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31998L0087

Commission Directive 98/87/EC of 13 November 1998 amending Council Directive 79/373/EEC on the marketing of compound feedingstuffs (Text with EEA relevance)

Official Journal L 318 , 27/11/1998 P. 0043 - 0044

COMMISSION DIRECTIVE 98/87/EC of 13 November 1998 amending Council Directive 79/373/EEC on the marketing of compound feedingstuffs (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (1), as last amended by Commission Directive 97/47/EC (2), and in particular Article 10(e) thereof,Whereas, under point VII.E.4 of Annex XV to the Act of Accession, the Kingdom of Sweden may maintain its national legislation making it compulsory to state the phosphorus content on the labelling of compound feedingstuffs intended for fish until 31 December 1997;Whereas, under Annex XV of the abovementioned Act, Sweden is required to accompany requests for the adaptation of the Community legislation for the mineral concerned by a detailed scientific statement of reasons;Whereas Sweden transmitted a statement of reasons on 5 June 1997;Whereas Directive 79/373/EEC provides for the regular updating of the Annex thereto in the light of scientific and technical knowledge;Whereas enrichment with phosphorus is disturbing the ecological balance of lakes and seas; whereas eutrophication effects frequently observed in inland lakes are blue-green algae blooms, oxygen deficiency, high fish mortality and reduced biodiversity;Whereas it is therefore necessary to restrict phosphorus emissions to an absolute minimum; whereas the compulsory indication of phosphorus content on the labelling of compound feedingstuffs for fish would make a significant contribution to that objective by facilitating good feeding practice;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 The Annex to Directive 79/373/EEC is hereby amended in accordance with the Annex hereto.Article 2 1. Member States shall adopt and publish not later than 30 June 1999 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall immediately inform the Commission thereof.They shall apply those provisions from 1 July 1999.When Member States adopt the provisions they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 13 November 1998.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 86, 6. 4. 1979, p. 30.(2) OJ L 211, 5. 8. 1997, p. 45.ANNEX In Part B of the Annex, the section 'Complete feedingstuffs` is replaced by the following:>TABLE>


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31999L0061

Commission Directive 1999/61/EC of 18 June 1999 amending the Annexes to Council Directives 79/373/EEC and 96/25/EC (Text with EEA relevance)

Official Journal L 162 , 26/06/1999 P. 0067 - 0068

COMMISSION DIRECTIVE 1999/61/ECof 18 June 1999amending the Annexes to Council Directives 79/373/EEC and 96/25/EC(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(1), as last amended by Directive 98/87/EC(2), and in particular Article 10(e) thereof,Having regard to Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC(3), as amended by Commission Directive 98/67/EC(4), and in particular Article 11(b) thereof,(1) Whereas Commission Decision 94/381/EC of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived protein(5), as last amended by Decision 1999/129/EC(6), bans the feeding to ruminants of protein obtained from mammalian tissue while exempting some products as they are considered not to present a health risk;(2) Whereas Decision 1999/129/EC extends the list of exempted products to the "hydrolysed proteins with a molecular weight below 10000 daltons derived from animal hides and skins", produced under certain conditions;(3) Whereas, for practical reasons and for the sake of legal consistency, Commission Decision 1999/420/EC(7) amends accordingly Commission Decision 91/516/EEC(8) establishing a list of ingredients whose use is prohibited in compound feedingstuffs;(4) Whereas Directives 96/25/EC and 79/373/EEC lay down respectively general and specific rules for the labelling of feed materials and compound feedingstuffs; whereas, to prevent the users of feedingstuffs containing protein derived from certain tissue of mammals from feeding them to ruminants through ignorance of current feedingstuffs and veterinary rules, these Directives foresee an appropriate labelling of such feedingstuffs calling the attention to the prohibition on their use in ruminant feed and including also the list of exempted products; whereas this list should therefore be amended accordingly;(5) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1Point 7.1, second paragraph, third indent in Part A of the Annex to Directive 79/373/EEC is replaced by the following text: "- hydrolysed proteins with a molecular weight below 10000 daltons which have been:(i) derived from hides and skins obtained from animals which have been slaughtered in a slaughterhouse and have undergone an ante mortem inspection by an official veterinarian in accordance with Chapter VI of Annex I of Directive 64/433/EEC and passed fit, as a result of such inspection, for slaughter for the purpose of that Directive;and(ii) produced by a production process which involves appropriate measures to minimise contamination of hides and skins, preparation of the hides and skins by brining, liming and intensive washing followed by exposure of the material to a pH of  > 11 for  > 3 hours at temperature  > 80 °C and followed by heat treatment at  > 140 °C for 30 minutes at  > 3,6 bar or a by an equivalent production process approved by the Commission after consultation of the appropriate Scientific Committee;and(iii) come from establishments which carry out an own checks program (HACCP);"Article 2Point 1, second paragraph, third indent in Part A chapter VIII of the Annex to Directive 96/25/EC is replaced by the following text: "- hydrolysed proteins with a molecular weight below 10000 daltons which have been:(i) derived from hides and skins obtained from animals which have been slaughtered in a slaughterhouse and have undergone an ante mortem inspection by an official veterinarian in accordance with Chapter VI of Annex I of Directive 64/433/EEC and passed fit, as a result of such inspection, for slaughter for the purpose of that Directive;and(ii) produced by a production process which involves appropriate measures to minimise contamination of hides and skins, preparation of the hides and skins by brining, liming and intensive washing followed by exposure of the material to a pH of  > 11 for  > 3 hours at temperature  > 80 °C and followed by heat treatment at  > 140 °C for 30 minutes at  > 3,6 bar or a by an equivalent production process approved by the Commission after consultation of the appropriate Scientific Committee;and(iii) come from establishments which carry out an own checks program (HACCP);"Article 31. Member States shall bring into force not later than 31 October 1999 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall immediately inform the Commission thereof.When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.Article 4This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 18 June 1999.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 86, 6.4.1979, p. 30.(2) OJ L 318, 27.11.1998, p. 43.(3) OJ L 125, 23.5.1996, p. 35.(4) OJ L 261, 24.9.1998, p. 10.(5) OJ L 172, 7.7.1994, p. 23.(6) OJ L 41, 16.2.1999, p. 14.(7) See page 69 of this Official Journal.(8) OJ L 281, 9.10.1991, p. 23.


