Avis juridique important

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31988L0379

Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations

Official Journal L 187 , 16/07/1988 P. 0014 - 0030 Finnish special edition: Chapter 13 Volume 17 P. 0084  Swedish special edition: Chapter 13 Volume 17 P. 0084

COUNCIL DIRECTIVE of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (88/379/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 A thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement  of goods, persons, services and capital is ensured;  Whereas rules on dangerous substances have already been laid down in Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of  dangerous substances (4), as last amended by Directive 79/831/EEC (5);  Whereas rules on certain dangerous preparations having very specific uses have already been laid down:  - in Council Directive 73/173/EEC of 4 June 1973 on the approximation of Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (solvents) (6), as last amended by  Directive 80/781/EEC (7),  - in Council Directive 77/728/EEC of 7 November 1977 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives  and similar products (8), as last amended by Directive 83/265/EEC (9),  Whereas, despite the abovementioned Community provisions, the rules, if any, applying to certain dangerous preparations in the Member States exhibit considerable differences as regards classification according to the degree of risk; whereas these  differences constitute a not insignificant barrier to trade and directly affect the establishment and functioning of the common market;  Whereas it is therefore necessary to remove this barrier by approximating the relevant legislation existing in the Member States and incorporating in it the ´acquis communautaires';  Whereas this Directive must, at the same time, ensure protection for the general public and, in particular, of persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, of consumers, especially  children and the visually handicapped, and also for the environment;  Whereas provisions on the classification, packaging and labelling of the preparations must be laid down at Community level; whereas the provisions concerning the information appearing on the label, the dimensions of the label and the assignment of the  various danger symbols, standard phrases concerning risks and safety advice have also to be brought into line with Directive 67/548/EEC;  Whereas some preparations, although they contain constituents which are dangerous to health, are not necessarily dangerous in the form in which they are placed on the market; whereas there are exceptions, however, and whereas the latter must be the  subject of special labelling, as appropriate, in accordance with the provisions of Directive 67/548/EEC as amended by Directive 79/831/EEC, or of Annex II to this Directive;  Whereas the assessment of the health hazards of a preparation may, under Article 3, be carried out by a calculation method, by determining the toxicological properties according to well-defined test methods or by a combination of the two; whereas  Directive 86/609/EEC stipulates in Article 7 (2) that an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the ¹ ¹ use of an animal, is reasonably and practically available; whereas this Directive makes use of the results of assessments of toxicological properties only when these are already known and entails no obligation to conduct further experiments on animals;  Whereas the label constitutes a basic tool for users of the preparations by giving them the initial essential concise information; whereas it nevertheless needs to be supplemented by a two-fold system of more detailed information, one intended for  professional users, and the second for the bodies appointed by the Member States and whose responsibility it is to give information reserved solely for medical purposes, both curative and preventive;  Whereas dangerous preparations may, although conforming to the provisions of this Directive, nevertheless constitute a danger to health or the environment; whereas it is therefore advisable to provide a procedure to reduce this danger;  Whereas the Commission will, on the basis of information to be supplied by the Member States be obliged to submit a report, within two years of application of this Directive, concerning any inadequacies or loopholes, as compared with the present  Directive, in Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides) (10), as last amended by Directive 84/291/EEC  (11); whereas on the basis of this report, the Commission will, if appropriate, submit the necessary proposals,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1.  The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States on the:  - classification,  - packaging, and - labelling of preparations dangerous to man and the environment when they are placed on the market in the Member States.  2.  This Directive shall apply to preparations which are placed on the market in the Member States and which:  - contain at least one substance classified as dangerous, within the meaning of Article 2, and - are regarded as dangerous within the meaning of Article 3.  This Directive shall also apply to the preparations listed in Annex II.  3.  This Directive shall not apply to:  (a) medicinal or veterinary products as defined by Directive 65/65/EEC (12), as last amended by Directive 87/21/EEC (13);  (b) cosmetic products as defined by Directive 76/768/EEC (14), as last amended by Directive 86/199/EEC (15);  (c) mixtures of substances which, in the form of waste, are covered by Directive 75/442/EEC (16) and Directive 78/319/EEC (17), as last amended by the Act of Accession of Spain and Portugal;  (d) pesticides covered by Directive 78/631/EEC, as last amended by Directive 83/291/EEC;  (e) munitions and explosives placed on the market with a view to obtaining a practical effect by explosion or a pyrotechnic effect.  In addition, this Directive shall not apply to:  (f) foodstuffs in a finished stage intended for the final consumer;  (g) animal feedingstuffs in a finished stage intended for the final consumer;  (h) the carriage of dangerous substances by rail, road, inland waterway, sea or air;  (i) preparations in transit which are under customs supervision provided they do not undergo any treatment or processing.  Article 2 The definitions appearing in Article 2 of Directive 67/548/EEC, with the exception of the definition in paragraph 1 (d) thereof, shall apply to this Directive.  Article 3 1.  The general principles of the classification and labelling of preparations shall be applied according to the criteria in Annex VI to Directive 67/548/EEC, save where the alternative criteria referred to below are applied.  2.  The requisite physico-chemical properties for the classification of preparations shall be determined by the methods specified in Annex V (A) to Directive 67/548/EEC.  Preparations shall be regarded as explosive, oxidizing, extremely flammable, highly flammable or flammable when the results of the tests carried out by the methods mentioned above comply with the definitions in Article 2 of Directive 67/548/EEC and the  specific evaluation criteria detailed in those methods.  By way of derogation from the preceding:  (a)  the determination of the explosive, oxidizing, extremely flammable, highly flammable or flammable properties is not necessary provided, however, that none of the constituents possesses such properties and that on the basis of the information  available to the manufacturer the preparation is unlikely to present dangers of this kind;  (b)  the preparations placed on the market in the form of aerosols are subject to the flammability criteria specified in paragraphs 1.8 and 2.2 (c) of the Annex to Directive 75/324/EEC (18), as last amended by the Act of Accession of Spain and  Portugal.  3.  The health hazards of a preparation shall be assessed by one or more of the following methods:  (a)  by the conventional method described below using concentration limits;  (b)  by determining by means of the methods specified in point B of Annex V to Directive 67/548/EEC, the toxicological properties of the preparation necessary for an appropriate classification and label in accordance with the criteria in Annex VI to  that Directive.  Any one or more of the toxicological properties of the preparation which are not assessed by the method set out in (b) hereof shall be assessed in accordance with the conventional method.  Where a toxicological property has been established by both the methods above, the result of method (b) shall be used for classifying the preparation except in the case of carcinogenic, mutagenic and teratogenic effects.  Furthermore, where it can be demonstrated that:  - toxicological effects on man differ from those suggested by a toxicological determination or a conventional assessment, then the preparation shall be classified according to its effects on man,  - owing to effects such as potentiation a conventional assessment would underestimate the toxicological hazard, these effects shall be taken into account in classifying the preparation,  - owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, these effects shall be taken into account in classifying the preparation.  4.  For preparations of a known composition classified in accordance with method 3 (b) above a new health hazard assessment either by method 3 (a) or (b) shall be performed whenever:  - changes of composition of the initial concentration as a weight/weight percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:  -    Initial concentration range of the constituent Permitted variation in initial concentration of the constituent >      §   2,5 % >  2,5 §  10   % > 10   §  25   % > 25   §  50   % > 50   § 100   % ± 15   % ± 10   % ±  6   % ±  5   % ±  2,5 % - changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions of this Directive, are introduced by the manufacturer.  5.  In accordance with Article 3 (3) (a), the health hazards shall be assessed by the conventional method described below, using individual concentration limits.  Where the dangerous substances listed in Annex I to Directive 67/548/EEC are assigned concentration limits necessary for the application of the method of assessment described below, these concentration limits must be used.  Where the dangerous substances do not appear in Annex I to Directive 67/548/EEC or appear there without the concentration limits necessary for the application of the method of evaluation described below, the concentration limits shall be assigned in accordance with the specifications in Annex I to this  Directive.  