CELEX: 51997PC0462
Language: en
Date: 1997-09-23
Title: Amended proposal for a European Parliament and Council Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations

COMMISSION OF THE EUROPEAN COMMUNITIES
   £   -il
  it    -tr
                                                    Brussels, 23.09.1997
                                                    COM(97) 462 final
                                                    96/0200 (COD)
                               Amended proposal for a
            EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
concerning the approximation of the laws, regulations and administrative provisions of
 ihe Member States relating to the classification, packaging and labelling of dangeiimc
                                      preparations
             (presented by the Commission pursuant to Article 189 a (2)
                                  of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                              EXPLANATORY MEMORANDUM
 1.      Introduction
 Pursuant to Article 189(a) paragraph 2 of the EC Treaty, the Commission submits an
 amended proposal for an European Parliament and Council Directive concerning the
 approximation of the laws, regulations and administrative provisions of the Member
 States relating to the classification, packaging and labelling of dangerous preparations.
 The amended proposal takes account a number of amendments from the European
Parliament, adopted at its Plenary Session on 26 June 1997 .
The Parliament adopted 26 amendments (originally 28, but amendment 10 was included
in amendment 11 and amendment 23 in amendment 22). The amendments are related to
the following topics: labelling, classification, packaging, other issues and editorial issues.
Out of 26 amendments the Commission can accept 13 as such and 3 amendments are
acceptable in principle.
Amendments relating to following issues are not acceptable:
        Article 3(3) (amendment 4)
        Article 10 paragraph 2.3.1 (amendment 8)
        Article 10 paragraph 2.3.2 (amendment 9)
        Article 10 paragraph 2.3.3 (amendment 11)
        Article 10 paragraph 2.3.4 (amendment 12)
        Article 10 paragraph 2.3.4 a (new) (amendment 13)
        Article 15, paragraph 1 (new) (amendment 16)
        Article 16 paragraph 2, first indent (amendment 40)
        Annex III, part C, paragraph 4, (amendment 20)
        Annex V, Part C (1) (first part of amendment 22)
        Annex V, Part Cb (new) (amendment 26).
2.      Labelling
The new recital 13 (a) (amendment 1) emphasises the need to launch a study on
comprehensibility of contents of labels and to review the existing rules on labelling, if
necessary. The Commission welcomes this amendment and will launch this study as soon
as possible.
Amendments to Article 10 paragraph 2.3.1 (amendment 8), paragraph 2.3.2 (amendment
9), paragraph 2.3.3 (amendment 11), paragraph 2.3.4 (amendment 12) and paragraph
2.3.4 a (new) (amendment 13) would result in a label overloaded with chemical names
whilst not improving the level of protection. The Commission is, by accepting a new
recital 13 (a) (amendment 1), committing itself to launch, as soon as possible, a study on
        Reference - minutes of the session of 26 June 1997, Baldi report A4-0186/97
                                                    2
 ---pagebreak--- the comprehensibility of labels to the users. This study will examine all labelling issues,
including those raised by amendments 8, 9, 11, 12 and 13. Based on the results of this
study the Commission will review all labelling requirements. Therefore the amendments
proposed on naming of substances on the label are not accepted by the Commission.
Amendment to Article 10 paragraph 4, first indent (amendment 14) introduces an
exemption from full labelling requirements also to be applied to preparations classified as
dangerous for the environment, when the preparation is supplied in small packages
(volume less than 125 ml). This amendment is acceptable and justified by the fact that
such small amounts of chemicals would not cause risk to the environment. Though full
labelling is not required the packages have to be labelled in any case by a warning
symbol indicating the danger to the environment.
Amendment to Article 10 paragraph 5 (amendment 15) prohibits using on labels of
preparations covered by the Directive expressions such as "environmentally friendly'' and
"ecological" or an expression that leads to an underestimation of the danger. This
amendment completes the text of the Commission's original proposal by adding
examples of such expressions which are related to environmental properties.
Amendment to Annex V, Part C (1) (amendment 22) addresses the specific warning on
sensitising effects to all persons. The Parliament's amendment for a more general version
covers in any case the target population and is therefore acceptable to the Commission.
Amendment to the first part of paragraph 1 of Annex V Part C (corresponding to the
original amendment 23 and combined with amendment 22) is not acceptable to the
Commission. It relates to labelling of sensitisers and would make the proposed provision
unworkable. The approach proposed by this amendment does not specify any limit for the
specific warning on sensitising effects. In practice this would mean that the general limit
of 1 % defined in Article 3 of the proposal will apply to all sensitisers. The Commission
thinks that this limit is too high to trigger this requirement.
