title: Commission Directive 2009/149/EC of 27 November 2009 amending Directive 2004/49/EC of the European Parliament and of the Council as regards Common Safety Indicators and common methods to calculate accident costs (Text with EEA relevance)

text:
               28.11.2009

               EN

               Official Journal of the European Union

               L 313/65

      COMMISSION DIRECTIVE 2009/149/EC
   of 27 November 2009
   amending Directive 2004/49/EC of the European Parliament and of the Council as regards Common Safety Indicators and common methods to calculate accident costs
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety of 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) (1), and in particular Article 5(2) thereof,
   Having regard to the recommendation of the European Railway Agency (ERA/REC/SAF/02-2008) of 29 September 2008,
   Whereas:

               (1)

               Article 5(2) of Directive 2004/49/EC, as corrected, provides for the possibility to revise Annex I to the said Directive in order to include common definitions of the Common Safety Indicators (CSIs) and methods to calculate accident costs.

               (2)

               In accordance with Article 5(1) of Directive 2004/49/EC information on CSIs is to be collected to facilitate the assessment of the achievement of the Common Safety Targets (CSTs). In conformity with Article 7(3) of the said Directive, the CSTs should be accompanied by an assessment of the economic impact in terms of societal acceptance of risk. The main purpose of CSIs should be to measure safety performance and to facilitate the economic impact assessment of CSTs. Therefore, it is necessary to move from indicators related to costs of all accidents borne by railways to indicators related to the economic impact of accidents on society.

               (3)

               Attributing monetary values to improved safety should be seen in the context of limited budget resources of public policy actions. Therefore, in order to select initiatives that ensure an efficient allocation of resources, it becomes necessary to prioritise across the different actions.

               (4)

               Article 9 of Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing a European Railway Agency (Agency Regulation) (2) mandates the Agency to set up a network with the national authorities responsible for safety and the national authorities responsible for the investigations in order to define the content of the CSIs listed in Annex I to Directive 2004/49/EC. In response to this mandate, on 29 September 2008 the Agency delivered its recommendation on the revision of Annex I to Directive 2004/49/EC: common definitions for the CSIs and methods to calculate the economic impact of accidents (ERA/REC/SAF/02-2008).

               (5)

               Annex I to Directive 2004/49/EC should therefore be amended.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 21 of Directive 96/48/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 2004/49/EC is replaced by the text in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 18 June 2010 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.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force 20 days after its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 27 November 2009.

            For the Commission

         Antonio TAJANI

            Vice-President

      (1)  OJ L 164, 30.4.2004, p. 44.

      (2)  OJ L 164, 30.4.2004, p. 1.

      ANNEX

            ‘ANNEX I

               COMMON SAFETY INDICATORS

            Common safety indicators shall be reported annually by the safety authorities. The first reporting period shall be 2010.
            Indicators relating to activities referred to in Article 2(2), (a) and (b), should be accounted for separately, if they are submitted.
            If new facts or errors are discovered after the submission of the report the indicators for one particular year shall be amended or corrected by the safety authority at the first convenient opportunity and at the latest in the next annual report.
            For indicators relating to accidents under heading 1, Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics (1) shall be applied as far as the information is available.
            1.   Indicators relating to accidents

                        1.1.

                        Total and relative (to train-kilometres) number of significant accidents and a break-down on the following types of accidents:

                                    —

                                    collisions of trains, including collisions with obstacles within the clearance gauge,

                                    —

                                    derailments of trains,

                                    —

                                    level crossing accidents, including accidents involving pedestrians at level crossings,

                                    —

                                    accidents to persons caused by rolling stock in motion, with the exception of suicides,

                                    —

                                    fires in rolling stock,

                                    —

                                    others.

                              Each significant accident shall be reported under the type of the primary accident, even if the consequences of the secondary accident are more severe, e.g. a fire following a derailment.

                        1.2.

                        Total and relative (to train-kilometres) number of persons seriously injured and killed by type of accident divided into the following categories:

                                    —

                                    passengers (also in relation to total number of passenger-kilometres and passenger train-kilometres),

                                    —

                                    employees including the staff of contractors,

                                    —

                                    level crossing users,

                                    —

                                    unauthorised persons on railway premises,

                                    —

                                    others.

                  2.   Indicators relating to dangerous goods

            Total and relative (to train-kilometres) number of accidents involving the transport of dangerous goods divided into the following categories:

                        —

                        accidents involving at least one railway vehicle transporting dangerous goods, as defined by the Appendix,

                        —

                        number of such accidents in which dangerous goods are released.

                  3.   Indicators relating to suicides

            Total and relative (to train-kilometres) number of suicides.
            4.   Indicators relating to precursors of accidents

            Total and relative (to train-kilometres) number of:

                        —

                        broken rails,

                        —

                        track buckles,

                        —

                        wrong-side signalling failures,

                        —

                        signals passed at danger,

                        —

                        broken wheels and axles on rolling stock in service.

                  All precursors are to be reported, both resulting and not resulting in accidents. Precursors resulting in an accident shall be reported under the CSIs on precursors; the accidents that occurred, if significant, shall be reported under the CSIs on accidents referred to in heading 1.
            5.   Indicators to calculate the economic impact of accidents

            Total in euro and relative (to train-kilometres):

                        —

                        number of deaths and serious injuries multiplied by the Value of Preventing a Casualty (VPC),

                        —

                        cost of damages to environment,

                        —

                        cost of material damages to rolling stock or infrastructure,

                        —

                        cost of delays as a consequence of accidents.

                  Safety authorities shall report either the economic impact of all accidents, or the economic impact of significant accidents only. This choice shall be clearly indicated in the annual report referred to in Article 18.
            The VPC is the value society attributes to the prevention of a casualty and as such shall not form a reference for compensation between parties involved in accidents.
            6.   Indicators relating to technical safety of infrastructure and its implementation

                        6.1.

                        Percentage of tracks with Automatic Train Protection (ATP) in operation, percentage of train-kilometres using operational ATP systems.

                        6.2.

                        Number of level crossings (total, per line kilometre and track kilometre) by the following eight types:

                                    (a)

                                    active level crossings with:

                                                (i)

                                                automatic user-side warning,

                                                (ii)

                                                automatic user-side protection,

                                                (iii)

                                                automatic user-side protection and warning,

                                                (iv)

                                                automatic user-side protection and warning, and rail-side protection,

                                                (v)

                                                manual user-side warning,

                                                (vi)

                                                manual user-side protection,

                                                (vii)

                                                manual user-side protection and warning.

                                    (b)

                                    passive level crossings.

                  7.   Indicators relating to the management of safety

            Internal audits accomplished by infrastructure managers and railway undertakings as set out in the documentation of the safety management system. Total number of audits accomplished and the number as a percentage of audits required (and/or planned).
            8.   Definitions

            Common definitions for the CSIs and methods to calculate the economic impact of accidents are laid down in the Appendix.

               Appendix

                  Common definitions for the CSIs and methods to calculate the economic impact of accidents

               1.   Indicators relating to accidents

                           1.1.

                           “significant accident” means any accident involving at least one rail vehicle in motion, resulting in at least one killed or seriously injured person, or in significant damage to stock, track, other installations or environment, or extensive disruptions to traffic. Accidents in workshops, warehouses and depots are excluded.

                           1.2.

                           “significant damage to stock, track, other installations or environment” means damage that is equivalent to EUR 150 000 or more.

                           1.3.

                           “extensive disruptions to traffic” means that train services on a main railway line are suspended for six hours or more.

                           1.4.

                           “train” means one or more railway vehicles hauled by one or more locomotives or railcars, or one railcar travelling alone, running under a given number or specific designation from an initial fixed point to a terminal fixed point. A light engine, i.e. a locomotive travelling on its own, is considered to be a train.

                           1.5.

                           “collision of trains, including collisions with obstacles within the clearance gauge” means a front to front, front to end or a side collision between a part of a train and a part of another train, or with:

                                       (i)

                                       shunting rolling stock,

                                       (ii)

                                       objects fixed or temporarily present on or near the track (except at level crossings if lost by a crossing vehicle or user).