When a preparation contains at least one substance which, in accordance with Article 8 (2) of Directive 67/548/EEC, bears the warning ´Caution - substance not yet fully tested', the label of the preparation must bear the warning ´Caution - this  preparation contains a substance not yet fully tested' if the substance is present in a concentration equal to or in excess of 1 %.  However, this substance must be treated on the same basis as the other substances present in the preparation when applying the method of evaluation by calculation, if the labelling gave at least an indication of the health hazard.  In that case,  (a) The following preparations shall be regarded as very toxic:  ii(i) owing to their acute lethal effects, preparations containing one or more substances classified or regarded as very toxic in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 1 of Annex I (Table I) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  i(ii) owing to their acute lethal effects, preparations containing more than one substance classified or regarded as very toxic in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at point 1 of Annex I  (Table I) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each very toxic substance in the preparation by the limit specified for that substance is 1 or more, i.e.    S  (  )  ·  1   S ( PT+ LT+ ) · 1 where:  PT+ = is the percentage by weight of each very toxic substance in the preparation,  LT+ = is the limit specified for each very toxic substance expressed as a percentage;  (iii) owing to their non-lethal irreversible effects after one exposure, preparations containing one or more dangerous substances that produce such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 2 of Annex I (Table II) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (b) The following preparations shall be regarded as toxic:  ii(i) owing to their acute lethal effects, preparations containing one or more substances classified or regarded as very toxic, toxic or in individual concentrations exceeding:  -  either the concentrations specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 1 of Annex I (Table I) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  i(ii) owing to their acute lethal effects, preparations containing more than one substance classified or regarded as very toxic or toxic in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at point 1 of  Annex I (Table I) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each substance in the preparation by the toxic limit specified for that substance is 1 or more, i.e.    S  (  +  )  ·  1   S ( PT+ LT + PT LT ) · 1 where:  PT+ is the percentage by weight of each very toxic substance in the preparation,  PT is the percentage by weight of each toxic substance in the preparation,  LT is the limit specified for each very toxic or toxic substance expressed as a percentage;  (iii) owing to their non-lethal irreversible effects after one exposure, preparations containing one or more dangerous substances that produce such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 2 of Annex I (Table II) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  i(iv) owing to their long-term effects, preparations containing one or more dangerous substances that produce such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 3 of Annex I (Table III) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (c) The following preparations shall be regarded as harmful:  ii(i) owing to their acute lethal effects, preparations containing one or more substances classified or regarded as very toxic, toxic or harmful in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 1 of Annex I (Table I) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  i(ii) owing to their acute lethal effects, preparations containing more than one of the substances classified or regarded as very toxic or toxic or harmful in individual concentrations not exceeding the limits specified either in Annex I to Directive  67/548/EEC or at point 1 of Annex I (Table I) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each substance in the preparation by the harmful limit specified for that substance is 1 or more, i.e.    S  (  +  +  )  ·  1   S ( PT+ LXn + PT LXn + PXn LXn ) · 1 where:  PT+ is the percentage by weight of each very toxic substance in the preparation,  PT is the percentage by weight of each toxic substance in the preparation,  PXn is the percentage by weight of each harmful substance in the preparation,  LXn is the limit specified for each very toxic, toxic or harmful substance expressed as a percentage;  (iii) owing to their non-lethal irreversible effects after one exposure, preparations containing one or more dangerous substances that produce such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 2 of Annex I (Table II) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  (iv) owing to their long-term effects, preparations containing one or more dangerous substances that produce such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 3 of Annex I (Table III) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  i(v) owing to their sensitizing effects by inhalation, preparations containing at least one dangerous substance to which is assigned phrase R 42 that produces such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 5 of Annex I (Table V) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (d) The following preparations shall be regarded as very corrosive (19):  i(i) preparations containing one or more substances classified or regarded as corrosive to which is assigned phrase R 35 in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 4 of Annex I (Table IV) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  (ii) preparations containing more than one substance classified or regarded as corrosive to which is assigned phrase R 35 in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at point 4 of Annex I  (Table IV) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each corrosive substance in the preparation by the corrosive limit specified for that substance is 1 or more, i.e.    S  (  )  ·  1   S ( PC, R 35 LC, R 35 ) · 1 where:  PC, R 35 is the percentage by weight of each corrosive substance in the preparation,  LC, R 35 is the corrosive limit specified for each corrosive substance to which is assigned phrase R 35 expressed as a percentage by weight.  (e) The following preparations shall also be regarded as corrosive:  i(i) preparations containing one or more substances classified or regarded as corrosive to which is assigned phrase R 34 in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 4 of Annex I (Table IV) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  (ii) preparations containing more than one substance classified or regarded as corrosive to which is assigned phrase R 34 in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at point 4 of Annex I  (Table IV) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each corrosive substance in the preparation by the corrosive limit specified for that substance is 1 or more, i.e.    S  (  +  )  ·  1   S ( PC, R 35 LC, R 34 + PC, R 34 LC, R 34 ) · 1 where:  PC, R 35 is the percentage by weight of each corrosive substance to which is assigned phrase R 35 in the preparation,  PC, R 34 is the percentage by weight of each corrosive substance to which is assigned phrase R 34 in the preparation,  LC, R 34 is the corrosive limit specified for each corrosive substance to which is assigned phrase R 34 expressed as a percentage by weight.  (f) The following preparations shall be regarded as liable to cause serious eye damage:  i(i) preparations containing one or more substances classified or regarded as irritant and to which is assigned phrase R 41 in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 4 of Annex I (Table IV) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  (ii) preparations containing more than one of the substances classified or regarded as corrosive or irritant to which is assigned phrase R 41 in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at  point 4 of Annex I (Table IV) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each substance in the preparation by the irritant limit specified for that substance is 1 or more, i.e.    S  (  )  ·  1   S ( PXi, R 41 LXi, R 41 ) · 1 where:  PXi, R 41 is the percentage by weight of each irritant substance to which is assigned phrase R 41 in the preparation,  LXi, R 41 is the irritant limit specified for each irritant substance to which is assigned phrase R 41 expressed as a percentage by weight.  (g) The following preparations shall be regarded as skin irritants:  ii(i) preparations containing one or more substances classified or regarded as corrosive or irritant to which is assigned phrase R 38 in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 4 of Annex I (Table IV) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  i(ii) preparations containing more than one of the substances classified or regarded as corrosive or irritant to which is assigned phrase R 38 in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at  point 4 of Annex I (Table IV) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each substance in the preparation by the irritant limit specified for that substance is 1 or more, i.e.  S  ( +  + )  ·  1  S ( PC, R 35 LXi, R 38 + PC, R 34 LXi, R 38 + PXi, R 38 LXi, R 38 ) · 1 where:  PC, R 35 is the percentage by weight of each corrosive substance to which is assigned phrase R 35 in the preparation,  PC, R 34 is the percentage by weight of each corrosive substance to which is assigned phrase R 34 in the preparation,  PXi, R 38 is the percentage by weight of each irritant substance to which is assigned phrase R 38 in the preparation,  LXi, R 38 is the irritant limit specified for each corrosive or irritant substance to which is assigned phrase R 38 expressed as a percentage by weight;  (iii) owing to their sensitizing effects by skin contact, preparations containing at least one dangerous substance to which is assigned phrase R 43 that produces such effects in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or -  the concentration specified at point 5 of Annex I (Table V) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (h) The following preparations shall be regarded as eye irritants:  i(i) preparations containing one or more substances classified or regarded as irritant to which is assigned phrase R 41 or R 36 in individual concentrations exceeding:  -  either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or -  the concentration specified at point 4 of Annex I (Table IV) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  (ii) preparations containing more than one of the substances classified or regarded as irritant to which is assigned phrase R 41 or phrase R 36 in individual concentrations not exceeding the limits specified in Annex I to Directive 67/548/EEC or at point 4  of Annex I (Table IV) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each substance in the preparation by the irritant limit specified for that substance is 1 or more, i.e.    