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32000D0529

2000/529/EC: European Environment Agency Decision of 20 March 2000 establishing a code of good administrative behaviour for the Agency

Official Journal L 216 , 26/08/2000 P. 0015 - 0019

European Environment Agency Decisionof 20 March 2000establishing a code of good administrative behaviour for the Agency(2000/529/EC)THE EUROPEAN ENVIRONMENT AGENCY,Having regard to the provisions on openness in the Amsterdam Treaty, and in particular Article 1 of the Treaty on European Union and Article 21 of the EC Treaty,Having regard to the initiative taken by Roy Perry, rapporteur for the report of the Committee on Petitions on its own activities in 1996-1997(1), in calling for a code of good administrative behaviour,Having regard to the resolution of the European Parliament of 16 July 1998 on the Annual Report on the activities of the European Ombudsman in 1997 (C4-0270/98)(2),Having regard to the own initiative inquiry of the European Ombudsman into the existence and the public accessibility, in the different Community institutions and bodies, of a code of good administrative behaviour for officials in their relations with the public,Having regard to the resolution of the European Parliament of 15 April 1999 on the Annual Report on the activities of the European Ombudsman in 1998 (C4-0138/99),Having regard to the existing Code of conduct concerning public access to Commission documents, contained in Decision 94/90/ECSC, EC, Euratom(3),Whereas the Amsterdam Treaty has explicitly introduced the concept of openness into the Treaty on European Union, by stating that it marks a new stage in the process of creating an ever closer union in which decisions are taken as openly as possible and as closely as possible to the citizen;Whereas the European Commission equally aims at reforming the procedures of the Community administration to fully implement this concept;Whereas, in order to bring the administration closer to the citizens and to guarantee a better quality of administration, a code should be adopted which contains the basic principles of good administrative behaviour for officials when dealing with the public;Whereas such a code is useful for both the officials, as it will inform them in a detailed manner of the rules they have to follow when dealing with the public, and the citizens, as it will provide them with information on the standard of conduct they are entitled to expect in dealings with the Community administrations;Whereas such a code can only be efficient if it is a publicly accessible document for the citizens, and thus published in the form of a decision like the abovementioned Decision on public access to Commission documents;Whereas, in its resolutions C4-0270/98 and C4-0138/99, the Parliament welcomed the initiative for a code of good administrative behaviour for the European institutions and bodies, and stressed the urgent need to draw up such a code as soon as possible;Whereas the Parliament equally stressed the importance for such a code to be as identical as possible for all European institutions and bodies, to be accessible to all European citizens, and to be published in the Official Journal;Considering for also as specific legal basis of this Code of conduct the Council Regulation (EEC) No 1210/90 on the establishment of the European Environment Agency and the European information and observation network, Regulation that has been amended by the Council Regulation (EC) No 933/1999 of 29 April 1999, in particular Article 17: "The staff of the Agency shall be subject to the Regulations and Rules applicable to officials and other servants of the European Communities", the "Staff Regulations and the Conditions of Employment of other servants of the European Communities" and the Decision of the Management Board of the European Environment Agency on public access to the EEA documents of 21 March 1997(4);Considering it therefore desirable to establish a code governing the principles of good administrative behaviour which the EEA staff members should respect in their relations with the public, and to make this code publicly available,HAS DECIDED AS FOLLOWS:Article 1General provisionIn their relations with the public, staff of the European Environment Agency shall respect the principles which are laid down in this Decision and which constitute the Code of good administrative behaviour, hereafter referred to as "the Code".Article 2Personal scope of application1. The Code shall apply to all officials and other servants to whom the Staff Regulations and the conditions of employment of other servants apply, in their relations with the public. Hereafter the term official refers to both the officials and the other servants.2. The European Environment Agency will take the necessary measures to ensure that the provisions set out in this Code also apply to other persons working for it, such as persons employed under private law contracts, experts on secondment from national civil services and trainees.3. The public refers to natural and legal persons, whether they reside or have their registered office in a Member State or not.Article 3Material scope of application1. This Code contains the general principles of good administrative behaviour which apply to all relations of the European Environment Agency's officials with the public, unless they are governed by specific provisions.2. The principles set out in this Code do not apply to the relations between the European Environment Agency and its officials. Those relations are governed by the Staff Regulations.Article 4LawfulnessThe official shall act according to law and apply the rules and procedures laid down in Community legislation. The official shall in particular take care that decisions which affect the rights or interests of individuals have a basis in law and that their content complies with the law.Article 5Absence of discrimination1. In dealing with requests from the public and in taking decisions, the official shall ensure that the principle of equality of treatment is respected. Members of the public who are in the same situation shall be treated in a similar manner.2. If any difference in treatment is made, the official shall ensure that it is justified by the objective relevant features of the particular case.3. The official shall in particular avoid any unjustified discrimination between members of the public based on nationality, sex, racial or ethnic origin, religion or belief, disability, age, or sexual orientation.Article 6Proportionality1. When taking decisions, the official shall ensure that the measures taken are proportional to the aim pursued. The official shall in particular avoid restricting the rights of the citizens or imposing charges on them, when those restrictions or charges are not in a reasonable relation with the purpose of the action pursued.2. When taking decisions, the official shall strike a fair balance between the interests of private persons and the general public interest.Article 7Absence of abuse of powerPowers shall be exercised solely for the purposes for which they have been conferred by the relevant provisions. The official shall in particular avoid using those powers for purposes which have no basis in the law or which are not motivated by any public interest.Article 8Impartiality and independence1. The official shall be impartial and independent. The official shall abstain from any arbitrary action adversely affecting members of the public, as well as from any preferential treatment on any grounds whatsoever.2. The official shall not be guided by any outside influences of whatever kind, including political influences, or by personal interests.3. The official shall abstain from being involved in the taking of a decision on a matter concerning his or her own interests, or those of his or her family, relatives, friends and acquaintances.Article 9ObjectivityWhen taking decisions, the official shall take into consideration the relevant factors and give each of them its proper weight in the decision, whilst excluding any irrelevant element from consideration.Article 10Legitimate expectations and consistency1. The official shall be consistent in his own administrative behaviour as well as with the administrative action of the European Environment Agency. The official shall follow the Institution's normal administrative practices, unless there are legitimate grounds for departing from those practices in an individual case.2. The official shall respect the legitimate and reasonable expectations that members of the public have in the light of how the European Environment Agency has acted in the past.Article 11FairnessThe official shall act fairly and reasonably.Article 12Courtesy1. The official shall be service-minded, correct, courteous and accessible in relations with the public. When answering correspondence, telephone calls and e-mails, the official shall try as much as possible to be helpful and to reply to the questions which are asked.2. If the official is not responsible for the