CELEX: 51976PC0433
Language: en
Date: 1976-09-08
Title: Proposal for a COUNCIL DIRECTIVE the sixth modification of the Council Directive of 27 June 1967 on the approximation of the laws of Member States relating to the classification, packaging and labelling of dangerous substances (sybmitted by the Commission to the Council)

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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                           >                  COM(76)433 final
                                              Brussels , 8 September 1976
                                                 \
                                    ■,                /          I :
                             /                            s
                                                    • \
                                 Proposal for a
                               COUNCIL DIRECTIVE
                               I
             the sixth modification of the Council Directive of
             27 June 1967 on the approximation of the laws of     ^ /
                    *                                     .               )
             Member States relating to the classification ,
             packaging and labelling of dangerous substances
                                                                            !
                 ( sybmitted by the Commission to the Council )
  (
?
                                  ι
    C0MC76 ) 433 final
                  /
 ---pagebreak---                            EXPLANATORY liEIORABIOM
1.  IFTRODUCTION
   During ohe past few years , the large scale changes in the chemical
    industry have led to a rapid increase in both the number and quantity
   of synthetic chemical compounds which has in turn given rise to more
   and more serious problems with respect to their control .
   Chemical compounds now have a place in most human activities and each
   year the list lengthens . There is a risk that among these compounds
   there may be substances which could have harmful effects directly or
   indirectly for man and the environment .
   At the moment on a Community basis this is regulated by the Council
   Directive of 27 June 1967 ( 67/548/CES) on dangerous substances which
   lays down conditions for their classification and the way in which
   they are offered for sale as well as by Council Directives on solvants
   ( 73/173/CEE , detergents ( 73/404/CEH) and methods of measurement of the
   biodegradibility of anionic surfactants ( 73/405/CE3) .
   Other directives on certain preparations are in course of adoption.
   Today scientific circles , public opinion and the aiithorities of Ifember
   States are confronted increasingly by problems caused by toxic , harmful
   or polluting substances . Polychlorbiphenyls (PCB), polychlorterphenyls
   (PCT), vinyl chloride monomer (VCM), mercpry compounds , and certain
   organohalogen compounds are the most current examples .              „
   A directive on the limitation of the placing on the market and us .• of
   the first three substances was approved by the Council on 30 June 1$)57 «
   This directive is not limited to these three pollutants it includes the
   possibility of extension of its field of application to any chemical
   substance which may prove to be dangerous .
 ---pagebreak---                                      - 2 -
  In view of the growing concern of public authorities there is now increased
  interest in the different ways of evaluating the effects of chemical products
 ■before these offer a real danger so that this danger can be avoided as much
 as possible .
 It seems more and more necessary at the moment not to continue placing on
the market chemical compounds potentially dangerous for man and the environ­
 ment without having available a minimum of knowledge about the ricks which   r
are produced .   By the nature and importance of the solutions and their impact
 on trade and the free circulation of goods this problem could only be solved
on a Community basis notably because of the fundamental objectives of the
European EoDnomic Community and in particular because of the measures arising
from the existence of the directive of 27 June 1967 .
In effect by the European Community Action Programme for the Environment of
22 November' 1973 the Council has charged the Commission to examine the
possibilities of harmonizing and reinforcing the control which the public
authorities should exercise on certain new synthetic substances and products
before they are placed on the market .
This examination has shown not only the necessity of setting up a system
of control but equally of establishing this with a view to preventing
pollution, in accordance with the first principle of the Environmental
Polioy Programme previously mentioned , and to undertake this in a systematic
way, that is to say by a generalised control .
In June 1975 "this French Government in accordance with the information agree­
ment on environment of 5 March 1973 » notified to the Commission a draft lav;
on the control of chemical products dispersed in the environment .    The
Commission invited the French authorities to postpone the application of
the measures envisaged in order that it could prepare proposals for Community
measures to be presented to the Council .   The preparatory work tvas carried
 ---pagebreak---  out with the help of the group of national experts "Elimination of technical
"barriers to trade : dangerous substances".          Three plenary meetings and one
restricted meeting were held to examine the draft modification of the
directive of 27 June 1967 .
In parallel with this work of modification of the directive of 19^7 to
include the criteria "dangerous for the environment" the Committee for
Ado. ptc .tion to Technical Progress unanimously voted a modification of
Anne ."0 3 I , III and IV of this directive respectively to the list of
dangerous substances indications of risk and safety advice .
The present proposal of modification of the directive of 27 June 1967
envisages the reinforcement of measures relating to the classification,
packaging and labelling of substances which had as its objective the i>
protection of users and workers .
In order to supervise*" the effects on man and the environment , it is
proposed that any placing on the market of a new substance would imply
the carrying out of a prior study by the manufacturer and notification
to the competent authorities when the substance was first placed on the
market in a Member State .           To follow closely the evolution of substances
placed on the market and their use , a system should b&osot 'up which.- provides
for, 'the!'. listing! of.rail /now sabstakcels which.' are-'< plac&iio oar the '.; n&a?lcBi .
... •/.:• < _           to       v.:>.
In this way, the competent authority of a Member State will be in a position
to evaluate the consequences which would result from the marketing of the
substance and could if necessary intervene immediately in modifying the
classification proposal either by limiting or forbidding the marketing of
the substance .
This limitation or prohibition would take place when the oompetent authority
judged it to be necessary and indispensible for the protection of man and
the environment .
                                                                                       V.
 ---pagebreak---                                    - 4 -
The present proposal of directive has as its objective the laying down of
Community measures in the field of chemical products in view of their
danger for man and the environment and is a natural sequel to directives
elaborated in the field of dangerous substances and preparations .
