary action. (11) Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy (9) applies to all fishing activities and all associated activities carried out on the territory and in the maritime waters subject to the sovereignty or jurisdiction of Member States, including those of Community fishing vessels operating in the waters of third countries or on the high seas, without prejudice to fishery agreements concluded between the Community and third countries or international conventions to which the Community is a Party. (12) The measures necessary for implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for exercise of implementing powers conferred on the Commission (10), HAS ADOPTED THIS REGULATION: Article 1 Purpose This Regulation lays down control and inspection measures relating to fishing for stocks of the highly migratory fish species listed in Annex I to this Regulation and shall apply to vessels flying the flag of Member States and registered in the Community, (hereinafter referred to as Community fishing vessels), operating in one of the zones specified in Article 2. Article 2 Zones For the purposes of this Regulation the following marine zones are specified: (a) Zone 1: All waters of the Atlantic Ocean and adjacent seas included in the ICCAT Convention area specified in Article I of that Convention. (b) Zone 2: All Indian Ocean waters included in the area of competence specified in Article II of the Agreement for the establishment of the IOTC. (c) Zone 3: All Eastern Pacific Ocean waters included in the area specified in Article III of the Agreement on the International Dolphin Conservation Programme. Article 3 Definitions For the purposes of this Regulation the following definitions shall apply: (a) ‘boarding’: the boarding of a fishing vessel within an organisation's area of competence by one or more authorised inspectors in order to make an inspection; (b) ‘transhipment’: unloading of any quantity of highly migratory fish and/or products from such fish from on board a fishing vessel to another vessel either at sea or in port, without the products having been recorded by a port State as landed; (c) ‘landing’: unloading of any quantity of highly migratory fish and/or products from such fish from on board a fishing vessel to port or to land; (d) ‘infringement’: any presumed act committed or omitted by a fishing vessel that is recorded in an inspection report and gives serious reason for suspecting a breach of the provisions of this Regulation or any other Regulation transposing a recommendation adopted by a regional organisation for one of the zones indicated in Article 2; (e) ‘vessel of a non-Contracting Party’: vessel observed and identified as engaged in fishing activities in one of the zones specified in Article 2 that is flying the flag of a country that is not a Contracting Party to the relevant regional organisation; (f) ‘stateless vessel’: vessel for which there are reasonable grounds for suspecting it to be without nationality. CHAPTER I CONTROL AND INSPECTION MEASURES APPLICABLE IN ZONE 1 Section 1 Control measures Article 4 Catch sampling 1. Sampling of catches shall be carried out in accordance with the provisions laid down in Council Regulation (EC) No 1543/2000 of 29 June 2000 establishing a Community framework for the collection and management of the data needed to conduct the common fisheries policy (11) and the requirements of the ‘Field manual for statistics and sampling Atlantic tunas and tuna-like fishes’ (Third edition, ICCAT, 1990). 2. Detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 24(2). Article 5 Catch notification 1. Member States shall transmit to the Commission, which in turn will transmit to the ICCAT Executive Secretariat, the annual nominal catch data (task I as defined by ICCAT), for those species that are indicated in Annex II. In order to fulfil the requirements of ICCAT, the data transmission from the Member States to the Commission shall be not later than: 1 March of following year: preliminary estimates for entire year; 15 April of following year: definitive estimates. 2. Member States shall transmit the following data (task II as defined by ICCAT) annually before 31 July to the ICCAT Executive Secretariat with electronic access for the Commission: (a) catch and fishing effort data for the previous year, giving a detailed spatio-temporal breakdown; (b) any data they have on sport fishing catches of fish of the species listed in Annex I. 3. Detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 24(2). Article 6 Information on shark catches 1. Member States shall transmit any available data on catches of and trade in sharks to the ICCAT Executive Secretariat with electronic access for the Commission. 2. Detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 24(2). Article 7 Undeclared catches For imports of frozen bluefin tuna and bigeye tuna products fished by long liners greater than 24 metres overall in length, at the Commission's request Member States shall collect and examine as much import data as possible and all related information such as vessel names, their registration and owner, species fished and weight, fishing zone and place of export. Article 8 Observation of vessels 1. For the purposes of this Article ‘observation’ means any observation, by a Member State's vessel, aircraft or competent authority responsible for inspection at sea, of: — a stateless vessel likely to be fishing for species listed in Annex I, — or a vessel flying the flag of another Contracting Party and likely to be fishing in breach of ICCAT conservation measures, — or a vessel flying the flag of a non-Contracting Party, entity or fishing entity and likely to be fishing in breach of ICCAT conservation measures. 2. The observation shall be transcribed onto a standard observation form and shall if possible give all the information for which that form provides. It may be accompanied by photographs of the vessel. 3. Observation forms shall be sent without delay to the competent authority of the observer's Member State, which shall immediately transmit them to the Commission, which shall inform the flag country of the vessel observed. The Commission shall immediately transmit observation forms to the ICCAT Executive Secretariat. 4. A Member State receiving observations on the activity of a vessel flying its flag from the competent authority of a Contracting Party shall immediately notify these and all relevant information to the Commission, which shall notify this information in due time to the Executive Secretariat for examination by the Compliance Committee. 5. Masters of Community fishing vessels shall transmit to their authority any information on vessels assumed to be fishing for bigeye tuna in the Convention area that are not on the list drawn up by the ICCAT Executive Secretariat. Member States shall notify these observations as soon as possible to the Commission, which shall inform the ICCAT Executive Secretariat. 6. Detailed rules for the application of this Article on the layout and the requirements of the observation form referred to in paragraph 2 shall be adopted in accordance with the procedure referred to in Article 24(2). Article 9 Annual report 1. Before 15 June each year Member States shall send the Commission a national report, using the layout adopted by ICCAT and including (a) information on implementation of the satellite surveillance system and (b) an ‘ICCAT declaration table’ for each fishery accompanied by comments, inter alia on breaches of the tolerance margins set by ICCAT for the minimum sizes of certain species and the action taken or to be taken. Member States shall also say how sport fishing for fish of the species listed in Annex I is regulated and give details of any transhipment operations involving their vessels during the previous year. 2. Detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 24(2). Section 2 Port inspection procedures Article 10 General 1. Member States shall assign to inspection duties at their ports inspectors responsible for the surveillance and inspection of transhipment and landing of the species listed in Annex I. 2. Member States shall ensure that inspection is non-discriminatory and in line with ICCAT port inspection arrangements. 3. The port State may, inter alia, inspect documents, fishing gear and catch on board fishing vessels, when such vessels are voluntarily in its ports or at its offshore terminals. Article 11 Inspectors 1. Member States shall issue a special identification document to each ICCAT inspector which he must carry and present before making an inspection. The particulars of the card shall be determined in accordance with the procedure referred to in Article 24(2). Member States shall notify a list of their inspectors to the Commission for transmission to the ICCAT Executive Secretariat. 2. Member States shall ensure that ICCAT inspectors discharge their tasks in conformity with the rules laid down in the ICCAT port inspection arrangements. Inspectors shall remain under the operational control of their competent authority and be responsible to it for their acts. Article 12 Inspection procedures 1. Member States shall ensure that their ICCAT inspectors: — in making their inspections cause minimum disturbance to the vessel's activities and cause no deterioration in fish quality, — draw up an inspection report in line with rules laid down in accordance with the procedure referred to in Article 24(2) and transmit it to their authority. 2. Inspectors have the ability to examine all zones, decks and chambers of the vessel, catches (processed or not), gear, equipment and any documentation thought to be needed to check compliance with the conservation measures adopted by ICCAT, including the log book and the loading papers in the case of mother ships and carriers. 