title: Directive 2008/28/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2005/32/EC establishing a framework for the setting of ecodesign requirements for energy-using products, as well as Council Directive 92/42/EEC and Directives 96/57/EC and 2000/55/EC, as regards the implementing powers conferred on the Commission

text:
               20.3.2008

               EN

               Official Journal of the European Union

               L 81/48

      DIRECTIVE 2008/28/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   amending Directive 2005/32/EC establishing a framework for the setting of ecodesign requirements for energy-using products, as well as Council Directive 92/42/EEC and Directives 96/57/EC and 2000/55/EC, as regards the implementing powers conferred on the Commission
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Directive 2005/32/EC of the European Parliament and of the Council (3) and three directives which constitute implementing measures thereto within the meaning of Article 15 thereof, namely Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (4), Directive 96/57/EC of the European Parliament and of the Council of 3 September 1996 on energy efficiency requirements for household electric refrigerators, freezers and combinations thereof (5) and Directive 2000/55/EC of the European Parliament and of the Council of 18 September 2000 on energy efficiency requirements for ballasts for fluorescent lighting (6), stipulate that certain measures should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

               (2)

               Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements.

               (3)

               In accordance with the statement by the European Parliament, the Council and the Commission (8) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

               (4)

               The statement comprises a list of instruments to be adjusted as a matter of urgency, including Directive 2005/32/EC. Adjusting that Directive necessitates adjusting Directives 92/42/EEC, 96/57/EC and 2000/55/EC.

               (5)

               The Commission should be empowered to amend or repeal Directives 92/42/EEC, 96/57/EC and 2000/55/EC. Such amendment or repeal must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (6)

               In addition, the Commission should be empowered to adopt implementing measures laying down ecodesign requirements for defined energy-using products, including the introduction of implementing measures during the transitional period, and including where appropriate provisions on the balancing of the various environmental aspects. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2005/32/EC by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny.

               (7)

               Directive 2005/32/EC and Directives 92/42/EEC, 96/57/EC and 2000/55/EC should therefore be amended accordingly.

               (8)

               Since the amendments made to Directive 2005/32/EC, as well as to Directives 92/42/EEC, 96/57/EC and 2000/55/EC, by this Directive are technical in nature and concern committee procedure only, they do not need to be transposed by the Member States. It is therefore not necessary to lay down provisions to that effect,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2005/32/EC
   Directive 2005/32/EC is hereby amended as follows:

               1.

               in Article 13, the following paragraph shall be inserted:
               ‘1a.   Guidelines covering specificities of SMEs active in the product sector affected may accompany an implementing measure. If necessary, and in accordance with paragraph 1, further specialised material may be produced by the Commission for facilitating implementation of this Directive by SMEs.’;

               2.

               Article 15 shall be amended as follows:

                           (a)

                           paragraph 1 shall be replaced by the following:
                           ‘1.   When an EuP meets the criteria listed under paragraph 2, it shall be covered by an implementing measure or by a self-regulation measure in accordance with paragraph 3(b). Such implementing measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).’;

                           (b)

                           paragraph 10 shall be replaced by the following:
                           ‘10.   Where appropriate, an implementing measure laying down ecodesign requirements shall include provisions on the balancing of the various environmental aspects. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).’;

               3.

               Article 16(2) shall be amended as follows:

                           (a)

                           in the introductory wording, the words ‘the procedure laid down in Article 19(2) and’ shall be deleted;

                           (b)

                           the following subparagraph shall be added:
                           ‘Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).’;

               4.

               Article 19(3) shall be replaced by the following:
               ‘3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

         Article 2
   Amendment to Directive 92/42/EEC
   In Article 10a of Directive 92/42/EEC, the words ‘in accordance with Article 19(2) of Directive 2005/32/EC’ shall be replaced by the words ‘in accordance with Article 19(3) of Directive 2005/32/EC’.
   Article 3
   Amendment to Directive 96/57/EC
   In Article 9a of Directive 96/57/EC, the words ‘in accordance with Article 19(2) of Directive 2005/32/EC’ shall be replaced by the words ‘in accordance with Article 19(3) of Directive 2005/32/EC’.
   Article 4
   Amendment to Directive 2000/55/EC
   In Article 9a of Directive 2000/55/EC, the words ‘in accordance with Article 19(2) of Directive 2005/32/EC’ shall be replaced by the words ‘in accordance with Article 19(3) of Directive 2005/32/EC’.
   Article 5
   Entry into force
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 6
   Adressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 11 March 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  OJ C 161, 13.7.2007, p. 45.

      (2)  Opinion of the European Parliament of 11 July 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008.

      (3)  OJ L 191, 22.7.2005, p. 29.

      (4)  OJ L 167, 22.6.1992, p. 17. Directive as last amended by Directive 2005/32/EC.

      (5)  OJ L 236, 18.9.1996, p. 36. Directive as amended by Directive 2005/32/EC.

      (6)  OJ L 279, 1.11.2000, p. 33. Directive as amended by Directive 2005/32/EC.

      (7)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

      (8)  OJ C 255, 21.10.2006, p. 1.


title: Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells  Text with EEA relevance

text:
               9.4.2015

               EN

               Official Journal of the European Union

               L 93/43

         COMMISSION DIRECTIVE (EU) 2015/565
   of 8 April 2015
   amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 (1) on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, and in particular Article 28 thereof,
   Whereas:

               (1)

               Directive 2004/23/EC requires that Member States ensure the traceability of human tissues and cells from the donor to the recipient and vice versa.

               (2)

               In order to facilitate traceability it is necessary to establish a unique identifier applied to tissues and cells distributed in the Union (Single European Code) providing information on the main characteristics and properties of those tissues and cells.

               (3)

               In order to ensure a uniform implementation of the Single European Code throughout the Union, obligations of the Member States competent authorities and of the tissue establishments for the application of the Single European Code should be set out. Only this approach will guarantee a consistent and coherent application of the code in the Union.

               (4)

               Traceability from donor to recipient and vice versa should be ensured through coding of tissues and cells and through accompanying documentation. At the recipient end, the Single European Code provides information on the donation and on the tissue establishment responsible for the procurement of tissues and cells. At the donor end, the tissue establishment responsible for the procurement of tissues and cells may track the tissues and cells distributed for human application by requesting the next operators in the chain to provide data related to the use of the tissues and cells based on the donation identification elements of the Single European Code as contained in the accompanying documentation.

               (5)

               The format of the Single European Code should be harmonised in order to facilitate its application by small and large establishments, whilst allowing some flexibility for establishments to continue using existing codes.

               (6)

               A Single European Code allowing for donation and product identification should be allocated to all tissues and cells distributed for human application, including those imported from third countries. Member States may allow certain exemptions from the application of the code.

               (7)

               Where tissues and cells are excluded or exempted from the application of the Single European Code, the Member States should ensure that appropriate traceability of these tissues and cells is guaranteed throughout the entire chain from donation and procurement to human application.

               (8)

               In situations where tissues and cells are released for circulation, other than for distribution (such as transfer to another operator for further processing with or without return), as a minimum the donation identification sequence should be applied at least in the accompanying documentation. Where tissues and cells are transferred from a tissue establishment to another operator just for storage and/or for further distribution, the tissue establishment may already apply the Single European Code on their final label in addition to the donation identification sequence which should be applied at least in the accompanying documentation.

               (9)

               In the case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across procurements. This may be ensured by developing a central system for the allocation of the unique donation numbers for each donation event recorded at national level, or by requiring all tissue establishments to ensure robust traceability links between the donation identification numbers allocated by each tissue establishment procuring or receiving tissue and cells originating from the same deceased donor.

               (10)

               The Commission should ensure the implementation of the Single European Code by providing the appropriate tools to the Member States competent authorities and tissue establishments. The Member States competent authorities should update the register for tissue establishments, reflecting any changes in tissue establishment accreditations, designations, authorisations, or licences and the Commission should ensure the update of the register of the tissues and cells whenever new products need to be included. For this the Commission should consult a group of experts, in particular experts nominated by the Member States competent authorities.

