title: Commission Directive 2012/7/EU of 2 March 2012 amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy safety  Text with EEA relevance

text:
               3.3.2012

               EN

               Official Journal of the European Union

               L 64/7

         COMMISSION DIRECTIVE 2012/7/EU
   of 2 March 2012
   amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy safety
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46.1 (b) thereof,
   Whereas:

               (1)

               Directive 2009/48 sets limit values for cadmium, based on the recommendations of the Dutch National Institute for Public Health and the Environment (RIVM) made in the 2008 report entitled "Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements". The RIVM recommendations are based on the assumption that exposure of children to chemicals in toys may not exceed a certain level, called “tolerable daily intake”. Since children are exposed to chemicals via other sources than toys, only a percentage of the tolerable daily intake should be allocated to toys. The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) recommended in its 2004 report that a maximum of 10 % of the tolerable daily intake may be allocated to toys. However, for cadmium and other chemical substances which are particularly toxic, the recommended allocation should not exceed 5 % of the tolerable daily intake, in order to ensure that only traces that are compatible with good manufacturing practice will be present

               (2)

               According to the RIVM recommendations, the maximum percentage of the tolerable daily intake should be multiplied by the weight of a child, estimated at 7.5 kg, and divided by the quantity of toy material ingested, in order to obtain the limit values for the chemical substances listed in Directive 2009/48/EC.

               (3)

               For cadmium, RIVM used the tolerable weekly intake of 7 μg/kg established by the Joint Food and Agriculture Organisation of the United Nations and the World Health Organisation Experts committee on food additives (JEFCA) in 1989 and confirmed by JECFA in 2001. A safety factor of two was applied, resulting in a tolerable weekly intake of 3.5 μg/kg and a tolerable daily intake of 0.5 μg/kg.

               (4)

               In order to define possible exposure scenarios to chemical substances, the quantity of toy material ingested was estimated by the RIVM at 8 mg per day for scraped-off toy material, 100 mg for brittle toy material and 400 mg for liquid or sticky toy material. Those ingestion limits were supported by the Scientific Committee on Health and Environmental Risks (SCHER) in its opinion entitled "Risks from organic CMR substances in toys" adopted on the 18 May 2010.

               (5)

               By applying 5 % of the tolerable daily intake, multiplied by the weight of the child and divided by the quantity of toy material ingested, the following limit values for cadmium were established: 23 mg/kg for scrapped-off material, 1.9 mg/kg for dry material and 0.5 mg/kg for liquid material.

               (6)

               The European Food Safety Authority (EFSA) concluded in its opinion of 30 January 2009 that the tolerable weekly intake established by JEFCA in 1989 and confirmed by JECFA in 2001 was no longer appropriate in view of the new developments related to the toxicology of cadmium. The EFSA established a new tolerable weekly intake of 2.5 μg/kg, resulting in a tolerable daily intake of 0.36 μg/kg.

               (7)

               Applying 5 % of the new tolerable daily intake, multiplied by the weight of the child and divided by the quantity of toy material ingested results in the following limits for cadmium: 17 mg/kg for scrapped-off material, 1.3 mg/kg for dry material and 0.3 mg/kg for liquid material.

               (8)

               Directive 2009/48/EC should therefore be amended accordingly.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee.

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Part III of Annex II to Directive 2009/48/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 20 January 2013 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
   They shall apply those provisions from 20 July 2013.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 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, 2 March 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 170, 30.6.2009, p. 1.

      ANNEX
      Part III of Annex II to Directive 2009/48/EC is amended as follows:
      In point 13, the entry for cadmium is replaced by the following:

                     Element

                     mg/kg
                     in dry, brittle, power-like or pliable toy material

                     mg/kg
                     in liquid or sticky toy material

                     mg/kg
                     in scrapped-off toy material

                     ‘Cadmium

                     1,3

                     0,3

                     17’


Avis juridique important

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31997L0051

Directive 97/51/EC of the European Parliament and of the Council of 6 October 1997 amending Council Directives 90/387/EEC and 92/44/EEC for the purpose of adaptation to a competitive environment in telecommunications