3. Inspectors shall sign their report in the presence of the master, who shall have the right to add or cause to be added any information that he considers relevant and sign it. The inspector shall indicate in the log book that an inspection has been made. Article 13 Master's obligations during inspection Masters of Community vessels shall: (a) raise no objection to inspections in national or foreign ports by authorised inspectors, not try to intimidate them or incommode them in the course of their work and ensure their safety; (b) cooperate in inspection of the vessel performed in accordance with the procedures laid down in this Regulation and lend their assistance thereto; (c) afford inspectors the means of examining the zones, decks and chambers of the vessel, catches (processed or not), gear, equipment and all documents, including fishing logs and loading papers. Article 14 Procedure in event of infringement 1. If an ICCAT inspector has serious reason to believe that a fishing vessel has engaged in an activity breaching the conservation measures adopted by ICCAT, he shall: (a) note the infringement in the inspection report; (b) take all necessary action to ensure safekeeping of the evidence for it; (c) immediately send the inspection report to his authority. 2. The inspecting Member State shall immediately send the original inspection report to the Commission, which shall immediately transmit it, with a copy to the ICCAT Executive Secretariat, to the competent authority of the flag country of the inspected vessel. Article 15 Follow-up of infringements 1. If a Member State is notified by an ICCAT Contracting Party or another Member State of an infringement by a vessel flying its flag, it shall take speedy action in line with its national legislation to obtain and examine the evidence, carry out any necessary investigation and if possible inspect the vessel. 2. Each Member State shall name the authority mandated to receive evidence of infringements and notify its name, address and other contact particulars to the Commission. 3. The flag Member State shall notify the Commission, which shall in turn notify the ICCAT Executive Secretariat, of the penalties imposed and measures taken with regard to the vessel concerned. Article 16 Treatment of inspection reports 1. Each Member State shall attach the same value to reports made by ICCAT inspectors of other Member States and other Contracting Parties as to those made by its own inspectors. 2. Each Member State shall cooperate with the Contracting Parties concerned by facilitating, in line with its national legislation, legal or other proceedings arising from a report submitted by an ICCAT inspector under the ICCAT port inspection arrangements. Section 3 Stateless and non-contracting parties' vessels Article 17 Transhipment 1. Community fishing vessels may not receive transhipments of fish of the species listed in Annex I from stateless vessels or those flying the flag of a non-Contracting Party that does not have the status of a cooperating party, entity or fishing entity. 2. The list of cooperating parties, entities and fishing entities adopted by ICCAT is published by the Commission in the Official Journal of the European Communities C series). 3. Before 15 September each year Member States shall send the Commission particulars of transhipments of fish of the species listed in Annex I made during the previous year between vessels flying their flag and vessels flying the flag of a non-Contracting Party enjoying the status of cooperating party, entity or fishing entity. The Commission shall forward this information to the ICCAT Executive Secretariat. Article 18 Control measures for fishing activities 1. The competent authority of a Member State that has boarded and/or inspected a stateless vessel shall immediately inform the Commission of the inspection findings and of any action it has taken under international law. The Commission shall send this information as soon as possible to the ICCAT Executive Secretariat. 2. Member States shall ensure that every stateless or non-Contracting Party vessel that enters a designated port within the meaning of Article 28(e)(2) of Regulation (EEC) No 2847/93 is inspected by their competent authority. Until inspection is completed the vessel's catches may not be landed or transhipped. 3. If inspection reveals that the vessel has on board resources covered by an ICCAT recommendation in force the Member State shall prohibit their landing or transhipment. 