               (11)

               For the donation identification sequence in the Single European Code, the importing tissue establishment should use the tissue establishment code allocated to it in the EU Tissue Establishment Compendium and should allocate a unique donation number if the donation number on the imported product is not globally unique.

               (12)

               Pooling of tissues or cells is allowed in some Member States. Therefore, the application of the Single European Code in case of pooling is also addressed by this Directive.

               (13)

               A transitional regime for tissues and cells already in storage at the end of the transposition period should be introduced.

               (14)

               This Directive does not prevent Member States from maintaining or introducing more stringent measures relating to coding of tissues and cells, provided that the provisions of the Treaty are met.

               (15)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 29 of Directive 2004/23/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Commission Directive 2006/86/EC (2) is hereby amended as follows:

               (1)

               In Article 2, the following points (k) to (y) are added:

                           ‘(k)

                           “Single European Code” or “SEC” means the unique identifier applied to tissues and cells distributed in the Union. The Single European Code consists of a donation identification sequence and a product identification sequence, as further specified in Annex VII to this Directive;

                           (l)

                           “donation identification sequence” means the first part of the Single European Code consisting of the EU tissue establishment code and the unique donation number;

                           (m)

                           “EU tissue establishment code” means the unique identifier for accredited, designated, authorised, or licensed tissue establishments in the Union. The tissue establishment code consists of an ISO country code and the tissue establishment number set out in the EU Tissue Establishment Compendium, as further specified in Annex VII to this Directive;

                           (n)

                           “unique donation number” means the unique number attributed to a specific donation of tissues and cells in line with the system in place in each Member State for allocating such numbers, as further specified in Annex VII to this Directive;

                           (o)

                           “product identification sequence” means the second part of the Single European Code consisting of the product code, the split number and the expiry date;

                           (p)

                           “product code” means the identifier for the specific type of tissue and cell in question. The product code consists of the product coding system identifier indicating the coding system used by the tissue establishment (“E” for the EUTC, “A” for ISBT128, “B” for Eurocode) and the tissues and cells product number foreseen in the respective coding system for the product type, as further defined in Annex VII to this Directive;

                           (q)

                           “split number” means the number which distinguishes and uniquely identifies tissues and cells having the same unique donation number and the same product code and originating from the same tissue establishment, as further defined in Annex VII to this Directive;

                           (r)

                           “expiry date” means the date by which the tissues and cells can be applied, as further defined in Annex VII to this Directive;

                           (s)

                           “EU Coding Platform” means the IT platform hosted by the Commission which contains the EU Tissue Establishment Compendium and the EU Tissue and Cell Product Compendium;

                           (t)

                           “EU Tissue Establishment Compendium” means the register of all tissue establishments which are authorised, licensed, designated or accredited by the Member States' competent authority or authorities and which contains the information about these tissue establishments as set out in Annex VIII to this Directive;

                           (u)

                           “EU Tissue and Cell Product Compendium” means the register of all types of tissues and cells circulating in the Union and the respective product codes under the three permitted coding systems (EUTC, ISBT128 and Eurocode);

                           (v)

                           “EUTC” means the product coding system for tissues and cells developed by the Union consisting of a register of all types of tissues and cells circulating in the Union and their corresponding product codes.

                           (w)

                           “released for circulation” means distribution for human application or transfer to another operator, e.g. for further processing with or without return.

                           (x)

                           “within the same centre” means that all steps from procurement to human application are carried out under the same responsible person, quality management system and traceability system, within a healthcare centre comprising at least an accredited, designated, authorised, or licensed tissue establishment and an organisation responsible for human application at the same location;

                           (y)

                           “pooling” means the physical contact or mixing in a single container, of tissues or cells from more than one procurement from the same donor, or from two or more donors.’

               (2)

               Article 9 is replaced by the following:
               ‘Article 9
               Traceability
               1.   Member States shall ensure that tissues and cells shall be traceable in particular through documentation and the use of the Single European Code from procurement to human application or disposal and vice versa. Tissues and cells used for advanced therapy medicinal products shall be traceable under this Directive at least until transferred to the ATMP manufacturer.
               2.   Member States shall ensure that tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, using an appropriate and readable storage medium.
               3.   In case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across the procurements.’

               (3)

               Article 10 is replaced by the following:
               ‘Article 10
               European coding system
               1.   Without prejudice to paragraphs 2 or 3 of this Article, a Single European Code shall be applied to all tissues and cells distributed for human application. For the other situations where tissues and cells are released for circulation, as a minimum the donation identification sequence shall be applied at least in the accompanying documentation.
               2.   Paragraph 1 shall not apply to:

                           (a)

                           reproductive cells from partner donation;

                           (b)

                           tissues and cells distributed directly for immediate transplantation to the recipient, as referred to in Article 6(5) of Directive 2004/23/EC;

                           (c)

                           tissues and cells imported into the Union in case of emergency authorised directly by the competent authority or authorities, as referred to in Article 9(3)b of Directive 2004/23/EC.

                     3.   Member States may also allow exemptions from the requirement provided for in paragraph 1 for:

                           (a)

                           tissues and cells other than reproductive cells for partner donation, when these tissues and cells remain within the same centre;

                           (b)

                           tissues and cells that are imported into the Union, when these tissues and cells remain within the same centre from importation to application, provided that the centre comprises a tissue establishment authorised, designated, accredited, or licensed to carry out importing activities.’

               (4)

               The following Articles are inserted:
               ‘Article 10a
               Format of the Single European Code
               1.   The Single European Code referred to in Article 10(1) shall comply with the specifications set out in this Article and in Annex VII.
               2.   The Single European Code shall be in eye-readable format and shall be preceded by the acronym “SEC”. The parallel use of other labelling and traceability systems is possible.
               3.   The Single European Code shall be printed with the Donation Identification Sequence and Product Identification Sequence separated by a single space or as two successive lines.
               Article 10b
               Requirements related to the application of the Single European Code
               1.   Member States shall ensure that the following minimum requirements are complied with by tissue establishments, including importing tissue establishments as defined by Commission Directive (EU) 2015/566 (3):

                           (a)

                           allocate a Single European Code to all tissues and cells requiring application of this code at the latest before their distribution for human application;

                           (b)

                           allocate a donation identification sequence after procuring the tissues and cells, or when receiving them from a procurement organisation, or when importing tissues and cells from a third country supplier. The donation identification sequence shall include:

                                       (1)

                                       their EU tissue establishment code as assigned in the EU Tissue Establishment Compendium;

                                       (2)

                                       a unique donation number allocated by the tissue establishment, unless such number is allocated centrally at national level or is a globally unique number as used by the ISBT128 coding system. Where allowed, in case of pooling of tissues and cells, a new donation identification number shall be allocated to the final product; traceability with the individual donations shall be ensured by the tissue establishment in which pooling is carried out;

                           (c)

                           do not alter the donation identification sequence once it is allocated to tissues and cells released for circulation, unless it is necessary to correct an encoding error; any correction requires proper documentation;

                           (d)

                           use one of the permitted product coding systems and the corresponding tissue and cell product numbers included in the EU Tissue and Cell Product Compendium at the latest before their distribution for human application;

                           (e)

                           use an appropriate split number and expiry date. For tissues and cells for which no expiry date is defined, the expiry date shall be 00000000 at the latest before their distribution for human application;

                           (f)

                           apply the Single European Code on the label of the product concerned in an indelible and permanent manner and mention that code in the relevant accompanying documentation at the latest before its distribution for human application. The tissue establishment may entrust this task to a third party or third parties, provided the tissue establishment ensures compliance with this Directive, in particular in terms of uniqueness of the code. Where the label size precludes the application of the Single European Code on the label, the code shall be unambiguously linked to tissues and cells packaged with such a label through the accompanying documentation;

                           (g)

                           notify the competent authority or authorities when:

                                       (1)

                                       information contained in the EU Tissue Establishment Compendium requires an update or correction;

                                       (2)

                                       the EU Tissue and Cell Product Compendium requires an update;

                                       (3)

                                       the tissue establishment observes a situation of significant non-compliance with the requirements relating to the Single European Code concerning tissues and cells received from other EU tissue establishments;

                           (h)

                           take the necessary measures in case of incorrect application of the Single European Code on the label.