S  (  +  )  ·  1   S ( PXi, R 41 LXi, R 36 + PXi, R 36 LXi, R 36 ) · 1 where:  PXi, R 41 is the percentage by weight of each irritant substance which is assigned phrase R 41 in the preparation,  PXi, R 36 is the percentage by weight of each irritant substance to which is assigned phrase R 36 in the preparation,  LXi, R 36 is the irritant limit specified for each irritant substance to which is assigned phrase R 41 or phrase R 36 expressed as a percentage by weight.  (i) The following preparations shall be regarded as irritants for the respiratory system:  i(i) preparations containing one or more substances classified or regarded as irritant to which is assigned phrase R 37 in individual concentrations exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or - the concentration specified at point 4 of Annex I (Table IV) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;  (ii) preparations containing more than one of the substances classified or regarded as irritant to which is assigned phrase R 37 in individual concentrations not exceeding the limits specified either in Annex I to Directive 67/548/EEC or at point 4 of Annex  I (Table IV) to this Directive if the sum of the quotients obtained by dividing the percentage by weight of each substance in the preparation by the irritant limit specified for that substance is 1 or kore, i.e.    S  (  )  ·  1   S ( PXi, R 37 LXi, R 37 ) · 1 where:  PXi, R 37 is the percentage by weight of each irritant substance to which is assigned phrase R 37 in the preparation,  PXi, R 37 is the irritant limit specified for each irritant substance to which is assigned phrase R 37 expressed as a percentage by weight.  (j) Preparations shall be regarded as:  carcinogenic and assigned at least the symbol and indication of danger ´toxic', if they contain a substance producing such effects, to which is assigned the standard phrase R 45, which denotes carcinogenic substances in category 1 and category 2, in a  concentration equal to or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (k) Preparations shall be regarded as:  suspect for humans owing to their possible carcinogenic effects and assigned at least the symbol and indication of danger ´harmful', if they contain a substance producing such effects to which is assigned the standard phrase R 40, which denotes  carcinogenic substances in category 3, in a concentration equal to or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 in Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (l) Preparations shall be regarded as:  mutagenic and assigned at least the symbol and indication of danger ´toxic' if they contain a substance producing such effects, to which is assigned the standard phrase R 46 which denotes mutagenic substances in category 1, in a concentration equal to  or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (m) Preparations shall be regarded as having to be treated as mutagenic and assigned at least the symbol and indication of danger ´harmful' if they contain a substance producing such effects to which is assigned the standard phrase R 46, which denotes  mutagenic substances in category 2, in a concentration equal to or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (n) Preparations shall be regarded as:  suspect for humans because of their possible mutagenic effects and assigned at least the symbol and indication of danger ´harmful' if they contain a substance producing such effects to which is assigned the standard phrase R 40, which denotes mutagenic  substances in category 3, in a concentration equal to or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (o) Preparations shall be regarded as:  teratogenic and assigned at least the symbol and indication of danger ´toxic' if they contain a substance producing such effects, which is assigned the standard phrase R 47, which denotes teratogenic substances in category 1, in a concentration equal to  or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (p) Preparations shall be regarded as:  having to be treated as teratogenic and assigned at least the symbol and indication of danger ´harmful', if they contain a substance producing such effects to which is assigned the standard phrase R 47, which denotes teratogenic substances in category  2, in a concentration equal to or exceeding:  - either the concentration specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.  (q) Preparations shall be regarded as:  having specific effects on health not further defined and assigned at least the symbol and indication of danger ´harmful' if they contain a substance which does not yet appear in Annex I to Directive 67/548/EEC but to which is provisionally assigned the  standard phrase R 40 denoting such substances in a concentration exceeding that specified at point 6 of Annex I (Table VI) to this Directive.  6.  For preparations covered by this Directive:  (a)  No account shall be taken of substances whether or not listed in Annex I to Directive 67/548/EEC, whether existing as impurities or as additives, if their concentration by weight is less than:  - 0,1 % for substances classified as very toxic or toxic,  - 1 % for substances classified as harmful, corrosive or irritant,  unless lower values have been specified in Annex I to Directive 67/548/EEC.  (b)  Dangerous substances not listed in Annex I to Directive 67/548/EEC but used as constituents of a preparation in a concentration by weight higher than that given at point (a) of this paragraph shall be given concentration limits characterizing the  health hazards.  Some substances may have more than one property harmful to health, e.g. harmfulness/irritation, corrosiveness/harmfulness, corrosiveness/sensitiza- tion; each of these properties must therefore be characterized by its specific concentration limit.  These concentration limits shall be determined in accordance with Annex I to this Directive by the manufacturer or any other person who places such a preparation on the market.  Article 4 The classification of dangerous preparations according to the degree of hazard and the specific nature of the risks involved shall be based on the definitions laid down in Article 2. The preparations shall be classified according to the  greatest degree of hazard in accordance with Article 7 (1) (d).  Article 5 1.  Member States shall take all necessary measures to ensure that the preparations envisaged by this Directive cannot be placed on the market unless they comply therewith.  2.  If there is any doubt with regard to the compliance referred to in paragraph 1, Member States may request information on the composition of the preparation and any other pertinent information.  3.  To this end, the manufacturer, or those responsible for placing the preparation on the market, shall hold the data used for the classification and labelling of the preparation at the disposal of the authorities of the Member States.  Article 6 1.  Member States shall take all the necessary measures to ensure that:  (a)  dangerous preparations are not placed on the market unless their packaging meets the requirements of Article 15 (1) of Directive 67/548/EEC with respect to their strength, leak-tightness and fastening systems;  (b)  containers which contain dangerous preparations offered or sold to the general public do not have:  - either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers,  - or a presentation and/or a designation used for human and animal foodstuffs, medicinal or cosmetic products.  2.  Member States shall take all the necessary measures to ensure that containers containing certain categories of dangerous preparations offered or sold to the general public and defined in accordance with the procedure referred to in paragraph 3:  - are fitted with child-resistant fastenings,  - carry a tactile warning of danger.  3.  The categories of dangerous preparations the packaging of which have to be fitted with the devices referred to in paragraph 2 shall be defined by the procedure referred to in Article 21 of Directive 67/548/EEC.  The technical specifications relating to such devices are given in parts A and B of Annex IX to Directive 67/548/EEC.  Article 7 1.  The following information shall be clearly and indelibly marked on any package:  (a) the trade name or designation of the preparation;  (b) the name and full address including the telephone number of the person established in the Community who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;  (c) the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules:  i(i) - in the case of preparations classified as T+, T or Xn in accordance with Article 3, only T+, T and Xn substances present in concentrations equal to or in excess of the lowest limit (Xn limit) for each of them laid down in Annex I to this  Directive or to Directive 67/548/EEC must be taken into consideration,  - in the case of preparations classified as C in accordance with Article 3, only C substances present in concentrations equal to or in excess of the lowest limit (Xi limit) laid down in Annex I to this Directive or to Directive 67/548/EEC must be taken  into consideration,  - in the case of preparations to which are assigned phrases R 42, R 43, or R 42/43 in accordance with Article 3, only substances to which those phrases are assigned and which are present in concentrations equal to or in excess of the limit laid down in  Annex I to this Directive or to Directive 67/548/EEC must be taken into consideration;  (ii) as a general rule a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary.  If the preparation is assigned in accordance with Article 3, one of the standard phrases R 39, R 40, R 42, R 43, R 42/43, R 45, R 46, R 47 and/or R 48, the name of the substance or substances must be mentioned.  The chemical name shall be one of the designations listed in Annex I to Directive 67/548/EEC or an internationally recognized designation if it is not yet listed therein.  Where a manufacturer can demonstrate that the disclosure of the chemical identity of a harmful substance not assigned one or more of the R phrases mentioned above on the label of a preparation will put at risk the confidential nature of his property, he  shall be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name.  Where this is the case, the manufacturer must inform the authorities of the Member State where the preparation is first placed on the market. These authorities shall inform the Commission and the other Member States.  