Avis juridique important

|

31975L0786

Council Directive 75/786/EEC of 18 December 1975 amending Directive 72/464/EEC on taxes other than turnover taxes which affect the consumption of manufactured tobacco

Official Journal L 330 , 24/12/1975 P. 0051 - 0051 Finnish special edition: Chapter 9 Volume 1 P. 0026  Greek special edition: Chapter 09 Volume 1 P. 0046  Swedish special edition: Chapter 9 Volume 1 P. 0026  Spanish special edition: Chapter 09 Volume 1 P. 0051  Portuguese special edition Chapter 09 Volume 1 P. 0051

COUNCIL DIRECTIVE  of 18 December 1975  amending Directive 72/464/EEC on taxes other than turnover taxes which affect the consumption of manufactured tobacco  (75/786/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, pursuant to Council Directive 72/464/EEC (3) of 19 December 1972 on taxes other than turnover taxes which affect the consumption of manufactured tobacco, as amended by Directive 74/318/EEC (4), the Council must adopt by 30 June 1975 a Directive laying down the special criteria applicable after the first stage which, under Article 7 (1), covers, subject to Article 1 (4), a period of 36 months from 1 July 1973;  Whereas the Commission has submitted a proposal to the Council on measures necessary to decide how manufactured tobacco should be defined and grouped in accordance with Article 3 (2) of the abovementioned Directive;  Whereas in order to lay down the special cirteria applicable in the following stage or stages, a further examination must be made of the conditions on the market in manufactured tobacco in the enlarged Community;  Whereas it is therefore necessary to extend the first stage for a further 12 months,  HAS ADOPTED THIS DIRECTIVE:    Article 1 In Article 7 (1) of Directive 72/464/EEC, the words "period of 36 months" shall be replaced by the words "period of 48 months".   Article 2 This Directive is addressed to the Member States.     Done at Brussels, 18 December 1975.  For the Council  The President  M. TOROS  (1)OJ No C 239, 20.10.1975, p. 21. (2)Opinion delivered 29.10.1975 (not yet published in the Official Journal). (3)OJ No L 303, 31.12.1972, p. 1. (4)OJ No L 180, 3.7.1974, p. 30.


Avis juridique important

|

31976L0911

Council Directive 76/911/EEC of 21 December 1976 amending Directive 72/464/EEC on taxes other than turnover taxes which affect the consumption of manufactured tobacco

Official Journal L 354 , 24/12/1976 P. 0033 - 0033 Finnish special edition: Chapter 9 Volume 1 P. 0027  Greek special edition: Chapter 09 Volume 1 P. 0047  Swedish special edition: Chapter 9 Volume 1 P. 0027  Spanish special edition: Chapter 09 Volume 1 P. 0053  Portuguese special edition Chapter 09 Volume 1 P. 0053

COUNCIL DIRECTIVE  of 21 December 1976  amending Directive 72/464/EEC on taxes other than turnover taxes which affect the consumption of manufactured tobacco  (76/911/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 Council Directive 72/464/EEC of 19 December 1972 on taxes other than turnover taxes which affect the consumption of manufactured tobacco (3), as amended by Directive 75/786/EEC (4), provides that the Council shall adopt by 30 June 1976 at the latest a Directive laying down the special criteria applicable after the first stage, which, under Article 7 (1) and subject to Article 1 (4), covers a period of 48 months from 1 July 1973 ; whereas the Council has not yet adopted such a Directive;  Whereas, in these circumstances, it is necessary to further extend the first stage,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 72/464/EEC shall be amended as follows:    1. In Article 1 (3) the words "at least six months" shall be substituted for "at least one year".       2. In Article 7 (1) the words "period of 54 months" shall be substituted for "period of 48 months".          Article 2 This Directive is addressed to the Member States.     Done at Brussels, 21 December 1976.  For the Council  The President  A.P.L.M.M. van der STEE  (1)OJ No C 259, 4.11.1976, p. 44. (2)OJ No C 278, 24.11.1976, p. 11. (3)OJ No L 303, 31.12.1972, p. 1. (4)OJ No L 330, 24.12.1975, p. 51.


Avis juridique important

|

31988L0095

Commission Directive 88/95/EEC of 8 January 1988 amending Annex I to Council Directive 66/400/EEC on the marketing of beet seed

Official Journal L 056 , 02/03/1988 P. 0042 - 0042 Finnish special edition: Chapter 3 Volume 26 P. 0100  Swedish special edition: Chapter 3 Volume 26 P. 0100

*****COMMISSION  DIRECTIVE  of 8 January 1988  amending Annex I to Council Directive 66/400/EEC on the marketing of  beet seed  (88/95/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/400/EEC of 14 June 1966 on the marketing of beet seed (1), as last amended by Commission Directive 87/120/EEC (2), and in particular Article 21a thereof,  Whereas, in the light of the development of scientific and technical knowledge, Annex I to Directive 66/400/EEC should be amended for the reasons set out below;  Whereas diseases which reduce the usefulness of seed should be at the lowest possible level;  Whereas it has been established that the Community production of beet, in particular of sugar and fodder beet, is increasingly at risk from the spread of rhizomania, a disease caused by necrotic yellow vein virus;  Whereas the inert matter in seed lots represents a risk for the spread of rhizomania; whereas standards in respect of the maximum content of inert matter in those types of beet seed which represent the major part of seed used in the Community should be adopted for the abovementioned reasons and in the light of the development of the seed quality normally achieved for the individual categories, respectively;  Whereas, however, in the case of multigerm seed the appropriate safeguards cannot yet be defined and whereas, owing to the quantitatively reduced risk, it appears justified to postpone the establishment of additional requirements in respect of this type of seed;  Whereas, nevertheless, areas in the Community which have been recognized as 'Rhizomania-free zones' under appropriate Community procedures should be effectively protected already against the risk of introducing rhizomania;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex I (B) (3) to Directive 66/400/EEC is hereby amended as follows:  1. The following is added to point (b):  '(cc) In the case of seed of the category ''basic seed", the percentage by weight of inert matter shall not exceed 1,0. In the case of seed of the category ''certified seed", the percentage by weight of inert matter shall not exceed 0,5. In the case of pelleted seed of both categories, the satisfaction of the relevant condition shall be examined on samples drawn, pursuant to Article 7 (1), from processed seed which has undergone partial decortication (rubbing or grinding) but has not yet been pelleted, without prejudice to the official examination of the minimum analytical purity of the pelleted seed.'  2. The following point is added:  '(c) Other special conditions:  Member States shall ensure that beet seed may not be introduced into areas recognized as ''Rhizomania-free zones" under appropriate Community procedures, unless the percentage by weight of inert matter does not exceed 0,5.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1988.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 8 January 1988.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No 125, 11. 7. 1966, p. 2290/66.  (2) OJ No L 49, 18. 2. 1987, p. 39.


Avis juridique important

|

31981L0855

Council Directive 81/855/EEC of 19 October 1981 adapting, consequent upon the accession of Greece, Directive 79/869/EEC concerning the methods of measurement and frequencies of sampling and analysis of surface water intended for the abstraction of drinking water in the Member States

Official Journal L 319 , 07/11/1981 P. 0016 - 0016 Spanish special edition: Chapter 15 Volume 3 P. 0075  Portuguese special edition Chapter 15 Volume 3 P. 0075  Finnish special edition: Chapter 15 Volume 3 P. 0160  Swedish special edition: Chapter 15 Volume 3 P. 0160

COUNCIL DIRECTIVE of 19 October 1981 adapting, consequent upon the accession of Greece, Directive 79/869/EEC concerning the methods of measurement and frequencies of sampling and analysis of surface water intended for the abstraction of drinking water in the Member States (81/855/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Whereas, to take account of the accession of Greece to the European Communities, Article 11 (2) of Council Directive 79/869/EEC of 9 October 1979 concerning the methods of measurement and frequencies of sampling and analysis of surface water intended for the abstraction of drinking water in the Member States (2) should be adapted;  Whereas, pursuant to the first paragraph of Article 198 of the Treaty, the Council consulted the Economic and Social Committee on the proposal from the Commission ; whereas the Committee was not in a position to submit its opinion within the time limit set by the Council ; whereas under the second paragraph of Article 198 of the Treaty the absence of an opinion shall not prevent the Council from taking further action ; whereas, having regard to the desirability of the rapid adoption of the required amendments, the Council considers it necessary to avail itself of this possibility,  HAS ADOPTED THIS DIRECTIVE:    Article 1 In Article 11 (2) of Directive 79/869/EEC, "41" shall be replaced by "45".   Article 2 This Directive shall take effect on 1 January 1981.   Article 3 This Directive is addressed to the Member States.     Done at Luxembourg, 19 October 1981.  For the Council  The President  P. WALKER   (1) OJ No C 144, 15.6.1981, p. 36.  (2) OJ No L 271, 29.10.1979, p. 44.


