title: Directive 2014/27/EU of the European Parliament and of the Council of 26 February 2014 amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council, in order to align them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

text:
               5.3.2014

               EN

               Official Journal of the European Union

               L 65/1

      DIRECTIVE 2014/27/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 26 February 2014
   amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council, in order to align them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 153(2) 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 Economic and Social Committee (1),
   Having consulted the Committee of the Regions,
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               Pursuant to Article 153 of the Treaty, the European Parliament and the Council may adopt, by means of directives, minimum requirements for encouraging improvements, in particular in the working environment, to ensure a better level of protection of the health and safety of workers. Such directives should avoid holding back the creation and development of small and medium-sized undertakings and their potential to create jobs. Good health and safety standards should not be considered as constraints, since they are fundamental rights and are to be applied without exception to all sectors of the labour market and all types of undertakings regardless of their size.

               (2)

               Article 31(1) of the Charter of Fundamental Rights of the European Union provides that every worker has the right to working conditions which respect his or her health, safety and dignity.

               (3)

               Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) established a new system for the classification and labelling of substances and mixtures within the Union, based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) at international level, within the framework of the United Nations Economic Commission for Europe.

               (4)

               Council Directives 92/58/EEC (4), 92/85/EEC (5), 94/33/EC (6) and 98/24/EC (7), and Directive 2004/37/EC of the European Parliament and of the Council (8) contain references to the previous classification and labelling system. Those Directives should therefore be amended in order to align them to the new system laid down in Regulation (EC) No 1272/2008.

               (5)

               The amendments are necessary to ensure the continued effectiveness of those Directives. The aim of this Directive is not to change the scope of those Directives. This Directive intends to maintain and not reduce the level of protection of workers that is provided by those Directives. However, in view of on-going technological progress, those Directives should be subject to periodic review in accordance with Article 17a of Council Directive 89/391/EEC (9) in order to ensure the coherency of legislation and an appropriate level of health and safety protection when hazardous chemical substances and mixtures are present in the working environment. Particular attention should be paid to employees within professions where there is frequent contact with hazardous substances and mixtures.

               (6)

               The amendments to Directive 92/85/EEC do not address the issue of hazardous substances and mixtures which can adversely affect fertility of pregnant workers or workers who have recently given birth or who are breastfeeding, since the aim of this Directive is only to update references and terminology set out in that Directive. However, taking account of the evolving scientific evidence regarding this issue together with the increased sophistication of classification of these effects, the Commission should consider the most appropriate means for addressing such effects.

               (7)

               The amendments to Directives 92/85/EEC and 94/33/EC should align the approach taken in those Directives to the wording adopted under Directive 98/24/EC in so far as the words ‘substances labelled’, in Section A point 3(a) of Annex I to Directive 92/85/EEC and ‘substances and preparations classified’ in Section I point 3(a) of the Annex to Directive 94/33/EC are replaced by the wording ‘substances and mixtures which meet the criteria for classification’. This Directive does not impose obligations on employers as regards classification, labelling and packaging of substances and mixtures covered by Regulation (EC) No 1272/2008. Regardless of whether or not the substances or mixtures are placed on the market, the employer needs to carry out an assessment of risk of all hazardous chemical agents in accordance with Directive 98/24/EC.

               (8)

               Section I point 2 and Section II point 1 of the Annex to Directive 94/33/EC contain references to repealed Council Directives 90/679/EEC (10) and 90/394/EEC (11). Those references should therefore be replaced by references to the relevant provisions of Directive 2000/54/EC of the European Parliament and of the Council (12) and Directive 2004/37/EC.

               (9)

               In accordance with Article 154 of the Treaty, the Commission consulted the social partners on the possible direction of Union action in this field and the social partners indicated that explanatory guidance in particular for small and medium-sized enterprises is useful.

               (10)

               Following this consultation, the Commission considered that Union action was desirable and consulted the social partners on the content of the envisaged proposal, in accordance with Article 154 of the Treaty.

               (11)

               Following this second phase of consultation, the social partners did not wish to initiate the process which could lead to the conclusion of an agreement as set out in Article 155 of the Treaty,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 92/58/EEC
   Directive 92/58/EEC is amended as follows:

               (1)

               In Article 1, paragraph 2 is replaced by the following:
               ‘2.   This Directive shall not apply to signs for the placing on the market of hazardous substances and mixtures, products and/or equipment, unless other Union provisions make specific reference thereto.’

               (2)

               In Annex I, Section 12 is replaced by the following:
               12.   Areas, rooms or enclosures used for the storage of significant quantities of hazardous substances or mixtures must be indicated by a suitable warning sign taken from Section 3.2 of Annex II, or marked as provided in Section 1 of Annex III, unless the labelling of the individual packages or containers is adequate for this purpose.
               If there is no equivalent warning sign in Section 3.2 of Annex II to warn about hazardous chemical substances or mixtures, the relevant hazard pictogram, as laid down in Annex V to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (13), must be used.

               (3)

               In Annex II, Section 3.2 is amended as follows:

                           (a)

                           warning sign ‘Harmful or irritant material’ is deleted.

                           (b)

                           the following footnote linked to warning sign ‘General danger’ is added:

                                       ‘***

                                       This warning sign shall not be used to warn about hazardous chemical substances or mixtures, except for cases when the warning sign is used in accordance with the second paragraph of Section 5 of Annex III to indicate the stores of hazardous substances or mixtures.’

               (4)

               Annex III is amended as follows:

                           (a)

                           Section 1 is replaced by the following:

                                       ‘1.

                                       Containers used at work for chemical substances or mixtures classified as hazardous according to the criteria for any physical or health hazard class in accordance with Regulation (EC) No 1272/2008, and containers used for the storage of such hazardous substances or mixtures, together with the visible pipes containing or transporting such hazardous substances and mixtures, must be labelled with the relevant hazard pictograms in accordance with that Regulation.
                                       The first paragraph does not apply to containers used at work for brief periods nor to containers whose contents change frequently, provided that alternative adequate measures are taken, in particular for information and/or training, which guarantee the same level of protection.
                                       The labels referred to in the first paragraph may be:

                                                   —

                                                   replaced by warning signs set out in Annex II, using the same pictograms or symbols. If there is no equivalent warning sign in Section 3.2 of Annex II, the relevant hazard pictogram set out in Annex V of Regulation (EC) No 1272/2008 must be used,

                                                   —

                                                   supplemented by additional information, such as the name and/or formula of the hazardous substance or mixture and the details of the hazard,

                                                   —

                                                   for the transporting of containers at the place of work, supplemented or replaced by signs that are applicable throughout the Union for the transport of hazardous substances or mixtures.’

                           (b)

                           in first and second paragraph of Section 5 the word ‘dangerous’ is replaced by ‘hazardous’ and the word ‘preparations’ by ‘mixtures’.

         Article 2
   Amendments to Directive 92/85/EEC
   Annex I to Directive 92/85/EEC is amended as follows:

               (1)

               Section A is amended as follows:

                           (a)

                           point 2 is replaced by the following:
                           ‘2.   Biological agents
                           Biological agents of risk groups 2, 3 and 4 within the meaning of points 2, 3 and 4 of second paragraph of Article 2 of Directive 2000/54/EC of the European Parliament and of the Council (14), in so far as it is known that such agents or the therapeutic measures necessitated by them endanger the health of pregnant women and the unborn child, and in so far as they do not yet appear in Annex II.

