title: Commission Directive 2006/39/EC of  12 April 2006  amending Council Directive 91/414/EEC to include clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole as active substances   (Text with EEA relevance)

text:
               13.4.2006

               EN

               Official Journal of the European Union

               L 104/30

      COMMISSION DIRECTIVE 2006/39/EC
   of 12 April 2006
   amending Council Directive 91/414/EEC to include clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For clodinafop the rapporteur Member State was The Netherlands and all relevant information was submitted on 7 November 2003. For pirimicarb the rapporteur Member State was United Kingdom and all relevant information was submitted on 4 November 2003. For rimsulfuron the rapporteur Member State was Germany and all relevant information was submitted on 6 August 2003. For tolclofos-methyl the rapporteur Member State was Sweden and all relevant information was submitted on 3 November 2003. For triticonazole the rapporteur Member State was Austria and all relevant information was submitted on 29 September 2003.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 14 March and 10 August 2005 in the format of the EFSA Scientific Reports for clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 January 2006 in the format of the Commission review reports for clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole.

               (4)

               The review of pirimicarb revealed a number of open questions which were addressed by the Scientific Panel on Plant Health, Plant Protection Products and their residues (PPR) of the European Food Safety Authority (EFSA). The Scientific Panel was asked to give an opinion on the use of a ‘time quotient approach’ in the acute risk assessment for birds and on the assessment of the acute risk for birds which had been carried out. In its opinion to the first question the PPR Panel concluded that the ‘time quotient approach’ suggested by OECD is equivalent to the current European first tier acute avian risk assessment except that Annex VI of Directive 91/414/EEC stipulates a specific safety factor of 10. Therefore, a detailed scientific analysis would be required to assess whether the current safety factor takes appropriate account of all relevant issues. Since this would require substantial further work that is beyond the scope of the opinion, the PPR Panel suggests that a case by case approach should be used. As result, on the second question, the PPR Panel carried out a refined risk assessment and concluded that even at the upper limit of credible exposures birds feeding on insects in the field are unlikely to achieve a lethal dose of pirimicarb (5).

               (5)

               The reviews of clodinafop, rimsulfuron, tolclofos-methyl and triticonazole did not reveal any open question to be addressed by the Scientific Panel on Plant Health, Plant Protection Products and their residues (PPR) of the European Food Safety Authority (EFSA).

               (6)

               It has appeared from the various examinations made that plant protection products containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (7)

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

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (9)

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

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 July 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 August 2007.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as active substances by 31 July 2007.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 January 2007 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2011 at the latest; or

               (b)

               in the case of a product containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

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

      Done at Brussels, 12 April 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/19/EC (OJ L 44, 15.2.2006, p. 15).

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

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  ‘EFSA Scientific Report (2005) 34, 1-78, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance clodinafop (finalised: 10 August 2005)’.
   ‘EFSA Scientific Report (2005) 43, 1-76, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance pirimicarb (finalised: 10 August 2005)’.
   ‘EFSA Scientific Report (2005) 45, 1-61, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance rimsulfuron (finalised: 10 August 2005)’.
   ‘EFSA Scientific Report (2005) 28, 1-77, Conclusion regarding the peer review of the pesticide risk assessment of the active substance triticonazole (finalised: 14 March 2005)’.
   ‘EFSA Scientific Report (2005) 28, 1-77, Conclusion regarding the peer review of the pesticide risk assessment of the active substance tolclofos-methyl (finalised: 14 March 2005)’.

      (5)  Opinion of the Scientific Panel on Plant Health, Plant protection products and their residues on a request from EFSA related to the evaluation of pirimicarb EFSA Journal (2005) 240, 1-21.

      (6)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

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

                     ‘No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     125

                     Clodinafop
                     CAS No 114420-56-3
                     CIPAC No 683

                     (R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid

                     ≥ 950 g/kg (expressed as clodinafop-propargyl)

                     1 February 2007

                     31 January 2017

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

                     126

                     Pirimicarb
                     CAS No 23103-98-2
                     CIPAC No 231

                     2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate

                     ≥ 950 g/kg

                     1 February 2007

                     31 January 2017

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
                     Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment.
                     Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.
                     The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     127

                     Rimsulfuron
                     CAS No 122931-48-0 (rimsulfuron)
                     CIPAC No 716

                     1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea

                     ≥ 960 g/kg (expressed as rimsulfuron)

                     1 February 2007

                     31 January 2017

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
                     Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

                     128

                     Tolclofos-methyl
                     CAS No 57018-04-9
                     CIPAC No 479

                     O-2,6-dichloro-p-tolyl O,O-dimethyl phosphorothioate
                     O-2,6-dichloro-4-methylphenyl O,O-dimethyl phosphorothioate

                     ≥ 960 g/kg

                     1 February 2007

                     31 January 2017

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing tolclofos-methyl for uses other than pre-planting tuber (seed) treatment in potato and soil treatment in lettuce within greenhouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tolclofos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

                     129

                     Triticonazole
                     CAS No 131983-72-7
                     CIPAC No 652

                     (±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

                     ≥ 950 g/kg

                     1 February 2007

                     31 January 2017

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States:

                                 —

                                 must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate,

                                 —

                                 must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones,

                                 —

                                 must pay particular attention to the protection of granivorous birds (long term risk).

                           Conditions of authorisation should include risk mitigation measures, where appropriate.
                     The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

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


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31974L0553

Council Directive 74/553/EEC of 7 November 1974 amending Article 5 (2) of Directive No 69/335/EEC concerning direct taxes on the raising of capital

Official Journal L 303 , 13/11/1974 P. 0009 - 0009 Greek special edition: Chapter 09 Volume 1 P. 0042  Spanish special edition: Chapter 09 Volume 1 P. 0046  Portuguese special edition Chapter 09 Volume 1 P. 0046

COUNCIL DIRECTIVE  of 7 November 1974  amending Article 5 (2) of Directive 69/335/EEC concerning indirect taxes on the raising of capital  (74/553/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 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 Article 5 (2) of Council Directive 69/335/EEC (3) of 17 July 1969 concerning indirect taxes on the raising of capital provides that, in the cases referred to in paragraph 1 (a), (b) and (c) thereof, the amount on which capital duty is charged shall not be less than the actual value of the shares in the company allotted or belonging to each member or the nominal amount of these shares if the latter exceeds their actual value;  Whereas the adoption of the actual value of the shares as a minimum basis of taxation does not in some of the above cases conform to the principles on which the harmonized capital duty is based and which aim at introducing a system whereby capital duty is to be charged only on transactions legally constituting a raising of capital and only in so far as such transactions contribute towards strengthening the economic potential of the company,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Article 5 (2) of Directive 69/335/EEC is replaced by the following:  "2. In the cases referred to in paragraph 1 (a) and (b), Member States may base the amount on which to charge capital duty on the actual value of the shares in the company allotted or belonging to each member. This does not apply, to those cases in which contributions are made only in cash. The amount on which duty is charged shall in no circumstances be less than the nominal amount of the shares in the company allotted or belonging to each member."   Article 2 This Directive is addressed to the Member States.     Done at Brussels, 7 November 1974.  For the Council  The President  A. JARROT  (1)OJ No C 76, 3.7.1974, p. 9. (2)OJ No C 109, 19.9.1974, p. 35. (3)OJ No L 249, 3.10.1969, p. 25.