                           1.6.

                           “train derailment” means any case in which at least one wheel of a train leaves the rails.

                           1.7.

                           “level crossing accidents” means accidents at level crossings involving at least one railway vehicle and one or more crossing vehicles, other crossing users such as pedestrians or other objects temporarily present on or near the track if lost by a crossing vehicle/user.

                           1.8.

                           “accidents to persons caused by rolling stock in motion” means accidents to one or more persons who are either hit by a railway vehicle or by an object attached to, or that has become detached from, the vehicle. Persons who fall from railway vehicles are included, as well as persons who fall or are hit by loose objects when travelling on board vehicles.

                           1.9.

                           “fires in rolling stock” means fires and explosions that occur in railway vehicles (including their load) when they are running between the departure station and the destination, including when stopped at the departure station, the destination or intermediate stops, as well as during re-marshalling operations.

                           1.10.

                           “other types of accidents” means all accidents other than those already mentioned (train collisions, train derailments, at level crossing, to persons caused by rolling stock in motion and fires in rolling stock).

                           1.11.

                           “passenger” means any person, excluding members of the train crew, who makes a trip by rail. For accident statistics, passengers trying to embark/disembark onto/from a moving train are included.

                           1.12.

                           “employees (staff of contractors and self-employed contractors are included)” means any person whose employment is in connection with a railway and is at work at the time of the accident. It includes the crew of the train and persons handling rolling stock and infrastructure installations.

                           1.13.

                           “level crossing users” means all persons using a level crossing to cross the railway line by any mean of transport or by foot.

                           1.14.

                           “unauthorised persons on railway premises” means any person present on railway premises where such presence is forbidden, with the exception of level crossing users.

                           1.15.

                           “others (third parties)” means all persons not defined as “passengers”, “employees including the staff of contractors”, “level crossing users” or “unauthorised persons on railway premises”.

                           1.16.

                           “deaths (killed person)” means any person killed immediately or dying within 30 days as a result of an accident, excluding suicides.

                           1.17.

                           “injuries (seriously injured person)” means any person injured who was hospitalised for more than 24 hours as a result of an accident, excluding attempted suicides.

                     2.   Indicators relating to dangerous goods

                           2.1.

                           “accident involving the transport of dangerous goods” means any accident or incident that is subject to reporting in accordance with RID (2)/ADR section 1.8.5.

                           2.2.

                           “dangerous goods” means those substances and articles the carriage of which is prohibited by RID, or authorised only under the conditions prescribed therein.

                     3.   Indicators relating to suicides

                           3.1.

                           “suicide” means an act to deliberately injure oneself resulting in death, as recorded and classified by the competent national authority.

                     4.   Indicators relating to precursors of accidents

                           4.1.

                           “broken rails” means any rail which is separated in two or more pieces, or any rail from which a piece of metal becomes detached, causing a gap of more than 50 mm in length and more than 10 mm in depth on the running surface.

                           4.2.

                           “track buckles” means faults related to the continuum and the geometry of track, requiring track obstruction or immediate reduction of permitted speed to maintain safety.

                           4.3.

                           “wrong side signalling failure” means any failure of a signalling system (either to infrastructure or to rolling stock), resulting in signalling information less restrictive than that demanded.

                           4.4.

                           “Signal Passed at Danger (SPAD)” means any occasion when any part of a train proceeds beyond its authorised movement.
                           Unauthorised movement means to pass:

                                       —

                                       a trackside colour light signal or semaphore at danger, order to STOP, where an Automatic Train Control System (ATCS) or ATP system is not operational,

                                       —

                                       the end of a safety related movement authority provided in an ATCS or ATP system,

                                       —

                                       a point communicated by verbal or written authorisation laid down in regulations,

                                       —

                                       stop boards (buffer stops are not included) or hand signals.

                                 Cases in which vehicles without any traction unit attached or a train that is unattended run away past a signal at danger are not included. Cases in which, for any reason, the signal is not turned to danger in time to allow the driver to stop the train before the signal are not included.
                           National Safety Authorities may report separately on the four indexes and shall report at least an aggregate indicator containing data on all four items.

                           4.5.

                           “broken wheels and broken axles” means a break affecting the essential parts of the wheel or the axle and creating a risk of accident (derailment or collision).

                     5.   Common methodologies to calculate the economic impact of accidents

                           5.1.

                           The Value of Preventing a Casualty (VPC) is composed of:

                                       1.

                                       Value of safety per se: Willingness to Pay (WTP) values based on stated preference studies carried out in the Member State for which they are applied.

                                       2.

                                       Direct and indirect economic costs: cost values appraised in the Member State, composed of:

                                                   —

                                                   medical and rehabilitation cost,

                                                   —

                                                   legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,

                                                   —

                                                   production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.

                           5.2.

                           Common principles to appraise the value of safety per se and direct/indirect economic costs:
                           For the value of safety per se, the assessment of whether available estimates are appropriate or not shall be based on the following considerations:

                                       —

                                       estimates shall relate to a system for valuation of mortality risk reduction in the transport sector and follow a WTP approach according to stated preference methods,

                                       —

                                       the respondent sample used for the values shall be representative of the population concerned. In particular, the sample has to reflect the age/income distribution along with other relevant socio-economic/demographic characteristics of the population,

                                       —

                                       method for eliciting WTP values: survey design shall be such that questions are clear/meaningful to respondents.

                                 Direct and indirect economic costs shall be appraised on the basis of the real costs borne by society.

                           5.3.

                           “Cost of damage to environment” means costs that are to be met by Railway Undertakings/Infrastructure Managers, appraised on the basis of their experience, in order to restore the damaged area to its state before the railway accident.

                           5.4.

                           “Cost of material damage to rolling stock or infrastructure” means the cost of providing new rolling stock or infrastructure, with the same functionalities and technical parameters as that damaged beyond repair, and the cost of restoring repairable rolling stock or infrastructure to its state before the accident. Both are to be estimated by Railway Undertakings/Infrastructure Managers on the basis of their experience. Also includes costs related to leasing rolling stock, as a consequence of non availability due to damaged vehicles.

                           5.5.

                           “Cost of delays as a consequence of accidents” means the monetary value of delays incurred by users of rail transport (passengers and freight customers) as a consequence of accidents, calculated by the following model:
                           VT= monetary value of travel time savings
                           Value of time for a passenger of a train (an hour)

                                       VTP = [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]

                                       VT measured in EUR per passenger per hour

                                 Value of time for a freight train (an hour)

                                       VTF = [VT of freight trains]*[(Tonne-Km)/(Train-Km)]

                                       VT is measured in EUR per freight tonne per hour

                                       Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)

                                 CM= Cost of 1 minute of delay of a train

                              Passenger train

                                       CMP = K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]

                                       Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)

                              Freight train

                                       CMF = K2* (VTF/60)

                                       Factors K1 and K2 are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.

                                 Cost of delays of an accident = CMP*(Minutes of delay of passenger trains) + CMF*(Minutes of delay of freight trains)

                  Scope of the model

               Cost of delays is to be calculated for all accidents, both significant and non-significant.
               Delays are to be calculated as follows:

                           —

                           real delays on the railway lines where accidents occurred,

                           —

                           real delays or, if not possible, estimated delays on the other affected lines.

                     6.   Indicators relating to technical safety of infrastructure and its implementation

                           6.1.

                           “Automatic Train Protection (ATP)” means a system that enforces obedience to signals and speed restrictions by speed supervision, including automatic stop at signals.

                           6.2.

                           “level crossing” means any level intersection between the railway and a passage, as recognised by the infrastructure manager and open to public or private users. Passages between platforms within stations are excluded, as well as passages over tracks for the sole use of employees.

                           6.3.

                           “passage” means any public or private road, street or highway, including footpaths and bicycle paths, or other route provided for the passage of people, animals, vehicles or machinery.

                           6.4.

                           “active level crossing” means a level crossing where the crossing users are protected from or warned of the approaching train by the activation of devices when it is unsafe for the user to traverse the crossing.