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31986L0424

First Commission Directive 86/424/EEC of 15 July 1986 laying down methods of sampling for chemical analysis of edible caseins and caseinates

Official Journal L 243 , 28/08/1986 P. 0029 - 0033 Finnish special edition: Chapter 13 Volume 15 P. 0256  Swedish special edition: Chapter 13 Volume 15 P. 0256

*****FIRST  COMMISSION DIRECTIVE  of 15 July 1986  laying down methods of sampling for chemical analysis of edible caseins and caseinates  (86/424/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to the Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) included for human consumption (1) and in particular Article 9 thereof,  Whereas under Article 9 of Directive 83/417/EEC, caseins and caseinates are required to be sampled according to Community procedures;  Whereas it is desirable to adopt an initial series of methods of sampling for chemical analysis in request of which studies are completed;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The sampling requirements referred to in Article 9, paragraph (b) of Directive 83/417/EEC shall be those outlined in the Annex to the present Directive.  Article 2  Member States shall take all necessary measures in order to comply with the present Directive by 15 January 1988 (2) at the latest. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to all the Member States.  Done at Brussels, 15 July 1986.  For the Commission  COCKFIELD  Vice-President  (1) OJ No L 237, 26. 8. 1983, p. 25.  (2) Date corresponding to 18 months after adoption of the present Directive.  ANNEX  METHODS OF SAMPLING RELATED TO THE CONTROL OF CHEMICAL ANALYSIS OF CERTAIN EDIBLE CASEINS AND CASEINATES INTENDED FOR HUMAN CONSUMPTION  I. GENERAL PROVISIONS  1. Administrative instructions  1.1. Personnel  Sampling shall be performed by an authorized qualified person as specified in the Member States' regulations.  1.2. Sealing and labelling of samples  Each sample taken for official use shall be sealed at the place of sampling and identified following the Member States' regulations.  1.3. Replicate samples  At least two equivalent representative samples shall be simultaneously prepared for analysis. Under reservation of Community legislation to be defined the procedure and number of samples to to taken depending upon the appropriate national legislation for each Member State.  The samples shall be dispatched to the laboratory as soon as possible after sampling.  1.4. Report  Samples shall be accompanied with a report which will be established following the Member States' legislation.  2. Sampling equipment  2.1. Specifications  All sampling equipment shall be made of suitable material of adequate strength, which does not bring about a change in the sample which may affect any result of the subsequent examination and should not cause any change in the samples while sampling is carried out. The use of stainless steel is recommended.  All surfaces shall be smooth and free from crevices and all corners shall be rounded. Sampling equipment shall comply with the requirements laid down with respect to each product to be sampled.  3. Sampling containers  3.1. Specifications  Sample containers and closures shall be of materials and construction which adequately protect the sample and which do not bring about in the sample a change which may affect any result of the subsequent analysis or examination. Materials which are appropriate include glass, some metals and some plastics. The containers shall preferably be opaque. If transparent or translucent the containers with contents shall be stored in a dark place.  Containers and closures shall be clean and dry. The shape and capacity of the container shall be appropriate to the requirements laid down for the product to be sampled.  Single service plastic containers, containers made from plastic, laminates including an aluminium foil or suitable plastic bags, with appropriate methods of closure, may be used.  Containers other than plastic bags shall be securely closed either by means of a suitable stopper or by a screw-cap of metal or plastic material having, if necessary, an air-tight plastic liner. Any stopper or liner used should be insoluble, non-absorbant and greaseproof, and will not influence the odour, flavour, properties or composition of the sample.  Stoppers shall be made of, or covered with, non-absorbant odourless materials.  4. Sampling technique  The sample container shall be closed immediately after sampling.  