Official Journal L 295 , 29/10/1997 P. 0023 - 0034

DIRECTIVE 97/51/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 October 1997 amending Council Directives 90/387/EEC and 92/44/EEC for the purpose of adaptation to a competitive environment in telecommunicationsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 28 May 1997,(1) Whereas Council Directive 90/387/EEC of 28 June 1990 on the establishment of the internal market for telecommunications services through the implementation of open network provision (4) (ONP) concerns the harmonization of conditions for open and efficient access to and use of public telecommunications networks and, where applicable, services; whereas, in accordance with that Directive, the Council adopted Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines (5);(2) Whereas the Council resolution of 22 July 1993 on the review of the situation in the telecommunications sector and the need for further development in that market (6), combined with the Council resolution of 22 December 1994 on the principles and timetable for the liberalization of telecommunications infrastructures (7), call for the liberalization of telecommunications services and infrastructures by 1 January 1998 (with transitional periods for certain Member States); whereas this is supported by the European Parliament resolution of 20 April 1993 on the Commission's 1992 review of the situation in the telecommunications sector (8), and the European Parliament resolution of 19 May 1995 on the Green Paper on the liberalization of telecommunications infrastructures and cable television networks (Part II) (9);(3) Whereas the Council resolution of 22 July 1993 considered as a major goal for the Community's telecommunications policy the application throughout the Community and, where necessary, the adaptation, in the light of further liberalization, of open network provision principles in respect of the entities covered and of such issues as universal service, interconnection and access charges as well as the consequent questions connected with licensing conditions; whereas the Council resolution of 18 September 1995 on the implementation of the future regulatory framework for telecommunications (10) called on the Commission, in accordance with the timetable set out in the Council resolutions of 22 July 1993 and 22 December 1994, to present to the European Parliament and the Council before 1 January 1996 all legislative provisions intended to establish the European regulatory framework for telecommunications accompanying the full liberalization of this sector, in particular concerning the adaptation of open network provision measures to the future competitive environment;(4) Whereas the European Parliament resolution of 6 May 1994 on the Commission communication accompanied by the proposal for a Council resolution on universal service principles in the telecommunications sector (11) emphasizes the central importance of universal service principles; whereas the Council resolution of 7 February 1994 on universal service principles in the telecommunications sector (12) provides a basic definition of universal service and calls upon the Member States to establish and maintain an appropriate regulatory framework in order to ensure universal service throughout their territories; whereas, as was recognized by the Council in that resolution, the concept of universal service must evolve to keep pace with advances in technology, market development and changes in user demand; whereas universal service in telecommunications will have a role to play in strengthening social and economic cohesion, in particular in remote, peripheral, landlocked and rural areas and islands of the Community; whereas, where justified, the net cost of universal service obligations may be shared by market players in accordance with Community law;(5) Whereas the basic principles concerning access to and the use of public telecommunications networks and services, set out within the open network provision framework, must be adapted to ensure Europe-wide services in a liberalized environment, in order to benefit users and organizations providing public telecommunications networks and/or services; whereas a voluntary approach based on common technical standards and specifications, with consultations undertaken where necessary to satisfy user needs, is appropriate in a liberalized environment; whereas, nevertheless, the provision of universal service and the availability of a minimum set of services must be guaranteed to all users in the Community in accordance with the Community measures applicable; whereas a general framework for interconnection to public telecommunications networks and public telecommunications services is needed in order to provide end-to-end interoperability of services for Community users;(6) Whereas open network provision conditions must not restrict the use of or access to public telecommunications networks or publicly available telecommunications services except on grounds of essential requirements or the exercise of special and exclusive rights retained by Member States in accordance with Community law;(7) Whereas the provisions of this Directive do not prevent a Member State from taking measures justified on grounds set out in Articles 36 and 56 of the Treaty, and in particular on grounds of public security, public policy and public morality;(8) Whereas a modus vivendi (13) between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994;(9) Whereas in accordance with the principle of the separation of regulatory and operational functions, Member States should guarantee the independence of the national regulatory authority or authorities with a view to ensuring the impartiality of their decisions, and ensure that the national regulatory authority or authorities of each Member State will play a keyrole in the implementation of the regulatory framework set out in relevant Community legislation; whereas this requirement of independence is without prejudice to the institutional autonomy and constitutional obligations of the Member States, or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership in accordance with Article 222 of the Treaty; whereas the national regulatory authorities should be in possession of all the resources necessary, in terms of staffing, expertise, and financial means, for the performance of their function;(10) Whereas numbering and the more general concepts of addressing and naming play an important role; whereas adherence to a harmonized approach for numbering/addressing and, where applicable, naming will contribute to Europe-wide end-to-end communications for users and the interoperability of services; whereas in addition to numbering it may be appropriate to apply the principles of objectivity, transparency, non-discrimination and proportionality in the allocation of names and addresses; whereas Commission Directive 96/19/EC of 13 March 1996 amending Directive 90/388/EEC with regard to the implementation of full competition in telecommunications markets (14) provides for adequate numbers to be available for all telecommunications services, and for numbers to be allocated in an objective, transparent, non-discriminatory and proportionate manner;(11) Whereas in order to guarantee the provision of leased lines throughout the Community, Member States should ensure that at every point in their territories users have access to a minimum set of leased lines from at least one organization; whereas organizations with obligations to provide leased lines should be designated by Member States; whereas Member States must notify the Commission of the organizations subject to this Directive, the leased line types within the minimum set which they are required to provide, and the geographical area in which this requirement applies; whereas, within a specific geographical area, all the leased line types provided by a notified organization are subject to the general provisions of this Directive;(12) Whereas the market power of an organization depends on a number of factors, including its share of the relevant product or service market in the relevant geographical market, its turnover relative to the size of the market, its ability to influence market conditions, its control of the means of access to end-users, its access to financial resources and its experience in providing products and services in the market; whereas determining which organizations have significant market power should be a function of national regulatory authorities, taking into account the situation on the relevant market;(13) Whereas the concept of leased-lines services will evolve with new technological advances and market demand, allowing users more flexible use of the leased-line bandwidth;(14) Whereas, in order to achieve more efficient communications within the Community, it is important that Member States encourage the provision of an additional harmonized set of higher-order leased lines, taking into account market demand and progress with standardization;(15) Whereas until an effective competitive environment is achieved, there is a need for the regulatory supervision of tariffs for leased lines with a view to ensuring cost orientation and transparency in accordance with the principle of proportionality; whereas it is appropriate to allow the requirements for cost orientation and transparency in specific markets to be set aside where no organization has significant market power or where effective competition ensures that tariffs for leased lines are reasonable;(16) Whereas common technical regulations (CTRs) adopted under Council Directive 91/263/EEC of 29 April 1991 on the approximation of the laws of the Member States concerning telecommunications terminal equipment, including the mutual recognition of their conformity (15), and Council Directive 93/97/EEC of 29 October 1993 supplementing Directive 91/263/EEC in respect of satellite earth station equipment (16) define the conditions for the connection of terminal equipment to leased lines;(17) Whereas certain amendments to existing open network provision measures are appropriate in order to ensure their consistency with new technical developments and with other regulatory measures that will form part of the overall regulatory framework for telecommunications;(18) Whereas all the areas identified in Annex I to Directive 90/387/EEC as possible areas for the application of open network provision conditions have been addressed in analysis reports subject to public consultation, in accordance with the procedure laid down in Article 4 of that Directive; whereas