                                       —

                                       Protection by the use of physical devices:

                                                   —

                                                   half or full barriers,

                                                   —

                                                   gates.

                                       —

                                       Warning by the use of fixed equipment at level crossings:

                                                   —

                                                   visible devices: lights,

                                                   —

                                                   audible devices: bells, horns, klaxons, etc.,

                                                   —

                                                   physical devices, e.g. vibration due to road bumps.

                                 Active level crossings are classified as:

                                       1.

                                       “Level crossing with crossing-user-side automatic protection and/or warning” means a level crossing where the crossing protection and/or warning are activated by the approaching train.
                                       These level crossings are classified as:

                                                   (i)

                                                   automatic user-side warning,

                                                   (ii)

                                                   automatic user-side protection,

                                                   (iii)

                                                   automatic user-side protection and warning,

                                                   (iv)

                                                   automatic user-side protection and warning, and rail-side protection.
                                                   “Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.

                                       2.

                                       “Level crossing with crossing-user-side manual protection and/or warning” means a level crossing where protection and/or warning is manually activated and there is not an interlocked railway signal showing, to the train, a running aspect only when protection and/or warning of level crossing are activated.
                                       These level crossings are classified as:

                                                   (v)

                                                   manual user-side warning,

                                                   (vi)

                                                   manual user-side protection,

                                                   (vii)

                                                   manual user-side protection and warning.

                           6.5.

                           “Passive level crossing” means a level crossing without any form of warning system and/or protection activated when it is unsafe for the user to traverse the crossing.

                     7.   Indicators relating to the management of safety

                           7.1.

                           “audit” means a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

                     8.   Definitions of the scaling bases

                           8.1.

                           “train-km” means the unit of measure representing the movement of a train over one kilometre. The distance used is the distance actually run, if available, otherwise the standard network distance between the origin and destination shall be used. Only the distance on the national territory of the reporting country shall be taken into account.

                           8.2.

                           “passenger-km” means the unit of measure representing the transport of one passenger by rail over a distance of one kilometre. Only the distance on the national territory of the reporting country shall be taken into account.

                           8.3.

                           “line km” means the length measured in kilometres of the railway network in Member States, whose scope is laid down in Article 2. For multiple-track railway lines, only the distance between origin and destination is to be counted.

                           8.4.

                           “track km” means the length measured in kilometres of the railway network in Member States, whose scope is laid down in Article 2. Each track of a multiple-track railway line is to be counted.

                     ’

         (1)  OJ L 14, 21.1.2003, p. 1.

         (2)  RID, Regulations concerning the International Carriage of Dangerous Goods by Rail, as adopted under Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).


Avis juridique important

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31991L0661

Commission Directive 91/661/EEC of 6 December 1991 amending Directive 86/547/EEC amending Annex III B to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products

Official Journal L 363 , 31/12/1991 P. 0040 - 0040

COMMISSION DIRECTIVE  of 6 December 1991  amending Directive 86/547/EEC amending Annex III B to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products   (91/661/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Commission Directive 91/27/EEC (2), and in  particular the first indent of Article 13 (2) thereof,  Having regard to the requests made by Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom,  Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas those measures include measures to be taken by Member States in respect of plants, plant  products and other objects coming from third countries;  Whereas certain Member States have stricter measures in respect of those plants and plant products;  Whereas those stricter measures include, in the requesting Member States, certain prohibitions applicable to certain products originating in a third country;  Whereas, by Commission Directive 86/547/EEC (3), Annex III B to Directive 77/93/EEC was amended so that the Member States concerned could also impose the relevant prohibitions where the products concerned, originating in a third country, come from other  Member States; whereas these amendments were only interim protective measures lasting for a period of three years;  Whereas that period was allotted for the Commission to study these protective measures in relation to the plant health situation existing in the various third countries concerned, in order to arrive, at the end of the period, at more permanent  provisions;  Whereas it appeared impossible to finalize this study within the period originally alloted by Directive 86/547/EEC;  Whereas Commission Directive 90/80/EEC (4) extended the said period for one year, namely until the end of 1990 and Commission Directive 91/103/EEC (5) extended the said period for a further year, namely until the end of 1991;  Whereas it appears impossible to finalize this study despite the two-year extension to the original period; whereas this period should be further extended accordingly;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,  HAS ADOPTED THIS DIRECTIVE:  Article 1  In Article 3 of Directive 86/547/EEC, '31 December 1991' is replaced by '31 December 1992'.  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.  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.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 6 December 1991. For the Commission  Ray MAC SHARRY  Member of the Commission   (1) OJ No L 26, 31. 1. 1977, p. 20. (2) OJ No L 16, 22. 1. 1991, p. 29. (3) OJ No L 323, 18. 11. 1986, p. 21. (4) OJ No L 51, 27. 2. 1990, p. 34. (5) OJ No L 52, 27. 2. 1991, p. 51.


Avis juridique important

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31995L0212

Council Directive 95/212/EC of 29 May 1995 concerning the Community list of less-favoured farming areas within the meaning of Directive 75/268/EEC (Austria)