                           (b)

                           point 3 is amended as follows:

                                       (i)

                                       point (a) is replaced by the following:

                                                   ‘(a)

                                                   substances and mixtures which meet the criteria for classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (15) in one or more of the following hazard classes and hazard categories with one or more of the following hazard statements, in so far as they do not yet appear in Annex II;

                                                               —

                                                               germ cell mutagenicity, category 1A, 1B or 2 (H340, H341);

                                                               —

                                                               carcinogenicity, category 1A, 1B or 2 (H350, H350i, H351);

                                                               —

                                                               reproductive toxicity, category 1A, 1B or 2 or the additional category for effects on or via lactation (H360, H360D, H360FD, H360Fd, H360Df, H361, H361d, H361fd, H362);

                                                               —

                                                               specific target organ toxicity after single exposure, category 1 or 2 (H370, H371).

                                       (ii)

                                       point (b) is replaced by the following:

                                                   ‘(b)

                                                   chemical agents in Annex I to Directive 2004/37/EC of the European Parliament and of the Council (16);

               (2)

               Section B is replaced by the following:
               ‘B.   Processes
               Industrial processes listed in Annex I to Directive 2004/37/EC.’

         Article 3
   Amendments to Directive 94/33/EC
   The annex to Directive 94/33/EC is amended as follows:

               (1)

               Section I is amended as follows:

                           (a)

                           in point 2 point (a) is replaced by the following:

                                       ‘(a)

                                       Biological agents of risk groups 3 and 4 within the meaning of points 3 and 4 of second paragraph of Article 2 of Directive 2000/54/EC of the European Parliament and of the Council (17).

                           (b)

                           point 3 is amended as follows:

                                       (i)

                                       point (a) is replaced by the following:

                                                   ‘(a)

                                                   Substances and mixtures which meet the criteria for classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (18) in one or more of the following hazard classes and hazard categories with one or more of the following hazard statements:

                                                               —

                                                               acute toxicity, category 1, 2 or 3 (H300, H310, H330, H301, H311, H331);

                                                               —

                                                               skin corrosion, category 1A, 1B or 1C (H314);

                                                               —

                                                               flammable gas, category 1 or 2 (H220, H221);

                                                               —

                                                               flammable aerosols, category 1 (H222);

                                                               —

                                                               flammable liquid, category 1 or 2 (H224, H225);

                                                               —

                                                               explosives, categories ‘Unstable explosive’, or explosives of Divisions 1.1, 1.2, 1.3, 1.4, 1.5 (H200, H201, H202, H203, H204, H205);

                                                               —

                                                               self-reactive substances and mixtures, type A, B, C or D (H240, H241, H242);

                                                               —

                                                               organic peroxides, type A or B (H240, H241);

                                                               —

                                                               specific target organ toxicity after single exposure, category 1 or 2 (H370, H371);

                                                               —

                                                               specific target organ toxicity after repeated exposure, category 1 or 2 (H372, H373);

                                                               —

                                                               respiratory sensitisation, category 1, subcategory 1A or 1B (H334);

                                                               —

                                                               skin sensitisation, category 1, subcategory 1A or 1B (H317);

                                                               —

                                                               carcinogenicity, category 1A, 1B or 2 (H350, H350i, H351);

                                                               —

                                                               germ cell mutagenicity, category 1A, 1B or 2 (H340, H341);

                                                               —

                                                               reproductive toxicity, category 1A or 1B (H360, H360F, H360FD, H360Fd, H360D, H360Df).

                                       (ii)

                                       point (b) is deleted;

                                       (iii)

                                       point (c) is deleted;

                                       (iv)

                                       point (d) is replaced by the following:

                                                   ‘(d)

                                                   Substances and mixtures referred to in point (ii) of point (a) of Article 2 of Directive 2004/37/EC of the European Parliament and of the Council (19);

               (2)

               In Section II, point 1 is replaced by the following:

                           ‘1.

                           Processes at work referred to in Annex I to Directive 2004/37/EC.’

         Article 4
   Amendments to Directive 98/24/EC
   Directive 98/24/EC is amended as follows:

               (1)

               In Article 2, point (b) is amended as follows:

                           (a)

                           point (i) is replaced by the following:

                                       ‘(i)

                                       any chemical agent which meets the criteria for classification as hazardous within any physical and/or health hazard classes laid down in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (20), whether or not that chemical agent is classified under that Regulation;

                           (b)

                           point (ii) is deleted;

                           (c)

                           point (iii) is replaced by the following:

                                       ‘(iii)

                                       any chemical agent which, whilst not meeting the criteria for classification as hazardous in accordance with point (i) of point (b) of this Article may, because of its physico-chemical, chemical or toxicological properties and the way it is used or is present in the workplace, present a risk to the safety and health of workers, including any chemical agent that is assigned an occupational exposure limit value under Article 3.’

               (2)

               In Article 4(1), the second indent is replaced by the following:

                           ‘—

                           information on safety and health that shall be provided by the supplier (e.g. the relevant safety data sheet in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (21)),

               (3)

               Article 8 is amended as follows:

                           (a)

                           in paragraph 1, the fourth indent is replaced by the following:

                                       ‘—

                                       access to any safety data sheet provided by the supplier in accordance with Article 31 of Regulation (EC) No 1907/2006;’

                           (b)

                           paragraph 3 is replaced by the following:
                           ‘3.   Member States may take measures necessary to ensure that employers are able to obtain on request, preferably from the producer or supplier, all information on hazardous chemical agents that is necessary to apply Article 4(1) of this Directive, insofar as neither Regulation (EC) No 1907/2006, nor Regulation (EC) No 1272/2008 include any obligation to provide information.’

         Article 5
   Amendments to Directive 2004/37/EC
   Directive 2004/37/EC is amended as follows:

               (1)

               In Article 1, paragraph 4 is replaced by the following:
               ‘4.   As regards asbestos, which is dealt with by Directive 2009/148/EC of the European Parliament and of the Council (22), the provisions of this Directive shall apply whenever they are more favourable to health and safety at work.

               (2)

               Article 2 is amended as follows:

                           (a)

                           point (a) is replaced by the following:

                                       ‘(a)

                                       “carcinogen” means:

                                                   (i)

                                                   a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (23);

                                                   (ii)

                                                   a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex;

                           (b)

                           point (b) is replaced by the following:

                                       ‘(b)

                                       “mutagen” means:
                                       a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008;’

               (3)

               In Article 4(1) the word ‘preparation’ is replaced by the word ‘mixture’.

               (4)

               In Article 5(2) the word ‘preparation’ is replaced by the word ‘mixture’.

               (5)

               In point (b) of Article 6, the word ‘preparations’ is replaced by the word ‘mixtures’.

               (6)

               In Annex I, in the heading, the word ‘preparations’ is replaced by the word ‘mixtures’.

         Article 6
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2015. They shall immediately inform the Commission thereof.
   When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.
   Article 7
   Entry into force and application
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 8
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 26 February 2014.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         D. KOURKOULAS

      (1)  OJ C 204, 9.8.2008, p. 47.

      (2)  Position of the European Parliament of 4 February 2014 (not yet published in the Official Journal) and decision of the Council of 20 February 2014.

      (3)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

      (4)  Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 245, 26.8.1992, p. 23).

      (5)  Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 348, 28.11.1992, p. 1).

      (6)  Council Directive 94/33/EC of 22 June 1994 on the protection of young people at work (OJ L 216, 20.8.1994, p. 12).

      (7)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

      (8)  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

      (9)  Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).

      (10)  Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 374, 31.12.1990, p. 1).

      (11)  Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 196, 26.7.1990, p. 1).

      (12)  Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 262, 17.10.2000, p. 21).

      (13)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).’