                     2.   Member States shall ensure that the following minimum requirements are applied by all competent authorities:

                           (a)

                           ensure the allocation of a unique tissue establishment number to all tissue establishments authorised, accredited, designated or licensed in its Member State. If a tissue establishment has different physical locations, but has one system for allocating unique donation numbers, it may be deemed to be one and the same tissue establishment. If a tissue establishment uses two or more systems to allocate unique donation numbers, such an entity shall be allocated separate tissue establishment numbers corresponding to the number of allocation systems used;

                           (b)

                           decide which system or systems shall be used for the allocation of unique donation numbers in their Member State. Permitted systems of allocation include national systems establishing centralised allocation of the nationally unique donation number or systems requiring each tissue establishment to allocate unique donation numbers or international systems that allocate globally unique donation numbers that are compatible with the Single European Code.

                           (c)

                           monitor and enforce the full implementation of the Single European Code in their Member State;

                           (d)

                           ensure the validation of the data on the tissue establishments contained in the EU Tissue Establishment Compendium for their Member State and update the Compendium without undue delay in particular in the following situations:

                                       (1)

                                       when a new tissue establishment is authorised, designated, accredited, or licensed;

                                       (2)

                                       when tissue establishment information changes or is not correctly recorded in the EU Tissue Establishment Compendium;

                                       (3)

                                       when the accreditation, designation, authorisation or licence details of a tissue establishment, as listed in Annex VIII to this Directive, change, including:

                                                   —

                                                   accreditation, designation, authorisation or licence for a new tissue or cell type,

                                                   —

                                                   accreditation, designation, authorisation or licence for a new prescribed activity,

                                                   —

                                                   details of any conditions and or exemptions added to an authorisation,

                                                   —

                                                   suspension, in part or in full, of a specific accreditation, designation, authorisation or licence for a particular activity or tissue or cell type;

                                                   —

                                                   revocation, in part or in full, of an accreditation, designation, authorisation or licence for a tissue establishment,

                                                   —

                                                   situations when a tissue establishment voluntarily ceases, in part or in full, the activity or activities for which it is authorised, accredited, designated or licensed.

                                 Without undue delay means in not later than 10 working days for any changes substantially affecting the authorisation, accreditation, designation or licence of the tissue establishments concerned.
                           When a tissue establishment is authorised by two or more competent authorities for different types of tissues and cells or different activities, each competent authority shall update the information relating to those activities for which it is responsible;

                           (e)

                           Alert the competent authorities of another Member State when they observe incorrect information in the EU Tissue Establishment Compendium relating to the other Member State or when they observe a situation of significant non-compliance with the provisions relating to the Single European Code relating to the other Member State;

                           (f)

                           Alert the Commission and the other Competent Authorities when in their assessment the EU Tissue and Cell Product Compendium requires an update.

                     3.   The application of the Single European Code does not preclude the additional application of other codes in accordance with Member States' national requirements.
               Article 10c
               Accessibility and maintenance of the European coding system
               1.   The Commission shall host and maintain an IT platform (“EU Coding Platform”) which contains:

                           (a)

                           the EU Tissue Establishment Compendium;

                           (b)

                           the EU Tissue and Cell Product Compendium.

                     2.   The Commission shall ensure that the information contained in the EU Coding Platform is publicly available before 29 October 2016.
               3.   The Commission shall update when needed the EUTC and ensure the overall update of the EU Tissue and Cell Product Compendium. The Commission considers that it is necessary that agreements are established with the organisations managing ISBT128 and Eurocode to ensure that updated product codes are regularly made available to the Commission for inclusion in the EU Tissue and Cell Product Compendium. If such organisations do not comply with the terms of the memoranda of understanding, the Commission may suspend, partially or in full, the future use of their respective product codes, having considered the sufficient supply of the concerned type of products in the Member States including a transitional period and having consulted the Member State experts through the Competent Authorities on Substances of Human Origin Expert Group.
               Article 10d
               Transitional period
               Tissues and cells already in storage on 29 October 2016 shall be exempted from the obligations relating to the Single European Code, provided the tissues and cells are released for circulation in the Union within five years following that date and under the condition that full traceability is ensured by alternative means. For tissues and cells which remain in storage and which are only released for circulation after the expiry of this five-year period and for which the application of the Single European Code is not possible, in particular because the tissues and cells are stored under deep-freeze conditions, the tissue establishments shall use the procedures applicable to products with small labels as laid down in Article 10b paragraph 1(f).

                  (3)  Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissue (OJ L 93, 9.4.2015, p. 56).’"

               (5)

               The Annexes are amended in accordance with Annex I to this Directive.

               (6)

               A new Annex VIII is added, the text of which is set out in Annex II to this Directive.

         Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 October 2016 at the latest. They shall forthwith communicate to the Commission the text of those provisions. They shall apply the legislation from 29 April 2017.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 8 April 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 102, 7.4.2004, p. 48.

      (2)  Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32).

      ANNEX I
      The Annexes to Directive 2006/86/EC are amended as follows:

                  (1)

                  Annex II, Part E, is amended as follows:

                              (a)

                              in point 1 the following point (g) is added:

                                          ‘(g)

                                          Single European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application’

                                    ;

                              (b)

                              the second subparagraph of point 1 is replaced by the following:
                              ‘If any of the information under points (d), (e) and (g) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container. This sheet must be packaged with the primary container in a manner that ensures that they remain together.’;

                              (c)

                              in point 2, the following point (j) is added:

                                          ‘(j)

                                          for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country)’

                                    .

                  (2)

                  Annexes III and IV are replaced by the following:‘
                     ANNEX III

                        NOTIFICATION OF SERIOUS ADVERSE REACTIONS

                     PART A

                        Rapid notification for suspected serious adverse reactions

                     Tissue establishment
                     EU tissue establishment code (if applicable)
                     Report identification
                     Reporting date (year/month/day)
                     Individual affected (recipient or donor)
                     Date and place of procurement or human application (year/month/day)
                     Unique donation identification number
                     Date of suspected serious adverse reaction (year/month/day)
                     Type of tissues and cells involved in the suspected serious adverse reaction
                     Single European Code of tissues or cells involved in the suspected serious adverse reaction (if applicable)
                     Type of suspected serious adverse reaction(s)
                     PART B

                        Conclusions of Serious Adverse Reactions Investigation

                     Tissue establishment
                     EU tissue establishment code (if applicable)
                     Report identification
                     Confirmation date (year/month/day)
                     Date of serious adverse reaction (year/month/day)
                     Unique donation identification number
                     Confirmation of serious adverse reaction (Yes/No)
                     Single European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)
                     Change of type of serious adverse reaction (Yes/No) If YES, specify
                     Clinical outcome (if known)

                                 —

                                 Complete recovery

                                 —

                                 Minor sequelae

                                 —

                                 Serious sequelae

                                 —

                                 Death

                           Outcome of the investigation and final conclusions
                     Recommendations for preventive and corrective actions

                     ANNEX IV

                        NOTIFICATION OF SERIOUS ADVERSE EVENTS

                     PART A

                        Rapid notification for suspected serious adverse events

                                 Tissue establishment

                                 EU tissue establishment code (if applicable)

                                 Report identification

                                 Reporting date (year/month/day)

                                 Date of serious adverse event (year/month/day)

                                 Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in:

                                 Specification

                                 Tissues and cells defect

                                 Equipment failure

                                 Human error

                                 Other (specify)

                                 Procurement

                                 Testing

                                 Transport

                                 Processing

                                 Storage

                                 Distribution

                                 Materials

                                 Others (specify)

                           PART B

                        Conclusions of Serious Adverse Events investigation

                     Tissue establishment
                     EU tissue establishment code (if applicable)
                     Report identification
                     Confirmation date (year/month/day)
                     Date of serious adverse event (year/month/day)
                     Root cause analysis (details)
                     Corrective measures taken (details)
                  ’

                  (3)

                  Annexes VI and VII are replaced by the following:‘
                     ANNEX VI

                        Minimum data to be kept in accordance with Article 9(2)

                     A.   BY TISSUE ESTABLISHMENTS

                                 (1)

                                 Donor identification

                                 (2)

                                 Donation identification that will include at least:

                                             —

                                             Identification of the procurement organisation (including contact details) or the tissue establishment

                                             —

                                             Unique donation number

                                             —

                                             Date of procurement

                                             —

                                             Place of procurement

                                             —

                                             Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)

                                 (3)

                                 Product identification that will include at least:

                                             —

                                             Identification of the tissue establishment

                                             —

                                             Type of tissue and cell/product (basic nomenclature)

                                             —

                                             Pool number (in case of pooling)

                                             —

                                             Split number (if applicable)

                                             —

                                             Expiry date (if applicable)

                                             —

                                             Tissue/cell status (i.e. quarantined, suitable for use, etc.)

