Avis juridique important

|

32000L0070

Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma

Official Journal L 313 , 13/12/2000 P. 0022 - 0024

Directive 2000/70/EC of the European Parliament and of the Councilof 16 November 2000amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasmaTHE 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(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) In addition to being directed at medical devices for in vitro diagnosis, the Commission proposal sought to amend Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(4) in order to extend its scope to medical devices manufactured by using non-viable tissues or substances of human origin derived from those tissues. This amendment was not included in Directive 98/79/EC(5) when it was adopted.(2) This Directive accordingly aims at amending Directive 93/42/EEC so as to include in its scope only devices which incorporate, as an integral part, substances derived from human blood or plasma. However, medical devices incorporating other substances derived from human tissues remain excluded from the scope of the said Directive.(3) The essential aim of any rules governing the production, distribution or use of medical devices must be to safeguard public health.(4) Furthermore, national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices must be harmonised in order to guarantee free movement of such devices within the internal market.(5) Medical devices incorporating, as an integral part, substances derived from human blood or plasma have the same purposes as other medical devices. There is therefore no reason to treat them differently as regards their free circulation.(6) Medical devices incorporating, as an integral part, a substance derived from human blood or plasma and which is liable to act upon the body with action ancillary to that of the device must comply with the provisions of Directive 93/42/EEC and other instruments supplementing the said Directive.(7) A human blood derivative, if used separately, may be considered to be a medicinal product constituent within the meaning of Council Directive 89/381/EEC(6). When it is incorporated into a medical device, the substance must be subject to appropriate checks by analogy with Council Directives 75/318/EEC(7) and 89/381/EEC. These checks will be carried out by the authorities empowered to implement the aforesaid Directives,HAVE ADOPTED THIS DIRECTIVE:Article 1Directive 93/42/EEC is hereby amended as follows:1. Article 1 shall be amended as follows:(a) the following paragraph shall be inserted:"4 a. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 89/381/EEC(8) and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a 'human blood derivative', that device must be assessed and authorised in accordance with this Directive.";(b) in paragraph 5, point (e) shall be replaced by the following:"(e) human blood, blood products, plasma or blood cells of human origin with the exception of human blood derivatives;"2. Annex I shall be amended as follows:(a) in section 7.4, the following subparagraphs shall be added:"Where a device incorporates, as an integral part, a human blood derivative, the notified body shall seek a scientific opinion from the European Agency for the Evaluation of Medicinal Products (EMEA) on the quality and safety of the derivative, taking account of the appropriate Community provisions and, in particular, by analogy with the provisions of Directives 75/318/EEC and 89/381/EEC. The usefulness of the derivative as a part of the medical device shall be verified, taking account of the intended purpose of the device.In accordance with Article 4(3) of Directive 89/381/EEC, a sample from each batch of bulk and/or finished product of the human blood derivative shall be tested by a State laboratory or a laboratory designated for that purpose by a Member State."(b) in section 13.3, the following subparagraph shall be added:"(n) in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative."3. Annex II shall be amended as follows:(a) in section 3.2(c), the fifth indent shall be replaced by the following:"- a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device.";(b) in section 4.3, the second and third subparagraphs shall be replaced by the following subparagraphs:"In the case of devices referred to in Annex I, section 7.4, first subparagraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent bodies designated by the Member States in accordance with Directive 65/65/EEC before taking a decision. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, section 7.4, second subparagraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.";(c) the following section shall be added:"8. Application to the devices referred to Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC."4. Annex III shall be amended as follows:(a) in section 3, the sixth indent shall be replaced by the following:"- a declaration stating whether or not the device incorporates, as an integral part, a substance or human blood derivative, referred to in section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device.";(b) in section 5, the second and third subparagraphs shall be replaced by the following subparagraphs:"In the case of devices referred to in Annex I, section 7.4, first subparagraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent bodies designated by the Member States in accordance with Directive 65/65/EEC before taking a decision. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.In the case of devices referred to in Annex I, section 7.4, second subparagraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA."5. In Annex IV, the following section shall be added:"9. Application to devices referred to in Article 1(4a):In the case of section 5, upon completing the manufacture of each batch of devices referred to in Article 1(4a), and in the case of verification under section 6, the manufacturer shall inform the notified body of the release of this batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC."6. In Annex V, the following section shall be added:"7. Application to devices referred to in Article 1(4a):Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC."7. In Annex IX, Part III, section 4.1, the following subparagraph shall be added:"All devices incorporating, as an integral part, a human blood derivative are in Class III."Article 2Implementation, transitional provisions1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 13 December 2001. They shall immediately inform the Commission thereof.Member States shall apply these measures with effect from 13 June 2002.When Member States adopt these measures, 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. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.3. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 16 of Directive 93/42/EEC for conformity assessment take account of all relevant information regarding the characteristics and performance of such devices, including in particular the results of any tests and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices.4. During a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of such devices which conform to the rules in force in their territory on the date on which this Directive enters into force. For a further period of two years, the said devices may be put into service.Article 3This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 16 November 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentR. Schwarzenberg(1) OJ C 172, 7.7.1995, p. 21 andOJ C 87, 18.3.1997, p. 9.(2) OJ C 18, 22.1.1996, p. 12.(3) Opinion of the European Parliament of 12 March 1996 (OJ C 96, 1.4.1996, p. 31), Council Common Position of 29 June 2000 (OJ C 245, 25.8.2000, p. 19) and European Parliament Decision of 24 October 2000.(4) OJ L 169, 12.7.1993, p. 1. Directive as amended by Directive 98/79/EC of the European Parliament and of the Council (OJ L 331, 7.12.1998, p. 1).(5) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).(6) Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (OJ L 181, 28.6.1989, p. 44).(7) Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ L 147, 9.6.1975, p. 1). Directive as last amended by Commission Directive 1999/83/EC (OJ L 243, 15.9.1999, p. 9).(8) Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (OJ L 181, 28.6.1989, p. 44).


Avis juridique important

|

31992L0058

Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)

Official Journal L 245 , 26/08/1992 P. 0023 - 0042 Finnish special edition: Chapter 5 Volume 5 P. 0182  Swedish special edition: Chapter 5 Volume 5 P. 0182