Official Journal L 137 , 21/06/1995 P. 0001 - 0041

COUNCIL  DIRECTIVEof 29 May 1995concerning the Community list of less-favoured farming areas within the  meaning of Directive 75/268/EEC (Austria)(95/212/EC)THE COUNCIL OF THE EUROPEAN  UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 75/268/EEC of 28 April 1975 on mountain and hill farming and  farming in certain less-favoured areas (1), and in particular Article 2 (2) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Whereas a significant proportion of the territory of the new Member States suffers from permanent  natural handicaps and Declaration No 37 of the 1994 Act of Accession recognizes that the boundaries  of the mountain and other less-favoured farming areas within the meaning of Article 3 of Directive  75/268/EEC should be established without delay; Whereas the permanent natural handicaps in these areas result in higher production costs and  prevent farmers in these areas from obtaining a reasonable income from their production at a level  similar to that available to comparable farmers in other regions; Whereas, in accordance with Article 2 (1) of Directive 75/268/EEC, the Austrian Government has sent  the Commission a list of municipalities (Gemeinden) liable to appear on the Community list of  less-favoured farming areas, together with the information relating to the characteristics of those  areas; Whereas the indices which have been selected are the existence of very difficult climatic  conditions, as referred to in the first indent of Article 3 (3) of Directive 75/268/EEC, and a  minimum altitude of 700 m (central point of the locality or the average altitude of the  municipality) or exceptionally, 600 m, in the Salzburg Alpine foreland and the area bordering the  Mur river (Murtal) in Upper Styria; Whereas the steep slopes referred to in the second indent of Article 3 (3) of Directive 75/268/EEC  are defined as being greater than 20 %; Whereas, where there is a combination of the above two factors, the characteristics selected are a  minimum altitude of 500 m and an average slope of at least 15 %; Whereas a limited number of the proposed municipalities do not fully satisfy the requirements, but  nevertheless fully satisfy those of Article 3 (4) of Directive 75/268/EEC; whereas, since their  economy is closely linked with that of neighbouring municipalities classified according to Article  3 (3) and their territory forms an enclave within these neighbouring municipalities and is  relatively small compared to them, these municipalities may nevertheless be classified among the  mountain areas; Whereas in cases involving the presence of infertile land and where the economic results of farming  are appreciably lower than the average, as referred to in Article 3 (4) (a) and (b) of Directive  75/268/EEC, the areas have been defined using a complex index; 'the agricultural comparability  index' (Betriebszahl, abbreviated as 'BZ'; Whereas for the less-favoured farming areas the maximum value of the average index has been fixed  at 30, this figure corresponding to 70 % of the national average index of 42; whereas, in specific  cases, this average index has been fixed at 35 for the less-favoured farming areas where permanent  grassland and pasture cover more than 80 % of the usable agricultural area; Whereas the following indices have been chosen in respect of low or dwindling population as  referred to in Article 3 (4) (c) of Directive 75/268/EEG: density of not more than 55 inhabitants  per km² (the national average is 93) or an annual depopulation rate exceeding 0,5 %, together with  the working population engaged in farming forming a significant proportion of the total working  population of the municipality; Whereas, in areas where the average index is below 30, certain municipalities may reach a density  of 70 inhabitants per km²; Whereas, for the definition of the areas affected by specific handicaps which may be included among  the less-favoured areas referred to in Article 3 (5) of Directive 75/268/EEC account is taken of  the occurrence of unfavourable natural conditions (BZ) below 30 and of specific permanent handicaps  characteristic of: - an extremely hilly area with pronounced slopes, - a wet or marshy area, - an area regularly subject to flooding, - a border area of the Community; Whereas the total surface area of the areas referred to in Article 3 (5) of Directive 75/268/EEC  does not exceed 4 % of the total surface area of the Member State; Whereas the nature and level of the above indices selected by the Austrian Government for  identifying the types of area notified to the Commission are in conformity with the characteristics  of mountain areas, less-favoured areas and the areas affected by specific handicaps respectively,  as referred to in Article 3 (3), (4) and (5) of Directive 75/268/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1The areas situated in the Republic of Austria which appear in Annexes  I, II and III shall form part of the Community list of less-favoured farming areas within the  meaning of Article 3 (3), (4) and (5) of Directive 72/268/EEC. Article 2This Directive is addressed to the Republic of Austria. Done at Brussels, 29 May 1995. For the CouncilThe PresidentPh. VASSEUR (1) OJ No L 128, 19. 5. 1975, p. 1.  Directive as last amended by the 1994 Act of Accession. (2) OJ No C 125, 22. 5. 1995, p. 1. (3) OJ No C 126, 22. 5. 1995.  ANEXO I Zonas desfavorecidas tal como se definen en el apartado 3 del artículo 3 de la  Directiva 75/268/CEE BILAG I Ugunstigt stillede omraader, jf. artikel 3, stk. 3, i direktiv  75/268/EOEF ANHANG I Benachteiligte Gebiete im Sinne von Artikel 3 Absatz 3 der Richtlinie  75/268/EWG ÐÁÑÁÑÔÇÌÁ É ÌaaéïíaaêôéêÝò ðaañéï÷Ýò êáôUE ôçí Ýííïéá ôïõ UEñèñïõ 3 ðáñUEãñáoeïò 3 ôçò ïaeçãssáò  75/268/AAÏÊ ANNEX I Less-favoured areas within the meaning of Article 3 (3) of Directive 75/268/EEC  ANNEXE I Zones défavorisées au titre de l'article 3 paragraphe 3 de la directive 75/268/CEE  ALLEGATO I Zone svantaggiate ai sensi dell'articolo 3, paragrafo 3 della direttiva 75/268/CEE  BIJLAGE I Probleemgebieden in de zin van artikel 3, lid 3, van Richtlijn 75/268/EEG ANEXO I Zonas  desfavorecidas na acepção do no. 3 do artigo 3o. da Directiva 75/268/CEE LIITE I Direktiivin  75/268/ETY 3 artiklan 3 kohdan mukaisesti epaesuotuisiksi maeaeritettyjae alueita BILAGA I Mindre  gynnade omraaden i enlighet med artikel 3.3 i direktiv 75/268/EEG >TABLE>>TABLE> >TABLE>>TABLE>>TABLE>>TABLE>>TABLE>>TABLE  POSITION> ANEXO II Zonas desfavorecidas tal como se definen en el apartado 4 del artículo 3 de la  Directiva 75/268/CEE BILAG II Ugunstigt stillede omraader, jf. artikel 3, stk. 4, i direktiv  75/268/EOEF ANHANG II Benachteiligte Gebiete im Sinne von Artikel 3 Absatz 4 der Richtlinie  75/268/EWG ÐÁÑÁÑÔÇÌÁ ÉÉ ÌaaéïíaaêôéêÝò ðaañéï÷Ýò êáôUE ôçí Ýííïéá ôïõ UEñèñïõ 3 ðáñUEãñáoeïò 4 ôçò ïaeçãssáò  75/268/AAÏÊ ANNEX II Less-favoured areas within the meaning of Article 3 (4) of Directive 75/268/EEC  ANNEXE II Zones défavorisées au titre de l'article 3 paragraphe 4 de la directive 75/268/CEE  ALLEGATO II Zone svantaggiate ai sensi dell'articolo 3, paragrafo 4 della direttiva 75/268/CEE  BIJLAGE II Probleemgebieden in de zin van artikel 3, lid 4, van Richtlijn 75/268/EEG ANEXO II Zonas  desfavorecidas na acepção do no. 4 do artigo 3o. da Directiva 75/268/CEE LIITE II Direktiivin  75/268/ETY 3 artiklan 4 kohdan mukaisesti epaesuotuisiksi maeaeritettyjae alueita BILAGA II Mindre  gynnade omraaden i enlighet med artikel 3.4 i direktiv 75/268/EEG >TABLE>>TABLE> >TABLE>>TABLE>>TABLE> ANEXO III Zonas desfavorecidas tal como se definen en el apartado 5 del artículo 3 de la  Directiva 75/268/CEE BILAG III Ugunstigt stillede omraader, jf. artikel 3, stk. 5, i direktiv  75/268/EOEF ANHANG III Benachteiligte Gebiete im Sinne von Artikel 3 Absatz 5 der Richtlinie  75/268/EWG ÐÁÑÁÑÔÇÌÁ ÉÉÉ ÌaaéïíaaêôéêÝò ðaañéï÷Ýò êáôUE ôçí Ýííïéá ôïõ UEñèñïõ 3 ðáñUEãñáoeïò 5 ôçò  ïaeçãssáò 75/268/AAÏÊ ANNEX III Less-favoured areas within the meaning of Article 3 (5) of Directive  75/268/EEC ANNEXE III Zones défavorisées au titre de l'article 3 paragraphe 5 de la directive  75/268/CEE ALLEGATO III Zone svantaggiate ai sensi dell'articolo 3, paragrafo 5 della direttiva  75/268/CEE BIJLAGE III Probleemgebieden in de zin van artikel 3, lid 5, van Richtlijn 75/268/EEG  ANEXO III Zonas desfavorecidas na acepção do no. 5 do artigo 3o. da Directiva 75/268/CEE LIITE III  Direktiivin 75/268/ETY 3 artiklan 5 kohdan mukaisesti epaesuotuisiksi maeaeritettyjae alueita BILAGA  III Mindre gynnade omraaden i enlighet med artikel 3.5 i direktiv 75/268/EEG >TABLE>> TABLE POSITION>>TABLE>>TABLE>>TABLE>>TABLE>


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31991L0127

Commission Directive 91/127/EEC of 14 February 1991 amending Directive 66/403/EEC on the marketing of seed potatoes

Official Journal L 060 , 07/03/1991 P. 0018 - 0018 Finnish special edition: Chapter 3 Volume 36 P. 0197  Swedish special edition: Chapter 3 Volume 36 P. 0197

COMMISSION DIRECTIVE  of 14 February 1991  amending Directive 66/403/EEC on the marketing of seed potatoes  (91/127/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/403/EEC (1) of14 June 1966 on the marketing of seed potatoes, as last amended by Council Directive 90/654/EEC (2), and in particular Article 15 (2a) thereof,  Whereas in principle, with effect from certain dates, Member States may no longer determine for themselves the equivalence of seed potatoes harvested in third countries with seed potatoes harvested within the Community and complying with that Directive;   Whereas, however, since work to establish Community equivalence for all the third countries concerned had not been completed, Article 15 (2a) of that Directive permitted Member States to extend to 31 March 1990 the period of validity of equivalence  which they had already determined in respect of certain countries not covered by the Community equivalences;  Whereas the said work is still incomplete;  Whereas the authorization may only be extended in accordance with Member States' obligations under the common rules on plant health, laid down by Council Directive 77/93/EEC (3);  Whereas by Commission Decisions 89/599/EEC (4) and 90/613/EEC (5) derogations provided for by certain Member States from certain provisions of Directive 77/93/EEC in respect of seed potatoes originating in Canada and Poland respectively have been  approved until 31 March 1991;  Whereas the authorization granted to Member States by Article 15 (2a) should accordingly be extended;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:  Article 1  In Article 15 (2a) of Directive 66/403/EEC, '31 March 1990' is replaced by '31 March 1991'.  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.  When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be adopted by Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 14 February 1991. For the Commission  Ray MAC SHARRY  Member of the Commission  (1) OJ No 125, 11. 7. 1966, p. 2320/66. (2) OJ No L 353, 17. 12. 1990, p. 48. (3) OJ No L 26, 31. 1. 1977, p. 20. (4) OJ No L 344, 25. 11. 1989, p. 31. (5) OJ No L 328, 28. 11. 1990, p. 20.