In order to facilitate the reading of the directive a new numbering of
the artioles is proposed .
 ---pagebreak---                                       - 5 -
    It is proposed to replace Articles 1 to 11 of the Council Direotive of
TV £7 Juno -1§67 by a- newi^oxtj,;          • ;•
   COimiTARIES ON THE MA.HT MODIFICATIONS ENVISAGED
             –'–             ■                         ■ ■
   Article T
   The field of application of this article has "been enlarged to include
   the notification of new substances .       The new sub-paragraph 2a states
   that substances used as foodstuff or animal feedingstuffs are submitted
   to other Community measures with respect to their labelling.
   Article 2
   In Article 2 ( c ) ( d) and ( e ) the definitions of new substances and
   notification are given. In paragraph 2 ( i) a^ new classification
   1 dangerous for the environment * is created to take account of the
   new objectives of the directive .
   Article 3
   The new paragraphs 2 and 3 of this article specify the method of
   determining the classification envisaged by the directive and refers
   to technical annexes VI , VII and VIII .
   Article 5
   This article fixes the general conditions ifc which new substances must
   be submitted to be placed on the market .
   Article 6
   This article sets out the general principle aocording to which the
   notifier must carry out a prior study with the aim of assessing the
   effects on man and the environment of the new substance .       It obliges
   him to communioate a certain number of indispensable results from
   the examination of the now substance . Paragraph 3 in particular
   envisages a continuity of information.
 ---pagebreak---                                    - 6 ~
 Article 7
 This artiole envisages "the nomination of competent authorities in fixing
 the framework of their responsibilities with regard to the marketing of
 a new substance .
Article 3
This artiole lists the sectors excluded from the notification procedure .
This exclusion is necessary either to oover the needs for research or for
other Community measures . Articles 9 » 1° and 11 set up the Community
notification procedure .
Article 14
The principal modification of this article is at sub-paragraph 2c which
unices the use of safety advice obligatory. It should also be noted that
the new paragraph 5 envisages that the indications enumerated at paragraph
2 must , where necessary, be accompanied by appropriate inscriptions
decided by application of Article 7 in "the framework of the requirements
relating to conditions of use .
Article 15
To paragraph 1 a new more complete format is proposed according to the
capacity of the package .
Article 21
Paragraph 1 enlarges the scope of the safeguard clause in the case where
a Member State deems that the information notified accroding to Article
6 are olearly false .
                                                                   /•
 ---pagebreak---                                          - 7 -
Annex v I
Characteristics for assessment of danger for the environment which is offered
"by substances .
Anne :: VIT
Charact eristics forming part of the technical dossier envisaged in Article 6 .
      : VU T
Determination of the applicability of the categories toxic , harmful , corrosive
and irritant .
III ,   CONSULTATION OF IMEH3STED PARTIES
        The proposal of directive was written in consultation with a Working
        Group of experts competent in the field of public health , of the
        t; rrvironmfirrt and of health and safety at work and with which represent­
        atives of the consumers and the appropriate industrial sector were
        associated .
IV .    CONSULTATION OP THE EUROPEAN PARLIAMENT AND THE ECONOMIC AND SOCIAL
        comms
        In application of Article 100 , paragraph 2 of the Treaty , taking iirbo
        account the fact that the application of this directive will require
        modifications to the legal provisions of Member States , the opinion
        of the European Par?.iament and the Economic and Social Committee is
        nocessary .
 ---pagebreak---                          PROPOSAL FOR A COTOTCIL DIRECTIVE
             the sixth nodification of the Council Directive of
             27«6.T9'67 on the approximation of the laws of Membor
             States relating to the classification, packing and
                          labelling of dangerous substances
TKS COUNCIL OP THE EUROPEAN COMMUNITIES
Iiaving regard to the Treaty establishing the European Eoonomic Community,
and in particular Article 100 thereof
Having regard to the proposal of the Commission
Iiaviivg' regard to the Opinion of the European Parliament
Having regard to the Opinion of the Economic and Social Committee ,
tuiereas to protect man and the environment against potential risks which
could arise from the placing on the market of new substances , it is
necessary to lay down appropriate measures and in particular to reinforce
the controls envisaged in Council Directive 67/54&/CEE of 27 Juno 1967 on
the approximation of tho legislative^ regulatory and administrative measures
relating to the classification, packing and labelling of dangerous substances
( 1 ) modified most recently "by Directive 75/409/CEE ( 2),
Wheres.3 it is necessary for these reasons to modify the Directive 67/54-8/CEE
xvhich at the moment by a classification, packing and labelling of dangerous
arubstanoen protects the population and principally the workers using them;
Whereas in order to control the effeots on can and the environment it is
advisable that any new substance placed on the market is subjected to a
prior study by the manufacturer and a notification to the competent author­
ities conveying mandatorily certain information ; and whereas it is , moreover ,
important to follow closely the evolution and use of new substances placed on
the market , and that in order to do this it is necessary to instituto a
system which allows all new substances to be listed ;
Uhereas it is necessary to envisage measures alloi/ing ^the Commission to
introduce the procedure of notification to all the l-Iember States ; and whereas
it is , moreover , necessary to envisage that the measures relating to the
classification, packing and labelling and the conditions of use of new
substances may be laid down at the Community level by Directives of the
Commission or Counoil as appropriate ;
( 1 ) GJ 3STo 196 , 16.3.1967, P.1
^ 2) aj ÎTOL103 , 14.7.1975 , P » 22
 ---pagebreak---  Whereas the competent authority of a Member - Stat-e mast be in a position
to appraise the consequences resulting from the placing on the market of
a new substance and may, inhere necessary, intervene in limiting or in
prohibiting the placing on the market of the aforementioned substance
when it judges this to "be necessary for the protection of man and the
environment ;
Whereas it is necessary to make it obligatory that safety advice accompanies
the packing of dangerous substances ;
Whereas Article 2 of the above directive classes substances and preparations
as toxic , harmful or corrosive by the use of general definitions ; whereas in
the ibsence , at the moment , of specifications allowing their allocation to
these classes , it seems appropriate to envisage precise criteria for classi­
fication ; whereas in addition Article 3 of the directive envisages an evalua­
tion of danger for the environment and that arising from this it is necessary
to enumerate oertain characteristics and parameters of assessment ;
Whereas for the better understanding of the directive a new presentation and
a different numbering of the articles have been necessary.