                                             —

                                             Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety.

                                             —

                                             Identification of the facility issuing the final label

                                 (4)

                                 Single European Code (if applicable)

                                 (5)

                                 Human application identification that will include at least:

                                             —

                                             Date of distribution/disposal

                                             —

                                             Identification of the clinician or end-user/facility

                           B.   BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION

                                 (1)

                                 Identification of the supplier tissue establishment

                                 (2)

                                 Identification of the clinician or end-user/facility

                                 (3)

                                 Type of tissues and cells

                                 (4)

                                 Product identification

                                 (5)

                                 Identification of the recipient

                                 (6)

                                 Date of application

                                 (7)

                                 Single European Code (if applicable)

                     ANNEX VII

                        THE STRUCTURE OF THE SINGLE EUROPEAN CODE

                                    DONATION IDENTIFICATION SEQUENCE

                                    PRODUCT IDENTIFICATION SEQUENCE

                                 EU TISSUE ESTABLISHMENT CODE

                                 UNIQUE DONATION NUMBER

                                 PRODUCT CODE

                                 SPLIT NUMBER

                                 EXPIRY DATE
                                 (YYYYMMDD)

                                 ISO country code

                                 Tissue establishment number

                                 Product Coding System identifier

                                 Product number

                                 2 alphabetic characters

                                 6 alpha-numeric characters

                                 13 alpha-numeric characters

                                 1 alphabetic character

                                 7 alpha-numeric characters

                                 3 alpha-numeric characters

                                 8 numeric characters

                           ’

      ANNEX II

            ‘ANNEX VIII

               Data to be recorded in the EU Tissue Establishment Compendium

            A.   Tissue establishment information

                        1.

                        Name of the tissue establishment

                        2.

                        National or international code of tissue establishment

                        3.

                        Name of the organisation in which the tissue establishment is located (if applicable)

                        4.

                        Address of the tissue establishment

                        5.

                        Publishable contact details: functional e-mail address, phone and fax

                  B.   Details on the authorisation, accreditation, designation, or license of the tissue establishment

                        1.

                        Name of the authorising, accrediting, designating or licensing competent authority or authorities

                        2.

                        Name of the national competent authority or authorities responsible for maintenance of the EU Tissue Establishment Compendium

                        3.

                        Name of the authorisation, accreditation, designation or licence holder (if applicable)

                        4.

                        Tissues and cells for which the authorisation, accreditation, designation or license was granted

                        5.

                        Activities actually carried out for which the authorisation, accreditation, designation or licence was granted

                        6.

                        Status of the authorisation, accreditation, designation or license (authorised, suspended, revoked, in part or in full, voluntary cessation of activities)

                        7.

                        Details of any conditions and exemptions added to the authorisation (if applicable).’


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31992L0019

Commission Directive 92/19/EEC of 23 March 1992 amending Directive 66/401/EEC on the marketing of fodder plant seed

Official Journal L 104 , 22/04/1992 P. 0061 - 0062 Finnish special edition: Chapter 3 Volume 41 P. 0218  Swedish special edition: Chapter 3 Volume 41 P. 0218

COMMISSION DIRECTIVE 92/19/EEC  of 23 March 1992  amending Directive 66/401/EEC on the marketing of fodder plant seedTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 90/654/EEC (2), and in particular Article 2 (1a) thereof,  Whereas in the light of the development of scientific and technical knowledge concerning the hybrids resulting from the crossing of species covered by Directive 66/401/EEC, the hybrids resulting from the crossing of Festuca pratensis Huds. with Lolium  multiflorum Lam. should, owing to their increased importance in the Community, be included in the scope of the said Directive;  Whereas in the light of the development of scientific and technical knowledge, Annexes II and III to the said Directive should be amended in order to adapt the conditions to be satisfied by the seed and the lot and sample weights of Festulolium species;   Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 66/401/EEC is hereby amended as follows:  1. The following is added to Article 2 (1) (A) (a):  'This definition shall also cover the following hybrid resulting from the crossing of species referred to above.   Festuca pratensis Huds. × Lolium multiflorum Lam.  Hybrid resulting from the crossing of tall fescue with Italian ryegrass (including Westerworld ryegrass) (× Festulolium) '. 2. In Article 3 (1), '× Festulolium' is inserted after 'Festuca  rubra L.'  3. In Annex I.3 'or x Festulolium' shall appear each time after 'Lolium species'.  4. In Annex II.I.2.A the following is inserted after 'Festuca rubra L.':                   1  2  3  4  5  6  7  8  9  10  11  12  13  14  15                  '× Festulolium  75 (a)   96  1,5  1,0  0,5  0,3     0  0 (j) (k)   5 (n)' 5. In Annex II.II.2.A the following is inserted after 'Festuca rubra L.':            1  2  3  4  5  6  7  8           '× Festulolium  0,3  20 (a)  2  5  5   (j)' 6. In Annex III the following is inserted after 'Festuca rubra L.':        1  2  3  4       '× Festulolium  10  200  60'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1992. They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 23 March 1992. For the Commission  Ray MAC SHARRY  Member of the Commission   (1) OJ No 125, 11. 7. 1966, p. 2298/66. (2) OJ No L 353, 17. 12. 1990, p. 48.


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32004L0020

Commission Directive 2004/20/EC of 2 March 2004 amending Council Directive 91/414/EEC to include chlorpropham as an active substance (Text with EEA relevance)

Official Journal L 070 , 09/03/2004 P. 0032 - 0034

Commission Directive 2004/20/ECof 2 March 2004amending Council Directive 91/414/EEC to include chlorpropham as an active substance(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes chlorpropham.(2) For chlorpropham, the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. Pursuant to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(3), the Netherlands was designated as rapporteur Member State. The Netherlands submitted the relevant assessment report and recommendations to the Commission on 30 April 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(3) This assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.(4) The review was finalised on 28 November 2003 in the format of the Commission review report for chlorpropham.(5) The review for chlorpropham did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(6) It has appeared from the various examinations made that plant protection products containing chlorpropham may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include chlorpropham in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing chlorpropham can be granted in accordance with the provisions of that directive.(7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.(8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing chlorpropham, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC.(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 31 July 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.They shall apply those provisions from 1 August 2005.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 31. Member States shall review the authorisation for each plant protection product containing chlorpropham to ensure that the conditions relating to chlorpropham set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 31 July 2005 at the latest, they shall amend or withdraw the authorisation.2. Member States shall, for each authorised plant protection product containing chlorpropham as either the only active substance or as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 January 2005 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 January 2009 at the latest, they shall amend or withdraw the authorisation.Article 4This Directive shall enter into force on 1 February 2005.Article 5This Directive is addressed to the Member States.Done at Brussels, 2 March 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2003/119/EC (OJ L 325, 12.12.2003, p. 41).(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regulation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).ANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:">TABLE>"


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31980L1107

Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work

Official Journal L 327 , 03/12/1980 P. 0008 - 0013 Finnish special edition: Chapter 5 Volume 2 P. 0126  Greek special edition: Chapter 05 Volume 4 P. 0042  Swedish special edition: Chapter 5 Volume 2 P. 0126  Spanish special edition: Chapter 05 Volume 2 P. 0224  Portuguese special edition Chapter 05 Volume 2 P. 0224