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31991L0102

Commission Directive 91/102/EEC of 18 February 1991 amending Directive 88/272/EEC amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products

Official Journal L 052 , 27/02/1991 P. 0050 - 0050

COMMISSION DIRECTIVE  of 18 February 1991  amending Directive 88/272/EEC amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant  products  (91/102/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Directive 91/27/EEC (2), and in particular  the second indent of Article 13 (2) thereof,  Having regard to the requests made by Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom,  Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas those measures include measures to be taken by Member States in respect of plants, plant  products and other objects coming from third countries;  Whereas certain Member States have stricter measures in respect of those plants and plant products;  Whereas those stricter measures include, in the requesting Member States, certain restrictions applicable to certain products originating in a third country;  Whereas, by Commission Directive 88/272/EEC (3), the Annexes to Directive 77/93/EEC were amended so that the Member States concerned could also impose the relevant restrictions where the products concerned, originating in a third country, come from  other Member States; whereas these amendments were only interim protective measures for a limited period to enable the Commission to study the phytosanitary basis of the restrictions case by case;  Whereas it appeared impossible to finalize this study within the limited period originally allowed by Directive 88/272/EEC;  Whereas Commission Directive 90/113/EEC (4) extended the originally limited period for one year;  Whereas it appears impossible to finalize this study despite the one year extension on the original period; whereas this period should be further extended accordingly;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,  HAS ADOPTED THIS DIRECTIVE:    Article 1  In Article 4 of Directive 88/272/EEC, '31 December 1990', is replaced by '31 December 1991'.  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.  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.  Article 3  This Directive is addressed to the Member States.   Done at Brussels, 18 February 1991. For the Commission  Ray MAC SHARRY  Member of the Commission   (1) OJ No L 26, 31. 1. 1977, p. 20. (2) OJ No L 16, 22. 1. 1991, p. 29. (3) OJ No L 116, 4. 5. 1988, p. 19. (4) OJ No L 67, 15. 3. 1990, p. 51.


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31981L0528

Council Directive 81/528/EEC of 30 June 1981 amending Directive 72/159/EEC on the modernization of farms

Official Journal L 197 , 20/07/1981 P. 0041 - 0043 Spanish special edition: Chapter 03 Volume 22 P. 0187  Portuguese special edition Chapter 03 Volume 22 P. 0187

COUNCIL DIRECTIVE of 30 June 1981 amending Directive 72/159/EEC on the modernization of farms (81/528/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 42 and 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Whereas Article 16 of Council Directive 72/159/EEC of 17 April 1972 on the modernization of farms (3), as last amended by Directive 80/370/EEC (4), stipulates that the measures provided for therein are to be re-examined after five years by the Council upon a proposal from the Commission;  Whereas non-agricultural workers have to spend part of their income and part of their time travelling to and from their place of work ; whereas farmers should be authorized to make a corresponding deduction from the comparable earned income;  Whereas it is the responsibility of the Member States to determine what constitutes an adequate return on the capital invested in the farm ; whereas a single rate should be fixed for the return on the farmer's capital, for the purpose of calculating the earned income;  Whereas the funds available must be used as effectively as possible ; whereas funds should be concentrated on development plans which do not provide for the attainment of an earned income far in excess of the comparable earned income and on farms which do not themselves have sufficient means for modernization;  Whereas, having regard to the rate of inflation in the Community since the entry into force of Directive 72/159/EEC, the maximum amount of investment per man-work unit should be increased;  Whereas special aid may facilitate the establishment of a farm development plan by young farmers after their first installation on a farm;  Whereas the Member States should be authorized to continue granting transitional aid in respect of investments to improve the situation of managers who do not at present, for various reasons, qualify for the agricultural reform measures,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 72/159/EEC is hereby amended as follows:    (1) Article 2 (2) shall be replaced by the following:  "2. its level of earned income is less than the modernization objective established by Member States in accordance with Article 4 (2) or whose earned income does not exceed 120 % of this modernization objective, and where its present structure is such as to jeopardize maintenance of that income at a comparable level ; in the latter case, the interest rate subsidy provided for in Article 8 (1) (b) shall apply only to two-thirds of the loan referred to in Article 8 (2).";       (2) Article 4 (2) shall be replaced by the following:  "2. A comparable earned income as referred to in paragraph 1 means the average gross wage for a non-agricultural worker to which Member States may apply a 5 % general corrective abatement.  Member States may, where necessary, take account of disparities between the social security   (1) OJ No C 124, 17.5.1979, p. 1.  (2) OJ No C 85, 8.4.1980, p. 53.  (3) OJ No L 96, 23.4.1972, p. 1.  (4) OJ No L 90, 3.4.1980, p. 43.   arrangements for farmers and those for non-agricultural workers.  Furthermore, Member States are authorized to accept, at the request of the farmer, development. plans whose income objective represents only 90 % of the comparable earned income fixed in accordance with this paragraph."       (3) The second indent of Article 4 (4) (a) shall be replaced by the following:  "- determine what constitutes an adequate return on the capital invested in the farm business. Member States may add to the earned income accruing from the farm the amount of any return on capital over and above 3 75 %."       (4) The following indent shall be added to Article 4 (4) (a):  "- lay down the conditions of application of paragraph 2, subparagraph 3."       (5) The following sentence shall be added to Article 4 (5):  "Moreover, income from forestry work on the farm may be included in the agricultural income."       (6) The second sentence of Article 4 (6) shall be replaced by the following:  "However, Member States may be authorized, under the procedure laid down in Article 18, to specify a longer period not exceeding nine years for certain regions or for young farmers who have not reached the age of 40 years and who carry out a development plan within five years after their first installation on a farm."       (7) The first sentence in the first subparagraph of Article 8 (2) shall be replaced by the following:  "2. The interest rate subsidy provided for in paragraph 1 (b) shall apply to the whole of the loan except for any part of the loan exceeding 72 538 ECU (A) per man-work unit and 217 612 ECU (A) per farm. However, the Member States may fix lower maximum amounts."       (8) The following paragraph shall be added to Article 8:  "3. Member States may grant special aid to young farmers who have not reached the age of 40 years and who within five years after their first installation on a farm fulfil the conditions referred to in Article 2.  The special aid shall at most be equal to 10 % of the amount of the investment provided for in the development plan and eligible within the meaning of paragraph 1, without, however, exceeding 7 254 ECU (A).  Where two or more young farmers who fulfil the conditions of the first subparagraph carry out a development plan in association, the special aid may not exceed 10 881 ECU (A).  The special aid shall be paid as a capital grant. Member States may, however, grant the aid in some other form.  The special aid may be paid in several instalments."       (9) Article 14 (2) (a) shall be replaced by the following:  "(a) with effect from 1 January 1981, Member States may grant transitional aid to farmers practising farming as their main occupation who:      - are unable to attain the earned income fixed pursuant to Article 4;           - are not yet eligible for the annuities provided for in Article 2 (1) of Council Directive 72/160/EEC of 17 April 1972 concerning measures to encourage the cessation of farming and the reallocation of utilized agricultural areas for the purpose of structural improvement (1).             The transitional aid may be granted only in respect of investment not exceeding 18 135 ECU (A) and it may not be granted on terms more favourable than those laid down in Article 8, taking account of Article 9 (1) of Council Directive 75/268/EEC of 28 April 1975 on mountain and hill farming and farming in certain less-favoured areas (2), as last amended by Council Directive 80/666/EEC (3).  The grant of this transitional aid shall not exclude the farmer from subsequent eligibility for aid pursuant to Article 1 (1) or to the first subparagraph of this paragraph;   (1) OJ No L 96, 23.4.1972, p. 9.  (2) OJ No L 128, 19.5.1975, p. 1.  (3) OJ No L 180, 14.7.1980, p. 34."        (10) The following paragraph shall be added to Article 14:  "4. Aid for the purchase of land shall not be covered by this Directive."       (11) The first subparagraph of Article 19 (1) shall be replaced by the following:  "1. The expenditure incurred by Member States for the purposes of any measures taken under Article 8 (1) (b), under the first subparagraph of paragraph 2, under paragraph 3, and under Articles 10, 11 and 12, shall be eligible for assistance under the Guidance Section of the European Agricultural Guidance and Guarantee Fund."          Article 2 Member States shall bring into force the measures necessary to comply with this Directive by 31 December 1981 at the latest.   Article 3 This Directive is addressed to the Member States.     Done at Luxembourg, 30 June 1981.  For the Council  The President  G. BRAKS