all the priority measures identified in Annex III thereto have been adopted;(19) Whereas in order to enable the Commission to carry out the monitoring task assigned to it by the Treaty, changes in national regulatory authority or authorities and the organizations affected must be swiftly communicated to the Commission;(20) Whereas, in accordance with the principles of subsidiarity and proportionality as stated in Article 3b of the Treaty, the objective of adapting Directives 90/387/EEC and 92/44/EEC to a competitive environment in telecommunications cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community;(21) Whereas the functioning of Directives 90/387/EEC and 92/44/EEC should be reviewed no later than 31 December 1999; whereas that review should take account of the increasing effectivness of competition in telecommunications markets;(22) Whereas, when bringing forward proposals for any further measures in pursuit of the aims of this Directive, consideration should be given to a single consolidated text incorporating all relevant European Parliament and Council Directives implementing the ONP provisions so as to improve the transparency of Community legislation;(23) Whereas pursuant to Articles 52 and 59 of the Treaty, the regulatory regime in the field of telecommunications should be compatible and consistent with the principles of freedom of establishment and freedom to provide services and should take into account the need to facilitate the introduction of new services as well as the widespread application of technological improvements,HAVE ADOPTED THIS DIRECTIVE:Article 1 Amendment of Directive 90/387/EEC Directive 90/387/EEC is hereby amended as follows:1. Article 1 shall be amended as follows:(a) paragraph 2 shall be replaced by the following:'2. The purpose of the conditions prescribed in paragraph 1 shall be to facilitate the provision of public telecommunications networks and/or public telecommunications services, within and between Member States, and in particular the provision of services by companies, firms or natural persons established in a Member State other than that of the company, firm or natural person for whom the services are intended.`;(b) the following paragraph shall be added:'3. Open network provision conditions shall aim at:- ensuring the availability of a minimum set of services,- securing access and interconnection to public telecommunications networks and public telecommunications services,- encouraging the provision of harmonized telecommunications services to the benefit of users, in particular by identifying and promoting by voluntary means harmonized technical interfaces for open and efficient access and interconnection, and associated standards and/or specifications and- guaranteeing the provision of universal service in telecommunications, taking account of any future evolution,throughout the Community.`2. Article 2 shall be replaced by the following:'Article 2For the purposes of this Directive:1. 'users` shall mean individuals, including consumers, or organizations using or requesting publicly available telecommunications services;2. 'telecommunications network` shall mean transmission systems and, where applicable, switching equipment and other resources which permit the conveyance of signals between defined termination points by wire, by radio, by optical or by other electromagnetic means;'public telecommunications network` shall mean a telecommunications network used, wholly or in part, for the provision of publicly available telecommunications services;3. 'telecommunications services` shall mean services the provision of which consists wholly or partly in the transmission and routing of signals on telecommunications networks, with the exception of radio and television broadcasting;4. 'universal service` shall mean a defined minimum set of services of specified quality which is available to all users regardless of their geographical location and, in the light of specific national conditions, at an affordable price;5. 'network termination point` shall mean the physical point at which a user is provided with access to a public telecommunications network. The locations of network termination points shall be defined by the national regulatory authority and shall represent a boundary, for regulatory purposes, of the public telecommunications network;6. 'essential requirements` shall mean the non-economic reasons in the public interest which may cause a Member State to impose conditions on the establishment and/or operation of telecommunications networks or the provision of telecommunications services. Those reasons shall be the security of network operations, the maintenance of network integrity and, where justified, the interoperability of services, data protection, the protection of the environment and town and country planning objectives as well as the effective use of the frequency spectrum and the avoidance of harmful interference between radio-based telecommunications systems and other space-based or terrestrial technical systems. Data protection may include protection of personal data, the confidentiality of information transmitted or stored and the protection of privacy;7. 'interconnection` shall mean the physical and logical linking of telecommunications networks used by the same or a different organization in order to allow the users of one organization to communicate with users of the same or another organization or to access services provided by another organizations. Services may be provided by the parties involved or other parties who have access to the network;8. 'open network provision conditions` shall mean the conditions, harmonized in accordance with this Directive, which govern open and efficient access to public telecommunications networks and, where applicable, public telecommunications services and the efficient use of those networks and services.Without prejudice to their application on a case-by-case basis, open network provision conditions may include harmonized conditions with regard to:- technical interfaces, including the definition and implementation of network termination points, where required,- usage conditions,- tariff principles and- access to frequencies and numbers/addresses/names, where required in accordance with the reference framework of the Annex;9. "technical specifications", "standards" and "terminal equipment" shall have the same meanings as in Article 1 of Directive 91/263/EEC (*).(*) OJ L 128, 23. 5. 1991, p. 1.`;3. Article 3 shall be amended as follows:(a) paragraphs 2 and 3 shall be replaced by the following:'2. Open network provision conditions shall not restrict access to public telecommunications networks or public telecommunications services, except on grounds of essential requirements within the framework of Community law. In addition, the conditions generally applicable to the connection of terminal equipment to the network shall apply.3. Open network provision conditions may not allow for any additional restrictions on the use of the public telecommunications networks and/or public telecommunications services, except those which are compatible with Community law.`;(b) paragraph 4 shall be deleted;(c) paragraph 5 shall be replaced by the following:'5. Without prejudice to the specific Directives adopted in the field of open network provision and in so far as the application of the essential requirements referred to in paragraph 2 may cause Member States to limit access to public telecommunications networks or services, the rules for uniform application of the essential requirements, in particular concerning the interoperability of services and the protection of data, shall be determined, where appropriate, by the Commission, in accordance with the procedure laid down in Article 10.`;4. Article 4 shall be deleted;5. Article 5 shall be replaced by the following:'Article 51. References to standards and/or specifications drawn up as a basis for harmonized technical interfaces and/or service features for open network provision shall be published in the Official Journal of the European Communities as suitable for the requirement of open and efficient access, interconnection and interoperability in order to encourage the provision of harmonized telecommunications services to the benefit of users throughout the Community.Where necessary, the Commission may, in consultation with the committee referred to in Article 9, request standards to be drawn up by European standardization bodies.2. Member States shall encourage the use of the standards and/or specifications to which reference is made in the Official Journal of the European Communities, in accordance with paragraph 1, for the provision of technical interfaces and/or network functions.As long as such standards and/or specifications are not adopted, Member States shall encourage:- standards and/or specifications adopted by European standardization bodies such as the European Telecommunications Standards Institute (ETSI) or the joint European standards institution, the European Committee for Standardization (CEN)/European Committee for Electrotechnical Standardization (Cenelec),or, in the absence of such standards and/or specifications,- international standards or recommendations adopted by the International Telecommunications Union (ITU), the International Organization for Standardization (ISO) or the International Electrotechnical Committee (IEC),or, in the absence of such standards and/or specifications,- national standards and/or specifications.3. If the implementation of the standards and/or specifications referred to in paragraph 1 appears to be inadequate to ensure the interoperability of transfrontier services in one or more Member States, the implementation of such standards and/or specifications may be made compulsory under the procedure laid down in Article 10, to the extent strictly necessary to ensure such interoperability and to improve freedom of choice for users, subject to Articles 85 and 86 of the Treaty.Before the implementation of the standards and/or specifications is made compulsory in accordance with the first subparagraph, the Commission shall, by publishing a notice to that effect in the Official Journal of the European Communities, invite public comment by all parties concerned.4. Where a Member State or the Commission considers that the harmonized standards and/or specifications referred to in paragraph 1 do not correspond to the objective of open and efficient access, interconnection and interoperability, in particular the basic principles and the essential requirements referred to in Article 3, it shall be decided whether or not it is necessary to withdraw references to those standards and/or specifications from the Official Journal of the European Communities in accordance with the procedure laid down in Article 10.5. The Commission shall inform the Member States of any such decision and publish information on the withdrawal of those standards and/or specifications in the Official Journal of the European Communities.