5. Storage of samples  The recommended storage temperatures of the samples of the various caseins and caseinates shall not exceed 25 °C.  6. Transport of samples  Samples shall be brought to the laboratory responsible for the tests as soon as possible (preferably within 24 hours of sample taking).  During transit, precautions shall be taken to prevent exposure to contaminating odours, to direct sunlight and to temperatures greater than 25 °C. II. METHOD - SAMPLING OF EDIBLE CASEINS AND CASEINATES  1. Scope and field of application  This method describes the sampling for chemical analysis of:  - edible acid caseins,  - edible rennet caseins,  - edible caseinates.  2. Equipment  See Section 2 of General Provisions.  2.1. Borers  Of sufficient length to reach the bottom of the product container. Borers conforming to the description given in Part III of this Directive are appropriate.  2.2. Spoon, spatula or scoop  Broad-loaded.  2.3. Sample containers  See Section 3 of General Provisions.  3. Procedure  3.1. General  Care shall be taken to minimize the uptake of atmospheric moisture by the content of the product container during or in the period prior to sampling for analysis. The product container shall be securely reclosed after sampling.  3.2. Procedure  3.2.1. Sampling  A sample of not less than 200 grams shall be taken. The clean and dry borer shall be passed through the product, if necessary with the container inclined or laid on its side. The slit shall be oriented downward and an even rate of penetration used. When the borer reaches the bottom of the container it shall be rotated through 180°, withdrawn and the contents discharged into the sample container. One or more bores shall be taken to make a sample of not less than 200 grams. The sample container shall be closed immediately after sampling is complete. Such sampling shall be carried out on the same batch.  3.2.2. Sampling products packed in small retail packages  The intact and unopened package may constitute the sample. As far as possible one or more packages of the same batch should be taken to form a sample of not less than 200 grams.  If this is not possible, use another method to constitute a representative sample.  3.2.3. Preservation, storage and transport of sample  Sections 5 and 6 of the General Provisions.  III. BORERS FOR THE SAMPLING OF EDIBLE CASEINS AND CASEINATES IN BULK  1. Types of borer  Type A: Long (see fig. 1);  Type B: Short (see fig. 1).  2. Materials  Blade and stem shall be made of polished metal, preferably stainless steel. The grip of the long type should preferably be made of stainless steel. The short type borer shall have a detachable grip of wood or plastic, fitted with a bayonet-catch in the blade.  3. Construction  3.1. Shape, material and finish shall be such as to permit the borer to be easily cleaned.  3.2. The protruding edge of the blade of type A shall be sufficiently sharp to serve as a scraper.  3.3. The point of the blade shall be sufficiently sharp as to facilitate sampling. 4. Principal dimensions  The borers shall conform to the dimensions (subject to a tolerance of 10 %) given in the table below:  (in mm)  1.2.3 //  //  //  //  // Type A Long   // Type B Short   //  //   //   // Length of blade   // 800   // 400   // Thickness of metal of blade   // 1 to 2   // 1 to 2   // Inner diameter of blade at point   // 18   // 32   // Inner diameter of blade at grip or stem   // 22   // 28   // Slit width at point   // 4   // 20   // Slit width at grip or stem   // 14   // 14   //  //   //  5. Note on use of borers  5.1. With less free-flowing powders, the borers can be inserted vertically. Type A borers are filled completely by turning and then can be withdrawn vertically.  Type B borers are already filled completely during insertion but must be withdrawn in an oblique position to prevent losses from the lower end.  5.2. In the case of free-flowing powder, the containers shall be inclined, the borers inserted nearly horizontally with the slit downwards and withdrawn with the slit upwards.  Figure  BORERS SUITABLE FOR THE SAMPLING OF CASEINS AND CASEINATES  (Dimensions in millimetres)  Section A-A  Section A-A  Section B-B  Type A  Type B


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31980L1267

Council Directive 80/1267/EEC of 16 December 1980 amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type- approval of motor vehicles and their trailers

Official Journal L 375 , 31/12/1980 P. 0034 - 0035 Finnish special edition: Chapter 13 Volume 11 P. 0048  Greek special edition: Chapter 13 Volume 10 P. 0105  Swedish special edition: Chapter 13 Volume 11 P. 0048  Spanish special edition: Chapter 13 Volume 11 P. 0121  Portuguese special edition Chapter 13 Volume 11 P. 0121