      (14)  Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 262, 17.10.2000, p. 21).’;

      (15)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).’;

      (16)  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).’

      (17)  Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 262, 17.10.2000, p. 21).’

      (18)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).’;

      (19)  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).’

      (20)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).’;

      (21)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).’

      (22)  Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p. 28).’

      (23)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).’


Avis juridique important

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31976L0766

Council Directive 76/766/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to alcohol tables

Official Journal L 262 , 27/09/1976 P. 0149 - 0152 Finnish special edition: Chapter 13 Volume 5 P. 0178  Greek special edition: Chapter 13 Volume 4 P. 0123  Swedish special edition: Chapter 13 Volume 5 P. 0178  Spanish special edition: Chapter 13 Volume 5 P. 0188  Portuguese special edition Chapter 13 Volume 5 P. 0188

COUNCIL DIRECTIVE  of 27 July 1976  on the approximation of the laws of the Member States relating to alcohol tables  (76/766/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas, in several Member States there are laws concerning the determination of the alcoholic strength of a mixture of water and ethanol, and whereas these laws differ from one Member State to another, thus creating obstacles to trade ; whereas, Community harmonization in this field and the establishment of a common definition are therefore necessary;  Whereas, in its resolution of 17 December 1973 (3) on industrial policy, the Council invited the Commission to forward to it before 1 December 1974 a proposal for a Directive on alcoholometry and alcoholometers;  Whereas harmonization of the laws, regulations and administrative provisions relating to the method for determining alcoholic strength from the results of measurements taken is essential also as a complement to the Directive on the harmonization of alcoholometers and alcohol hydrometers, in order to remove all risk of ambiguity or dispute,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive defines the method of expressing alcoholic strength, by volume or by mass, as defined in the Annex, and gives a formula to enable tables to be drawn up for calculating alcoholic strength on the basis of the measurements taken.   Article 2 As from 1 January 1980 Member States may not question the figures for alcoholic strength derived from the alcoholometric tables drawn up on the basis of the formula shown in the Annex, and from measurements taken with alcoholometers or alcohol hydrometers bearing the EEC marks and signs or with instruments providing at least an equivalent degree of accuracy, on grounds connected with the use of these tables or instruments.   Article 3 The symbols used to indicate alcoholic strength as mentioned in Article 2 and defined in the Annex shall be as follows:  "% vol" for alcoholic strength by volume,  "% mas" for alcoholic strength by mass.   Article 4 As from 1 January 1980, Member States shall prohibit the use of alcoholic strengths which do not comply with the requirements of this Directive.   Article 5 1. Member States shall adopt and publish within a period of 24 months from the date of notification  (1)OJ No C 76, 7.4.1975, p. 39. (2)OJ No C 248, 29.10.1975, p. 22. (3)OJ No C 117, 31.12.1973, p. 1.   of this Directive the measures necessary to conform with this Directive and shall forthwith inform the Commission thereof.  They shall apply these measures from 1 January 1980 at the latest.  2. Member States shall inform the Commission of the texts of the main provisions of national law which they adopt in the field covered by this Directive.   Article 6 This Directive is addressed to the Member States.     Done at Brussels, 27 July 1976.  For the Council  The President  M. van der STOEL     ANNEX ALCOHOLIC STRENGTH    1. DEFINITION  The "alcoholic strength by volume" of a mixture of water and ethanol is the ratio of the volume of pure alcohol present in the mixture at 20 ºC to the total volume of the mixture at the same temperature.  The "alcoholic strength by mass" of a mixture of water and ethanol is the ratio of the mass of alcohol present in this mixture to the total mass of the mixture.       2. EXPRESSION OF ALCOHOLIC STRENGTH  The alcoholic strength is expressed as the parts of alcohol per hundred parts of the mixture.  The relevant symbols are:  "% vol" for the alcoholic strength by volume,  "% mas" for the alcoholic strength by mass.       3. DETERMINATION OF ALCOHOLIC STRENGTH  The procedures to be carried out to determine the alcoholic strength by means of the instruments provided for in the Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to alcoholometers and alcohol hydrometers (1) shall be as follows:      - the reading of an alcoholometer or alcohol hydrometer, at the temperature of the mixture,           - the measurement of the temperature of the mixture.             The results shall be obtained from the international alcohol tables.       4. FORMULA FOR THE CALCULATION OF INTERNATIONAL ALCOHOL TABLES FOR MIXTURES OF WATER AND ETHANOL >PIC FILE= "T0009534">   (1)See page 143 of this Official Journal. >PIC FILE= "T9000936">         NUMERICAL COEFFICIENTS IN THE FORMULA  >PIC FILE= "T0009535">


Avis juridique important

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31992L0073

Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to medicinal products and laying down additional provisions on homeopathic medicinal products

Official Journal L 297 , 13/10/1992 P. 0008 - 0011 Finnish special edition: Chapter 13 Volume 23 P. 0187  Swedish special edition: Chapter 13 Volume 23 P. 0187