4. The prohibition referred to in paragraph 3 shall not be issued if the master of the inspected vessel or his representative demonstrates to the competent authority's satisfaction that: (a) the catches on board were taken outside the zone; or (b) the catches on board were taken without infringing the conservation measures in force. Article 19 Member States' nationals Each Member State shall try, as its national legislation permits, to deter its nationals from participating in activities of non-Contracting Parties that conflict with implementation of the ICCAT conservation and management measures. CHAPTER II CONTROL AND SURVEILLANCE MEASURES APPLICABLE IN ZONE 2 Article 20 General Each Member State shall take the action necessary in order that vessels flying its flag respect the measures applicable in the zone. Article 21 Observations 1. Masters of Community vessels authorised to fish in the zone shall transmit to their national authority their observations of non-Contracting Parties' vessels presumed or known to be fishing for bigeye, yellowfin or skipjack tuna in the zone. 2. Member States shall send this information as soon as possible to the Commission, which shall forward it to the IOCT. CHAPTER III CONTROL AND SURVEILLANCE MEASURES APPLICABLE IN ZONE 3 Article 22 General Each Member State shall take the action necessary in order that vessels flying its flag respect the IATTC measures transposed into Community law and the International Dolphin Conservation Programme Agreement measures applicable. CHAPTER IV FINAL PROVISIONS Article 23 The measures necessary for the implementation of Article 4(2), Article 5(3), Article 6(2), Article 8(6) and Article 9(2) shall be adopted in accordance with the management procedure referred to in Article 24(2). Article 24 1. The Commission shall be assisted by the Committee established by Article 17 of Council Regulation (EEC) No 3760/92. 2. Where reference is made to this paragraph Articles 4 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 25 1. Regulation (EC) No 1351/1999 is hereby repealed. 2. Article 22(1) of Regulation (EC) No 2742/1999 is hereby repealed. 3. References made to the repealed Regulation (EC) No 1351/1999 shall be construed as being made to this Regulation, and should be read in accordance with the correlation table in Annex III. Article 26 This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 September 2001. For the Council The President R. LANDUYT (1) OJ C 62 E, 27.2.2001, p. 79. (2) Opinion delivered on 28 February 2001 (not yet published in the Official Journal). (3) OJ L 162, 18.6.1986, p. 34. (4) OJ L 162, 26.6.1999, p. 6. (5) OJ L 341, 31.12.1999, p. 1. Regulation as last amended by Regulation (EC) No 2765/2000 (OJ L 321, 19.12.2000, p. 5). (6) OJ L 236, 5.10.1995, p. 24. (7) OJ L 132, 27.5.1999, p. 1. (8) OJ L 147, 12.6.1999, p. 23. (9) OJ L 261, 20.10.1993, p. 1. Regulation as last amended by Regulation (EC) No 2846/98 (OJ L 358, 31.12.1998, p. 5). (10) OJ L 184, 17.7.1999, p. 23. (11) OJ L 176, 15.7.2000, p. 1. ANNEX I LIST OF SPECIES REFERRED TO IN THIS REGULATION — Albacore: Thunnus alalunga — Bluefin tuna: Thunnus thynnus — Bigeye tuna: Thunnus obesus — Skipjack: Katsuwonus pelamis — Atlantic bonito: Sarda sarda — Yellowfin tuna: Thunnus albacares — Blackfin tuna: Thunnus atlanticus — Little tuna: Euthynnus spp. — Southern bluefin tuna: Thunnus maccoyii — Frigate tuna: Auxis spp. — Oceanic sea bream: Bramidae — Marlin: Tetrapturus spp.; Makaira spp. — Sailfish: Istiophorus spp. — Swordfish: Xiphias gladius — Sauries: Scomberesox spp.; Cololabis spp — Dolphinfish; common dolphinfish: Coryphaena hippurus; Coryphaena equiselis. — Shark: Hexanchus griseus; Cetorhinus maximus; Alopiidae; Rhincodon typus; Carcharhinidae; Sphyrnidae; Isuridae; Lamnidae — Cetaceans (whales and porpoises): Physeteridae; Belaenopteridae; Balenidae; Eschrichtiidae; Monodontidae; Ziphiidae; Delphinidae. ANNEX II LIST OF SPECIES SUBJECT TO COMMUNICATION TO ICCAT Latin name English name Thunnus thynnus Bluefin tuna Thunnus maccoyii Southern bluefin tuna Thunnus albacares Yellowfin tuna Thunnus alalunga Albacore Thunnus obesus Bigeye tuna Thunnus atlanticus Blackfin tuna Euthynnus alletteratus Atlantic black skipjack Katsuwonus pelamis Skipjack Sarda sarda Atlantic bonito Auxis thazard Frigate tuna Orcynopsis unicolor Plain bonito Acanthocybium solandri Wahoo Scomberomorus maculatus Spotted Spanish mackerel Scomberomorus cavalla King mackerel Istiophorus albicans Atlantic sailfish Makaira indica Black marlin Makaira nigricans Atlantic blue marlin Tetrapturus albidus Atlantic white marlin Xiphias gladius Swordfish Tetrapturus pfluegeri Spearfish Scomberomorus tritor West African Spanish mackerel Scomberomorus regalis Cero Auxis rochei Bullet tuna Scomberomorus brasiliensis Serra Spanish mackerel ANNEX III CORRELATION TABLE Regulation (EC) No 1351/1999 This Regulation Articles 1, 2, 3 Article 8 Article 4 Article 18 Article 5 Article 17

Summary: Conservation of certain stocks of migratory fish Conservation of certain stocks of migratory fish SUMMARY OF: Regulation (EC) No 1936/2001 — control measures applicable to fishing for certain stocks of highly migratory fish WHAT IS THE AIM OF THE REGULATION? It aims to specify the control and inspection measures that apply to fishing for certain highly migratory fish and mammals listed in Annex I of the regulation. The main species concerned are: tuna; swordfish; sharks; whales; and porpoises. KEY POINTS The regulation applies to fishing vessels flying the flag of EU countries and registered in the EU, operating in one of the following marine zones: Zone 1: all waters of the Atlantic Ocean and adjacent seas included in the area covered by the International Convention for the