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31996L0053

Council Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international traffic

Official Journal L 235 , 17/09/1996 P. 0059 - 0075

COUNCIL DIRECTIVE 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international traffic THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),(1) Whereas Council Directive 85/3/EEC of 19 December 1984 on the weights, dimensions and certain other technical characteristics of certain road vehicles (4) established, in the framework of the common transport policy, common standards permitting improved use of road vehicles in traffic between Member States;(2) Whereas Directive 85/3/EEC has been significantly amended on many occasions; whereas on the occasion of its further amendment it should for reasons of clarity and rationality be recast in a single text together with Council Directive 86/364/EEC of 24 July 1986 relating to proof of compliance of vehicles with Directive 85/3/EEC (5);(3) Whereas differences between standards in force in the Member States with regard to the weights and dimensions of commercial road vehicles could have an adverse effect on the conditions of competition and constitute an obstacle to traffic between Member States;(4) Whereas, under the principle of subsidiarity, action should be taken at Community level in order to remove this obstacle;(5) Whereas the abovementioned standards reflect a balance between the rational and economical use of commercial road vehicles and the requirements of infrastructure maintenance, road safety and the protection of the environment and the fabric of live;(6) Whereas common standards on the dimensions of vehicles intended for the carriage of goods should remain stable in the long term;(7) Whereas additional technical requirements related to the weights and dimensions of vehicles may apply to commercial vehicles registered or put into circulation in a Member State; whereas these requirements must not constitute an obstacle to the circulation of commercial vehicles between Member States;(8) Whereas the definition of 'thick-walled refrigerated vehicle` in Article 2 of Directive 85/3/EEC, as amended by Directive 89/388/EEC (6), should be broadened in order to permit Member States to allow refrigerated vehicles no longer meeting the insulation requirements defined in that Article to circulate in their territory;(9) Whereas it is necessary to clarify the concept of 'indivisible load` in order to ensure uniform application of this Directive in respect of permits for vehicles or vehicle combinations carrying such loads;(10) Whereas the tonne is universally used and understood as the unit of measurement for vehicle weight and is, therefore, applied in this Directive whilst recognizing that the formal unit of weight is the newton;(11) Whereas, in implementation of the internal market, the scope of this Directive should be extended to national transport insofar as it concerns characteristics that significantly affect the conditions of competition in the transport sector and in particular the values relating to the maximum authorized length and width of vehicles and vehicle combinations intended for the carriage of goods;(12) Whereas, for the other vehicle characteristics, Member States are authorized to apply in their territory different values from those laid down in this Directive only to vehicles used in national traffic;(13) Whereas road trains using extensible coupling systems in practice attain a maximum length of 18,75 m when fully extended; whereas the same maximum length should be authorized for road trains using fixed coupling systems;(14) Whereas the maximum authorized width of 2,50 m for vehicles intended for the carriage of goods can leave insufficient internal space for the efficient loading of pallets, which has given rise to the application of different tolerances beyond that level in the legislation of the Member States concerning domestic traffic; whereas a general adaptation to the current situation is therefore necessary in order to provide for clarity in technical requirements, bearing in mind the road safety aspects of these characteristics;(15) Whereas if the maximum width of vehicles intended for the carriage of goods is increased to 2,55 m, that standard should also be applied to buses; whereas, in respect of buses, it is however necessary to provide for a transitional period to allow the manufacturers concerned to adapt industrial plant;(16) Whereas, to prevent excessive road damage and to ensure manoeuvrability, when authorizing and using vehicles preference should be given to pneumatic or equivalent suspension rather than mechanical suspension; whereas certain maximum axle loads should not be exceeded, and the vehicle must be capable of turning through 360° within certain limit values for the path followed;(17) Whereas Member States should be permitted, in national goods transport, to allow vehicles or vehicle combinations with dimensions deviating from those laid down in this Directive to circulate in their territory if the transport operations carried out by such vehicles are defined by this Directive as not significantly affecting international competition in the transport sector, i.e. operations carried out by specialized vehicles and operations carried out according to a modular concept;(18) Whereas, in the case of modular concept operations, there should be provision for a transitional period to enable a Member State to adapt its road infrastructure;(19) Whereas vehicles or vehicle combinations constructed applying new technologies or new concepts, according to standards which deviate from those laid down by this Directive, should be allowed to carry out local transport operations for a trial period to enable profit to be drawn from technical progress;(20) Whereas vehicles which entered into service before the date of implementation of this Directive and which do not comply with the dimension characteristics laid down in this Directive, owing to previously differing national provisions or methods of measurement, should be allowed for a transitional period to continue to provide transport services within the Member State in which the vehicle is registered or put into circulation;(21) Whereas progress has been made towards adopting Type-Approval Directives for vehicle combinations with five or six axles; whereas, the requirements regarding conformity with characteristics other than weights and dimensions as laid down in Annex II of Directive 85/3/EEC should therefore be deleted;(22) Whereas such a modification is also necessary in order to avoid rules conflicting with international conventions on road traffic and circulation;(23) Whereas in order to facilitate the monitoring of compliance with this Directive, it is necessary to ensure that vehicles carry proof of such compliance;(24) Whereas this Directive does not affect the obligations of the Member States concerning the deadlines for transposition into national law and for application of the Directives which this Directive replaces,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive applies to:(a) the dimensions of motor vehicles in categories M2, M3 and N2 and N3 and their trailers in categories 03 and 04, as defined in Annex II to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (7);(b) the weights and certain other characteristics of the vehicles defined in (a) and specified in Annex I (2) to this Directive.2. All the values of weights indicated in Annex I are valid as circulation standards and thus refer to loading conditions, not production standards, which will be defined in a later Directive.Article 2For the purposes of this Directive:- 'motor vehicle` shall mean any power-driven vehicle which travels on the road by its own means,- 'trailer` shall mean any vehicle intended to be coupled to a motor vehicle excluding semi-trailers, and constructed and equipped for the carriage of goods,- 'semi-trailer` shall mean any vehicle intended to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle with a substantial part of its weight and of the weight of its load being borne by the motor vehicle, and constructed and equipped for the carriage of goods,- 'vehicle combination` shall mean either:- a road train consisting of a motor vehicle coupled to a trailer; or- an articulated vehicle consisting of a motor vehicle coupled to a semi-trailer,- 'conditioned vehicle` shall mean any vehicle whose fixed or movable superstructures are specially equipped for the carriage of goods at controlled temperatures and whose side walls, inclusive of insulation, are each at least 45 mm thick,- 'bus` shall mean a vehicle with more than nine seats including the driver's seat, constructed and equipped to carry passengers and their luggage. It may have one or two decks and may also draw a luggage trailer,- 'articulated bus` shall mean a bus consisting of two rigid sections connected to each other by an articulated section. On this type of vehicle the passenger compartments in each of the two rigid sections shall be intercommunicating. The articulated section shall