COUNCIL DIRECTIVE  of 27 November 1980  on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work  (80/1107/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1), drafted following consultation with the Advisory Committee on Safety, Hygiene and Health Protection at work,  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the Council resolution of 29 June 1978 on an action programme of the European Communities on safety and health at work (4), provides for the harmonization of provisions and measures regarding the protection of workers with respect to chemical, physical and biological agents ; whereas efforts must therefore be made towards approximation, while the improvement is being maintained, of the laws, regulations and administrative provisions of the Member States in accordance with Article 117 of the Treaty;  Whereas certain differences are revealed by an examination of the measures taken by Member States to protect workers from the risks related to exposure to chemical, physical and biological agents at work ; whereas, therefore, in the interests of balanced development, these measures, which directly affect the functioning of the common market, should be approximated and improved ; whereas this approximation and improvement should be based on common principles;  Whereas the said protection should as far as possible be ensured by measures to prevent exposure or keep it at as low a level as is reasonably practicable;  Whereas to this end it is appropriate that the Member States should, when they adopt provisions in this field, comply with a set of requirements, including in particular the laying down of limit values ; whereas an initial list of agents may be adopted in this Directive for the application of further more specific requirements ; whereas the Member States will determine whether and to what extent each of these requirements is applicable to the agent concerned;  Whereas provision should be made, within the time limits set by this Directive, for the implementation, in respect of a limited number of agents, of provisions to ensure, for the workers concerned, appropriate surveillance of their state of health during exposure and the provision of appropriate information;  Whereas the Council will lay down the limit values and other specific requirements for certain agents in individual Directives;  Whereas certain technical aspects concerning the specific requirements established in the individual directives can be reviewed in the light of experience and progress made in the technical and scientific fields;  (1)OJ No C 89, 5.4.1979, p. 6. (2)OJ No C 59, 10.3.1980, p. 73. (3)OJ No C 297, 28.11.1979, p. 5. (4)OJ No C 165, 11.7.1978, p. 1.   Whereas representatives of employers and workers have a role to play in the protection of workers;  Whereas, since the Hellenic Republic is to become a member of the European Economic Community on the 1 January 1981 in accordance with the 1979 Act of Accession, it should be granted a longer period in which to implement this Directive so as to enable it to set up the necessary legislative, social and technical structures, in particular those concerning consultation of both sides of industry, the setting up of a system for monitoring the health of workers as well as the supervision of such implementation,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. The aim of this Directive is the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise at work from exposure to chemical, physical and biological agents considered harmful.  2. This Directive shall not apply to:    - workers exposed to radiation covered by the Treaty establishing the European Atomic Energy Community,       - sea transport,       - air transport.          Article 2 For the purposes of this Directive:    (a) "agent" means any chemical, physical or biological agent present at work and likely to be harmful to health;       (b) "worker" means any employed person exposed or likely to be exposed to such agents at work;       (c) "limit value" means the exposure limit or biological indicator limit in the appropriate medium, depending on the agent.          Article 3 1. In order that the exposure of workers to agents be avoided or kept at as low a level as is reasonably practicable, Member States shall, when they adopt provisions for the protection of workers, concerning an agent, take:    - the measures set out in Article 4,       - the additional measures set out in Article 5, where the agent appears in the initial list in Annex I.         2. For the purposes of paragraph 1, the Member States shall determine the extent, if any, to which each of the measures provided for in Articles 4 and 5 is to apply, taking into account the nature of the agent, the extent and duration of the exposure, the gravity of the risk and the available knowledge concerning it, together with the degree of urgency of the measures to be adopted.  3. Member States shall adopt the measures necessary to ensure:    - in the case of the agents listed in Annex II, Part A, appropriate surveillance of the state of health of workers during the period of exposure,       - in the case of the agents listed in Annex II, Part B, access for workers and/or their representatives at the place of work to appropriate information on the dangers which these agents present.         4. The adoption of the measures referred to in paragraph 3 by the Member States shall not oblige them to apply paragraphs 1 and 2.   Article 4 The measures referred to in the first indent of Article 3 (1) shall be:    1. limitation of the use of the agent at the place of work;       2. limitation of the number of workers exposed or likely to be exposed;       3. prevention by engineering control;       4. establishment of limit values and of sampling procedures, measuring procedures and procedures for evaluating results;       5. protection measures involving the application of suitable working procedures and methods;       6. collective protection measures;       7. individual protection measures, where exposure cannot reasonably be avoided by other means;       8. hygiene measures;       9. information for workers on the potential risks connected with their exposure, on the technical preventive measures to be observed by workers, and on the precautions taken by the employer and to be taken by workers;        10. use of warning and safety signs;       11. surveillance of the health of workers;       12. keeping updated records of exposure levels, lists of workers exposed and medical records;       13. emergency measures for abnormal exposures;       14. if necessary, general or limited ban on the agent, in cases where use of the other means available does not make it possible to ensure adequate protection.          Article 5 The additional measures referred to in the second indent of Article 3 (1) shall be:    1. providing medical surveillance of workers prior to exposure and thereafter at regular intervals. In special cases, it shall be ensured that a suitable form of health surveillance is available to workers who have been exposed to the agent, after exposure has ceased;       2. access by workers and/or their representatives at the place of work to the results of exposure measurements and to the anonymous collective results of the biological tests indicating exposure when such tests are provided for;       3. access by each worker concerned to the results of his own biological tests indicating exposure;       4. informing workers and/or their representatives at the place of work where the limit values referred to in Article 4 are exceeded, of the causes thereof and of the measures taken or to be taken in order to rectify the situation;       5. access by workers and/or their representatives at the place of work to appropriate information to improve their knowledge of the dangers to which they are exposed.          Article 6 Member States shall see to it that:    - workers' and employers' organizations are consulted before the provisions for the implementation of the measures referred to in Article 3 are adopted and that workers' representatives in the undertakings or establishments, where they exist, can check that such provisions are applied or can be involved in their application,       - any worker temporarily suspended on medical grounds in accordance with national laws or practices from exposure to the action of an agent is, where possible, provided with another job,       - the measures adopted in implementation of this Directive are consistent with the need to protect public health and the environment.          Article 7 This Directive and the individual Directives referred to in Article 8 shall not prejudice the right of Member States to apply or introduce laws, regulations or administrative provisions ensuring greater protection for workers.   Article 8 1. In the individual Directives which it adopts on the agents listed in Annex I, the Council shall, acting on a proposal from the Commission, lay down the limit value or values and the other specific requirements applicable.  2. The titles of the individual Directives shall include serial numbers.  3. Adaptation to technical progress in accordance with the procedure in Article 10 shall be restricted to the technical aspects listed in Annex III under the conditions laid down in the individual Directives.   Article 9 1. With a view to the adaptation to technical progress referred to in Article 8 (3) a committee is hereby established consisting of representatives of the Member States and presided over by a representative of the Commission.  2. The Committee shall draw up its own rules of procedure.   Article 10 1. Where the procedure laid down in this Article is invoked, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.  2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on this draft within a time limit which the chairman may set according to the urgency of the matter. Decisions shall be taken by a majority of 41 votes, the votes of Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.   3.    (a) The Commission shall take the proposed measures where they are in accordance with the opinion of the Committee.       (b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is delivered the Commission shall without delay propose to the Council the measures to be taken. The Council shall act by a qualified majority.       (c) If the Council has not acted within three months of receiving the proposal, the proposed measures shall be adopted by the Commission.         Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within a period of three years of its notification and shall forthwith inform the Commission thereof.  However, in the case of Article 3 (3), first indent, this period shall be four years.  In derogation from the above provisions, the time limits laid down in the first and second subparagraphs shall be four and five years respectively in the case of the Hellenic Republic.  2. Member States shall communicate to the Commission the provisions of the national law which they adopt in the field governed by this Directive.   Article 12 This Directive is addressed to the Member States.     Done at Brussels, 27 November 1980.  For the Council  The President  J. SANTER     ANNEX I List of agents referred to in Article 3 (1), second indent, and Article 8 (1)  Acrylonitrile  Asbestos  Arsenic and compounds  Benzene  Cadmium and compounds  Mercury and compounds  Nickel and compounds  Lead and compounds  Chlorinated hydrocarbons : - chloroform    - paradichlorobenzene       - carbon tetrachloride          ANNEX II  A. List of agents referred to in Article 3 (3), first indent      1. Asbestos           2. Lead and compounds             B. List of agents referred to in Article 3 (3), second indent      1. Asbestos           2. Arsenic and compounds           3. Cadmium and compounds           4. Mercury and compounds           5. Lead and compounds              ANNEX III Technical aspects referred to in Article 8 (3)    1. Sampling procedures and measuring methods (including quality control) with respect to the limit values in so far as such procedures and methods have no effect on the quantitative significance of those limit values.       2. Practical recommendations on medical surveillance before and during exposure and after such exposure has ceased and keeping of records. on the results of such medical surveillance.       3. Practical procedures regarding the establishment and keeping of records concerning ambient measurement results and lists of exposed workers.       4. Practical recommendations for alarm systems to be installed at workplaces where abnormal exposures are likely to occur.       5. Practical recommendations for emergency measures to be taken in the event of abnormal emissions.       6. Collective and individual protection measures for certain operations (e.g. servicing and repairs) during which it cannot be guaranteed that concentrations or intensities of the agents will be kept below the limit values.       7. Procedures regarding general hygiene requirements, and means of ensuring personal hygiene.       8. Signs to identify areas where significant exposure is likely to occur and to indicate the precautions which have to be taken.