COUNCIL DIRECTIVE 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down  additional provisions on homeopathic medicinal productsTHE 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 differences currently existing between the provisions laid down by law, regulation or administrative action in the Member States may hinder trade in homeopathic medicinal products within the Community and lead to discrimination and distortion of  competition between manufacturers of these products;  Whereas the essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health;  Whereas, despite considerable differences in the status of alternative medicines in the Member States, patients should be allowed access to the medicinal products of their choice, provided all precautions are taken to ensure the quality and safety of  the said products;  Whereas the anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products;  Whereas the provisions of Directive 65/65/EEC (4) and the Second Directive 75/319/EEC (5), are not always appropriate for homeopathic medicinal products;   Whereas homeopathic medicine is officially recognized in certain Member States but is only tolerated in other Member States;  Whereas, even if homeopathic medicinal products are not always officially recognized, they are nevertheless prescribed and used in all Member States;  Whereas it is desirable in the first instance to provide users of these medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety;  Whereas the rules relating to the manufacture, control and inspection of homeopathic medicinal products must be harmonized to permit the circulation throughout the Community of medicinal products which are safe and of good quality;  Whereas, having regard to the particular characteristics of these medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials,  it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk  for the patient;  Whereas, however, the usual rules governing the authorization to market medicinal products should be applied to homeopathic medicinal products placed on the market with therapeutic indications or in a form which may present risks which must be balanced  against the desired therapeutic effect; whereas, in particular, those Member States which have a homeopathic tradition should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and  efficacy of these medicinal products provided that they notify them to the Commission,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I  Scope Article 1  1. For the purposes of this Directive, 'homeopathic medicinal product' shall mean any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by  the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States.  2. A homeopathic medicinal product may also contain a number of principles.  Article 2  1. The provisions of this Directive shall apply to homeopathic medicinal products for human use, to the exclusion of homeopathic medicinal products prepared in accordance with a magistral or an officinal formula as defined in Article 1 (4) and (5) of  Directive 65/65/EEC and of homeopathic medicinal products which satisfy the criteria laid down in Article 2 (4) of the said Directive.  2. The medicinal products referred to in paragraph 1 shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.   CHAPTER II  Manufacture, control and inspection Article 3  The provisions of Chapter IV of Directive 75/319/EEC shall apply to the manufacture, control, import and export of homeopathic medicinal products.  Article 4  The supervision measures and the sanctions provided for in Chapter V of Directive 75/319/EEC shall apply to homeopathic medicinal products, together with Articles 31 and 32 of the same Directive.  However, the proof of therapeutic efficacy referred to in Article 28 (1) (b) of the same Directive shall not be required for homeopathic medicinal products registered in accordance with Article 7 of this Directive or, where appropriate, admitted in  accordance with Article 6 (2).  Article 5  Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles  30 and 33 of Directive 75/319/EEC.  CHAPTER III  Placing on the market Article 6  1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorized in accordance with Articles 7, 8 and 9. Each Member State shall take due account of registrations  and authorizations previously granted by another Member State.  2. A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 7. A Member State applying this provision shall inform the Commission accordingly. The Member  State concerned shall, by 31 December 1995 at the latest, allow the use in its territory of homeopathic medicinal products registered by other Member States in accordance with Articles 7 and 8.  3. Advertising of the homeopathic medicinal products referred to in paragraph 2 of this Article and in Article 7 (1) shall be subject to the provisions of Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (¹),  with the exception of Article 2 (1) of that Directive.  However, only the information specified in Article 7 (2) may be used in the advertising of such medicinal products.  Moreover, each Member State may prohibit in its territory any advertising of the homeopathic medicinal products referred to in paragraph 2 and in Article 7 (1).  Article 7  1. Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:  - they are administered orally of externally,  - no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto,  - there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used  in allopathy with regard to active principles whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription.  At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product.  2. In addition to the clear mention of the words 'homeopathic medicinal product', the labelling and, where appropriate, package insert for the medicinal products referred to in paragraph 1 shall bear the following, and no other, information:  - the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1 (1),  - name and address of the person responsible for placing the product on the market and, where appropriate, of the manufacturer,  - method of administration and, if necessary, route,  - expiry date, in clear terms (month, year),  - pharmaceutical form,  - contents of the sales presentation,  - special storage precautions, if any,  - a special warning if necessary for the medicinal product,  - manufacturer's batch number,  - registration number,  - 'homeopathic medicinal product without approved therapeutic indications',  - a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product.  3. Notwithstanding paragraph 2, Member States may require the use of certain types of labelling in order to show:  - the price of the medicinal product,  - the conditions for refunds by social security bodies.  4. The criteria and rules of procedure provided for in Articles 5 to 12 of Directive 65/65/EEC shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic  efficacy.  Article 8  An application for special, simplified registration submitted by the person responsible for placing the product on the market may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be  included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned:  - scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,  - dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography,  - manufacturing and control file for each pharamceutical form and a description of the method of dilution and potentization,  - manufacturing authorization for the medicinal product concerned,  - copies of any registrations or authorizations obtained for the same medicinal product in other Member States;  - one or more specimens or mock-ups of the sales presentation of the medicinal products to be registered,  - data concerning the stability of the medicinal product.  Article 9  1. Homeopathic medicinal products other than those referred to in Article 7 of this Directive shall be authorized and labelled in accordance with Articles 4 to 21 of Directive 65/65/EEC including the provisions concerning proof of therapeutic effect and  Articles 1 to 7 of Directive 75/319/EEC.  2. A Member State may introduce or retain in its territory specific rules for the pharmacological and toxicological tests and clinical trials of homeopathic medicinal products other than those referred to in Article 7 (1) in accordance with the  principles and characteristics of homeopathy as practised in that Member State.  In this case, the Member State concerned shall notify the Commission of the specific rules in force.   CHAPTER IV  Final provisions Article 10  1. Member States shall take the measures necessary to comply with this Directive by 31 December 1993. They shall forthwith inform the Commission thereof.  When Member States adopt the said measures, they shall contain a reference to this Directive or be accompanied by such reference when they are officially published. The procedure for making such reference shall be adopted by the Member States.  2. Applications for registration or for marketing authorization for medicinal products covered by this Directive lodged after the date set in paragraph 1 shall comply with the provisions of this Directive.  3. Not later than 31 December 1995, the Commission shall present a report to the European Parliament and the Council concerning the application of this Directive.  Article 11  This Directive is addressed to the Member States.  Done at Brussels, 22 September 1992.  For the Council The President R. NEEDHAM (1) OJ No C 108, 1. 5. 1990, p. 10 and OJ No C 244, 19. 9. 1991, p. 8.(2) OJ No C 183, 15. 7. 1991, p. 322 and OJ No C 241, 21. 9. 1992.(3) OJ No C 332, 31. 12. 1990, p. 29.(4) OJ No 22, 9. 2. 1965, p. 369/65. Directive as 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 as last amended by Directive 89/341/EEC (OJ No L 142, 25. 5. 1989, p. 11).(6) OJ No L 113, 30. 4. 1992, p. 13.


Avis juridique important

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31972L0306

Council Directive 72/306/EEC of 2 August 1972 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles

Official Journal L 190 , 20/08/1972 P. 0001 - 0023 Finnish special edition: Chapter 13 Volume 2 P. 0142  Danish special edition: Series I Chapter 1972(III) P. 0846  Swedish special edition: Chapter 13 Volume 2 P. 0142  English special edition: Series I Chapter 1972(III) P. 0889  - 0908 Greek special edition: Chapter 13 Volume 2 P. 0033  Spanish special edition: Chapter 13 Volume 2 P. 0154  Portuguese special edition Chapter 13 Volume 2 P. 0154