Conservation of Atlantic Tunas (ICCAT Convention)*. This Convention enabled the creation of a fisheries organisation which the EU joined in 1997: the International Commission for the Conservation of Atlantic Tunas (ICCAT); Zone 2: all Indian Ocean waters covered by the Indian Ocean Tuna Commission (IOTC)*; Zone 3: all eastern Pacific Ocean waters including the zone defined in the agreement on the International Dolphin Conservation Programme. CONTROL AND INSPECTION MEASURES APPLICABLE IN ZONE 1 Regulation (EC) No 1936/2001 has been amended several times, most recently by Regulation (EU) 2017/2107. The 2017 regulation repealed parts of Regulation (EC) No 1936/2001 to take account of various changes adopted in ICCAT recommendations since 2008. Fattening of bluefin tuna A register of bluefin tuna fattening* farms was introduced in 2004. An EU country has to notify the European Commission of the fattening farms under its jurisdiction which it authorises to carry out fattening of bluefin tuna caught in the ICCAT Convention area. Unregistered fattening farms may not carry out fattening of bluefin tuna caught in the Convention area. Where bluefin tuna are transferred for fattening from an EU fishing vessel to a transport vessel, the masters of the two vessels are required to enter certain data in their respective logbooks (the quantities of bluefin tuna transferred, the catch zone, the date and position where the transfer took place, etc.). EU countries must: register the quantities of bluefin tuna put into cages by vessels flying their flag; notify the Commission of data relating to the quantities of bluefin tuna caught and caged by vessels flying their flag, and exports and imports of bluefin tuna caught and intended for fattening; ensure that bluefin tuna fattening farms under their jurisdiction submit a caging declaration to their competent authority and are listed on the register; ensure that fattening farms submit to them each year a marketing declaration for the bluefin tuna fattened and, on the basis of this information, then inform the Commission of the quantities of bluefin tuna caged and the quantities marketed during the previous year. CONTROL AND INSPECTION MEASURES APPLICABLE IN ZONE 2 Each EU country must: ensure that vessels flying its flag respect the measures applicable in the zone;send to the Commission the list of vessels of more than 24 metres overall length flying its flag and registered in its territory that it authorises to fish for tuna and tuna-like fish in the IOTC area. The Commission sends this information to the IOTC Executive Secretariat;ensure that only registered vessels carry out fishing activities. Vessels registered on the IOTC list which fish by longlining* must obtain authorisation from the competent authorities of the flag EU country before carrying out transshipment* procedures in the IOTC fishing area. The fishing gear of EU vessels authorised to fish in the IOTC zone must bear special markings. EU countries must: transmit to the IOTC secretariat various statistical data on fishing effort and catches concerning migratory species;set up a computerised database containing the required statistical data, with access for the Commission;assign inspectors to inspection duties at their ports who will be responsible for the surveillance and inspection of transhipment and landing of the species listed in Annex I;issue a special identification document to each inspector. The master of the vessel must cooperate with the vessel inspection and provide the means for examining the zones, equipment and documents. If there is a serious reason to believe that a fishing vessel has breached the IOTC’s conservation measures, the inspector notes the infringement in the inspection report. He must ensure the safekeeping of the evidence and send the inspection report to his authority. The EU country which has been notified of an infringement by a vessel flying its flag must take speedy action to obtain and examine the evidence, carry out any necessary investigation and inspect the vessel. It then notifies the Commission of the penalties imposed and measures taken with regard to the vessel concerned. The Commission, in turn, informs the IOTC Executive Secretariat. EU fishing vessels are prohibited from receiving transhipments of fish of the species listed in Annex I from stateless vessels* or those flying the flag of a country that is not a cooperating party. EU countries send any inspection findings of stateless vessels and any action they have taken under international law to the Commission. CONTROL AND INSPECTION MEASURES SPECIFIC TO ZONE 3 Each EU country must ensure that vessels flying its flag respect the Inter-American Tropical Tuna Commission measures incorporated into EU law and the relevant International Dolphin Conservation Programme agreement measures. FROM WHEN DOES THE REGULATION APPLY? It has applied since 23 October 2001. BACKGROUND The EU participates in regional fisheries organisations (RFMOs) which allow cooperation on