COUNCIL DIRECTIVE 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)THE COUNCIL OF THE  EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 118 a thereof,  Having regard to the proposal from the Commission (1), submitted following consultation of the Advisory Committee on Safety, Hygiene and Health Protection at Work,  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 118 a of the Treaty provides that the Council must adopt, by means of directives, minimum requirements to encourage improvements, especially in the working environment, as regards the health and safety of workers;  Whereas, under that Article, such directives must avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings;  Whereas the Commission communication on its programme concerning safety, hygiene and health at work (4) provides for a revision and extension of the scope of Council Directive 77/576/EEC of 25 July 1977 on the approximation of the laws, regulations and  administrative provisions of the Member States relating to the provision of safety signs at places at work (5);  Whereas, in its Resolution of 21 December 1987 on safety, hygiene, and health at work (6), the Council took note of the Commission's intention of submitting to it within a short period of time a proposal for revising and extending the abovementioned  Directive;  Whereas Directive 77/576/EEC should be replaced by this Directive for the sake of consistency and clarity;  Whereas this Directive is an individual Directive within the meaning of Article 16 (1) of 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 (7); wheres the  provisions of Directive 89/391/EEC therefore apply in full to the provision of safety and health signs at work, without prejudice to more stringent and/or specific provisions contained in this Directive;  Whereas existing Community rules relate mainly to safety signs and the marking of dangerous obstacles and locations, and are therefore restricted to a limited number of types of signs;  Whereas the effect of this restriction is that some hazards are not appropriately marked; whereas new types of signs should therefore be introduced in order to enable employers and workers to identify and avoid risks to safety and/or health at work;  Whereas safety and/or health signs must be provided where hazards cannot be adequately reduced by techniques for collective protection or by measures, methods or procedures used in the organization of work;  Whereas the many differences between the safety and/or health signs currently in use in the Member States lead to uncertainty, and this may become more widespread with the free movement of workers within the internal market;  Whereas the use of standardized signs at work is, in general, likely to reduce the hazards which may arise from linguistic and cultural differences between workers;  Whereas this Directive constitutes a tangible step towards developing the social dimension of the internal market;  Whereas, pursuant to Decision 74/325/EEC (8), as last amended by the Act of Accession of Spain and Portugal, the Advisory Committee on Safety, Hygiene and Health Protection at Work is to be consulted by the Commission on the drafting of proposals in  this field,  HAS ADOPTED THIS DIRECTIVE:  SECTION I GENERAL PROVISIONS   Article 1  Object 1. This Directive, which is the ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum requirements for the provision of safety and/or health signs at work.  2. This Directive shall not apply to signs for the placing on the market of dangerous substances and preparations, products and/or equipment, unless other Community provisions make specific reference thereto.  3. This Directive shall not apply to signs used for regulating road, rail, inland waterway, sea or air transport.  4. The provisions of Directive 89/391/EEC shall apply in full to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions in this Directive.  Article 2  Definitions For the purposes of this Directive:  (a) safety and/or health signs means signs referring to a specific object, activity or situation and providing information or instructions about safety and/or health at work by means of a signboard, a colour, an illuminated sign or acoustic signal, a  verbal communication or a hand signal, as the case may be;  (b) prohibition sign means a sign prohibiting behaviour likely to incur or cause danger;  (c) warning sign means a sign giving warning of a hazard or danger;  (d) mandatory sign means a sign prescribing specific behaviour;  (e) emergency escape or first-aid sign means a sign giving information on emergency exits or first-aid or rescue facilities;  (f) information sign means a sign providing information other than that referred to in (b) to (e);  (g) signboard means a sign which provides specific information by a combination of a geometric shape, colours and a symbol or pictogram and which is rendered visible by lighting of sufficient intensity;  (h) supplementary signboard means a signboard used together with one of the signs described under (g), which provides supplementary information;  (i) safety colour means a colour to which a specific meaning is assigned;  (j) Symbol or pictogram means a figure which describes a situation or prescribes specific behaviour and which is used on a signboard or illuminated surface;  (k) illuminated sign means a sign produced by a device made of transparent or translucent materials which are illuminated from the inside or the rear in such a way as to give the appearance of a luminous surface;  (l) acoustic signal means a coded sound signal which is released and transmitted by a device designed for that purpose, without the use of a human or artificial voice;  (m) verbal communication means a predetermined spoken message communicated by a human or artificial voice;  (n) hand signal a movement and/or position of the arms and/or hands, in coded form, for guiding persons who are carrying out manoeuvres which constitute a hazard or danger for workers.   SECTION II EMPLOYERS' OBLIGATIONS   Article 3  General rules 1. Employers shall provide safety and/or health signs as laid down in this Directive where hazards cannot be avoided or adequately reduced by techniques for collective protection or measures, methods or procedures used in the organization of work, or  ensure that such signs are in place.  Employers shall take into account any risk evaluation made in accordance with Article 6 (3) (a) of Directive 89/391/EEC.  2. Without prejudice to the provisions of Annex V, the signs used for road, rail, inland waterway, sea and air transport shall be installed, wherever appropriate for such forms of transport, inside undertakings and/or firms.  Article 4  Safety and/or health signs used for the first time Without prejudice to Article 6, a safety and/or health sign used at work for the first time on or after the date referred to in Article 11 (1) first subparagraph must fulfil the minimum requirements set out in Annexes I to IX.  Article 5  Safety and/or health signs already in use Without prejudice to Article 6, a safety and/or health sign which was already in use at work before the date referred to in Article 11 (1) first subparagraph must fulfil the minimum requirements set out in Annexes I to IX by no later than eighteen  months after that date.  Article 6  Exemptions 1. Taking account of the types of activity and/or size of the undertakings concerned, Member States may specify categories of undertakings allowed to replace totally, partially or temporarily the illuminated signs, and/or acoustic signals provided for  in this Directive by alternative measures which afford the same level of protection.  2. Member States may derogate, after consulting both sides of industry, from the application of Annex VIII, section 2 and/or Annex IX, section 3, whilst laying down alternative measures guaranteeing the same level of protection.  3. Member States shall consult, in accordance with national laws and/or practice, employers' and workers' organizations when implementing paragraph 1.  Article 7  Information and instruction for workers 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all the measures to be taken concerning the safety and/or health signs used at work.  2. Without prejudice to Article 12 of Directive 89/391/EEC, workers must be given suitable instruction, in particular in the form of specific directions concerning the safety and/or health signs used at work.  In particular, the instruction referred to in the first subparagraph shall cover the meaning of the signs, especially signs incorporating words, and the general and specific behaviour to be adopted.  Article 8  Consultation of workers and workers' participation Consultation and participation of workers and/or their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive, including Annexes I to IX.   SECTION III MISCELLANEOUS PROVISIONS   Article 9  Adaptation of the Annexes Adaptations of a technical nature to Annexes I to IX shall be adopted, in accordance with the procedure provided for in Article 17 of Directive 89/391/EEC, in the light of:  - the adoption of directives on technical harmonization and standadization concerning the design and manufacture of safety and/or health signs or devices at work,  - technical progress, changes in international rules or specifications and advances in knowledge in the field of safety and/or health signs at work.  Article 10  1. Directive 77/576/EEC shall be repealed on the date referred to in Article 11 (1), first subparagraph.  However, in the cases referred to in Article 5, that Directive shall continue to apply for a maximum period of eighteen months following that date.  2. Any reference to the repealed Directive shall be taken to refer to the corresponding provisions of this Directive.  