matter concerned, he or she shall direct the citizen to the appropriate official.3. If an error occurs which negatively affects the rights or interests of a member of the public, the official shall apologise for it.Article 13Reply to letters in the language of the citizenThe official shall ensure that every citizen of the Union or any member of the public who writes to the European Environment Agency in one of the Treaty languages receives an answer in the same language.Article 14Acknowledgement of receipt and indication of the competent official1. Every letter or complaint to the Institution shall receive an acknowledgement of receipt within a period of two weeks, except if a substantive reply can be sent within that period.2. The reply or acknowledgement of receipt shall indicate the name and the telephone number of the official who is dealing with the matter, as well as the service to which he or she belongs.3. No acknowledgement of receipt and no reply need be sent in cases where letters or complaints are abusive because of their excessive number or because of their repetitive or pointless character.Article 15Obligation to transfer to the competent service of the Institution1. If a letter or a complaint to the European Environment Agency is addressed or transmitted to a programme or unit which has no competence to deal with it, its services shall ensure that the file is transferred without delay to the competent service of the European Environment Agency.2. The service which originally received the letter or complaint shall notify the author of this transfer and shall indicate the name and the telephone number of the official to whom the file has been passed.3. If a letter or a complaint to the European Environment Agency is addressed for which the European Environment Agency is not competent to deal with its services shall ensure that the letter is transferred to the competent European body and inform the sender to whom the file has been passed.Article 16Right to be heard and to make statements1. In cases where the rights or interests of individuals are involved, the official shall ensure that, at every stage in the decision-making procedure, the rights of defence are respected.2. Every member of the public shall have the right, in cases where a decision affecting his rights or interests has to be taken, to submit written comments and, when needed, to present oral observations before the decision is taken.Article 17Reasonable time limit for taking decisions1. The official shall ensure that a decision on every request or complaint to the Institution is taken within a reasonable time limit, without delay, and in any case no later than two months from the date of receipt. The same rule shall apply for answering letters from members of the public.2. If a request or a complaint to the European Environment Agency cannot, because of the complexity of the matters which it raises, be decided upon within the abovementioned time limit, the official shall inform the author thereof as soon as possible. In that case, a definitive decision should be notified to the author in the shortest time.Article 18Duty to state the grounds of decisions1. Every decision of the European Environment Agency which may adversely affect the rights or interests of a private person shall state the grounds on which it is based by indicating clearly the relevant facts and the legal basis of the decision.2. The official shall avoid making decisions which are based on brief or vague grounds or which do not contain individual reasoning.3. If it is not possible, because of the large number of persons concerned by similar decisions, to communicate in detail the grounds of the decision and where standard replies are therefore made, the official shall guarantee that he or she subsequently provides the citizen who expressly requests it with an individual reasoning.Article 19Indication of the possibilities of appeal1. A decision of the European Environment Agency which may adversely affect the rights or interests of a private person shall contain an indication of the appeal possibilities available for challenging the decision. It shall in particular indicate the nature of the remedies, the bodies before which they can be exercised, as well as the time-limits for exercising them.2. Decisions shall in particular refer to the possibility of judicial proceedings and complaints to the Ombudsman under the conditions specified in, respectively, Articles 230 and 195 of the Treaty establishing the European Community.Article 20Notification of the decision1. The official shall ensure that decisions which affect the rights or interests of individual persons are notified in writing, as soon as the decision has been taken, to the person or persons concerned.2. The official shall abstain from communicating the decision to other sources until the person or persons concerned have been informed.Article 21Data protection1. The official who deals with personal data concerning a citizen shall respect the principles laid down in the Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and the free movement of such data.2. The official shall in particular avoid processing personal data for non-legitimate purposes or the transmission of such data to non-authorised persons.Article 22Requests for information1. The official shall, when he or she has responsibility for the matter concerned, provide members of the public with the information that they request. The official shall take care that the information communicated is clear and understandable.2. If an oral request for information is too complicated or too comprehensive to be dealt with, the official shall advise the person concerned to formulate his demand in writing.3. If, because of its confidentiality, an official may not disclose the information requested, he or she shall, in accordance with Article 18 of this Code, indicate to the person concerned the reasons why he or she cannot communicate the information.4. Further to requests for information on matters for which he or she has no responsibility, the official shall direct the requester to the competent person and indicate his or her name and telephone number. Further to requests for information concerning another Community institution or body, the official shall direct the requester to that institution or body.5. Where appropriate, the official shall, depending on the subject of the request, direct the person seeking information to the service of the Institution responsible for providing information to the public.Article 23Requests for public access to documents1. Further to requests for access to documents of the European Environment Agency, the official shall give access to these documents in accordance with the Decision of the Management Board of the European Environment Agency on public access to EEA documents of 21 March 1997(5).2. If the official cannot comply with an oral request for access to documents, the citizen shall be advised to formulate it in writing.Article 24Keeping of adequate recordsThe European Environment Agency's departments shall keep adequate records of their incoming and outgoing mail, of the documents they receive, and of the measures they take.Article 25Public access to the Code1. The European Environment Agency will take the necessary measures in order to ensure that this Code enjoys the widest possible publicity amongst the citizens. It will in particular ensure the spreading of a leaflet called "The Code of good administrative behaviour of the European Environment Agency" which will contain a presentation of this Code and which will include its full text in an annex.2. The European Environment Agency will provide a copy of this Code to any citizen who requests it.Article 26Right to complain to the European OmbudsmanAny failure of an official to comply with the principles set out in this Code may be the subject of a complaint to the European Ombudsman in accordance with Article 195 of the Treaty establishing the European Community and the Statute of the European Ombudsman(6).Article 27RevisionThis Decision shall be reviewed after two years of operation. In 2002, the Executive Director shall submit a report on the implementation of this Decision in the period from 2000 to 2002, in preparation of that review to the European Ombudsman.Article 28Entry into forceThis Decision is adopted by the Management Board of the European Environment Agency, on 20 March 2000 and will take effect as of 20 June 2000 after publication in the Official Journal of the European Communities.Done at Copenhagen, 20 March 2000.For the EEA Management BoardKees ZoetemanChairmanFor the European Environment AgencyDomingo Jiménez-BeltránThe Executive Director(1) A4-0190/97.(2) OJ C 292, 21.9.1998, p. 168.(3) OJ L 46, 18.2.1994, p. 58.(4) OJ C 282, 18.9.1997, p. 5.(5) See footnote 4.(6) Decision 94/262/ECSC, EC, Euratom of the European Parliament of 9 March 1994 on the Regulations and General Conditions governing the performance of the European Ombudsman's duties, (OJ L 113, 4.5.1994, p. 15).