the conservation and management of stocks of highly migratory fish. As a contracting party, it is required to apply the control and monitoring measures resulting from recommendations adopted by these RFMOs. KEY TERMS International Convention for the Conservation of Atlantic Tunas (ICCAT Convention): this convention set up the International Commission for the Conservation of Atlantic Tunas (ICCAT). Its recommendations on conservation and management in the convention area are binding on the contracting parties. Indian Ocean Tuna Commission: this Commission works to strengthen international cooperation for the purpose of conserving and rationally using tuna and related species in the Indian Ocean and adjacent areas. It adopts recommendations which are binding on the contracting parties. Fattening: the raising of individuals in cages to increase their weight or fat content with a view to marketing. Longlining: a commercial fishing method that makes use of long lines with baited hooks attached at intervals as fishing gear. Transshipment: the transfer of a catch from a smaller fishing boat to a larger one which then incorporates it into a larger batch for shipment. Stateless vessels: vessels for which there are reasonable grounds for suspecting it to be without nationality. MAIN DOCUMENT Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, pp. 1-8) Amendments to Regulation (EC) No 1936/2001 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, pp. 1-21) 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, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1-50) See consolidated version. Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, pp. 1-32) See consolidated version. Council Regulation (EC) No 1984/2003 of 8 April 2003 introducing a system for the statistical monitoring of trade in bluefin tuna, swordfish and bigeye tuna within the Community (OJ L 295, 13.11.2003, pp. 1-42) See consolidated version. last update 14.12.2018


EUR-Lex - 32002D0494 - EN Avis juridique important | 32002D0494 2002/494/JHA: Council Decision of 13 June 2002 setting up a European network of contact points in respect of persons responsible for genocide, crimes against humanity and war crimes Official Journal L 167 , 26/06/2002 P. 0001 - 0002 Council Decisionof 13 June 2002setting up a European network of contact points in respect of persons responsible for genocide, crimes against humanity and war crimes(2002/494/JHA)THE COUNCIL OF THE EUROPEAN UNION,Having regard to Title VI of the Treaty on European Union, and in particular Article 30 and Article 34(2)(c) thereof,Having regard to the initiative of the Kingdom of the Netherlands,Having regard to the opinion of the European Parliament(1),Whereas:(1) The International Criminal Tribunals for the former Yugoslavia and for Rwanda have since 1995 been investigating, prosecuting and bringing to justice violations of laws and customs of war, genocide and crimes against humanity.(2) The Rome Statute of the International Criminal Court of 17 July 1998 affirms that the most serious crimes of concern to the international community as a whole, in particular genocide, crimes against humanity and war crimes, must not go unpunished and that their effective prosecution must be ensured by taking measures at national level and by enhancing international cooperation.(3) The Rome Statute recalls that it is the duty of every State to exercise its criminal jurisdiction over those responsible for such international crimes.(4) The Rome Statute emphasises that the International Criminal Court established under it is to be complementary to national criminal jurisdictions.(5) All Member States of the European Union have either signed or ratified the Rome Statute.(6) The investigation and prosecution of, and exchange of information on, genocide, crimes against humanity and war crimes is to remain the responsibility of national authorities, except as affected by international law.(7) Member States are being confronted with persons who were involved in such crimes and are seeking refuge within the European Union's frontiers.(8) The successful outcome of effective investigation and prosecution of such crimes at national level depends to a high degree on close cooperation between the various authorities involved in combating them.(9) It is essential that the relevant authorities of the States Parties to the Rome Statute, including the Member States of the European Union, cooperate closely in this connection.(10) Close cooperation will be enhanced if the Member States make provision for direct communication between centralised, specialised contact points.(11) Close cooperation between such contact points may provide a more complete overview of persons involved in such crimes, including the question of in which Member States they are the subject of investigation.