Article 11  Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions required to comply with this Directive no later than 24 June 1994.  They shall immediately inform the Commission thereof.  2. When Member States adopt these measures 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 a reference shall be laid down by the Member  States.  3. Member States shall communicate to the Commission the text of the provisions of domestic law which they have already adopted or adopt in the field covered by this Directive.  4. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the views of employers and workers.  The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health at Work thereof.  5. The Commission shall forward periodically to the European Parliament, the Council and the Economic and Social Committee a report on the implementation of this Directive, taking into account paragraphs 1 to 4.  Article 12  This Directive is addressed to the Member States.  Done at Luxembourg, 24 June 1992.  For the Council The President José da SILVA PENEDA (1) OJ No C 53, 28. 2. 1991, p. 46 and OJ No C 279, 26. 10. 1991, p. 13.(2) OJ No C 240, 16. 9. 1991, p. 102 and OJ No C 150, 15. 6. 1992.(3) OJ No C 159, 17. 6. 1991, p. 9.(4) OJ No C 28, 3. 2. 1988, p. 3.(5) OJ No L 229, 7. 9. 1977, p. 12.  Last amended by Commission Directive 79/640/EEC. (OJ No L 183, 19. 7. 1979, p. 11.)(6) OJ No C 28, 3. 2. 1989, p. 1.(7) OJ No L 183, 29. 6. 1989, p. 1.(8) OJ No L 185, 9. 7. 1974, p. 15.   ANNEX I  GENERAL MINIMUM REQUIREMENTS CONCERNING SAFETY AND/OR HEALTH SIGNS AT WORK  1.   Preliminary remarks 1.1. Where health and/or safety signs are required by the general rule in Article 3 of the Directive, they must conform to the specific requirements in Annexes II to IX.  1.2. This Annex introduces those requirements, describes the different uses of safety and/or health signs, and gives general rules on the interchanging and combining of signs.  1.3. Health and/or safety signs must be used only to convey the message or information specified in the Directive.  2. Types of signs 2.1. Permanent signs 2.1.1. Permanent signboards must be used for signs relating to prohibitions, warnings and mandatory requirements and the location and identification of emergency escape routes and first-aid facilities.  Signboards and/or a safety colour must be used to mark permanently the location and identification of fire-fighting equipment.  2.1.2. Signboards on containers and pipes must be placed as laid down in Annex III.  2.1.3. Places where there is a risk of colliding with obstacles or of falling must be permanently marked with a safety colour and/or with signboards.  2.1.4. Traffic routes must be permanently marked with a safety colour.  2.2. Occasional signs 2.2.1. Illuminated signs, acoustic signals and/or verbal communication must be used where the occasion requires, taking into account the possibilities for interchanging and combining signs set out in Section 3, to signal danger, to call persons to take  a specific course of action and for the emergency evacuation of persons.  2.2.2. Hand signals and/or verbal communication must be used where the occasion requires, to guide persons carrying out hazardous or dangerous manoeuvres.  3. Interchanging and combining signs 3.1. Any one of the following may be used if equally effective:  - a safety colour or a signboard to mark places where there is an obstacle or a drop,  - illuminated signs, acoustic signals or verbal communication,  - hand signals or verbal communication.  3.2. Some types of signs may be used together:  - illuminated signs and acoustic signals,  - illuminated signs and verbal communication,  - hand signals and verbal communication.  4. The instructions in the table below apply to all signs incorporating a safety colour:     Colour Meaning or purpose  Instructions and information Red Prohibition sign Dangerous behaviour Danger alarm Stop, shutdown, emergency cutout devices Evacuate Fire-fighting equipment Identification and location Yellow or Amber Warning sign Be careful, take precautions Examine Blue Mandatory sign Specific behaviour or action  Wear personal protective equipment Green Emergency escape, first aid sign Doors, exits, routes, equipment, facilities No danger Return to normal  5. The effectiveness of a sign must not be adversely affected by:  5.1. the presence of another emission source of the same type which interferes with visibility or audibility; therefore, in particular,  5.1.1. the placing of too many signs too close together should be avoided;  5.1.2. two illuminated signs which are likely to be confused are not to be used at the same time;  5.1.3. an illuminated sign is not to be used in the proximity of another similar illuminated source;  5.1.4. two acoustic signals are not to be used at the same time;  5.1.5. an acoustic signal is not be used if there is too much ambient noise;  5.2. poor design, insufficient number, incorrect positioning, poor state of repair or incorrect functioning of the signs or signalling devices.  6. Depending on requirements, signs and signalling devices must be cleaned, maintained, checked, repaired, and if necessary replaced on a regular basis to ensure that they retain their intrinsic and/or functional qualitities.  7. The number and positioning of signs or signalling devices to be installed will depend on the extent of the hazards or dangers or on the zone to be covered.  8. Signs requiring some form of power must be provided with a guaranteed emergency supply in the event of a power cut, unless the hazard has thereby been eliminated.  9. The triggering of an illuminated sign and/or acoustic signal indicates when the required action should start, the sign or signal must be activated for as long as the action requires.  Illuminated signs and acoustic signals must be reactivated immediately after use.  10. Illuminated signs and acoustic signals must be checked to ensure that they function correctly and that they are effective before they are put into service and subsequently at sufficiently frequent intervals.  11. If the hearing or the sight of the workers concerned is impaired, including impairment caused by the wearing of personal protective equipment, measures must be taken to supplement or replace the signs concerned.  12. Areas, rooms or enclosures used for the storage of significant quantities of dangerous substances or preparations must be indicated by a suitable warning sign taken from section 3.2. of Annex II, or marked as provided in section 1 of Annex III,  unless the labelling of the individual packages or containers is adequate for this purpose.   ANNEX II  MINIUM GENERAL REQUIREMENTS CONCERNING SIGNBOARDS  1.  Intrinsic features 1.1. The shape and colours of signboards are set out in section 3, in accordance with their specific object (signboards indicating a prohibition, a warning, a mandatory action, an escape route, an emergency or fire-fighting equipment).  1.2. Pictograms must be as simple as possible and should contain only essential details.  1.3. The pictograms used may be slightly different from or more detailed than those shown in section 3, provided that they convey the same meaning and that no difference or adaptation obscures the meaning.  1.4. Signboards are to be made of shock and weather-resistant material suitable for the surrounding environment.  1.5. The dimensions and colorimetric and photometric features of signoboards must be such that they can be easily seen and understood.  2. Conditions of use 2.1. Signboards are in principle to be installed at a suitable height and in a position appropriate to the line of sight, taking account of any obstacles, either at the access point to an area in the case of a general hazard, or in the immediate  vicinity of a specific hazard or object and in a well-lit and easily accessible and visible location.  Without prejudice to the provisions of Directive 89/654/EEC, phosphorescent colours, reflective materials or artificial lighting should be used where the level of natural light is poor.  2.2. The signboard must be removed when the situation to which it refers ceases to exist.     ANNEX III  MINIMUM REQUIREMENTS GOVERNING SIGNS ON CONTAINERS AND PIPES  1. Containers used at work for dangerous substances or preparations defined in Directives 67/548/EEC (¹) and 88/379/EEC (²) and containers used for the storage of such dangerous substances or  preparations, together with the visible pipes containing or transporting dangerous substances and preparations, must be labelled (pictogram or symbol against a coloured background) in accordance with those Directives.  Paragraph 1 does not apply to containers used at work for brief periods nor to containers whose contents change frequently, provided that alternative adequate measures are taken, in particular for information and/or training, which guarantee the same  level of protection.  The labels referred to in paragraph 1 may be:  - replaced by warning signs as provided for in Annex II, using the same pictograms or symbols,  - supplemented by additional information, such as the name and/or formula of the dangerous substance or preparation and details of the hazard,  - for the transporting of containers at the place of work, supplemented or replaced by signs applicable throughout the Community for the transport of dangerous substances or preparations.  2. Signs must be mounted as follows:  - on the visible side(s),  - in unpliable, self-adhesive or painted form.  3. Where appropriate, the signs referred to in section 1 of this Annex must have the intrinsic features defined in section 1.4. of Annex II and must fulfil the conditions of use for signboards laid down in section 2 of Annex II.  4. Without prejudice to sections 1, 2 and 3, the labels used on pipes must be positioned visibly in the vicinity of the most dangerous points, such as valves and joint, and at reasonable intervals.  