Avis juridique important

|

31992L0054

Council Directive 92/54/EEC of 22 June 1992 amending Directive 77/143/EEC on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers (brakes)

Official Journal L 225 , 10/08/1992 P. 0063 - 0067 Finnish special edition: Chapter 7 Volume 4 P. 0111  Swedish special edition: Chapter 7 Volume 4 P. 0111

COUNCIL DIRECTIVE 92/54/EEC of 22 June 1992 amending Directive 77/143/EEC on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers (brakes)THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community and in particular Article 75 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 77/143/EEC (4) provides for the regular roadworthiness testing of all categories of vehicles listed in Annex I thereto;  Whereas that Directive provides for the adoption of separate directives for testing the standard of the items listed in Annex II thereto and the establishment of a technical committee to advise the Commission before it adopts measures to adjust  roadworthiness tests to technical progress;  Whereas most Member States have adopted procedures for testing heavy commercial vehicles with regard to the condition of the braking system;  Whereas several Member States have national rules for testing the lighter vehicles, including passenger cars, and that those rules are commensurate with the scheme outlined in this Directive;  Whereas assessment of the type approval procedures for testing vehicle braking for all vehicle types shows that applying those procedures in the roadworthiness test presents some difficulty;  Whereas in-service testing should be relatively simple, quick and inexpensive;  Whereas at this stage it would be premature to set values for the required braking efficiencies, air pressure settings and build up times, etc. given the variance in test equipments and methods within the Community; whereas the aim of brake performance  testing must be that a realistic judgment can be made at the time of testing that the vehicle, irrespective of its laden condition within the bounds of its gross weights, would be safe and reliable on the road and that, if tested to the technical  requirements of Council Directive 71/320/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and of their trailers (5), then it would pass;  Whereas Member States may extend the scope of the braking test to include vehicles or test items outside the scope of this Directive;  Whereas Member States may enhance the severity of the braking test or increase the frequency of testing,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex II of Directive 77/143/EEC is hereby amended as follows:  1. the introductory note and the two columns of heading 1 (braking systems) shall be replaced by the text set out in the Annex to this Directive;  2. under heading 1, the following headings shall be inserted above the two columns:   VEHICLES IN CATEGORIES 1, 2, 3 and 4 VEHICLES IN CATEGORIES 5 and 6  Article 2  1. Member States shall implement the laws, regulations and administrative measures necessary to comply with this Directive within one year of the date of its adoption. They shall forthwith inform the Commission thereof.  When the Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member  States.  2. Member States shall communicate to the Commission the texts of the provisions of domestic law which they adopt in the field governed by this Directive.  Article 3  This Directive is addressed to the Member States.   Done at Luxembourg, 22 June 1992.  For the Council The President Joaquim FERREIRA DO AMARAL (1) OJ No C 189, 20. 7. 1991, p. 16.(2) OJ No C 94, 13. 4. 1992.(3) OJ No C 49, 24. 2. 1992, p. 64.(4) OJ No L 47, 18. 2. 1977, p. 47. Last amended by Directive 91/328/EEC (OJ No L 178, 6. 7. 1991, p. 29).(5) OJ No L 202, 6. 9. 1971, p. 37.  Last amended by Commission Directive 91/422/EEC (OJ No L 233, 22. 8. 1991, p. 2).   ANNEX  'ANNEX II The test shall cover at least the items listed below, since these refer to the obligatory equipment of the vehicle tested in the Member State in question.  The tests covered by this Annex may be carried out visually without disassembly of vehicle parts.  Where the vehicle is found to be defective with regard to the test items below, the competent authorities in the Member States shall adopt a procedure for setting the conditions under which the vehicle may be used before passing another roadworthiness  test.   VEHICLES IN CATEGORIES 1, 2, 3, 4, 5 AND 6 1. BRAKING SYSTEMS  The following items are to be included in the roadworthiness test of vehicle braking systems. The test results achieved during the checks of the braking systems shall be equivalent as far as is practicable to the technical requirements of Directive  71/320/EEC.  Items to be checked/tested Reasons for failure 1.1.  Mechanical condition and operation 1.1.1.  Footbrake pedal pivot - too tight - bearing worn - excessive wear/play;  1.1.2.  Pedal condition and travel of the brake operating device - excessive or insufficient reserve travel - brake control not releasing correctly - anti-slip provision on brake pedal missing, loose or worn smooth;  1.1.3.  Vacuum pump or compressor and reservoirs - time taken to build up air pressure/vacuum for the effective operation of the brakes is excessive - insufficient air pressure/vacuum to give assistance for at least two applications of the brake after the warning device has operated (or gauge shows unsafe reading) - air leak causing a noticeable drop in pressure or audible air leaks;  1.1.4.  Low pressure warning indicator or gauge - malfunctioning or defective low pressure indicator/air pressure gauge;  1.1.5.  Hand operated brake control valve - cracked or damaged control, excessive wear - malfunction of control valve - control insecure on valve spindle or valve unit insecure - connections loose or leak in system - unsatisfactory operation;  1.1.6.  Parking brake, lever control, parking brake ratchet - parking brake ratchet not holding correctly - excessive wear at lever pivot or ratchet mechanism - excessive movement of lever indicating incorrect adjustment;  Items to be checked/tested Reasons for failure 1.1.7.  Braking valves (footvalves, unloaders, governors etc.) - damaged, excessive air leakage - excessive discharge of oil from compressor - insecure/inadequate mounting - discharge of hydraulic brake fluid;  1.1.8.  Couplings for trailer brakes - defective isolation taps or self-sealing valve - insecure/inadequate mounting - excessive leaks;  1.1.9.  Energy storage reservoir pressure tank - damaged, corroded, leaking - drain device inoperative - insecure/inadequate mounting;  1.1.10.  Brake servo units, master cylinder (hydraulic systems) - servo unit is defective or ineffective - master cylinder defective or leaking - master cylinder insecure - insufficient quantity of brake fluid - master cylinder reservoir cap missing - brake fluid warning light illuminated or defective - incorrect functioning of brake fluid level warning device;  1.1.11.  Rigid brake pipes - risk of failure or fracture - leaks from pipes or connections to couplings - damaged or excessively corroded - misplaced;  1.1.12.  Flexible brake hoses - risk of failure or fracture - damaged, chafing, brake hoses too short, twisted - leaks from hoses or couplings - hose bulging under pressure - porosity;  1.1.13.  Brake coverings (lining spads) - excessive wear - contaminated (oil, grease, etc.);  1.1.14.  Brake drums, brake discs - excessive wear, excessive scoring, cracks, insecure or fractured - contaminated (oil, grease, etc.) - back plate insecure;  1.1.15.  Brake cables, rods, levers linkage - cables damaged, knotted - excessively worn or corroded - cable or rod joint insecure - cable guide defective - any restriction to free movement of the brake system - any abnormal movement of levers/rods/linkage indicating maladjustment or excessive wear;  1.1.16.  Brake actuators (including spring brakes or hydraulic wheel cylinders) - cracked or damaged - leaking - insecure/inadequate mounting - excessively corroded - excessive travel of operating piston or diaphragm mechanism - dust protection cover missing or excessively damaged;  Items to be checked/tested Reasons for failure 1.1.17.  Load sensing valve - defective linkage - incorrect adjustment - seized, not working - missing;  1.1.18.  Automatic slack adjusters indicating - seized or abnormal movement, excessive wear or wrong adjustment - defective;  1.1.19.  Retarder system (where fitted or required) - insecure connectors or mountings - defective;  1.2.  Service brake performance and efficiency 1.2.1.  Performance (progressively increased to maximum effort) - little or no braking effort on one or more wheels - braking effort from any wheel is less than 70 % of the highest recorded effort from another wheel on the same axle (where road test necessary then vehicle's deviation from a straight line on braking is excessive) - no gradual variation of brake effort (grabbing) - abnormal time-lag in brake operation at any wheel - excessive fluctuation of brake effort due to ovality of discs or drums;  1.2.2.  Efficiency - brakes inefficient, minimum performance not met;  1.3.  Secondary (emergency) brake performance and efficiency (if met by separate system) 1.3.1.  Performance - brake(s) inoperative on one side - braking effort from any wheel is less than 70 % of the highest recorded effort from another wheel on the same axle - no gradual variation of efficiency (grabbing) - automatic brake system not working in the case of trailers 1.3.2.  Efficiency - brake inefficient, minimum performance not met;  1.4.  Parking brake performance and efficiency 1.4.1.  Performance - brake inoperative on one side 1.4.2.  Efficiency - brake inefficient, minimum performance not met;  1.5.  Retarder or exhaust brake system performance - no gradual variation of efficiency (retarder) - defective;  1.6.  Anti-lock braking - malfunction of the anti-lock warning device - defective'.