              ΤΓ ΛΪ 3?Γ:ΐαΤΓΓΊ
HAS ADOPTED THIS DIRECTIVE
                                  Article 1
»• Articles 1 to tl of the Counoil Directive of 27 June 19&7 relating to
    the approximation of legislative , regulatory and administrative
    measures concerning the classification, paolcaging and labelling of .
    dangerous substances ( 67/MS/EEC) modified in the last instance by
    Directive 75/409/SEC are replaced by the following artioles :
 ---pagebreak---                                                   _ 3 -
                                              " Article 1
1.  The purpose of "this Directive is to approximate the laws , regulations
    and. a&mini strat ive provisions of the IJenber States on :
    - notification of new substances
    - classification
    • • pr.c]caging, and
               5 1 ' r /*
     of sut stances dangerous for man and the environment which are placed
     on the market in the Ifember States of the Community .
2.  This Directive does notctqjs&ljrrtothe provisions relating to :
    a) medicinal products , narcotics and radioactive substances ;
    b) the carriage of dangerous substances by rail , road , inland
    waterway, sea or air ;
    c) munitions and objects containing explosive matter in the form
    of igniters or motor fuSls :
    d) adtii-jtéyss                            orCiit åMlDQalt;feédl2igErh^fs;cc: io                                 : r. • il?..
      •^ .• "i • 1 -  •   -n                  r»     S    ^      -* , * r. *•»■?•
                                                                           • '4, .*. , •.1 .. • *L,S > *h
                                                                                                        Ui.'J * .* v/ . * .*. e
                                                                                                                              c •*   vo
                                                                                                                                   ..i \*
    o- t.:*- Ci* •••.•.yd.', r.'iv'sotivoe ».•*':
3 . The classification, packaging and labelling provisions of this directive
    do not apply to dangerous substances exported to third countries .
4« Articles 13 to 15 of this Directive do not apply to containers for
    gases wnich are compressed , liquefied or dissolved under pressure .
                                                                                                              •/
 ---pagebreak---                                Article 2
For the purpose of this Directive :
a)    * substance s' moans
     chemical elements and their compounds as they occur in the natural
      state or as produced by industry;
b)    preparations' means
     mixtures or solutions composed of two or more substances ;
c)   'new substances'
     substances which have not previously been placed on the market
     either as a substance or mixture before         3aizaaa?y,i97§~ *-
     ,'jr      ''3 with the exception of those made available to research
     laboratories .
d)   environment
     Water , air , earth , biological forms ; the relation between them
     and with man .
e)   notification
     An informative declaration to the competent authority by the
     manufacturer or any other person placing a new substance on
   N the market , hereafter called the notifier .
 ---pagebreak--- The following substances and preparations are 'dangerous1 within the
meaning of this Directive :
a) explosive
    substances and preparations which may explode under the effect of
    flame or which are more sensitive to shocks or friction than dini-
    trobenaene ;
b) o:ridising
    substances and preparations which give rise to highly exothermic
    reaction when in contact with other substances , particularly flam­
    mable substances ;
c) easily flammable
    - substances and preparations which may become hot and finally catbh
       fire in contact with air at ambient temperature without any applic­
       ation of energy, or
    - solid substances and preparations which may readily catch fire after
       brief contact with a source of ignition and which continue to burn
       or to be consumed after removal of the source of ignition, or
    - liquid substances and preparations having a flash point below 21 °C ,
       or
    - gaseous substances and preparations which are flammable in air at
       normal pressure , or
    ~ substances and preparations which in contact with water or damp air ,
       evolve highly flammable gases in dangerous quantities ;
d) flammable
    liquid substances and preparations having a flash point between 21 °C
    and 55°C ;
e ) toxic
    substances and preparations which, if they are inhaled or taken inter­
    nally or if they penetrate the skin, may involve serious , acute . or
    chronic health risks and even death ;
                                                                       /
 ---pagebreak---  f) harmful
    substances and preparations which , if they are inhaled or taken
    internally or if they penetrate the skin, may involve limited
    health risks :
 g) corrosive
    substances and preparations which may, on contact with living tissue 3 ,
    destroy them;
 h) irritant .
    non-corrosive substances and preparations which, through immediate ,
    prolonged or repeated contact with the skin or mucous membrane , can
    cause inflammation.
 i) dangerous for the environment
    substances , the use of which presents or could present immediate or
    prolonged risks for the environment .
                                 Article 3                         .
1.  The flash point of the flammable liquid substances and preparations
    mentioned in Article 2 paragraph 2 ( c ) and ( d) shall be determined
    according to the methods and with the apparatus laid down in Annex V.
2.  The environmental or potential environmental hazard shall be determined
    in accordance with the characteristics set out in Annex VII taking into
    account the parameters of ; appreciation contained in Annex VI .
3.  The determination of the categories toxic , harmful , corrosive and
    irritant mentioned in Article 2 , paragraph 2 , e ), f), g) and h) as is
    carried out according to the oriteria in Annex VIII .