`;6. the following Article shall be inserted:'Article 5a1. Where the tasks assigned to the national regulatory authority in Community legislation are undertaken by more than one body, Member States shall ensure that the tasks to be undertaken by each body are made public.2. In order to guarantee the independence of national regulatory authorities:- national regulatory authorities shall be legally distinct from and functionally independent of all organizations providing telecommunications networks, equipment or services,- Member States that retain ownership or a significant degree of control of organizations providing telecommunications networks and/or services shall ensure effective structural separation of the regulatory function from activities associated with ownership or control.3. Member States shall ensure that suitable mechanisms exist at national level under which a party affected by a decision of the national regulatory authority has a right of appeal to a body independent of the parties involved.4. Member States may take steps to ensure that national regulatory authorities are able to obtain from organizations providing telecommunications networks and/or services all the information necessary for them to apply Community legislation.`;7. Articles 6 and 7 shall be deleted;8. Article 8 shall be replaced by the following:'Article 8The Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion no later than 31 December 1999. The report shall be based inter alia on the information supplied by the Member States to the Commission and to the committee referred to in Articles 9 and 10. Where necessary, the report shall examine what provisions of this Directive should be adapted in the light of the developments in the market. Further measures may be proposed in the report in pursuit of the aims of this Directive. The Commission shall also investigate in the report the added value of the setting up of a European Regulatory Authority to carry out those tasks which would prove to be better undertaken at Community level.`;9. in the second paragraph of Article 9 (1), 'telecommunications organizations` shall be replaced by 'organizations providing public telecommunications networks and/or publicly available telecommunications services.`;10. Annexes I and III shall be deleted;11. Annex II shall be replaced by Annex I to this Directive.Article 2 Amendment of Directive 92/44/EEC Directive 92/44/EEC is hereby amended as follows:1. 'telecommunications organizations` shall be replaced by 'organizations notified in accordance with Article 11 (1) (a)` throughout;2. the following paragraphs shall be added to Article 1:'Member States shall ensure that at every point in their territory at least one organization is subject to the provisions of this Directive.Member States shall ensure that obligations arising out of this Directive are not imposed on organizations without significant market power in the relevant leased-lines market, unless there are no organizations with significant market power in the relevant leased-lines market in a given Member State.`;3. Article 2 shall be replaced by the following:'Article 2Definitions1. The definitions given in Directive 90/387/EEC, as amended by Directive 97/51/EC (*), shall apply, where relevant, to this Directive.2. In addition, for the purposes of this Directive,- "leased lines" shall mean the telecommunications facilities which provide for transparent transmission capacity between network termination points and which do not include on-demand switching (switching functions which the user can control as part of the leased line provision),- "Open Network Provision Committee" shall mean the committee referred to in Articles 9 and 10 of Directive 90/387/EEC,- "national regulatory authority" shall mean the body referred to in Article 5a of Directive 90/387/EEC.3. For the purposes of this Directive, an organization shall be presumed to have significant market power when its share of the relevant leased-lines market in a Member State is 25 % or more. The relevant leased-lines market shall be assessed on the basis of the type(s) of leased line offered in a particular geographical area. The geographical area may cover the whole or part of the territory of a Member State.National regulatory authorities may determine that an organization with a market share that is less than 25 % of the relevant leased-lines market has significant market power. They may also determine that an organization with a market share that is 25 % or more of the relevant leased-lines market does not have significant market power.In either case, the determination shall take into account the organization's ability to influence the leased-lines market conditions, its turnover relative to the size of the market, its access to financial resources and its experience in providing products and services in the market.(*) OJ L 295, 29. 10. 1991, p. 23.`;4. Article 3 shall be amended as follows:(a) the second sentence of paragraph 1 shall be replaced by the following:'Changes in existing offerings and information on new offerings shall be published as soon as possible. The national regulatory authority may lay down a suitable period of notice.`;(b) paragraph 3 shall be deleted;5. The first subparagraph of the second indent in Article 4 shall be replaced by the following:'- the typical delivery period, which is the period, counted from the date when the user has made a firm request for a leased line, in which 95 % of all leased lines of the same type have been put through to the customers,`;6. Article 6 shall be amended as follows:(a) paragraph 1 shall be replaced by the following:'1. Member States shall ensure that when access to and use of leased lines is restricted in accordance with Community law those restrictions are imposed by the national regulatory authorities through regulatory means.No technical restrictions shall be introduced or maintained for the interconnection of leased lines among each other or for the interconnection of leased lines and public telecommunications networks.`;(b) the second subparagraph of paragraph 3 (a) shall be replaced by the following:'An emergency situation in this context shall mean an exceptional case of force majeure, such as extreme weather, earthquakes, flood, lightning or fire.`;(c) the first subparagraph of paragraph 4 and footnote 1 shall be replaced by the following:'Access conditions relating to terminal equipment shall be considered to be fulfilled when the terminal equipment complies with the approval conditions laid down for its connection to the network-termination point of the type of leased line concerned in accordance with Directive 91/263/EEC (*) or 93/97/EEC (**).(*) OJ L 128, 23. 5. 1991, p. 1.(**) OJ L 290, 24. 11. 1993, p. 1.`;7. Article 7 shall be amended as follows:(a) the following paragraph shall be inserted:'2a. Member States shall encourage provision of the additional types of leased lines specified in Annex III, taking into account market demand and progress with standardization`;(b) paragraph 3 shall be replaced by the following:'3. The amendments necessary to adapt Annexes II and III to new technical developments and to changes in market demand, including the possible deletion of certain types of leased lines from the Annexes, shall be adopted by the Commission under the procedure provided for in Article 10 of Directive 90/387/EEC, taking into account the state of development of national networks.`;8. Article 8 (2) shall be replaced by the following:'2. The national regulatory authority shall ensure that the organizations notified in accordance with Article 11 (1) (a) adhere to the principle of non-discrimination when providing leased lines. Those organizations shall apply similar conditions in similar circumstances to organizations providing similar services, and shall provide leased lines to others under the same conditions and of the same quality as they provide for their own services, or those of their subsidiaries or partners, where applicable.`;9. Article 9 shall be deleted;10. Article 10 shall be amended as follows:(a) paragraph 1 (a) shall be replaced by the following:'(a) tariffs for leased lines shall be independent of the type of application which the users of the leased lines implement, without prejudice to the principle of non-discrimination set out in Article 8 (2);`(b) paragraph 2 (b) (iii) shall be replaced by the following:'(iii) when neither direct nor indirect measures of cost allocation can be found, the cost category shall be allocated on the basis of a general allocator computed by using the ratio of all expenses directly assigned or allocated to leased lines, on the one hand, to those allocated to other services, on the other hand;`(c) the following paragraph shall be added:'4. The national regulatory authority shall not apply the requirements of paragraph 1 where an organization does not have significant market power in respect of a specific leased-lines offering in a specific geographical area.The national regulatory authority may decide not to apply the requirements of paragraph 1 in a specific geographical area where it is satisfied that there is effective competition in the relevant leased-lines market as evidenced by tariffs that already comply with those requirements.`;11. Article 11 shall be amended as follows:(a) paragraph 1 shall be replaced by the following:'1. Member States shall notify the Commission of their national regulatory authority or authorities responsible for carrying out the tasks specified in this Directive.They shall promptly notify the Commission of any changes in their national regulatory authorities.`;(b) the following paragraph shall be inserted:'1a. National regulatory authorities shall notify the Commission of the names of those organizations providing leased lines subject to requirements pursuant to this Directive. That notification shall, where appropriate, include the types of leased lines that each organization is required to provide in each geographical area in order to comply with Article 1 and shall include any cases where, pursuant to Article 10 (4), Article 10 (1) is not applied.