CELEX: 51989PC0575
Language: en
Date: 1990-01-09
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING FOR THE SEVENTH TIME DIRECTIVE 67/548/EEC ON THE APPROXIMATION OF THE LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS RELATING TO THE CLASSIFICATION, PACKAGING AND LABELLING OF DANGEROUS SUBSTANCES

13. 2. 90                             Official Journal of the European Communities                                      N o C 33/3
                                                                  II
                                                       (Preparatory Acts)
                                                  COMMISSION
               Proposal for a Council Directive amending for the seventh time Directive 67/548/EEC on the
               approximation of the laws, regulations and administrative provisions relating to the classifi­
                                   cation, packaging and labelling of dangerous substances
                                               COM(89)     575 final — SYN 227
                                     (Submitted by the Commission on 26 January 1990)
                                                         ( 9 0 / C 33/03)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              6 7 / 5 4 8 / E E C ('),   as last amended    by    Directive
                                                                       8 8 / 4 9 0 / E E C ( 2 );
 Having regard t o the Treaty establishing the European
                                                                       Whereas it is necessary f o r these reasons t o amend
 Economic Community, and in particular Article 100a
                                                                       Directive 6 7 / 5 4 8 / E E C which currently protects the
 thereof,
                                                                       population and in particular the workers using dangerous
                                                                       substances, by an adequate classification, packaging and
 Having regard t o the proposal f r o m the Commission,                labelling of such substances;
                                                                       Whereas it is appropriate t o reduce t o a minimum the
 In cooperation with the European Parliament,                          number of animals used f o r experimental purposes
                                                                       according t o the provisions of Council Directive
                                                                       8 6 / 6 0 9 / E E C of 24 November 1986 o n the approxi­
 Having regard t o the opinion of the Economic and                     mation of laws, regulations and administrative provisions
 Social Committee,                                                     of the Member States regarding the protection of
                                                                       animals used f o r experimental and other scientific
                                                                       purposes ( J );
 Whereas disparity between the laws, regulations and
 administrative provisions relating t o the classification,           Whereas Council Directive 8 7 / 1 8 / E E C of 18 December
 packaging and labelling of dangerous substances and t o               1986 o n the harmonization of laws, regulations and
 the notification of new substances in the Member States               administrative provisions relating t o the application of
 may lead t o barriers t o trade between Member States                 the principles of good laboratory practice and the verifi­
 arid may create unequal conditions of competition;                    cation of their application f o r tests o n chemical
                                                                       substances (4) specifies the Community principles of good
                                                                       laboratory practice which must be followed f o r tests o n
Whereas disparities in these conditions in the Member                  chemicals;
 States directly affect the functioning of the internal
market;
                                                                      Whereas Council Directive 8 8 / 3 2 0 / E E C of 9 June 1988
                                                                      concerning the inspection and verification of good
Whereas measures f o r the approximation of the                       laboratory practice ( 5 ) specifies h o w the application of
provisions of the Member States which have as their                   the principles of good laboratory practice shall be
object the establishment and functioning of the internal              verified;
market shall, in as much as they concern health, safety,
environmental and consumer protection, take a high                    Whereas in order t o ensure the safety of workers and the
level of protection as a base and provide, despite existing           environment, it is opportune that safety data o n
differences in economies of the Member States, f o r equal            dangerous substances be available t o the persons
standards of protection throughout the Community;                     responsible f o r worker safety and environmental safety;
Whereas to protect man and the environment against                   (') .OJ No 196, 16. 8. 1967, p. 1.
potential risks which could arise from the placing on the            O OJ No L 259, 19. 9. 1988, p. 1.
market of new substances, it is necessary to lay down                C) OJ No L 358, 18. 12. 1986, p. 1.
appropriate measures and in particular to reinforce                  (4) OJ No L 15, 17. 1. 1987, p. 29.
the recommendations set out in Council Directive                     (5) OJ No L 145, 11. 6. 1988, p. 35.
 ---pagebreak--- N o C 33/4                              Official Journal of the European Communities                                        13. 2. 90
                                                                                                                                /
Whereas in order to control the effects on man and the               (a) the notification of substances;
environment it is advisable that any new substance placed
on the market be the subject of a prior study by the                 (b) the exchange                 of     information on notified
manufacturer o r importer and be notified to the                            substances;
competent authorities by means of a notification
containing certain mandatory information; whereas it is,             (c) the assessment of the potential risk t o man and
moreover, important to follow closely the evolution and                     the environment of notified substances;
use of new substances placed on the market, and
                                                                     (d) the classification, packaging and labelling of
whereas it is necessary, in order to d o so, to institute a
                                                                            substances dangerous to man o r the environment,
system which allows all new substances to be listed;
                                                                     which are placed on the market in the Member States.
Whereas, moreover, it is necessary, if the Directive is to
be properly applied, to draw up an inventory of
                                                                      2.      This Directive does not apply t o the provisions
substances on the Community market by 18 September
1981;                                                                relating to:
                                                                      (a) medicinal products for human use, as defined in
Whereas it is necessary to provide for measures making                      Directive 65/65/EEC ('), medicinal products for
it possible t o introduce a procedure of notification to                    veterinary use,                as defined in Directive
one Member State which is then valid for the                                 81/851/EEC (2), narcotics, as defined in the
Community; whereas, it is, moreover, necessary t o                           United Nations' Single Convention on Narcotic
provide that measures relating to the classification and                     Drugs, 1961, as amended by the 1972 protocol,
labelling of substances may be laid down at Community                        and radioactive substances as defined in Directive
level;                                                                       80/836/Euratom ( 3 );
Whereas in order to ensure an adequate level of                       (b) the carriage of dangerous substances by rail, road,
protection for man and the environment it is necessaiy to                    inland waterway, sea o r air;
introduce measures for the packaging and provisional
labelling of dangerous substances not yet appearing in                (c) foodstuffs, in the finished state, intended for the
Annex I to Directive 67/548/EEC; and whereas for the                         final user;
same reason it is necessary to make the indication of
safety advice obligatory;                                             (d) animal feedingstuffs in the finished state intended
                                                                             for the final user;
Whereas Article % of the abovementioned Directive                     (e) plant protection products in the finished state, as
 classifies substances and preparations as toxic, harmful,                   intended for the final user, which are covered by
 corrosive or irritant by the use of general definitions;                    Directive . . . / . . . / . . . ( 4 );
 whereas experience has shown that it is necessary to
 improve this classification; whereas in the absence, at the           (f) substances and mixtures of substances in the form
 moment, of specifications necessary. for allocation to                      of waste, which are covered by Directives
 these classes, it seems appropriate to provide precise                      75/442/EEC (5) and 78/319/EEC ( 6 );
 criteria for classification; whereas, in addition, Article 3
 of the Directive provides for an assessment of risk for               (g) substances in transit which are under customs
 the environment and it is therefore necessary to                            supervision provided they d o not undergo any
 enumerate certain characteristics and parameters of                         treatment o r processing.
 assessment, and to establish a phased study programme,
                                                                       Article   2
 HAS A D O P T E D THIS DIRECTIVE:
                                                                                                       Definitions
                            Article 1                                  1.      For the purpose of this Directive:
 Directive 67/548/EEC is amended as follows:                           (a) 'substances' means chemical elements and their
                                                                              compounds in the natural state o r obtained by any
  1. Articles 1 to 27 of Directive 67/548/EEC are                             production process, including any additive
     replaced by the following Articles:
                                                                       C)   OJ N o 22, 9. 2. 1965, p. 369.
      !Article 1                                                       O    OJ N o L 317, 6. 11. 1981, p. 1.
                                                                        O   OJ N o L 246, 17. 9. 1980, p. 1.
                        Objectives and scope                            (4) OJ N o C 89, 10. 4. 1989, p. 22. COM(89) 34 final — a
                                                                            modified proposal for a Council Directive concerning the
     1. T h e purpose of this Directive is to approximate                   placing on the market of plant protection products.
     the laws, regulations and administrative provisions of             (') OJ N o L 194, 25. 7. 1975, p. 39.
     the Member States o n :                                            (*) OJ N o L 84, 31. 3. 1978, p. 43.
 ---pagebreak--- 13. 2. 90                                  Official Journal of the European Communities                                N o C 33/5
          necessary to preserve the stability of the product             (b) oxidizing:
          and any impurity deriving inevitably from the
                                                                              substances and preparations which give rise to a
          process used, but excluding any separable solvent;                  highly exothermic reaction in contact with other
                                                                              substances, particularly flammable substances;
    (b)    'preparations' means mixtures o r           solutions
         composed of two o r more substances;                            (c) extremely flammable:
                                                                              substances and preparations having an extremely
                                                                              low flash point and a low boiling point;
    (c) 'notification' means the documents with the
         requisite information presented t o the competent
         authority of a Member "State:                                   (d) highly flammable:
         — for       substances     manufactured       in    the              — substances and preparations which may
              Community, by the manufacturer established                         become hot and finally catch fire in contact
              in the Community who places on the market a
                                                                                 with air at ambient temperature without any
              substance on its own o r in a preparation,
                                                                                 application of energy,
         — for substances manufactured outside the                               or
              Community by the legal o r natural person
              established within the Community who, for                      — solid substances and preparations which may
              the purpose of submitting the notification                         readily catch fire after brief contact with a
              relating to a given substance in conformity                        source of ignition and which continue to burn
              with this Directive, is designated by the manu­                    or to be consumed after removal of the source
              facturer as being his sole representative.                         of ignition,
                                                                                 or
                                                                             — liquid substances and preparations having a
         T h e person presenting a notification as described                     very low flash point,
         above shall hereinafter be referred to as 'the
         notifier';                                                              or
                                                                             — substances and preparations which, in contact
                                                                                 with water o r damp air, evolve highly
   (d) 'placing on the market' means supplying o r making                        flammable gases in dangerous quantities;
         available to third parties.
         Importation into the Community customs
        territory shall be deemed to be placing on the                  (e) flammable:
        market for the purposes of this Directive;                           liquid substances and preparations having a low
                                                                             flash point;
   (e) 'scientific research and development'              means
        scientific experimentation, analysis o r chemical               (f) very toxic:
        research carried out under controlled conditions;                    substances and preparations which, if they are
        it includes the determination of intrinsic proper­                   inhaled o r ingested o r if they penetrate the skin,
        ties, performance and efficacy as well as scientific                 may involve extremely serious, acute o r chronic
        investigation related t o product development;                       health hazards and even death;
   (f) 'process-orientated research and development' means              (g) toxic:
        the phase preceding the full commercialization of
                                                                            substances and preparations which, if they are
        a substance in the course of which, by means of
                                                                            inhaled o r ingested o r if they penetrate the skin,
        pilot plant o r production trials, the technical
                                                                            may involve serious, acute o r chronic health
        specifications of the substance are modified in the
                                                                            hazards and even death;
        light of customer response.