5. Areas, rooms or enclosures used for the storage of significant quantities of dangerous substances or preparations must be indicated by a suitable warning sign taken from section 3.2 of Annex II, or marked as provided in section 1 of Annex III, unless  the labelling of the individual packages or containers is adequate for this purpose, taking into account Annex II, point 1.5 with regard to dimensions.  Stores of a number of dangerous substances or preparations may be indicated by the warning sign for general danger.  The signs or labels referred to above must be positioned, as appropriate, near the storage area or on the door leading into the storage room.  (¹) OJ No L 196, 16. 8. 1967, p. 1.  (²) OJ No L 187, 16. 7. 1988, p. 14.   ANNEX IV  MINIMUM REQUIREMENTS FOR THE IDENTIFICATION AND LOCATION OF FIRE-FIGHTING EQUIPMENT  1. Preliminary remark This Annex applies to equipment used exclusively for fire-fighting purposes.  2. Fire-fighting equipment must be identified by using a specific colour for the equipment and placing a location signboard, and/or by using a specific colour for the places where such equipment is kept, or their access points.  3. The colour for identifying this equipment is red.  The red area must be sufficiently large to allow the equipment to be identified easily.  4. The signboards provided for in section 3.5 of Annex Ii must be used to mark the locations of this equipment.   ANNEX V  MINIMUM REQUIREMENTS GOVERNING SIGNS USED FOR OBSTACLES AND DANGEROUS LOCATIONS, AND FOR MARKING TRAFFIC ROUTES  1. Signs for obstacles and dangerous locations 1.1. Places where there is a risk of colliding with obstacles, of falling or of objects falling should be marked with alternating yellow and black, or red and white stripes in built-up zones in the undertaking to which workers have access during their  work.  1.2. The dimensions of the markings must be commensurate with the scale of the obstacle or dangerous location in question.  1.3. The yellow and black or red and white stripes must be at an angle of approximately 45o and of more or less equal size.  1.4. Example:  2. Marking of traffic routes 2.1. Where the use and equipment of rooms so requires for the protection of workers, traffic routes for vehicles must be clearly identified by continous stripes in a clearly visible colour, preferably white or yellow, taking into account the colour of  the ground.  2.2. The stripes must be located so as to indicate the necessary safe distance between the vehicles and any object which may be near by, and between pedestrians and vehicles.  2.3. Permanent traffic routes in built-up areas outdoors should, as far as is practicable, be similarly marked, unless they are provided with suitable barriers or pavements.   ANNEX VI  MINIMUM REQUIREMENTS FOR ILLUMINATED SIGNS  1. Intrinsic features 1.1. The light emitted by a sign must produce a luminous contrast which is appropriate to its environment, in accordance with the intended conditions of use of the sign, but without producing glare for an excessive amount of light or poor visibility as  a result of insufficient light.  1.2. The luminous area emitting a sign may be of a single colour or contain a pictogram on a specified background.  1.3. The single colour must correspond to the table of colours and their meanings set out in section 4 of Annex I.  1.4. Likewise, when the sign contains a pictogram, the latter must comply with all the relevant rules set out in Annex II.  2. Specific rules governing use 2.1. If a device can emit both continuous and intermittent signs, the intermittent sign should be used to indicate a higher level of danger or a more urgent need for the requested/imposed intervention or action than is indicated by the continuous sign.   The duration of each flash and the frequency of the flashers of an intermittent illuminated sign must be such as to - ensure the proper perception of the message, and - avoid any confusion either between different illuminated signs or with a continuous illuminated sign.  2.2. If a flashing sign is used instead of - or together with - an acoustic signal, identical codes must be used.  2.3. Devices for emitting flashing signs in the event of grave danger must be under special surveillance or be fitted with an auxiliary lamp.   ANNEX VII  MINIMUM REQUIREMENTS FOR ACOUSTIC SIGNS  1. Intrinsic features 1.1. Acoustic signals must:  (a) have a sound level which is considerably higher than the level of ambient noise, so that it is audible without being excessive or painful;  (b) be easily recognizable, particularly in terms of pulse length and the interval between pulses or groups of pulses, and be clearly distinct from any other acoustic signal and ambient noises. 1.2. If a device can emit an acoustic signal at variable and constant frequencies, the variable frequency should be used to indicate a higher level of danger or a more urgent need for the requested/imposed intervention or action in relation to the  stable frequency.  2. Code The signal for evacuation must be continuous.   ANNEX VIII  MINIMUM REQUIREMENTS FOR VERBAL COMMUNICATION  1. Intrinsic features 1.1. Verbal communication between a speaker or emitter and one or more hearers is to take the form of (sometimes coded) short texts, phrases, groups of words and/or individual words.  1.2. Spoken messages are to be as short, simple and clear as possible; the verbal skills of the speaker and the hearing abilities of the hearer(s) must be such as to ensure reliable verbal communication.  1.3. Verbal communication is direct (by means of the human voice) or indirect (by means of a human or artificial voice which is broadcast by whatever means is appropriate).  2. Specific rules governing use 2.1. The persons involved must have a good knowledge of the language used so that they are able to pronounce and understand the spoken message correctly and consequently behave in a way which is appropriate to health and/or safety.  2.2. If verbal communication is used instead of - or together with - gestures, code words should be used such as:   - start to indicate the start of a command   - stopto interrupt or end a movement  - endto stop the operation  - raiseto have a load raised  - lowerto have a load lowered  - forwards - backwards - right - left aa to be coordinated with the corresponding hand signals  - dangerfor an emergency stop  - quicklyto speed up a movement for safety reasons.   ANNEX IX  MINIMUM REQUIREMENTS FOR HAND SIGNALS  1. Features Hand signals must be precise, simple, expansive, easy to make and to understand, and clearly distinct from other such signals.  Where both arms are used at the same time, they must be moved symmetrically and for giving one sign only.  Provided that they fulfil the conditions given above, the signals used may vary slightly from or be more detailed than those shown in section 3; they must, however, be equally meaningful and comprehensible.  2. Specific rules governing use 2.1. The person giving the signs, hereinafter referred to as the 'signalman', will use arm/hand movements to give manoeuvring instructions to the person receiving the signs, hereinafter referred to as the (operator).  2.2. The signalman must be able to monitor all manoeuvres visually without being endangered thereby.  2.3. The signalman's duties must consist exclusively of directing manoeuvres and ensuring the safety of workers in the vicinity.  2.4. If the conditions described in point 2.2 are not fulfilled, one or more extra singnalmen should be deployed.  2.5. The operator must interrupt the ongoing manoeuvre in order to request new instructions when he is unable to carry out the orders he has received with the necessary safety guarantees.  2.6. Accessories:  The operator must be able to recognize the signalman without difficulty.  The signalman is to wear one or more appropriate distinctive items, e.g. a jacket, helmet, sleeves or armbandds, or carry bats.  The distinctive items are to be brightly coloured, preferably all of the same colour and for the exclusive use of signalmen.  3. Coded signals to be used Preliminary remark:  The following set of coded signals are without prejudice to other codes applicable at Community level, used for the same manoeuvres in certain sectors:    Meaning Description Illustration  3.   Meaning Description Illustration A. General signals START Attention Start of  command both arms are extended horizontally with the palms facing forward STOP Interruption End of movement the right arm points upwards with the palm facing forwards END of the operation both hands are clasped at chest height B. Vertical movements RAISE the right arm points upwards with the palm facing forward and slowly makes a circle LOWER the right arm points downwards with the palm facing inwards and slowly makes a circle VERTICAL DISTANCE the hands indicate the relevant distance 3.   Meaning Description Illustration C. Horizontal Movements MOVE FORWARDS both arms are bent with the palms facing upwards, and the forearms make slow movements towards the body MOVE BACKWARDS both arms are bent with the palms facing downwards, and the forearms make slow movements away from the body RIGHT to the  signalman's the right arm is extended more or less horizontally with the palm facing downwards and slowly makes small movements to the right LEFT to the signalman's the left arm is extended more or less horizontally with the palm facing downwards and slowly makes small movements to the left HORIZONTAL DISTANCE the hands indicate the relevant distance  3.   Meaning Description Illustration D. Danger DANGER Emergency stop both arms point upwards with the palms facing forwards QUICK all movements faster  SLOW all movements slower