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31983L0570

Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products

Official Journal L 332 , 28/11/1983 P. 0001 - 0010 Finnish special edition: Chapter 13 Volume 13 P. 0163  Spanish special edition: Chapter 13 Volume 14 P. 0205  Swedish special edition: Chapter 13 Volume 13 P. 0163  Portuguese special edition Chapter 13 Volume 14 P. 0205

COUNCIL DIRECTIVE of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (83/570/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas the Directives on the approximation of the laws relating to proprietary medicinal products must be adapted to scientific progress and take account of the experience obtained since their adoption;  Whereas Article 15 (2) of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (3) provides that the Commission shall submit to the Council a proposal containing appropriate measures leading towards the abolition of any remaining barriers to the free movement of proprietary medicinal products, not later than four years after the entry into force of the abovementioned Directive;  Whereas it is necessary from the point of view of public health and the free movement of medicinal products for the competent authorities to have at their disposal all useful information on authorized proprietary products, based in particular on summaries, adopted in the other Member States, of the characteristics of products;  Whereas it is necessary to specify certain provisions relating to physicochemical, biological or microbiological tests on proprietary medicinal products and to introduce the principle of bio-availability and mutagenesis tests in order to safeguard public health;  (1) OJ No C 287, 9.11.1981, p. 127. (2) OJ No C 189, 30.7.1981, p. 39. (3) OJ No L 147, 9.6.1975, p. 13.   Whereas the approximation of laws brought about in this connection must enable a proprietary product, manufactured and marketed in one Member State on the basis of harmonized provisions, to be allowed into another Member State, taking into due consideration the initial authorization, save in exceptional cases submitted for an opinion to the Committee for Proprietary Medicinal Products set up by Directive 75/319/EEC,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (1) is hereby amended as follows:    1. The second paragraph of Article 4 is amended as follows:      (a) in point 6, "if less than three years" is deleted;           (b) in point 8 (a) of the English version, "a List of published references" is replaced by "a bibliography";           (c) point 9 is replaced by the following:  "9. A summary, in accordance with Article 4a, of the product characteristics, one or more specimens or mock-ups of the sales presentation of the proprietary product, together with a package leaflet where one is to be enclosed."                  2. The following Article 4a is inserted:  "Article 4a  The summary of the product characteristics referred to in point 9 of the second paragraph of Article 4 shall contain the following information:      1. Name of the proprietary product.           2. Qualitative and quantitative composition in terms of the active ingredients and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product ; the international non-proprietary names recommended by the World Health Organization shall be used, where such names exist, or failing this, the usual common name or chemical description.           3. Pharmaceutical form.       4. Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars.       5. Clinical particulars:      5.1. therapeutic indications,           5.2. contra-indications,           5.3. undesirable effects (frequency and seriousness),           5.4. special precautions for use,           5.5. use during pregnancy and lactation,           5.6. interaction with other medicaments and other forms of interaction,           5.7. posology and method of administration for adults and, where necessary, for children,  (1) OJ No 22, 9.2.1965, p. 369/65.            5.8. overdose (symptoms, emergency procedures, antidotes)           5.9. special warnings,           5.10. effects on ability to drive and to use machines.                  6. Pharmaceutical particulars:      6.1. incompatibilities (major),           6.2. shelf life, when necessary after reconstitution of the product or when the container is opened for the first time,           6.3. special precautions for storage,           6.4. nature and contents of container,           6.5. name or style and permanent address or registered place of business of the holder of the marketing authorization."              3. The following Article 4b is inserted:  "Article 4b  When the marketing authorization referred to in Article 3 is issued, the person responsible for placing that product on the market shall be informed, by the competent authorities of the Member State concerned, of the summary of the product characteristics as approved by them. The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorization is issued or subsequently."   4. The following Article 9a is inserted:  "Article 9a  After an authorization has been issued, the person responsible for placing the product on the market must, in respect of the control methods provided for in Article 4 (7), take account of technical and scientific progress and introduce any changes that may be required to enable the proprietary medicinal product to be checked by means of generally accepted scientific methods. These changes must be accepted by the competent authorities of the Member State concerned."   5. Article 10 is amended as follows:  "Article 10  An authorization shall be valid for five years and be renewable for five-year periods on application by the holder at least three months before expiry."   6. The second paragraph of Article 11 shall be amended as follows:  "An authorization shall also be suspended or revoked where the particulars supporting the application as provided for in Articles 4 and 4a are incorrect or have not been amended in accordance with Article 9a, or when the controls referred to in Article 8 of this Directive or in Article 27 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (1)have not been carried out.  (1) OJ No L 147, 9.6.1975, p. 13."   7. in the first paragraph of Article 13, points 1, 2 and 7 are amended as follows:  "    1. Name of the proprietary products, which may be a brand name or a common name accompanied by a trade mark or the name of the manufacturer, or a scientific name accompanied by a trade mark or the name of the manufacturer.   Where the special name of a medicinal product containing only one active ingredient is a brand name, this name must be followed in legible characters by the international non-proprietary name recommended by the World Health Organization, where such name exists, or, where no such name exists, by the usual common name.   2. A statement of the active ingredients expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a particular volume or weight, using the international non-proprietary names recommended by the World Health Organization, where such names exist, or, where no such names exist, the usual common names. "  "7. Expiry date in plain language."          Article 2 The Annex to 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 proprietary medicinal products (1) is hereby amended as follows:    1. In part 1 (C) 1, the seventh paragraph is replaced by the following:  "The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization. If tests other than those mentioned in the pharmacopoeia are used, proof must be supplied that the starting materials meet the quality requirements of that pharmacopoeia."  The following is added to the eighth paragraph:  "The competent authorities shall inform the authorities responsible for the pharmacopoeia in question."       2. In part 1 (C) the following paragraph 3 is added:  "3. Physico-chemical characteristics liable to affect bio-availability  The following items of information concerning active ingredients, whether or not listed in the pharmacopoeias, shall be provided as part of the general description of the active principles if the bio-availability of the medicinal product depends on them:      - crystalline form and solubility coefficients,           - particle size, where appropriate after pulverization,           - state of hydration,           - oil/water coefficient of partition (1).             The first three indents are not applicable to substances used solely in solution.  (1) The competent authorities may also request the pK and pH values if they think this information is essential."       3. In part 1 (E) the following is inserted as first paragraph:  "For the control of the finished product, a batch of a proprietary medicinal product comprises all the units of a pharmaceutical form which are made from the  (1) OJ No L 147, 9.6.1975, p. 1.  same initial mass of material and have undergone a single series of manufacturing operations or a single sterilization operation or, in the case of a continuous production process, all the units manufactured in a given period of time."       4. The following fourth paragraph is added to part 1 (E) (1):  "Furthermore, solid pharmaceutical forms having to be administered orally shall be subjected to in vitro studies on the liberation and dissolution rate of the active ingredient or ingredients ; these studies shall also be carried out where administration is by another means if the competent authorities of the Member State concerned consider this necessary. The conditions of the test, the apparatus employed and the standards shall be described in precise detail as long as they are not given in the European Pharmacopoeia or the national pharmacopoeia of the Member States ; the same shall apply in cases where the methods prescribed by such pharmacopoeias are not applicable."       5. In part 1 (E) (2) the following new paragraphs are inserted between the second and third paragraphs:  "Unless there is appropriate justification, the maximum acceptable deviation in the active-ingredient content of the finished product shall not exceed ± 5 % at the time of manufacture.  On the basis of the stability tests, the manufacturer must propose and justify maximum acceptable deviations in the active-ingredient content of the finished product up to the end of the proposed shelf-life."       6. In part 1 (E) (3), the third paragraph is replaced by the following:  "An upper limit test shall be obligatory in respect of preserving agents and any other excipient constituent liable to affect adversely physiological functions ; an upper and lower limit test shall be obligatory in respect of the excipient if it is liable to affect the bio-availability of an active substance, unless bio-availability is guaranteed by other appropriate tests."       7. In part 1 (E) (5), the first paragraph is replaced by the following:  "If general monographs on pharmaceutical forms appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeias of the Member States, finished products must meet the requirements contained therein. If not, the finished-product specifications should include the following tests as appropriate for the formulation."  In addition, the ninth, 12th, 13th and 15th paragraphs are amended as follows:  Injectable preparations : "10 ml" is replaced by "15 ml".  "Ointments, creams, etc. : colour and consistency ; particle size of the active ingredients ; weight and acceptable margin of variation ; nature of container ; microbiological control tests, if necessary."  "Suspensions : colour, sedimentation rate ; where settlement occurs, the ease with which suspensions can be restored."  "Suppositories and pessaries : colour ; particle size of the active ingredients ; weight and acceptable variations in unit weight ; melting temperature or disintegration time, with the methods used to determine these."   8. In chapter I of part 2, the following section Da is inserted between titles D and E:  "Da. MUTAGENIC POTENTIAL  The purpose of the study of mutagenic potential is to reveal the changes which a substance may cause in the genetic material of individuals or cells and which have the effect of making successors permanently and hereditarily different from their predecessors. This study is obligatory for any new substance.  The number and types of results and the criteria for their evaluation shall depend on the state of scientific knowledge at the time when the application is lodged."   9. In chapter I of part 2, section E is replaced by:  "E. CARCINOGENIC POTENTIAL  Tests to reveal carcinogenic effects shall normally be required:      1. in respect of substances having a close chemical analogy with known carcinogenic or cocarcinogenic compounds;           2. in respect of substances which have given rise to suspicious changes during the long term toxicological tests;           3. in respect of substances which have given rise to suspicious results in the mutagenic-potential tests or in other short-term carcinogenicity tests.             Such tests may also be required in respect of substances to be included in proprietary medicinal products likely to be administered regularly over a prolonged period of a patient's life.  The state of scientific knowledge at the time when the application is lodged shall be taken into account when determining the details of the tests."   10. In chapter I (G) of part 2, the following new paragraph is inserted between the fourth and fifth paragraphs:  "For medicinal products which must be subjected to a bio-availability assessment, the data must include changes in the results as a function of time and, more generally, indicate the bio-availability of the product or of its metabolities."   11. Chapter II of part 3 is amended as follows:   - the title is replaced by:  "A. PHARMACOLOGICAL PARTICULARS (Clinical pharmacology and bio-availability)"   - the following paragraph is added:  "5. The assessment of bio-availability must be undertaken in all cases where it is essential in the interests of patients, e.g. where the therapeutic safety index number is low or where the previous tests have revealed anomalies which may be related to variable absorption, or if this process is necessary for the proprietary products referred to in Article 4 (8) of Directive 65/65/EEC."           Article 3 Chapter III of Directive 75/319/EEC is hereby replaced by the following:  "CHAPTER III  Committee for Proprietary Medicinal Products   Article 8 1. In order to facilitate the adoption of a common position by the Member States with regard to decisions on the issuing of marketing authorizations and to promote thereby the free movement of proprietary medicinal products, a Committee for Proprietary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up. The Committee shal consist of representatives of the Member States and of the Commission.  2. The Committee's task shall be to examine, at the request of a Member State or the Commission and in accordance with Articles 9 to 14, questions concerning the application of Articles 5, 11 or 20 of Directive 65/65/EEC.  3. The Committee shall draw up its own rules of procedure.   Article 9 1. In order to make it easier to obtain a marketing authorization in at least two other Member States taking into due consideration an authorization issued in one Member State in accordance with Article 3 of Directive 65/65/EEC, the holder of the latter authorization may submit an application to the competent authorities of the Member States concerned together with the information and documents referred to in Articles 4, 4a and 4b of Directive 65/65/EEC. He shall testify to its identity with the dossier accepted by the first Member State, specifying any additions it may contain, and shall certify that all the dossiers filed as part of this procedure are identical.  2. The holder of the marketing authorization shall notify the Committee of this application, inform it of the Member States concerned and send it a copy of his authorization. He shall also inform the Member State which granted him the initial authorization and notify it of any additions to the original dossier ; that State may require the applicant to provide it with all the particulars and documents necessary to enable it to check the identity of the dossiers filed with the dossier on which took its decision.  3. The holder of the marketing authorization shall notify the dates on which the dossiers were sent to the Member States concerned. As soon as the Committee has noted that all the Member States concerned are in possession of the dossier, it shall forthwith inform all the Member States and the applicant of the date on which the last Member State concerned received the dossier. The Member State(s) concerned shall either grant the authorization valid for their markets within a period of 120 days of the aforementioned date, taking into due consideration the authorization issued within the meaning of paragraph 1, or put forward a reasoned objection.  Article 10 1. Where a Member State considers that it is unable to grant a marketing authorization, it shall forward to the Committee and to the person responsible for placing  the proprietary medicinal product on the market its reasoned objection in accordance with Article 5 of Directive 65/65/EEC, within the time limits stipulated in Article 9 (3).  2. Upon the expiry of this period, the matter shall be referred to the Committee and the procedure referred to in Article 14 shall be applied.  3. On receipt of the reasoned objection referred to in paragraph 1, the person responsible for placing the product on the market shall immediately send the Committee a copy of the particulars and documents enumerated in Article 9 (1).  Article 11 If several applications submitted in accordance with Articles 4 and 4a of directive 65/65/EEC have been made for a marketing authorization for a particular proprietary medicinal product, and one or more Member States have granted an authorization while one or more of the other Member States have refused it, one of the Member States concerned or the Commission may refer the matter to the Committee for application of the procedure referred to in Article 14 of this Directive.  The same shall apply where one or more Member States have suspended or revoked a marketing authorization while one or more other Member States have not done so.  In both cases, the person responsible for placing the proprietary medicinal product on the market shall be informed of any decision of the Committee to apply the procedure laid down in Article 14.  Article 12 The competent authorities of Member States may, in specific cases where the interests of the Community are involved, refer the matter to the Committee before reaching a decision on a request for a marketing authorization or on the suspension or revocation of an authorization.  Article 13 1. The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and toxico-pharmacological tests on, and clinical trials of, any proprietary products containing a new active substance which are the subject of a request for a marketing authorization in the Member States concerned for the first time.  2. As soon as the notification referred to in Article 9 is received, the competent authorities shall immediately communicate to the Member States concerned any assessment report accompanied by a summary of the dossier relating to a particular proprietary product. This report shall also be communicated to the Committee where a matter is referred to the Committee pursuant to Article 10.  The assessment report shall also be forwarded to the other Member States concerned and to the Committee as soon as a matter is referred to the Committee under the procedure laid down in Article 11. Any assessment report so forwarded shall remain confidential.  The competent authorities shall bring the assessment report up to date as soon as it is in possession of information which is of importance for the evaluation of the balance between effectiveness and risk.   Article 14 1. When reference is made to the procedure described in this Article, the Committee shall consider the matter concerned and issue a reasoned opinion within 60 days of the date on which the matter was referred to it.  In the cases referred to in Article 10 the person responsible for placing the product on the market may, at his request, explain himself orally or in writing before the Committee issues its opinion. The Committee may extend the time limit referred to in the preceding paragraph to give the applicant time to explain himself orally or in writing.  In the case referred to in Article 11, the person responsible for placing the product on the market may be asked to explain himself orally or in writing.  2. The Committee's opinion shall concern the grounds for the objection provided for in Article 10 (1) and the grounds on which the marketing authorization has been refused, suspended or withdrawn in the cases described in Article 11.  The Committee shall immediately inform the Member State(s) concerned and the person responsible for placing the product on the market of its opinion or of those of its members in the case of divergent opinions.  3. The Member State(s) concerned shall decide what action to take on the Committee's opinion within 60 days of receipt of the information referred to in paragraph 2. They shall immediately inform the Committee of their decision.  Article 15 1. The Commission shall report to the Council every two years on the operation of the procedure laid down in this chapter and its effects on the development of intra-Community trade.  2. In the light of experience, the Commission shall, not later than four years after the entry into force of this Directive, submit to the Council a proposal containing appropriate measures leading towards the abolition of any remaining barriers to the free movement of proprietary medicinal products.  3. The Councli shall decide on the Commission proposal no later than one year after its submission."   Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within 24 months of its notification (1). They shall forthwith inform the Commission thereof.  Requests for marketing authorizations lodged after expiry of the time limit referred to in the first paragraph must comply with the provisions of this Directive.  (1) This Directive was notified to the Member States on 31 October 1983.   Articles 1 and 2 of this Directive, where relevant, shall be progressively extended to existing proprietary medicinal products by the end of the period stipulated in Article 39 (2) of Directive 75/319/EEC.  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 5 This Directive is addressed to the Member States.     Done at Luxembourg, 26 October 1983.  For the Council  The President  G. MORAITIS