                                                                       (h) harmful:
  2. T h e following substances and preparations are                        substances and preparations which, if they are
  'dangerous' within the meaning of this Directive:                         inhaled o r ingested or if they penetrate the skin,
                                                                            may involve limited health hazards;
  (a) explosive:
        substances and preparations which may explode                  (i) corrosive:
        under the effects of a flame o r upon heating or                    substances and preparations which may, on
        which are very sensitive to shocks o r friction;                    contact with living tissues, destroy them;
 ---pagebreak--- N o C 33/6                                  Official Journal of the European Communities                                          13.^2. 90
   (j) irritant:                                                         provisions of Directive 86/609/EEC ( J ) regarding the
                                                                         protection of animals used for experimental and other
        non-corrosive substances and preparations which,
                                                                         scientific purposes.
        through immediate, prolonged or repeated
        contact with the skin or mucous membrane, can
        cause inflammation;                                              2. T h e real o r potential enviromental risk shall be
                                                                         assessed on the basis of the elements set out in
                                                                         Annexes VII and VIII and taking into account any
   (k) sensitizing:                                                      existing internationally recognized procedures.
        substances and preparations which, if they are
        inhaled or if they penetrate the skin, are capable
        of eliciting a reaction of the immune system                     Article 4
        (hypersensitization) such that on further exposure
        t o the substance o r preparation, characteristic                                           Classification
        adverse effects are produced;
                                                                          1.      Substances shall be classified on the basis of
                                                                         their intrinsic properties according to the categories
   (1) carcinogenic:                                                     laid down in Article 2 (2).
        substances or preparations which, if they are
        inhaled o r ingested o r if they penetrate the skin,             2. T h e general principles of the classification and
        may induce cancer o r increase its incidence;                    labelling of substances and preparations shall be
                                                                         applied according to the criteria in Annex V I ("), save
   (m) mutagenic:                                                        where contrary requirements for dangerous prepa­
        substances and preparations which, if they are                   rations are specified in separate Directives.
        inhaled o r ingested o r if they penetrate the skin,
        may induce heritable genetic defects or increase                  3.      Annex I (5) contains the list of substances
        their incidence;                                                  classified in accordance with the principles outlined in
                                                                          Article 4 (1) and (2) together with their harmonized
                                                                          classification and labelling. T h e decision to place a
   (n) toxic for reproduction:
                                                                          substance in Annex I together with the harmonized
        substances and preparations which, if they are                    classification and labelling shall be taken in
        inhaled o r ingested o r if they penetrate the skin,              accordance with the procedure laid down in Article
        may produce, o r increase the incidence of,                       24.
        non-heritable adverse effects in the progeny and
        o r an impairment of male o r female reproductive
        functions o r capacity;                                           4. T h e dangerous substances listed in Annex I
                                                                          shall, where appropriate, be characterized by concen­
                                                                          tration limits o r any other parameter enabling the
   (o) dangerous for the environment:                                     health or environmental hazard of preparations to be
         substances and preparations which, should they                   assessed.
         enter the environment, present o r may present an
         immediate o r delayed danger for one o r more
         compartments of the environment.                                 Article 5
                                                                                           Duties of the Member States
   Article 3                                                              1. T h e Member States shall take all the measures
                                                                          necessary t o ensure that, without prejudice to Article
    Testing and assessment of the properties of substances                8, substances cannot be placed on the market on their
                                                                          own o r in preparations unless the substances have
    1. T h e physico-chemical properties of the                           been:
   substances and preparations shall be determined
   according to the methods specified in Annex V Part                     — notified to the competent authority of one of the
   A ('); their toxicity shall be determined according to                       Member States in accordance with this Directive,
   the methods specified in Annex V Part B (') and their
   ecotoxicity according to those specified in Annex V
   Part C 0).
                                                                          O O J N o L 358, 18. 12. 1986, p. 1.
                                                                          ( 4 ) See also OJ N o L 257, 16. 9. 1983, p. 1.
    Laboratory tests shall be carried out in compliance
                                                                          ( 5 ) See also the following adaptations t o technical progress:
   with the principles of good laboratory practice                              — OJ N o L 360, 30. 12. 1976, p. 1,
   provided for in Directive 87/18/EEC (2) and the                              — OJ N o L 88, 7. 4. 1979, p. 1,
                                                                                — O J N o L 351, 7. 12. 1981, p. 5,
                                                                                — OJ N o L 106, 21. 4. 1982, p. 18,
    (') See the following adaptations t o technical progress:                   — O J N o L 257, 16. 9. 1983, p. 1,
        — O j N o L 251, 19. 9. 1984, p. 1,                                     — O J N o L 247, 1 . 9 . 1986, p. 1,
        — O J N o L 133, 30. 5. 1988, p. 1.                                     — OJ N o L 239, 21. 8. 1987, p. 1,
    O O J N o L 15, 17. 1. 1987, p. 29.                                         — OJ N o L 259, 19. 9. 1988, p. 1.
 ---pagebreak--- 13. 2. 90                                Official Journal of the European Communities                                   N o C 33/7
   — packaged and labelled in accordance with Articles                 — a proposal for a safety data sheet,
        18 t o 20 and with the criteria in Annex VI, and in
        accordance with the results of the tests provided              — in the case of a manufacturer located outside the
        f o r in Annexes VII and VIII, save in the case of                     Community the notifier shall include a statement
        preparations where provisions exist in separate                        from the manufacturer to the effect that, for the
        Directives.                                                            purpose of submitting a notification for the
                                                                               substance in question, he is designated as the
   In addition, the Member States will take all the                            manufacturer's sole representative,
   measures necessary t o ensure that the provisions
   concerning safety data sheets as laid down in Article               — if so desired, a statement by the notifier requesting,
   21 are respected.                                                           with justification, that the notification be
                                                                               exempted from the provisions of Article 10 (2) for
                                                                               a maximum period which shall not in any case
   2. T h e measures referred to in the second indent of                       exceed one year following the date of notification.
   paragraph 1 of Article 5 (1) shall apply until the
   substance is listed in Annex I o r until a decision not to          2. T h e notifier need not supply the information
   list it has been taken in accordance with the                       required for the technical dossier in Annex VII Part A
   procedure laid down in Article 24.                                  with the exception of items 1 and 2 if:
   Dangerous substances not yet appearing in Annex I                       (i) the data were originally submitted at least ten
   but included in the list referred to in Article 16 (1) o r                   years previously;
   already on the market before 18 September 1981
   must, in so far as the manufacturer, whether o r not                         or
   established in the Community, may reasonably be
   expected t o be aware of their dangerous properties,                  (ii) the substance has been submitted previously by
   be packaged and provisionally labelled by the manu­                          the notifier for approval as an active substance
   facturer o r his representative in accordance with the                       for use in plant protection products in
   rules laid down in Articles 17 t o 20 and with the                           conformity with the provisions of Directive
   criteria in Annex VI.                                                                      O;
                                                                                or
  Article 6
                                                                      (iii) the substance has been submitted previously by
                      Duties of the notifier                                    the notifier for approval as an additive, or a
                                                                                substance for use, in animal feedingstuffs in
   1.     Without prejudice to Articles 1 (4), 7 (1), 8 (1)                     accordance with the provisions of Directive
   and 11 (1), any notifier of a substance shall be                             70/524/EEC (2).
   required to submit t o the competent authority
   referred to in Article 11 (1) of the Member State in               3.        The substance may be placed on the market only
   which the substance is manufactured, o r in the case of            when the notifier has received a written acknowl­
   a manufacturer located outside the Community, the                  edgement from the competent authority that the noti­
   Member State within which the notifier is established,             fication has been accepted as being in conformity with
   a notification including:                                          the Directive, and in any case not earlier than 60 days
                                                                      after the date of receipt of the notification by the
  — a technical dossier supplying the information                     authority.
       necessary for evaluating the foreseeable risks,
       whether immediate o r delayed, which the                       4.        Without prejudice to Article 9 any notifier of a
       substance may entail for man and the envi­                     substance already notified shall inform the competent
       ronment, and containing all available relevant data            authority:
       f o r this purpose. As a minimum the dossier shall
       contain at least the information and results of the            — when the quantity of the substance placed on the
       studies referred t o in Annex VII Part A, together                     market reaches 10 tonnes per year per manu­
       with a detailed and full description of the studies                    facturer o r when the total quantity placed on the
       conducted and of the methods used o r a biblio­                        market reaches 50 tonnes per manufacturer; in
       graphical reference t o them,                                          this case, the competent authority may require
                                                                              some o r all the additional tests/studies laid down
  — a declaration concerning the unfavourable effects                         in Annex VIII, level 1 to be carried out within a
       of the substance in terms of the various uses                          time limit it will determine,
       envisaged,
  — the proposed classification and labelling of the                  (') COM(89) 34 final. OJ N o C 89, 10. 4. 1989, p. 22.
       substance in accordance with this Directive,                   ( 2 ) OJ N o L 270, 14. 12. 1970, p. 1.
 ---pagebreak--- N o C 33/8                                 Official Journal of the European Communities                                    13. 2. 90
   — when the quantity of the substance placed o n the                  — in the case of a manufacturer located outside the
        market reaches 100 tonnes per year per manu­                          Community the notifier shall include a statement
        facturer o r when the total quantity placed o n the                   from the manufacturer t o the effect that, f o r the
        market reaches 500 tonnes per manufacturer; in                        purpose of submitting a notification f o r the
        this case, the competent authority shall require the                  substance in question, he is designated as the
        additional tests/studies laid down in Annex VIII,                     manufacturer's sole representative,
        level 1 t o be carried o u t within a time limit it will
        determine, unless the notifier can justify that a               — if so desired a statement by the notifier requesting,
        given test/study is not appropriate o r an alter­                     with justification, that the notification be
        native scientific test/study would be preferable,                     exempted f r o m the provisions of Article 10 (2) f o r
                                                                              a maximum period which shall n o t in any case
                                                                              exceed one year following the date of notification.
   — when the quantity of a substance placed o n the
        market reaches 1 000 tonnes per year per manu­                  Moreover, when the quantities t o be placed o n the
        facturer o r when the total quantity placed o n the             market are below 100 kilograms per year per manu­
        market reaches 5 000 tonnes per manufacturer; in                facturer the notifier may, without prejudice t o Article
        this case, the competent authority shall draw u p a             11 (1), restrict the information f o r the technical
        programme of tests/studies according t o Annex                  dossier of the notification referred t o above t o that
        VIII, level 2, t o be carried out by the notifier               provided f o r in Annex V I I Part C .
        within a time limit it will determine.
                                                                        2. T h e notifier need n o t supply the information
   5.     W h e n additional testing is carried out in                  required f o r the technical dossiers of Parts B o r C of
   accordance with the requirements of paragraph 4                      Annex V I I with the exception of items 1 and 2
   above the notifier shall provide the competent                       thereof if:
   authority with the results of the studies carried out.