COUNCIL DIRECTIVE  of 16 December 1980  amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers  (80/1267/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas the provisions relating to the fuel consumption and engine power of motor vehicles differ in some Member States from those in others ; whereas it is therefore necessary that common provisions be henceforward adopted either in addition to or in place of the provisions currently in force in the Member States;  Whereas checks on compliance with these requirements should be carried out under the EEC type-approval procedure for each type of vehicle as laid down in Council Directive 70/156/EEC of 6 February 1970 on the appoximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (3), as amended by Directive 78/547/EEC (4) ; whereas that Directive should accordingly be supplemented by inserting the provisions for that purpose in both Annex I (model information document) and Annex II (model EEC type-approval certificate), without prejudice to other amendments to the Directive, in particular those contained in the Commission proposal of 5 January 1977,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Annex I to Directive 70/156/EEC shall be amended as follows:    1. section 3.2.5 shall be replaced by the following text:  "3.2.5. Maximum net power : ... kW at ... r/min (q')";       2. section 3.2.6 shall be replaced by the following text:  "3.2.6. Maximum net torque : ... Nm at ... r/min (q')";       3. the following section shall be added:  "3.5. Fuel consumption (q")      3.5.1. Urban cycle : ... l/100 km           3.5.2. Constant speed at 90 km/h : ... l/100 km           3.5.3. Constant speed at 120 km/h : ... l/100 km";       4. the following notes shall be inserted between notes (q) and (r):  "(q') Determined in accordance with the requirements of Directive 80/1267/EEC of 16 December 1980.  (q") Determined in accordance with the requirements of Directive 80/1267/EEC of 16 December 1980".          Article 2 Annex II to Directive 70/156/EEC shall be amended as follows:  (1)OJ No C 118, 16.5.1977, p. 29. (2)OJ No C 114, 11.5.1977, p. 1. (3)OJ No L 42, 23.2.1970, p. 1. (4)OJ No L 168, 26.6.1978, p. 39.   >PIC FILE= "T0014253">    Article 3 1. Member States shall bring into force the provisions necessary to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.  2. Member States shall ensure that the texts of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission.   Article 4 This Directive is adressed to the Member States.     Done at Brussels, 16 December 1980.  For the Council  The President  Colette FLESCH


title: Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices   (Text with EEA relevance)

text:
               12.8.2005

               EN

               Official Journal of the European Union

               L 210/41

      COMMISSION DIRECTIVE 2005/50/EC
   of 11 August 2005
   on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices
   (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), and in particular Article 13(1)(b) thereof,
   Having regard to the request submitted by France and the United Kingdom,
   Whereas:

               (1)

               On the basis of the classification rules set out in Annex IX to Directive 93/42/EEC, total joint replacements are class IIb medical devices.

               (2)

               France and the United Kingdom requested the classification of total joint replacements as class III medical devices by way of derogation from the provisions of Annex IX to Directive 93/42/EEC, in order to ensure an appropriate conformity assessment of total joint replacements before their placing on the market.

               (3)

               Conformity assessment is based on a number of elements such as a proper classification, the designation and monitoring of the notified bodies and the proper implementation of the conformity assessment modules as described in Directive 93/42/EEC.

               (4)

               Reclassification by derogation to the classification rules set out in Annex IX to Directive 93/42/EEC is indicated where the shortcomings identified due to the specific characteristics of a product will be more properly addressed under the conformity assessment procedures corresponding to the new category.

               (5)

               Hip, knee and shoulder replacements should be distinguished from other total joint replacements, due to the particular complexity of the joint function to be restored and the consequent increased risk of failure due to the device itself.

               (6)

               In particular, hip and knee replacements are weight-bearing and extremely sophisticated implants, for which the risk of revision surgery is significantly greater than for other joints.

               (7)

               Shoulder implants are a more recent technique, which are subject to similar dynamic forces; their possible replacement is in principle connected with serious medical problems.

               (8)

               Furthermore, hip, knee and shoulder replacement surgery is increasingly taking place on young people with a high life expectancy; consequently, the need for such implants to function properly over the life expectancy of the patients and to reduce revision surgery and its risks has been increased.

               (9)

               Specific clinical data, including long term performance data are not always available for hip, knee and shoulder replacements before they are placed on the market and put into service; consequently, conclusions on clinical data collected by the manufacturer in the framework of the evaluation of the conformity of these products with the requirements concerning their characteristics and performance referred to in Sections 1 and 3 of Annex I to Directive 93/42/EEC should be subject to particular attention and examination in order to verify the appropriateness of the clinical data available.

               (10)

               Total joint replacements can be subject to multiple modifications following their introduction into clinical use and placing on the market, as shown by hip and knee replacements on the market. However, experience has shown that what appear at first sight to be minor post-marketing changes to the design of previously trouble-free replacements can lead to serious problems due to unintended consequences, which may lead to early failure and major safety concerns.

               (11)

               In order to achieve the optimal level of safety and health protection and to reduce the design related problems to the lowest level, the design dossier of hip, knee and shoulder replacements, including the clinical data used by the manufacturer to support the claimed performance and the subsequent post-marketing design and manufacturing changes should be examined in detail by the notified body before these devices are introduced in general clinical use.

               (12)

               Consequently, the notified body should, under the full quality assurance system, effectively carry out an examination of the design dossier and of the changes to the approved design in accordance with point 4 of Annex II to Directive 93/42/EEC.