title: 2010/200/: Decision of the European Parliament and of the Council of 9 March 2010 on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 28 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management

text:
               8.4.2010

               EN

               Official Journal of the European Union

               L 88/13

         DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 9 March 2010
   on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 28 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management
   (2010/200/EU)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (1), and in particular point 28 thereof,
   Having regard to Regulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 establishing the European Globalisation Adjustment Fund (2), and in particular Article 12(3) thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               The European Globalisation Adjustment Fund (EGF) was established to provide additional support to redundant workers who suffer from the consequences of major structural changes in world trade patterns and to assist them with their reintegration into the labour market.

               (2)

               The scope of the EGF was broadened for applications submitted from 1 May 2009 to include support for workers made redundant as a result of the global financial and economic crisis.

               (3)

               The Interinstitutional Agreement of 17 May 2006 allows the mobilisation of the EGF within the annual ceiling of EUR 500 million.

               (4)

               Lithuania submitted an application to mobilise the EGF, in respect of redundancies in the construction industry, on 23 September 2009. This application complies with the requirements for determining the financial contributions as laid down in Article 10 of Regulation (EC) No 1927/2006, therefore the Commission proposes to deploy an amount of EUR 1 118 893.

               (5)

               The EGF should, therefore, be mobilised in order to provide a financial contribution for the application submitted by Lithuania,

         HAVE ADOPTED THIS DECISION:
   Article 1
   For the general budget of the European Union for the financial year 2010, the European Globalisation Adjustment Fund (EGF) shall be mobilised to provide the sum of EUR 1 118 893 in commitment and payment appropriations.
   Article 2
   This Decision shall be published in the Official Journal of the European Union.

      Done at Strasbourg, 9 March 2010.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         M. Á. MORATINOS

      (1)  OJ C 139, 14.6.2006, p. 1.