title: Commission Directive 2007/52/EC of 16 August 2007 amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (Text with EEA relevance )

text:
               17.8.2007

               EN

               Official Journal of the European Union

               L 214/3

      COMMISSION DIRECTIVE 2007/52/EC
   of 16 August 2007
   amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances
   (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 Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish 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 ethoprophos, pirimiphos-methyl and fipronil.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For ethoprophos and pirimiphos-methyl the rapporteur Member State was the United Kingdom and all relevant information was submitted on 19 January 2004 and 4 November 2003 respectively. For fipronil, the rapporteur Member State was France and all relevant information was submitted on 10 February 2004.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 3 March 2006 for ethoprophos, on 10 August 2005 for pirimiphos-methyl, on 3 March 2006 for fipronil, in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 March 2007 in the format of the Commission review reports for ethoprophos, pirimiphos-methyl and fipronil.

               (4)

               It has appeared from the various examinations made that plant protection products containing ethoprophos, pirimiphos-methyl and fipronil 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 reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points concerning ethoprophos, pirimiphos-methyl and fipronil. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that ethoprophos, pirimiphos-methyl and fipronil should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers.

               (6)

               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.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing ethoprophos, pirimiphos-methyl and fipronil to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (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 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 March 2008 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 April 2008.
   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 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing ethoprophos, pirimiphos-methyl and fipronil as active substances by 31 March 2008.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to ethoprophos, pirimiphos-methyl and fipronil are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing ethoprophos, pirimiphos-methyl and fipronil 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 30 September 2007 at the latest, Member States shall 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 and taking into account part B of the entry in Annex I to that Directive concerning ethoprophos, pirimiphos-methyl and fipronil respectively. 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.
   Following that determination Member States shall:

               (a)

               in the case of a product containing ethoprophos, pirimiphos-methyl or fipronil as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or

               (b)

               in the case of a product containing ethoprophos, pirimiphos-methyl or fipronil as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 October 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 16 August 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

      (2)  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  EFSA Scientific Report (2006) 66, 1-72, Conclusion regarding the peer review of the pesticide risk assessment of the active substance ethoprophos (finalised: 3 March 2006). EFSA Scientific Report (2005) 44, 1-53, Conclusion regarding the peer review of the pesticide risk assessment of the active substance pirimiphos-methyl (finalised: 10 August 2005). EFSA Scientific Report (2006) 65, 1-110, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fipronil (finalised: 3 March 2006 version of 12 April 2006).

      (5)  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. 27).

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification Nos

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘161

                     ethoprophos
                     CAS No: 13194-48-4
                     CIPAC No: 218

                        O-ethyl S,S-dipropyl phosphorodithioate

                     > 940 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as nematicide and insecticide in soil application can be authorised.
                     Authorisations should be limited to professional users.
                     PART B
                     In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the residues and evaluate the dietary exposure of consumers in view of future revisions of Maximum Residue Levels,

                                 —

                                 the operator safety. Authorised conditions of use must prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of closed transfer system for the distribution of the product,

                                 —

                                 the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil.

                           The concerned Member States shall request the submission of further studies to confirm the short and long term risk assessment for birds and for earthworms eating mammals. They shall ensure that the notifiers at whose request ethoprophos has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     162

                     pirimiphos-methyl
                     CAS No: 29232-93-7
                     CIPAC No: 239

                        O-2-diethylamino-6-methylpyrimidin-4-yl

                        O,O-dimethylphosphorothioate

                     > 880 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as insecticide for post-harvest storage can be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure,

                                 —

                                 the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

                           The Member States concerned shall request the submission of further studies to confirm the operator exposure assessment. They shall ensure that the notifiers at whose request pirimiphos-methyl has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     163

                     Fipronil
                     CAS No: 120068-37-3
                     CIPAC No: 581

                     (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile

                     ≥ 950 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as insecticide for use as seed treatment may be authorised. The seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to:

                                 —

                                 the packaging of the marketed products to avoid the generation of photo-degradation products of concern,

                                 —

                                 the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

                                 —

                                 the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees,

                                 —

                                 the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application.

                           Conditions of authorisation should include risk mitigation measures, where appropriate.
                     The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds and mammals, and honey bees, especially bee brood. They shall ensure that the notifier at whose request fipronil has been included in this Annex provide such studies to the Commission within one year from the entry into force of this Directive.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Directive 2008/110/EC of the European Parliament and of the Council of 16 December 2008 amending Directive 2004/49/EC on safety on the Community’s railways (Railway Safety Directive) (Text with EEA relevance)

text:
               23.12.2008

               EN

               Official Journal of the European Union

               L 345/62

      DIRECTIVE 2008/110/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 16 December 2008
   amending Directive 2004/49/EC on safety on the Community’s railways (Railway Safety Directive)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 71(1) 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)

               With a view to pursuing the efforts to create a single market in rail transport services, the European Parliament and the Council have adopted Directive 2004/49/EC (3) establishing a common regulatory framework for railway safety.