Confidential information brought to the attention of the authorities of a Member State or of the Commission shall be treated in accordance with Article 11 (4) of Directive 67/548/EEC;  (d) the symbols, where specified in this Directive, for and indications of the dangers involved in the use of the preparation, in accordance with Article 16 (2) (c) of Directive 67/548/EEC read in conjunction with Annex II thereto, and, in the case of  aerosol preparations, in accordance with points 1.8 and 2.2 (c) of the Annex to Directive 75/324/EEC as far as flammability hazards are concerned.  Where more than one danger symbol has to be assigned to a preparation:  - the obligation to apply the symbol T shall make the symbols C and X optional,  - the obligation to apply the symbol C shall make the symbol X optional,  - the obligation to apply the symbol E shall make the symbols F and O optional;  (e) standard phrases indicating the special risks arising from such dangers (R phrases).  The indications concerning special risks (R phrases) shall conform to the wording in Annex III to Directive 67/548/EEC and shall be provided by the manufacturer or any other person placing the preparation on the market, in accordance with Annex I to  this Directive and Annex VI, point II (D) to Directive 67/548/EEC.  As a general rule a maximum of four R phrases shall suffice to describe the risks; for this purpose the combined phrases listed in the aforementioned Annex III shall be regarded as single phrases. If the preparation falls within more than one danger  category, however, these standard phrases must cover all the principal hazards associated with the preparation.  Thus, if a preparation is classified as both harmful and irritant, it shall be labelled ´harmful' and attention shall be drawn to its twin harmful and irritant characteristics by the appropriate R phrases.  The standard phrases ´extremely flammable' or ´highly flammable' need not appear if they repeat an indication of danger used pursuant to paragraph (d);  (f) one or more standard phrases indicating the safety advice relating to the use of the preparation (S phrases).  The indications giving safety advice (S phrases) shall conform to the wording in Annex IV to Directive 67/548/EEC and shall be provided by the manufacturer or any other person placing the preparation on the market, in accordance with Annex II to this  Directive and Annex VI, point II (D) to Directive 67/548/EEC.  As a general rule, a maximum of four S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in the aforementioned Annex IV shall be regarded as single phrases.  The package shall be accompanied by safety advice on the use of the preparation where it is physically impossible to include the advice on the label or package itself.  In the case of highly flammable and flammable oxidizing preparations, there is no need to give a reminder of the special risks or the safety advice if the contents of the package do not exceed 125 ml. The same shall apply in the case of irritant  preparations except where they contain substances that might cause sensitization.  (g) the nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations sold to the general public.  2.  The special provisions applicable to certain preparations are set out in Annex II.  3.  Article 3 (6) (a) shall apply mutatis mutandis to labelling.  4.  Information such as ´non toxic', ´not harmful' or any other statement indicating that the preparation is not dangerous may not appear on the packaging or labelling of the preparations referred to in this Directive.  Article 8 1.  Where the particulars required by Article 7 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that the said particulars can be read horizontally when the package is set down normally. The  dimensions of the label shall be as follows:    Capacity of the package Dimensions (in millimetres) - not exceeding three litres:  if possible at least 52×74 - greater than three litres but not exceeding 50 litres:  at least 74×105 - greater than 50 litres but not exceeding 500 litres:  at least 105×148 - greater than 500 litres:  at least 148×210 Each symbol shall cover at least one-tenth of the surface area of the label but shall not be less than 1 cm$. The entire surface of the label shall adhere to the package immediately containing the preparation.  These dimensions are intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information.  2.  A label is not required when the particulars are clearly shown on the package itself, as specified in paragraph 1.  3.  The colour and presentation of the label - or, in the case of paragraph 2, of the package - shall be such that the danger symbol and its background stand out clearly from it.  4.  Member States may make the placing of dangerous preparations on the market in their territory subject to the use of their official language or languages for the purposes of labelling.  5.  For the purpose of this Directive, labelling requirements shall be deemed to be satisfied:  (a)  in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous preparations and the inner package or packages are labelled in accordance with this Directive;  (b)  in the case of a single package, if such a package is labelled in accordance with international rules on the transport of dangerous preparations and with Article 7 (1) (a), (b), (c), (e) and (f), and (3).  For dangerous preparations that are not leaving the territory of a Member State, the labelling may be in accordance with national regulations instead of with the international rules on the transport of dangerous preparations.  Article 9 1.  Member States may:  (a)  permit the labelling required by Article 7 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 8 (1) and (2);  (b)  by way of derogation from Articles 6 and 7, permit the packaging of dangerous preparations which are neither explosive, very toxic nor toxic to be unlabelled or to be labelled in some other way if they contain such small quantities that there is no  reason to fear any danger to persons handling such preparations or to other persons.  2.  If a Member State makes use of the options provided for in paragraph 1, it shall forthwith inform the Commission thereof.  Article 10 Member States shall take the measures necessary to implement a system of specific information (in safety data-sheet form) relating to dangerous preparations.  The detailed arrangements for this system shall be laid down in accordance with the procedure provided for in Article 21 of Directive 67/548/EEC within a period of three years after the adoption of the Directive, taking into account the systems in force  in the Member States.  This information is principally intended for use by industrial users and must enable them to take the necessary measures as regards the protection of health and safety at the place of work.  Article 11 This Directive shall not affect the right of Member States to specify, in due compliance with the Treaty, the requirements they deem necessary to ensure that workers are protected when using the dangerous preparations in question, provided this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in  this Directive.  Article 12 Member States shall appoint the body or bodies responsible for receiving information on dangerous preparations, including their chemical composition, placed on the market.  Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet any medical demand by  formulating preventive and curative measures, in particular in emergencies.  Member States shall ensure that the information is not used for other purposes.  For preparations already on the market, Member States shall take measures to comply with this Directive within three years from the adoption thereof.  Member States shall ensure that the appointed bodies shall have at their disposal all the information required to carry out the tasks for which they are responsible from the manufacturers or persons responsible for marketing. Article 13 Member States shall not prohibit, restrict or impede, on the grounds of classification, packaging or labelling as defined in this Directive, the placing on the market of dangerous preparations which satisfy thisDirective and in particular  Annex II thereto.  Article 14 1.  Where a Member State has detailed evidence that a preparation, although satisfying the requirements of this Directive, constitutes a hazard by reason of its classification, packaging or labelling, it may provisionally prohibit the sale of  that hazardous preparation or subject it to special conditions in its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.  2.  In the case referred to in paragraph 1, the Commission shall consult the Member States concerned as soon as possible and then deliver its opinion without delay and take the appropriate measures.  If the Commission considers that technical adaptations to this Directive are necessary, such adaptations shall be adopted in accordance with the procedure laid down in Article 21 of Directive 67/548/EEC. In such a case, Member States which have adopted  safeguard measures may maintain them until the adaptations enter into force.  Article 15 Amendments required to adapt the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 21 of Directive 67/548/EEC.  Article 16 1.  Member States shall bring into force not later than 36 months after the adoption of this Directive the laws, regulations and administrative provisions necessary to comply therewith. They shall forthwith inform the Commission thereof.  2.  Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive not more than six months thereafter.  3.  On the date this Directive enters into force, Directives 73/173/EEC and 77/728/EEC shall cease to apply. Nevertheless, preparations which are in conformity with the specifications of the abovementioned Directives may continue to be placed on the  market until one year after the abovementioned date.  Article 17 This Directive is addressed to the Member States.   Done at Luxembourg, 7 June 1988.  For the Council The President M. BANGEMANN EWG:L777UMBE05.95 FF: 7UEN;   SETUP: 01;   Hoehe: 6282 mm;   1280 Zeilen;   52671 Zeichen;  Bediener: MARL   Pr.: C;  Kunde: 41951 Montan England 05           (1) OJ No C 317, 10. 12. 1986, p. 10 and OJ No C 353, 30. 12. 1987, p. 1. (2) OJ No C 318, 30. 11. 1987, p. 73 and Decision of 13 April 1988 (not yet published in the Official Journal). (3) OJ No C 189, 28. 7. 1986, p. 1. (4) OJ No 196, 16. 8. 1967, p. 1. (5) OJ No L 259, 15. 10. 1979, p. 10. (6) OJ No L 189, 11. 7. 1973, p. 7. (7) OJ No L 229, 30. 8. 1980, p. 57.(8) OJ No L 303, 28. 11. 1977, p. 23.(9) OJ No L 147, 6. 6. 1983, p. 11. (10) OJ No L 358, 18. 12. 1986, p. 1.(11) OJ No L 206, 29. 7. 1978, p. 13. (12) OJ No L 144, 30. 5. 1984, p. 1.(13) OJ No 22, 9. 2. 1965, p. 369/65. (14) OJ No L 15, 17. 1. 1987, p. 36. (15) OJ No L 262, 27. 9. 1976, p. 169. (16) OJ No L 149, 3. 