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31985L0585

Council Directive 85/585/EEC of 20 December 1985 amending Directive 64/54/EEC on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption

Official Journal L 372 , 31/12/1985 P. 0043 - 0043 Finnish special edition: Chapter 13 Volume 15 P. 0014  Spanish special edition: Chapter 13 Volume 19 P. 0053  Swedish special edition: Chapter 13 Volume 15 P. 0014  Portuguese special edition Chapter 13 Volume 19 P. 0053

 COUNCIL DIRECTIVE    of 20 December 1985    amending Directive 64/54/EEC on the approximation   of the laws of the Member States concerning the   preservatives authorized for use in foodstuffs   intended for human consumption     ( 85/585/EEC )    THE COUNCIL OF THE EUROPEAN COMMUNITIES ,    Having regard to the Treaty establishing the European   Economic Community , and in particular Article 100   thereof ,    Having regard to the proposal from the Commission (1) ,    Having regard to the opinion of the European   Parliament (2) ,    Having regard to the opinion of the Economic and   Social Committee (3) ,    Whereas Directive 64/54/EEC (4) , as last amended by   Directive 85/172/EEC (5) , lays down a list of   preservatives which may be used for the protection of   foodstuffs intended for human consumption against   deterioration caused by micro-organisms ;    Whereas potassium acid sulphite ( potassium bisulphite )   may be used in wine production as an alternative to   other sulphites already permitted by the said Directive ,   and therefore should be added to the list under No E 228 ;    Whereas , without prejudice to future general   Community rules on the surface treatment of fruit , in   order to remove any uncertainty about the acceptability   of thiabendazole ( E 233 ) , the deadline for its authorized   use should be removed with effect from 16 September   1984 ,    HAS ADOPTED THIS DIRECTIVE :    Article 1    The Annex to Directive 64/54/CEE is hereby amended   as follows :     ( i ) the following shall be inserted under entry I :    EEC No * Name * Conditions of use *    E 228 * Potassium acid sulphite ( Potassium   bisulphite ) * *     ( ii ) Under E 233 in the column " Conditions of use " ,   point ( c ) shall be deleted with effect from 1 January   1986 .    Article 2    Member States shall bring into force not later than 31   December 1986 the laws , regulations or administrative   procedures necessary to comply with this Directive . They   shall forthwith inform the Commission thereof .    Article 3    This Directive is addressed to the Member States .    Done at Brussels , 20 December 1985 .    For the Council    The President    R. STEICHEN    (1) OJ No C 33 , 17 . 12 . 1981 , p. 7 .    (2) OJ No C 125 , 17 . 5 . 1982 , p. 117 .    (3) OJ No C 178 , 15 . 7 . 1982 , p. 4 .    (4) OJ No 12 , 27 . 1 . 1964 , p. 161/64 .    (5) OJ No L 65 , 6 . 3 . 1985 , p. 22 .


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32000L0039

Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (Text with EEA relevance)

Official Journal L 142 , 16/06/2000 P. 0047 - 0050

Commission Directive 2000/39/ECof 8 June 2000establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work(1), and in particular Article 3(2) thereof,Having regard to the opinion of the Advisory Committee on safety, hygiene and health protection at work,Whereas:(1) Pursuant to Directive 98/24/EC, the Commission is to propose European objectives in the form of indicative occupational exposure limit values for the protection of workers from chemical risks, to be set at Community level.(2) The Commission, in carrying out this task, is assisted by the Scientific Committee for occupational exposure limits to chemical agents (SCOEL), instituted by Commission Decision 95/320/EC(2).(3) For any chemical agent for which indicative occupational exposure limit values are established at Community level, Member States are required to establish a national occupational exposure limit value, taking into account the Community limit value, determining its nature in accordance with national legislation and practice.(4) Indicative occupational exposure limit values should be regarded as an important part of the overall approach to ensuring the protection of the health of workers at the workplace, against the risks arising from hazardous chemicals.(5) A first and a second list of indicative occupational exposure limit values were established by Commission Directives 91/322/EEC(3) and 96/94/EC(4) in the framework of Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work(5).(6) Directive 80/1107/EEC has been repealed with effect from 5 May 2001 by Directive 98/24/EC.(7) It is appropriate to reenact, in the framework of Directive 98/24/EC, the indicative occupational exposure limit values which had been established by Directives 91/322/EEC and 96/94/EC in the framework of Directive 80/1107/EEC.(8) The list set out in the Annex contains the substances set out in the Annex to Directive 96/94/EC and incorporates a number of other agents for which indicative occupational exposure limit values have been recommended by SCOEL, following the evaluation of the latest available scientific data on occupational health effects and taking into account the availability of measuring techniques. In view of the foregoing and in the interests of clarity Directive 96/94/EC should be recast.(9) It is necessary to establish short-term exposure limit values for certain substances to take account of effects arising from short-term exposure.(10) For some agents, it is necessary to have regard also to the possibility of penetration through the skin, in order to ensure the best possible level of protection.(11) This Directive constitutes a practical step towards the achievement of the social dimension of the internal market.(12) The measures provided for in this Directive are in accordance with the opinion of the Committee instituted by Article 17 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(6),HAS ADOPTED THIS DIRECTIVE:Article 1Community indicative occupational exposure limit values are hereby established for the chemical agents set out in the Annex.Article 2Member States shall establish national occupational exposure limit values for the chemical agents listed in the Annex, taking into account the Community values.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2001 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference at the time 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 provisions of national law which they adopt in the field covered by this Directive.Article 4Directive 96/94/EC is repealed with effect from the date referred to in Article 3(1).Article 5This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 6This Directive is addressed to the Member States.Done at Brussels, 8 June 2000.For the CommissionAnna DiamantopoulouMember of the Commission(1) OJ L 131, 5.5.1998, p. 11.(2) OJ L 188, 9.8.1995, p. 14.(3) OJ L 177, 5.7.1991, p. 22.(4) OJ L 338, 28.12.1996, p. 86.(5) OJ L 327, 3.12.1980, p. 8.(6) OJ L 183, 29.6.1989, p. 1.ANNEXINDICATIVE OCCUPATIONAL EXPOSURE LIMIT VALUES>TABLE>