Amendment to Annex V Part C (2) (amendment 24) introduces a modification of the
specific phrase for packages of non-classified preparations for which the Safety Data
Sheet is available on request. The label is to be placed on preparations used exclusively
by professional users. Such preparations are not available to the public at large. The label
is put only on preparations which are not classified as dangerous. Since this amendment
supports the provision on a Safety Data Sheet for non classified preparations the
Commission can accept it in a slightly modified form.
Amendment to Annex V, Part Ca (new) (amendment 25) proposes a specific part of
Annex V to be introduced for labelling of Plant Protection Products. The Commission
agrees that this part to Annex V is necessary.
Amendment to Annex V, Part Cb (new) (amendment 26) proposes a specific part of
Annex V to be introduced for labelling of Biocides. The Commission cannot accept this
amendment as it contradicts the position taken by the Parliament and the Council on the
proposal for the Directive on Biocides which has already passed its second reading.
 ---pagebreak---  3.       Classification
 Amendment to Article 3(3) (amendment 4) would introduce changes to application of the
 conventional method. The Commission cannot accept this amendment as it would
 eventually lead to unnecessary animal testing because the conventional method would be
 unworkable.
 Amendment to Article 6 paragraph 3 (amendment 6) introduces restrictions on animal
 testing in cases where alternative methods are available and also provides for provisions
 on specification of data on effects on man. The Commission welcomes this amendment
 but introduces it in a reworded form.
 The new formulation of paragraphs 1 and 2 enables references to harmonised in vivo and
 in vitro test methods of Annex V to Directive 67/548/EEC.
 The formulation of paragraph 3 clearly states as amendment 6, that the conventional
method or the in vitro test methods (alternative methods) are given the preference in
classification of preparations. The in vivo methods using vertebrate animals could only be
used in cases where the person responsible for placing on the market can demonstrate
that the alternative methods cannot be used. The results of existing animal tests can be
used for classification.
Amendment to Annex III, Part B, Table V (amendment 18) introduces a lower
concentration limit (0,1 % instead of 0,5%) for classification of preparations containing
ozone depleting substances. The amendment will ensure a high level of protection by
laying down the practice already existing, as the marketing of ozone depleting substances
has already been prohibited by Regulation 3093/94 .
Amendment to Annex III, Part C, paragraph 4 (amendment 20) provides that the existing
test results should be applicable for assessment of effects dangerous for the environment.
According to the Commission's view this is superfluous as this is already the case.
4.        Packaging
Amendment to Article 9 paragraph 2 (new) (amendment 7) lays down the practice
already existing between transport and supply packages. This amendment improves the
clarity of the legislation.
Amendment to Annex IV, Part B, paragraph 2 (new) (amendment 21) removes the
requirement for a tactile danger warning (a special warning for blind persons) on aerosols
classified as extremely flammable and highly flammable. This amendment is introduced
at the request of the European Blind Association. According to the Commission this
amendment can be accepted but recognises at the same time that there is a need to
examine the comprehensibility of the system of warnings for blind and visually
handicapped persons, and to review the present legislation, if necessary. This
examination can be linked to the study introduced by the new recital 13 (a).
         OJNo. L 333 ,22.12.1994, p. 1
 ---pagebreak--- 5.        Other issues
Amendment to Article 15 paragraph 1 (amendment 16) goes beyond what is the
Commission's intention with this provision. The intention of the Commission's proposal
is not to introduce provisions for advertisement, but to deal with a very specific situation
of offering a product for sale on the market through the so-called "distance selling".
Amendment 16 is not accepted by the Commission.
Amendment to Article 16 paragraph 2, first indent, (amendment 40) is related to Safety
Data Sheets for non-classified preparations. Although the Commission understands the
rationale for this amendment the Commission would like to have more time to examine
in depth what kind of consequences such an amendment will have in practice and, in
particular, in relation to the implementation of such a requirement by the small and
medium size enterprises. All classification and labelling rules concerning preparations
deemed dangerous for the environment, as well as the obligation to establish a Safety
Data Sheet for non-classified preparations, are completely new elements in the field of
harmonised rules for dangerous preparations. The introduction of this additional
requirement could increase further the burden on industry. Commission cannot therefore
accept this amendment.
Article 21 of the Commission's original proposal specifies the Committee procedure
which will be used in the context of Directive on dangerous preparations leaving open,
however, which of the two Committee procedures specified in Article 29 of Directive
 67/548/EEC will be applied.
 Article 20a (new) (amendment 17) adopted by the Parliament specifies exclusively the
 Committee procedure which is applied to adaptation for technical progress of the
 Directive. The reworded amendment should replace the text of Article 21. This
 amendment is acceptable in principle to the Commission as it makes the provision more
 transparent. The text of the amendment should be reworded to take into consideration the
 fact that the Committee is the same as in the context of Directive 67/548/EEC.