COUNCIL DIRECTIVE  of 2 August 1972  on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles  (72/306/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament;  Having regard to the Opinion of the Economic and Social Committee;  Whereas the technical requirements which motor vehicles must satisfy pursuant to national laws relate, inter alia, to the emission of pollutants from diesel engines for use in vehicles;  Whereas those requirements differ from one Member State to another ; whereas it is therefore necessary that all the Member States adopt the same requirements either in addition to or in place of their existing rules, in order, in particular, to allow the EEC type approval procedure which was the subject of the Council Directive 1 of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers to be applied in respect of each type of vehicle;  Whereas, it is desirable to follow the technical requirements adopted by the UN Economic Commission for Europe in its Regulation No 24 (Uniform provisions concerning the approval of vehicles equipped with diesel engines with regard to the emission of pollutants by the engine), which is annexed to the Agreement of 20 March 1958 concerning the adoption of uniform conditions of approval and reciprocal recognition of approval for motor vehicle equipment and parts 2;  HAS ADOPTED THIS DIRECTIVE:    Article 1 For the purposes of this Directive, "vehicle" means any vehicle with a diesel engine, intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, with the exception of vehicles which run on rails, agricultural tractors and machines and public works vehicles.   Article 2 No Member State may refuse to grant a vehicle EEC type approval or national type approval on the ground that pollutants are emitted by the diesel engine which drives the vehicle, if the engine complies with Annexes I, II, III, IV and VI.   Article 3 The Member State which has granted type approval shall take the necessary measures to ensure that it is informed of any modification of a part or characteristic referred to in item 2.2 of Annex I. The competent authorities of that Member State shall decide whether fresh tests should be carried out on the modified vehicle and a fresh report drawn up. Where the tests reveal failure to comply with this Directive, the modification shall not be approved.  1OJ No L 42, 23.2.1970, p. 1. 2Doc. E/EEC/324 - E/EEC/TRANS/505, Rev l/add 23, 23.8.1971.    Article 4 The amendments necessary for adjusting the Annexes so as to take account of technical progress shall be adopted in accordance with the procedure laid down in Article 13 of the Council Directive of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers.   Article 5 1. Member States shall put into force the provisions needed in order to comply with this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.  2. Furthermore, once notification of this directive has been effected the Member States shall ensure that the Commission is informed, in time for it to submit its comments, of the most important laws, regulations and administrative provisions which they envisage adopting in the field covered by this Directive.   Article 6 This Directive is addressed to the Member States.     Done at Brussels, 2 August 1972  For the Council  The President  T. WESTERTERP    ANNEX 1a DEFINITIONS, APPLICATION FOR EEC TYPE APPROVAL, SYMBOL OF THE CORRECTED ABSORPTION COEFFICIENT, SPECIFICATIONS AND TESTS AND CONFORMITY OF PRODUCTION     (1.)        2. DEFINITIONS  For the purposes of this Directive:      (2.1.)            2.2. "Vehicle type as regards the limitation of the emission of pollutants from the engine" means motor vehicles which do not differ in such essential respects as the vehicle and engine characteristics defined in Annex II;           2.3. "Diesel engine" means an engine which works on the compression-ignition principle;           2.4. "Cold-start device" means a device which by its operation temporarily increases the amount of fuel supplied to the engine and is intended to facilitate the starting of the engine;           2.5. "Opacimeter" means an instrument for continuous measurement of the absorption coefficients of the light by the exhaust gases emitted by vehicles.                  3. APPLICATION FOR EEC TYPE APPROVAL      3.1. The application for approval must be submitted by the vehicle manufacturer or by his duly accredited representative.           3.2. It must be accompanied by the undermentioned documents in triplicate and the following particulars:  aThe text of the Annexes is similar to that of Regulation No 24 of the UN Economic Commission for Europe ; in particular the breakdown into items is the same. For this reason, where an item of Regulation No 24 has no counterpart in this Directive, its number is given in brackets as a token entry.         3.2.1. A description of the engine type including all the particulars referred to in Annex II;               3.2.2. Drawings of the combustion chamber and of the upper face of the piston.                          3.3. An engine and the equipment prescribed in Annex II to the Regulation for fitting to the vehicle to be approved shall be submitted to the technical service conducting the approval tests defined in item 5. However, if the manufacturer so requests and the technical service conducting the approval tests agrees, a test may be carried out on a vehicle representative of the vehicle type to be approved.      3a EEC TYPE APPROVAL  A certificate conforming to that shown in Annex X shall be attached to the EEC type approval certificate.         4. SYMBOL OF THE CORRECTED ABSORPTION COEFFICIENT      (4.1.)            (4.2.)            (4.3.)            4.4. To every vehicle conforming to a vehicle type approved under this Regulation there shall be affixed, conspicuously and in a readily accessible place specified in the Annex to the type approval certificate shown in Annex X, a symbol being a rectangle surrounding a figure expressing in m-1 the corrected absorption coefficient obtained, at the time of approval, during the test under free acceleration, and determined at the time of approval by the method described in item 3.2 of Annex IV.           4.5. The symbol must be clearly legible and indelible.           4.6. Annex IX gives an example of the symbol.                  5. SPECIFICATIONS AND TESTS      5.1. General  The components liable to affect the emission of pollutants shall be so designed, constructed and assembled as to enable the vehicle, in normal use, despite the vibration to which it may be subjected, to comply with the provisions of this Directive.           5.2. Specifications concerning cold-start devices        5.2.1. The cold-start device shall be so designed and constructed that it cannot be brought into or kept in action when the engine is running normally.               5.2.2. The provisions of item 5.2.1 above shall not apply if at least one of the following conditions is met:          5.2.2.1. The light absorption coefficient of the gases emitted by the engine at steady speeds when measured by the method described in Annex III with the cold-start device operating is within the limits prescribed in Annex VI.                   5.2.2.2. Keeping the cold-start device in operation causes the engine to stop within a reasonable time.                                             5.3. Specifications concerning the emission of pollutants        5.3.1 The emission of pollutants by the vehicle type submitted for approval shall be measured by the two methods described in Annexes III and IV, relating respectively to tests at steady speeds and to tests under free acceleration.a               5.3.2. The emission of pollutants, as measured by the method described in Annex III, shall not exceed the limits prescribed in Annex VI.  aA test under free acceleration shall be carried out, especially in order to provide a reference figure for administrations which use this method to check vehicles in use.                5.3.3. In the case of engines with an exhaust-driven supercharger the absorption coefficient measured under free acceleration shall not exceed the limit prescribed in Annex VI for the nominal flow value corresponding to the maximum absorption coefficient measured during the tests at steady speeds, plus 0 75 m-1.                          5.4. Equivalent measuring instruments shall be allowed. If an instrument other than those described in Annex VII is used, proof of its equivalence for the engine considered shall be required.                  (6.)        7. CONFORMITY OF PRODUCTION      7.1. Every vehicle in the series must conform, with regard to components affecting the emission of pollutants by the engine, to the vehicle type approved.           (7.2.)            7.3. As a general rule conformity of the vehicle with the approved type as regards the emission of pollutants from diesel motors shall be verified on the basis of the description given in the Annex to the EEC approval certificate shown in Annex X. In addition:        7.3.1. Where a check is carried out on a vehicle taken from the series, the tests shall be carried out as follows:          7.3.1.1. A vehicle which has not been run in shall be subjected to the test under free acceleration described in Annex IV. The vehicle shall be deemed to conform to the approved type if the absorption coefficient determined does not exceed by more than 0 75 m-1 the figure shown in the approval mark.                   7.3.1.2. If the figure determined in the test referred to in item 7.3.1 above exceeds by more than 0 75 m-1 the figure shown in the approval mark, a vehicle of the type considered or its engine shall be subjected to the test at steady speeds over the full-load curve, as described in Annex III. The emission levels shall not exceed the limits prescribed in Annex VI.                                                    (8.)        (9.)           ANNEX II >PIC FILE= "T0010768""PIC FILE= "T0010769">    >PIC FILE= "T0010770">     ANNEX III TEST AT STEADY SPEEDS OVER THE FULL-LOAD CURVE     1. INTRODUCTION      1.1. This annex describes the method of determining emissions of pollutants at different steady speeds over the full-load curve.           1.2. The test may be carried out either on an engine or on a vehicle.                  2. MEASUREMENT PRINCIPLE      2.1. The opacity of the exhaust gases produced by the engine shall be measured with the engine running under full load and at steady speed. Six measurements shall be made at engine speeds spaced out uniformly between that corresponding to maximum power and the higher of the following two engine speeds:        - 45 per cent of the engine speed corresponding to maximum power ; and               - 1 000 rpm.                 The extreme points of measurement shall be situated at the limits of the interval defined above.           