                                                                           (i) the data were originally submitted at least ten
                                                                               years previously;
   Article 7                                                                   or
   Reduced notification requirements for substances                      (ii) the substance has been submitted previously by
   placed on the market in quantities less than one tonne                      the notifier f o r approval as an active substance
                    per annum per manufacturer                                 f o r use in plant protection products in
                                                                               conformity with the provisions of Directive
   1.      Without prejudice t o Article 1 (4), 8 (1) and
   11 (1), any notifier of a substance placed o n the
   Community market in quantities less than one tonne                          or
   per annum per manufacturer shall be required t o
   submit t o the competent authority referred t o in                   (iii) the substance has been submitted previously by
   Article 11 (1) of the Member State in which the                             the notifier f o r approval as an additive, o r a
   substance is manufactured, o r in the case of a manu­                       substance f o r use, in animal feedingstuffs in
   facturer located outside the Community, the Member                          accordance with the provisions of Directive
   State within which the notifier is established, a notifi­                   7 0 / 5 2 4 / E E C ( 2 ).
   cation including:
                                                                        3.      In the absence of any indication t o the contrary
                                                                        f r o m the competent authority, the substance may be
   — a technical dossier supplying the information
                                                                        placed o n the market 15 days after the receipt of the
        necessary f o r evaluating the foreseeable risks,
                                                                        dossier by the competent authority subject t o any
        whether immediate o r delayed, which the
      ' substance may entail f o r man and the envi­                    conditions which may subsequently be imposed by the
        ronment, and containing all available relevant data             authority.
        f o r this purpose. As a minimum the dossier shall
        contain at least the information and results of the             4.      In the case of a notifier w h o has submitted a
        studies referred t o in Annex V I I Part B, together            reduced notification dossier in conformity with the
        with an indication of the methods used o r a                    second subparagraph of paragraph 1 then 15 days
        bibliographical reference t o them,                             before the quantity of the substance placed o n the
                                                             ]          market reaches 100 kilograms per year per manu­
                                                                        facturer o r before the total quantity placed o n the
   — a declaration concerning the unfavourable effects                  market reaches 500 kilograms per manufacturer, the
        of the substance in terms of the various uses                   notifier shall provide the competent authority with the
        envisaged,
                                                                        additional information necessary t o complete the
                                                                        technical dossier t o the level of Annex V I I Part B.
   — the proposed classification and labelling of the
        substance in accordance with this Directive,
                                                                        (') OJ N o C 89, 10. 4. 1989, p. 22.
   — a proposal for a safety data sheet,                                ( 2 ) OJ N o L 362, 31. 12. 1985, p. 8.
 ---pagebreak--- 13. 2. 90                               Official Journal of the European Communities                               N o C 33/9
   Similarly when a notifier has submitted a reduced                  — substances placed on the market in quantities less
   notification in conformity with the first subparagraph                 than 10 kilograms per annum per manufacturer,
   of paragraph 1 above then before the quantity of the
   substance placed on the market reaches 1 tonne per
   annum per manufacturer, or before the total quantity               — substances placed on the market in limited quan­
   placed on the market reaches 5 tonnes per manu­                        tities, and in any case not exceeding 100 kilograms
   facturer, the notifier shall submit a full notification                per manufacturer per annum, and intended solely
   according to the requirements of Article 6.                            for purposes of scientific research and devel­
                                                                          opment carried out under controlled conditions,
   5. The substances notified in conformity with                      — any manufacturer or importer making use of this
   paragraph 1 and the first subparagraph of paragraph 4                  exemption must maintain written records
   must, in so far as the notifier may reasonably be                      containing the identity of the substance, labelling
   expected to be aware of their properties, be packaged                  data, quantities and a list of customers; this infor­
   and provisionally labelled in accordance with the rules                mation shall be made available upon request to the
   laid down in Articles 17 to 20 and with the criteria                   competent authorities of each Member State
   imposed in Annex VI. In accordance with the prin­                      where the manufacture, importation, or scientific
   ciples set out in Article 18, the label should bear, in                research and development takes place,
   addition to the label deriving from the tests already
   carried out, the warning 'Caution—substance not yet
   fully tested'.                                                     — substances placed on the market for the purposes
                                                                          of process-orientated research and development
                                                                          with a limited number of registered customers in
   Article 8                                                              quantities which are limited to the purpose of
                                                                          process-orientated research and development.
                                                                          These substances shall qualify for an exemption
                           Exemptions                                     for a period of one year provided that the manu­
                                                                          facturer or importer communicates their identity,
   1. The following substances are exempted from the
  provisions of Articles 6, 7, 9 and 10:                                  labelling data, quantity, the justification for the
                                                                          quantity and a list of customers to the competent
                                                                          authorities of each Member State where the
  — substances which appear in the inventory referred '                   manufacture, importation or process orientated
       to in Article 16 (1),                                              research and development takes place and
                                                                          complies with any conditions imposed by these
                                                                          authorities on such research and development.
  — from the date of entry into force of Directive                        After this period these substances will normally be
                         'on the placing of plant protection              subject to notification.
       products on the market' to active > substances
       intended for exclusive use in such products and as
       covered by the above Directive,                               The manufacturer or importer shall also give an
                                                                     assurance that the substance or the preparation in
                                                                     which it is incorporated will be handled only by
  — additives and substances for exclusive use in
                                                                     customers' staff in controlled conditions and will not
       animal feedingstuffs as covered by Directive
                                                                     be made ^available at any time either on its own or in
       70/524/EEC and by Directive 82/471/EEC (2),
                                                                     preparation to the general public.
  — substances used exclusively as additives in food­
       stuffs as covered by Directive 89/107/EEC (3).                The one-year exemption period referred to above may
                                                                     in exceptional circumstances be extended for a further
                                                                     year if the notifier can demonstrate to the satisfaction
  2. T h e substances listed below, shall be considered              of the competent authority that such an extension is
  as having been notified within the meaning of this                 justified.
  Directive when the following conditions are fulfilled:
                                                                     3. The substances referred to in paragraph 2, must,
  — polymerizates, polycondensates and polyadducts                   in so far as the manufacturer may reasonably be
      except those containing 2 % or more of any                     expected to be aware of their dangerous properties,
      substance not listed in the inventory referred to in           be packaged and provisionally labelled by the manu­
      Article 16 (1),
                                                                     facturer or his representative in accordance with the
                                                                     rules laid down in Articles 17 to 20 and with the
                                                                     criteria imposed in Annex VI.
  (') OJ N o C 89, 10. 4. 1989, p. 22.
  (2) OJ N o L 213, 21. 7. 1982, p. 8.                              If is not possible to label completely because the
  C) OJ N o L 40, 11. 2. 1989, p. 27.                               results of tests provided for in Annex VII Part A are
 ---pagebreak--- N o C 33/10                               Official Journal of the European Communities                                      13. 2. 90
   not all available and in accordance with the principles             2.      Before carrying o u t testing o n vertebrate animals
   set out in Article 18, the label should bear, in addition           f o r the purpose of submitting a notification in
   t o the label deriving from tests already carried out,              conformity with Articles 6 (1) o r 7 (1), and without
   the warning: 'Caution — substance not yet fully                     prejudice t o Article 10 (1), prospective notifiers shall
   tested'.                                                            enquire of the competent authority of the Member
                                                                       State within which they intend subsequently t o notify,
                                                                       as t o
   4.     W h e r e a substance as referred t o in paragraph 2,
   labelled in accordance with the principles set o u t in
                                                                        (a) whether o r not the substance they intend t o notify
   Article 18, is very toxic o r toxic, the manufacturer o r
                                                                             has already been notified;
   importer of such a substance must transmit t o the
   competent authority any appropriate information as
   regards Annex V I I Part A, points 2.3, 2.4 and 2.5.                 (b) the name and address of the first notifier. This
                                                                             enquiry shall be supported by evidence that the
                                                                             prospective notifier has the intention t o place the
   Article 9                                                                 substance o n the market and of the quantities he
                                                                             intends t o place o n the market.
                        Follow-up information
                                                                        In the event
   Any notifier of a substance already notified in
   conformity with Articles 6 (1) o r 7 (1) shall be
   responsible o n his own initiative f o r informing the               (a) that the competent authority receiving the enquiry
   competent authority t o which the initial notification                    is satisfied that the prospective notifier has the
   was submitted o f :                                                       intention t o place the substance o n the market in
                                                                             the quantities stated;
   — changes in the annual o r total quantities placed o n
        the market by him in accordance with the tonnage                     and
        range laid down in Annex V I I Parts A, B o r C ,
        point,2.2.1,                                                    (b) that the substance has been notified previously;
   — new knowledge of the effects of the substance o n                        and
        man a n d / o r the environment of which he may
        reasonably be expected t o have become aware,                   (c) that the first notifier has not requested and been
                                                                              granted a temporary exemption f r o m the
   — new uses f o r which the substance is placed o n the                     provisions of this Article,
        market of which he may reasonably be expected t o
        have become aware,                                              the competent authority shall provide the prospective
                                                                        notifier with the name and address of the first notifier
                                                                        and will at the same time inform the first notifier of
   — any change in the composition of the substance as
                                                                        the name and address of the prospective notifier.
        given in Annex V I I Parts A, B o r C , point 1.3,
                                                                        T h e first notifier and the prospective notifier shall
    — any change in his status, such as manufacturer o r
                                                                        take all reasonable steps t o reach an agreement o n the
        importer.
                                                                        sharing of information so as t o avoid the duplication
                                                                        of testing o n vertebrate animals.
    Article 10
                                                                         3.    Notifiers of the same substance w h o have agreed
    Re-notification of the same substance and avoidance                  t o share information relating t o Annex V I I in
            of duplicating testing on vertebrate animals                 accordance with the provisions of paragraphs 1 and 2
                                                                         shall also take all reasonable steps t o reach an
    1.     In the case of a substance which has already                  agreement o n the sharing of, information concerns
    been notified in accordance with Articles 6 (1) o r 7                testing o n vertebrate animals submitted in conformity
    (1), the competent authority may agree that the                      with Article 6 (4).
    subsequent notifier of that substance may, f o r the
    purposes of items 3, 4 and 5 of Parts A and B of
    Annex V I I and items 3 and 4 of Annex VIII Part C ,                 Article 11
    refer t o the results of the tests/studies carried out by
    the first notifier, insofar as the subsequent notifier can                 Rights and duties of the competent authorities
    provide evidence that the substance renotified is the
    same as the one previously notified, including the                    1.    Member States shall appoint the competent
    degree of purity and the nature of impurities. T h e                 authority o r authorities responsible f o r receiving the
    first notifier must give his agreement in writing t o the            information provided f o r in Articles 6 t o 9 and
    reference t o the results of the tests/studies he has                examining its conformity with the requirements of the
    carried out before such reference can be made.                       Directive.