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31992L0038

Council Directive 92/38/EEC of 11 May 1992 on the adoption of standards for satellite broadcasting of television signals

Official Journal L 137 , 20/05/1992 P. 0017 - 0020

COUNCIL DIRECTIVE 92/38/EEC  of 11 May 1992  on the adoption of standards for satellite broadcasting of television signalsTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 3 of Council Directive 86/529/EEC of 3 November 1986 on the adoption of common technical specifications of the MAC/packet family of standards for direct satellite television broadcasting (4) made provision for the adoption of measures to  replace that Directive;  Whereas the Community, through Decision 89/337/EEC (5) and Decision 89/630/EEC (6), recognized the strategic importance of high-definition television (HDTV) for the European consumer electronics industry and for the European television and film  industries, and established the strategy framework for the introduction of HDTV services in Europe;  Whereas Directive 86/529/EEC, in particular in Article 2, established a dual regime by limiting the application of the Directive to one type of satellite, and, as a result, a dual market appeared with the use of MAC standards in broadcasting satellite  service (BSS) and mainly PAL and Secam in fixed satellite service (FSS); whereas this should be avoided in the future in order to prevent a split in the satellite market;  Whereas, in order to reach Community goals as set out in the abovementioned Decisions and to contribute to the achievement of an internal market, as provided for in Article 8 (a) of the Treaty, in satellite broadcasting of television signals, it is  necessary to take steps to create a convergence of standards, using in parallel a regulatory instrument and an agreement between major actors in the market;  Whereas it is in the best interests of European consumers to follow a path towards HDTV based on the criteria of compatibility and evolution, in order to avoid discontinuities and duplication of investments;  Whereas HD-MAC has been developed as the European transmission standard for HDTV services based on those criteria of compatibility and evolution and D2-MAC offers the best available path towards the development of HDTV with wide-screen 16: 9 D2-MAC as  the main step in that direction;  Whereas there is a need to establish common standards for satellite transmission as an enabling element for effective free-market competition, taking into account the fact that standards promote competitiveness by lowering costs for producers, shaping  customer preferences for products by their familiarity and giving rise to the emergence of new markets, particularly for developing technologies, where they are becoming a pre-condition for industrial production or marketing;  Whereas services for satellite television broadcasting using 4: 3 aspect ratio format should not be forced to a compulsory stop or change so as not to jeopardize the present market or inconvenience users; whereas, however, incentives may be provided,  through a parallel legal instrument, in order to support, in addition, the use of the D2-MAC standard, in particular in 16: 9 format, inter alia through simultaneous transmissions ('simulcast');  Whereas it is important that, from a certain date on, new services, that is to say services that are not extensions of existing services, will transmit in the D2-MAC norm;  Whereas it is vital to ensure that audiovisual programmes adapted to the new 16: 9 format are available in sufficient quantity and quality and provide therefore, where appropriate, through a parallel legal instrument, for Community financial incentives;   Whereas, in the medium term, the capacity of satellite systems is limited and, as a result, the scope for the simulcast transmissions of programmes in different standards is also limited; it will be necessary to make a selection of programmes for such  transmissions;  Whereas satellite television transmissions not receivable within the Community by domestic satellite receiving equipment and occasional transmissions are not covered by the obligations of this Directive;  Whereas, in the interests of the consumer, it is necessary to establish a common conditional access system compatible with D2-MAC and HD-MAC, without hampering the technological development of these systems; whereas, therefore, the best solution is a  system consisting of a common-access unit to which one or more smart cards can be added;  Whereas the Commission has expressed its intention to issue a mandate to a European standardization organization for the development of a European standard for conditional access to encrypted satellite broadcasts;  Whereas the said standard shall in principle allow for the use of more than one conditional-access encryption system, subject to the following objectives:  - that the standard shall incorporate, or refer to, a standard for a consumer conditional-access unit,  - that any conditional-access encryption system conforming to the standard shall be fully compatible with the abovementioned consumer access unit,  - that the standard shall be backwards compatible with equipment placed on the market prior to the adoption of this Directive for use with any system fully compatible with D2-MAC,  - that the standards shall allow for the updating of encryption methods from time to time without replacement or modification of the consumer conditional-access unit;  Whereas cable TV networks and their technical capabilities as defined by the Member States are a relevant feature in the television infrastructure of many Member States and will be of crucial importance to the future of HDTV services;  Whereas master antenna systems as defined by Member States are not affected by this Directive;  Whereas Decision 89/337/EEC called for an action plan for the introduction of HDTV to be prepared in close coordination at Community level between the Commission, the Member States and the European industry;  Whereas it is essential that there should be complete agreement between broadcasters, satellite operators, manufacturers and cable operators on the introduction, as soon as possible, of 16: 9 D2-MAC services in conformity with the objectives set out in  Decision 89/337/EEC; whereas such agreement might be reached by means of a Memorandum of Understanding;  Whereas the said Memorandum of Understanding will set out the obligations of the respective parties for the development and promotion of 16: 9 D2-MAC services in Europe in accordance with the terms and provisions of this Directive and will constitute an  integral part of the overall strategy for the introduction of HDTV;  Whereas European research efforts must remain in the forefront of all new significant developments, such as a trend towards digital television broadcasting emissions; whereas Europe has to consolidate its research efforts through collaboration and in  the framework of Community research programmes;  Whereas a strategy for the introduction of HDTV has been laid down at Community level and European undertakings have made significant investments involving many jobs;  Whereas, in view of the foreseeable technical progress in this sector, account should now be taken of any subsequent developments of the existing systems and provision made for an eventual review of this Directive;  Whereas it is in the general interest, as well as in the interest of the major actors in the market, that this Directive should be put into application at the earliest possible date;  Whereas it is necessary to evaluate this Directive at regular intervals; whereas such evaluation should take into account all relevant market factors, including the services at the time of the evaluation,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Member States shall take all appropriate measures to promote and support the introduction and development of advanced satellite broadcasting services for television programmes, using the HD-MAC standard for not completely digital  high-definition television transmission and the D2-MAC standard for other not completely digital transmission in the 16: 9 aspect ratio format.  Article 2  1. For any transmission of a television service in the high-definition television format that is not completely digital, only the HD-MAC standard may be used.  Completeley digital transmissions receivable by viewers using domestic satellite receiving equipment, even if such transmissions are intended to be redistributed by cable networks, may use only a system standardized by the European Telecommunications  Standards Institute (ETSI) but are otherwise not covered by this Directive.  2. For any not completely digital transmission of a 625 line satellite television service receivable by viewers using domestic satellite receiving equipment, even if such transmissions are intended to be redistributed by cable networks:  - in respect of any service in the 16: 9 aspect ratio format, only the D2-MAC standard may be used,  - in respect of any other service starting after 1 January 1995, the D2-MAC standard must be used. These services may also be transmitted simultaneously in PAL, SECAM or D-MAC. This provision will take effect only three months after adoption by the  Council of a proposal from the Commission, based on the appropriate Article of the Treaty, to provide financial support for the said services.  Article 3  As regards services other than those referred to in Article 2, efforts geared to the widespread introduction up to 1 January 1995 of transmissions using the D2-MAC standard, with an increasing share of 16: 9, will be made as from 1992 by  means of appropriate measures. Without prejudice to Article 7, the Commission will submit proposals as from 30 June 1992, and not later than 31 December 1993, in order to implement all the appropriate measures required for the widest possible  broadcasting in D2-MAC.  Article 4  Member States shall take all measures to ensure that, as from 1 January 1994, all new television sets and all new domestic satellite receivers and video-recorders for sale or rent in the Community:  - in respect of all television sets with 16: 9 format, possess a D2-MAC decoder,  - in respect of all other such equipment except miniature television sets, possess at least a standardized socket as standardized by Cenelec by means of which a D2-MAC decoder may be connected to the equipment permitting an open interface standard.  Article 5  Member States shall take appropriate measures to ensure that:  - any new TV cable redistribution system, or any existing TV cable redistribution system having the necessary technical capability, shall be configured in such a way that HD-MAC signals can be transmitted through the network from head-end to individual  homes,  - if cable operators decide the redistribution by cable of programmes received by them using the 16: 9 aspect ratio format and the D2-MAC standard or the HD-MAC standard, operators shall distribute these programmes using the 16: 9 aspect ratio format  and the D2-MAC or HD-MAC standard.  Article 6  In the case of all services using the D2-MAC standard, which are encrypted and employ a conditional access system, Member States shall take all the necessary measures to ensure that only a conditional access system fully compatible with  D2-MAC and standardized as such by a European standardization organization by 1 July 1993 is used.  Article 7  1. This Directive shall apply until 31 December 1998.  2. Before 1 January 1994 and every two years thereafter, the Commission shall submit to the European Parliament, to the Council and to the Economic and Social Committee a report on the effects of the application of this Directive, on the evolution of  the market, in particular on market penetration measured by objective criteria, and the use of the Community funding. If necessary, the Commission shall make proposals to the Council to adapt this Directive to these developments.  3. Before 1 January 1995 the Commission shall submit, if necessary, proposals to the Council on a policy of standardization for HDTV, in accordance with the objective of achieving total harmonization of all television broadcasting media, whether  analogue or digital, by satellite, cable or terrestrial redistribution. These proposals should take into account the results of European collaboration in research and development and the work of the relevant standardizing organizations in Europe and  relevant interest groups.  Article 8  The rules laid down in this Directive shall be accompanied by commercial measures based on the signing, by the parties concerned, of a Memorandum of Understanding coordinating the actions of the various signatories and, where appropriate, by  simultaneous measures designed to support the creation of a European market for the D2-MAC, 16: 9 and HD-MAC standards.  Article 9  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than six months after the date of its notification except for the obligations in the second indent of  Article 2 (2). They shall forthwith inform the Commission thereof.  2. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.  Article 10  This Directive is addressed to the Member States. Done at Brussels, 11 May 1992. For the Council  The President  Joao PINHEIRO   (1) OJ No C 194, 25. 7. 1991, p. 20 and OJ No C 332, 21. 12. 1991, p. 13. (2) OJ No C 326, 16. 12. 1991, p. 71 and OJ No C 94, 13. 4. 1992. (3) OJ No C 40, 17. 2. 1992, p. 101. (4) OJ No L 311, 6. 11. 1986, p. 28. (5) OJ No L 142, 25. 5. 1989,  p. 1. (6) OJ No L 363, 13. 12. 1989, p. 30.