(12) The Member States, in Council Common Position 2001/443/CFSP of 11 June 2001 on the International Criminal Court(2), have expressed that the crimes within the jurisdiction of the International Criminal Court are of concern for all Member States, which are determined to cooperate for the prevention of those crimes and for putting an end to the impunity of the perpetrators thereof.(13) This Decision does not affect any convention, agreement or arrangement regarding mutual assistance in criminal matters between judicial authorities,HAS DECIDED AS FOLLOWS:Article 1Designation and notification of contact points1. Each Member State shall designate a contact point for the exchange of information concerning the investigation of genocide, crimes against humanity and war crimes such as those defined in Articles 6, 7 and 8 of the Rome Statute of the International Criminal Court of 17 July 1998.2. Each Member State shall notify the General Secretariat of the Council in writing of its contact point within the meaning of this Decision. The General Secretariat shall ensure that this notification is passed on to the Member States, and inform the Member States of any changes in these notifications.Article 2Collection and exchange of information1. Each contact point's task shall be to provide on request, in accordance with the relevant arrangements between Member States and applicable national law, any available information that may be relevant in the context of investigations into genocide, crimes against humanity and war crimes as referred to in Article 1(1), or to facilitate cooperation with the competent national authorities.2. Within the limits of the applicable national law, contact points may exchange information without a request to that effect.Article 3Informing the European ParliamentThe Council will inform the European Parliament of the functioning and effectiveness of the European network of contact points in the context of the annual debate held by the European Parliament pursuant to Article 39 of the Treaty.Article 4ImplementationMember States shall ensure that they are able to cooperate fully in accordance with the provisions of this Decision at the latest one year after this Decision takes effect.Article 5Taking effectThis Decision shall take effect on the date of its adoption.Done at Luxembourg, 13 June 2002.For the CouncilThe PresidentM. Rajoy Brey(1) OJ C 295, 20.10.2001, p. 7.(2) Opinion delivered on 9 April 2002 (not yet published in the Official Journal).

Summary: European Genocide Network European Genocide Network SUMMARY OF: Decision 2002/494/JHA – network of contact points on genocide, crimes against humanity and war crime issues SUMMARY WHAT DOES THIS DECISION DO? It establishes a network of national contact points (one in each EU country) for improving cooperation in combating genocide*, crimes against humanity*, and war crimes*. KEY POINTS National contact points for exchanging information on investigations of such crimes are established in each EU country. The details of each contact point must be sent to the General Secretariat of the Council of the EU, which then forwards the information to the national contact points in other EU countries. National contact points provide each other with information relevant to investigations into genocide, crimes against humanity and war crimes upon request from other national contact points. The Council of the EU annually briefs the European Parliament on the activities of the network of contact points. The network meets twice a year at meetings convened by the Presidency of the Council of the EU to coordinate on-going efforts to investigate and prosecute persons suspected of having committed or participated in genocide, crimes against humanity and war crimes. FROM WHEN DOES THE DECISION APPLY? It entered into force on 13 June 2002. BACKGROUND All EU countries ratified the Rome Statute of 17 July 1998 setting up the International Criminal Court (ICC) to hear cases involving genocide, crimes against humanity and war crimes. However, the investigation and prosecution of genocide, crimes against humanity and war crimes are primarily the responsibilities of national authorities. This is why closer cooperation between national authorities is needed to ensure these crimes are combated successfully. Genocide Network KEY TERMS * Genocide: acts committed with intent to destroy, in whole or in part, a national, ethnic, racial, or religious group. * Crimes against humanity: acts committed as part of a widespread and systematic attack directed against civilian populations. * War crimes: acts committed that violate the law of war (e.g. the Geneva Conventions). Examples include mistreating prisoners-of-war, killing hostages, or deliberately destroying cities, towns or villages. ACT Council Decision 2002/494/JHA of 13 June 2002 setting up a European network of contact points in respect of persons responsible for genocide, crimes against humanity and war crimes (OJ L 167, 26.6.2002, pp. 1–2) RELATED ACTS Council Decision 2003/335/JHA of 8 May 2003 on the investigation and prosecution of genocide, crimes against humanity and war crimes (OJ L 118, 14.5.2003, pp. 12–14) last update 26.11.2015