6. 1986, p. 38. (17) OJ No L 194, 25. 7. 1975, p. 39. (18) OJ No L 84, 31. 3. 1978, p. 43.(19) OJ No L 147, 9. 6. 1975, p. 40.(20) Within the meaning of this Directive ´very corrosive substance' means a substance to which is assigned the symbol C and the phrase denoting a risk R 35.   ANNEX I   CONCENTRATION LIMITS TO BE USED IN APPLYING THE CONVENTIONAL METHOD OF ASSESSING HEALTH HAZARDS IN ACCORDANCE WITH ARTICLE 3 (5)  An assessment must be made of all the health hazards that the use of a substance might entail. For that purpose the  dangerous health effects have been subdivided into:  - acute lethal effects,  - non-lethal irreversible effects after a single exposure,  - severe effects after repeated or prolonged exposure;  - corrosive effects,  - irritant effects,  - sensitizing effects;  - carcinogenic effects,  - mutagenic effects,  - teratogenic effects.  The systematic assessment of all the dangerous health effects is expressed by means of concentration limits in conjunction with the classification of the substance, i.e. the symbol and phrases denoting the risk. Therefore given the symbol priority rule,  it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration.  1. Acute lethal effects The concentration limits fixed in Table I determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.  TABLE I      Classification of the substance Classification of the preparation T+ T Xn T+ with R 26, R 27, R 28 concentration · 7 % 1 % § concentration <  7 % 0,1 % § concentration <  1 % T with R 23, R 24, R 25   concentration · 25 % 3 % § concentration <  25 % Xn with R 20, R 21, R 22     concentration · 25 % The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:  - the label shall include one or more of the abovementioned R phrases according to the classification used,  - in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.  2. Non-lethal irreversible effects after a single exposure For substances that produce non-lethal irreversible effects after a single exposure (R 39, R 40), the individual concentration limits specified in Table II determine, when appropriate, the classification of the preparation and shall determine which  particular standard R phrase is to be assigned to it.  TABLE II      Classification of the substance Classification of the preparation T+ T Xn T+ with R 39 concentration · 10 % R 39 (*) obligatory 1 % § concentration <  10 % R 39 (*) obligatory 0,1 % § concentration <  1 % R 40 (*) obligatory T with R 39   concentration · 10 % R 39 (*) obligatory 1 % § concentration <  10 % R 40 (*) obligatory Xn with R 40     concentration · 10 % R 40 (*) obligatory (*) In accordance with the labelling guide of Annex VI, point II (D) of Directive 67/548/EEC and depending on the classification, the standard R phrases R 20 to R 28 are also to be assigned to indicate route of administration or means of exposure.  3. Severe effects after repeated or prolonged exposure For substances that produce severe effects after repeated or prolonged exposure (R 48), the individual concentration limits specified in Table III determine, when appropriate, the classification of the preparation and shall determine which particular  standard R phrase is to be assigned to it.  TABLE III    Classification of the substance Classification of the preparation T Xn T with R 48 concentration · 10 % R 48 (*) obligatory 1 % § concentration <  10 % R 48 (*) obligatory Xn with R 48   concentration · 10 % R 48 (*) obligatory (*) In accordance with the labelling guide of Annex VI, point II (D) of Directive 67/548/EEC and depending on the classification, the standard R phrases R 20 to R 28 are also to be assigned to indicate route of administration or means of exposure.  4. Corrosive and irritant effects For substances that produce corrosive effects (R 34, R 35) or irritant effects (R 36, R 37, R 38, R 41) the individual concentration limits specified in Table IV determine, when appropriate, the classification of the preparation.  TABLE IV    Classification of the substance and/or relevant standard risk phrase Classification of the preparation and standard risk phrase at least C with R 35 at least C with R 34 at least Xi with R 41 at least Xi with R 36, R 37, R 38 at least C with R 35 concentration · 10 % R 35;  obligatory 5 % § concentration <  10 % R 34;  obligatory   1 % § concentration <  5 % R 36, R 38;  obligatory at least C with R 34   concentration · 10 % R 34;  obligatory   5 % § concentration <  10 % R 36, R 38;  obligatory at least Xi with R 41     concentration · 10 % R 41;  obligatory 5 % § concentration <  10 % R 36 obligatory at least Xi with R 36, R 37, R 38       concentration · 20 % R 36, R 37 and R 38 are obligatory in the light of the concen- tration present if they apply to the substances under consideration 5. Sensitizing effects Substances that produce such effects are classified:  - at least as harmful (Xn) and assigned R 42 if this effect can be produced by inhalation,  - at least as irritant (Xi) and assigned R 43 if this effect can be produced through contact with the skin,  - at least as harmful (Xn) and assigned R 42/43 if this effect can be produced in both these ways.  The individual concentration limits specified in Table V determine, when appropriate, the classification of the preparation, and shall determine which particular R phrase is to be assigned to it.  TABLE V    Classification of the substance Classification of the preparation and standard risk phrase At least Xn and R 42 At least Xi and R 43 At least Xn and R 42 concentration · 1 % R 42 obligatory   At least Xi and R 43   concentration · 1 % R 43 obligatory At least Xn and R 42/43 concentration · 1 % R 42/43 obligatory   6. Carcinogenic/mutagenic/teratogenic effects For substances which produce such effects and for which specific concentration limits do not yet appear in Annex I to Directive 67/548/EEC and for those which, in accordance with point 3.1.1 of Annex III to Directive 83/467/EEC, are provisionally  assigned the phrase R 40, the concentration limits laid down in Table VI shall determine, where appropriate, the classification of the preparation and the compulsory R phrase to be assigned to it. TABLE VI    Substance Classification of the preparation and standard risk phrase At least T At least Xn At least T with R 45 for carcinogenic substances of category 1 or 2 · 0,1 % R 45 obligatory   At least Xn with R 40 for carcinogenic substances of category 3   · 1 % R 40 obligatory At least T with R 46 for mutagenic substances of category 1 · 0,1 % R 46 obligatory   At least Xn with R 46 for mutagenic substances of category 2   · 0,1 % R 46 obligatory At least Xn with R 40 for mutagenic substances of category 3   · 1 % R 40 obligatory At least T with R 47 for teratogenic substances of category 1 · 0,5 % R 47 obligatory   At least Xn with R 47 for teratogenic substances of category 2   · 5 % R 47 obligatory At least Xn and R 40 provisionally in accordance with point 3.1.1 of Annex III to Directive 83/467/EEC   · 1 % R 40 obligatory EWG:L777UMBE06.95 FF: 7UEN;   SETUP: 01;   Hoehe: 772 mm;   266 Zeilen;   7043 Zeichen;  Bediener: JUTT   Pr.: C;  Kunde: 41951 Montan England 06            ANNEX II   SPECIAL PROVISIONS ON THE LABELLING OF CERTAIN PREPARATIONS  1.  PREPARATIONS CLASSIFIED AS VERY TOXIC, TOXIC OR CORROSIVE, SOLD TO THE GENERAL PUBLIC 1.1.  The labels on packages containing such preparations must compulsorily bear the safety advice S1/S2 and S46 in addition to the specific safety advice.  1.2.  Where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where necessary, instructions for the  destruction of the empty package.  2.  PREPARATIONS CONTAINING LEAD 2.1.  Paints and varnishes Labels of packages of paints and varnishes containing lead in quantities exceeding 0,25 % expressed as weight of metal, of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984 must show the following particulars:  ´Contains lead. Should not be used on surfaces liable to be chewed or sucked by children.' In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows:  ´Warning. Contains lead.' 3.  PREPARATIONS CONTAINING CYANOACRYLATES 3.1.  Glues The immediate packaging of glues based on cyanoacrylate must bear the following inscriptions:  ´Cyanoacrylate.  Danger.  Bonds skin and eyes in seconds.  Keep out of the reach of children.' Appropriate advice on safety must accompany the package.  4.  PREPARATIONS CONTAINING ISOCYANATES The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions:  ´Contains isocyanates.  See information supplied by the manufacturer.' 5.  PREPARATIONS CONTAINING EPOXY CONSTITUENTS WITH AN AVERAGE MOLECULAR WEIGHT § 700 The package labels of preparations containing epoxy constituents with an average molecular weight § 700 must bear the following inscriptions:  ´Contains epoxy constituents.  See information supplied by the manufacturer.' 6.  PREPARATIONS INTENDED FOR USE BY SPRAYING The package label on preparations intended for use by spraying must bear the safety advice S 23 and S 38 or S 23 and S 51 depending on the application criteria specified in Directive 83/467/EEC.  EWG:L777UMBE07.95 FF: 7UEN;   SETUP: 01;   Hoehe: 253 mm;   41 Zeilen;   2306 Zeichen;  Bediener: JUTT   Pr.: C;  Kunde: 41951 Montan England 07


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31996L0075

Council Directive 96/75/EC of 19 November 1996 on the systems of chartering and pricing in national and international inland waterway transport in the Community

Official Journal L 304 , 27/11/1996 P. 0012 - 0014