Avis juridique important

|

31978L0816

Council Directive 78/816/EEC of 26 September 1978 amending Directive 66/403/EEC on the marketing of seed potatoes

Official Journal L 281 , 06/10/1978 P. 0018 - 0018 Greek special edition: Chapter 03 Volume 22 P. 0230

++++COUNCIL DIRECTIVE  OF 26 SEPTEMBER 1978  AMENDING DIRECTIVE 66/403/EEC ON THE MARKETING OF SEED POTATOES   ( 78/816/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLES 43 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 IT RESULTS FROM ARTICLE 15 OF COUNCIL DIRECTIVE 66/403/EEC OF 14 JUNE 1966 ON THE MARKETING OF SEED POTATOES ( 3 ) , AS LAST AMENDED BY DIRECTIVE 78/692/EEC ( 4 ) , THAT AFTER 1 JULY 1975 MEMBER STATES MAY NO LONGER ESTABLISH UNDER THEIR OWN RESPONSIBILITY THE EQUIVALENCE OF INSPECTIONS AND CHECKS CARRIED OUT IN THIRD COUNTRIES ; WHEREAS , HOWEVER , THE WORK INTENDED TO ENABLE SUCH EQUIVALENCE TO BE DETERMINED AT COMMUNITY LEVEL HAS NOT YET BEEN COMPLETED ;  WHEREAS , THEREFORE , IN ORDER TO PREVENT THE MEMBER STATES' TRADITIONAL TRADE PATTERNS BEING DISTURBED , THE MEMBER STATES SHOULD BE GRANTED THE POSSIBILITY OF EXTENDING THE VALIDITY OF DECISIONS ON EQUIVALENCE ALREADY TAKEN BY THEM ;  WHEREAS , HOWEVER , THE USE OF THIS POSSIBILITY IS SUBJECT TO THE COMMUNITY PHYTOSANITARY RULES APPLICABLE FROM 23 DECEMBER 1978 ; WHEREAS , AS A RESULT , SEED POTATOES MAY NOT BE INTRODUCED INTO THE COMMUNITY AFTER THAT DATE EXCEPT IN SO FAR AS PERMITTED BY THE ABOVEMENTIONED PHYTOSANITARY RULES ; WHEREAS , HOWEVER , SEED POTATOES INTRODUCED BEFORE THAT DATE MAY IN ANY CASE , AS REGARDS MARKETING WITHIN THE MEMBER STATE CONCERNED , BENEFIT FROM THE EQUIVALENCE UNTIL THE DATE LAID DOWN IN THIS DIRECTIVE ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  WITHOUT PREJUDICE TO THE PROVISIONS OF COUNCIL DIRECTIVE 77/93/EEC OF 21 DECEMBER 1976 ON PROTECTIVE MEASURES AGAINST THE INTRODUCTION INTO MEMBER STATES OF HARMFUL ORGANISMS OF PLANT OR PLANT PRODUCTS ( 5 ) THE DATE " 30 JUNE 1978 " SET OUT IN ARTICLE 15 ( 2 ) ( A ) OF DIRECTIVE 66/403/EEC SHALL BE REPLACED BY " 30 JUNE 1979 " .  ARTICLE 2  MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE WITH EFFECT FROM 1 JULY 1978 .  THEY SHALL FPRTJWOTJ INFORM THE COMMISSION THEREOF .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 26 SEPTEMBER 1978 .  FOR THE COUNCIL  THE PRESIDENT  J . ERTL  ( 1 ) OPINION DELIVERED ON 15 SEPTEMBER 1978 ( NOT YET PUBLISHED IN THE OFFICIAL JOURNAL ) .  ( 2 ) OPINION DELIVERED ON 12 AND 13 JULY 1978 ( NOT YET PUBLISHED IN THE OFFICIAL JOURNAL ) .  ( 3 ) OJ NO 125 , 11 . 7 . 1966 , P . 2320/66 .  ( 4 ) OJ NO L 236 , 26 . 8 . 1978 , P . 13 .  ( 5 ) OJ NO L 26 , 31 . 1 . 1977 , P . 20 .


title: Directive 2008/35/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment as regards the implementing powers conferred on the Commission

text:
               20.3.2008

               EN

               Official Journal of the European Union

               L 81/67

      DIRECTIVE 2008/35/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   amending Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment as regards the implementing powers conferred on the Commission
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Directive 2002/95/EC of the European Parliament and of the Council (3) provides that certain measures are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4).

               (2)

               Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements.

               (3)

               In accordance with the statement by the European Parliament, the Council and the Commission (5) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

               (4)

               The Commission should be empowered to adapt the annexes. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2002/95/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (5)

               Directive 2002/95/EC should therefore be amended accordingly.

               (6)

               Since the amendments made to Directive 2002/95/EC by this Directive are technical in nature and concern committee procedure only, they do not need to be transposed by the Member States. It is therefore not necessary to lay down provisions to that effect,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments
   Directive 2002/95/EC is hereby amended as follows:

               1.

               Article 5(1) shall be amended as follows:

                           (a)

                           the introductory wording shall be replaced by the following:
                           ‘1.   Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted:’;

                           (b)

                           the following subparagraph shall be added:
                           ‘The measures referred to in points (a), (b) and (c) of the first subparagraph, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(2).’;

               2.

               Article 7 shall be replaced by the following:
               ‘Article 7
               Committee
               1.   The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC of 15 July 1975 on waste (6).
               2.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

         Article 2
   Entry into force
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 3
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 11 March 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  OJ C 161, 13.7.2007, p. 45.

      (2)  Opinion of the European Parliament of 11 July 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008.

      (3)  OJ L 37, 13.2.2003, p. 19. Directive as last amended by Commission Decision 2006/692/EC (OJ L 283, 14.10.2006, p. 50).

      (4)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

      (5)  OJ C 255, 21.10.2006, p. 1.

      (6)  OJ L 194, 25.7.1975, p. 39. 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).’.