permit the free movement of travellers between the rigid sections. Connection and disconnection of the two sections shall be possible only in a workshop,- 'maximum authorized dimensions` shall mean the maximum dimensions for use of a vehicle, as laid down in Annex I to this Directive,- 'maximum authorized weight` shall mean the maximum weight for use of a laden vehicle in international traffic,- 'maximum authorized axle weight` shall mean the maximum weight for use in international traffic of a laden axle or group of axles,- 'indivisible load` shall mean a load that cannot, for the purpose of carriage by road, be divided into two or more loads without undue expense or risk of damage and which owing to its dimensions or mass cannot be carried by a motor vehicle, trailer, road train or articulated vehicle complying with this Directive in all respects,- 'tonne` shall mean the weight executed by the mass of a tonne and shall correspond to 9,8 kilonewtons (kN),All maximum authorized dimensions specified in Annex I shall be measured in accordance with Annex I to Directive 70/156/EEC, with no positive tolerances.Article 31. A Member State may not reject or prohibit the use in its territory:- in international traffic, of vehicles registered or put into circulation in any other Member State for reasons relating to their weights and dimensions,- in national traffic, of goods vehicles registered or put into circulation in any other Member State for reasons relating to their dimensions,provided that such vehicles comply with the limit values specified in Annex I.This provision shall apply notwithstanding the fact that:(a) the said vehicles are not in conformity with the requirements of that Member State with regard to certain weight and dimension characteristics not covered by Annex I;(b) the competent authority of the Member State in which the vehicles are registered or put into circulation has authorized limits not referred to in Article 4 (1) exceeding those laid down in Annex I.2. However, paragraph 1 (a) shall not affect the right of Member States, with due regard to Community law, to require vehicles registered or put into circulation in their own territory to be in conformity with their national requirements on weight and dimension characteristics not covered by Annex I.3. Member States may require conditioned vehicles to carry an ATP certificate or ATP certification plate provided for in the Agreement of 1 September 1970 on the international carriage of perishable foodstuffs and on the special equipment to be used for such carriage.Article 41. Member States shall not allow the normal circulation of vehicles or vehicle combinations for the national transport of goods in their territory which are not in conformity with the characteristics set out in points 1.1, 1.2, 1.4 to 1.8, 4.2 and 4.4 of Annex I.2. Member States may nonetheless allow circulation in their territory of vehicles or vehicle combinations for the national transport of goods freight which are not in conformity with the characteristics set out in 1.3, 2, 3, 4.1 and 4.3 of Annex I.3. Vehicles or vehicle combinations which exceed the maximum dimensions may only be allowed to circulate on the basis of special permits issued without discrimination by the competent authorities, or on the basis of similar non-discriminatory arrangements agreed on a case-by-case basis with those authorities, where these vehicles or vehicle combinations carry or are intended to carry indivisible loads.4. Member States may allow vehicles or vehicle combinations used for goods transport which carry out certain national transport operations that do not significantly affect international competition in the transport sector to circulate in their territory with dimensions deviating from those laid down in points 1.1, 1.2, 1.4 to 1.8, 4.2 and 4.4 of Annex I.Transport operations shall be considered not significantly to affect international competition in the transport sector if one of the conditions under (a) and (b) is fulfilled:(a) the transport operations are carried out in a Member State's territory by specialized vehicles or specialized vehicle combinations in circumstances in which they are not normally carried out by vehicles from other Member States, e.g. operations linked to logging and the forestry industry;(b) the Member State which permits transport operations to be carried out in its territory by vehicles or vehicle combinations with dimensions deviating from those laid down in Annex I also permits motor vehicles, trailers and semi-trailers which comply with the dimensions laid down in Annex I to be used in such combinations as to achieve at least the loading length authorized in that Member State, so that every operator may benefit from equal conditions of competition (modular concept).The Member State concerned which has to adapt its road infrastructure in order to be able to fulfil the condition under (b) may nevertheless prohibit, until 31 December 2003 at the latest, the circulation in its territory, in national goods transport operations, of vehicles or vehicle combinations which exceed current national standards on dimensions, provided that national legislation continues to apply to all Community carriers in a non-discriminatory manner.The Member States shall inform the Commission of the measures taken pursuant to this paragraph.5. Member States may allow vehicles or vehicle combinations incorporating new technologies or new concepts which cannot comply with one or more requirements of this Directive to carry out certain local transport operations for a trial period. Member States shall inform the Commission thereof.6. Member States may allow vehicles or vehicle combinations used for goods transport and registered or put into circulation before the implementation of this Directive to circulate in their territory until 31 December 2006 with dimensions exceeding those laid down in points 1.1, 1.2, 1.4 to 1.8, 4.2 and 4.4 of Annex I by virtue of differing national provisions or methods of measurement.Article 5Without prejudice to Article 4 (6):(a) articulated vehicles put into circulation before 1 January 1991 which do not comply with the specifications contained in points 1.6 and 4.4 of Annex I shall be deemed to comply with such specifications for the purposes of Article 3 if they do not exceed a total length of 15,50 m;(b) road trains, the motor vehicle of which was put into circulation before 31 December 1991 and which do not comply with the specifications contained in points 1.7 and 1.8 of Annex I, shall until 31 December 1998 be deemed to comply with such specifications for the purposes of Article 3 if they do not exceed a total length of 18,00 m.Article 61. Member States shall take the necessary measures to ensure that Article 1 vehicles referred to in Article 1 and complying with this Directive carry one of the proofs referred to in (a), (b) and (c):(a) a combination of the following two plates:- the 'manufacturer's plate` established and attached in accordance with Directive 76/114/EEC (8),- the plate relating to dimensions, in accordance with Annex III, established and attached in accordance with Directive 76/114/EEC;(b) a single plate established and attached in accordance with Directive 76/114/EEC and containing the information on the two plates referred to in (a);(c) a single document issued by the competent authorities of the Member State in which the vehicle is registered or put into circulation. Such document shall bear the same headings and information as the plates referred to in (a). It shall be kept in a place easily accessible to inspection and shall be adequately protected.2. If the characteristics of the vehicle no longer correspond to those indicated on the proof of compliance, the Member State in which the vehicle is registered shall take the necessary steps to ensure that the proof of compliance is altered.3. The plates and documents referred to in paragraph 1 shall be recognized by the Member States as the proof of vehicle compliance provided for in this Directive.4. Vehicles carrying proof of compliance may be subject:- as regards common standards on weights, to random checks,- as regards common standards on dimensions, only to checks where there is a suspicion of non-compliance with this Directive.5. The middle column of the proof of compliance relating to weights shall contain, where appropriate, the Community weight standards applicable to the vehicle in question. As regards vehicles referred to in point 2.2.2 (c) of Annex I, the entry '44 tonnes` shall be included in brackets under the maximum authorized weight of the vehicle combination.6. Each Member State may decide, in respect of any vehicle registered or put into circulation in its territory, that the maximum weights authorized by its national legislation shall be indicated in the proof of compliance in the left-hand column and the technically permissible weights in the right-hand column.Article 7This Directive shall not preclude the application of road traffic provisions in force in each Member State which permit the weight and/or dimensions of vehicles