COUNCIL DIRECTIVE 96/75/EC of 19 November 1996 on the systems of chartering and pricing in national and international inland waterway transport in the CommunityTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),Whereas the growing problems of road and rail saturation, transport safety, environment, energy saving and quality of life of the citizen call, in the public interest, for greater development and better use of the transport potential offered by inland waterway, in particular by improving its competitiveness;Whereas the difference in national laws on the systems for the commercial operation of inland waterway transport, does not make for the smooth functioning of the internal market in this sector; whereas, therefore, common provisions should be introduced at Community level for the whole of the inland waterways market, in accordance with the Council Resolution of 24 October 1994 on structural improvements in inland waterway transport (4);Whereas the smooth functioning of the internal market calls for an adjustment in inland waterways transport to the organization of chartering by rotation, so as to move towards greater commercial flexibility and a system of freedom of chartering and pricing;Whereas, to this end provision should be made for a transitional period, the scope of the rotation system being gradually limited for carriers to adapt to the conditions of a free market and, where appropriate, to set up trade groupings better suited to the logistical needs of shippers;Whereas, in accordance with the principle of subsidiarity, it is both necessary and adequate to set a uniform timetable at Community level for the gradual liberalization of the market, while leaving with the Member States the responsibility for putting such liberalization into effect;Whereas provisions must be adopted to allow action to be taken on the transport market in question in the event of a serious disturbance; whereas, to this end, the Commission should be given the power to take appropriate measures, in accordance with the procedure of an advisory committee,HAS ADOPTED THIS DIRECTIVE:Article 1 For the purposes of this Directive:(a) 'system of chartering by rotation` shall mean a system which consists of allocating in a charter exchange requests for transport operations, at previously fixed prices and under conditions made known, from customers on the basis of the order in which vessels become available after unloading. Carriers are asked, in the order of their registration on the rota, to choose in turn a load from those on offer. Those who make no choice nonetheless keep their position in the order;(b) 'carrier` shall mean an owner or an operator of one or more inland waterway vessels;(c) 'competent authority` shall mean the authority appointed by the Member State to manage and organize the system of chartering by rotation;(d) 'serious market disturbance` shall mean the emergence, in the inland waterway transport market, of problems specific to that market likely to cause a serious and potentially persistent excess of supply over demand, thereby posing a serious threat to the financial stability and survival of a large number of inland waterway carriers, unless the short and medium-term forecasts for the market in question indicate substantial and lasting improvements.Article 2 In the field of national and international inland waterway transport in the Community, contracts shall be freely concluded between the parties concerned and prices freely negotiated.Article 3 Notwithstanding Article 2, Member States may, for a transitional period up to 1 January 2000, maintain a system of minimum compulsory tariffs and systems of chartering by rotation, provided that:- there is compliance with the conditions set out in Articles 4, 5 and 6; and- the rotation and pricing systems imposed are freely accessible under the same conditions to all Member States' carriers.Article 4 During the transitional period referred to in Article 3, the following shall not be subject to such systems of chartering by rotation:(a) oil and gas, liquid cargo and dry bulk freight, special cargoes such as heavy and indivisible loads, container transport, transport within port areas, any kind of own-account transport and any type of transport operation already outside the system of chartering by rotation;(b) loads which cannot be effectively dealt with by such systems, in particular:- transport requiring goods handling equipment,- combined transport, namely intermodal transport where the routes are principally by inland waterway and the initial and/or terminal legs (as short as possible) are by road or rail.Article 5 During the transitional period referred to in Article 3, Member States shall take the necessary steps to maximize flexibility in the systems of chartering by rotation, in particular:- by providing shippers with the opportunity of concluding contracts for multiple trips, i.e. a series of successive trips using the same vessel,- by providing that single or multiple trips offered twice consecutively under the system of chartering by rotation without finding any takers shall be taken out of that system and be freely negotiated.Article 6 Within a period of two years from the entry into force of this Directive, Member States involved in systems of chartering by rotation shall take the necessary measures to enable shippers to have a free choice between three types of contract:- contracts on a time basis, including leasing contracts, where the carrier makes one or more vessels and crew exclusively available to a customer for a specific period for the transport of goods for that customer against payment of a given sum of money per day. The contract is freely concluded between the parties,- tonnage contracts where the carrier undertakes to transport, for a period laid down in the contract, a given tonnage against payment of cargo rates by the tonne. The contract is freely concluded between the parties and must involve large consignments,- contracts for single or multiple trips.Article 7 1. In the event of a serious disturbance in the inland waterway transport market, the Commission may, without prejudice to Council Regulation (EEC) No 1101/89 of 27 April 1989 on structural improvements in inland waterway transport (5), at the request of a Member State, take suitable measures, and in particular measures designed to prevent any new increase in the transport capacity on offer on the market in question. The decision shall be taken in accordance with the procedure laid down in Article 8 (2).2. In the event of a request from a Member State for suitable measures, a decision shall be taken within a period of three months from receipt of the request.3. The request from a Member State for suitable measures to be taken must be accompanied by all the information needed to assess the economic situation in the sector in question, in particular:- indication of the average costs and prices for the different types of transport,- the rate of utilization of the hold,- forecast demand.This information may be used only for statistical purposes. It may not be used for tax purposes or communicated to third parties.4. Decisions taken pursuant to this Article, which may not exceed the duration of the disturbance in the market, shall be notified immediately to the Member States.Article 8 1. The Commission shall be assisted by the Committee established by Directive 91/672/EEC (6).2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, where necessary by vote, within a time limit which the Chairman may lay down according to the urgency of the matter.The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.Article 9 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1997. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall forthwith communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.Article 10 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.Article 11 This Directive is addressed to the Member States.Done at Brussels, 19 November 1996.For the CouncilThe PresidentH. COVENEY(1) OJ No C 318, 29. 11. 1995, p. 8.(2) OJ No C 39, 12. 2. 1996, p. 96.(3) Opinion of the European Parliament of 13 February 1996 (OJ No C 65, 4. 3. 1996, p. 32) common position of the Council of 27 June 1996 (OJ No C 264, 11. 9. 1996) and Decision of the European Parliament of 17 September 1996 (OJ No C 320, 28. 6. 1996).(4) OJ No C 309, 5. 11. 1994, p. 5.(5) OJ No L 116, 28. 4. 1989, p. 25. Regulation as last amended by Regulation (EC) No 2254/96 (see page 1 of this Official Journal).(6) OJ No L 373, 31. 12. 1991, p. 29. Directive as amended by the 1994 Act of Accession.


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31983L0477

Council Directive 83/477/EEC of 19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC)

Official Journal L 263 , 24/09/1983 P. 0025 - 0032 Finnish special edition: Chapter 5 Volume 4 P. 0003  Spanish special edition: Chapter 05 Volume 4 P. 0014  Swedish special edition: Chapter 5 Volume 4 P. 0003  Portuguese special edition Chapter 05 Volume 4 P. 0014

*****COUNCIL  DIRECTIVE  of 19 September 1983  on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC)  (83/477/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the Council resolution of 29 June 1978 on an action programme of the European Communities on safety and health at work (4) provides for the establishment of specific harmonized procedures regarding the protection of workers with respect to asbestos;  Whereas Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (5) laid down certain provisions which have to be taken into account for this protection; whereas that Directive provides for the laying down in individual Directives of limit values and specific requirements for those agents listed in Annex I, which include asbestos;  Whereas asbestos is a harmful agent found in a large number of circumstances at work; whereas many workers are therefore exposed to a potential health risk; whereas crocidolite is considered to be a particularly dangerous type of asbestos;  Whereas, although current scientific knowledge is not such that a level can be established below which risks to health cease to exist, a reduction in exposure to asbestos will nonetheless reduce the risk of developing asbestos-related disease; whereas this Directive includes minimum requirements which will be reviewed on the basis of experience acquired and of developments in technology in this area;  Whereas optical microscopy, although it does not allow a counting of the smallest fibres detrimental to health, is the most currently used method for the regular measuring of asbestos;  Whereas, therefore, preventive measures for the protection of the health of workers exposed to asbestos and the commitment envisaged for Member States with regard to the surveillance of their health are important,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. This Directive, which is the second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC, has as its aim the protection of workers against risks to their health, including the prevention of such risks, arising or likely to arise from exposure to asbestos at work. It lays down limit values and other specific requirements.  2. This Decision shall not apply to:  - sea transport,  - air transport.  3. This Directive shall not prejudice the right of Member States to apply or introduce laws, regulations or administrative provisions ensuring greater protection for workers, in particular as regards the replacement of asbestos by less-dangerous substitutes.  Article 2  For the purposes of this Directive, 'asbestos' means the following fibrous silicates:  - Actinolite, CAS No 77536-66-4 (*) (1),  - Asbestos gruenerite (amosite) CAS No 12172-73-5 (*) (1),  - Anthophyllite, CAS No 77536-67-5 (*) (1),  - Chrysotile, CAS No 12001-29-5 (1),  - Crocidolite, CAS No 12001-28-4 (1),  - Tremolite, CAS No 77536-68-6 (*) (1).  Article 3  1. This Directive shall apply to activities in which workers are or may be exposed in the course of their work to dust arising from asbestos or materials containing asbestos.  