 ---pagebreak--- 13. 2. 90                                 Official Journal of the European Communities                                 N o C 33/11
    Moreover, if it can be shown t o be necessary f o r the              In the case of the further information referred t o in
    evaluation of the risk which may be caused by a                     Article 11 (1) the competent authority shall notify the
    substance, the competent authority may ask f o r                    Commission of the tests chosen, the reasons f o r their
    further information, supplementary testing and verifi­              choice, the results and, if appropriate, an assessment
    cation/confirmatory tests concerning the substances                 of the results. In the case of the information received
    o r their degradation products (metabolites), of which              in conformity with Article 8 (2) competent authorities
    they have been notified o r have received information               shall forward t o the Commission such elements as
    under this Directive; this may also include requesting              would be of common interest f o r the Commission and
    any of the information referred t o in Annex VIII                   the other competent authorities.
    earlier than provided f o r in Article 6 (4).
   Additionally, the competent authority may:                           Article 13
   — carry o u t such sampling as is necessary f o r control
        purposes,                                                                         Duties of the Commission
                                                                        1.    O n receipt of the dossiers/information referred
   — take appropriate measures relating t o safe use of a               t o in Article 12, the Commission shall forward copies
        substance pending the introduction of Community                 t o the Member States. I addition, the Commission
        provisions.                                                     may also forward any other relevant information it
                                                                        has collected pursuant t o this Directive, as it sees fit.
   2.     For notifications submitted in conformity with
   Article 6 ( 1 ) the competent authority shall only accept
   the notification dossier when it is in full conformity               2.    T h e competent authority of any Member State
   with the Directive and shall inform the notifier in                  may consult direct the competent authority which
   writing of this acceptance. T h e authority shall at the             received the original notification, o r the Commission,
   same time advise the notifier of the official number                 o n specific details of the data contained in the dossier
   which has been allocated t o his notification.                       required under this Directive; it may also suggest that
                                                                        further tests o r information be requested. If the
                                                                        competent authority which received the original noti­
   3.     For notifications submitted in conformity with                fication fails t o comply with the suggestions of other
  Article 7 (1) the competent authority shall, within a                 authorities regarding further information, confir­
  period of 15 days following receipt of the notification,              mation tests o r amendments in the study programmes
  decide whether the notification is in conformity with                 provided f o r in Annex VIII, it shall give its reasons t o
  the Directive and, in the event that the notification is              the other authorities concerned. Should it n o t be
  adjudged n o t t o be in conformity, inform the notifier              possible f o r the authorities concerned t o reach
  accordingly. In the event that the notification is in                 agreement and should any one authority feel, o n the
  conformity with the Directive, the authority shall,                   basis of detailed reasons, that additional information,
  within the 15-day period following receipt of the                     confirmation tests o r amendments in the study
  dossier, advise the notifier of the official number                   programmes are nevertheless really necessary t o
  which has been allocated t o his notification.                        protect man and the environment, it may ask the
                                                                        Commission t o take a decision in accordance with the
                                                                        procedure laid down in Article 24.
  4. T h e procedure laid down in Article 24 shall be
  followed in confirming o r amending proposals f o r
  classification and labelling.
                                                                       Article 14
  5.      Without prejudice t o Article 14 (1), Member
  States and the Commission shall ensure that any                                          Confidentiality of data
  information concerning commercial exploitation o r
  manufacturing is kept secret.                                        1.     If he considers that there is a confidentiality
                                                                       problem, the notifier may indicate the information
                                                                       provided f o r in Articles 6 t o 9 which he considers t o
  Article 12                                                           be commercially sensitive and disclosure of which
                                                                       might harm him industrially o r commercially, and
  Involvement of the Commission in the notification                    which he therefore wishes t o be kept secret f r o m all
                           procedure                                   persons other than the competent authorities and the
                                                                       Commission. Full justification must be given in such
 W h e n a Member State has received the notification
                                                                       cases.
  dossier referred t o in Articles 6 (1) and 7 (1) o r infor­
  mation o n the supplementary testing carried o u t in
  accordance with Article 6 (4) and 7 (3) o r follow-up               With respect t o the notifications and information
  information submitted in conformity with Article 9, it              submitted in conformity with Articles 6 (1), 6 (4), 7
  shall forthwith send t o the Commission a copy of the               (1) and 7 (3), industrial and commercial secrecy shall
  dossier/further information o r a summary thereof.                  n o t apply t o :
 ---pagebreak--- N o C 33/12                             Official Journal of the European Communities                                          13. 2. 90
   (a) the trade name of the substance;                              — may be brought t o the attention only of the auth­
                                                                            orities whose responsibilities are specified in
   (b) the name of the manufacturer and the notifier;                       Article 11 (1),
   (c) physico-chemical data concerning the substance in
                                                                     — may, however, be divulged t o persons directly
        connection with Annex VII, point 3;
                                                                            involved in administrative o r legal proceedings
   (d) the possible ways of rendering the substance                         involving sanctions which are undertaken f o r the
                                                                            purpose of controlling substances placed o n the
        harmless;
                                                                            market.
   (e) the summary results of the toxicological and
        ecotoxicological tests;                                      This Article and Article 15 shall n o t oblige a Member
                                                                     State whose legislation o r administrative practices
   (f) if appropriate in the context of classification and           impose stricter limits f o r the protection of industrial
        labelling f o r the purpose of introducing the               and commercial secrecy than those laid down in these
        substance into Annex I, the degree of purity of              Articles t o supply information, where the State
        the substance and the identity of impurities                 concerned does n o t take steps t o comply with these
        a n d / o r additives which are known t o be                 stricter limits.
        dangerous within the meaning of Article 2 (2);
   (g) the recommended methods and precautions
        referred t o in Annex VII, point 2.3 and the                 Article 15
        emergency measures referred to, in Annex VII,
        points 2.4 and 2.5;                                                          Exchange of the summary dossier
   (h) the information contained in the safety data sheet.            1.      T h e data supplied in accordance with Articles 12
                                                                      and 13 (1) may be forwarded t o the Commission and
   If the notifier, manufacturer o r importer himself                 the Member States in summary form.
   discloses previously confidential information, he shall
   inform the competent authority accordingly.
                                                                      In such cases and in the context of Article 13 (2), the
                                                                      competent authorities of a Member State and the
   2.    T h e authority receiving the notification/infor-            Commission shall have access t o the notification
   mation shall decide o n its own responsibility which               dossier and the additional information a t all times.
   information is covered by industrial and commercial
   secrecy in accordance with paragraph 1.
                                                                      2.      For the purpose of the exchange of information
   3.     For substances appearing in the list provided f o r         referred t o in Articles 12 and 13 (1), the Commission
   in Article 16 (2) and which are not classified as                  shall develop a common format. This format shall be
   dangerous within the meaning of this Directive, the                adopted by the procedure laid down in Article 24.
   name may be included in the form of its trade name
   in those cases where the competent authority t o which
   the notification has been submitted so requests.                   Article 16
   Normally, such substances may be included in the list
   in the form of their trade name f o r a maximum of
   three years. However, if the competent authority t o                             Lists of existing and new substances
   which the dossier was submitted considers that the                 1.      T h e Commission shall, o n the basis in particular,
   publication of the chemical name in the IUPAC                      of information provided by the Member States, draw
   nomenclature          itself would reveal information              u p an inventory of substances on the Community
   concerning commercial exploitation o r manufac­                    market by 18 September 1981 ('). This inventory shall
   turing, the name of the substance shall be recorded                be drawn u p in accordance with the guidelines laid
   under its trade name alone f o r as long as this                   down in Commission Decision 8 1 / 4 3 7 / E E C ( 2 ).
   competent authority sees fit.
   Dangerous        substances may, at the   request of the           2.      T h e Commission shall keep a list of all
   competent        authority receiving the  notification, be         substances notified under this Directive. This list shall
   entered on       the list in the form of the trade name            be complied in accordance with the provisions of
   alone until       such time as they are  introduced into           Commission Decision 8 5 / 7 1 / E E C ( } ).
   Annex I.
   4.     Confidential information brought t o the
    attention either of the Commission o r of a Member                (') T h e inventory will b e published in the Official Journal of
    State shall be kept secret.                                             the European Communities early in 1990.
                                                                      ( 2 ) O J N o L 167, 24. 6. 1981, p. 31.
    In all cases such information:                                    ( 3 ) O J N o L 30, 2. 2. 1985, p. 33.
 ---pagebreak--- 13. 2. 90                                              Official J o u r n a l of t h e E u r o p e a n Communities                                           N o C 33/13
   3.       T h e Commission shall allocate a n u m b e r ( E E C                                 Article 18
   n u m b e r ) t o each substance contained in t h e inventory
   referred t o in p a r a g r a p h 1 a n d t h e list referred t o in                                                            Labelling
   p a r a g r a p h 2.
                                                                                                  1.        M e m b e r States shall t a k e all necessary measures
                                                                                                  t o ensure t h a t d a n g e r o u s substances c a n n o t b e placed
   Article 17                                                                                     o n t h e m a r k e t unless t h e labelling o n their packaging
                                                                                                  satisfies t h e following requirements.
                                       Packaging
    1.      M e m b e r States shall t a k e all necessary measures                               2.        Every package shall s h o w clearly a n d indelibly
   t o ensure t h a t d a n g e r o u s substances c a n n o t be placed                          t h e following:
   o n t h e m a r k e t unless their packaging satisfies t h e
   following requirements:                                                                       — t h e n a m e of t h e substance,
   (a) it shall be so designed and constructed t h a t its
                                                                                                 — t h e origin of t h e substance,
          contents c a n n o t escape; this requirement shall n o t
          apply w h e r e special safety devices a r e prescribed;
                                                                                                 — t h e d a n g e r symbol, w h e n laid d o w n , a n d indi­
                                                                                                        cation of t h e d a n g e r involved in t h e use of t h e
   (b) t h e materials constituting t h e packaging a n d
                                                                                                        substance,
          fastenings must n o t b e susceptible t o adverse
          a tta c k b y t h e contents, o r liable t o f o r m
          d a n g e r o u s c o m p o u n d s with t h e contents;                               — standard phrases indicating t h e special risks arising
                                                                                                        f r o m such dangers,
   (c) packaging a n d fastenings must b e strong a n d solid
          t h r o u g h o u t t o ensure t h a t they will n o t loosen                          — standard phrases indicating t h e safety advice
          a n d will safely meet t h e normal stresses a n d                                            relating t o t h e use of t h e substance,
          strains of handling;
                                                                                                 — t h e E E C n u m b e r (when k n o w n ) o r t h e official
   (d)-containers fitted with replaceable fastening                                                     n u m b e r of t h e notification dossier allocated b y t h e
          devices shall b e s o designed t h a t t h e packaging                                        competent authority o r t h e w o r d s 'substance
          can be refastened repeatedly w i t h o u t t h e contents                                     falling u n d e r Article 8 (2) of Directive
          escaping.                                                                                     67/548/EEC'.