Avis juridique important

|

31992L0025

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use

Official Journal L 113 , 30/04/1992 P. 0001 - 0004 Finnish special edition: Chapter 13 Volume 22 P. 0029  Swedish special edition: Chapter 13 Volume 22 P. 0029

COUNCIL DIRECTIVE 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human useTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission(1) ,  in cooperation with the European Parliament(2) ,  Having regard to the opinion of the Economic and Social Committee(3) ,  Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market is to comprise an area without internal frontiers in which the free movement  of goods, persons, services and capital is ensured;  Whereas the wholesale distribution of medicinal products is at present subject to different provisions in the various Member States; whereas many operations involving the wholesale distribution of medicinal products for human use may cover several  Member States simultaneously;  Whereas it is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public, so as to guarantee that such products are stored, transported  and handled in suitable conditions; whereas the requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products;  Whereas any person involved in the wholesale distribution of medicinal products should be in possession of a special authorization; whereas pharmacists and persons authorized to supply medicinal products directly to the public, and who confine  themselves to this activity, should be exempt from obtaining this authorization; whereas it is however necessary, in order to control the complete chain of distribution of medicinal products, that pharmacists and persons authorized to supply medicinal  products to the public keep records showing transactions in products received;  Whereas authorization must be subject to certain essential conditions and it is the responsibility of the Member State concerned to ensure that such conditions are met; whereas each Member State must recognize authorizations granted by other Member  States;  Whereas certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorized to supply medicinal products to the public certain public service obligations; whereas those Member States must be able to  continue to impose those obligations on wholesalers established within their territory; whereas they must also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those  which they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1.  This Directive covers the wholesale distribution in the Community of medicinal products for human use to which Chapters II to V of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law,  regulation or administrative action relating to medicinal products(4)  apply.  2.  For the purposes of this Directive:  - wholesale distribution of medicinal products shall mean all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public; such activities are carried out with  manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned,  - public service obligation shall mean the obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very  short time over the whole of the area in question.  Article 2  Without prejudice to Article 3 of Directive 65/65/EEC, Member States shall take all appropriate action to ensure that only medicinal products in respect of which a marketing authorization has been granted in accordance with Community law are  distributed on their territory.  Article 3  1.  Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler in medicinal products, stating the  place for which it is valid.  2.  Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1.  3.  Possession of an authorization, as mentioned in Article 16 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(5) ,  shall include authorization to distribute by wholesale the medicinal products covered by that authorization. Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to  possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.  4.  At the request of the Commission or any Member State, Member States shall supply all appropriate information concerning the individual authorizations which they have granted under paragraph 1.  5.  Checks on the persons and establishments authorized to engage in the activity of wholesaler in medicinal products and the inspection of their premises shall be carried out under the responsibility of the Member State which granted the authorization.   6.  The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization if the conditions of authorization cease to be met. It shall forthwith inform the other Member States and the Commission thereof.   7.  Should a Member State consider that, in respect of a person holding an authorization granted by another Member State under the terms of paragraph 1, the conditions of authorization are not, or are no longer, met, it shall forthwith inform the  Commission and the other Member State involved. The latter shall take the measures necessary and shall inform the Commission and the first Member State of the decisions taken and the reasons for those decisions.  Article 4  1.  Member States shall ensure that the time taken for the procedure for examining the application for the authorization referred to in Article 3 (1) does not exceed 90 days from the day on which the competent authority of the Member State  concerned receives the application.  The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in this paragraph shall be suspended until the  requisite additional data have been supplied.  2.  All decisions to refuse, suspend or revoke the authorization referred to in Article 3 (1) shall state in detail the reasons on which they are based. A decision shall be notified to the party concerned, who shall at the same time be informed of the  redress available to him under the laws in force and of the time limit allowed for access to such redress.  Article 5  In order to obtain the authorization referred to in Article 3 (1), applicants must fulfil the following minimum requirements:  (a) they must have suitable and adequate premises, installations and equipment so as to ensure proper conservation and distribution of the medicinal products;  (b) they must have staff, and in particular a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned;  (c) they must undertake to fulfil the obligations incumbent on them under the terms of Article 6.  Article 6  Holders of the authorization referred to in Article 3 (1) must fulfil the following minimum requirements:  (a) they must make the premises, installations and equipment referred to in Article 5 (a) accessible at all times to the persons responsible for inspecting them;  (b) they must obtain their supplies of medicinal products only from persons who are themselves in possession of the authorization referred to in Article 3 (1) or who are exempt from obtaining such authorization under the terms of Article 3 (3);  (c) they must supply medicinal products only to persons who are themselves in possession of the authorization referred to in Article 3 (1) or who are authorized or entitled to supply medicinal products to the public in the Member State concerned;  (d) they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or holder of the marketing authorization for the product  concerned;  (e) they must keep records either in the form of purchase/sales invoices, or on computer, or in any other form giving for any transaction in medicinal products received or dispatched at least the following information:  - date,  - name of the medicinal product,  - quantity received or supplied,  - name and address of the supplier or consignee, as appropriate;  (f) they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years;  (g) they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 10.  Article 7  With regard to the supply of medicinal products to pharmacists and persons authorized or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of an authorization referred to in Article 3 (1)  which has been granted by another Member State, any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorized to engage in equivalent activities.  The said obligations should, moreover, be justified, in keeping with the Treaty, on grounds of public health protection and be proportionate in relation to the objective of such protection.  Article 8  For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain:  - the date,  - the name and pharmaceutical form of the medicinal product,  - the quantity supplied,  - the name and address of the supplier and consignor.  Member States shall take all appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product.   Article 9  The provisions of this Directive shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:  - narcotic or psychotropic substances within their territory,  - medicinal products derived from blood governed by Directive 89/381/EEC(6) ,  - immunological medicinal products governed by Directive 89/342/EEC(7) ,  - radiopharmaceuticals governed by Directive 89/343/ EEC(8) .  Article 10  The Commission shall publish guidelines on good distribution practice. To this end it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee.  Article 11  1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1993.  They shall forthwith inform the Commission thereof.  2.  When these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down  by the Member States.  Article 12  This Directive is addressed to the Member States.  Done at Brussels, 31 March 1992.  For the Council The President Vitor MARTINS   (1) OJ No C 58, 8. 3. 1990, p. 16 and OJ No C 207, 8. 8. 1991, p. 11.  (2) OJ No C 183, 15. 7. 1991, p. 139, and OJ No C 67, 16. 3. 1992.  (3) OJ No C 269, 14. 10. 1991, p. 84.  (4) OJ No 22, 9. 2. 1965, p. 369/65. Directive last amended by Directive 89/341/EEC (OJ No L 142, 25. 5. 1989, p. 11).  (5) OJ No L 147, 9. 6. 1975, p. 13. Directive last amended by Directive 89/381/EEC (OJ No L 181, 28. 6. 1989, p. 44).  (6) OJ No L 181, 28. 6. 1989, p. 44.  (7) OJ No L 142, 25. 5. 1989, p. 14.  (8) OJ No L 142, 25. 5. 1989, p. 16.


title: Council Directive 2013/62/EU of 17 December 2013 amending Directive 2010/18/EU implementing the revised Framework Agreement on parental leave concluded by BUSINESSEUROPE, UEAPME, CEEP and ETUC, following the amendment of the status of Mayotte with regard to the European Union

text:
               28.12.2013

               EN

               Official Journal of the European Union

               L 353/7

      COUNCIL DIRECTIVE 2013/62/EU
   of 17 December 2013
   amending Directive 2010/18/EU implementing the revised Framework Agreement on parental leave concluded by BUSINESSEUROPE, UEAPME, CEEP and ETUC, following the amendment of the status of Mayotte with regard to the European Union
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 349 thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinion of the European Parliament (1),
   Acting in accordance with a special legislative procedure,
   Whereas:

               (1)

               By European Council Decision 2012/419/EU (2), the European Council decided to amend the status of Mayotte with regard to the Union with effect from 1 January 2014. From that date, Mayotte will cease to be an overseas country or territory and will become an outermost region of the Union within the meaning of Article 349 and Article 355(1) of the Treaty on the Functioning of the European Union (TFEU). Following this amendment of the legal status of Mayotte, Union law will apply to Mayotte from 1 January 2014. Taking account of the particular structural social and economic situation of Mayotte, certain specific measures aimed at laying down the conditions of application of Union law should be established.