2. In the case of any activity likely to involve a risk of exposure to dust arising from asbestos or materials containing asbestos, this risk must be assessed in such a way as to determine the nature and degree of the workers' exposure to dust arising from asbestos or materials containing asbestos.  3. If the assessment referred to in paragraph 2 shows that the concentration of asbestos fibres in the air at the place of work in the absence of any individual protective equipment is, at the option of the Member States, at a level as measured or calculated in relation to an eight-hour reference period,  - lower than 0,25 fibre per cm3 and/or  - lower than a cumulative dose of 15,00 fibre-days per cm3 over three months,  Articles 4, 7, 13, 14 (2), 15 and 16 shall not apply.  4. The assessment provided for in paragraph 2 shall be the subject of consultation with the workers and/or their representatives within the undertaking or establishment and shall be revised where there is reason to believe that it is incorrect or there is a material change in the work.  Article 4  Subject to Article 3 (3), the following measures shall be taken:  1. The activities referred to in Article 3 (1) must be covered by a notification system administered by the responsible authority of the Member State.  2. The notification must be submitted by the employer to the responsible authority of the Member State, in accordance with national laws, regulations and administrative provisions. This notification must include at least a brief description of:  - the types and quantities of asbestos used,  - the activities and processes involved,  - the products manufactured.  3. Workers and/or their representatives in undertakings or establishments shall have access to the documents which are the subject of notification concerning their own undertaking or establishment in accordance with national laws.  4. Each time an important change occurs in the use of asbestos or of materials containing asbestos, a new notification must be submitted.  Article 5  The application of asbestos by means of the spraying process must be prohibited.  Article 6  For all activities referred to in Article 3 (1), the exposure of workers to dust arising from asbestos or materials containing asbestos at the place of work must be reduced to as low a level as is reasonably practicable and in any case below the limit values laid down in Article 8, in particular through the following measures if appropriate:  1. The quantity of asbestos used in each case must be limited to the minimum quantity which is reasonably practicable.  2. The number of workers exposed or likely to be exposed to dust arising from asbestos or materials containing asbestos must be limited to the lowest possible figure.  3. Work processes must, in principle, be so designed as to avoid the release of asbestos dust into the air.  If this is not reasonably practicable, the dust should be eliminated as near as possible to the point where it is released.  4. All buildings and/or plant and equipment involved in the processing or treatment of asbestos must be capable of being regularly and effectively cleaned and maintained.  5. Asbestos as a raw material must be stored and transported in suitable sealed packing.  6. Waste must be collected and removed from the place of work as soon as possible in suitable sealed packing with labels indicating that it contains asbestos. This measure shall not apply to mining activities.  The waste referred to in the preceding paragraph shall then be dealt with in accordance with Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (1).  Article 7  Subject to Article 3 (3), the following measures shall be taken:  1. In order to ensure compliance with the limit values laid down in Article 8, the measurement of asbestos in the air at the place of work shall be carried out in accordance with the reference method described in Annex I or any other method giving equivalent results. Such measurement must be planned and carried out regularly, with sampling being representative of the personal exposure of the worker to dust arising from asbestos or materials containing asbestos.  For the purposes of measuring asbestos in the air, as referred to in the preceding paragraph, only fibres with a length of more than five micrometres and a length/breadth ratio greater than 3: 1 shall be taken into consideration.  The Council, acting on a proposal from the Commission, and taking account in particular of progress made in scientific knowledge and technology and of experience gained in the application of this Directive, shall re-examine the provisions of the first sentence of paragraph 1 within five years following the adoption of this Directive, with a view to establishing a single method for measurement of asbestos-in-air concentrations at Community level.  2. Sampling shall be carried out after consulting the workers and/or their representatives in undertakings or establishments.  3. Sampling shall be carried out by suitably qualified personnel. The samples taken shall be subsequently analyzed in laboratories equipped to analyze them and qualified to apply the necessary identification techniques.  4. The amount of asbestos in the air shall be measured as a general rule at least every three months and, in any case, whenever a technical change is introduced. The frequency of measurements may, however, be reduced in the circumstances specified in paragraph 5.  5. The frequency of measurements may be reduced to once a year where:  - there is no substantial change in conditions at the place of work, and  - the results of the two preceding measurements have not exceeded half the limit values fixed in Article 8.  Where groups of workers are performing identical or similar tasks at the same place and are thus being exposed to the same health risk, sampling may be carried out on a group basis.  6. The duration of sampling must be such that representative exposure can be established for an eight-hour reference period (one shift) by means of measurements or time-weighted calculations. The duration of the various sampling processes shall be determined also on the basis of point 6 of Annex I.  Article 8  The following limit values shall be applied:  (a) concentration of asbestos fibres other than crocidolite in the air at the place of work:  1,00 fibres per cm3 measured or calculated in relation to an eight-hour reference period;  (b) concentration of crocidolite fibres in the air at the place of work:  0,50 fibres per cm3 measured or calculated in relation to an eight-hour reference period;  (c) concentration of asbestos fibres in the air at the place of work in the case of mixtures of crocidolite and other asbestos fibres:  the limit value is at a level calculated on the basis of the limit values laid down in (a) and (b), taking into account the proportions of crocidolite and other asbestos types in the mixture.  Article 9  The Council, acting on a proposal from the Commission, shall, taking into account, in particular, progress made in scientific knowledge and technology and in the light of experience gained in applying this Directive, review the provisions laid down in Article 3 (3) and in Article 8 before 1 January 1990.  Article 10  1. Where the limit values laid down in Article 8 are exceeded, the reasons for the limits being exceeded must be identified and appropriate measures to remedy the situation must be taken as soon as possible.  Work may not be continued in the affected area until adequate measures have been taken for the protection of the workers concerned.  2. In order to check the effectiveness of the measures mentioned in the first subparagraph of paragraph 1, a further determination of the asbestos-in-air concentrations shall be carried out immediately.  3. Where exposure cannot reasonably be reduced by other means and where the wearing of individual respiratory protective equipment proves necessary, this may not be permanent and shall be kept to the strict minimum necessary for each worker.  Article 11  1. In the case of certain activities in respect of which it is foreseeable that the limit values laid down in Article 8 will be exceeded and in respect of which technical preventive measures for limiting asbestos-in-air concentrations are not reasonably practicable, the employer shall determine the measures intended to ensure protection of the workers while they are engaged in such activities, in particular the following:  (a) workers shall be issued with suitable respiratory equipment and other personal protective equipment, which must be worn; and  (b) warning signs shall be put up indicating that it is foreseeable that the limit values laid down in Article 8 will be exceeded.  2. The workers and/or their representatives in the undertaking or establishment shall be consulted on these measures before the activities concerned are carried out.  Article 12  1. A plan of work shall be drawn up before demolition work or work on removing asbestos and/or asbestos-containing products from buildings, structures, plant or installations or from ships is started.  2. The plan referred to in paragraph 1 must prescribe the measures necessary to ensure the safety and health of workers at the place of work.  The plan must in particular specify that:  - as far as is reasonably practicable, asbestos and/or asbestos-containing products are removed before demolition techniques are applied,  - the personal protective equipment referred to in Article 11 (1) (a) is provided, where necessary.  Article 13  1. In the case of all activities referred to in Article 3 (1), and subject to Article 3 (3), appropriate measures shall be taken to ensure that:  (a) the places in which the above activities take place shall:  (i) be clearly demarcated and indicated by warning signs;  (ii) not be accessible to workers other than those who by reason of their work or duties are required to enter them;  (iii) constitute areas where there should be no smoking;  (b) areas are set aside where workers can eat and drink without risking contamination by asbestos dust;  (c) (i) workers are provided with appropriate working or protective clothing;  (ii) this working or protective clothing remains within the undertaking. It may, however, be laundered in establishments outside the undertaking which are equipped for this sort of work if the undertaking does not carry out the cleaning itself; in that event the clothing shall be transported in closed containers;  (iii) separate storage places are provided for working or protective clothing and for street clothes;  (iv) workers are provided with appropriate and adequate washing and toilet facilities, including showers in the case of dusty operations;  (v) protective equipment shall be placed in a well-defined place and shall be checked and cleaned after each use; appropriate measures shall be taken to repair or replace defective equipment before further use.  2. Workers may not be charged with the cost of measures taken pursuant to paragraph 1. Article 14  1. In the case of all activities referred to in Article 3 (1), appropriate measures shall be taken to ensure that workers and their representatives in the undertaking or establishment receive adequate information concerning:  - the potential risks to health from exposure to dust arising from asbestos or materials containing asbestos,  - the existence of statutory limit values and the need for the atmosphere to be monitored,  - hygiene requirements, including the need to refrain from smoking,  - the precautions to be taken as regards the wearing and use of protective equipment and clothing,  - special precautions designed to minimize exposure to asbestos.  