      (2)  OJ L 406, 30.12.2006, p. 1.


title: Decision (EU) 2015/43 of the European Parliament and of the Council of 17 December 2014 on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 13 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (application EGF/2014/013 EL/Odyssefs Fokas, from Greece)

text:
               14.1.2015

               EN

               Official Journal of the European Union

               L 8/16

         DECISION (EU) 2015/43 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 17 December 2014
   on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 13 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management
   (application EGF/2014/013 EL/Odyssefs Fokas, from Greece)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (1), and in particular Article 15(4) thereof,
   Having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (2), and in particular Article 12 thereof,
   Having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (3), and in particular point 13 thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               The European Globalisation Adjustment Fund (EGF) was established to provide support for workers made redundant and self-employed persons whose activity has ceased as a result of major structural changes in world trade patterns due to globalisation, as a result of a continuation of the global financial and economic crisis addressed in Regulation (EC) No 546/2009 of the European Parliament and of the Council (4), or as a result of a new global financial and economic crisis and to assist them with their reintegration into the labour market.

               (2)

               The EGF shall not exceed a maximum annual amount of EUR 150 million (2011 prices), as laid down in Article 12 of Regulation (EU, Euratom) No 1311/2013.

               (3)

               On 29 July 2014 Greece submitted an application to mobilise the EGF, in respect of redundancies in Odyssefs Fokas SA in Greece, and supplemented it by additional information as provided by Article 8(3) of Regulation (EU) No 1309/2013. This application complies with the requirements for determining a financial contribution from the EGF as laid down in Article 13 of Regulation (EU) No 1309/2013.

               (4)

               In accordance with Article 6(2) of Regulation (EU) No 1309/2013, Greece has decided to provide personalised services co-financed by the EGF also to young persons not in employment, education or training (NEETs).

               (5)

               The EGF should, therefore, be mobilised in order to provide a financial contribution of an amount of EUR 6 444 000 for the application submitted by Greece,

         HAVE ADOPTED THIS DECISION:
   Article 1
   For the general budget of the European Union for the financial year 2014, the European Globalisation Adjustment Fund shall be mobilised to provide the sum of EUR 6 444 000 in commitment and payment appropriations.
   Article 2
   This decision shall be published in the Official Journal of the European Union.

      Done at Strasbourg, 17 December 2014.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         B. DELLA VEDOVA

      (1)  OJ L 347, 20.12.2013, p. 855.

      (2)  OJ L 347, 20.12.2013, p. 884.

      (3)  OJ C 373, 20.12.2013, p. 1.

      (4)  Regulation (EC) No 546/2009 of the European Parliament and of the Council of 18 June 2009 amending Regulation (EC) No 1927/2006 on establishing the European Globalisation Adjustment Fund (OJ L 167, 29.6.2009, p. 26).


title: 2013/455/EU: Council Decision of 9 July 2013 on the position to be adopted, on behalf of the European Union, in the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco

text:
               14.9.2013

               EN

               Official Journal of the European Union

               L 245/14

         COUNCIL DECISION
   of 9 July 2013
   on the position to be adopted, on behalf of the European Union, in the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco
   (2013/455/EU)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 in conjunction with Article 218(9) thereof,
   Having regard to Council Decision 2003/885/EC of 17 November 2003 concerning the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco (1), and in particular Article 3(2) thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               The Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (2) (hereinafter referred to as ‘the Agreement’) entered into force on 1 May 2004.

               (2)

               Article 1(1) of the Agreement provides that the Annex to the Agreement shall be amended by the Joint Committee established by the Agreement to ensure that Union acts falling within the scope of the Agreement apply on the territory of Monaco.

               (3)

               Since the entry into force of the Agreement, the Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. It is therefore necessary to update the Annex to include the new acts and to delete the acts that have been repealed. In addition, it is necessary to include acts falling within the scope of the Agreement but not currently referenced in the Annex, including Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (3) and Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, resting, processing, preservation, storage and distribution of human tissues and cells (4) because certain of their provisions apply to the manufacturing of medicinal products.

               (4)

               The position of the Union in the Joint Committee should be based on the attached draft Decision,

         HAS ADOPTED THIS DECISION:
   Article 1
   The position to be taken by the European Union within the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco shall be based on the draft Decision of the Joint Committee attached to this Decision.
   Technical modifications to the draft Decision may be agreed to by the representatives of the Union in the Joint Committee without further decision of the Council.
   Article 2
   The Decision of the Joint Committee shall be published in the Official Journal of the European Union.
   Article 3
   This Decision shall enter into force on the day of its adoption.

      Done at Brussels, 9 July 2013.

            For the Council

            The President

         R. ŠADŽIUS

      (1)  OJ L 332, 19.12.2003, p. 41.

      (2)  OJ L 332, 19.12.2003, p. 42.

      (3)  OJ L 33, 8.2.2003, p 30.

      (4)  OJ L 102, 7.4.2004, p. 48.