   2.       T h e M e m b e r States m a y also prescribe t h a t :                               In addition, f o r substances appearing in A n n e x I t h e
                                                                                                  label shall also include t h e w o r d s 'approved E C label
   — packages shall be closed initially with a seal in                                            in accordance with Directive 6 7 / 5 4 8 / E E C ' .
         such a w a y t h a t w h e n t h e package is o p e n e d f o r
         t h e first time t h e seal is irreparably d a m a g e d ,                               (a) T h e n a m e of t h e substance shall b e o n e of the-
                                                                                                         terms listed in A n n e x I ; if .this is n o t t h e case t h e
   — containers with a' capacity n o t exceeding t hree                                                  n a m e must be given in accordance with inter­
         litres which contain d a n g e r o u s substances                                               nationally recognized nomenclature.
         intended f o r domestic use shall have child-
         resistant fastenings,                                                                    (b) T h e indication of origin shall include t h e n a m e
                                                                                                         and address of t h e m a n u f a c t u r e r , t h e distributor
   — containers with a capacity n o t exceeding o n e litre                                              o r t h e importer established in t h e C o m m u n i t y .
         which contain very toxic, toxic o r corrosive liquids
         intended f o r domestic use shall carry a tactile                                        (c) T h e symbols shall c o n f o r m t o those in A n n e x
         w a r n i n g of danger.                                                                        II ( ' ) ; they shall be printed in black o n a n o r a n g e -
                                                                                                         yellow background.
   3.       A n y technical specifications which m a y                         be                        T h e use of t h e symbols and indications of d a n g e r
   necessary with regard to. t h e devices referred t o                        in                        is specified in A n n e x V I .
   p a r a g r a p h 2 shall b e a d o p t e d by t h e p r o c e d u r e      in
   Article 24 a n d shall be given in A n n e x I X ,                          in
                                                                                                  (d) T h e special risks involved in using t h e substances
   particular:
                                                                                                         shall be indicated b y o n e o r m o r e of t h e standard
                                                                                                         phrases which, in accordance with t h e references
   — in A n n e x I X P a r t A relating t o child-resistant                                             contained in t h e list in A n n e x I, a r e set o u t in
         fastenings,
                                                                        I
                                                                                                  (') See the following adaptations t o technical progress:
   — in An n e x I X P a r t B relating t o tactile w a r n i n g s of                                 OJ N o L 257, 16. 9. 1983, p. 1, and OJ N o L 2 4 7 ,
         danger.                                                                                        1 . 9 . 1986, p. 1.
 ---pagebreak--- N o C 33/14                                                     Official Journal of t h e European Communities                                                                                         13. 2 . 9 0
          A n n e x I I I ( ' ) . I n t h e c a s e o f a s u b s t a n c e n o t listed                          (g) Indications such as 'non-toxic', ' n o n - h a r m f u l ' o r
          in A n n e x I , t h e r e f e r e n c e t o t h e special risks                                                  a n y o t h e r similar i n d i c a t i o n s m u s t n o t a p p e a r o n
          a t t r i b u t e d t o t h e d a n g e r o u s s u b s t a n c e s shall                                         t h e label o r p a c k a g i n g o f s u b s t a n c e s s u b j e c t t o
          c o m p l y w i t h a p p r o p r i a t e i n d i c a t i o n s g iv e n in                                       this D i r e c t i v e .
          A n n e x III.
                                                                                                                  3.          I n t h e case of irritant, highly flammable,
          T h e phrases 'extremely flammable' o r 'highly
                                                                                                                  flammable a n d oxidizing substances, a n indication of
          flammable' need n o t b e indicated w h e r e t h e y
                                                                                                                  special risks a n d s a f e t y a d v i c e n e e d n o t b e g i v e n
          repeat t h e w o r d i n g of a n indication of d a n g e r
                                                                                                                  w h e r e t h e p a c k a g e d o e s n o t c o n t a i n m o r e t h a n 125
          u s e d in a c c o r d a n c e w i t h (c) a b o v e .
                                                                                                                  ml. T h i s shall a l s o a p p l y in t h e c a s e o f t h e s a m e
   (e) T h e s a f e t y a d v i c e r e l a t i n g t o t h e u s e o f t h e                                    v o l u m e of h a r m f u l s u b s t a n c e s n o t r e t a i l e d t o t h e
          s u b s t a n c e s shall b e i n d i c a t e d b y s t a n d a r d p h r a s e s                       g e n e r a l public.
          w h i c h , in a c c o r d a n c e w i t h t h e r e f e r e n c e s
                                                                                                                  4.          W h e n m o r e t h a n o n e d a n g e r s y m b o l is a s s i g n e d
          c o n t a i n e d in t h e list in A n n e x I , a r e s e t o u t in
                                                                                                                  t o a substance:
          A n n e x I V ( 2 ).
          T h e p a c k a g i n g shall b e a c c o m p a n i e d b y t h e s a f e t y                           — t h e obligation t o indicate t h e symbol T m a k e s t h e
          a d v i c e r e q u i r e d b y t h e a b o v e p a r a g r a p h w h e r e it                                  s y m b o l s X a n d C o p t i o n a l , unle s s A n n e x I
          is m a t e r i a l l y impossible f o r this t o b e g iv en o n t h e                                          includes provision t o t h e contrary,
          label o r p a c k a g e itself.                                                                         — t h e obligation t o indicate t h e symbol C m a k e s t h e
          I n t h e c a s e o f a s u b s t a n c e n o t listed in A n n e x I ,                                         symbol X optional,
          t h e safety advice relating t o t h e dangerous
                                                                                                                  — t h e obligation t o indicate t h e symbol E m a k e s t h e
          s u b s t a n c e s shall c o m p l y w i t h a p p r o p r i a t e i n d i ­
                                                                                                                          symbols F a n d O optional.
          c a t i o n s g iv en in A n n e x I V .
                                                                                                                  5.          I n a d d i t i o n t o t h e p r o v i s i o n s f o r t h e labelling o f
   ( f ) T h e E E C n u m b e r shall b e o b t a i n e d e i t h e r f r o m
                                                                                                                  d a n g e r o u s s u b s t a n c e s specified a b o v e , M e m b e r S t a t e s
          t h e i n v e n t o r y o r f r o m t h e list r e f e r r e d t o in A r t i c l e
                                                                                                                  shall a l s o t a k e all n e c e s s a r y m e a s u r e s t o e n s u r e t h a t
          16. T h e o f f i c i a l n u m b e r of t h e n o t i f i c a t i o n d o s s i e r
                                                                                                                  a n y s u b s t a n c e a p p e a r i n g in t h e i n v e n t o r y r e f e r r e d t o
          shall b e o b t a i n e d f r o m t h e c o m p e t e n t a u t h o r i t y a s
                                                                                                                  in A r t i c l e 1 6 ( 1 ) o r n o t i f i e d in a c c o r d a n c e w i t h
          p r o v i d e d f o r in A r t i c l e 11 (2) a n d (3).
                                                                                                                  Articles 6 a n d 7 o r c o v e r e d b y A r t i c l e 8 (2) c a n n o t b e
                                                                                                                  p l a c e d o n t h e m a r k e t unle s s t h e labelling o r p a c k a g i n g
                                                                                                                  includes t h e E E C n u m b e r (where k n o w n ) o r t h e
   (') See the following adaptations t o technical progress
                                                                                                                  o f f i c i a l n u m b e r of t h e n o t i f i c a t i o n d o s s i e r a l l o c a t e d b y
         — OJ N o L 360, 30. 12. 1976, p. 1;
                                                                                                                  the competent authority o r the w o r d s 'substance
         — O J N o L 88, 7. 4. 1979, p. 1;
         — OJ N o L 257, 16. 9. 1983, p. 1;                                                                       f a l l i n g u n d e r A r t i c l e 8 (2) o f D i r e c t i v e 6 7 / 5 4 8 / E E C ' .
         — OJ N o L 247, 1. 9. 1986, p. 1.                                                                        T h e E E C n u m b e r shall b e o b t a i n e d e i t h e r f r o m t h e
   ( 2 ) See the following adaptations t o technical progress                                                     i n v e n t o r y o r t h e list r e f e r r e d t o in A r t i c l e 16. T h e
         — OJ N o L 360, 30. 12. 1976, p. 1;                                                                      offic ia l n u m b e r o f t h e n o t i f i c a t i o n d o s s i e r shall b e
         — O J N o L 88, 7. 4. 1979, p. 1;                                                                        obtained f r o m t h e competent authority as provided
         — OJ N o L 257, 16. 9. 1983, p. 1.                                                                       f o r in A r t i c l e 11 (2) a n d (3).
                      Article        19
                                                                      Implementation o f labelling requirements
                       1.       W h e r e t h e p a r t i c u l a r s r e q u i r e d b y A r t i c l e 18 a p p e a r o n a label, t h a t label shall b e f i r m l y
                      a f f i x e d t o o n e o r m o r e s u r f a c e s of t h e p a c k a g i n g s o t h a t t h e s e p a r t i c u l a r s c a n b e r e a d h o r i ­
                      z o n t a l l y w h e n t h e p a c k a g e is s e t d o w n n o r m a l l y . T h e d i m e n s i o n s o f t h e label shall b e a s
                      follows:
                                              Capacity o f the package                                                           D i m e n s i o n s (in millimetres)
                      not exceeding three litres                                                             if possible, at least 55 x 78
                      greater than three litres but not exceeding 50 litres                                  at least 78 x 110
                      greater than 50 litres but not exceeding 500 litres                                    at least 110 x 155
                      greater than 500 litres                                                                at least 155 x 221
 ---pagebreak--- 13. 2. 9 0                                             Official J o u r n a l of t h e E u r o p e a n Communities                                           N o C 33/15
                   E a c h symbol shall cover a t least o n e t ent h of t h e surface area of the label b u t n o t be less t h a n
                   1 cm 2 . T h e entire surface of t h e label shall a d h e r e t o t h e package immediately containing t h e
                   substance.
                   T h e s e dimensions a r e intended solely f o r provision of t h e information required b y this
                   Directive a n d if necessary of a n y supplementary health o r safety indications.
                   2.      A label is n o t required w h e r e t h e particulars a r e clearly show n o n t h e package itself, as
                   specified in p a r a g r a p h 1.
                   3.      T h e c o l o u r a n d presentation df t h e label — o r , in t h e case of p a r a g r a p h 2, of t h e package
                   — shall be such t h a t t h e d a n g e r symbol a n d its b a c k g r o u n d stand o u t clearly.
                   4.      M e m b e r States m a y m a k e t h e placing o n t h e m a r k e t of d a n g e r o u s substances in their
                   territories subject t o t h e use of t h e official language o r languages in respect of t h e labelling
                   thereof.