               (13)

               For these reasons, it is necessary to proceed to the reclassification of hip, knee and shoulder total joint replacements as class III medical devices.

               (14)

               It is necessary to provide for an adequate transitional period for hip, knee and shoulder total joint replacements already assessed as class IIb medical devices under the full quality assurance system of Annex II to Directive 93/42/EEC, allowing for their complementary assessment under point 4 of Annex II to the Directive.

               (15)

               Hip, knee and shoulder total joint replacements already certified following the procedure relating to the EC type examination set out in Annex III to Directive 93/42/EEC, coupled with the procedure relating to the EC verification set out in Annex IV or the procedure relating to the EC declaration of conformity set out in Annex V to that Directive, are not affected by the present Directive as these certification schemes are the same for both class IIb and class III medical devices.

               (16)

               It is necessary to provide for an adequate transitional period for hip, knee and shoulder total joint replacements that have already been subject to the procedure relating to the EC type examination under Annex III to Directive 93/42/EEC coupled with the procedure relating to the EC declaration of conformity set out in Annex VI to that Directive, allowing for their assessment under Annex IV or Annex V to Directive 93/42/EEC.

               (17)

               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 of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (2),

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   By way of derogation from the rules set out in Annex IX to Directive 93/42/EEC, hip, knee and shoulder replacements shall be reclassified as medical devices falling within class III.
   Article 2
   For the purpose of this Directive, a hip, knee or shoulder replacement means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint. Ancillary components (screws, wedges, plates and instruments) are excluded from this definition.
   Article 3
   1.   Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(a) of Directive 93/42/EEC before 1 September 2007 shall be subject to a complementary conformity assessment under point 4 of Annex II to Directive 93/42/EEC leading to an EC design examination certificate before 1 September 2009. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(b) of Directive 93/42/EEC.
   2.   Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(b)(iii) of Directive 93/42/EEC before 1 September 2007 may be subject to a conformity assessment as class III medical devices pursuant to Article 11(1)(b)(i) or (ii) before 1 September 2010. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(a) of Directive 93/42/EEC.
   3.   Member States shall accept until 1 September 2009 the placing on the market and the putting into service of hip, knee and shoulder replacements covered by a Decision in accordance with Article 11(3)(a) of Directive 93/42/EEC issued before 1 September 2007.
   4.   Member States shall accept until 1 September 2010 the placing on the market of hip, knee and shoulder replacements which are covered by a Decision in accordance with Articles 11(3)(b)(iii) of Directive 93/42/EEC issued before 1 September 2007 and permit such total joint replacements to be put into service beyond that date.
   Article 4
   1.   Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 March 2007. They shall immediately inform the Commission thereof.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. Member States shall determine how such a reference is to be made.
   Member States shall apply those provisions from 1 September 2007.
   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 5
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 11 August 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council.


title: Commission Directive 2007/48/EC of 26 July 2007 amending Directive 2003/90/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species (Text with EEA relevance)

text:
               27.7.2007

               EN

               Official Journal of the European Union

               L 195/29

      COMMISSION DIRECTIVE 2007/48/EC
   of 26 July 2007
   amending Directive 2003/90/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2)(a) and (b) thereof,
   Whereas:

               (1)

               Commission Directive 2003/90/EC (2) was adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties that Directive provides that the guidelines of the International Union for the Protection of new Varieties of Plants (UPOV) are to apply.

               (2)

               The CPVO and UPOV have since established further guidelines for a number of other species or have updated existing ones.

               (3)

               Directive 2003/90/EC should therefore be amended accordingly.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I and II to Directive 2003/90/EC are replaced by the text in the Annex to this Directive.
   Article 2
   For examinations started before 1 November 2007 Member States may apply Directive 2003/90/EC in the version applying before its amendment by this Directive.
   Article 3
   Member States shall adopt and publish, by 31 October 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 November 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 4
   This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 26 July 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 193, 20.7.2002, p. 1. Directive as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 1).

      (2)  OJ L 254, 8.10.2003, p. 7. Directive as amended by Directive 2005/91/EC (OJ L 331, 17.12.2005, p. 24).

      ANNEX
      ‘
            ANNEX I
            List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Species listed in the Common Catalogue