`;(c) the second subparagraph of paragraph 2 shall be replaced by the following:'The national regulatory authority shall keep available and submit to the Commission on request the data on all cases in which access to or use of leased lines has been restricted, as well as details of the measures taken, including the reasons why they were taken.`;12. Article 14 shall be replaced by the following:'Article 14ReportThe Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion no later than 31 December 1999. The report shall be based inter alia on the information supplied by the Member States to the Commission and to the Open Network Provision Committee. The report shall include an assessment of the need for continuation of this Directive, taking account of developments towards a fully competitive environment. Where necessary, the report shall examine what provisions of this Directive should be adapted in the light of the developments in the market, and further measures may be proposed in the report in pursuit of the aims of this Directive.`;13. Annex I shall be amended as follows:(a) footnote 1 shall be replaced by the following:'OJ L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 94/10/EC of the European Parliament and of the Council (OJ L 100, 19. 4. 1994, p. 30).`;(b) in Section D, points 1, 2, 3, 5 and 6 shall be deleted;(c) Section E shall be replaced by the following:'E. Conditions for the attachment of terminal equipmentThe information on the attachment conditions must include a complete overview of the requirements with which terminal equipment to be attached to the relevant leased line must comply in accordance with Directive 91/263/EEC or 93/97/EEC.`;14 Annex II to this Directive shall be added as Annex III.Article 3 Transposition 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1997. They shall immediately inform the Commission thereof.When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.Article 4 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5 Addressees This Directive is addressed to the Member States.Done at Brussels, 6 October 1997.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentJ. POOS(1) OJ C 62, 1. 3. 1996, p. 3 andOJ C 291, 4.10. 1996, p. 18.(2) OJ C 204, 15. 7. 1996, p. 14.(3) Opinion of the European Parliament of 22 May 1996 (OJ C 166, 10. 6. 1996, p. 87), Council common position of 12 September 1996 (OJ C 315, 24. 10. 1996, p. 41) and Decision of the European Parliament of 11 December 1996 (OJ C 20, 20. 1. 1997, p. 55). Decision of the European Parliament of 16 July 1997. Council Decision of 22 July 1997.(4) OJ L 192, 24. 7. 1990, p. 1.(5) OJ L 165, 19. 6. 1992, p. 27. Directive as amended by Commission Decision 94/439/EC (OJ L 181, 15. 7. 1994, p. 40).(6) OJ C 213, 6. 8. 1993, p. 1.(7) OJ C 379, 31. 12. 1994, p. 4.(8) OJ C 150, 31. 5. 1993, p. 39.(9) OJ C 151, 19. 6. 1995, p. 479.(10) OJ C 258, 3. 10. 1995, p. 1.(11) OJ C 205, 25. 7. 1994, p. 551.(12) OJ C 48, 16. 2. 1994, p. 1.(13) OJ C 102, 4. 4. 1996, p. 1.(14) OJ L 74, 22. 3. 1996, p. 13.(15) OJ L 128, 23. 5. 1991, p. 1. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30. 8. 1993, p. 1).(16) OJ L 290, 24. 11. 1993, p. 1.ANNEX I 'ANNEXREFERENCE FRAMEWORK FOR THE APPLICATION OF ONP CONDITIONSThe application of open network provision conditions as defined in Article 2 (8) should be in accordance with the following reference framework, taking into account the relevant rules of the Treaty:1. Harmonized technical interfaces and/or network functionsWhen open network provision conditions are drawn up the following scheme should be taken into account for the definition of specifications for technical interfaces and/or network functions:- for existing services and networks, existing interface specifications should be adopted,- for entirely new services or the improvement of existing services, existing interface specifications should also be adopted, as far as feasible. When existing interfaces are not suitable, enhancements and/or new interface specifications will have to be specified,- for networks that are still to be introduced but for which the standardization programme has already commenced, open network provision requirements falling within the terms of Article 3 should be taken into account when new interface and network functions specifications are developed.Open network provision proposals must, whenever possible, be in line with the ongoing work in the European standardization bodies, in particular the ETSI, and must also take into account work in international standardization organizations, such as the ITU-T.2. Harmonized supply and usage conditionsSupply and usage conditions identify conditions of access and of provision of services, as far as required.(a) supply conditions concern conditions under which a service is offered to users. They may include:- typical delivery period,- typical repair time,- quality of service, in particular availability and quality of transmission,- maintenance and network management;(b) usage conditions concern conditions which apply to users, such as:- conditions for network access,- conditions for shared use,- conditions regarding protection of personal data and confidentiality of communications, where required.3. Harmonized tariff principlesTariff principles must be consistent with the principles started in Article 3 (1).Those principles imply, in particular, that:- tariffs must be based on objective criteria and, until such time as competition becomes effective in keeping down prices for users, must in principle be cost oriented, on the understanding that the fixing of the actual tariff level will continue to be the province of national legislation and is not the subject of open network provisions conditions. Where an organization no longer has significant market power in the relevant market, the requirement for cost orientation may be set aside by the competent national regulatory authority. One of the aims should be the definition of efficient tariff principles throughout the Community while ensuring a general service for all,- tariffs must be transparent and must be properly published,- in order to leave users a choice between the individual service elements and where technology so permits, tariffs must be sufficiently unbundled in accordance with the competition rules of the Treaty. In particular, additional features introduced to provide certain specific extra services must, as a general rule, be charged independently of the inclusive features and transportation as such,- tariffs must be non-discriminatory and guarantee equality of treatment, except for restrictions which are compatible with Community law.Any charge for access to network resources or services must comply with the principles set out above and with the competition rules of the Treaty and must also take into account the principle of fair sharing in the global cost of the resources used, the need for a reasonable level of return on investment and, where appropriate, the financing of universal service in accordance with the interconnection Directive (*).There may be different tariffs, in particular to take account of excess traffic during peak periods and lack of traffic during off-peak periods, provided that the tariff differentials are commercially justifiable and do not conflict with the above principles.4. Harmonized approach to numbering/addressing/namingNumbering/addressing and in some instances naming provide for the selection of the destination or destinations, or for the selection of a service, of a service provider or a network operator.Adherence to a harmonized approach for numbering/addressing and, where applicable, naming is therefore essential to guarantee Europe-wide end-to-end interconnection of users and the interoperability of services. Furthermore, the allocation of numbers/addresses/names should be fair, proportionate and consistent with the requirements for equal access.To achieve that, it is necessary:- to ensure the provision, according to harmonized principles, of adequate ranges of numbers and addresses, prefixes and short codes and, where applicable, of adequate naming, for all public telecommunications services,- to ensure the coordination of national positions in international organizations and fora where decisions are taken on numbering/addressing/naming, taking into account possible future developments in numbering/addressing/naming at European level,- to ensure that the relevant national telecommunications numbering/addressing/naming plans are under the supervision of the national regulatory authority, in order to guarantee independence from organizations providing public telecommunications networks or publicly available telecommunications services,- to ensure the effective implementation of number portability in order to remove any obstacles for users in choosing their suppliers,- to ensure that the procedures for allocating individual numbers/addresses/names, prefixes and short codes and/or addressing/numbering ranges are transparent, equitable and timely and that the allocation is carried out in an objective, transparent and non-discriminatory manner, taking into account the principle of proportionality,- to give national regulatory authorities the possibility of laying down conditions for the use in numbering/addressing plans of certain prefixes or certain short codes, in particular where these are used for services of general public interest (e.g. directory services or emergency services), or to ensure equal access.5. Access to frequenciesMember States must ensure that frequencies are made available for telecommunications services in accordance with Community law. Access to frequencies granted by means of licences or other authorizations must comply with the Council resolution of 19 November 1992 on the implementation in the Community of the European Radiocommunications Committee Decisions (**).(*) Directive 97/33/EC of the European Parliament and of the Council of 30 June 1997 on interconnection in telecommunications with regard to ensuring universal service and interoperability through application of the principles of open network provision (ONP) (OJ L 199, 26. 7. 1997, p. 32).(**) OJ C 318, 4. 12. 1992, p. 1.`ANNEX II 'ANNEX IIIDEFINITION OF LEASED LINES THE PROVISION OF WHICH IS TO BE ENCOURAGED IN ACCORDANCE WITH ARTICLE 7 (2) (a)>TABLE>Commission statement The Commission states that, in verifying the full and timely transposition of Community telecommunications Directives into national law, it will take particular care to ensure that the arrangements put in place by the Member States in relation to the costing and financing of universal service do not limit access to the relevant markets.