on certain roads or civil engineering structures to be limited, irrespective of the State of registration of such vehicles.Article 8Article 3 shall not apply in Ireland and the United Kingdom until 31 December 1998:(a) as regards the standards referred to in points 2.2, 2.3.1, 2.3.3, 2.4 and 3.3.2 of Annex I:- with the exception of the articulated vehicles referred to in point 2.2.2 where:(i) the total laden weight does not exceed 38 tonnes;(ii) the weight on any tri-axle at the spacing specified in point 3.3.2 does not exceed 22,5 tonnes,- with the exception of the vehicles referred to in points 2.2.3, 2.2.4, 2.3 and 2.4, where the total laden weight does not exceed:(i) 35 tonnes for the vehicles referred to in points 2.2.3 and 2.2.4;(ii) 17 tonnes for the vehicles referred to in point 2.3.1;(iii) 30 tonnes for the vehicles referred to in point 2.3.3, subject to compliance with the conditions specified in that point and in point 4.3;(iv) 27 tonnes for the vehicles referred to in point 2.4,(b) as regards the standard referred to in point 3.4 of Annex I, with the exception of the vehicles referred to in points 2.2, 2.3 and 2.4, where the weight per driving axle does not exceed 10,5 tonnes.Article 9As regards the standard referred to in point 1.2 (a) of Annex I, a Member State may reject or prohibit the use in its territory, until 31 December 1999, of buses with a width exceeding 2,5 m.Member States shall inform the Commission of the measures taken pursuant to this Article. The Commission shall inform the other Member States thereof.Article 10The Directive listed in Annex IV, Part A, shall be repealed with effect from the date in Article 11, without prejudice to the obligations of the Member States concerning the deadlines for transposition set out in Annex IV, Part B.References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex V.Article 111. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 September 1997. 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 reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive.Article 12This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 13This Directive is addressed to the Member States.Done at Brussels, 25 July 1996.For the CouncilThe PresidentH. COVENEY(1) OJ No C 38, 8. 2. 1994, p. 3 and OJ NO C 247, 23. 9. 1995, p. 1.(2) OJ No C 295, 22. 10. 1994, p. 72.(3) Opinion of the European Parliament delivered on 15 November 1994 (OJ No C 341, 5. 12. 1994, p. 39), Council common position of 8 December 1995 (OJ No C 356, 30. 12. 1995, p. 13), and Decision of the European Parliament of 14 March 1996 (OJ No C 96, 4. 4. 1996, p. 233).(4) OJ No L 2, 3. 1. 1985, p. 14. Directive as last amended by Directive 92/7/EEC (OJ No L 57, 2. 3. 1992, p. 29).(5) OJ No L 221, 7. 8. 1986, p. 48).(6) OJ No L 142, 25. 5. 1989, p. 3.(7) OJ No L 42, 23. 2. 1970, p. 1. Directive as last amended by the 1994 Act of Accession.(8) OJ No L 24, 30. 1. 1976, p. 1. Directive as amended by Commission Directive 78/507/EEC (OJ No L 155, 13. 6. 1978, p. 31).ANNEX I >TABLE>ANNEX II CONDITIONS RELATING TO EQUIVALENCE BETWEEN CERTAIN NON-AIR SUSPENSION SYSTEMS AND AIR SUSPENSION FOR VEHICLE DRIVING AXLE(S) 1. DEFINITION OF AIR SUSPENSION A suspension system is considered to be air suspended if at least 75 % of the spring effect is caused by the air spring.2. EQUIVALENCE TO AIR SUSPENSION A suspension recognized as being equivalent to air suspension must conform to the following:2.1. during free transient low frequency vertical oscillation of the sprung mass above a driving axle or bogie, the measured frequency and damping with the suspension carrying its maximum load must fall within the limits defined in points 2.2 to 2.5;2.2. each axle must be fitted with hydraulic dampers. On tandem axle bogies, the dampers must be positioned to minimize the oscillation of the bogies;2.3. the mean damping ratio D must be more than 20 % of critical damping for the suspension in its normal conditions with hydraulic dampers in place and operating;2.4. the damping ratio D of the suspension with all hydraulic dampers removed or incapacitated must be not more than 50 % of D;2.5. the frequency of the sprung mass above the driving axle or bogie in a free transient vertical oscillation must not be higher than 2,0 Hz;2.6. the frequency and damping of the suspension are given in paragraph 3. The test procedures for measuring the frequency and damping are laid down in paragraph 4.3. DEFINITION OF FREQUENCY AND DAMPING In this definition a sprung mass M (kg) above a driving axle or bogie is considered. The axle or bogie has a total vertical stiffness between the road surface and the sprung mass of K Newtons/metre (N/m) and a total damping coefficient of C Newtons per metre per second (N.s/m). The vertical displacement of the sprung mass is Z. The equation of motion for free oscillation of the sprung mass is:M >NUM>d² Z>DEN>dt² + C >NUM>d Z>DEN>dt + kZ = 0The frequency of oscillation of the sprung mass F >NUM>(rad/>DEN>sec) is:F = √>NUM>K>DEN>M - >NUM>C²>DEN>4M²The damping is critical when C = C°,whereC° = 2√KMThe damping ratio as a fraction of critical damping is >NUM>C/>DEN>C°.During free transient oscillation of the sprung mass the vertical motion of the mass will follow a damped sinusoidal path (Figure 2). The frequency can be estimated by measuring the time for as many cycles of oscillation as can be observed. The damping can be estimated by measuring the heights of successive peaks of the oscillation in the same direction. If the peak amplitudes of the first and second cycles of the oscillation are A1 and A2, then the damping ratio D is;D = >NUM>C>DEN>C° = >NUM>1>DEN>2ð . ln >NUM>A1>DEN>A2'ln` being the natural logarithm of the amplitude ratio.4. TEST PROCEDURE To establish by test the damping ratio D, the damping ratio with hydraulic dampers removed, and the frequency F of the suspension, the loaded vehicle should either:(a) be driven at low speed (5 km/hr ± 1 km/hr) over an 80 mm step with the profile shown in Figure 1. The transient oscillation to be analyzed for frequency and damping occurs after the wheels on the driving axle have left the step;or(b) be pulled down by its chassis so that the driving axle load is 1,5 times its maximum static value. The vehicle held down is suddenly released and the subsequent oscillation analyzed;or(c) be pulled up by its chassis so that the sprung mass is lifted by 80 mm above the driving axle. The vehicle held up is suddenly dropped and the subsequent oscillation analyzed;or(d) be subjected to other procedures insofar as it has been proved by the manufacturer, to the satisfaction of the technical department, that they are equivalent.The vehicle should be instrumented with a vertical displacement transducer between driving axle and chassis, directly above the driving axle. From the trace, the time interval between the first and second compression peaks can be measured to obtain the frequency F and the amplitude ratio to obtain the damping. For twin-drive bogies, vertical displacement transducers should be fitted between each driving axle and the chassis directly above it.>REFERENCE TO A GRAPHIC>ANNEX III PLATE RELATING TO DIMENSIONS REFERRED TO IN ARTICLE 6 (1) (a) I. The plate relating to dimensions, as far as possible affixed next to the plate referred to in Directive 76/114/EEC, must contain the following data:1. name of the manufacturer (1);2. vehicle identification number (2);3. length of the motor vehicle, trailer or semi-trailer (L);4. width of the motor vehicle, trailer or semi-trailer (W);5. data for the measurement of the length of vehicle combinations:- the distance (a) between the front of the motor vehicle and the centre of the coupling device (coupling hook or fifth wheel); in the case of a fifth wheel with several coupling points, the minimum and maximum values must be given (amin and amax),- the distance (b) between the centre of the coupling device of the trailer (fifth wheel ring) or of the semi-trailer (kingpin) and the rear of the trailer or of the semi-trailer; in the case of a device with several coupling points, the minimum and maximum values must be given (bmin and bmax).The length of vehicle combinations is the length of the motor vehicle and trailer or semi-trailer placed in a straight line behind each other.II. The values given on the proof of compliance shall reproduce exactly the measurements carried out directly on the vehicle.(1) This information need not be repeated where the vehicle carries a single plate containing data on both weights and dimensions.ANNEX IV PART A REPEALED DIRECTIVES (referred to in Article 10) - Directive 83/3/EEC on the weights, dimensions and certain other technical characteristics of certain road vehicles and its successive amendments:- Directive 86/360/EEC- Directive 88/218/EEC- Directive 89/338/EEC- Directive 89/460/EEC- Directive 89/461/EEC- Directive 91/60/EEC- Directive 92/7/EEC- Directive 86/364/EEC relating to proof of compliance of vehicles with Directive 85/3/EEC on the weights, dimensions and certain other technical characteristics of certain road vehicles.PART B >TABLE>ANNEX V >TABLE>