 ---pagebreak---                                        - 7 -
                                   Article 4
   The classification of dangerous substances according to tho degree of
   hazard and specific nature of risks shall "be based on the categories
   laid down in Article 2 ( 2). For categories (a) to ( h) the substanoes
   shall "be olassifiod acoording to the greatest degree of hazard#
1» Member States shall take all the necessary measures to ensure that tho
   now substances referred to in Article 2 are not placed on the market
   unless they have been :
              ~ notified to the competent authority in accordance with
                this directive ;
              - paokaged in accordance with the principles of Art . 13 ;
              - labelled in accordance with the principles of Art . 14 ;
2. These               Ci .:5      ..-n:: are valid until the substance is listed
   into Annex I.   Prom the time the substance is listed in Annex I it
   must be i
              ~ packaged according to Art . 13 ;
              - labelled aocording to Art . 14 ;
              ~ and used under . the conditions which, when necessary, have
                been laid down in respect of it in Annex I.
                                   Artiole 6
1. Tho notifier is required to carry out a study prior to marketing a now
   substance to enpb^e . its effects on man and tho environment to bo
                   Siibiniir
   assessed and to           to the competent authority envisaged in Art . 7 »
   at the latest on the date of marketing, a notification with.'. art        '
   acknowledgement of receipt inoluding:              .
 ---pagebreak---                                     η
                                  – fj mm
   – a technical dossier containing all the information necessary to
       evaluate forseeable direct or indirect risks which the new substance
      might entail for man and the environment in respect of the various 1
      uses envisaged and which contains at least comments relating to the
      characteristics listed in Annex VII which hear an asterisk .
   – a declaration concerning the unfavourable effects of the substance ;
   - the classification and labelling of the substance in accordance
      with this directive ;
   - proposals for any measures relating to the conditions of use which
      are intended to limit the unfavourable effects .
2. The notifier may at the same time send a copy of the dossier to the
   Commission *
3. The notifier is further required to inform the competent authority
   of any significant change in or addition to the information previously
   notified in particular in relation to :
   - new uses for which he markets the substance ( see Annex VII , para 2.1 )
   - annual increases in the quantities which he markets ( see Annex VII,
      para 2.2)
   - toxic or ecotoxic characteristics not previously notified .
                                Article 7
1. Lieinber States shall appoint a competent authority ( or authorities)
   who shall be responsible for :
   - receiving the notification and examining its conformity with the
      prescriptions of the directive ;                            j
   - examining the forseoable risks that these new substances might give
      rise to ;
   - examining the classification and labelling proposal ;
   - examining the proposals of measures relating to the conditions of
      use ;
 ---pagebreak--- Moreover , if the authorities see fit they may :
- ask for further information and/or verification tests ;
- carry out such sampling as is necessary for control purposes }
- take appropriate measures relating to conditions of use while
awaiting Community dispositions *
 " cc                  s 'o >:t hq? pioDCftiirsc ïUiid- daraiiL'i# 'Art xaiooJ■$£ ±t^j?ropb&alg Sor
          io ...- *. v                                             ov                                      tropea.*. *3 i.cr :
- classification
~ labelling
- dispositions relating to conditions of use .
Member States and the Commission shall ensure that any information
concerning marketing or manufacturing shall "be kept secret .
                                                                               Article 3
Substances in as much as they are placed on the market in the fillow-
ing ways shall "be excluded from the notification procedure :
a) for research , development or analysis ;
b) a3 substance or in mixtures for :
     - spécial pharmaceut ical products
     – component s-'" of 'iaafisjpisiis or objects intended to oome into
     -• contact'; with                                                                               J       '
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                          , Λ V .ο -ι   Λ .- ······ -»·ι , 3
                                             . Λ.ν· . ι .
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                                                                 .Λ ~ ^ .
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                                                                                                             > ·»■!·» ·.· ·.·.. *· '"■'*· Λι ·»·,"·»»· ' *·
                                                                                                                                   « „ - . . ο . . ο. –
     – donpoS^jixs or pest ioides"'subjected~*to type approval" "
     .» "    * * 1 , " 'i       r        *.                 » il -  1     V*   ' (                       •4    J*»V*               f.
        4»>. .   •' y       ,V*' k1, . ..                  .'.V. / ii     +.*"                                 i vA w   i • <>• , W           V•
     - cosmetic products .
 ---pagebreak---                                                - 10 -
                                              Article 9
   A Member State which has received the notification dossier or
   additional information envisaged in Article 6 shall \ 1'.:?: oh.2
        ■ .oiit C -*A ths :v -;- :v ."..-;r send a copy of it immediately to the
   Commission together with any relevant comments .
                                              Article 10
   On receipt of the copy of the notification dossier or some other
   complementary information from a Member State , the Commission shall
   transmit :
   ~ the elements of the notification to the other Member States ;
   – any relevant information which it has gathered to all Member States .
   This transmission shall ha deemed to constitute a notification to the
   competent authorities of other Member States within the meaning of ■.
   Artiole 6 .
                                              Article 11
1. The Commission shall keep at the disposal of the Member States a cata­
   logue of all substances notified under this Directive .
2. Tho Member States may be called upon to give the Commission any infor­
   mation necessary to up-date this catalogue notably in respect of quanti­
   ties placed on the market .
                                              Article 12
   Annex I of this Directive contains the list of substances classified
   under the provisions of Article 4 and where appropriate dispositions
   relating to conditions of use .
                                                                               . •/.