                        CPVO protocol

                        Field pea

                        Pea, TP 7/1 of 6.11.2003

                        Swede rape

                        Oilseed rape, TP 36/1 of 25.3.2004

                        Sunflower

                        Sunflower, TP 81/1 of 31.10.2002

                        Oats

                        Oats, TP 20/1 of 6.11.2003

                        Barley

                        Barley, TP 19/2 of 6.11.2003

                        Rice

                        Rice, TP 16/1 of 18.11.2004

                        Rye

                        Rye, TP 58/1 of 31.10.2002

                        Triticale

                        Triticale, TP 121/2 of 22.1.2007

                        Wheat

                        Wheat, TP 3/3 of 6.11.2003

                        Durum wheat

                        Durum wheat, TP 120/2 of 6.11.2003

                        Maize

                        Maize, TP 2/2 of 15.11.2001

                        Potato

                        Potato, TP 23/2 of 1.12.2005

                        Flax/Linseed

                        Flax/Linseed, TP 57/1 of 21.3.2007

                  The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

            ANNEX II
            List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

                        Species listed in the Common Catalogue

                        UPOV guidelines

                        Fodder beet

                        Fodder beet, guideline TG/150/3 of 4.11.1994

                        Velvet bent

                        Bent, guideline TG/30/6 of 12.10.1990

                        Red top

                        Bent, guideline TG/30/6 of 12.10.1990

                        Creeping bent

                        Bent, guideline TG/30/6 of 12.10.1990

                        Brown top

                        Bent, guideline TG/30/6 of 12.10.1990

                        Rescue grass

                        Rescue grass, guideline TG/180/3 of 4.4.2001

                        Alaska brome-grass

                        Alaska brome-grass, guideline TG/180/3 of 4.4.2001

                        Cocksfoot

                        Cocksfoot, guideline TG/31/8 of 17.4.2002

                        Tall fescue

                        Tall fescue, guideline TG/39/8 of 17.4.2002

                        Sheep’s fescue

                        Sheep's fescue, guideline TG/67/5 of 5.4.2006

                        Meadow fescue

                        Meadow fescue, guideline TG/39/8 of 17.4.2002

                        Red fescue

                        Red fescue, guideline TG/67/5 of 5.4.2006

                        Italian ryegrass

                        Ryegrass, guideline TG/4/8 of 5.4.2006

                        Perennial ryegrass

                        Ryegrass, guideline TG/4/8 of 5.4.2006

                        Hybrid ryegrass

                        Ryegrass, guideline TG/4/8 of 5.4.2006

                        Timothy

                        Timothy, guideline TG/34/6 of 7.11.1984

                        Smooth-stalked meadow grass

                        Kentucky bluegrass, guideline TG/33/6 of 12.10.1990

                        White lupin

                        White lupin, guideline TG/66/4 of 31.3.2004

                        Blue lupin

                        Blue lupin, guideline TG/66/4 of 31.3.2004

                        Yellow lupin

                        Yellow lupin, guideline TG/66/4 of 31.3.2004

                        Lucerne

                        Lucerne, guideline TG/6/5 of 6.4.2005

                        Red clover

                        Red clover, guideline TG/5/7 of 4.4.2001

                        White clover

                        White clover, guideline TG/38/7 of 9.4.2003

                        Field bean

                        Field bean, guideline TG/8/6 of 17.4.2002

                        Common vetch

                        Common vetch, guideline TG/32/6 of 21.10.1988

                        Swede

                        Swede, guideline TG 89/6 of 4.4.2001

                        Fodder radish

                        Fodder radish, guideline TG/178/3 of 4.4.2001

                        Groundnut/Peanut

                        Groundnut, guideline TG/93/3 of 13.11.1985

                        Turnip rape

                        Turnip rape, guideline TG/185/3 of 17.4.2002

                        Safflower

                        Safflower, guideline TG/134/3 of 12.10.1990

                        Cotton

                        Cotton, guideline TG/88/6 of 4.4.2001

                        Opium poppy

                        Opium/Seed poppy, guideline TG/166/3 of 24.3.1999

                        White mustard

                        White mustard, guideline TG/179/3 of 4.4.2001

                        Soya bean

                        Soya bean, guideline TG/80/6 of 1.4.1998

                        Sorghum

                        Sorghum, guideline TG/122/3 of 6.10.1989

                  The text of these guidelines can be found on the UPOV web site (www.upov.int).
         ’


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32001L0051

Council Directive 2001/51/EC of 28 June 2001 supplementing the provisions of Article 26 of the Convention implementing the Schengen Agreement of 14 June 1985