                   5.      F o r t h e p u r p o s e of this Directive, labelling requirements shall be d e e m e d t o b e satisfied:
                   (a) in t h e case of a n o u t e r package containing o n e o r m o r e inner packages, if t h e o u t e r
                         p a c k a g e is labelled in accordance with international rules o n t h e transport of d a n g e r o u s
                         substances a n d t h e inner p a c k a g e o r packages are labelled in accordance with this
                         Directive;
                   (b) in t h e case of a single package, if such a package is labelled in accordance with inter­
                         national rules o n t h e t r a n s p o r t of d a n g e r o u s substances a n d with Article 18 (2) (a), (b), (d),
                         (e) a n d (f).
                   W h e r e d a n g e r o u s substances d o n o t leave t h e territory of a M e m b e r State, labelling m a y be
                   permitted which complies with national rules instead of with international rules o n t h e
                   transport of d a n g e r o u s substances.
   Article 20                                                                                     (b) b y w a y of derogation f r o m Articles 18 a n d 19
                                                                                                          permit t h e packaging of d a n g e r o u s substances
                                                                                                          which are n o t explosive, very toxic o r toxic t o b e
              Exemptions from labelling and packaging
                                                                                                          unlabelled o r t o b e labelled in s o m e o t h e r w a y if
                                     requirements
                                                                                                          t h e y contain such small quantities t h a t there is n o
    1.     Articles 17 t o 19 d o n o t apply t o t h e provisions                                        reason t o f e a r a n y d a n g e r t o persons handling
    governing:                                                                                            such substances o r o t h e r persons.
    (a) t h e following d a n g e r o u s gases, compressed,
         liquefied o r u n d e r pressure, o r a n y mixture
                                                                                                  3.         If a M e m b e r State makes use of t h e options
         t h e r e o f : b u ta n e , p r o p a n e , oxygen, h y d r o g e n ,
         acetylene;                                                                               provided f o r in p a r a g r a p h 2, it shall i n f o r m t h e
                                                                                                  Commission thereof forthwith.
    (b) aerosols which comply with t h e requirements of
         Council Directive 7 5 / 3 2 4 / E E C ( ' ) ;
                                                                                                  Article 21
    (c) munitions a n d explosives placed o n t h e m a r k e t
         with a view t o p r o d u c i n g a practical effect b y
         explosion o r a pyrotechnic effect.
                                                                                                                              Safety data sheet
    2.     In addition, M e m b e r States m a y :                                                 1.       A t o r , if appropriate, b e f o r e t h e first delivery of
                                                                                                   a d a n g e r o u s substance o r preparation, a n y m a n u ­
                                                                                                   facturer, importer o r distributor shall communicate t o
    (a) permit t h e labelling required b y Article 18 t o b e
                                                                                                   t h e recipient the information necessary f o r protection
         applied in some o t h e r appropriate m a n n e r o n
         packages which a r e either t o o small o r otherwise                                     of m a n a n d t h e environment b y t h e means of a safety
         unsuitable f o r labelling in accordance with Article                                     d a t a sheet. T h i s d a t a sheet m a y b e communicated o n
         1 9 ( 1 ) a n d (2);                                                                      p a p e r o r electronically. Subsequently, t h e m a n u ­
                                                                                                   facturer, importer o r distributor shall f o r w a r d t o t h e
                                                                                                   recipient of t h e safety d a t a sheet a n y n e w relevant
                                                                                                   information o n t h e substance o r preparation which
    (') OJ N o L 147, 9. 6. 1975, p. 40.                                                           has become k n o w n t o him.
 ---pagebreak--- N o C 33/16                                         Official J o u r n a l of t h e E u r o p e a n Communities                                             13. 2. 9 0
   2.        Detailed regulations o n t h e elaboration, distri­                                    (c) If, o n t h e expiry of a period t o b e laid d o w n in
   bution, contents a n d f o r m a t of t h e safety d a t a sheet                                       each act t o b e a d o p t e d b y t h e Council u n d e r
   r e f e r r e d t o in p a r a g r a p h 1 will be t h e subject of a                                  this p a r a g r a p h b u t which m a y in n o case
   f u t u r e C o m m u n i t y legal instrument.                                                        exceed three m o n t h s f r o m t h e d a t e of referral
                                                                                                          t o t h e Council, t h e Council has n o t acted, t h e
                                                                                                          proposed measures shall be a d o p t e d b y t h e
   Article 22
                                                                                                          Commission.
                      Adaptation t o technical progress
                                                                                               Article 25
   T h e a m e n d m e n t s necessary f o r adapting t h e Annexes
   t o technical progress, shall b e a d o p t e d in accordance                                                         Free circulation clause
   with t h e p r o c e d u r e laid d o w n in Article 24.
                                                                                               T h e M e m b e r States m a y n o t prohibit, restrict o r
                                                                                               impede t h e placing o n t h e m a r k e t of substances which
   Article 23                                                                                  comply with t h e requirements of this Directive, o n
                                                                                               g r o u n d s relating t o notification, classification,
          Committee f o r adaptation t o technical progress                                    packaging o r labelling within t h e meaning of this
                                                                                               Directive. -
   1.        A C o m m i t t e e (hereinafter called ' t h e C o m ­
   mittee') is hereby set u p t o a d a p t t o technical progress                             Article 26
   t h e Directives concerning t h e elimination of technical
   barriers t o t r a d e in d a n g e r o u s substances a n d p r e p a ­                                                Safeguard clause
   rations. I t shall consist of representatives of t h e
   M e m b e r States, with a Commission representative as                                     1.      W h e r e , f o r substances appearing in t h e inventory
   c h a ir m a n .                                                                            referred t o in Article 1 6 ( 1 ) o r notified in accordance
                                                                                               with Articles 6 o r 7 o r falling u n d e r Article 8 (2), a
                                                                                               M e m b e r State has detailed evidence t h a t , altho ugh
   2.       T h e C o m m i t t e e shall a d o p t its o w n rules of
                                                                                               satisfying t h e requirements of this Directive, t h e
  procedure.
                                                                                               substance nevertheless constitutes a d a n g e r f o r m a n o r
                                                                                               t h e environment, it m a y temporarily prohibit t h e
  Article 24                                                                                   placing o n t h e m a r k e t of t h a t substance o r subject it
                                                                                               t o special conditions in its territory. It shall
          Procedure f o r adaptation t o technical progress                                    immediately i n f o r m t h e Commission a n d t h e o t h e r
                                                                                               M e m b e r States of such action a n d give reasons f o r its
   1.       W h e r e reference is m a d e t o t h e p r o c e d u r e laid                    decision.
  d o w n in this Article, t h e matter shall be referred t o
  t h e C o m m i t t e e b y its chairman, either o n his o w n                               2.      T h e Commission shall consult t h e M e m b e r
  initiative o r a t t h e request of t h e representative of a                                States within six weeks, t h e n give its view w i t h o u t
  M e m b e r State.                                                                           delay and t a k e t h e appropriate measures.
  2.        T h e representative of t h e Commission shall                                     3.      If t h e Commission considers t h a t
  submit t o t h e C o m m i t t e e a d r a f t of t h e measures t o be
                                                                                              — technical adaptations t o t h e Annexes of this
  t a k e n . T h e C o m m i t t e e shall deliver its opinion o n t h e
                                                                                                    Directive are necessary, such adaptations shall b e
  d r a f t within a time limit which t h e chairman m a y lay
                                                                                                    a d o p t e d , either b y t h e Commission o r b y t h e
  d o w n according t o t h e urgency of t h e matter.
                                                                                                    Council, in accordance with t h e p r o c e d u r e laid
                                                                                                    d o w n in Article 24,
  T h e opinion shall be delivered b y t h e majority laid
  d o w n in Article 148 (2) of t h e T r e a t y in t h e case of                            — h a r m o n i z e d measures a r e necessary concerning
  decisions which t h e Council is required t o a d o p t o n a                                     restrictions o n t h e marketing a n d use of certain
  proposal f r o m t h e Commission. T h e votes of t h e                                           d a n g e r o u s substances it will submit a proposal
  representatives of t h e M e m b e r States within t h e                                          within t h e f r a m e w o r k either of Directive
  C o m m i t t e e shall, be weighted in t h e m a n n e r set o u t in                            7 6 / 7 6 9 / E E C o r o t h e r appropriate C o m m u n i t y
  t h a t Article. T h e chairman shall n o t vote.                                                 measures concerned with restrictions o n marketing
                                                                                                    a n d use.
  3. (a) T h e • Commission shall a d o p t t h e measures
                                                                                              In b o t h cases t h e M e m b e r State which has a d o p t e d
               envisaged if t h e y a r e in accordance with the
                                                                                              t h e safeguard measures rtiay maintain t h e m until t h e
               opinion of t h e Committee.
                                                                                              adaptations enter into force.
       (b) If t h e measures envisaged are n o t in
               accordance with t h e opinion of t h e Committee,                             Article 27
               o r if n o opinion is delivered, t h e Commission
                                                                                                                                Reports
               shall w i t h o u t delay, submit t o t h e Council a
               proposal relating t o t h e measures t o be taken.                             1.      Every three years, M e m b e r States shall f o r w a r d
               T h e Council shall act b y a qualified majority.                             t o t h e Commission a r e p o r t o n t h e implementation of
 ---pagebreak---                                                  Official Journal of the European Communities                                     N o C 33/17
13. 2. 90
    this Directive in their respective countries. T h e first                  — replace 'Article 8 (2) of Directive 6 7 / 5 4 8 / E E C ' by
    report shall be submitted three years after the                                 'Article 8 (3) of Directive 6 7 / 5 4 8 / E E C ' in Article
    implementation of this Directive.                                               3 (5),
    2.      Every three years, the Commission shall prepare
                                                                               — replace 'teratogenic' by 'toxic f o r reproduction'
    a composite report based o n the information referred
                                                                                    and      replace 'teratogenic substances' with
    t o in paragraph 1, which shall be forwarded t o the
                                                                                    'substances toxic f o r reproduction' in Article 3 (5)
     Member States.'
                                                                                    (0)>
2. T h e Annexes are amended as follows:
                                                                                — replace 'teratogenic' with 'toxic f o r reproduction'
    — Annex II is modified by the addition of a symbol                               and     replace 'teratogenic substances' with
         f o r 'dangerous f o r the environment' as in Annex I                       'substances toxic f o r reproduction' in Article 3 (5)
         t o this Directive,
                                                                                     (p)>
     — Annex V I P a r t 1 (A) is replaced b y Annex II t o
         this Directive,                                                        — replace Article 15 (1) by Article 17 (1) in Article
     — Annex V I I is replaced by Annex III t o this                                  16 (1) (a),
         Directive,
     — Annex V I I I is replaced by Annex I V t o this                          — replace Article 21 by Article 24 in Article 6 (3),
         Directive.