 ---pagebreak---                                         - 11 -
                                      Article 13
        Member States shall take all necessary measures to ensure that
        dangerous substances cannot be placed on the market unless tho
        strength and impermeability of their packaging satisfies the
        following requirements , any packaging meeting these requirements
        being regarded as adequate :
    1 . ±'hc pac':agings must be so arranged and fastened as to preclude any
        loss of the contents ; this requirement does not apply where special
        safety devices are prescribed ;
   -2 . The materials constituting the packaging and fastenings must not be
        liable to attack by the contents , or liable to form harmful or
        dangerous compounds with the contents ;
  2,1 , The packaging and fastenings must be strong and solid throughout to
        ensure that they will not loosen and will safely meet the normal
        stresses and strains of normal handling.
                                    ' Article 14
  1„    Member States shall take all necessary measures to ensure that dangerous
        substances cannot bo placed on the market unless tho labelling on their
        packaging satisfies the following requirements .
''2 .   Every package must show clearly and indelibly the following s
        ~ the name of the substance .
        – the origin of tho substance ,
        ~ tho danger symbol , when laid down, and indication of danger involved
           in the use of tho substance , ,
        - a reference to the speoial risks arising from such dangers ;
        a) the name of the substance must bo one of the terms listed in Annex
            I to this Directive ;
        b) the indication of origin must include the name and address of the
            manufacturer , the- distributor or the importer ;
                                                                           •/.
 ---pagebreak---                                      - 12 -
   c) thk following symbols and indications of danger are to be used :
       -• explosive                      : an exploding "bomb (E) •
       - oxidising                       : a flame over a circle (o)
       - vary .flammable .             ' : a flame (F)
       - toxic                           : a death's head and crossbones
       - harmful                         : a St. Andrew* s Cross (Xn)
       - ooii'csive                      : the symbol showing the danr.gin-j
                                           effect of any aoid ( C )
       « irritant                        s a St . Andrew1 s Cross ( Xi)
       The symbols must conform to those in Annex II to this Directive ;
       they shall be printed in black on an orange-yellow background.
   d) The nature of the special risks involved in using the substances
       mat ba indicated by one or more of the standard phrases which, in
       conformity with the references contained in the list in Annex I , are
       sot out in Annex III to this Directive .
<• £ ) The packaging shall be acoompanied by safety advice relating to the
       use of the substances where it is materially impossible for these to
       be given on the label or package itself .     The wording of such pre­
       cautions ste.ll , in conformity with the references contained in the
       list in Annex I , be based on Annex IV to this Directive .
3.     For packages of harmful , irritant , highly flammable , flammable and
       oxidising substances , indication need not be given of special risks
       and Eafety advice where the paokage ' contains no more than 125 ml .
4.     When more than one danger symbol is assigned to a preparation :
       - the obligation to indicate the symbol T makes , in general , the
          symbols X and 0 optional ;
       - the obligation to indicate the symbol C makes the symbol X optional ;
       - the obligation to indioato the symbol S makes the symbols F and 0
          optional .
 ---pagebreak---                                    - 13 -
5. Tho indications mentioned in paragraph 2 must , where necessary, "be
   accompanied "by appropriate indications required in application of
   .Article 7 with respect to measures relating to conditions of use .
                                 Article 15
1. ITnen the particulars required "by Artiole 14 appear on a label , the
    latter must "be placed on one or more faces of the package so that
    it can be read horizontally when the package is put down normally.
   The dimensions of the label must "bo as follows :
                Package content                                   Dimension
   ~ less than or equal to 0.5 litres       : if possible ,      52 x 74 nm
                                              at least
   - groator than 0.5 litres , and not
       exceeding 1 litre                    : at least           74 x 105 mm
   ~ greater than 1 litre , and not
       exceeding 10 litres                  : at least        . 105 x 14^ mm
   - greater than 10 litres , and not
       exceeding 50 litres                  : at least          140 x 210 mm
   - greater than 50 litres                 : at least          210 x 2J6 mm
   Each symbol must oover at least one-tenth of the surface of the label
                          2
   and be at least 1 cm .     The entire area of the label must adhere to the
   package immediately containing the substance .
2. A label is not required where tho particulars are clearly shown on
   tho immediate package , as specified in paragraph 1 .
3. The oolour and presentation of tho label – or in the case of paragraph
    2 , of the package - must be such that the danger symbol stands out
    clearly from the background .
4. Member States may make the pla6ing on tho market of dangerous substances
    in their territories subject to the use of the national language or
    languages in respect of the labelling thereof .
 ---pagebreak---                                 - 14 -
 For the purpose of this Directive , labelling requirements shall "bo
 deemed to "bo satisfied :
 a) in the case of an outer package containing one or more inner
    packages , where the outer paokage is labelled in accordance
    with international rules on the transport of dangerous substances
    and the inner paokage or paokage s ore labelled in accordanco with
    this Directive ;
 b) in the case of a single package , where such a package is labelled
    in accordance with international rules on the transport of dangerous
    substances and with Artiole 14 ( 2) (a), (b) and ( d).
 In the case of dangerous substances , which do not leave the sovereign
 territory of a Member State , labelling may bo permitted which complies
 with national rules instoad of with international rules on tho trans­
 port of dangerous substances .
                              Article 16
 Member States may :
 a) permit the labelling required by Article 14 to bo applied in some
    other appropriate manner on packages which are either too small
    or otherwise unsuitable to allow labelling in accordance with
    Article 15 .
 b) by way of derogation from Articles 14 and 15 , permit the packaging
    of dangerous substances which aro neither explosive nor toxic to
    be uniabelled , or to bo labelled in some other way if they oorrtain
    suoh small quantities that there is no danger to workers or others .