      DRAFT
      DECISION No …/… OF THE EU-MONACO JOINT COMMITTEE
      established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco
      of …
      amending the Annex to that Agreement
      THE JOINT COMMITTEE,
      Having regard to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (1), signed in Brussels on 4 December 2003 (hereinafter referred to as ‘the Agreement’), and in particular Article 1(1) thereof,
      Whereas:

                  (1)

                  Since the entry into force of the Agreement on 1 May 2004, the Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. A Decision of the Joint Committee is therefore necessary to update the Annex to include the new acts and to delete the acts that have been repealed.

                  (2)

                  It is recalled that acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement are applicable on the territory of Monaco without the need for a Joint Committee Decision, as provided for by Article 1(2) of the Agreement,

            HAS ADOPTED THIS DECISION:
      Article 1
      The text set out in the Annex to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco is replaced by the text set out in the Annex to this Decision.
      Article 2
      This Decision shall enter into force on the day of its adoption.

               By the Joint Committee

               The Chairman

         (1)  OJ L 332, 19.12.2003, p. 42.

         ANNEX

            ‘I.   MEDICINAL PRODUCTS

            ACTS REFERRED TO

                        1.

                        Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by:

                                    —

                                    Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1);

                                    —

                                    Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74);

                                    —

                                    Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (OJ L 348, 31.12.2010, p. 74);

                                    —

                                    Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (OJ L 242 15.9.2009, p. 3);

                                    —

                                    Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (OJ L 168, 30.6.2009, p. 33);

                                    —

                                    Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (OJ L 81, 20.3.2008, p. 51);

                                    —

                                    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121);

                                    —

                                    Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1);

                                    —

                                    Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 34);

                                    —

                                    Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 85);

                                    —

                                    Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46) and

                                    —

                                    Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p 30).

                        2.

                        Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by:

                                    —

                                    Regulation (EU) no 1027/2012 of the European Parliament and of the Council of 25 October 2012 as regards pharmacovigilance. (OJ L 316, 14.11.2012, p. 38);

                                    —

                                    Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (OJ L 348, 31.12.2010, p. 1);

                                    —

                                    Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11);

                                    —

                                    Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two (OJ L 87, 31.3.2009, p. 109);

                                    —

                                    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. (OJ L 324 10.12.2007, p. 121) and

                                    —

                                    Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. (OJ L 378, 27.12.2006, p. 1).

                        3.

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

                                    —

                                    Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four (OJ L 188, 18.7.2009, p. 14);

                                    —

                                    Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33);

                                    —

                                    Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11) and

                                    —

                                    Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (OJ L 44, 14.2.2009, p. 10).

                                    —

                                    Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58).

                        4.

                        Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by:

                                    —

                                    Council Regulation (EC) No 2743/98 of 14 December 1998 (OJ L 345, 19.12.1998, p. 3);

                                    —

                                    Commission Regulation (EC) No 494/2003 of 18 March 2003 (OJ L 73, 19.3.2003, p. 6);

                                    —

                                    Council Regulation (EC) No 1905/2005 of 14 November 2005 (OJ L 304, 23.11.2005, p. 1);

                                    —

                                    Commission Regulation (EC) No 312/2008 of 3 April 2008 (OJ L 93, 4.4.2008, p. 8);

                                    —

                                    Commission Regulation (EC) No 249/2009 of 23 March 2009 (OJ L 79, 25.3.2009, p. 34);

                                    —

                                    Commission Regulation (EU) No 261/2010 of 25 March 2010 (OJ L 80, 26.3.2010, p. 36);

                                    —

                                    Commission Regulation (EU) No 301/2011 of 28 March 2011 (OJ L 81, 29.3.2011, p. 5);

                                    —

                                    Commission Regulation (EU) No 273/2012 of 27 March 2012 (OJ L 90, 28.3.2012, p. 11) and

                                    —

                                    Commission Regulation (EU) No 220/2013 of 13 March 2013 (OJ L 70, 14.3.2013, p. 1).

                        5.

                        Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

                        6.

                        Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (OJ L 194, 25.7.2009, p. 7).

                        7.

                        Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as amended by:

                                    —

                                    Commission Regulation (EU) No 758/2010 of 24 August 2010 (OJ L 223, 25.8.2010, p. 37);

                                    —

                                    Commission Regulation (EU) No 759/2010 of 24 August 2010 (OJ L 223, 25.8.2010, p. 39);

                                    —

                                    Commission Regulation (EU) No 761/2010 of 25 August 2010 (OJ L 224, 26.8.2010, p. 1);

                                    —

                                    Commission Regulation (EU) No 890/2010 of 8 October 2010 (OJ L 266, 9.10.2010, p. 1);

                                    —

                                    Commission Regulation (EU) No 914/2010 of 12 October 2010 (OJ L 269, 13.10.2010, p. 5);

                                    —

                                    Commission Regulation (EU) No 362/2011 of 13 April 2011 (OJ L 100, 14.4.2011, p. 26);

                                    —

                                    Commission Regulation (EU) No 363/2011 of 13 April 2011 (OJ L 100, 14.4.2011, p. 28);

                                    —

                                    Commission Implementing Regulation (EU) No 84/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 1);

                                    —

                                    Commission Implementing Regulation (EU) No 85/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 4);

                                    —

                                    Commission Implementing Regulation (EU) No 86/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 6);

                                    —

                                    Commission Implementing Regulation (EU) No 107/2012 of 8 February 2012 (OJ L 36, 9.2.2012, p. 25);