               (2)

               Considering the specific structural social and economic situation of Mayotte, in particular the fact that the labour market is underdeveloped and the employment rate is low due to its remoteness, insularity, difficult topography and climate, an additional implementation period for Council Directive 2010/18/EU (3) should be provided for in order to ensure that equal treatment in the particular field of parental leave is achieved progressively and in a way that does not destabilise the gradual economic development of Mayotte. That additional implementation period should allow the specific disadvantaged structural social and economic situation of Mayotte, as a new outermost region, to be improved.

               (3)

               Directive 2010/18/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Article 3(2) of Directive 2010/18/EU, the following subparagraph is added:

      ‘By way of derogation from the first subparagraph, the additional period referred to therein shall be extended to 31 December 2018 as regards Mayotte as an outermost region of the Union within the meaning of Article 349 TFEU.’.

   Article 2
   This Directive shall enter into force on 1 January 2014.
   Article 3
   This Directive is addressed to the French Republic.

      Done at Brussels, 17 December 2013.

            For the Council

            The President

         L. LINKEVIČIUS

      (1)  Opinion of 12 December 2013 (not yet published in the Official Journal).

      (2)  European Council Decision 2012/419/EU of 11 July 2012 amending the status of Mayotte with regard to the European Union (OJ L 204, 31.7.2012, p. 131).

      (3)  Council Directive 2010/18/EU of 8 March 2010 implementing the revised Framework Agreement on parental leave concluded by BUSINESSEUROPE, UEAPME, CEEP and ETUC and repealing Directive 96/34/EC (OJ L 68, 18.3.2010, p. 13).


Avis juridique important

|

31978L1017

Council Directive 78/1017/EEC of 24 November 1978 amending Directive 72/159/EEC on the modernization of farms and Directive 73/131/EEC on the guidance premium provided for in Article 10 of the Directive of 17 April 1972 on the modernization of farms

Official Journal L 349 , 13/12/1978 P. 0032 - 0032 Greek special edition: Chapter 03 Volume 23 P. 0088  Spanish special edition: Chapter 03 Volume 15 P. 0062  Portuguese special edition Chapter 03 Volume 15 P. 0062

COUNCIL DIRECTIVE  of 24 November 1978  amending Directive 72/159/EEC on the modernization of farms and Directive 73/131/EEC on the guidance premium provided for in Article 10 of the Directive of 17 April 1972 on the modernization of farms  (78/1017/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),  Whereas under Article 14 (2) (a) of Council Directive 72/159/EEC of 17 April 1972 on the modernization of farms (3), as last amended by Council Directive 77/390/EEC (4), Member States may, during a period of five years from the time when the said Directive takes effect, grant temporary aids to farmers who are not capable of attaining the level of earned income laid down under Article 4 of that Directive and who are not yet eligible for the annuities provided for in Article 2 (1) of Council Directive 72/160/EEC of 17 April 1972 concerning measures to encourage the cessation of farming and the reallocation of utilized agricultural area for the purposes of structural improvement (5);  Whereas, pending the re-examination of Directive 72/159/EEC provided for in Article 16 of the said Directive, the period of application of this measure was extended until 31 December 1977 by Directive 77/390/EEC;  Whereas, since this re-examination is still in progress, it would seem appropriate to extend the period laid down in Article 14 (2) (a) of Directive 72/159/EEC until 31 December 1979 as regards the measures provided for under that Article in force in the Member States on 15 March 1977;  Whereas the provision in the development plan for the farm to concentrate on the production of beef, veal, mutton or lamb may require differing efforts ; whereas the amounts fixed by Council Directive 73/131/EEC of 15 May 1973 on the guidance premium provided for in Article 10 of the Directive of 17 April 1972 on the modernization of farms (6) should be changed into ceiling amounts,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The period laid down in Article 14 (2) (a) of Directive 72/159/EEC shall be extended until 31 December 1979 as regards the measures provided for under that Article in force in the Member States on 15 March 1977.   Article 2 The second paragraph of Article 1 of Directive 73/131/EEC shall be replaced by the following:  "The maximum amount of this premium shall be:    - 48 units of account per hectare within a ceiling of 4 800 units of account per farm in the first year,       - 32 75 units of account per hectare within a ceiling of 3 250 units of account per farm in the second year,       - 16 75 units of account per hectare within a ceiling of 1 650 units of account per farm in the third year."          Article 3 Article 1 shall take effect as from 1 January 1978.   Article 4 This Directive is addressed to the Member States.     Done at Brussels, 24 November 1978.  For the Council  The President  J. ERTL  (1)OJ No C 230, 28.9.1978, p. 15. (2)OJ No C 261, 6.11.1978, p. 46. (3)OJ No L 96, 23.4.1972, P. 1. (4)OJ No L 145, 13.6.1977, p. 43. (5)OJ No L 96, 23.4.1972, p. 9. (6)OJ No L 153, 9.6.1973, p. 24.


Avis juridique important

|

31980L0509

First Commission Directive 80/509/EEC of 2 May 1980 amending the Annex to Council Directive 79/373/EEC on the marketing of compound feedingstuffs

Official Journal L 126 , 21/05/1980 P. 0009 - 0011 Finnish special edition: Chapter 3 Volume 12 P. 0030  Greek special edition: Chapter 03 Volume 28 P. 0166  Swedish special edition: Chapter 3 Volume 12 P. 0030  Spanish special edition: Chapter 03 Volume 18 P. 0014  Portuguese special edition Chapter 03 Volume 18 P. 0014