                              Articlo 17
-The amendments necessary to adapt tho Annexes to technical progress
 shall be adapted in accordance with the procedure laid down in Artiolo
 19
 ---pagebreak---                                      - 15 -
                                     Article 18
 1.    A Commit toe shall "bo established for the adaptation to technical progress
       of Directives for removing technical "barriers to trade in the sector of
       dangerous substances and preparations , hereinafter called 'Committee * , ;
       which shall consist of representatives of the Member States under tho
       Chairmanship of a representative of the Commission.
2.     The Committee shall establish its internal regulations .
                                    Article 19
1.     In the event that reference is made to the procedure laid down in this
       Article , the matter shall "bo referred to the Committee "by the Chairman,
       either on his initiative , or at tho request of the representative of a
       Member State ,
2.     The representative from the Commission shall submit a draft of tho ;■
       measures to "be taken to the Committee .  Tho Committee shall e:cpress its
     . Opinion on this draft within a period specified by tho Chairman in the
       light of the urgency of the matter in question. A majority of 41 votes
       shall suffice for a Decision, tho votes of the Member States being
       woighted as laid down in Article 143 subparagraph 2 of the Treaty.
    "' The Chairman shall not vote .
3 . a) The Commission shall adapt the measures envisaged when they are in
          accordance with tho Opinion of the Committee . "
       b) When the measures have not been agreed on by the Committee , or in
          the absence of an Opinion, tho Commission shall submit to the Council
          without delay a proposal on tho measures to be taken.      The Council
          shall give judgement by the qualified majority.
       o) If , after the matter has been before the Council for a period of
          three months , there has been no decision by the Council , tho
          proposed measures shall be adopted by tho Commission.
 ---pagebreak---                                    - 16 -
                                 Article 20
   I&mtar States shall not prohibit , restrict or impede on the grounds of
   notification, classification,- packaging or labelling as defined in this
   Directive , the placing on the market of dangerous substances which
   satisfy the requirements of this Directive and the Annex thereto .
                                 Article 21
1. Where a Member State has detailed grounds for establishing that a
   dangerous substa.nce , although satisfying the requirements of this
   D.Iraotive , constitutes a hazard to health or safety, it may provision­
   ally prohibit the sale of that substance or subject it to special
   oondit ions ruling in its territory.     It may similarly take suoh
   iroas'.iros where it is obvious that the information notified aocording
   to Article 6 is fdlseiv filco .
   It shall immediately inform the Commission and the other Member States
   thereof and give reasons for its decision.
2. The Commission shall , within six weeks , consult with the Member States
   conoemod, express its Opinion without delay and take the appropriate
   stops .
3. llhere the Commission is of the opinion that technical adaptations to this
   Directive are necessary, suoh adaptations shall be adopted by either the
   Commission or the Council tinder the procedure laid down in Artiole 19 *
   In this event , the Member State having adopted safeguard measures may
   mairrtain thera until suoh adaptations enter into force .
                                 Article 22
   Member States shall inform the Commission of all laws , regulations and
   administrative provisions whioh they adopt in the field covered by this
   Diroctive ."
 ---pagebreak---                                 - 17 -
                                             /
Annexes VI , VII and VIII , which appear m the annex to this directive ,
are added to the directive mentioned in the first paragraph of this
artiole .
                             Article 2'
llenber States shall adopt the measures needed in order to comply
with this Directive and shall apply then "by 1st January 1979 at
the latest .  They will inform the Commission and the other Member
States immediately of such measures .
                             Article 3..'.
This Direotive is addressed to the Member States .
 ---pagebreak---                                        1
                                  . A2WEX VI
              Parameters for evaluating the environmental risk of
                              cerfrain substances
 The environmental risk of a substance is evaluated, on the "basis of the
 following primary ooncepts and their possible correlation.
 A.     Quantities
 B.    Potential toxicity for various targets
 C.    Exposure of various targets
As regards these concepts the following parameters should particularly
"be taken into account :
       Tonnages forecast "by the manufacturer, expressed in tonnes/year
A.2    Production broken down according to type of utilization and expressed
       as a percentage of the total production.
            ι
B.1    Acute toxicity to man determined by experiments on rnamnals depending
       on the intended use of the substance . They may be administered in
       these tests orally, percutaneously or by inhalation, '
B.2    Chronic and miscellaneous toxicity
       The following parameters should be taken into consideration as
       appropriate :
       - sub-chronic toxioity (repeated daily doses on rats for 90 <3^ys) »
       - chronic toxicity ( studies on rats (1 year) and possibly on dogs
          (3 years)),
       - carcinogenesis
       - mutagenesis over three generations ,
       - teratoganesis
 ---pagebreak---                                   ~ 2 ~
B.3 To:d.o effects on other living creatures
    Depending on the anticipated uses of the substance and on the poter>-
    tial receiving media , an analysis should "be nade of the toxicologioal
    effects on other forms of life such as baoteria , algae , fish and "birds ,
C.1 Anticipated uses
                   ι
    '• Initial 'media : the specific purpose of the substance should "bo
       considered with a view to identifying primary targets liable to
       exposure ;
    - type of distribution :    this involves an assessment of dispersal
       risks . As a guide , the following distinctions might be borne in
       mind :
       .  substances whose use is confined to olosed systems ;
       .  substances used only by approved users or specialists ; substances
          whose use is confined to a limited number of industrial estaT>-
          lishments ;
       •  substances used only by professional specialists worl:ing in in­
          dustry, oraft trades and agriculture ;
       •  substances retailed to the general publio .
C.2 Dispersal : In this case tho transport of a substanoe from its
    initial medium should be assessed as far as possible with the aim of
    identifying the receiving media# Aocount should be taken of tho
    physioal ohemical and biochemical properties of the substance .