                                                                                — replace Article 11 (4) by Article 14 (4) in Article 7
                                     Article 2                                        (1) (c) (ii),
T h e following Directives are amended as follows:
                                                                                — replace Article 16 (2) (c) b y Article 18 (2) (c) in
 1. Directive 7 3 / 1 7 3 / E E C ( ' ) :                                             Article 7 (1),
     — replace 'Article 6 ' b y 'Article 18' in Article 5 (2)
          (c),                                                                  — replace Article 21 by Article 24 in Articles 10, 14
                                                                                      (2) and 15.
     — replace 'Article 8 (c)' b y 'Article 24' in Articles 9
          (2) and 10;
                                                                                — replace 'teratogenic effects' by 'effects o n repro­
 2. Directive 7 7 / 7 2 8 / E E C ('):                                                duction' in the title of Annex I Part 6,
     — replace 'Article 6 ' b y 'Article 18' in Article 6 (2)
           (c),                                                               . — replace 'teratogenic substances' by 'substances
     — replace 'Article 8 (c)' by 'Article 24' in Articles 10                         toxic f o r reproduction' in Annex I Table V I .
           (3) and 11;
 3. Directive 7 8 / 6 3 1 / E E C :                                                                       Article 3
      — replace 'Article 6 ' b y 'Article 18' in Article 6 (2)               1. N o later than 1 January 1992 the Member States
           (g)>                                                              shall adopt and publish the laws, regulations and admin­
                                                                             istrative provisions necessary t o comply with this
      — replace 'Article 8 (c)' b y 'Article 24' in Articles 10
                                                                             Directive. T h e y shall immediately inform the
           (3) and 11.
                                                                             Commission thereof.
 4. Directive 8 8 / 3 7 9 / E E C :
      — replace the reference t o Directive 7 9 / 8 3 1 / E E C by           2. T h e measures adopted pursuant t o the first
           a reference t o the present Directive in the second               paragraph shall make express reference t o this Directive.
           and eighth recitals,
      — replace 'carcinogenic, mutagenic and teratogenic                     3. T h e Member States shall communicate t o the
           effects' b y 'carcinogenic and mutagenic effects and              Commission the text of the provisions of national law
           effects o n reproduction' in Article 3 (3),                       which they adopt in the field covered by this Directive.
  (') Directives 7 3 / 1 7 3 / E E C and 7 7 / 7 2 8 / E E C will cease t o                                Article 4
       apply o n 8 June 1991 o n the date o f entry into force of
       Directive 8 8 / 3 7 9 / E E C .                                       This Directive is addressed t o the Member States.
 ---pagebreak--- N o C 33/18                                              Official Journal of the European Communities                                                                                                13. 2. 9 0
                                                                                                 ANNEX               I
           A n n e x I I t o D i r e c t i v e 6 7 / 5 4 8 / E E C is m o d i f i e d b y t h e a d d i t i o n o f t h e f o l l o w i n g s y m b o l
                                                                                                                                                             dangerousf o r the
                                                                                                                                                             environment'
                                                                                               ANNEX               II
          A n n e x V I p a r t 1 ( A ) t o D i r e c t i v e 6 7 / 5 4 8 / E E C is r e p l a c e d b y t h e f o l l o w i n g :
                 ' G e n e r a l classification a n d labelling r e q u i r e m e n t s f o r d a n g e r o u s substances
                 PARTI
                 A . S a v e w h e r e o t h e r w i s e p r o v i d e d f o r in t h e s e p a r a t e Directives o n d a n g e r o u s p r e p a r a t i o n s , t h e
                       substances a n d p r e p a r a t i o n s shall b e classified a s v e r y toxic, toxic o r h a r m f u l a c c o r d i n g t o t h e
                       following criteria:
                       ( a ) classification a s v e r y t o x i c , t o x i c o r h a r m f u l shall b e e f f e c t e db y d e t e r m i n i n g t h e a c u t e toxicity
                              o f t h e c o m m e r c i a l s u b s t a n c e o r p r e p a r a t i o n in a n i m a l s , expressed i n L D S 0 o f L C 5 0 values w i t h
                              t h e followingparameters being taken as reference values:
                                                                                      LD50 absorbed                           LD50 percutaneous                      LC50 absorbed b y
                                             Category                                  orally in r a i                  absorption in rat o r rabbit                   inhalation in rat
                                                                                          mg/kg                                       mg/kg                         m g / l i t r e / f o u r hour s
                             V e r y toxic                                                 < 25                                        S 50                                    < 0,25
                             Toxic                                                      25 — 200                                   50 — 400                                0,25 —             1
                             Harmful                                                 200 — 2 000                                400 — 2 000                                     1 — 5
                      ( b ) if f a c t s s h o w t h a t f o r t h e p u r p o s e s o f c l a s s i f i c a t i o n i t i s i n a d v i s a b l e t o u s e t h e L D 5 0 o r L C 5 0
                             values a s a principal basis because the substances o r preparations p r o d u c e o t h e r effects, t h e
                             s u b s t a n c e so r p r e p a r a t i o n s s h a l l b e c l a s s i f i e d a c c o r d i n g t o t h e m a g n i t u d e o r t h e s e e f f e c t s . '
 ---pagebreak---                                                   \
13. 2. 9 0                               Official Journal of the European Communities                                   N o C 33/19
                                                             ANNEX       IIIA
                                                 Annex VILA to Directive 67/548/EEC
                        Information required for the technical dossier Chase set') referred to in Article 6 (1)
           If it is not technically possible or if it does not appear scientifically necessary to give information, the
           reasons shall be clearly stated and be subject to acceptance by the competent authority.
           The name of the body or bodies responsible for carrying out the studies shall be mentioned.
           0. IDENTITY O F MANUFACTURER A N D T H E IDENTITY O F T H E NOTIFIER
            1. IDENTITY O F T H E SUBSTANCE
                1.1.        Name
                1.1.1.      Names in the IUPAC nomenclature
                1.1.2.      Other names (usual name, trade name, abbreviation)
                1.1.3.      CAS number (if available)
                1.2.        Molecular and structural formula
                 1.3.       Composition of the substance
                 1.3.1.     Degree of purity (%)
                 1.3.2.     Nature of impurities, including isomers and by-products
                 1.3.3.     Percentage of (significant) main impurities
                 1.3.4.     If the substance contains a stabilizing agent or an inhibitor or other additives, specify:
                            nature, order of magnitude: . . . ppm; . . . %
                 1.3:5.     Identification data (UV, IR, N M R or mass spectrum, HPLC, GC)
                 1.4.       Methods of detection and determination.
                            A full description of the methods used or the appropriate bibliographical references
            2. INFORMATION O N T H E SUBSTANCE
                 2.0.       Production
                 2.0.1.     Technological process used in production
                 2.0.2.      Exposure estimates related to production:
                             — working environment
                             — environment
                 2.1.        Proposed uses
                 2.1.1.     Types of use: description of the function and the desired effects
                 2.1.1.1.    Technological process(es) related to the use of the substance (where known)
                 2.1.1.2     Exposure estimate(s) related to use (where known):
                             — working environment
                             — environment
                  2.1.1.3.   Form under which the substance is marketed: substance, preparation, product
                  2.1.1.4.   Concentration in marketed preparations and products
                  2.1.2.     Fields of application with approximate breakdown
                             — industries
                             — farmers and skilled trades
                             — use by the public at large
 ---pagebreak--- N o C 33/20                              Official Journal o f the European Communities                                   13. 2. 9 0
                 2.1.3.    Where known and where appropriate the identity of the recipients of the substance
                 2.2.      Estimated production and/or imports for each of the anticipated uses or fields of application
                 2.2.1.    Overall production and/or imports in tonnes per year
                          — the first calendar year
                          — the following calendar years
                 2.2.2.   Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a
                          percentage
                          — the first calendar year
                          — the following calendar year
                 2.3.     Recommended methods and precautions concerning:
                2.3.1.    handling
                2.3.2.    storage
                2.3.3.    transport
                2.3.4.    fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
                2.3.5.    other dangers, particularly chemical reaction with water
                2.4.      Emergency measures in the case of accidental spillage
                2.5.     Emergency measures in the case of injury to persons (e.g. poisoning)
                2.6.     Packaging
           3.   PHYSICO-CHEMICAL PROPERTIES O F T H E SUBSTANCE
                3.0.     State of the substance at 20 C and 101,3 kPa
                3.1.     Melting point
                3.2.     Boiling point
               3.3.      Relative density
               3.4.      Vapour pressure
               3.6.      Water solubility
               3.7.      Fat solubility
               3.8.      Partition coefficient (n-octanol/water)
               3.9.      Flash point
               3.10.     Flammability
               3.11.     Explosive properties
               3.12.     Self ignition temperature
               3.13.     Oxidizing properties
          4. TOXICOLOGICAL STUDIES
               4.1.     Acute toxicity
              4.1.1.    Administered orally
              4.1.2.    Administered by inhalation (particle size and vapour pressure are among the criteria to be
                        taken into account for the choice of this route of administration)
              4.1.3.    Administered cutaneously (percutaneous absorption)
              4.1.4.    Substances other than gases shall be administered via two routes at least, one of which
                        should be the oral route. The other route will depend on the intended use and on the
                        physical properties of the substance.
                        Gases and volatile liquids should be administered by inhalation,
              4.1.5.    Skin irritation
              4.1.6.    Eye irritation
              4.1.7.    Skin sensitization
              4.2.      Repeated dose
              4.2.1.    Repeated dose toxicity (28 days)
 ---pagebreak--- 13. 2. 9 0                          Official Journal o f the European Communities                                      N o C 33/21
              4.2.2.  The route of administration should be the most appropriate having regard to the intended
                      use, the acute toxicity and the physical and chemical properties of the substance. In the
                      absence of contra-indications, the oral route is usually the preferred one.
              4.3.    Other effects
              4.3.1.  Mutagenicity (including carcinogenic pre-screening test)
                      The substance should be examined initially by means of a series of two tests, one of which
                      should be a bacteriological test (reverse mutation test) with and without metabolic activation,
                      and one a non-bacteriological test to detect chromosome abberations or damage. In the
                      event of a positive result in either test further testing according to the strategy described in
                      Annex V should be carried out.