2.2. In the case of diesel engines which are fitted with an air supercharger which can be engaged at will, and in which engines the entry into operation of the air supercharger automatically brings about an increase in the quantity of fuel injected, the measurements shall be made both with and without the supercharger working.  For each engine speed, the result of the measurement shall be the higher of the two figures obtained.                  3. TEST CONDITIONS      3.1. Vehicle or engine        3.1.1. The engine or the vehicle shall be submitted in good mechanical condition. The engine shall have been run in.               3.1.2. The engine shall be tested with the equipment described in Annex II.               3.1.3. The settings of the engine shall be those described by the manufacturer and by Annex II.               3.1.4. The exhaust device shall not have any orifice through which the gases emitted by the engine might be diluted.               3.1.5. The engine shall be in the normal working condition prescribed by the manufacturer. In particular, the cooling water and the oil shall each be at the normal temperature indicated by the manufacturer.                          3.2. Fuel  The fuel shall be the reference fuel whose specifications are given in Annex V.           3.3. Test laboratory        3.3.1. The absolute temperature T of the laboratory, expressed in degrees Kelvin, and the atmospheric pressure H, expressed in torr, shall be measured, and the factor F shall be determined by the formula               3.3.2.  >PIC FILE= "T0010771">                           3.4. Sampling and measuring apparatus  The light-absorption coefficient of the exhaust gases shall be measured with an opacimeter satisfying the conditions laid down in Annex VII and installed in conformity with Annex VIII.                  4. LIMIT VALUES      4.1. For each of the six engine speeds at which the absorption coefficient is measured pursuant to paragraph 2.1 above, the nominal gas flow G, expressed in litres per second, shall be calculated by means of the following formulae: >PIC FILE= "T0010772">   where:  V is the cylinder capacity of the engine expressed in litres ; and  n is the engine speed in revolutions per minute.           4.2. For each engine speed the absorption coefficient of the exhaust gases shall not exceed the limit value given in the table in Annex VI. Where the value of the nominal flow is not one of those given in that table, the limit value applicable shall be obtained by interpolation on the principle of proportional parts.                     ANNEX IV TEST UNDER FREE ACCELERATION     1. TEST CONDITIONS      1.1. The test shall be carried out on the vehicle or engine which has undergone the test at steady speeds described in Annex III.        1.1.1. If the engine is tested on a bench the test shall be carried out as soon as possible after the test for measurement of opacity under full load at steady speed. In particular, the cooling water and the oil shall be at the normal temperatures indicated by the manufacturer.               1.1.2. If the test is carried out on a stationary vehicle, the engine shall first be brought to normal operating condition by a road run. The test shall be carried out as soon as possible after completion of the road run.                          1.2. The combustion chamber shall not have been cooled or fouled by a prolonged period of idling preceding the test.           1.3. The test conditions described in Annex III, items 3.1, 3.2 and 3.3, shall apply.           1.4. The conditions described in Annex III, item 3.4, with regard to the sampling and measuring apparatus shall apply.                  2. TEST METHODS      2.1. If the test is a bench test, the engine shall be disconnected from the brake, the latter being replaced either by the rotating parts driven when no gear is engaged or by an inertia substantially equivalent to that of the rotating parts.           2.2. If the test is carried out on a vehicle, the gear-change control shall be set in the neutral position and the engine in gear.           2.3. With the engine idling, the accelerator control shall be operated quickly, but not violently, so as to obtain maximum delivery from the injection pump. This position shall be maintained until maximum engine speed is reached and the governor comes into action. As soon as this speed is reached the accelerator shall be released until the engine resumes its idling speed and the opacimeter reverts to the corresponding conditions.           2.4. The operation described in item 2.3 above shall be repeated not less than six times in order to clear the exhaust system and to allow for any necessary adjustment of the apparatus. The maximum opacity values read at each successive acceleration shall be noted until stabilized values are obtained. No account shall be taken of the values read while the engine is idling after each acceleration. The values read shall be regarded as stabilized when four consecutive readings are situated within a band width of 0 725 m-1 and do not form a decreasing sequence. The absorption coefficient XM to be recorded shall be the arithmetic mean of these four values.           2.5. Engines fitted with an air supercharger shall be subject, where appropriate, to the following special requirements:        2.5.1 In the case of engines with an air supercharger which is coupled with or driven mechanically by the engine and is capable of being disengaged, two complete measurement cycles with preliminary accelerations shall be carried out, the air supercharger being engaged in one case and disengaged in the other. The measurement result recorded shall be the higher of the two results obtained;               2.5.2. In the case of engines with an air supercharger which can be cut out by means of a driver-operated bypass, the test shall be carried out with and without the bypass. The measurement result recorded shall be the higher of the results obtained.                                  3. DETERMINATION OF THE CORRECTED VALUE OF THE ABSORPTION COEFFICIENT      3.1. Notation  XM = value of the absorption coefficient under free acceleration measured as described in item 2.4 of this Annex;  XL = corrected value of the absorption coefficient under free acceleration;  SM = value of the absorption coefficient measured at steady speed (Annex III, item 2.1.) which is closest to the prescribed limit value corresponding to the same nominal flow;  SL = value of the absorption coefficient (Annex III, item 4.2.) for the nominal flow corresponding to the point of measurement which gave the value SM;  L = effective length of the light path in the opacimeter.           3.2. When the absorption coefficients are expressed in m-1 and the effective length of the light path in metres, the corrected value XL is given by the smaller of the following two expressions: >PIC FILE= "T0010773">                      ANNEX V SPECIFICATIONS OF REFERENCE FUEL PRESCRIBED FOR APPROVAL TESTS AND TO VERIFY CONFORMITY OF PRODUCTION  >PIC FILE= "T0010774">  Note : The fuel must be based only on straight-run distillates, hydrodesulphurized or not, and must contain no additives.    ANNEX VI LIMIT VALUES APPLICABLE IN THE TEST AT STEADY SPEEDS  >PIC FILE= "T0010775"> Note : Although the above values are rounded to the nearest 0 701 or 0 7005, this does not mean that the measurements need to be made to this degree of accuracy.    ANNEX VII CHARACTERISTICS OF OPACIMETERS     1. SCOPE  This annex defines the conditions to be met by opacimeters used in the tests described in Annexes III and IV.       2. BASIC SPECIFICATION FOR OPACIMETERS      2.1. The gas to be measured shall be confined in an enclosure having a non-reflecting internal surface.           2.2. In determining the effective length of the light path through the gas, account shall be taken of the possible influence of devices protecting the light source and the photoelectric cell. This effective length shall be indicated on the instrument.          2.3.   >PIC FILE= "T0010776">                   3. CONSTRUCTION SPECIFICATIONS      3.1. General  The design shall be such that under steady-speed operating conditions the smoke chamber is filled with smoke of uniform opacity.           3.2. Smoke chamber and opacimeter casing        3.2.1. The impingement on the photoelectric cell of stray light due to internal reflections or diffusion effects shall be reduced to a minimum (e.g. by finishing internal surfaces in matt black and by a suitable general layout).               3.2.2. The optical characteristics shall be such that the combined effect of diffusion and reflection does not exceed one unit on the linear scale when the smoke chamber is filled with smoke having an absorption coefficient near 1 77 m-1.                          3.3. Light source  The light source shall be an incandescent lamp with a colour temperature in the range 2 800 to 3 250 ºK.           3.4. Receiver        3.4.1. The receiver shall consist of a photoelectric cell with a spectral response curve similar to the photopic curve of the human eye (maximum response in the range 550/570 nm ; less than 4 per cent of that maximum response below 430 nm and above 680 nm).               3.4.2. The construction of the electrical circuit, including the indicating dial, shall be such that the current output from the photoelectric cell is a linear function of the intensity of the light received over the operating-temperature range of the photoelectric cell.                          3.5. Measuring scales        3.5.1.  >PIC FILE= "T0010777">         - either by the method described in item 4 of this Annex ; or               - through correlation with another type of opacimeter for which the effective length is known.                               3.5.2. The relationship between the 0-100 linear scale and the light absorption coefficient k is given by the formula >PIC FILE= "T0010778">   where N is a reading on the linear scale and k the corresponding value of the absorption coefficient.              3.5.3. The indicating dial of the opacimeter shall enable an absorption coefficient of 1 77 m-1 to be read with an accuracy of 0 7025 m-1.           3.6. Setting and testing of the measuring apparatus        3.6.1. The electrical circuit of the photoelectric cell and of the indicating dial shall be adjustable so that the pointer can be reset at zero when the light flux passes through the smoke chamber filled with clean air or through a chamber having identical characteristics.         3.6.2.   >PIC FILE= "T0010779">                3.6.3. An intermediate check shall be carried our by placing in the smoke chamber a screen representing a gas whose known light-absorption coefficient k, measured as described in item 3.5.1, is between 1 76 m-1 and 1 78 m-1. The value of k must be known to within 0 7025 m-1. The check consists in verifying that this value does not differ by more than 0 705 m-1 from that read on the opacimeter indicating dial when the screen is introduced between the source of light and the photoelectric cell.                          3.7. Opacimeter response        3.7.1. The response time of the electrical measuring circuit, being the time necessary for the indicating dial to reach 90 per cent of full-scale deflection on removal of a screen fully obscuring the photoelectric cell, shall be 0 79 to 1 71 second.               