                                    —

                                    Commission Implementing Regulation (EU) No 122/2012 of 13 February 2012 (OJ L 40, 14.2.2012, p. 2);

                                    —

                                    Commission Implementing Regulation (EU) No 123/2012 of 13 February 2012 (OJ L 40, 14.2.2012, p. 4);

                                    —

                                    Commission Implementing Regulation (EU) No 201/2012 of 8 March 2012 (OJ L 71, 9.3.2012, p. 37);

                                    —

                                    Commission Implementing Regulation (EU) No 202/2012 of 8 March 2012 (OJ L 71, 9.3.2012, p. 40);

                                    —

                                    Commission Implementing Regulation (EU) No 221/2012 of 14 March 2012 (OJ L 75, 15.3.2012, p. 7);

                                    —

                                    Commission Implementing Regulation (EU) No 222/2012 of 14 March 2012 (OJ L 75, 15.3.2012, p. 10);

                                    —

                                    Commission Implementing Regulation (EU) No 436/2012 of 23 May 2012 (OJ L 134, 24.5.2012, p. 10);

                                    —

                                    Commission Implementing Regulation (EU) No 466/2012 of 1 June 2012 (OJ L 143, 2.6.2012, p. 2);

                                    —

                                    Commission Implementing Regulation (EU) No 1161/2012 of 7 December 2012 (OJ L 336, 8.12.2012, p. 14);

                                    —

                                    Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012 (OJ L 338, 12.12.2012, p. 20);

                                    —

                                    Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012 (OJ L 340, 13.12.2012, p. 35);

                                    —

                                    Commission Implementing Regulation (EU) No 59/2013 of 23 January 2013 (OJ L 21, 24.1.2013, p. 21);

                                    —

                                    Commission Implementing Regulation (EU) No 115/2013 of 8 February 2013 (OJ L 38, 9.2.2013, p. 11.);

                                    —

                                    Commission Implementing Regulation (EU) No 116/2013 of 8 February 2013, (OJ L 38, 9.2.2013, p. 14);

                                    —

                                    Commission Implementing Regulation (EU) No 394/2013 of 29 April 2013, (OJ L 118, 30.4.2013, p. 17) and

                                    —

                                    Commission Implementing Regulation (EU) No 406/2013 of 2 May 2013, (OJ L 121, 3.5.2013, p. 42).

                        8.

                        Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 150, 9.6.2012, p. 68).

                        9.

                        Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 209, 4.8.2012, p. 4).

                        10.

                        Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2013, p. 17).

                        11.

                        Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).

                        12.

                        Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10).

                        13.

                        Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121), as amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 1).

                        14.

                        Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10).

                        15.

                        Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:

                                    —

                                    Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (OJ L 152, 16.6.2009, p. 1) and

                                    —

                                    Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 (OJ L 378, 27.12.2006, p. 20).

                        16.

                        Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6).

                        17.

                        Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4).

                        18.

                        Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13).

                        19.

                        Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44), as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109).

                        20.

                        Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28) as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109).

                        21.

                        Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

                        22.

                        Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5), as amended by:

                                    —

                                    Commission Regulation (EC) No 1876/2004 of 28 October 2004 (OJ L 326, 29.10.2004, p. 22) and

                                    —

                                    Commission Regulation (EC) No 1662/2005 of 11 October 2005 (OJ L 267, 12.10.2005, p. 19).

                        23.

                        Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1), as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14).

                        24.

                        Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70).

                        25.

                        Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems. (OJ L 40, 11.2.1989, p. 8).

                        26.

                        Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34), as amended by:

                                    —

                                    Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1) and

                                    —

                                    Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14).

                        27.

                        Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30) (only as regards the collection and testing of blood and blood components used as starting materials for manufacturing medicinal products).

                        28.

                        Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48) (only as regards the procurement, donation, coding and testing of tissue and cells, as well as the coding of donations and packaging thereof, used as starting materials for advanced therapy medicinal products as referred to in Regulation (EC) No 1394/2007 of the European Parliament and of the Council).

                  II.   COSMETICS

            ACTS REFERRED TO

                        1.

                        Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169), as amended by:

                                    —

                                    Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p. 35);

                                    —

                                    Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26);

                                    —

                                    Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1);

                                    —

                                    Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p. 25);

                                    —

                                    Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15);

                                    —

                                    Commission Directive 83/496/EEC of 22 September 1983 (OJ L 275, 8.10.1983, p. 20);

                                    —

                                    Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38);

                                    —

                                    Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31);

                                    —

                                    Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p. 40);

                                    —

                                    Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40);

                                    —

                                    Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38);

                                    —

                                    Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20);

                                    —

                                    Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p. 11);

                                    —

                                    Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p. 46);

                                    —

                                    Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10);

                                    —

                                    Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p. 25);

                                    —

                                    Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40);

                                    —

                                    Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59);

                                    —

                                    Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23);

                                    —

                                    Commission Directive 92/86/EEC of 21 October 1992 (OJ L 325, 11.11.1992, p. 18);

                                    —

                                    Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32);

                                    —

                                    Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24);

                                    —

                                    Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p. 31);

                                    —

                                    Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19);