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31990L0423

Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot-and-mouth disease, Directive 64/432/EEC on animal health problems affecting intra- Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries

Official Journal L 224 , 18/08/1990 P. 0013 - 0018 Finnish special edition: Chapter 3 Volume 33 P. 0129  Swedish special edition: Chapter 3 Volume 33 P. 0129

COUNCIL DIRECTIVE of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot-and-mouth disease, Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine  and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries (90/423/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 85/511/EEC (4) introduced Community measures for the control of foot-and-mouth disease;  Whereas, in view of the completion of the internal market for 1 January 1993, it is necessary to amend the measures already taken at Community level to control foot-and-mouth disease in the entire Community; whereas it is essential that a uniform policy  should be implemented throughout the Community;  Whereas a Commission study on control of foot-and-mouth disease has shown that the adoption of a non-vaccination policy for the Community as a whole would be preferable to a vaccination policy; whereas it has been concluded that a risk exists in the  manipulation of virus in laboratories due to the possibility of escape to local susceptible animals and in the use of vaccine if inactivation procedures do not ensure its safety;  Whereas the Commission's study as regards a vaccination policy for the future has clearly shown that an official withdrawal of vaccination against the disease should be implemented from a given date and that such withdrawal should be accompanied by a  policy of total slaughter and destruction (stamping out) of infected animals;  Whereas Commission Decision 88/379/EEC of 12 July 1988 coordinating rules laid down by Member States in application of Article 6 of Council Directive 85/511/EEC (5) has already provided for a minimum set of  rules to be applied in all Member States when granting exceptions from total slaughter on an infected holding;  Whereas, in extreme situations where an epizootic disease threatens to become extensive, it may be necessary to have recourse to emergency vaccination; whereas it is necessary to lay down conditions under which this vaccination may be carried out;  Whereas the adoption of a uniform Community policy in the campaign against foot-and-mouth disease involves an adjustment of the rules governing intra-Community trade in live animals and the import, from third countries, of live animals and certain  animal products;  Whereas financial support to Member States concerning slaughter, destruction and other emergency actions should be laid down in separate measures;  Whereas the functioning of the new measures must be kept under the review of the Commission, which shall report to the Council annually on their implementation,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 85/511/EEC is hereby amended as follows:   1.  Article 1 is replaced by the following:  'Article 1 This Directive defines the Community control measures to be applied in the event of outbreaks of foot-and-mouth disease, whatever the type of virus concerned.'  2.  In Article 5:  (a)  in point 2, '(a) in Member States or regions where vaccination is prohibited' and the whole of point (b) are deleted;  (b)  in point 3 'shall not apply' is replaced by 'need not apply'.   3.  In Article 6:  (a)  in the first subparagraph of paragraph 1, 'Article 5 (2) (a), first and second indents and (2) (b) (i)' is replaced by 'Article 5 (2), first and second indents';  (b) in the second subparagraph of paragraph 1, '(a)' is deleted;  (c) paragraph 2 is replaced by the following:  '2.  When recourse is had to paragraph 1, Member States shall apply the measures specified in Commission Decision 88/397/EEC (*).  (*) OJ No L 189, 20. 7. 1988, p. 25.'  4.  In Article 9:  (a)  the last sentence of paragraph 1 is replaced by the following:  'The definition of zones shall take account of natural boundaries, supervision facilities and technological progress which make it possible to foresee the possible dispersion of the virus by air or any other means and will have to be reviewed, if  necessary, in the light of such elements.' (b)  in paragraph 2 (a), the first indent is replaced by the two following indents:  '- a census of all the holdings with animals of susceptible species must be carried out,  '- holdings which are the subject of such a census must periodically undergo a veterinary inspection,'.   5.  In Article 11 (1), first and second indents, 'Annex' and 'Annex I' are replaced each time by 'Annex B'.   6.  Article 13 is replaced by the following:  'Article 13 1.  Member States shall ensure that:  - the use of foot-and-mouth vaccines is prohibited,  - the manipulation of foot-and-mouth virus for research, diagnosis and/or manufacture of vaccines shall be carried out only in approved establishments and laboratories listed in Annex A and B,  - the storage, supply, distribution and sale of foot-and-mouth vaccines on the territory of the Community are carried out under official control,  - the establishments and laboratories referred to in the second indent shall be approved only if they fulfil the minimum standards recommended by the FAO for laboratories working on foot-and-mouth viruses in vitro and in vivo.  2.  Veterinary experts from the Commission, in collaboration with the competent authorities of the Member States, shall carry out spot-checks to ascertain whether the security systems applied in the establishments and laboratories referred to in Annexes  A and B comply with the FAO's minimum standards.  The Commission shall carry out these checks at least once a year, the first of these checks being due before 1 January 1992, and shall submit, also before that date, an initial report to the Standing Veterinary Committee. The list of establishments and  laboratories in Annexes A and B may be reviewed in the light of these checks by the Commission, in accordance with the procedure referred to in Article 17, by 31 December 1991. The list will be regularly updated in accordance with the same procedure.  In accordance with the same procedure, a decision may be taken to adopt a uniform code of good conduct for the security systems applied in the establishments and laboratories listed in Annexes A and B.  3.  Notwithstanding the provisions of paragraph 1 concerning the use of foot-and-mouth disease vaccine, it may be decided, when foot-and-mouth disease has been confirmed and threatens to become extensive, that emergency vaccination using technical  procedures guaranteeing the animals' total immunity may be introduced. In this case, the measures to be taken shall include:  - the extent of the geographical area in which emergency vaccination is to be carried out,  - the species and the age of the animals to be vaccinated,  - the duration of the vaccination campaign,  - a specific standstill of vaccinated animals and their products,  - the special identification and special registration of the vaccinated animals,  - other matters appropriate to the emergency situation.  The decision to introduce emergency vaccination shall be taken by the Commission in collaboration with the Member State concerned, acting in accordance with the procedure laid down in Article 16. This decision shall have particular regard to the degree  of concentration of animals in certain regions and the need to protect special breeds.  However, by way of derogation from the first subparagraph, the decision to introduce emergency vaccination around the outbreak may be taken by the Member State concerned following notification to the Commission, provided that basic Community interests  are not endangered. This decision shall be immediately reviewed in the Standing Veterinary Committee in accordance with the procedure laid down in Article 16.'  7.  Article 14 is replaced by the following:  'Article 14 1.  Pending the setting up of Community reserves of foot-and-mouth disease vaccine, Member States shall be authorized to retain reserves of antigens in one of the establishments referred to in the Annexes.  For the purposes of the first subparagraph, contracts between the Commission and those responsible in the establishments designated by the Member States shall be concluded; the contracts will in particular specify the quantities of antigen doses  necessary, taking account of the requirements estimated in the context of the plans referred to in Article 5 (1) of Directive 90/423/EEC (*), for a maximum of 10 serotypes.  After this transitional period, Member States shall be authorized under Community supervision to retain establishments for the packaging and storage of ready-to-use vaccines for emergency vaccination.  2.  Before 1 April 1991, the Council, acting by a qualfied majority on a proposal from the Commission, shall designate a specialized institute for vaccine and cross-immunity checks and shall determine its powers.  3.  Before 1 April 1991, the Commission shall submit to the Council a report accompanied, where appropriate, by proposals on the rules relating to the packaging, production, distribution and state of the stocks of anti-foot-and-mouth disease vaccines in  the Community, together with proposals on the setting up of at least two Community reserves of anti-foot-and-mouth disease vaccines.' (*) OJ No L 224, 18. 8. 1990, p. 13.   8.  Article 15 is deleted.   9.  Article 18 is replaced by the following:  'Article 18 On the basis of a report from the Commission on the experience gained in the application of this Directive, accompanied by proposals where appropriate, the Council shall review the situation within two years of the adoption of Directive 90/423/EEC (*).   (*) OJ No L 224, 18. 8. 1990, p. 13.' 10.  An Annex, which shall be known as 'Annex A' and which appears in the Annex to this Directive, shall be added. The present Annex, entitled 'National Laboratories dealing with Foot-and-Mouth Disease', becomes Annex B.  Article 2 Article 4a of Directive 64/432/EEC (6), as last amended by Directive 89/662/EEC (7), is hereby amended as follows:  1.  In the first subparagraph, in point 1:  ii(i)  line 3 reads: '. . . which have not practised vaccination for at least 12 months and . . .';   i(ii)  B is replaced by the following:  'B.  where the animal comes from a Member State which has, during the previous 12 months, practised prophylactic vaccination or has had recourse, in exceptional cases, to emergency vaccination on its territory';  (iii)  the following subparagraph is added at the end of B and at the end of the first subparagraph of point 2:  'In this case, the aforementioned guarantees may be required for a period of 12 months after completion of the emergency vaccination operations.' 