****( 1 ) OJ NO L 86 , 6 . 4 . 1979 , P . 30 .    FIRST COMMISSION DIRECTIVE   OF 2 MAY 1980   AMENDING THE ANNEX TO COUNCIL DIRECTIVE 79/373/EEC ON THE MARKETING OF COMPOUND FEEDINGSTUFFS  ( 80/509/EEC )   THE COMMISSION OF THE EUROPEAN COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,   HAVING REGARD TO COUNCIL DIRECTIVE 79/373/EEC OF 2 APRIL 1979 ON THE MARKETING OF COMPOUND FEEDINGSTUFFS ( 1 ), AND IN PARTICULAR ARTICLE 10 ( A ) THEREOF ,   WHEREAS , IN VIEW OF PROGRESS MADE IN SCIENCE AND TECHNOLOGY , THE ANNEX TO THE ABOVEMENTIONED DIRECTIVE MUST BE AMENDED AS TO THE TOLERANCES TO BE PERMITTED WHERE , ON OFFICIAL INSPECTION , THE COMPOSITION OF A COMPOUND FEEDINGSTUFF IS FOUND TO DEPART FROM THAT DECLARED BY THE MANUFACTURER ;   WHEREAS SUCH TOLERANCES ARE NECESSARY TO ALLOW FOR DEVIATIONS DUE TO THE METHOD USED FOR SAMPLING THE FEEDINGSTUFF , THE MANUFACTURING PROCESS OR ANALYTICAL ERROR ;   WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   ITEM 9 OF THE ANNEX TO DIRECTIVE 79/373/EEC IS AMENDED TO READ AS FOLLOW :   ' 9 . WHERE , ON OFFICIAL INSPECTION PURSUANT TO ARTICLE 12 , THE COMPOSITION OF A COMPOUND FEEDINGSTUFF IS FOUND TO DEPART FROM THE DECLARED COMPOSITION , THE FOLLOWING MINIMUM TOLERANCES SHALL BE PERMITTED , SUBJECT TO ARTICLE 3 :   9.1 . WHERE THE CONTENT RECORDED IS LESS THAN THE DECLARED CONTENT :   9.1.0 . CRUDE PROTEIN :   -  2 UNITS FOR DECLARED CONTENTS OF 20 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 20 % BUT NOT LESS THAN 10 % ,   -  1 UNIT FOR DECLARED CONTENTS OF LESS THAN 10 % .   9.1.1 . SOLUBLE PROTEIN :   -  3 UNITS FOR DECLARED CONTENTS OF 25 % OR MORE ,   -  12 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 25 % BUT NOT LESS THAN 15 % ,   -  1.8 UNITS FOR DECLARED CONTENTS OF LESS THAN 15 % .   9.1.2 . TOTAL SUGAR :   -  2 UNITS FOR DECLARED CONTENTS OF 20 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 20 % BUT NOT LESS THAN 10 % ,   -  1 UNIT FOR DECLARED CONTENTS OF LESS THAN 10 % .   9.1.3 . STARCH :   -  2.5 UNITS FOR DECLARED CONTENTS OF 25 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 25 % BUT NOT LESS THAN 10 % ,   -  1 UNIT FOR DECLARED CONTENTS OF LESS THAN 10 % .   9.1.4 . CRUDE OILS AND FATS :   -  1.5 UNITS FOR DECLARED CONTENTS OF 15 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 15 % BUT NOT LESS THAN 8 % ,   -  0.8 UNIT FOR DECLARED CONTENTS OF LESS THAN 8 % .   9.1.5 . SODIUM AND MAGNESIUM :   -  1.5 UNITS FOR DECLARED CONTENTS OF 15 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 15 % BUT NOT LESS THAN 7.5 % ,   -  0.75 UNIT FOR DECLARED CONTENTS OF LESS THAN 7.5 % BUT NOT LESS THAN 5 % ,   -  15 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 5 % BUT NOT LESS THAN 0.7 % ,   -  0.1 UNIT FOR DECLARED CONTENTS OF LESS THAN 0.7 % .   9.1.6 . TOTAL PHOSPHORUS AND CALCIUM :   -  1.2 UNITS FOR DECLARED CONTENTS OF 16 % OR MORE ,   -  7.5 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 16 % BUT NOT LESS THAN 12 % ,   -  0.9 UNIT FOR DECLARED CONTENTS OF LESS THAN 12 % BUT NOT LESS THAN 6 % ,   -  15 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 6 % BUT NOT LESS THAN 1 % ,   -  0.15 UNIT FOR DECLARED CONTENTS OF LESS THAN 1 % .   9.1.7 . MENTHIONINE AND LYSINE :   -  15 % OF THE DECLARED CONTENT .   9.1.8 . CYSTINE :   -  20 % OF THE DECLARED CONTENT .   9.2 . WHERE THE CONTENT RECORDED IS MORE THAN THE DECLARED CONTENT :   9.2.1 . MOISTURE :   -  1 UNIT FOR DECLARED CONTENTS OF 10 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 10 % BUT NOT LESS THAN 5 % ,   -  0.5 UNIT FOR DECLARED CONTENTS OF LESS THAN 5 % .   9.2.2 . CRUDE ASH :   -  1 UNIT FOR DECLARED CONTENTS OF 10 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 10 % BUT NOT LESS THAN 5 % ,   -  0.5 UNIT FOR DECLARED CONTENTS OF LESS THAN 5 % .   9.2.3 . CRUDE FIBRE :   -  1.8 UNITS FOR DECLARED CONTENTS OF 12 % OR MORE ,   -  15 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 12 % BUT NOT LESS THAN 6 % ,   -  0.9 UNIT FOR DECLARED CONTENTS OF LESS THAN 6 % .   9.2.4 . ASH INSOLUBLE IN HYDROCHLORIC ACID :   -  1 UNIT FOR DECLARED CONTENTS OF 10 % OR MORE ,   -  10 % OF THE DECLARED CONTENT FOR DECLARED CONTENTS OF LESS THAN 10 % BUT NOT LESS THAN 4 % ,   -  0.4 UNIT FOR DECLARED CONTENTS OF LESS THAN 4 % .   9.3 . WHERE THE VARIATION NOTED IS IN THE OPPOSITE DIRECTION TO THOSE REFERRED TO RESPECTIVELY IN 9.1 . AND 9.2 :   9.3.1 .  -  CRUDE PROTEIN , CRUDE OILS AND FATS , TOTAL SUGAR , STARCH : TOLERANCE TWICE THAT PERMITTED FOR THESE SUBSTANCES IN 9.1 ,   -  TOTAL PHOSPHORUS , CALCIUM , MAGNESIUM , SODIUM , CRUDE ASH , CRUDE FIBRE : TOLERANCE THREE TIMES THAT PERMITTED FOR THESE SUBSTANCES IN 9.1 AND 9.2 . '   ARTICLE 2   THE MEMBER STATES SHALL BRING INTO FORCE THE NECESSARY LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS TO ENABLE THEM TO COMPLY WITH THIS DIRECTIVE WITH EFFECT FROM 1 JANUARY 1981 AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF .   ARTICLE 3   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 2 MAY 1980 .   FOR THE COMMISSION   FINN GUNDELACH   VICE-PRESIDENT


Avis juridique important

|

31995L0037

Commission Directive 95/37/EC of 18 July 1995 amending Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 172 , 22/07/1995 P. 0021 - 0022

COMMISSION DIRECTIVE 95/37/EC  of 18 July 1995 amending Council Directive 70/524/EEC concerning additives in 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 70/524/EEC of 23 November 1970 concerning additives in  feedingstuffs  (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in  particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take  account of advances in scientific and technical knowledge; whereas the Annexes were consolidated by  Commission Directive 91/248/EEC  (2); Whereas a new use of an additive belonging to the group of 'Antibiotics` and a new additive  belonging to the group of 'Coccidiostats and other medicinal substances` have been widely tested in  several Member States; whereas, on the basis of experience gained and studies undertaken, it  appears that this new use and this new additive can be authorized throughout the Community; Whereas the measures provided for in this Directive are in accordance with the opinion of the  Standing Committee for Feedingstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 Annex I to Directive 70/524/EEC is hereby amended as set out in the  Annex of this Directive. Article 2 1.  Member States shall bring into force the laws, regulations or administrative  provisions necessary to comply with this Directive by 30 June 1996 at the latest. They shall  immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive of shall  be accompanied by such reference at the time of their official publication. The procedure for such  reference shall be adopted 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 governed by this Directive. Article 3 This Directive shall enter into force on the third 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, 18 July 1995. For the Commission Franz FISCHLER Member of the Commission  ANNEX Annex I to Directive 70/524/EEC, is amended as follows: 1. In part A 'Antibiotics`, the following is added to entry No E 717, 'Avilamycin`: >TABLE> 2. In part D 'Coccidiostats and other medicinal substances`, the following item is added: >TABLE>


Avis juridique important

|

31979L0920

Council Directive 79/920/EEC of 29 October 1979 amending Directive 76/630/EEC concerning surveys of pig production to be made by Member States

Official Journal L 281 , 10/11/1979 P. 0041 - 0041 Greek special edition: Chapter 03 Volume 27 P. 0004  Spanish special edition: Chapter 03 Volume 16 P. 0324  Portuguese special edition Chapter 03 Volume 16 P. 0324

****( 1 ) OPINION DELIVERED ON 26 OCTOBER 1979 ( NOT YET PUBLISHED IN THE OFFICIAL JOURNAL ).  ( 2 ) OJ NO L 223 , 16 . 8 . 1976 , P . 4 .        COUNCIL DIRECTIVE   OF 29 OCTOBER 1979   AMENDING DIRECTIVE 76/630/EEC CONCERNING SURVEYS OF PIG PRODUCTION TO BE MADE BY MEMBER STATES  ( 79/920/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 ,   HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT  ( 1 ),   WHEREAS DIRECTIVE 76/630/EEC ( 2 ) PROVIDED FOR SURVEYS OF PIG PRODUCTION TO BE MADE BY MEMBER STATES ;   WHEREAS SOME OF THE PROVISIONS OF THAT DIRECTIVE MUST BE SPECIFIED MORE PRECISELY AND SUPPLEMENTED IN ORDER TO PROMOTE THE HARMONIZATION OF FORECASTS IN THE PIGMEAT SECTOR AND TO IMPROVE THE FORECASTING METHODS USED ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   ARTICLE 8 OF DIRECTIVE 76/630/EEC IS HEREBY REPLACED BY THE FOLLOWING :   ' ARTICLE 8   1 .  MEMBER STATES SHALL PROVIDE FORECASTS OF GROSS DOMESTIC PRODUCTION OF PIGS BROKEN DOWN BY TWO-MONTHLY PERIODS , FOR THE PERIODS 1 DECEMBER TO 30 NOVEMBER , 1 APRIL TO 31 MARCH AND 1 AUGUST TO 31 JULY . THE PERIODS MAY BE ALTERED IN ACCORDANCE WITH THE PROCEDURE PROVIDED FOR IN ARTICLE 11 .   GROSS DOMESTIC PRODUCTION COVERS ALL PIGS SLAUGHTERED , WHETHER OF DOMESTIC OR FOREIGN ORIGIN , PLUS THE BALANCE OF FOREIGN TRADE IN LIVE PIGS .   2 .  THE FORECASTS REFERRED TO IN PARAGRAPH 1 SHALL BE FORWARDED TO THE COMMISSION WITHIN TIME LIMITS TO BE LAID DOWN IN ACCORDANCE WITH THE PROCEDURE PROVIDED FOR IN ARTICLE 11 . '   ARTICLE 2   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT LUXEMBOURG , 29 OCTOBER 1979 .   FOR THE COUNCIL   THE PRESIDENT   B . LENIHAN