Avis juridique important

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31979L0174

Council Directive 79/174/EEC of 6 February 1979 concerning the flood protection programme in the Hérault Valley

Official Journal L 038 , 14/02/1979 P. 0018 - 0019

****( 1 ) OJ NO C 197 , 18 . 8 . 1978 , P . 4 .  ( 2 ) OJ NO C 239 , 9 . 10 . 1978 , P . 61 .  ( 3 ) OJ NO L 94 , 28 . 4 . 1970 , P . 13 .  ( 4 ) OJ NO L 295 , 30 . 12 . 1972 , P . 1 .  ( 5 ) OJ NO L 96 , 23 . 4 . 1972 , P . 1 .  ( 1 ) OJ NO L 206 , 29 . 7 . 1978 , P . 1 .    COUNCIL DIRECTIVE   OF 6 FEBRUARY 1979   CONCERNING THE FLOOD PROTECTION PROGRAMME IN THE HERAULT VALLEY  ( 79/174/EEC )   THE COUNCIL OF THE EUROPEAN   COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLE 43 THEREOF ,   HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ( 1 ),   HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT  ( 2 ),   WHEREAS ARTICLE 39 ( 2 ) ( A ) OF THE TREATY PROVIDES THAT , IN WORKING OUT THE COMMON AGRICULTURAL POLICY , ACCOUNT SHOULD BE TAKEN OF THE SOCIAL STRUCTURE OF AGRICULTURE AND THE STRUCTURAL AND NATURAL DISPARITIES BETWEEN THE VARIOUS AGRICULTURAL REGIONS ;   WHEREAS , IN ORDER TO ACHIEVE THE OBJECTIVES OF THE COMMON AGRICULTURAL POLICY SET OUT IN ARTICLE 39 ( 1 ) ( A ) AND ( B ), SPECIAL MEASURES APPROPRIATE TO THE PRODUCTION CONDITIONS IN THE LEAST-FAVOURED AGRICULTURAL AREAS SHOULD BE ADOPTED AT COMMUNITY LEVEL ;   WHEREAS CERTAIN MEDITERRANEAN REGIONS OF THE COMMUNITY ARE IN AN UNFAVOURABLE SITUATION AS REGARDS AGRICULTURAL INCOMES AND SUFFER FROM UNDER-EMPLOYMENT NOT ONLY IN AGRICULTURE BUT ALSO GENERALLY ; WHEREAS THE HERAULT VALLEY IS ONE OF THESE REGIONS ;   WHEREAS ACTION SHOULD BE CONCENTRATED ON BASIC ASPECTS OF THE STRUCTURAL DEVELOPMENT OF THESE REGIONS WHICH WILL HAVE RAPID AND LASTING EFFECTS ON AGRICULTURAL INCOMES ;   WHEREAS AGRICULTURAL PRODUCTION IN THE HERAULT VALLEY IS SERIOUSLY AFFECTED BY FLOODING ;   WHEREAS THE PROVISION OF THE NECESSARY FLOOD PROTECTION MEASURES MUST BE SPEEDED UP BY MEANS OF COMMUNITY AID , THEREBY FACILITATING IN THIS AREA THE CONVERSION OF AREAS UNDER VINES WITHIN THE FRAMEWORK OF THE PROGRAMME TO ACCELERATE THE RESTRUCTURING AND CONVERSION OF VINEYARDS IN CERTAIN MEDITERRANEAN REGIONS OF FRANCE ;   WHEREAS THESE OBJECTIVES SHOULD BE PURSUED BY WAY OF A MEASURE COVERING THIS AREA AS PART OF A PROGRAMME EXTENDING OVER SEVERAL YEARS ;   WHEREAS IT FOLLOWS FROM THE FOREGOING THAT THE MEASURES REFERRED TO ABOVE CONSTITUTE A COMMON MEASURE WITHIN THE MEANING OF ARTICLE 6 OF COUNCIL REGULATION ( EEC ) NO 729/70 OF 21 APRIL 1970 ON THE FINANCING OF THE COMMON AGRICULTURAL POLICY ( 3 ), AS LAST AMENDED BY REGULATION ( EEC ) NO 2788/72  ( 4 );   WHEREAS IT IS THE TASK OF THE COMMISSION , AFTER RECEIVING THE OPINION OF THE STANDING COMMITTEE ON AGRICULTURAL STRUCTURE , TO APPROVE A PROGRAMME PRESENTED BY THE FRENCH REPUBLIC ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   1 .  IN ORDER TO IMPROVE THE AGRICULTURAL SITUATION IN THE LOWER AND MIDDLE AREAS OF THE HERAULT VALLEY BY MEANS OF HYDRAULIC ENGINEERING TO PREVENT FLOODING , A COMMON MEASURE SHALL BE INTRODUCED TO PROTECT THIS AREA FROM FLOODING , BY THE CONSTRUCTION OF A BARRAGE AND DAMS , AND THUS TO BRING ABOUT THE CONDITIONS NECESSARY FOR THE CONVERSION OF VINEYARDS , AND TO FACILITATE THE REORIENTATION OF PRODUCTION TO MARKET REQUIREMENTS AND THE INTRODUCTION OF DEVELOPMENT PLANS WITHIN THE MEANING OF ARTICLES 2 AND 4 OF COUNCIL DIRECTIVE 72/159/EEC OF 17 APRIL 1972 ON THE MODERNIZATION OF FARMS ( 5 ).   2 .  ALL THE MEASURES PROVIDED FOR BY THIS DIRECTIVE CONSTITUTE A COMMON MEASURE WITHIN THE MEANING OF ARTICLE 6  ( 1 ) OF REGULATION ( EEC ) NO 729/70 .   ARTICLE 2   1 .  THE FINANCIAL CONTRIBUTION OF THE COMMUNITY MAY BE USED ONLY IN THE CONTEXT OF A PROGRAMME APPLYING TO ALL THE MEASURES FOR FLOOD PROTECTION IN THE AREA REFERRED TO IN ARTICLE 1 .   