Official Journal L 187 , 10/07/2001 P. 0045 - 0046

Council Directive 2001/51/ECof 28 June 2001supplementing the provisions of Article 26 of the Convention implementing the Schengen Agreement of 14 June 1985THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 61(a) and Article 63(3)(b) thereof,Having regard to the initiative of the French Republic(1),Having regard to the opinion of the European Parliament(2),Whereas:(1) In order to combat illegal immigration effectively, it is essential that all the Member States introduce provisions laying down the obligations of carriers transporting foreign nationals into the territory of the Member States. In addition, in order to ensure a greater effectiveness of this objective, the financial penalties currently provided for by the Member States for cases where carriers fail to meet their control obligations should be harmonised to the extent possible, taking into account the differences in legal systems and practices between the Member States.(2) This measure is among the general provisions aimed at curbing migratory flows and combating illegal immigration.(3) Application of this Directive is without prejudice to the obligations resulting from the Geneva Convention relating to the Status of Refugees of 28 July 1951, as amended by the New York Protocol of 31 January 1967.(4) The freedom of the Member States to retain or introduce additional measures or penalties for carriers, whether referred to in this Directive or not, should not be affected.(5) Member States should ensure that in any proceedings brought against carriers which may result in the application of penalties, the rights of defence and the right of appeal against such decisions can be exercised effectively.(6) This Directive builds on the Schengen acquis, in accordance with the Protocol integrating it into the framework of the European Union, as laid down by Annex A to Council Decision 1999/435/EC of 20 May 1999 concerning the definition of the Schengen acquis for the purpose of determining, in conformity with the relevant provisions of the Treaty establishing the European Community and the Treaty on European Union, the legal basis for each of the provisions or decisions which constitute the acquis(3).(7) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland annexed to the Treaty on European Union and the Treaty establishing the European Community, the United Kingdom gave notice, by letter of 25 October 2000, of its wish to take part in the adoption and application of this Directive.(8) Pursuant to Article 1 of the aforementioned Protocol, Ireland is not participating in the adoption of this Directive. Consequently and without prejudice to Article 4 of the aforementioned Protocol, the provisions of this Directive do not apply to Ireland.(9) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark annexed to the Treaty on European Union and the Treaty establishing the European Community, Denmark is not participating in the adoption of this Directive, and is therefore not bound by it or subject to its application. Given that this instrument aims to build upon the Schengen acquis under the provisions of Title IV of the Treaty establishing the European Community, in accordance with Article 5 of the abovementioned Protocol, Denmark shall decide within a period of 6 months after the Council has adopted this Directive whether it will implement it in its national law.(10) As regards the Republic of Iceland and the Kingdom of Norway, this Directive constitutes a development of the Schengen acquis within the meaning of the Agreement concluded on 18 May 1999 by the Council of the European Union and those two States concerning the lattter's association with the implementation, application and development of the Schengen acquis(4),HAS ADOPTED THIS DIRECTIVE:Article 1The aim of this Directive is to supplement the provisions of Article 26 of the Convention implementing the Schengen Agreement of 14 June 1985, signed at Schengen on 19 June 1990(5) (hereinafter referred to as "the Schengen Convention") and to define certain conditions with respect to their implementation.Article 2Member States shall take the necessary steps to ensure that the obligation of carriers to return third country nationals provided for in the provisions of Article 26(1)(a) of the Schengen Convention shall also apply when entry is refused to a third-country national in transit if:(a) the carrier which was to take him to his country of destination refuses to take him on board;(b) or the authorities of the State of destination have refused him entry and have sent him back to the Member State through which he transited.Article 3Member States shall take the necessary measures to oblige carriers which are unable to effect the return of a third-country national whose entry is refused to find means of onward transportation immediately and to bear the cost thereof, or, if immediate onward transportation is not possible, to assume responsibility for the costs of the stay and return of the third-country national in question.Article 41. Member States shall take the necessary measures to ensure that the penalties applicable to carriers under the provisions of Article 26(2) and (3) of the Schengen Convention are dissuasive, effective and proportionate and that:(a) either the maximum amount of the applicable financial penalties is not less than EUR 5000 or equivalent national currency at the rate of exchange published in the Official Journal on 10 August 2001, for each person carried, or(b) the minimum amount of these penalties is not less than EUR 3000 or equivalent national currency at the rate of exchange published in the Official Journal on 10 August 2001, for each person carried, or(c) the maximum amount of the penalty imposed as a lump sum for each infringement is not less that EUR 500000 or equivalent national currency at the rate of exchange published in the Official Journal on 10 August 2001, irrespective of the number of persons carried.2. Paragraph 1 is without prejudice to Member States' obligations in cases where a third country national seeks international protection.Article 5This Directive shall not prevent Member States from adopting or retaining, for carriers which do not comply with the obligations arising from the provisions of Article 26(2) and (3) of the Schengen Convention and of Article 2 of this Directive, other measures involving penalties of another kind, such as immobilisation, seizure and confiscation of the means of transport, or temporary suspension or withdrawal of the operating licence.Article 6Member States shall ensure that their laws, regulations and administrative provisions stipulate that carriers against which proceedings are brought with a view to imposing penalties have effective rights of defence and appeal.Article 71. Member States shall take the necessary measures to comply with this Directive not later than 11 February 2003. They shall forthwith inform the Commission thereof.2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.3. Member States shall communicate the main provisions of national law which they adopt in the field covered by this Directive to the Commission.Article 8This Directive shall enter into force 30 days after its publication in the Official Journal of the European Communities.Article 9This Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.Done at Luxembourg, 28 June 2001.For the CouncilThe PresidentB. Rosengren(1) OJ C 269, 20.9.2000, p. 8.(2) Opinion delivered on 13 March 2001 (not yet published in the Official Journal).(3) OJ L 176, 10.7.1999, p. 1.(4) OJ L 176, 10.7.1999, p. 3.(5) OJ L 239, 22.9.2000, p. 1.