title: Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (Text with EEA relevance. )

text:
               16.9.2017

               EN

               Official Journal of the European Union

               L 238/44

         COMMISSION DIRECTIVE (EU) 2017/1572
   of 15 September 2017
   supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular the first paragraph of Article 47 thereof,
   Whereas:

               (1)

               Commission Directive 2003/94/EC (2) applies to both medicinal products for human use and investigational medicinal products for human use.

               (2)

               In accordance with Article 63(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council (3) the Commission is empowered to adopt a delegated act laying down principles of good manufacturing practice for investigational medicinal products for human use. It is therefore necessary to adapt the provisions of Directive 2003/94/EC by deleting the references to investigational medicinal products for human use.

               (3)

               The definition of a pharmaceutical quality system and some terminology should be updated to reflect the international developments or the actual usage of that terminology of inspectors and manufacturers.

               (4)

               All medicinal products for human use manufactured or imported into the Union, including medicinal products intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice. However, for the manufacturer to be able to comply with those principles and guidelines, cooperation between the manufacturer and the marketing authorisation holder, when they are different legal entities, is necessary. The obligations of the manufacturer and marketing authorisation holder vis-à-vis each other should be defined in a technical agreement between them.

               (5)

               The manufacturer of medicinal products has to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients at risk due to inadequate quality. To achieve this quality objective reliably the manufacturer must implement a comprehensively designed and correctly implemented pharmaceutical quality system incorporating good manufacturing practice and quality risk management.

               (6)

               In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of manufacturer.

               (7)

               It is necessary to ensure that all medicinal products available on the EU territory comply with the same quality standards, therefore medicinal products imported into the Union should be manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union.

               (8)

               In order to ensure the consistent application of the principles of good manufacturing practice, manufacturers of medicinal products for human use and inspectors should consider the guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. However, for advanced therapy medicinal products, the guideline referred in Article 5 of Regulation (EC) No 1394/2007 (4) should be applied. Principles and guidelines of good manufacturing practice for medicinal products for human use should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, outsourced operations, complaints, product recall, and self-inspections. As regards the advanced therapy medicinal products those principles and guidelines should be adapted to the specific characteristic of those products in accordance with the risk-based approach.

               (9)

               Since many of the provisions of Directive 2003/94/EC need to be adjusted, for the sake of clarity, that Directive should be repealed.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Subject-matter
   This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture or import requires the authorisation referred to in Article 40 of Directive 2001/83/EC.
   Article 2
   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               (1)

               ‘manufacturer’ means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC is required;

               (2)

               ‘pharmaceutical quality system’ means the total sum of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use;

               (3)

               ‘good manufacturing practice’ means the part of the quality assurance which ensures that medicinal products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use.

         Article 3
   Inspections
   1.   By means of the repeated inspections referred to in Article 111(1a) of Directive 2001/83/EC, the Member States shall ensure that manufacturers authorised in accordance with Article 40(1) and (3) of Directive 2001/83/EC respect the principles and guidelines of good manufacturing practice laid down by this Directive.
   Member States shall also take into account the compilation, published by the Commission, of Union procedures on inspections and exchange of information.
   2.   For the interpretation of the principles and guidelines of good manufacturing practice, manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. In the case of advanced therapy medicinal products, the guidelines on good manufacturing practice specific to advanced therapy medicinal products referred to in Article 5 of Regulation (EC) No 1394/2007 on advanced therapy medicinal products shall be taken into account.
   3.   Member States shall establish and implement in their inspectorates a properly designed quality system that shall be complied with by inspectorates' personnel and management. The quality system shall be updated as appropriate.
   Article 4
   Conformity with good manufacturing practice
   1.   The Member States shall ensure that the manufacturing operations are carried out by manufacturers in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export.
   2.   For medicinal products imported from third countries, the Member States shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union and that such products have been manufactured by manufacturers duly authorised to do so.
   Article 5
   Compliance with marketing authorisation
   1.   The Member States shall ensure that all manufacturing or import operations for medicinal products subject to a marketing authorisation are carried out by manufacturers in accordance with the information provided in the application for that marketing authorisation.
   2.   The Member States shall oblige the manufacturer to regularly review his manufacturing methods in light of scientific and technical progress.
   If a variation to the marketing authorisation dossier is necessary, the variation shall take place by the arrangements established in accordance with Article 23b of Directive 2001/83/EC.
   Article 6
   Pharmaceutical quality system
   The Member States shall ensure that the manufacturers establish, implement and maintain an effective pharmaceutical quality system, involving the active participation of the senior management and the personnel of the different departments.
   Article 7
   Personnel
   1.   The manufacturer shall be obliged to have at each manufacturing or import site a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the objective of the pharmaceutical quality system.
   2.   The duties of the managerial and supervisory staff, including the qualified persons referred to in Article 48 of Directive 2001/83/EC, responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisation chart. Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.
   3.   The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.
   4.   The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice.
   5.   Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.
   Article 8
   Premises and equipment
   1.   As regards the premises and manufacturing equipment the manufacturer shall be obliged to ensure that they are located, designed, constructed, adapted and maintained to suit the intended operations.
   2.   The Member States shall require that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.
   3.   Premises and equipment to be used for manufacturing or import operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.
   Article 9
   Documentation
   1.   The manufacturer shall be obliged to establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. The documentation system shall ensure data quality and integrity. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch to be traced.
   The manufacturer shall be required to retain the batch documentation for at least 1 year after the expiry date of the batches to which it relates or at least 5 years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
   2.   When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall be required to first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities upon request. The electronically stored data shall be protected, by techniques such as duplication or back-up and transfer to another storage system, against unlawful access, loss or damage of data, and audit trails shall be maintained.
   Article 10
   Production
   1.   The Member States shall ensure that the manufacturers carry out the different production operations in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available by the manufacturer for the in-process controls. All process deviations and product defects shall be documented and thoroughly investigated.
   2.   The manufacturers shall be required to take appropriate technical and organisational measures to avoid cross contamination and mix-ups.
   3.   Any new manufacturing or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly revalidated.
   Article 11
   Quality control
   1.   The manufacturer shall be obliged to establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.
   That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials and packaging materials and the testing of intermediate and finished medicinal products.
   2.   For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.
   3.   During the final control of the finished medicinal product before its release for sale or distribution, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.
   4.   Samples of each batch of finished medicinal product shall be retained for at least 1 year after the expiry date.
   Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least 2 years after the release of the product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities.
   Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.
   Article 12
   Outsourced operations
   1.   The Member States shall require that any manufacturing or import operation or operation linked thereto which is outsourced is the subject of a written contract.
   2.   The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person referred to in Article 48 of Directive 2001/83/EC responsible for certifying each batch is to discharge his responsibilities.
   3.   The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.
   4.   The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned laid down in the Union and shall submit to inspections carried out by competent authorities pursuant to Article 111 of Directive 2001/83/EC.
   Article 13
   Complaints and product recall
   1.   The Member States shall ensure that manufacturers implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall be required to inform the competent authority and, if applicable, the marketing authorisation holder of any defect that could result in a recall or an abnormal restriction on supply and, in so far as possible, indicate the countries of destination.
   2.   Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.
   Article 14
   Self-inspection
   The manufacturer shall be required to conduct repeated self-inspections as part of the pharmaceutical quality system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures and/or preventive actions. Records shall be maintained of such self-inspections and any corrective actions subsequently taken.
   Article 15
   Repeal of Directive 2003/94/EC
   Directive 2003/94/EC is repealed with effect from 6 months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later.
   References to the repealed Directive shall be construed as references to this Directive and to Commission Delegated Regulation (EU) 2017/1569 (5) and read in accordance with the correlation table in the Annex.
   Article 16
   Transposition
   1.   Member States shall adopt and publish, by 31 March 2018 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 6 months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 17
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 18
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 15 September 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 311, 28.11.2001, p. 67.