                                                                  •Α ν
 ---pagebreak---                                   - 3 -
C.3  Stability m -the presenoe of natural agents
     This involves Assessing the stability of a substance under abiotic
    and biotic conditions in various environments .
    The physico-chemical properties of the substance should be takon
    into account , for example , stability as a function of pH , thermo­
    stability, redoc potential , and the possibilities of biodo gradation
    in the receiving medium.    Where studies have been carried out tfm
    models , consideration should be givon to the half-life figures ; whore
    this is not possible , a rough assessment of this period should be made
    on the basis of the data available .
C.4 Accumulation within receiving media and the creatures living therein
    Tho aim here is to assess as far as possible whether the substance
    is likely to build up in a given target in the receivingjjaedium.
    This may either take tho form of ge ©accumulation or bi©accumulation.
    IJhcre studios (e.g. , accumulation in fish) have been carried out on
    modols , consideration should be given to relative preferential accu­
    mulation figures ; when this cannot be done , the possible extent of
    any accumulation phenomena should be considered in the light of the
    relevant physico-ohemical properties , e.g. , tho partition coefficients
    of H20/organio solvents.
C.5 Possibilities of disposal
    At issue here is whether the substance , onoe it has become waste ma­
    terial , can be disposed of by suitable treatment bearing in mind . the
    behaviour of the substanoe in a 'purification or incineration plant .
 ---pagebreak---                                       AflNEX       VII
                    IHFOHMATION REQUIRED FOR THE TECHNICAL DOSSIER
                      REFERRED TO IN ARTICLE 6 OF THIS DIRECTIVE
Thi' Annex is in-tended as a guide .             Consequently , some of the information
requested may at time he superfluous or alternatively require amplification.
Ί.' : ' · ' Γ  ί
The obligatory information which the manufacturer must provide is marked
by an asterisk; if it is not possible to give an answer, the reasons must
be stated.
*    I. ID5NTITY QF THE SUBSTANCE         .           . • .
  * I«l « Chemical name
  * I.l.l .      Name in the IUPAC nomenclature
  * 1.1.2.       Other names          -     . , .   .       ...
  * 1.2. Empirical and structural formula
  * I*3 » Composition of the chemical product
  * I.3«l« Degree of purity ($ )               '
  * 1.3*2. Nature of impurities , including isomers .- and bqooMaryjproduct s
  * I* 3 * 3 * Percentage of main impurities
  * I.4« Methods of detection and determination
              A full descrpition of the methods used or the appropriate
              bibliographical referenoes^
 ---pagebreak--- *  2*    DATA ON UTILIZATION
                                                       v
  * 2.1. Proposed uses
  * 2.1.1 . Type of use
                                                                  i   i i i i i i
              Describe : – the function of the substance
                          - the desired effects •*•.•••••.
  * 2.1.2 . Type of distribution
              Indicate destination of substance :
              – Closed system ...................................... /V
              – Processing industries                                              /
              - Farmers and skilled trådes ...••••           ••••••«              fl
              – The substance is retailed to the public
  * 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 :
              – First 12 months                *         t/year
              – Thereafter .......       ....... ....... t/year
  * 2.2.2. Breakdown of production and/or imports according to points 2.1.1.
              and 2.1.2 , expressed as a percentage
              – First 12 months ... ll^.l ..*!*....... \ «'<*;: VA .? .
              – Thereafter                                          -
  * 2.3 * Recommended methods and precautions concerning :
  * 2 . 3*1 * Handling
  * 2.3*2. Storage
  * 2.3*3* Transport          * 1 ..... 1..1 .
  * 2.3*4* Fire
  * 2.4* Emergenoy measures in case of accidental spillage
 ---pagebreak---                                                                              3
     3 . PHYS IC 0–CJHHJ-1IC AL S PROPERTIES OF1 THE SUBSTANCE
           ( state whether this is the pure or the commercial substance and give
             the reference of the internationally recognized, methods or a. .
             desoription of the methods used ).
   * 3.1 . Melting point
                  t   «   »   i   i   i  i   i  >
                                                   °C
   * 3*2. Boiling point
                                                   °C at ........ Pa
  * 3 » 3 » Relative density
                                                      o>4 20)
  * 3.4. Vapour pressure
                                                  Pa at                 °C
              • »   •   i   «   i    » ♦   i      __          . .   . ,    .
              ......... Pa at                                           °C
  * 3»5 » Surfaoe tension
                                               N/m (              ,. °C )
  * 3.6 . Water-solubility
                                    1 . mg/l .(••••.•••. °C )
  * 3«7 * Pat-solubility
             Solvent s ^/fish oil - corn oilf
                                             mg/l00 gr. solvent (#^..°C )
 * 3*8. Partition coefficient
             Water/non-miscible solvent (please specify):
             Water/lipid (please specify);
 * 3*9 * Plash point
                                                 °C [J open-air situation f~~} enclosed situation
* 3«10. Explodability (within the meaning of Directive 67/548/EEC )
'• 3.11. Redox potential
    3.12. Stability related pH
    3.13* Other properties (e.g. chelating tendancy )
 ---pagebreak--- 4 J TOXICOLOGZCAL . STUDIES
 ( state whether the tests were carried out with the pure or the commercial
   s-abst.auses )
 4.1. Acute toxicity
 4.1.1. Absorbed, orally
         U)       (rat ) . .. ..   !••••. ... . . (mg/kg)
          Symptoms observed in the organs affected                     ;         • • •
          ( including allergic reactions )
 4.1.2. Absorbed through the skin
            LD– (rat ) ..................... (mg/kg)
            Symptoms observed in the organs affected
            ( including allergic reactions ) .........