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31994L0048

Directive 94/48/EC of the European Parliament and of the Council of 7 December 1994 amending for the 13th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations

Official Journal L 331 , 21/12/1994 P. 0007 - 0009 Finnish special edition: Chapter 13 Volume 27 P. 0053  Swedish special edition: Chapter 13 Volume 27 P. 0053

DIRECTIVE 94/48/EC OF THE EUROPEAN  PARLIAMENT AND OF THE COUNCIL of 7 December 1994 amending for the 13th time Directive 76/769/EEC on  the approximation of the laws, regulations and administrative provisions of the Member States  relating to restrictions on the marketing and use of certain dangerous substances and preparationsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas Article 7a of the Treaty establishes an area without internal frontiers in which it must be  possible for goods, persons, services and capital to move freely; Whereas the progress of the internal market should gradually improve the quality of life, the  health protection and the safety of consumers; whereas the measures proposed by this Directive are  in line with the Council resolution of 9 November 1989 on future priorities for relaunching  consumer protection policy (4); Whereas certain substances and preparations used in aerosol generators are of a particularly  flammable nature; Whereas risks to consumers arise from the increasing use in aerosol generators of flammable  substances in place of chlorofluorocarbons (CFC); whereas such risks are particularly acute in the  case of aerosol generators intended for entertainment and decorative purposes; Whereas these risks can be offset by adapting to technical progress Council Directive 75/324/EEC of  20 May 1975 on the harmonization of the laws of the Member States relating to aerosol dispensers  (5) and by limiting thereby the use of flammable substances in aerosol generators intended for  entertainment and decorative purposes; Whereas the limits planned by one Member State on the marketing of certain aerosol generators  intended for entertainment and decorative purposes directly affect the completion and functioning  of the internal market; whereas it is therefore necessary to approximate the laws of the Member  States in this field and consequently amend Annex I to Directive 76/769/EEC (6); Whereas, according to the scope and effects of the proposed action, the Community measures  envisaged by this Directive are not only necessary but also indispensable for the attainment of the  stated objectives; whereas these objectives cannot be achieved by Member States individually and  whereas, furthermore, their attainment at Community level is already provided for by Directive  76/769/EEC, HAVE ADOPTED THIS DIRECTIVE: Article 1 Annex I to Directive 76/769/EEC is hereby amended in accordance with  the Annex hereto. Article 2 1.  Member States shall adopt the laws, regulations and administrative provisions  necessary to comply with this Directive no later than: - either six months after adoption of a Commission Directive adjusting Directive 75/324/EEC on  aerosol dispensers to technical progress to cover all testing procedures used to certify the  conformity of products with this Directive, - or one year after the adoption of this Directive if that date is later than the first. They shall apply these provisions six months after expiry of the relevant period. 2.  When Member States adopt the provisions referred to in paragraph 1, they shall contain a  reference to this Directive or shall be accompanied by such reference at the time of their official  publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States. Done at Brussels, 7 December 1994. For the European Parliament The President K. HAENSCH For the Council The President G. REXRODT (1) OJ No 306, 12. 11. 1993, p. 14. (2) OJ No C 133, 16. 5. 1994, p. 15. (3) Opinion of the European Parliament of 15 December 1993 (OJ No C 20, 24. 1. 1994, p. 77),  Council common position of 27 June 1994 (OJ No C 244, 31. 8. 1994, p. 13) and Decision of the  European Parliament of 15 September 1994 (not yet published in the Official Journal). (4) OJ No C 294, 23. 11. 1989, p. 1. (5) OJ No L 147, 9. 6. 1975, p. 40, Directive as last amended by Directive 94/1/EC (OJ No L 23, 28.  1. 1994, p. 28). (6) OJ No L 262, 27. 9. 1976, p. 201, Directive as last amended by Directive 91/339/EEC (OJ No L  186, 12. 7. 1991, p. 64).  ANNEX Substances either - appearing in Annex I to Directive 67/548/EEC which are classified as flammable or extremely  flammable and labelled as such, or - not yet appearing in Annex I to Directive 67/548/EEC but conforming to the criteria of  flammability of Annex VI to Directive 67/548/EEC and being provisionally classified and labelled as  flammable, highly flammable or extremely flammable according to Article 5 (2) of Directive  67/548/EEC. 1. May not be used as such or in the form of preparations in aerosol generators marketed and  intended for sale to the general public for entertainment and decorative purposes such as the  following: - metallic glitter intended mainly for decoration, - artificial snow and frost, - 'whoopee` cushions, - silly string aerosols, - imitation excrement, - horns for parties, - decorative flakes and foams, - artificial cobwebs, - stink bombs, - etc. 2. Without prejudice to the application of other Community provisions on the classification,  packaging and labelling of dangerous substances, the following words must appear legibly and  indelibly on the packaging of aerosol generators referred to above; 'For professional users only`. 3. By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol generators referred to  in Article 9a of Directive 75/324/EEC. 4. The products referred to above may not be placed on the market unless they conform to the  requirements indicated.