Avis juridique important

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31973L0358

Council Directive 73/358/EEC of 19 November 1973 amending certain Directives following the enlargement of the Community

Official Journal L 326 , 27/11/1973 P. 0017 - 0018 Finnish special edition: Chapter 3 Volume 5 P. 0182  Greek special edition: Chapter 01 Volume 1 P. 0200  Swedish special edition: Chapter 3 Volume 5 P. 0182

COUNCIL DIRECTIVE  of 19 November 1973  amending certain Directives following the enlargement of the Community  (73/358/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 42, 43, 100 and 209, thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament;  Whereas following the enlargement of the Community the number of votes required for adoption of the opinions of the Committees referred to in certain Directives should be amended and the Directives concerning statistical surveys should be supplemented by determining the territorial divisions for the new Member States,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The figure "twelve" is replaced by "forty-one" in the following:    - Article 18 (2) of the Council Directive of 17 April 1972 (1) on the modernization of farms;       - Article 9 (2) of the Council Directive of 17 April 1972 (2) concerning measures to encourage the cessation of farming and the reallocation of utilized agricultural area for the purposes of structural improvement;       - Article 11 (2) of the Council Directive of 17 April 1972 (3) concerning the provision of socio-economic guidance for and the acquisition of occupational skills by persons engaged in agriculture;       - Article 7 (2) of the Council Directive of 31 July 1972 (4) on the statistical surveys to be made by Member States on milk and milk products;       - Article 9 (3) of the Council Directive of 12 December 1972 (5) on health problems affecting intra-Community trade in fresh meat;       - Article 29 (3) and Article 30 (3) of the Council Directive of 12 December 1972 (6) on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries.          Article 2 The following are added to the Annex to the Council Directive of 26 July 1971 (7) concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain types of fruit trees:   (a) "Denmark : forms a single area;  Ireland : forms a single area;  United Kingdom (1):    1. South Eastern Region,       2. Eastern Region,       3. West Midland Region,       4. South Western Region,       5. Other Regions";  (1)OJ No L 96, 23.4.1972, p. 1. (2)OJ No L 96, 23.4.1972, p. 9. (3)OJ No L 96, 23.4.1972, p. 15. (4)OJ No L 179, 7.8.1972, p. 2. (5)OJ No L 302, 31.12.1972, p. 24. (6)OJ No L 302, 31.12.1972, p. 28. (7)OJ No L 179, 9.7.1971, p. 21.          (b) a footnote:  "(1) These regions correspond to the areas used for statistical surveys by the Ministry of Agriculture, Fisheries and Food."    Article 3    (a) The list of territorial divisions in subparagraph (a) of Article 4 (3) of the Council Directive of 31 July 1972 on the statistical surveys to be made by Member States on milk and milk products shall be completed as follows:  "Denmark : -  Ireland : -  United Kingdom : Scotland, Northern Ireland, Wales, English agricultural regions";       (b) The United Kingdom is hereby authorized, when making returns for 1973, to give estimates for the English agricultural regions.         Article 4 This Directive is addressed to the Member States.     Done at Brussels, 19 November 1973.  For the Council  The President  Ib FREDERIKSEN


title: Commission Directive 2013/47/EU of 2 October 2013 amending Directive 2006/126/EC of the European Parliament and of the Council on driving licences  Text with EEA relevance

text:
               3.10.2013

               EN

               Official Journal of the European Union

               L 261/29

         COMMISSION DIRECTIVE 2013/47/EU
   of 2 October 2013
   amending Directive 2006/126/EC of the European Parliament and of the Council on driving licences
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2006/126/EC of the European Parliament and of the Council of 20 December 2006 on driving licences (1), and in particular Article 8 thereof,
   Whereas:

               (1)

               Commission Directive 2012/36/EU of 19 November 2012 amending Directive 2006/126/EC of the European Parliament and of the Council on driving licences (2) provides for technical adaptation of its Annex II in relation to the specifications for test vehicles taking into account the technical evolution of the different vehicle classes.

               (2)

               Annex II, I, B point 5.2 of Directive 2006/126/EC, as amended by Directive 2012/36/EU, establishes that the vehicles of category A used in tests of skills and behaviour shall comply with certain minimum criteria. In particular, motorcycles used for the test shall have an unladen mass of more than 180 kg, with a power rating of at least 50 kW. If the motorcycle is powered by an internal combustion engine, the cubic capacity of the engine shall be at least 600 cm3. If the motorcycle is powered by an electric motor, the power to weight ratio of the vehicle shall be at least 0,25 kW/kg.

               (3)

               With a view to allowing the training sector to adapt their equipment including motorcycles to technological evolution of the vehicles available on the market, a transitional period should be introduced to allow Member States to authorise the use of category A motorcycles complying with the specifications as existing prior to the amendments introduced by Directive 2012/36/EU until 31 December 2018.

               (4)

               Directive 2006/126/EC should therefore be amended accordingly.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Committee on driving licences,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex II, I, B, point 5.2 of Directive 2006/126/EC concerning vehicles for category A, the following paragraph is added:

      ‘Member States may authorise the use of motorcycles of category A whose unladen mass is below 180 kg, and with a power rating of at least 40 kW and below 50 kW, until 31 December 2018.’

   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 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, 2 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 403, 30.12.2006, p. 18.

      (2)  OJ L 321, 20.11.2012, p. 54.


title: Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU  (Text with EEA relevance)

text:
               1.6.2010

               EN

               Official Journal of the European Union

               L 134/66

         COUNCIL DIRECTIVE 2010/32/EU
   of 10 May 2010
   implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU
   (Text with EEA relevance)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 155(2) thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               The social partners may, in accordance with Article 155(2) of the Treaty on the Functioning of the European Union (the TFEU), jointly request that agreements concluded by them at the level of the Union in matters covered by Article 153 of the TFEU be implemented by a Council decision on a proposal from the Commission.

               (2)

               By letter of 17 November 2008, the European social partner organisations HOSPEEM (the European Hospital and Healthcare Employers’ Association, a sectoral organisation representing employers) and EPSU (the European Federation of Public Services Unions, a European trade union organisation) informed the Commission of their wish to enter into negotiations in accordance with Article 138(4) and Article 139 of the Treaty establishing the European Community (the EC Treaty) (1) with a view to concluding a Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector.

               (3)

               On 17 July 2009 the European social partners signed the text of a Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector.

               (4)

               Since the objectives of the Directive, namely to achieve the safest possible working environment by preventing injuries to workers caused by all medical sharps (including needle-sticks) and protecting workers at risk in the hospital and healthcare sector, cannot be sufficiently achieved by the Member States and can therefore be better achieved at the level of the Union, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

               (5)

               When drafting its proposal for a Directive, the Commission took account of the representativeness of the signatory parties, having regard to the scope of the Agreement, for the hospital and healthcare sector, their mandate and the legality of the clauses in the Framework Agreement and its compliance with the relevant provisions concerning small and medium-sized undertakings.

               (6)

               The Commission informed the European Parliament and the European Economic and Social Committee of its proposal.

               (7)

               The European Parliament adopted on 11 February 2010 a resolution on the proposal.

               (8)

               The purpose of the Framework Agreement as set out in Clause 1 thereof is to further the achievement of one of the objectives of social policy, namely the improvement of working conditions.

               (9)

               Clause 11 allows the Member States and the Community (since 1 December 2009 replaced by the Union) to maintain and introduce provisions which are more favourable to workers’ protection from injuries caused by medical sharps.

               (10)

               The Member States should provide for effective, proportionate and dissuasive penalties in the event of any breach of the obligations under this Directive.

               (11)

               The Member States may entrust the social partners, at their joint request, with the implementation of this Directive, as long as they take all the steps necessary to ensure that they can at all times guarantee the results imposed by this Directive.