              4.3.2.  Teratogenicity: pre-screening test
           5. ECOTOXICOLOGICAL STUDIES
              5.1.    Effects on organisms
              5.1.1.  Acute toxicity for fish
              5.1.2.  Acute toxicity for daphnia
              5.1.3.  Growth inhibition test on algae
              5.2.    Degradation
                      — biotic
                       — abiotic:
                          — if the substance is not readily biodegradable then consideration should be given to the
                              need to carry out the following tests:
                              — hydrolysis as a function of p H
                              — photodegradation screening test
               5.3.    Adsorption/desorption screening test
           6.  POSSIBILITY O F RENDERING T H E SUBSTANCE HARMLESS
               6.1.    For industry/skilled trades
               6.1.1.  Possibility of recycling
               6.1.2.  Possibility of neutralization of unfavourable effects
               6.1.3.  Possibility of destruction:
                       — controlled discharge
                       — incineration
                       — water purification station
                       — others
               6.2.    For the public at large
               6.2.1.  Possibility of recycling
               6.2.2.  Possibility of neutralization of unfavourable effects
               6.2.3.  Possibility of destruction
                       — controlled discharge
                       — incineration
                       — water treatment station
                       — others
 ---pagebreak--- N o C 33/22                             Official Journal o f the European Communities                                   13. 2. 9 0
                                                             ANNEX      IIIB
                                                Annex VIIB to Directive 67/548/EEC
                             Information required for the technical dossier referred to in Article 7 (1)
           If it is not technically possible or if it does not appear scientifically necessary to give information, the
           reasons shall be clearly stated and be subject to acceptance by the competent authority.
           The name of the body or bodies responsible for carrying out the studies shall be mentioned.
           0.   IDENTITY O F MANUFACTURER A N D T H E IDENTITY O F T H E NOTIFIER
           1.  IDENTITY O F T H E SUBSTANCE
                1.1.      Name
                1.1.1.    Names in the IUPAC nomenclature
                1.1.2.    Other names (usual name, trade name, abbreviation)
                1.1.3.    CAS number (if available)
                1.2.      Molecular and structural formula
                1.3.      Composition of the substance
               1.3.1.     Degree of purity (%)
               1.3.2.     Nature of impurities, including isomers and by-products
               1.3.3.     Percentage of (significant) main impurities
               1.3.4.     If the substance contains a stabilizing agent or an inhibitor or other additives, specify:
                          nature, order of magnitude: . . . ppm; . . . %
               1.3.5.    Identification data (UV, IR, N M R or mass spectrum, HPLC, GC)
               1.4.      Methods of detection and determination
                         A full description of the methods used or the appropriate bibliographical references
          2. INFORMATION O N T H E SUBSTANCE
               2.0.      Production
              2.0.1.     Technological proces$(es) used in production
              2.0.2.     Exposure estimate related to production:
                         — working environment
                         — environment
              2.1.       Proposed uses
              2.1.1.     Types of use: description of the function and the desired effects
              2.1.1.1.   Technological process(es) related to the use of the substance (where known)
              2.1.1.2.   Exposure estimate(s) related to the use of the substance (where known):
                         — working environment
                         — environment
              2.1.1.3.   Form under which the substance is marketed: substance, preparation, product
              2.1.1.4.   Concentration in marketed preparations and products
              2.1.2.     Fields of application with approximate breakdown
                         — industries
                         — farmers and skilled trades
                         — use by the public at large
              2.1.3.    Where known and where appropriate the identity of the recipients of the substance
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13. 2. 9 0
              2.2.     Estimated production and/or imports for each of the anticipated uses or fields of application
              2.2.1.   Overall production and/or imports in tonnes per year
                       — the first calendar year
                       — the following calendar years
               2.2.2.  Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a
                       percentage
                       — the first calendar year
                       — the following calendar years
               2.3.    Recommended methods and precautions concerning:
               2.3.1.  handling
               2.3.2.  storage
               2.3.3.  transport
               2.3.4.  fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
               2.3.5.  other dangers, particularly chemical reaction with water
               2.4.    Emergency measures in the case of accidental spillage
               2.5.    Emergency measures in the case of injury to persons (e. g. poisoning)
               2.6/    Packaging
           3.  PHYSICO-CHEMICAL PROPERTIES O F T H E SUBSTANCE
               3.0.    State of the substance at 20 C and 101,3 kPa
               3.1.     Melting point
               3.2.     Boiling point
               3.6.    Water solubility
                3.8.    Partition coefficient (n-octanol/water)
                3.9.    Flash point
                3.10.   Flammability
           4. TOXICOLOGICAL STUDIES
                4.1.    Acute toxicity
                4.1.1.  Administered orally
                4.1.2.  Administered by inhalation (particle size and vapour pressure are criteria for the choice of
                        this route of administration)
                4.1.3.  Administered cutaneously (percutaneous absorption)
                4.1.4.  For the acute toxicity test, one route of administration is sufficient. For substances other than
                        gases, the route shall depend on the intended use and on the physical properties of the
                        substance
                        Gases and volatile liquids should be administered by inhalation
                4.1.5.  Skin irritation
                4.1.6.  Eye irritation
                4.1.7.  Skin sensitization
                4.3.    Other effects
                4.3.1.  Mutagenicity: bacteriological test with and without metabolic activation (reverse mutation
                        test)
            5. ECOTOXICOLOGICAL STUDIES
                 5.2.    Degradation
                        — biotic
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                                                                   ANNEX     IIIC
                                                      Annex   VIIC to Directive 67/548/EEC
                                  Information required for the technical dossier referred to in Article 7 (2)
           If it is not technically possible o r if it does not appear scientifically necessary t o give information, the
           reasons shall be clearly stated and be subject t o acceptance by the competent authority.
           T h e name of the body o r bodies responsible f o r carrying out the studies shall be mentioned.
           0.    I D E N T I T Y O F M A N U F A C T U R E R A N D T H E N O T I F I E R I F T H E S E A R E N O T T H E SAME
           1.   I D E N T I T Y O F T H E SUBSTANCE
                 1.1.         Name
                 1.1.1.       Names in the I U P A C nomenclature
                 1.1.2.       O t h e r names (usual name, trade name, abbreviation)
                 1.1.3.       CAS number (if available)
                 1.2.         Molecular and structural formula
                 1.3.         Composition of the substance
                 1.3.1.       Degree of purity ( % )
                1.3.2.        Nature of impurities, including isomers and by-products
                1.3.3.        Percentage of (significant) main impurities
                1.3.4.        If the substance contains a stabilizing agent o r an inhibitor o r other additives, specify:
                              nature, order of magnitude: . . . ppm; . . . %
                1.3.5.        Identification data (UV, IR, N M R o r mass spectrum, H P L C , G C )
                1.4.          Methods of detection and determination.
                              A full description of the methods used of the appropriate bibliographical references.
          2.   I N F O R M A T I O N O N T H E SUBSTANCE
               2.0.          Production
               2.0.1.        Technological process(es) used in production
               2.0.2.        Exposure estimate related to production:
                             — working environment
                             — environment
               2.1.          Proposed uses
               2.1.1.        Types of use: description of the function and the desired effects
              2.1.1.1.       Technological process(es) related t o the use of the substance (where known)
              2.1.1.2.       Exposure estimate(s) related t o the use of the substance (where known):
                             — working environment
                             — environment
              2.1.1.3.       Form under which the substance is marketed: substance, preparation, product
              2.1.1.4.      Concentration in marketed preparations and products
              2.1.2.        Fields of application with approximate breakdown
                            — industries
                            — farmers and skilled trades
                            — use by the public at large
              2.1.3.        W h er e known and where appropriate the identity of the recipients of the substance
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               2.2.        Estimated production and/or imports for each of the anticipated uses or fields of application
               2.2.1.      Overall production and/or imports in tonnes per year
                           — the first calendar year
                           — the following calendar year
                2.2.2.     Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a
                           percentage
                           — the first calendar year
                           — the following calendar year
                2.3.       Recommended methods and precautions concerning:
                2.3.1.     handling
                2.3.2.     storage
                2.3.3.     transport
                2.3.4. ,    fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
                2.3.5.      other dangers, particularly chemical reaction with water
                2.4.        Emergency measures in the case of accidental spillage
                2.5.        Emergency measures in the case of injury to persons (e.g. poisoning)
                2.6.        Packaging
           3.   PHYSICO-CHEMICAL PROPERTIES O F T H E SUBSTANCE
                3.0.        State of the substance at 20 C and 101,3 kPa
                3.9.        Flash point
                3.10.       Flammability
           4. TOXICOLOGICAL STUDIES
                 4.1.       Acute toxicity
                 4.1.1.     Administrated orally
                                                                ANNEX IV
                                                  Annex VIII to Directive 67/548/EEC
                                   Additional information and tests required pursuant to Article 6 (4)
            If it is not technically possible or if it does not appear scientifically necessary to give information, the
           reasons shall be clearly stated and be subject to acceptance by the competent authority.
           T h e name of the body or bodies responsible for carrying out the studies shall be indicated.
                                                                 LEVEL 1
            Toxicological studies
            — Fertility study (one species, one generation, male and female, most appropriate route of adminis­
                 tration).
                 If there are equivocal findings in the first generation, study of a second generation is required.
                 Depending upon the dosing schedule it may be possible in this study to obtain an indication of
                 teratogenicity. A positive indication should be examined in a formal teratology study.
             — Teratology study (one species, most appropriate route of administration)
                 This study is required if teratogenicity has not been examined in the fertility study.
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           — Sub-chronic and/or chronic toxicity study, including special studies (one species, male and female,
               most appropriate route of administration) shall be required if the results of the repeated-dose study in
               Annex VII o r other relevant information demonstrate the need for further appropriate investigation.
               The effects which would indicate the need for such a study could include for example:
               (a) serious or irreversible lesions;
               (b) a very low or absence of a 'no effect' level:
               (c) a clear relationship in chemical structure between the substance being studied and othfer substances
                    which have been proved dangerous.
           — Additional mutagenesis studies and/or screening study(ies) for carcinogenesis as prescribed in the
               testing strategy described in Annex V.
               When both tests in the base set were negative, one test for a,different end point in another organism
               should be performed as supplementary study.
               When a test or both tests were positive in the base set, a supplementary study should include the same
               o r different end points in other in vivo test methods.
           — Basic toxicokinetic information.
           Ecotoxicology studies
           — Prolonged toxicity study with Daphnia magna (21 days)
          — Test on higher plants
          — Test on earthworms
          — Prolonged toxicity study with fish
          — Tests for species accumulation; one species, preferably fish.
          — Supplementary biodegradation study(ies), if sufficient degradation has not been proved by the studies
              laid down in Annex VII
              Further studies on adsorption/desorption dependent upon the results of the investigations laid down in
              Annex VII.
                                                               LEVEL 2
          Toxicological studies
          The test programme shall cover the following aspects unless there are strong reasons to the contrary,
          supported by evidence, that it should not be followed:
          — chronic toxicity study,
          — carcinogenicity study,
          — fertility study (e.g. three-generation study); only if an effect on fertility has been established at level 1,
          — developmental toxicity study on peri and postnatal effects,
          — teratology study (especies not employed in the respective level 1),
             additional toxicokinetic studies which cover biotransformation, pharmacokinetics,
          — additional tests to investigate organ or system toxicity.
          Ecotoxicity studies
         — Additional tests for accumulation, degradation, mobility and absorption/desorption
         — Further toxicity studies with fish
         — Toxicity study with birds
         — Additional toxicity studies with other organisms.