3.7.2. The damping of the electrical measuring circuit shall be such that the initial overswing beyond the final steady reading after any momentary variation in input (e.g. the calibration screen) does not exceed 4 per cent of that reading in linear scale units.               3.7.3. The response time of the opacimeter which is due to physical phenomena in the smoke chamber is the time between the entry of the gas into the measuring apparatus and the complete filling of the smoke chamber ; it shall not exceed 0 74 second.               3.7.4. These provisions shall apply solely to opacimeters used to measure opacity under free acceleration.                          3.8. Pressure of the gas to be measured and of scavenging air        3.8.1. The pressure of the exhaust gas in the smoke chamber shall not differ by more than 75 mm (water gauge) from the atmospheric pressure.               3.8.2. The variations in the pressure of the gas to be measured and of the scavenging air shall not cause the absorption coefficient to vary by more than 0 705 m-1 in the case of a gas having an absorption coefficient of 1 77 m-1.               3.8.3. The opacimeter shall be equipped with appropriate devices for measuring the pressure in the smoke chamber.               3.8.4. The limits of pressure variation of gas and scavenging air in the smoke chamber shall be indicated by the manufacturer of the apparatus.                          3.9. Temperature of the gas to be measured        3.9.1. At every point in the smoke chamber the gas temperature at the instant of measurement shall be between 70 ºC and a maximum temperature, specified by the opacimeter manufacturer, such that the readings over this temperature range do not vary by more than 0 71 m-1 if the chamber is filled with a gas having an absorption coefficient of 1 77 m-1.               3.9.2. The opacimeter shall be equipped with appropriate devices for measuring the temperature in the smoke chamber.                                  4. EFFECTIVE LENGTH "L" OF THE OPACIMETER      4.1. General        4.1.1. In some types of opacimeter the gas between the light source and the photoelectric cell, or between transparent parts protecting the source and the photoelectric cell, is not of constant opacity. In such cases the effective length L shall be that of a column of gas of uniform opacity which gives the same absorption of light as that obtained when the gas is admitted in a normal way into the opacimeter.               4.1.2. The effective length of the light path is obtained by comparing the reading N of the opacimeter operating normally with the reading No obtained with the opacimeter modified so that the test gas fills a well defined length Lo.               4.1.3. It will be necessary to take comparative readings in quick succession to determine the correction to be made for shifts of zero.                          4.2. Method of assessment of L        4.2.1. The test gas shall be exhaust gas of constant opacity or a light-absorptive gas of a gravimetric density similar to that of the exhaust gas.               4.2.2. A column of length Lo of the opacimeter, which can be filled uniformly with the test gases, and the ends of which are substantially at right angles to the light path, shall be accurately determined. This length Lo shall be close to the presumed effective length of the opacimeter.               4.2.3. The mean temperature of the test gas in the smoke chamber shall be measured.               4.2.4. If necessary, an expansion tank of compact design and of sufficient capacity to damp the pulsations may be incorporated in the sampling line as near to the probe as possible. A cooler may also be fitted. The addition of the expansion tank and of the cooler must not unduly disturb the composition of the exhaust gas.               4.2.5. The test for determining the effective length shall consist of passing a sample of test gas alternately through the opacimeter operating normally and through the same apparatus modified as indicated in item 4.1.2.          4.2.5.1. The opacimeter readings shall be recorded continuously during the test with a recorder whose response time is equal to or shorter than that of the opacimeter.                   4.2.5.2. With the opacimeter operating normally, the reading on the linear scale of opacity is N and that of the mean gas temperature expressed in Kelvin degrees is T.                   4.2.5.3. With the known length Lo filled with the same test gas, the reading on the linear scale of opacity is No and that of the mean gas temperature expressed in Kelvin degrees is To.                                  4.2.6. The effective length will be >PIC FILE= "T0010780">                4.2.7. The test shall be repeated with at least four test gases giving readings evenly spaced between the 20 and 80 on the linear scale.               4.2.8. The effective length L of the opacimeter will be the arithmetic mean of the effective lengths obtained as stated in item 4.6 with each of the gases.                                    ANNEX VIII INSTALLATION AND USE OF THE OPACIMETER     1. SCOPE  This annex specifies the installation and use of opacimeters for the tests described in Annexes III and IV. 2. SAMPLING OPACIMETER      2.1. Installation for steady-speed tests        2.1.1. The ratio of the cross-sectional area of the probe to that of the exhaust pipe shall not be less than 0 705. The back pressure measured in the exhaust pipe at the intake of the probe shall not exceed 75 mm (water gauge).               2.1.2. The probe shall be a tube with an open end facing forwards in the axis of the exhaust pipe, or of the extension pipe if one is required. It shall be situated in a section where the distribution of smoke is approximately uniform. To achieve this, the probe shall be placed as far downstream in the exhaust pipe as possible, or, if necessary, in an extension pipe so that, if D is the diameter of the exhaust pipe at the outlet, the end of the probe is situated in a straight portion at least 6 D in length upstream of the sampling point and 3 D in length downstream. If an extension pipe is used, no air shall be allowed to enter the joint.               2.1.3. The pressure in the exhaust pipe and the characteristics of the pressure drop in the sampling line shall be such that the probe collects a sample substantially equivalent to that which would be obtained by isokinetic sampling.               2.1.4. If necessary, an expansion tank of compact design and of sufficient capacity to damp the pulsations may be incorporated in the sampling line as near to the probe as possible. A cooler may also be fitted.  The design of the expansion tank and cooler shall not unduly disturb the composition of the exhaust gas.               2.1.5. A butterfly valve or other means of increasing the sampling pressure may be placed in the exhaust pipe at least three 3 D downstream from the sampling probe.               2.1.6. The connecting pipes between the probe, the cooling device, the expansion tank (if required) and the opacimeter shall be as short as possible while satisfying the pressure and temperature requirements described in Annex VII, items 3.8 and 3.9. The pipe shall be inclined upwards from the sampling point to the opacimeter, and sharp bends where soot might accumulate shall be avoided. If not embodied in the opacimeter, a bypass valve shall be provided upstream.               2.1.7. A check shall be carried out during the test to ensure that the requirements of Annex VII, item 3.8, concerning pressure and those of Annex VII, item 3.9, concerning the temperature in the measuring chamber are observed.                          2.2. Installation for tests under free acceleration        2.2.1. The ratio of the cross-sectional area of the probe to that of the exhaust pipe shall not be less than 0 705. The back pressure measured in the exhaust pipe at the intake of the probe shall not exceed 75 mm (water gauge).               2.2.2. The probe shall be a tube with an open end facing forwards in the axis of the exhaust pipe, or of the extension pipe if one is required. It shall be situated in a section where the distribution of smoke is approximately uniform. To achieve this, the probe shall be  placed as far downstream in the exhaust pipe as possible or, if necessary, in an extension pipe so that, if D is the diameter of the exhaust pipe at the outlet, the end of the probe is situated in a straight portion at least 6 D in length upstream of the sampling point and 3 D in length downstream. If an extension pipe is used, no air shall be allowed to enter the joint.               2.2.3. The sampling system shall be such that at all engine speeds the pressure of the sample at the opacimeter is within the limits specified in Annex VII, item 3.8.2. This may be checked by noting the sample pressure at engine idling and maximum no-load speeds. Depending on the characteristics of the opacimeter, control of sample pressure can be achieved by a fixed restriction or a butterfly valve in the exhaust pipe or extension pipe. Whichever method is used, the back pressure measured in the exhaust pipe at the intake of the probe shall not exceed 75 mm (water gauge).               2.2.4. The pipes connecting with the opacimeter shall be as short as possible. The pipe shall be inclined upwards from the sampling point to the opacimeter, and sharp bends where soot might accumulate shall be avoided. A bypass valve may be provided upstream of the opacimeter to isolate it from the exhaust-gas flow when no measurement is being made.                                 3. FULL-FLOW OPACIMETER  The only general precautions to be observed in steady-speed and free-acceleration tests are the following:      3.1. Joints in the connecting pipes between the exhaust pipe and the opacimeter shall not allow air to enter from outside.           3.2. The pipes connecting with the opacimeter shall be as short as possible, as in the case of sampling opacimeters. The pipe system shall be inclined upwards from the exhaust pipe to the opacimeter, and sharp bends where soot might accumulate shall be avoided. A bypass valve may be provided upstream of the opacimeter to isolate it from the exhaust-gas flow when no measurement is being made.           3.3. A cooling system may also be required upstream of the opacimeter.                    ANNEX IX EXAMPLE OF THE SYMBOL OF THE CORRECTED ABSORPTION COEFFICIENT   >PIC FILE= "T0010781">    ANNEX X >PIC FILE= "T0010782">  >PIC FILE= "T0010830">