               (2)

               Originally, authorisation procedures for placing in service railway vehicles were dealt with by Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system (4) and Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the conventional rail system (5) for new or upgraded parts of the Community rail system, and Directive 2004/49/EC for vehicles already in use. In accordance with better regulation, and with a view to simplifying and modernising Community legislation, all provisions regarding authorisations for placing railway vehicles in service should be incorporated in a single legal text. Therefore, the current Article 14 of Directive 2004/49/EC should be deleted and a new provision regarding authorisation of placing in service vehicles already in use should be included in Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (recast) (6), (hereinafter referred to as the ‘Railway Interoperability Directive’), that has replaced Directives 96/48/EC and 2001/16/EC.

               (3)

               The entry into force of the 1999 Convention concerning International Carriage by Rail (COTIF) on 1 July 2006 brought in new rules governing contracts for the use of vehicles. According to the CUV (Uniform Rules concerning Contracts of Use of Vehicles in International Rail Traffic) appended thereto, wagon keepers are no longer obliged to register their wagons with a railway undertaking. The former ‘Regolamento Internazionale Veicoli’ (RIV) Agreement between railway undertakings has ceased to apply and was partially replaced by a new private and voluntary agreement (General Contract of Use for Wagons, GCU) between railway undertakings and wagon keepers whereby the latter are in charge of the maintenance of their wagons. In order to reflect these changes and to facilitate the implementation of Directive 2004/49/EC as far as safety certification of railway undertakings is concerned, the concept of the ‘keeper’ and the concept of ‘entity in charge of maintenance’ should be defined, as well as the specification of the relationship between these entities and railway undertakings.

               (4)

               The definition of the keeper should be as close as possible to the definition used in the 1999 COTIF Convention. Many entities can be identified as a keeper of a vehicle, for example, the owner, a company making business out of a fleet of wagons, a company leasing vehicles to a railway undertaking, a railway undertaking or an infrastructure manager using vehicles for maintaining its infrastructure. These entities have the control over the vehicle with a view to its use as a means of transport by the railway undertakings and the infrastructure managers. In order to avoid any doubt, the keeper should be clearly identified in the National Vehicle Register (NVR) provided for in Article 33 of the Railway Interoperability Directive.

               (5)

               In order to ensure consistency with existing railway legislation and avoid undue burden, Member States should be allowed to exclude heritage, museum and tourist railways from the scope of this Directive.

               (6)

               Before a vehicle is placed in service or used on the network, an entity in charge of its maintenance should be identified in the NVR. A railway undertaking, an infrastructure manager or a keeper could be an entity in charge of maintenance.

               (7)

               Member States should be allowed to fulfil the obligations to identify the entity in charge of maintenance and to certify it through alternative measures in the case of vehicles registered in a third country and maintained according to the law of that country, vehicles which are used on networks or lines the track gauge of which is different from that of the main rail network within the Community and for which the requirement to identify an entity in charge of maintenance is ensured alternatively by international agreements with third countries and vehicles used by heritage, museum and tourist railways or military equipment and special transport requiring an ad hoc national safety authority permit to be delivered prior to the service. In these situations the relevant Member State should be allowed to accept vehicles on the network for which it is competent without an entity in charge of maintenance being assigned to these vehicles or without such an entity being certified. However, such derogations should be subject to formal decisions of the relevant Member State and be analysed by the European Railway Agency (hereinafter referred to as the ‘Agency’) in the context of its report on safety performance.

               (8)

               When a railway undertaking or infrastructure manager uses a vehicle for which no entity in charge of maintenance is registered or for which the entity in charge of maintenance is not certified, it should control all risks associated with the use of such a vehicle. The capacity to control such risks should be demonstrated by the railway undertaking or the infrastructure manager through the certification of their safety management system and, where applicable, through their safety certification or authorisation.

               (9)

               For freight wagons, the entity in charge of maintenance should be certified according to a system to be developed by the Agency and to be adopted by the Commission. Where the entity in charge of maintenance is a railway undertaking or an infrastructure manager, this certification should be included in the procedure for safety certification or authorisation. The certificate delivered to such an entity would guarantee that the maintenance requirements of this Directive are met for any freight wagon of which it is in charge. This certificate should be valid in the whole Community and should be delivered by a body able to audit the maintenance system set up by such entities. As freight wagons are frequently used in international traffic and as an entity in charge of maintenance may want to use workshops established in more than one Member State, the certification body should be able to perform its controls in the whole Community.

               (10)

               Maintenance requirements are being developed in the context of the Railway Interoperability Directive, in particular as part of the ‘rolling stock’ technical specifications for interoperability (TSIs). As a result of the entry into force of this Directive there is a need to ensure coherence between these TSIs and the certification requirements for the entity in charge of maintenance to be adopted by the Commission. The Commission will achieve this by modifying, where appropriate, the relevant TSIs using the procedure envisaged by the Railway Interoperability Directive.

               (11)

               Since the objective of this Directive, namely further developing and improving safety on the Community’s railways, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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 that objective.

               (12)

               The measures necessary for the implementation of Directive 2004/49/EC 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).

               (13)

               In particular, the Commission should be empowered to revise and adapt the Annexes to Directive 2004/49/EC, to adopt and revise common safety methods and common safety targets, and also to establish a maintenance certification system. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/49/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (14)

               A Member State which has no railway system and which does not envisage having one in the near future, would be under a disproportionate and pointless obligation if it had to transpose and implement this Directive. Therefore, such a Member State should be exempted, for as long as it has no railway system, from the obligation to transpose and implement this Directive.

               (15)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and make them public.

               (16)

               Directive 2004/49/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments
   Directive 2004/49/EC is hereby amended as follows:

               1.

               the following points shall be added to Article 2(2):

                           ‘(d)

                           heritage vehicles that run on national networks provided that they comply with national safety rules and regulations with a view to ensuring safe circulation of such vehicles;

                           (e)

                           heritage, museum and tourist railways that operate on their own network, including workshops, vehicles and staff.’;

               2.

               the following points shall be added to Article 3:

                           ‘(s)

                           “keeper” means the person or entity that, being the owner of a vehicle or having the right to use it, exploits the vehicle as a means of transport and is registered as such in the National Vehicle Register (NVR) provided for in Article 33 of Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (recast) (9), (hereinafter referred to as the “Railway Interoperability Directive”);

                           (t)

                           “entity in charge of maintenance” means an entity in charge of maintenance of a vehicle, and registered as such in the NVR;

                           (u)

                           “vehicle” means a railway vehicle suitable for circulation on its own wheels on railway lines, with or without traction. A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems.

               3.

               in Article 4(4) the term ‘wagon keeper’ shall be replaced by ‘keeper’;

               4.

               Article 5(2) shall be replaced by the following:
               ‘2.   Before 30 April 2009 Annex I shall be revised, in particular to incorporate therein the common definitions of the CSIs and the common methods for calculating accident costs. This measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               5.