2. In addition to the measures referred to in paragraph 1, and subject to Article 3 (3), appropriate measures shall be taken to ensure that:  (a) workers and/or their representatives in the undertaking or establishment have access to the results of asbestos-in-air concentration measurements and can be given explanations of the significance of those results;  (b) if the results exceed the limit values laid down in Article 8 the workers concerned and their representatives in the undertaking or establishment are informed as quickly as possible of the fact and the reason for it and the workers and/or their representatives in the undertaking or establishment are consulted on the measures to be taken or, in an emergency, are informed of the measures which have been taken.  Article 15  Subject to Article 3 (3) the following measures shall be taken:  1. An assessment of each worker's state of health must be available prior to the beginning of exposure to dust arising from asbestos or materials containing asbestos at the place of work.  This assessment must include a specific examination of the chest. Annex II gives practical recommendations to which the Member States may refer for the clinical surveillance of workers; these recommendations shall be adapted to technical progress in accordance with the procedure set out in Article 10 of Directive 80/1107/EEC.  A new assessment must be available at least once every three years for as long as exposure continues.  An individual health record shall be established in accordance with national laws and practices for each worker referred to in the first subparagraph.  2. Following the clinical surveillance referred to in point 1, the doctor or authority responsible for the medical surveillance of the workers should, in accordance with national laws, advise on or determine any individual protective or preventive measures to be taken; these may include, where appropriate, the withdrawal of the worker concerned from all exposure to asbestos.  3. Information and advice must be given to workers regarding any assessment of their health which they may undergo following the end of exposure.  4. The worker concerned or the employer may request a review of the assessments referred to in point 2, in accordance with national laws.  Article 16  Subject to Article 3 (3) the following measures shall be taken:  1. The employer must enter the workers responsible for carrying out the activities referred to in Article 3 (1) in a register, indicating the nature and duration of the activity and the exposure to which they have been subjected. The doctor and/or the authority responsible for medical surveillance shall have access to this register. Each worker shall have access to the results in the register which relate to him personally. The workers and/or their representatives shall have access to anonymous, collective information in the register.  2. The register referred to in point 1 and the medical records referred to in point 1 of Article 15 shall be kept for at least 30 years following the end of exposure, in accordance with national laws.  Article 17  Member States shall keep a register of recognized cases of asbestosis and  Article 18  1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1987. They shall forthwith inform the Commission thereof. The date 1 January 1987 is, however, postponed until 1 January 1990 in the case of asbestos-mining activities. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.  Article 19  This Directive is addressed to the Member States.  Done at Brussels, 19 September 1983.  For the Council  The President  G. VARFIS  (1) OJ No C 262, 9. 10. 1980, p. 7 and OJ No C 301, 18. 11. 1982, p. 6.  (2) OJ No C 310, 30. 11. 1981, p. 43.  (3) OJ No C 125, 17. 5. 1982, p. 155.  (4) OJ No C 165, 11. 7. 1978, p. 1.  (5) OJ No L 327, 3. 12. 1980, p. 8.  (1) Number in the register of the Chemical Abstract Service (CAS).  (1) OJ No L 84, 31. 3. 1978, p. 43.  ANNEX I  Reference method referred to in Article 7 (1) for the measurement of asbestos in air at the place of work  1. Samples shall be taken within the individual worker's breathing zone: i.e. within a hemisphere of 300 mm radius extending in front of the face and measured from the mid-point of a line joining the ears.  2. Membrane filters (mixed esters of cellulose or cellulose nitrate) of pore size 0,8 to 1,2 micrometres with printed squares and a diameter of 25 mm shall be used.  3. An open-faced filter holder fitted with a cylindrical cowl extending between 33 and 44 mm in front of the filter exposing a circular area of at least 20 mm in diameter shall be used. In use, the cowl shall point downwards.  4. A portable battery-operated pump carried on the worker's belt or in a pocket shall be used. The flow shall be smooth and the rate initially set at 1,0 litres per minute ± 5 %. The flow rate shall be maintained within ± 10 % of the initial rate during the sampling period.  5. The sampling time shall be measured to within a tolerance of 2 %.  6. The optimal fibre-loading on filters shall be within the range 100 to 400 fibres/mm2.  7. In order of preference, the whole filter, or a section of the filter, shall be placed on a microscope slide, made transparent using the acetone-triacetin method, and covered with a glass coverslip.  8. A binocular microscope shall be used for counting and shall have the following features:  - Koehler illumination,  - its substage assembly shall incorporate an Abbe or achromatic phase-contrast condenser in a centring focusing mount. The phase-contrast centring adjustment shall be independent of the condenser centring mechanism,  - a 40 times bar-focal positive phase-contrast achromatic objective with a numerical aperture of 0,65 to 0,70 and phase ring absorption within the range 65 to 85 %,  - 12,5 times compensating eyepieces; at least one eyepiece must permit the insertion of a graticule and be of the focusing type,  - a Walton-Beckett circular eyepiece graticule with an apparent diameter in the object plane of 100 micrometres ± 2 micrometres, when using the specified objective and eyepiece, checked against a stage micrometer.  9. The microscope shall be set up according to the manufacturer's instructions, and the detection limit checked using a 'phase-contrast test slide'. Up to code 5 on the AIA test slides or up to block 5 on the HSE/NPL mark 2 test slide must be visible when used in the way specified by the manufacturer. This procedure shall be carried out at the beginning of the day of use.  10. Samples shall be counted in accordance with the following rules:  - a countable fibre is any fibre referred to in the second subparagraph of point 1 of Article 7 which does not touch a particle with a maximum diameter greater than three micrometers,  - any countable fibre with both ends within the graticule area shall be counted as one fibre; any fibre with only one end within the area shall count as half,  - graticule areas for counting shall be chosen at random within the exposed area of the filter,  - an agglomerate of fibres which at one or more points on its length appears solid and undivided but at other points is divided into separate strands (a split fibre) is counted as a single fibre if it conforms with the description in the second subparagraph of point 1 of Article 7 and indent 1 of this paragraph, the diameter measured being that of the undivided part, not that of the split part, - in any other agglomerate of fibres in which individual fibres touch or cross each other (a bundle), the fibres shall be counted individually if they can be distinguished sufficiently to determine that they conform with the description in the second subparagraph of point 1 of Article 7 and indent 1 of this paragraph. If no individual fibres meeting the definition can be distinguished, the bundle is considered to be a countable fibre if, taken as a whole, it conforms with the description in the second subparagraph of point 1 of Article 7 and indent 1 of this paragraph,  - if more than one-eighth of a graticule area is covered by an agglomerate of fibres and/or particles, the graticule area must be rejected and another counted,  - 100 fibres shall be counted, which will enable a minimum of 20 graticule areas to be examined, or 100 graticule ares shall be examined.  11. The mean number of fibres per graticule is calculated by dividing the number of fibres counted by the number of graticule areas examined. The effect on the count of marks on the filter and contamination shall be kept below three fibres/100 graticule areas and shall be assessed using blank filters.  Concentration in air = (number per graticule area × exposed area of filter) / (graticule area × volume of air collected).  ANNEX II  Practical recommendations for the clinical assessment of workers, as referred to in Article 15 (1)  1. Current knowledge indicates that exposure to free asbestos fibres can give rise to the following diseases:  - asbestosis,  - mesothelioma,  - bronchial carcinoma,  - gastro-intestinal carcinoma.  2. The doctor and/or authority responsible for the medical surveillance of workers exposed to asbestos must be familiar with the exposure conditions or circumstances of each worker.  3. Clinical surveillance of workers should be carried out in accordance with the principles and practices of occupational medicine; it should include at least the following measures:  - keeping records of a worker's medical and occupational history,  - a personal interview,  - a clinical examination of the chest,  - a respiratory function examination.  Further examinations, including a standard format radiograph of the chest and laboratory tests such as a sputum cytology test, are desirable. These examinations should be decided upon for each worker when he is the subject of medical surveillance, in the light of the most recent knowledge available to occupational medicine.