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31977L0504

Council Directive 77/504/EEC of 25 July 1977 on pure- bred breeding animals of the bovine species

Official Journal L 206 , 12/08/1977 P. 0008 - 0010 Finnish special edition: Chapter 3 Volume 9 P. 0049  Greek special edition: Chapter 03 Volume 19 P. 0058  Swedish special edition: Chapter 3 Volume 9 P. 0049  Spanish special edition: Chapter 03 Volume 13 P. 0024  Portuguese special edition Chapter 03 Volume 13 P. 0024

COUNCIL DIRECTIVE  of 25 July 1977  on pure-bred breeding animals of the bovine species  (77/504/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 cattle production occupies a very important place in Community agriculture, and satisfactory results depend to a large extent on the use of pure-bred breeding animals;  Whereas most Member States have hitherto endeavoured, as part of their national breeding policies, to promote the production of livestock of a limited number of breeds meeting specific zootechnic standards ; whereas the breeds and standards vary from one Member State to another ; whereas these disparities hinder intra-Community trade;  Whereas, if these disparities are to be removed, thereby increasing agricultural productivity in this sector, intra-Community trade in all pure-bred breeding animals must be progressively liberalized ; whereas complete liberalization of trade requires a later additional harmonization particularly regarding approval for breeding;  Whereas it must be possible for the Member States to insist on pedigree certificates drawn up in accordance with a Community procedure being presented;  Whereas implementing measures in certain technical areas should be taken ; whereas, for the adoption of such measures, a procedure should be provided for establishing close cooperation between Member States and the Commission within the Standing Committee on Zootechnics ; whereas, until the adoption of those implementing measures, the provisions which are at present in force in the areas in question must remain unchanged;  Whereas it must be ensured that importation of pure-bred breeding animals of the bovine species from non-member countries cannot be carried out on conditions which are less severe than those applied within the Community,  HAS ADOPTED THIS DIRECTIVE:    Article 1 For the purposes of this Directive the following definitions shall apply:    (a) pure-bred breeding animal of the bovine species : any bovine animal the parents and grandparents of which are entered or registered in a herd-book of the same breed, and which is itself either entered or registered and eligible for entry in such a herd-book;  (1)OJ No C 76, 3.7.1974, p. 52. (2)OJ No C 116, 30.9.1974, p. 33.        (b) herd-book : any book, register, file or data medium    - which is maintained by a breeders' organization or association officially recognized by a Member State in which the breeders' organization or association was constituted, and       - in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors.             Article 2 The Member States shall ensure that the following shall not be prohibited, restricted or impeded on zootechnical grounds:    - intra-Community trade in pure-bred breeding animals of the bovine species,       - intra-Community trade in the semen and embryos of pure-bred breeding animals of the bovine species,       - the establishment of herd-books, provided that they comply with the requirements laid down pursuant to Article 6,       - the recognition of organizations or associations which maintain herd-books, in accordance with Article 6, and       - subject to Article 3, intra-Community trade in bulls used for artificial insemination.          Article 3 The Council, acting on a proposal from the Commission, shall, before 1 July 1980, adopt Community provisions for the approval of pure-bred breeding animals of the bovine species for breeding.  Until the entry into force of such provisions, approval of pure-bred breeding animals of the bovine species for breeding and approval of bulls to be used for artificial insemination as well as the use of semen and embryos shall remain subject to national law, on the understanding that that law may not be more restrictive than that applicable to pure-bred breeding animals of the bovine species, semen and embryos in the Member State of destination.   Article 4 Breeders' organizations or associations officially recognized by a Member State may not oppose the entry in their herd-books of pure-bred breeding animals of the bovine species from other Member States provided that they satisfy the requirements laid down in accordance with Article 6.   Article 5 Member States may require that pure-bred breeding animals of the bovine species and the semen or embryos from such animals shall be accompanied, in intra-Community trade, by a pedigree certificate which complies with a specimen drawn up in accordance with the procedure laid down in Article 8, particularly with regard to zootechnical performance.   Article 6 1. The following shall be determined in accordance with the procedure laid down in Article 8:    - performance monitoring methods and methods for assessing cattle's genetic value,       - the criteria governing the recognition of breeders' organizations and associations,       - the criteria governing the establishment of herd-books,       - the criteria governing entry in herd-books,       - the particulars to be shown on the pedigree certificate.         2. Until the entry into force of the provisions provided for in the first, second and third indents of paragraph 1:    (a) the official checks referred to in the first indent of paragraph 1 carried out in each Member State and the herd-books in existence at present shall be recognized by the other Member States;       (b) the recognition of breeders' organizations and associations shall continue to be governed by the rules at present in force in each Member State;       (c) the introduction of new herd-books shall continue to meet the conditions at present in force in each Member State.          Article 7 Until the implementation of Community rules on the subject, the conditions applicable to imports of pure-bred breeding animals of the bovine species from non-member countries must not be more favourable than those governing intra-Community trade.  Member States shall not authorize the import of pure-bred breeding animals of the bovine species from non-member countries unless they are accompanied by a pedigree certificate certifying that they are entered or registered in a herd-book in the exporting non-member country. Proof must be provided that the animals are either entered or registered and eligible for entry in a herd-book in the Community.   Article 8 1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Committee on Zootechnics (hereinafter referred to as "the Committee") set up by the Council Decision 77/505/EEC.  2. Within the Committee the votes of Member States shall be weighted as provided in Article 148 (2) of the Treaty. The Chairman shall not vote.   3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within a time limit set by the Chairman according to the urgency of the matters concerned. Opinions shall be delivered by a majority of 41 votes.  4. The Commission shall adopt the measures and shall apply them immediately where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.  If, within three months from the date on which the proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately save where the Council has decided by a simple majority against those measures.   Article 9 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1979 at the latest and shall forthwith inform the Commission thereof.   Article 10 This Directive is addressed to the Member States.     Done at Brussels, 25 July 1977.  For the Council  The President  H. SIMONET