                                    —

                                    Commission Directive 96/41/EC of 25 June 1996 (OJ L 198, 8.8.1996, p. 36);

                                    —

                                    Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85);

                                    —

                                    Commission Directive 97/18/EC of 17 April 1997 (OJ L 114, 1.5.1997, p. 43);

                                    —

                                    Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77);

                                    —

                                    Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44);

                                    —

                                    Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20);

                                    —

                                    Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42);

                                    —

                                    Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22);

                                    —

                                    Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25);

                                    —

                                    Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 19);

                                    —

                                    Commission Directive 2003/1/EC of 6 January 2003 (OJ L 5, 10.1.2003, p. 14);

                                    —

                                    Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24);

                                    —

                                    Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ L 66, 11.3.2003, p. 26);

                                    —

                                    Commission Directive 2003/80/EC of 5 September 2003 (OJ L 224, 6.9.2003, p. 27);

                                    —

                                    Commission Directive 2003/83/EC of 24 September 2003 (OJ L 238, 25.9.2003, p. 23);

                                    —

                                    Commission Directive 2004/87/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 4);

                                    —

                                    Commission Directive 2004/88/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 5);

                                    —

                                    Commission Directive 2004/94/EC of 15 September 2004 (OJ L 294, 17.9.2004, p. 28);

                                    —

                                    Commission Directive 2004/93/EC of 21 September 2004 (OJ L 300, 25.9.2004, p. 13);

                                    —

                                    Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46);

                                    —

                                    Commission Directive 2005/42/EC of 20 June 2005 (OJ L 158, 21.6.2005, p. 17);

                                    —

                                    Commission Directive 2005/52/EC of 9 September 2005 (OJ L 234, 10.9.2005, p. 9);

                                    —

                                    Commission Directive 2005/80/EC of 21 November 2005 (OJ L 303, 22.11.2005, p. 32);

                                    —

                                    Commission Directive 2006/65/EC of 19 July 2006 (OJ L 198, 20.7.2006, p. 11);

                                    —

                                    Commission Directive 2006/78/EC of 29 September 2006 (OJ L 271, 30.9.2006, p. 56);

                                    —

                                    Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 1.2.2007, p. 9);

                                    —

                                    Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.3.2007, p. 27);

                                    —

                                    Commission Directive 2007/22/EC of 17 April 2007 (OJ L 101, 18.4.2007, p. 11);

                                    —

                                    Commission Directive 2007/53/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 19);

                                    —

                                    Commission Directive 2007/54/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 21);

                                    —

                                    Commission Directive 2007/67/EC of 22 November 2007 (OJ L 305, 23.11.2007, p. 22);

                                    —

                                    Commission Directive 2008/14/EC of 15 February 2008 (OJ L 42, 16.2.2008, p. 43);

                                    —

                                    Commission Directive 2008/42/EC of 3 April 2008 (OJ L 93, 4.4.2008, p. 13);

                                    —

                                    Commission Directive 2008/88/EC of 23 September 2008 (OJ L 256, 24.9.2008, p. 12);

                                    —

                                    Commission Directive 2008/123/EC of 18 December 2008 (OJ L 340, 19.12.2008, p. 71);

                                    —

                                    Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 (OJ L 345, 23.12.2008, p. 68);

                                    —

                                    Commission Directive 2009/6/EC of 4 February 2009 (OJ L 36, 5.2.2009, p. 15);

                                    —

                                    Commission Directive 2009/36/EC of 16 April 2009 (OJ L 98, 17.4.2009, p. 31);

                                    —

                                    Commission Directive 2009/129/EC of 9 October 2009 (OJ L 267, 10.10.2009, p. 18);

                                    —

                                    Commission Directive 2009/130/EC of 12 October 2009 (OJ L 268, 13.10.2009, p. 5);

                                    —

                                    Commission Directive 2009/134/EC of 28 October 2009 (OJ L 282, 29.10.2009, p. 15);

                                    —

                                    Commission Directive 2009/159/EU of 16 December 2009 (OJ L 336, 18.12.2009, p. 29);

                                    —

                                    Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 (OJ L 342, 22.12.2009, p. 59);

                                    —

                                    Commission Directive 2009/164/EU of 22 December 2009 (OJ L 344, 23.12.2009, p. 41);

                                    —

                                    Commission Directive 2010/3/EU of 1 February 2010 (OJ L 29, 2.2.2010, p. 5);

                                    —

                                    Commission Directive 2010/4/EU of 8 February 2010 (OJ L 36, 9.2.2010, p. 21);

                                    —

                                    Commission Directive 2011/59/EU of 13 May 2011 (OJ L 125, 14.5.2011, p. 17);

                                    —

                                    Council Directive 2011/84/EU of 20 September 2011 (OJ L 283, 29.10.2011, p. 36) and

                                    —

                                    Commission Implementing Directive 2012/21/EU of 2 August 2012 (OJ L 208, 3.8.2012, p. 8).

                              Directive 76/768/EEC will be repealed with effect from 11 July 2013 and will be replaced by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

                        2.