               (12)

               In accordance with point 34 of the Interinstitutional agreement on better law-making (2), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   This Directive implements the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector signed by the European social partners HOSPEEM and EPSU on 17 July 2009, as set out in the Annex.
   Article 2
   Member States shall determine what penalties are applicable when national provisions enacted pursuant to this Directive are infringed. The penalties shall be effective, proportionate and dissuasive.
   Article 3
   1.   The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive or shall ensure that the social partners have introduced the necessary measures by agreement by 11 May 2013 at the latest. They shall forthwith inform the Commission thereof.
   When the Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The Member States shall determine how such reference is to be made.
   2.   The 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 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 10 May 2010.

            For the Council

            The President

         Á. GONZÁLEZ-SINDE REIG

      (1)  Renumbered: Articles 154(4) and 155 of the TFEU.

      (2)  OJ C 321, 31.12.2003, p. 1.

      ANNEX

         FRAMEWORK AGREEMENT ON PREVENTION FROM SHARP INJURIES IN THE HOSPITAL AND HEALTHCARE SECTOR

         Preamble

                  1.

                  Health and safety at work is an issue, which should be important to everyone in the hospital and healthcare sector. Taking action to prevent and protect against unnecessary injuries if properly carried out, will have a positive effect on resources;

                  2.

                  Health and safety of workers is paramount and is closely linked to the health of patients. This underpins the quality of care;

                  3.

                  The process of policy making and implementation in relation to medical sharps should be the result of social dialogue;

                  4.

                  HOSPEEM (European Hospital and Healthcare Employers’ Association) and EPSU (European Public Services Union), the recognised European Social partners in the hospital and healthcare sector, have agreed the following:

         General considerations

                  1.

                  Having regard to the Treaty establishing the European Community and in particular Articles 138 and 139 (2) thereof (1);

                  2.

                  Having regard to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (2);

                  3.

                  Having regard to Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work (3);

                  4.

                  Having regard to Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (4);

                  5.

                  Having regard to the Community strategy 2007-2012 on health and safety at work (5);

                  6.

                  Having regard to the Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community (6);

                  7.

                  Having regard to the resolution of the European Parliament of 6 July 2006 on protecting European healthcare workers from blood-borne infections due to needle-stick injuries (2006/2015(INI));

                  8.

                  Having regard to the first and second stage consultation of the European Commission on protecting European healthcare workers from blood-borne infections due to needle-stick injuries;

                  9.

                  Having regard to the outcomes of the EPSU-HOSPEEM technical seminar on needle-stick injuries of 7 February 2008;

                  10.

                  Having regard to the hierarchy of general principles of prevention laid down in Article 6 of Directive 89/391/EEC as well as to the preventative measures defined in Articles 3, 5 and 6 of Directive 2000/54/EC;

                  11.

                  Having regard to the joint ILO/WHO guidelines on health services and HIV/AIDS and to the joint ILO/WHO guidelines on post-exposure prophylaxis to prevent HIV infection;

                  12.

                  With full respect to existing national legislation and collective agreements;

                  13.

                  Whereas action needs to be taken to assess the extent of the incidence of sharp injuries in the hospital and healthcare sector, scientific evidence shows that preventive and protection measures can significantly reduce the occurrence of accidents and infections;

                  14.

                  Whereas a full risk-assessment process is a precondition to take appropriate action to prevent injuries and infections;

                  15.

                  Whereas the employers, and workers’ health and safety representatives need to cooperate to prevent and protect workers against injuries and infections from medical sharps;

                  16.

                  Whereas healthcare workers are primarily but not exclusively concerned by sharp injuries;

                  17.

                  Whereas students undertaking clinical training, as part of their education, are not considered as workers under this agreement, they should be covered by the prevention and protection measures outlined in this agreement, with liabilities being regulated according to national legislation and practice;

         Clause 1:   Purpose

      The purpose of this framework agreement is:

                  —

                  to achieve the safest possible working environment,

                  —

                  to prevent workers’ injuries caused by all medical sharps (including needle-sticks),

                  —

                  to protect workers at risk,

                  —

                  to set up an integrated approach establishing policies in risk assessment, risk prevention, training, information, awareness raising and monitoring,

                  —

                  to put in place response and follow-up procedures.

         Clause 2:   Scope

      This agreement applies to all workers in the hospital and healthcare sector, and all who are under the managerial authority and supervision of the employers. Employers should deploy efforts to ensure that subcontractors follow the provisions laid down in this agreement.

         Clause 3:   Definitions

      Within the meaning of this agreement:

            1.
            Workers: any persons employed by an employer including trainees and apprentices in the hospital and healthcare sector-directly related services and activities. Workers who are employed by temporary employment business within the meaning of Council Directive 91/383/EEC supplementing the measures to encourage improvements in the safety and health at work of workers with fixed-duration employment relationship or a temporary employment relationship (7) fall within the scope of the agreement;

            2.
            Workplaces covered: healthcare organisations/services in public and private sectors, and every other place where health services/activities are undertaken and delivered, under the managerial authority and supervision of the employer;

            3.
            Employers: natural/legal persons/organisations having an employment relationship with workers. They are responsible for managing, organising and providing healthcare and directly related services/activities delivered by workers;

            4.
            Sharps: objects or instruments necessary for the exercise of specific healthcare activities, which are able to cut, prick, cause injury and/or infection. Sharps are considered as work equipment within the meaning of Directive 89/655/EEC on work equipment;

            5.
            Hierarchy of measures: is defined in order of effectiveness to avoid, eliminate and reduce risks as defined in Article 6 of Directive 89/391/EEC and Articles 3, 5 and 6 of Directive 2000/54/EC;

            6.
            Specific preventative measures: measures taken to prevent injury and/or transmission of infection in the provision of hospital and healthcare directly related services and activities, including the use of the safest equipment needed, based on the risk assessment and safe methods of handling the disposal of medical sharps;

            7.
            Workers’ representatives: any person elected, chosen or designated in accordance with national law and/or practice to represent workers;

            8.
            Worker’s health and safety representatives are defined in accordance with Article 3(c) of Directive 89/391/EEC as any person elected, chosen or designated in accordance with national law and/or practices to represent workers where problems arise relating to the safety and health protection of workers at work;

            9.
            Subcontractor: any person who takes action in hospital and healthcare directly related services and activities within the framework of working contractual relations established with the employer.

         Clause 4:   Principles

                  1.

                  A well trained, adequately resourced and secure health service workforce is essential to prevent the risk of injuries and infections from medical sharps. Exposure prevention is the key strategy for eliminating and minimising the risk of occupationally acquired injuries or infections;

                  2.

                  The role of health and safety representatives is key in risk prevention and protection;

                  3.

                  The employer has a duty to ensure the safety and health of workers in every aspect related to the work, including psycho-social factors and work organisation;

                  4.

                  It shall be the responsibility of each worker to take care — as far as possible — of their own safety and health and that of other persons affected by their actions at work, in accordance with their training and the instructions given by their employer;

                  5.

                  The employer shall develop an environment where workers and their representatives are participating in the development of health and safety policies and practices;

                  6.

                  The principle of the following specific preventative measures indicated in clauses 5 to 10 of the present agreement means never assuming that there is no risk. The hierarchy of general principles of prevention according to Article 6 of Directive 89/391/EEC and Articles 3, 5 and 6 of Directive 2000/54/EC is applicable;

                  7.