THIS PROGRAMME SHALL BE SUBMITTED TO THE COMMISSION BY THE FRENCH REPUBLIC .   2 .  THE PROGRAMME AND ANY AMENDMENTS THERETO SHALL BE EXAMINED AND APPROVED , AFTER CONSULTATION OF THE COMMITTEE OF THE EUROPEAN AGRICULTURAL GUIDANCE AND GUARANTEE FUND , HEREINAFTER CALLED ' THE FUND ' , ON THE FINANCIAL ASPECTS THEREOF , IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 18 ( 2 ) AND ( 3 ) OF DIRECTIVE 72/159/EEC .   3 .  THE PROGRAMME MAY BE APPROVED ONLY AFTER AUTHORIZATION OF THE PROGRAMME PROVIDED FOR IN ARTICLE 2 OF COUNCIL DIRECTIVE 78/627/EEC OF 19 JUNE 1978 ON THE PROGRAMME TO ACCELERATE THE RESTRUCTURING AND CONVERSION OF VINEYARDS IN CERTAIN MEDITERRANEAN REGIONS OF FRANCE ( 1 ).   ARTICLE 3   THE PROGRAMME REFERRED TO IN ARTICLE 2 SHALL INCLUDE IN PARTICULAR THE FOLLOWING INFORMATION :  ( A ) THE DELIMITATION AND THE LOCATION OF THE AREA AFFECTED BY FLOODING ;  ( B ) THE DELIMITATION OF THE VINEYARDS LOCATED IN THE AREA REFERRED TO IN ( A ) AND THE NUMBER OF HECTARES OF VINES FOR WHICH CONVERSION TO OTHER TYPES OF PRODUCTION IS PLANNED , TOGETHER WITH THE MEASURES ANTICIPATED FOR REORIENTATING PRODUCTION TOWARDS , IN PARTICULAR , FODDER CROPS ( MAIZE , BARLEY , LUCERNE , CLOVER , FIELD BEANS , SORGHUM , SOYA , ETC .) AND THE DEVELOPMENT OF LIVESTOCK RAISING ;  ( C ) A DESCRIPTION AND PLAN OF THE WORK NECESSARY FOR FLOOD PROTECTION , AND A TIMETABLE FOR THE PROGRAMME ;  ( D ) THE ESTIMATED COST OF EACH OF THE MEASURES AND THE TOTAL COST OF IMPLEMENTING THE PROGRAMME .   ARTICLE 4   NO COMMUNITY OR NATIONAL AID FOR THE RESTRUCTURING OF VINEYARDS SHALL BE GRANTED IN THE AREA PROTECTED UNDER THIS COMMON MEASURE .   ARTICLE 5   1 .  EXPENDITURE INCURRED BY THE FRENCH REPUBLIC UNDER THE PROGRAMME REFERRED TO IN ARTICLE 2 , UP TO A TOTAL OF 23 000 000 UNITS OF ACCOUNT AND RELATING TO THE CONSTRUCTION OF  ( A ) A BARRAGE ,  ( B ) DAMS ,   SHALL BE ELIGIBLE FOR AID FROM THE GUIDANCE SECTION OF THE FUND .   2 .  THE GUIDANCE SECTION OF THE FUND SHALL REIMBURSE TO THE FRENCH REPUBLIC 35 % OF THE EXPENDITURE ELIGIBLE IN ACCORDANCE WITH PARAGRAPH 1 .   ARTICLE 6   1 .  THE PERIOD OF DURATION OF THE MEASURE SHALL BE SEVEN YEARS FROM THE DATE ON WHICH THIS DIRECTIVE IS TO APPLY .   2 .  THE TOTAL ESTIMATED COST OF THE COMMON MEASURE TO BE BORNE BY THE FUND SHALL BE 9 000 000 EUROPEAN UNITS OF ACCOUNT FOR THE ENTIRE PERIOD .   3 .  ARTICLE 6 ( 5 ) OF REGULATION ( EEC ) NO 729/70 SHALL APPLY TO THIS DIRECTIVE .   ARTICLE 7   WHEN THE PROGRAMME REFERRED TO IN ARTICLE 2 IS BEING APPROVED , THE COMMISSION SHALL , IN AGREEMENT WITH THE FRENCH REPUBLIC , LAY DOWN THE DETAILED RULES BY WHICH IT SHALL BE KEPT INFORMED OF THE PROGRESS OF THE PROGRAMME . THE FRENCH REPUBLIC SHALL AT THE SAME TIME DESIGNATE THE AGENCIES RESPONSIBLE FOR THE TECHNICAL EXECUTION OF THE PROGRAMME .   ARTICLE 8   1 .  REQUESTS FOR REIMBURSEMENT SHALL RELATE TO EXPENDITURE INCURRED BY THE FRENCH REPUBLIC DURING A SINGLE CALENDAR YEAR AND SHALL BE SUBMITTED TO THE COMMISSION BEFORE 1 JULY OF THE FOLLOWING YEAR .   2 .  AID FROM THE FUND SHALL BE DECIDED UPON IN ACCORDANCE WITH ARTICLE 7 ( 1 ) OF REGULATION ( EEC ) NO 729/70 .   3 .  THE FUND MAY GRANT ADVANCES IN ACCORDANCE WITH THE FINANCING ARRANGEMENTS ADOPTED BY THE FRENCH REPUBLIC AND ACCORDING TO THE PROGRESS OF THE PROJECTS .   4 .  THE DETAILED RULES FOR THE APPLICATION OF THIS ARTICLE SHALL BE ADOPTED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 13 OF REGULATION ( EEC ) NO 729/70 .   ARTICLE 9   THIS DIRECTIVE WILL APPLY AS SOON AS THE COUNCIL HAS TAKEN A DECISION ON THE COMMISSION PROPOSAL FOR AN AMENDMENT TO REGULATION ( EEC ) NO 729/70 .   ARTICLE 10   THIS DIRECTIVE IS ADDRESSED TO THE FRENCH REPUBLIC .   DONE AT BRUSSELS , 6 FEBRUARY 1979 .   FOR THE COUNCIL   THE PRESIDENT   P . MEHAIGNERIE