2.  In the first subparagraph, in point 2, the introductory words are replaced by the following:  '2.  Member States having recourse, in exceptional cases, to emergency vaccination on the whole of their territory and allowing vaccinated animals on to their territory shall make the introduction into their territory of live cattle subject to the  following conditions:' 3.  The following subparagraph is inserted before the last subparagraph:  'Where a Member State is authorized, in accordance with Article 13 (3) of Directive 85/511/EEC (*), as last amended by Directive 90/423/EEC (**), to have recourse to emergency vaccination on a limited part of its territory, the status of the remainder  of the territory shall not be affected, providing that the immobilization measures for the vaccinated animals are effective during a period of 12 months following the end of the vaccination operations.  *(*) OJ No L 315, 26. 11. 1985, p. 11.  (**) OJ No L 224, 18. 8. 1990, p. 13.' Article 3 Directive 72/462/EEC (8), as last amended by Directive 89/662/EEC (9), is hereby amended as follows:  1.  Article 6 is replaced by the following:  'Article 6 1.  Without prejudice to Article 3 (1), Member States shall not authorize importation of animals covered by this Directive unless they come from third countries:  (a)  which have been free of those diseases to which the animals are susceptible:  - for the previous 12 months, in respect of cattle plague, contagious pleuro-pneumonia, blue- tongue, African swine fever and contagious porcine paralysis (Teschen disease),  - for the previous six months, in respect of contagious vesicular stomatitis;  (b)  in which, during the preceding 12 months, vaccination against the diseases referred to in the first indent of (a) to which these animals are susceptible has not been carried out.   2.  Member States shall make the introduction into their territory of animals which are of a species susceptible to foot-and-mouth disease from the territory of a third country subject to the following conditions:  1.  where the animals come from a third country which has been free of foot-and-mouth disease for at least two years, which has not practised vaccination for at least 12 months and which does not allow on to its territory animals which have been  vaccinated less than one year previously, a guarantee that they have not been vaccinated against foot-and-mouth disease;  2.  where the animals come from a third country which has been free of foot-and-mouth disease for at least two years, which practises vaccination and which allows vaccinated animals on to its territory:  (a)  a guarantee that the animals have not been vaccinated against foot-and-mouth disease;  (b) a guarantee that the cattle have reacted negatively to a foot-and-mouth virus test carried out by the laryngo pharyngeal scrape method (probang test);  (c) a guarantee that the animals have reacted negatively to a serological test carried out to detect the presence of foot-and-mouth antibodies;  (d) a guarantee that the animals have been isolated in the exporting country at a quarantine station for 14 days under the surveillance of an official veterinarian. In this connection, no animal located at the quarantine station shall have been vaccinated  against foot-and-mouth disease during the 21 days preceding exportation and no animal, other than those forming part of the consignment, shall have been introduced to the quarantine station during that same period;  (e) placing in quarantine for a period of 21 days.  3.  where the animals come from a third country which has not been free of foot-and-mouth disease for at least two years:  (a) the guarantees referred to in point 2;  (b) further guarantees to be decided on in accordance with the procedure laid down in Article 30.  For the purposes of this paragraph, a third country may continue to be considered as having been free of foot-and-mouth disease for at least two years, even if a limited number of outbreaks of the disease have been recorded on a limited part of its  territory, on condition that such outbreaks were stamped out within a period of less than three months.  3.  In accordance with the procedure laid down in Article 29:  (a)  without prejudice to Article 3 (1), a list shall be adopted of the third countries which are authorized to export animals to the Community and which satisfy the requirements of paragraph 2;  (b)  a list shall be adopted of the quarantine stations from which those countries may export animals to the Community; and (c)  a decision shall be taken on any further guarantees in relation to each such country.' 2.  Article 14 is hereby amended as follows:  1.  In paragraph 2 (a) the words 'exotic foot-and-mouth disease' are deleted.  2.  The following paragraph is added:  '3.  Without prejudice to Article 3 (1):  (a)  the import of fresh meat from third countries in which:  - foot-and-mouth disease (strains A, O, C) is endemic,  - systematic slaughtering is not carried out where an outbreak of foot-and-mouth disease occurs,  - vaccination is practised,  shall be permitted only under the following conditions:  i(i)  the third country or a region within the third country is approved under the procedure laid down in Article 29;  (ii)  the meat is matured, its pH controlled, deboned and the major lymphatic glands removed.  The import of offals for human consumption shall be restricted, taking into account expert scientific opinion. Special conditions may be possible for offals for the pharmaceutical and petfood industry. These restrictions and conditions shall be adopted  according to the procedure laid down in Article 29.  (b)  The import of fresh meat from third countries in which vaccination against foot-and-mouth disease strains SAT or ASIA 1 is used shall be permitted only under the following conditions:  ii(i)  the third country has regions where vaccination is not permitted and no foot-and-mouth disease has occured for 12 months; the regions shall be approved under the procedure laid down in Article 29;  (ii)  the meat is matured, deboned, and the major lymphatic glands have been removed, and is not imported until 3 weeks after slaughter;  (iii)  the importation of offal from these countries is not permitted.  (c) the import of fresh meat from third countries - in which vaccination is practised, and - which have been free of foot-and-mouth disease for 12 months shall be permitted in accordance with conditions established under the procedure laid down in Article 29.  (d) the import of fresh meat from third countries in which:  - routine vaccination is not carried out, and - freedom from foot-and-mouth disease has been established shall be permitted under the procedure laid down in Article 29 and in accordance with the rules governing intra-Community trade.  Additional rules which may apply to the countries referred to in (a) and (b) of the first subparagraph shall be established in accordance with the procedure laid down in Article 29.' Article 4 1.  Member States which practise prophylactic vaccination in the whole or part of their territory shall forego vaccination by 1 January 1992 at the latest and shall prohibit, from the date on which they stop vaccination, vaccinated animals  from being introduced into their territory.  2.  However, paragraph 1 shall take effect on the date of the application of the decisions referred to in Article 14 (3) of Directive 85/511/EEC and Article 23 (1) of Directive 90/425/EEC in respect of live animals and animal products which are  susceptible to foot-and-mouth disease.  3.  If the decisions referred to in paragraph 2 have not been adopted by 30 June 1991, the Commission will make the necessary proposals.  Article 5 1.  Each Member State shall draw up a plan of warning, specifying the national measures to be implemented in the event of an outbreak of foot-and-mouth disease.  This plan should allow access to the plant, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak. It must give a precise indication of the vaccine requirements which each Member State  concerned considers it needs in the event of the reinstatement of emergency vaccination.  2.  The Commission shall, in accordance with the procedure in Article 16 of Directive 85/511/EEC, lay down by 31 December 1990 the criteria to be applied for drawing up plans.  3.  Plans drawn up in accordance with the criteria provided for in paragraph 2 shall be submitted to the Commission by 31 December 1991.  4.  The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required in particular to ensure that they are compatible with those  of the other Member States.  The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid down in Article 16 of Directive 85/511/EEC.  The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation.  5.  The Commission may, in accordance with the procedure laid down in Article 6 of Directive 82/894/EEC, establish, by way of derogation from Article 3 (1) thereof, an early warning system for informing the Commission and the other Member States of  outbreaks of foot-and-mouth- disease.  Article 6 In order to take account of possible difficulties, in particular when recourse is had to Article 13 (3) of Directive 85/511/EEC, which might result from the transition from the arrangements which existed before the application of this  Directive in one or more Member States to the arrangements established by this Directive, or where implementation of the plans provided for in Article 5 makes it necessary, the Commission may, in accordance with the procedure provided for in Article 16  of Directive 85/511/EEC, adopt appropriate measures for a maximum period of two years. In particular, without prejudice to Article 4 (a) of Directive 64/432/EEC, measures shall be adopted before 1 January 1991 in respect of the movement of animals not  vaccinated during the course of the last 12 months.  Article 7 Before 1 January 1992, the Commission shall submit a report on the structure of the veterinary services in the Community.  Article 8 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof.  Article 9 This Directive is addressed to the Member States.   Done at Luxembourg, 26 June 1990.  For the Council The President M. O'KENNEDY  (1) OJ No C 327, 30. 12. 1989, p. 84. (2) OJ No C 113, 7. 5. 1990, p. 179. (3) OJ No C 62, 12. 3. 1990, p. 44. (4) OJ No L 315, 26. 11. 1985, p. 11. (5) OJ No L 189, 20. 7. 1988, p. 25.(6) OJ No 121, 29. 7. 1964, p. 1977/64. (7) OJ No L 395, 30. 12. 1989, p. 13.(8) OJ No L 302, 31. 12. 1972, p. 28. (9) OJ No L 395, 30. 12. 1989, p. 13.   ANNEX     'ANNEX A      Member State Establishments Public Private Belgium Uccle - Denmark Lindholm - Germany -  Cooper Behringwerke Bayer Greece Athens - France LCRV Alfort Rhône-Merieux Ireland -  - Italy Brescia Padua Perugia - Luxembourg -  - Netherlands Lelystad - Portugal -  - Spain MadridCooper Hipra Sabrino United Kingdom -  Cooper'