                  Employers and workers’ representatives shall work together at the appropriate level to eliminate and prevent risks, protect workers’ health and safety, and create a safe working environment, including consultation on the choice and use of safe equipment, identifying how best to carry out training, information and awareness-raising processes;

                  8.

                  Action needs to be taken through a process of information and consultation, in accordance with national laws and/or collective agreements;

                  9.

                  The effectiveness of awareness-raising measures entails shared obligations of the employers, the workers and their representatives;

                  10.

                  In achieving the safest possible workplace a combination of planning, awareness-raising, information, training, prevention and monitoring measures is essential;

                  11.

                  Promote a ‘no blame’ culture. Incident reporting procedure should focus on systemic factors rather than individual mistakes. Systematic reporting must be considered as accepted procedure.

         Clause 5:   Risk assessment

                  1.

                  Risk-assessment procedures shall be conducted in compliance with Articles 3 and 6 of Directive 2000/54/EC, and Articles 6 and 9 of Directive 89/391/EEC;

                  2.

                  Risk assessment shall include an exposure determination, understanding the importance of a well resourced and organised working environment and shall cover all situations where there is injury, blood or other potentially infectious material;

                  3.

                  Risk assessments shall take into account technology, organisation of work, working conditions, level of qualifications, work related psycho-social factors and the influence of factors related to the working environment. This will:

                              —

                              identify how exposure could be eliminated,

                              —

                              consider possible alternative systems.

         Clause 6:   Elimination, prevention and protection

                  1.

                  Where the results of the risk assessment reveal a risk of injuries with a sharp and/or infection, workers’ exposure must be eliminated by taking the following measures, without prejudice to their order:

                              —

                              specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. These procedures shall be regularly reassessed and shall form an integral part of the measures for the information and training of workers referred in clause 8,

                              —

                              eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms,

                              —

                              the practice of recapping shall be banned with immediate effect;

                  2.

                  Having regard to the activity and the risk assessment, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the safety and health of the workers concerned. The following measures are to be applied in the light of the results of the risk assessment:

                              —

                              place effective disposal procedures and clearly marked and technically safe containers for the handling of disposable sharps and injection equipment as close as possible to the assessed areas where sharps are being used or to be found,

                              —

                              prevent the risk of infections by implementing safe systems of work, by:

                                          (a)

                                          developing a coherent overall prevention policy, which covers technology, organisation of work, working conditions, work related psycho-social factors and the influence of factors related to the working environment;

                                          (b)

                                          training;

                                          (c)

                                          conducting health surveillance procedures, in compliance with Article 14 of Directive 2000/54/EC;

                              —

                              use of personal protective equipment;

                  3.

                  If the assessment referred to in clause 5 reveals that there is a risk to the safety and health of workers due to their exposure to biological agents for which effective vaccines exist, workers shall be offered vaccination;

                  4.

                  Vaccination and, if necessary, revaccination shall be carried out in accordance with national law and/or practice, including the determination of the type of vaccines:

                              —

                              workers shall be informed of the benefits and drawbacks of both vaccination and non-vaccination,

                              —

                              vaccination must be offered free of charge to all workers and students delivering healthcare and related activities at the workplace.

         Clause 7:   Information and awareness-raising

      As sharps are considered as work equipment within the meaning of Directive 89/655/EEC (8), in addition to information and written instructions to be provided to workers specified in Article 6 of Directive 89/655/EEC, the employer shall take the following appropriate measures:

                  —

                  to highlight the different risks,

                  —

                  to give guidance on existing legislation,

                  —

                  to promote good practices regarding the prevention and recording of incidents/accidents,

                  —

                  to raise awareness by developing activities and promotional materials in partnership with representative trade unions and/or workers’ representatives,

                  —

                  to provide information on support programmes available.

         Clause 8:   Training

      In addition to measures established by Article 9 of Directive 2000/54/EC, appropriate training shall be made available on policies and procedures associated with sharps injuries, including:

                  —

                  the correct use of medical devices incorporating sharps protection mechanisms,

                  —

                  induction for all new and temporary staff,

                  —

                  the risk associated with blood and body fluid exposures,

                  —

                  preventive measures including standard precautions, safe systems of work, the correct use and disposal procedures, the importance of immunisation, according to the procedures at the workplace,

                  —

                  the reporting, response and monitoring procedures and their importance,

                  —

                  measures to be taken in case of injuries.

            Employers must organise and provide training which is mandatory for workers. Employers must release workers who are required to attend training. This training shall be made available on a regular basis taking into account results of monitoring, modernisation and improvements.

         Clause 9:   Reporting

                  1.

                  This includes the revision of the reporting procedures in place with health and safety representatives and/or appropriate employers/workers representatives. Reporting mechanisms should include local, national and European-wide systems;

                  2.

                  Workers shall immediately report any accident or incident involving sharps to the employers and/or the person in charge, and/or to the person responsible for safety and health at work.

         Clause 10:   Response and follow-up

      Policies and procedures shall be in place where a sharp injury occurs. All workers must be made aware of these policies and procedures. These should be in accordance with European, national/regional legislation and collective agreements, as appropriate.
      In particular the following action shall be taken:

                  —

                  the employer takes the immediate steps for the care of the injured worker, including the provision of post-exposure prophylaxis and the necessary medical tests where indicated for medical reasons, and appropriate health surveillance in accordance with clause 6(2)(c),

                  —

                  the employer investigates the causes and circumstances and records the accident/incident, taking — where appropriate — the necessary action. The worker must provide the relevant information at the appropriate time to complete the details of the accident or incident,

                  —

                  the employer shall, in cases of injury, consider the following steps including counselling of workers where appropriate and guaranteed medical treatment. Rehabilitation, continued employment and access to compensation shall be in accordance with national and/or sectoral agreements or legislation.

            Confidentiality of injury, diagnosis and treatment is paramount and must be respected.

         Clause 11:   Implementation

      This agreement will be without prejudice to existing, future national and Community (9) provisions which are more favourable to workers’ protection from medical sharps’ injuries.
      The signatory parties request the Commission to submit this framework agreement to the Council for a decision in order to make this agreement binding in the Member States of the European Union.
      If implemented through Council decision, at European level and without prejudice to the respective role of the Commission, national courts and the European Court of Justice, the interpretation of this agreement, could be referred by the Commission to the signatory parties who will give their opinion.
      The signatory parties shall review the application of this agreement five years after the date of the Council decision if requested by one of the parties to the agreement.

         Brussels, 17 July 2009.

            For EPSU
            Karen JENNINGS

            For HOSPEEM
            Godfrey PERERA

         (1)  Renumbered: Articles 154 and 155(2) of the TFEU.

         (2)  OJ L 183, 29.6.1989. p. 1.

         (3)  OJ L 393, 30.12.1990, p. 13. Subsequently the Directive has been codified into Directive 2009/104/EC (OJ L 260, 3.10.2009, p. 5).

         (4)  OJ L 262, 17.10.2000, p. 21.

         (5)  COM(2007) 62 final, 21.2.2007.

         (6)  OJ L 80, 23.3.2002, p. 29.

         (7)  OJ L 206, 29.7.1991, p. 19.

         (8)  Subsequently the Directive has been codified into Directive 2009/104/EC.

         (9)  ‘Community’ has been replaced since 1 December 2009 by ‘Union’.