      (2)  Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

      (3)  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

      (4)  Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).

      (5)  Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (see page 12 of this Official Journal).

      ANNEX

         Correlation table

                  Directive 2003/94/EC

                  This Directive

                  Commission Delegated Regulation (EU) 2017/1569 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections

                  Article 1

                  Article 1

                  Article 1

                  Article 2

                  Article 2

                  Article 2

                  Article 3

                  Article 3

                  —

                  Article 4

                  Article 4

                  Article 3

                  Article 5

                  Article 5

                  Article 4

                  Article 6

                  Article 6

                  Article 5(1)

                  Article 7

                  Article 7

                  Article 6

                  Article 8

                  Article 8

                  Article 7

                  Article 9

                  Article 9

                  Article 8

                  Article 10

                  Article 10

                  Article 9

                  Article 11

                  Article 11

                  Article 10

                  Article 12

                  Article 12

                  Article 13

                  Article 13

                  Article 13

                  Article 14

                  Article 14

                  Article 14

                  Article 15

                  Article 15

                  —

                  —

                  Article 16

                  —

                  —

                  Article 17

                  —

                  —

                  Article 18

                  —

                  —

                  Article 19

                  —

                  —


Avis juridique important

|

31991L0342

Council Directive 91/342/EEC of 20 June 1991 amending Directive 83/643/EEC on the facilitation of physical inspections and administrative formalities in respect of the carriage of goods between Member States

Official Journal L 187 , 13/07/1991 P. 0047 - 0048

COUNCIL DIRECTIVE  of 20 June 1991  amending Directive 83/643/EEC on the facilitation of physical inspections and administrative formalities in respect of the carriage of goods between Member States  (91/342/EEC) THE COUNCIL OF THE  EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 83/643/EEC (4), as amended by Directive 87/53/EEC (5), contains a set of measures designed to reduce waiting time for carriers of goods crossing internal Community frontiers;  Whereas Article 8a of the Treaty provides for the progressive establishment, over a period expiring on 31 December 1992, of an internal market comprising an area without internal frontiers in which the free movement of goods, inter alia, is ensured;  Whereas, pending the removal of internal frontiers, it is possible to make further early progress in simplifying and speeding up intra-Community movement of goods;  Whereas the principle stated in Directive 83/643/EEC that inspections should be carried out by means of spot checks except in duly justified circumstances applies only to physical inspections; whereas experience has shown that it is desirable to cut  waiting time at frontiers to a minimum by defining the terms 'inspection', 'formalities' and lay down conditions for carrying out spot checks;  Whereas, in particular under the Community transit arrangements, operators may initiate the transit procedure inside the Member State of departure and/or opt for the release of the goods for home use or their entry for another procedure at a point  inside the Member State of destination; whereas in this context the centralization of different controls in a single place pursuant to Directive 83/643/EEC will improve the situation at frontiers only if it takes place preferably at the point of  departure or destination of the goods, without prejudice to the operator's freedom of choice;  Whereas the minimum business hours of major inspection offices inside Member States should be extended in order to facilitate the completion of controls and formalities at the place of departure or destination of goods,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 83/643/EEC is hereby amended as follows:  1. the following paragraph shall be added to Article 1:  '3. For the purposes of this Directive:  - "inspection" means the carrying out by customs or any other supervisory department of an operation which consists of the physical examination, including visual inspection, of the means of transport and/or the goods themselves with the aim of checking  that their nature, origin, state, quantity or value conform to the particulars given in the documents which have been presented,  - "formalities" means any formality imposed on operators by the administration, consisting in the presentation or examination of documents and certificates accompanying goods or other particulars, irrespective of form or medium, relating to the goods or  means of transport.';  2. Article 2 shall be replaced by the following:  'Article 2  1. Member States shall take the necessary measures to ensure that in the course of any carriage operation the various inspections and formalities are carried out with the minimum of delay necessary and:  - as far as possible, in one place, preferably the place of departure and/or destination of the goods,  - with the inspections being carried out by means of spot checks, except in duly justified circumstances.  2. For the purposes of the second indent of paragraph 1, the sample base for spot checks shall be the totality of consignments passing through a frontier post or presented at a customs office or department carrying out inspections in a given period, not  the totality of goods in each consignment.  Spot checks must take into account the degree of risk connected with consignments passing through a frontier post or presented at a customs office or department carrying out inspections.  3. Member States shall facilitate, in circumstances which they deem appropriate, the use of simplified procedures, such as those laid down by the regulations for the despatch, distribution and release for consumption of goods, at the place of origin or  destination of the goods.  4. Members States shall endeavour to deploy customs offices in such a way, including in the interior of their territory, as best to take account of the requirements of commercial operators.';  3. Article 5 (1) and (2) shall be replaced by the following:  '1. Where the volume of traffic so warrants, Member States shall see to it that:  (a) frontier posts are open, except when traffic is prohibited, in such a way that:  - frontiers can be crossed 24 hours a day, with corresponding provisions for the inspections and formalities relating to goods placed under a customs transit procedure and their means of transport, and to vehicles travelling unladen, save where frontier  inspection is necessary to prevent the spread of disease,  - inspections and formalities relating to the movement of means of transport and goods which have not been placed under a customs transit procedure may be performed from Monday to Friday during an uninterrupted period of at least 10 hours, and on  Saturday during an uninterrupted period of at least six hours, unless the day is a public holiday;  (b) customs offices and other services carrying out inspections and formalities in respect of the import or export of goods, which are situated inside the country, are open to enable inspections and formalities relating to goods presented to them to be  performed daily from Monday to Friday during a period of at least 10 hours and on Saturday during a period of at least six hours, unless the day is a public holiday;  (c) as regards vehicles and goods transported by air, the hours referred to in the second indent of subparagraph (a) are adapted in such a way as to meet actual needs and for that purpose may be split in accordance with the flow of traffic;  (d) transhipments which, under existing regulations, customs services allow to be carried out without their immediate supervision can be effected at any time in such a way as to meet actual needs.  2. Where general compliance with the periods referred to in paragraph 1 (a), second indent, (b) and (c), poses problems for veterinary services, Member States shall see to it that, with at least 12 hours' notice from the carrier, a veterinary expert is  available during those periods: in the case of the transport of live animals, however, this notice may be increased to eighteen hours.';  4. the following paragraph shall be added to Article 11:  '4. This Directive shall be repealed as from the date of implementation of Council Regulation (EEC) No 2726/90 of 17 September 1990 on Community transit (*).   (*) OJ No L 262, 26. 9. 1990, p. 1.'  Article 2  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 1991 at the latest.  When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member  States.  2. Member States shall communicate to the Commission the texts of the main provisions they adopt in the field governed by this Directive.  Article 3  This Directive is addressed to the Member States. Done at Luxembourg, 20 June 1991. For the Council  The President  R. GOEBBELS  (1) OJ No C 204, 15. 8. 1990, p. 15. (2) OJ No C 19, 28. 1. 1991, p. 81 and Decision of 12 June 1991 (not yet published in the Official Journal). (3) OJ No C 69, 18. 3. 1991, p. 8. (4) OJ No L 359, 22. 12. 1983, p. 8. (5) OJ No L 24, 27. 1.  1987, p. 33.