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32003L0032

Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)

Official Journal L 105 , 26/04/2003 P. 0018 - 0023

Commission Directive 2003/32/ECof 23 April 2003introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1), as last amended by Directive 2001/104/EC of the European Parliament and of the Council(2), and in particular Article 14(b) thereof,Whereas:(1) On 5 March 2001 France adopted a national measure prohibiting the manufacture, placing on the market, distribution, import, export and use of medical devices manufactured from materials of animal origin, where these are used as dura mater substitutes.(2) France justified the measure by the uncertainties that exist with regard to the risk of transmission to humans of animal spongiform encephalopathies from such medical devices, and by the fact that alternatives are available, in the form of synthetic materials or autologous materials taken from the patient.(3) Other Member States have taken unilateral national measures on other legal bases in relation to the use of certain raw materials originating from animal tissues and presenting specific risks of transmitting animal spongiform encephalopathies.(4) All those national measures are related to the general protection of public health against the risks of transmitting the animal spongiform encephalopathies via medical devices.(5) With regard to the sourcing of materials used in medical devices the provisions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(3) apply.(6) In order to improve the level of safety and health protection, it is necessary to further reinforce the protective measures against the overall risk of transmitting animal spongiform encephalopathies via medical devices.(7) The Scientific Committee on Medicinal Products and Medical Devices has adopted an opinion on the use of Transmissible Spongiform Encephalopathies (TSE) risk materials for the manufacture of implantable medical devices, which recommends that manufacturers of these devices that utilise animal tissues or derivatives be required, as an essential part of the risk management, to fully justify the use of these tissues in the context of the benefits to patients and of the comparison with alternative materials.(8) The Scientific Steering Committee has adopted several opinions on specified risk materials and on the products derived from ruminant tissues, such as gelatine and collagen, which are of direct relevance to the safety of medical devices.(9) Medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable are Class III devices in accordance with the classification rules set out in Annex IX to Directive 93/42/EEC, except where such devices are intended to come into contact with intact skin only.(10) Prior to being placed on the market, medical devices, whether they originate in the Community or are imported from third countries, are subject to the conformity assessment procedures laid down in Directive 93/42/EEC.(11) Annex I to Directive 93/42/EEC sets out the essential requirements that medical devices must meet pursuant to that Directive. Points 8.1 and 8.2 of that Annex set out specific requirements intended to eliminate or reduce as far as possible the risk of infection for the patient, user and third parties due to tissues of animal origin and specifies that the solutions adopted by the manufacturer in the design and construction of the devices must conform to safety principles taking into account the generally acknowledged state of the art.(12) With regard to medical devices manufactured utilising tissues of animal origin it is necessary to adopt more detailed specifications in relation to the requirements of point 8.2 of Annex I to Directive 93/42/EEC and to specify certain aspects relating to the risk analysis and risk management in the framework of the conformity assessment procedures referred to in Article 11 of that Directive.(13) Some of the terms used in Directive 93/42/EEC should be further clarified in order to ensure a uniform implementation of this Directive.(14) It is necessary to provide for an adequate transitional period for medical devices already covered by an EC design-examination certificate or by an EC type examination certificate.(15) The measures provided for in this Directive are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Council Directive 90/385/EEC(4),HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.2. The animal tissues covered by this Directive are those originating from bovine, ovine and caprine species, as well as deer, elk, mink and cats.3. Collagen, gelatin and tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.4. This Directive does not apply to medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.Article 2For the purposes of this Directive, the following definitions shall apply in addition to the definitions set out in Directive 93/42/EEC:(a) "cell" means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;(b) "tissue" means an organisation of cells and/or extra-cellular constituents;(c) "derivative" means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;(d) "non-viable" means having no potential for metabolism or multiplication;(e) "transmissible agents" means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalophathies agents and scrapie agents;(f) "reduction, elimination or removal" means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;(g) "inactivation" means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;(h) "source country" means the country in which the animal was born, has been reared and/or has been slaughtered;(i) "starting materials" means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.Article 3Before lodging an application for a conformity assessment pursuant to Article 11(1) of Directive 93/42/EEC, the manufacturer of medical devices referred to in Article 1(1), shall carry out the risk analysis and the risk management scheme set out in the Annex to this Directive.Article 4Member States shall verify that bodies notified under Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices referred to in Article 1(1) with the provisions of Directive 93/42/EEC and with the specifications laid down in the Annex to this Directive.If, on the basis of that verification, it is necessary for a Member State to amend the tasks of a notified body, that Member State shall notify the Commission and the other Member States accordingly.Article 51. Conformity assessment procedures for medical devices referred to in Article 1(1), shall include the evaluation of their compliance with the essential requirements of Directive 93/42/EEC and the specifications laid down in the Annex to this Directive.2. Notified bodies shall evaluate the manufacturer's risk analysis and risk management strategy, and in particular:(a) the information provided by the manufacturer;(b) the justification for the use of animal tissues or derivatives;(c) the results of elimination and/or inactivation studies or of literature search;(d) the manufacturer's control of the sources of raw materials, finished products and subcontractors;(e) the need to audit matters related to sourcing, including third party supplies.3. Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter "TSE certificate", for starting materials, where available.4. Except for medical devices using starting materials for which a TSE certificate has been issued as referred to in paragraph 3, national bodies shall, through their competent authority, seek the opinion of the competent authorities of the other Member States on their evaluation of and conclusions on the risk analysis and risk management of the tissues or the derivatives intended to be incorporated in the medical device as established by the manufacturer.Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within 12 weeks from the date on which the opinion of the national competent authorities was sought.Article 6Member States shall take all necessary steps to ensure that medical devices referred to in Article 1(1) are placed on the market and put into service only if they comply with the provisions of Directive 93/42/EEC and the specifications laid down in the Annex to this Directive.Article 71. Holders of EC design-examination certificates or EC type-examination certificates issued before 1 April 2004 for medical devices referred to in Article 1(1) shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in the Annex to this Directive.2. Until 30 September 2004, Member States shall accept the placing on the market and the putting into service of medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1 April 2004.Article 81. Member States shall adopt and publish before 1 January 2004 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions with effect from 1 April 2004.When Member States adopt those 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 texts of the provisions of national law which they adopt in the field covered by this Directive.Article 9This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 10This Directive is addressed to the Member States.Done at Brussels, 23 April 2003.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 169, 12.7.1993, p. 1.(2) OJ L 6, 10.1.2002, p. 50.(3) OJ L 273, 10.10.2002, p. 1.