               Article 6 shall be amended as follows:

                           (a)

                           paragraph 1 shall be replaced by the following:
                           ‘1.   An initial series of CSMs covering, as a minimum, the methods described in paragraph 3(a) shall be adopted by the Commission before 30 April 2008. They shall be published in the Official Journal of the European Union.
                           A second series of CSMs covering the remaining methods described in paragraph 3 shall be adopted by the Commission before 30 April 2010. They shall be published in the Official Journal of the European Union.
                           These 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 27(2a).’;

                           (b)

                           point (c) of paragraph 3 shall be replaced by the following:

                                       ‘(c)

                                       as far as they are not yet covered by TSIs, methods to check that the structural subsystems of the railway system are operated and maintained in accordance with the relevant essential requirements.’;

                           (c)

                           paragraph 4 shall be replaced by the following:
                           ‘4.   The CSMs shall be revised at regular intervals, taking into account the experience gained from their application and the global development of railway safety and the obligations on Member States as laid down in Article 4(1). This measure, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               6.

               Article 7 shall be amended as follows:

                           (a)

                           the first and second subparagraphs of paragraph 3 shall be replaced by the following:
                           ‘3.   The first set of draft CSTs shall be based on an examination of existing targets and safety performance in the Member States and shall ensure that the current safety performance of the rail system is not reduced in any Member State. It shall be adopted by the Commission before 30 April 2009 and shall be published in the Official Journal of the European Union. This measure, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).
                           The second set of draft CSTs shall be based on the experience gained from the first set of CSTs and their implementation. It shall reflect any priority areas where safety needs to be further improved. It shall be adopted by the Commission before 30 April 2011 and shall be published in the Official Journal of the European Union. This measure, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

                           (b)

                           paragraph 5 shall be replaced by the following:
                           ‘5.   The CSTs shall be revised at regular intervals, taking into account the global development of railway safety. This measure, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               7.

               Article 10 shall be amended as follows:

                           (a)

                           the second subparagraph of paragraph 1 shall be replaced by the following:
                           ‘The purpose of the safety certificate is to provide evidence that the railway undertaking has established its safety management system and can meet requirements laid down in TSIs and other relevant Community legislation and in national safety rules in order to control risks and provide transport services safely on the network.’;

                           (b)

                           point (b) of paragraph 2 shall be replaced by the following:

                                       ‘(b)

                                       certification confirming acceptance of the provisions adopted by the railway undertaking to meet specific requirements necessary for the safe supply of its services on the relevant network. These requirements may concern the application of the TSIs and national safety rules, including the network operating rules, acceptance of staff certificates and authorisation to operate vehicles used by railway undertakings. The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV.’;

               8.

               the following Article shall be inserted:
               ‘Article 14a
               Maintenance of vehicles
               1.   Each vehicle, before it is placed in service or used on the network, shall have an entity in charge of maintenance assigned to it and this entity shall be registered in the NVR in accordance with Article 33 of the Railway Interoperability Directive.
               2.   A railway undertaking, an infrastructure manager or a keeper may be an entity in charge of maintenance.
               3.   Without prejudice to the responsibility of the railway undertakings and infrastructure managers for the safe operation of a train as provided for in Article 4, the entity shall ensure that the vehicles for which it is in charge of maintenance are in a safe state of running by means of a system of maintenance. To this end, the entity in charge of maintenance shall ensure that vehicles are maintained in accordance with:

                           (a)

                           the maintenance file of each vehicle;

                           (b)

                           the requirements in force including maintenance rules and TSI provisions.

                     The entity in charge of maintenance shall carry out the maintenance itself or make use of contracted maintenance workshops.
               4.   In the case of freight wagons, each entity in charge of maintenance shall be certified by a body accredited or recognised in accordance with paragraph 5, or by a national safety authority. The accreditation process shall be based on criteria of independence, competence and impartiality, such as the relevant EN 45 000 series European standards. The recognition process shall also be based on criteria of independence, competence and impartiality.
               Where the entity in charge of maintenance is a railway undertaking or an infrastructure manager, compliance with the requirements to be adopted under paragraph 5 shall be checked by the relevant national safety authority pursuant to the procedures referred to in Articles 10 or 11 and shall be confirmed on the certificates specified in those procedures.
               5.   Based on a recommendation by the Agency, the Commission shall, by 24 December 2010, adopt a measure establishing a system of certification of the entity in charge of maintenance for freight wagons. Certificates granted in accordance with this system shall confirm compliance with the requirements referred to in paragraph 3.
               The measure shall include the requirements concerning:

                           (a)

                           the maintenance system established by the entity;

                           (b)

                           the format and validity of the certificate granted to the entity;

                           (c)

                           the criteria for accreditation or recognition of body or bodies responsible for issuing certificates and ensuring controls necessary for the functioning of the certification system;

                           (d)

                           the date of application of the certification system, including a transition period of one year for existing entities in charge of maintenance.

                     This measure, 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 27(2a).
               Based on a recommendation by the Agency, the Commission shall, by 24 December 2018 review this measure in order to include all vehicles and to update, if necessary, the certification system applicable to freight wagons.
               6.   The certificates granted in accordance with paragraph 5 shall be valid throughout the Community.
               7.   The Agency shall evaluate the certification process implemented in accordance with paragraph 5 by submitting a report to the Commission, no later than three years after the entry into force of the relevant measure.
               8.   Member States may decide to fulfil the obligations to identify the entity in charge of maintenance and to certify it through alternative measures, in the following cases:

                           (a)

                           vehicles registered in a third country and maintained according to the law of that country;

                           (b)

                           vehicles which are used on networks or lines the track gauge of which is different from that of the main rail network within the Community and for which fulfilment of the requirements referred to in paragraph 3 are ensured by international agreements with third countries;

                           (c)

                           vehicles identified in Article 2(2), and military equipment and special transport requiring an ad hoc national safety authority permit to be delivered prior to the service. In this case derogations shall be granted for periods not longer than five years.

                     Such alternative measures shall be implemented through derogations to be granted by the relevant national safety authority:

                           (a)

                           when registering vehicles pursuant to Article 33 of the Railway Interoperability Directive, as far as the identification of the entity in charge of maintenance is concerned;

                           (b)

                           when delivering safety certificates and authorisations to railway undertakings and infrastructure managers pursuant to Articles 10 and 11 of this Directive, as far as the identification or certification of the entity in charge of maintenance is concerned.

                     Such derogations shall be identified and justified in the annual safety report referred to in Article 18 of this Directive. Where it appears that undue safety risks are being taken on the Community rail system, the Agency shall immediately inform the Commission thereof. The Commission shall make contact with the parties involved and, where appropriate, request the Member State to withdraw its derogation decision.’;

               9.