 4»I«3 . Absorbed by inhalation
                   /    *        I.ltlll ««!..    /   , *  * . ♦ . i t i » I I  t
            LC50 (rat)                            (ppri) (...                  h)
            Symptoms observed in the organs affected*
                ^                      - _ 0 –            –
            ( inoluding allergic reactions ) .......
 4.1.4. Irritant/corrosive effects
            (Within the meaning of this directive , Annex VIII Points 2 & 3 ),
 4*2 . Delayed toxicity
 4.2.1. Subacute toxicity (90 days )
            Symptoms observed according to the concentrations used:
 4.2.2. Chronio toxicity ( substance and its metaholites)
            Symptoms observed during tests lasting more than 90 dayss
4*2.2.1 Substances retailed to the public as forseen on point 2.1.2 /th dash.
4.2.2.2 Other substances
 ---pagebreak---                                                5
    4.3 . Other_ef feet s
    4.3.1 .       Mutagenic effects
* 4.3.1.1 Screening -test*
       .      ..              -
    4*3"»1«2 "Whole study '
    4; 3.2        Carcinogenic effects
    4.3.3         Effects on reproduction , including teratogenicity
    4.4# Special studies specific to the substance
    For example : "biochemical kinetic studies , neurophysiologies! toxicity
                         studies
 *; 5. ECOTO x IÇOLOG IÇAL_ STL'D I E S '
          ( State whether the tests were carried out with the pure or the
         commercial substance ).
    5*1* Effects on typical species
*                Effects on fish : at least two species including rainbow trout
                 LC ^ Q .......... mg/l; durâtion of test :              h
    5.1.2 . Specific effects of the substance on other typical species in
                 relation with its dispersion in the environment .
                 For example : birds t bacteria
 * 6. BIOTIC AND ABIOTIC PEGRADABILITY AND EERSISTAMCE
         Evaluate the half-life of the substance :
                           T 1         1 year    a
                             2
         3 months <L. T 1              1 year    a
                             2
         1 month <1        T 1         3 months  un
                             2
         I' week       ^   T 1         1 month   n
                             2
                           T 1    <*" 1 woek     π
         Specify the data on which this evaluation is based ( stability to heat
         photoohemioal stability , biodegradability etc ).
 ---pagebreak---                                       6
* 7 . POSSIBILITIES OF RENDERING THE SUBSTANCE HARMLESS
* 7»1 « For industry/craft trades
*         Recovery possibilities :
*'1.1.2, Neutralizatiori possibilities :
* 1,1,3 * Destruction poasibilities :
          – Controlled discharga
          – Incineration
          – Water purification station
          - Others
* 7.2 . For tho public at large
* 1,2, 1. Recovery possibilities :
* 1.2.2. Destruotion possibilities :
          – Controlled discharge
          – Incineration
          - Water purification station
          - Others
  8. SPECIAL STUDIES
  8.1 .   Degradation products and metabolites
  8.2.    Biotio accumulation
  8.3.    Abiotio accumulation
 ---pagebreak---                                      AHHEX VIII
     DET3PJ.IDTATI01T OP CLASSIFICATION EST TH3 CATEGORIES , TOXIC , KARIJFJL ,
                                 CORROSIVE AND IRRITAFT
                                 ( See Art . 3 > para 3)
1.   Substances and preparations shall "be classified by establishing the
     actual acute toxicity of the commercial product , expressed in LD^ Q
     values, determined in animals . For this purpose the following LC ^ Q
     values shall be taken as reference values :
    Absorbed orally: (LD^^ oral in rat)
         up to 25 mg/kg body weight : • "highly 1 020.0",
         over 25 mg/kg but nab more than 200 mg/kg body weight : "Toxic"
         over 200 mg/kg but not more than 2,000 iag/kg body weight : "harmful".
   Absorbed through the skin: (LD^^ cutaneous in rat or iabbit)
         up to 50 mg/kg body .weight : "highly toxic" ,
         over 50 mg/kg but not more than 400 mg/kg body weight : "toxic"
         over 400 mg/kg but not more than 2,000 mg/kg body weight : "harmful".
   Absorbed by inhalation ( LC ^ Q inhalation in rat)
         For gaseous and volatile products or products whioh contain
         volatile components :
         up to 0.5 ng/l air: "highly toxic"
         over 0.5 mg/l air but not more than 2 mg/l air: "toxic",
         over 2 mg/l air but not more than 20 mg/l air: "harmful".
   For mixtures of components with varying vapour pressures , for preparations
   as are not unequivocally gasedus and for fumigants and aerosols , it must
   be checked whether' the commercial preparation contains volatile components
   w&ich could be released into the environment in aotively toxio quantities :
 ---pagebreak--- If the rat does not die within 14 days of being exposed for 1 hour to
   c; +nratecl a-'r-vapovir mixture ( not acute respiratory toxicity) , the
classification shall "be aligned on the LD^ Q values found. Should death
occur, the LC ^ Q value will have to "be ascertained.
Substances and preparations shall "be classified as :
" corrosive" if , in tests on rabbits , the commercial product destroys
the tissue ( necrosis) within 30 minutes of "being in uninterrupted
contact with the skin for a period 6£ 7 days in a quantity of 0.5 ail
or 0.5 gf
Substances and preparations shall be classified as :
" irritant " if , in tests on rabbits , they cause inflammation within 30
minutes of being in uninterrupted contact with the skin for a period
of 3 days in a quantity of 0.5 ml or 0.5 g.
If there are indications of the existence of toxic effects , apart from
acute effects ( e.g. carcinogenic effects , etc .), substances and prepara­
tions may also be classified as highly toxic , toxic or harmful depending
on the importance of these effects .