                        Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. (OJ L 342, 22.12.2009, p. 59), as amended by:

                                    —

                                    Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 114, 25.4.2013, p. 1) and

                                    —

                                    Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 139, 25.5.2013, p. 8).

                        3.

                        Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 383, 31.12.1980, p. 27), as amended by Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56).

                        4.

                        Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 185, 30.6.1982, p. 1), as amended by Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92).

                        5.

                        Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 291, 24.10.1983, p. 9).

                        6.

                        Commission Directive 85/490/EEC of 11 October 1985 on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 295, 7.11.1985, p. 30).

                        7.

                        Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking the composition of cosmetic products (OJ L 231, 14.9.1993, p. 34).

                        8.

                        Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products (OJ L 140, 23.6.1995, p. 26), as amended by:

                                    —

                                    Commission Directive 2006/81/EC of 23 October 2006 (OJ L 362, 20.12.2006, p. 92) and

                                    —

                                    Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (OJ L 236, 23.9.2003, p. 33).

                              Commission Directive 95/17/EC will be repealed with effect from 11 July 2013.

                        9.

                        Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 178, 28.7.1995, p. 20).

                        10.

                        Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 213, 22.8.1996, p. 8).

                        11.

                        Commission Decision of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (OJ L 132, 1.6.1996, p. 1) as amended by Commission Decision 2006/257/EC, (OJ L 97, 5.4.2006, p. 1).

                  III.   MEDICAL DEVICES

            ACTS REFERRED TO

                        1.

                        Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17), as amended by:

                                    —

                                    Council Directive 93/42/EEC of 14 June 1993 (OJ L 169, 12.7.1993, p. 1);

                                    —

                                    Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1);

                                    —

                                    Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and

                                    —

                                    Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p. 21).

                        2.

                        Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1), as amended by:

                                    —

                                    Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1);

                                    —

                                    Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ L 313, 13.12.2000, p. 22);

                                    —

                                    Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (OJ L 6, 10.1.2002, p. 50);

                                    —

                                    Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and

                                    —

                                    Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p. 21).

                        3.

                        Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as amended by:

                                    —

                                    Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1);

                                    —

                                    Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14) and

                                    —

                                    Commission Directive 2011/100/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 50).

                        4.

                        Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (OJ L 131, 16.5.2002, p. 17), as amended by:

                                    —

                                    Commission Decision 2009/108/EC of 3 February 2009 (OJ L 39, 10.2.2009, p. 34);

                                    —

                                    Commission Decision 2009/886/EC of 27 November 2009 (OJ L 318, 4.12.2009, p. 25) and

                                    —

                                    Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 63).

                        5.

                        Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43).

                        6.

                        Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).

                        7.

                        Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41).

                        8.

                        Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45).

                        9.

                        Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28).

                        10.

                        Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).’


Avis juridique important

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41993D0001

93/1/Euratom, ECSC, EEC: Decision of the representatives of the Governments of the Member States of the European Communities of 21 December 1992 appointing members of the Commission of the European Communities

Official Journal L 002 , 06/01/1993 P. 0005 - 0006 Finnish special edition: Chapter 1 Volume 3 P. 0003  Swedish special edition: Chapter 1 Volume 3 P. 0003

DECISION  OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN COMMUNITIES  of 21 December 1992  appointing members of the Commission of the European Communities  (93/1/Euratom, ECSC, EEC)THE REPRESENTATIVES OF  THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing a Single Council and a Single Commission of the European Communities, and in particular Articles 10 and 11 thereof,  Whereas the second paragraph of Article 11 of that Treaty stipulates, inter alia, that the term of office of members of the Commission shall be four years; whereas the persons appointed by this Decision are therefore, on the basis of that provision,  appointed members of the Commission for the period from 6 January 1993 to 5 January 1997 inclusive; whereas, however, the entry into force of the Treaty on European Union, signed at Maastricht on 7 February 1992, and in particular of the new Article 158  added to the Treaty establishing the European Community, will mean that the term of office of the Commission members thus appointed will expire on 6 January 1995 instead of 5 January 1997,  HAVE DECIDED AS FOLLOWS:  Sole Article  Subject to the implementation, following entry into force of the Treaty on European Union, of the new Article 158 added by that Treaty to the Treaty establishing the European Community, the following are hereby appointed members of the  Commission of the European Communities from 6 January 1993 for the period provided for in the second paragraph of Article 11 of the Treaty establishing a Single Council and a Single Commission of the European Communities:  Dr Martin BANGEMANN  The Right Honourable Sir Leon BRITTAN QC  Mr Henning CHRISTOPHERSEN  Prof. Dr. Joao de DEUS ROGADO SALVADOR PINHEIRO  Mr Jacques DELORS  Mr Pádraig FLYNN  Mr Manuel MARÍN GONZÁLEZ  Mr Abel MATUTES JUAN  The Right Honourable Bruce MILLAN  Mr Yannis D. PALEOCRASSAS  Prof. Antonio RUBERTI  Mr Peter M. SCHMIDHUBER  Ms Christiane SCRIVENER  Mr René STEICHEN  Mr Hans VAN DEN BROEK  Mr Karel VAN MIERT  Mr Raniero VANNI d'ARCHIRAFI Done at Brussels, 21 December 1992. The President D. HURD