               Article 16(2) shall be amended as follows:

                           (a)

                           point (a) shall be replaced by the following:

                                       ‘(a)

                                       authorising the placing in service of the structural subsystems constituting the rail system in accordance with Article 15 of the Railway Interoperability Directive and checking that they are operated and maintained in accordance with the relevant essential requirements;’;

                           (b)

                           point (b) shall be deleted;

                           (c)

                           point (g) shall be replaced by the following:

                                       ‘(g)

                                       supervising that vehicles are duly registered in the NVR and that safety related information contained therein, is accurate and kept up to date;’;

               10.

               the following point shall be added to Article 18:

                           ‘(e)

                           the derogations that have been decided in accordance with Article 14a(8).’;

               11.

               Article 26 shall be replaced by the following:
               ‘Article 26
               Adaptation of the Annexes
               The Annexes shall be adapted to scientific and technical progress. This measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               12.

               Article 27 shall be amended as follows:

                           (a)

                           the following paragraph shall be inserted:
                           ‘2a.   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.’;

                           (b)

                           paragraph 4 shall be deleted;

               13.

               point 3 of Annex II shall be deleted.

         Article 2
   Implementation and transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 24 December 2010. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt these measures, 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.
   The obligations for transposition and implementation of this Directive shall not apply to the Republic of Cyprus and the Republic of Malta for as long as no railway system is established within their respective territories.
   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
   Entry into force
   This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 16 December 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         B. LE MAIRE

      (1)  OJ C 256, 27.10.2007, p. 39.

      (2)  Opinion of the European Parliament of 29 November 2007 (OJ C 297 E, 20.11.2008, p. 133), Council Common Position of 3 March 2008 (OJ C 122 E, 20.5.2008, p. 10) and Position of the European Parliament of 9 July 2008 (not yet published in the Official Journal). Council Decision of 1 December 2008.

      (3)  Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) (OJ L 164, 30.4.2004, p. 44). Corrected by OJ L 220, 21.6.2004, p. 16.

      (4)  OJ L 235, 17.9.1996, p. 6.

      (5)  OJ L 110, 20.4.2001, p. 1.

      (6)  OJ L 191, 18.7.2008, p. 1.

      (7)  OJ L 184, 17.7.1999, p. 23.

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

      (9)  OJ L 191, 18.7.2008, p. 1.’;


title: Council Directive 2013/24/EU of 13 May 2013 adapting certain directives in the field of company law, by reason of the accession of the Republic of Croatia

text:
               10.6.2013

               EN

               Official Journal of the European Union

               L 158/365

         COUNCIL DIRECTIVE 2013/24/EU
   of 13 May 2013
   adapting certain directives in the field of company law, by reason of the accession of the Republic of Croatia
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to the Treaty of Accession of Croatia, and in particular Article 3(4) thereof,
   Having regard to the Act of Accession of Croatia, and in particular Article 50 thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               Pursuant to Article 50 of the Act of Accession of Croatia, where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in that Act of Accession or in the Annexes thereto, the Council, acting by qualified majority on a proposal from the Commission, shall, to this end, adopt the necessary acts, if the original act was not adopted by the Commission.

               (2)

               The Final Act of the Conference which drew up and adopted the Treaty of Accession of Croatia indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt those adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Directives 78/660/EEC (1), 83/349/EEC (2), 2009/101/EC (3), 2009/102/EC (4), 2011/35/EU (5) and 2012/30/EU (6) should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directives 78/660/EEC, 83/349/EEC, 2009/101/EC, 2009/102/EC, 2011/35/EU and 2012/30/EU are amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by the date of accession of Croatia to the Union 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 the date of accession of Croatia to the Union.
   When Member States adopt those measures, 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 subject to and as from the date of the entry into force of the Treaty of Accession of Croatia.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 13 May 2013.

            For the Council

            The President

         S. COVENEY

      (1)  Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 50(2)(g) of the Treaty on the annual accounts of certain types of companies (OJ L 222, 14.8.1978, p. 11). Editorial note: the title of Directive 78/660/EEC has been adjusted to take account of the renumbering of the articles of the Treaty establishing the European Community, in accordance with Article 5 of the Treaty of Lisbon; the original reference was to Article 54(3)(g) of the Treaty.

      (2)  Seventh Council Directive 83/349/EEC of 13 June 1983 based on Article 50(2)(g) of the Treaty on consolidated accounts (OJ L 193, 18.7.1983, p. 1). Editorial note: the title of Directive 83/349/EEC has been adjusted to take account of the renumbering of the articles of the Treaty establishing the European Community, in accordance with Article 5 of the Treaty of Lisbon; the original reference was to Article 54(3)(g) of the Treaty.

      (3)  Directive 2009/101/EC of the European Parliament and of the Council of 16 September 2009 on coordination of safeguards which, for the protection of the interests of members and third parties, are required by Member States of companies within the meaning of the second paragraph of Article 54 of the Treaty, with a view to making such safeguards equivalent (OJ L 258, 1.10.2009, p. 11). Editorial note: the title of Directive 2009/101/EC has been adjusted to take account of the renumbering of the articles of the Treaty establishing the European Community, in accordance with Article 5 of the Treaty of Lisbon; the original reference was to the second paragraph of Article 48 of the Treaty.

      (4)  Directive 2009/102/EC of the European Parliament and of the Council of 16 September 2009 in the area of company law on single-member private limited liability companies (OJ L 258, 1.10.2009, p. 20).

      (5)  Directive 2011/35/EU of the European Parliament and of the Council of 5 April 2011 concerning mergers of public limited liability companies (OJ L 110, 29.4.2011, p. 1).

      (6)  Directive 2012/30/EU of the European Parliament and of the Council of 25 October 2012 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 54 of the Treaty on the Functioning of the European Union, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent (OJ L 315, 14.11.2012, p. 74).

      ANNEX
      PART A

         COMPANY LAW

                  1.

                  In Article 1 of Directive 2009/101/EC, the following is inserted after the entry for France:

                              ‘—

                              Croatia:
                              dioničko društvo, društvo s ograničenom odgovornošću;’.

                  2.

                  In Annex I to Directive 2009/102/EC, the following is inserted after the entry for France:

                              ‘—

                              Croatia:
                              “društvo s ograničenom odgovornošću, dioničko društvo,” ’.

                  3.

                  In Article 1(1) of Directive 2011/35/EU, the following is inserted after the entry for France:

                              ‘—

                              Croatia:

                                          —

                                          dioničko društvo,’.

                  4.

                  In Annex I to Directive 2012/30/EU, the following is inserted after the entry for France:

                              ‘—

                              Croatia:
                              dioničko društvo;’.

            PART B

         ACCOUNTING STANDARDS

                  1.

                  Article 1(1) of Directive 78/660/EEC is amended as follows:

                              (a)

                              the following is added to the first subparagraph:

                                          ‘—

                                          in Croatia:
                                          dioničko društvo, društvo s ograničenom odgovornošću.’;

                              (b)

                              the following is added to the second subparagraph:

                                          ‘(ab)

                                          in Croatia:
                                          javno trgovačko društvo, komanditno društvo,’.

                  2.

                  In Article 4(1) of Directive 83/349/EEC, the following is added to the first subparagraph:

                              ‘(ab)

                                 in Croatia:

                              dioničko društvo, društvo s ograničenom odgovornošću.’.