(4) OJ L 189, 20.7.1990, p. 17.ANNEX1. RISK ANALYSIS AND RISK MANAGEMENT1.1. Justification for the use of animal tissues or derivativesThe manufacturer must justify, on the basis of his overall risk analysis and risk management strategy for a specific medical device, the decision to use animal tissues or derivatives, referred to in Article 1, (specifying animal species and tissues) taking into account the expected clinical benefit, potential residual risk and suitable alternatives.1.2. Assessment procedureIn order to ensure a high level of protection for patients or users, the manufacturer of devices utilising animal tissues or derivatives referred to in point 1.1 must implement an appropriate and well documented risk analysis and risk management strategy, to address all relevant relating aspects to TSE. He must identify the hazards associated with those tissues or derivatives, establish documentation on measures taken to minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the device utilising such tissues or derivatives, taking into account the intended use and the benefit of the device.The safety of a device, in terms of its potential for passing on a transmissible agent, is dependent on all the factors described in points 1.2.1 to 1.2.7, which must be analysed, evaluated and managed. These measures in combination determine the device safety.There are two key steps that must be considered.These are:- selecting starting materials (tissues or derivatives) considered appropriate regarding their potential contamination with transmissible agents (see 1.2.1, 1.2.2 and 1.2.3) taking into account further processing,- applying a production process to remove or inactivate transmissible agents on controlled sourced tissues or derivatives (see 1.2.4).Furthermore, the characteristics of the device and its intended use must be taken into account (see 1.2.5, 1.2.6 and 1.2.7).In performing the risk analysis and risk management strategy, due consideration must be given to opinions adopted by the relevant scientific committees, and where appropriate to the opinions of the Committee for Proprietary Medicinal Products CPMP, the references of which have been published in the Official Journal of the European Union.1.2.1. Animals as a source of materialThe TSE risk is related to the source species, strains and nature of the starting tissue. As the accumulation of TSE infectivity occurs over an incubation period of several years, sourcing from young healthy animals is considered to be a factor reducing the risk. Risk animals such as fallen stock, emergency slaughtered and TSE suspected animals must be excluded.1.2.2. Geographical sourcingPending the classification of countries according to the BSE status in Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(1), the Geographical BSE risk (GBR) is used when assessing the risk of the source country. The GBR is a qualitative indicator of the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, at a given point in time, in a country. Where presence is confirmed, the GBR gives an indication of the level of infection as specified in the table below.>TABLE>Certain factors influence the geographical risk of BSE infection associated with the use of raw tissues or derivatives from individual countries. These factors are defined in Article 2.3.13.2, point 1) of the International Animal Health Code of the OIE (Office International des Épizooties), which is available at web-site www.oie.int/eng/normes/Mcode/A_00067.htmThe Scientific Steering Committee has made an assessment of Geographical BSE Risk (GBR) of several third countries and Member States, and will continue to do so for all the countries, which applied for BSE status categorisation, taking the main OIE factors into account.1.2.3. Nature of starting tissueThe manufacturer must take into account the classification of the hazards relating to different type of starting tissue. Sourcing of animal tissue must be subject to control and individual inspection by a veterinarian and the animal carcass must be certified as fit for human consumption.The manufacturer must ensure that no risk of cross-contamination occurs at the time of slaughtering.The manufacturer must not source animal tissue or derivatives classified as potentially high TSE infectivity, unless sourcing of these materials is necessary in exceptional circumstances, taking into account the important benefit for the patient and the absence of an alternative starting tissue.In addition, the provisions in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption must be applied.1.2.3.1. Sheep and goatsA classification of infectivity in tissues for sheep and goats has been established based on actual knowledge on the basis of the titres of transmissible agents in tissues and body fluids from naturally infected sheep and goats with clinical scrapie. A table was presented in the Scientific Steering Committee (SSC) opinion of 22-23 July 1999 on "The policy of breeding and genotyping of sheep", (as an annex)(2) and further updated in the opinion of the SSC - TSE infectivity distributed in ruminant tissues state of knowledge December 2001 - adopted 10-11 January 2002(3).The classification may be reviewed in the light of new scientific evidence (for example using relevant opinions from the Scientific Committees, the Committee for Proprietary Medicinal Products CPMP and Commission Measures regulating the use of material presenting risks as regards TSE). A review of the references to relevant documents/opinions will be published in the Official Journal of the European Union and will be listed after a Commission Decision has been taken.1.2.3.2. CattleThe list of specified risk material (SRM) laid down in Regulation (EC) No 999/2001 shall be considered as potentially high TSE infective.1.2.4. Inactivation or removal of transmissible agents1.2.4.1. For devices which cannot withstand an inactivation/elimination process without undergoing unacceptable degradation, the manufacturer must rely principally on the control of sourcing.1.2.4.2. For other devices, if claims are made by the manufacturer for the ability of manufacturing processes to remove or inactivate transmissible agents, these will have to be substantiated by appropriate documentation.Relevant information from an appropriate scientific literature search and analysis can be used to support inactivation/elimination factors, where the specific processes referred to the literature are comparable to those used for the device. This search and analysis should also cover the available scientific opinions that may have been adopted by a EU Scientific Committee. These opinions shall serve as a reference, in cases where there are conflicting opinions.When the literature search failed to substantiate the claims, the manufacturer must set up a specific inactivation and/or elimination study on a scientific basis and the following need to be considered:- the identified hazard associated with the tissue,- identification of the relevant model agents,- rationale for the choice of the particular combinations of model agents,- identification of stage chosen to eliminate and/or inactivate the transmissible agents,- calculation of the reduction factors.A final report must identify manufacturing parameters and limits that are critical to the effectiveness of the inactivation or elimination process.Appropriate documented procedures must be applied to ensure that the validated processing parameters are applied during routine manufacture.1.2.5. Quantities of animal starting tissues or derivatives required to produce one unit of the medical deviceThe manufacturer must evaluate the quantity of raw tissues or derivatives of animal origin required to produce a single unit of the medical device. Where a purification process is involved, the manufacturer must assess whether it may have the potential to concentrate levels of transmissible agents present in the animal starting tissues or derivatives.1.2.6. Tissues or derivatives of animal origin coming into contact with the patients and usersThe manufacturer must consider:(i) the quantity of animal tissues or derivatives;(ii) the contact area: its surface, type (e.g. skin, mucous tissue, brain) and condition (e.g. healthy or damaged);(iii) the type of the tissues or derivatives coming into contact with the patients and/or users; and(iv) how long the device is intended to remain in contact with the body (including bioresorption effect).The number of medical devices that could be used in a given procedure shall be taken into account.1.2.7. Route of administrationThe manufacturer must take into account the route of administration recommended in the product information, from the highest risk down to the lowest.1.3. Review of the assessmentThe manufacturer must establish and maintain a systematic procedure to review information gained about their medical device or similar devices in the post-production phase. The information must be evaluated for possible relevance to safety, especially:(a) if previously unrecognised hazards are detected;(b) if the estimated risk arising from a hazard is no longer acceptable;(c) if the original assessment is otherwise invalidated.If any of the above apply, the results of the evaluation shall be fed back as an input to the risk management process.In the light of this new information, a review of the appropriate risk management measures for the device must be considered (including rationale for choosing an animal tissue or derivative). If there is a potential that the residual risk or its acceptability has changed, the impact on previously implemented risk control measures must be re-evaluated and justified.The results of this evaluation must be documented.2. EVALUATION OF CLASS III MEDICAL DEVICES BY NOTIFIED BODIESFor devices falling into Class III under rule 17(4) of Annex IX to Directive 93/42/EEC, manufacturers must provide to the notified bodies referred to in Article 4 of this Directive all relevant information to allow evaluation of their current risk analysis and risk management strategy. Any new information on TSE risk, collected by the manufacturer and relevant for their devices must be sent to the notified body for information.Any change in relation to processes of sourcing, collection, handling and inactivation/elimination and that could modify the result of the manufacturer's risk management dossier must be transmitted to the notified body for the purpose of an additional approval prior to its implementation.(1) OJ L 147, 31.5.2001, p. 1.(2) Available on the website of the Commissionhttp://europa.eu.int/comm/ food/fs/sc/ssc/outcome_en.html.(3) Available on the website of the Commissionhttp://europa.eu.int/comm/ food/fs/sc/ssc/outcome_en.html.(4) All medical devices utilising animal tissue or derivatives rendered non-viable except devices intended to come into contact with intact skin only.