 Amendment to Annex VIII, Part A (amendment 27) proposes that reference to Directive
 96/65/EC should be added to the list of Directives that need to be repealed. This
 amendment is acceptable and necessary.
6.        Editorial issues
 Amendments to Article 1 paragraph 1, (amendment 2), to Article 1 paragraph 3
 (amendment 3), to Article 4 paragraph 2 (amendment 5), to Article 10 paragraph 2.3.3
 (amendment 10 included in amendment 11) and to Annex III, Introduction to paragraphs
  1 (a) to 1 (e) (amendment 19) are editorial and they improve the text.
 The Commission has introduced a clarification on the heading of Article 15 to bring it in
 line with its contents.
 ---pagebreak---                                Amended proposal for a
            EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
concerning the approximation of the laws, regulations and administrative provisions of
the Member States relating to the classification, packaging and labelling of dangerous
                                     preparations
 ---pagebreak--- Pursuant to Article 189(a) paragraph 2 of the EC Treaty, the Commission has decided to
amend the proposal 3 for an European Parliament and Council Directive concerning the
approximation of the laws, regulations and administrative provisions of the Member
States relating to the classification, packaging and labelling of dangerous preparations as
follows:
              Original proposal                                     Modified proposal
                                       Recital 13 a (new)
                                                        Whereas the Commission will, on the
                                                        basis of information to be supplied by the
                                                        Member States and the various parties
                                                        concerned, submit a report to the
                                                        European Parliament and the Council
                                                        within two years of the entry into force of
                                                        this Directive on experience with the
                                                        present overall approach to labelling of
                                                        dangerous preparations and in particular
                                                        on its understanding and application by
                                                        users.     experience     with    publicity
                                                        campaigns and educational and training
                                                        programmes: whereas on the basis of this
                                                        report    the     Commission     will.    if
                                                        appropriate.     submit    the   necessary
                                                        proposals:
                                          Article 1(1)
  1.      This Directive aims at the                     1.     This Directive aims at the
  approximation of the laws, regulations                approximation of the laws, regulations
  and administrative provisions of the                  and administrative provisions of the
  Member States concerning:                             Member States concerning:
          the classification, packaging and                     the classification, packaging and
  labelling of dangerous preparations,                  labelling of dangerous preparations,
          specific provisions for certain                       specific provisions for certain
  preparations which may present hazards,               preparations which may present hazards,
  whether or not they are classified as                 whether or not they are classified as
  dangerous within the meaning of this                  dangerous within the meaning of this
  Directive, when such preparations are                 Directive,
  placed on the market.                                 when such preparations are placed on the
                                                        market of the Member States.
         OJ No C 283, 26.9.1996, p. 1
 ---pagebreak---                                            Article 1(3)
3.       The specific provisions set out:                3.       The specific provisions set out:
         in Article 9 and defined                                 in Article 9 and defined
in Annex IV,                                             in Annex IV,
         in Article 10 and defined in                             in Article 10 and defined in
Annex V, and                                             Annex V, and
         in Article 16                                            in Article 16
of this Directive shall also apply to                    of this Directive shall also apply to
preparations which are not considered                    preparations which are not considered
dangerous within the meaning of Articles                 dangerous within the meaning of Articles
5, 6 or 7 but may nevertheless present a                 5, 6 or 7 but may nevertheless present a
hazard to the user.                                      specific hazard to the user.
                                           Article 4(2)
2.       The general principles of the                   2.       The general principles of the
classification      and       labelling      of          classification      and      labelling      of
preparations shall be applied according to               preparations shall be applied according to
the criteria in Annex VI to Directive                    the criteria in Annex VI to Directive
67/548/EEC save where alternative                        67/548/EEC save where alternative
criteria referred to in Articles 5, 6 or 7 of            criteria referred to in Articles 5, 6, 7 or 10
this Directive are applied.                              and the corresponding Annexes of this
                                                         Directive are applied.
                                    Article 6(1), (2) and (3)
 1.      The     health    hazards      of    a           1. The health hazards of a preparation
 preparation shall be assessed by one or                  shall be assessed by one or more of the
 more of the following procedures :                       following procedures:
 (a)     by the conventional method                       (a)      by the conventional method
 described in Annex II parts A and B to                   described in Annex II parts A and B to
 this Directive using concentrationiimits;                this Directive using concentration limits:
 (b)     by determining, by means of the                  (b) by determining, by means of the
 methods specified in point B of Annex V                  methods using vertebrate animals and
 to      Directive      67/548/EEC          the           specified in part B of Annex V to
 toxicological       properties      of     the           Directive 67/548/EEC, the toxicological
 preparation necessary for appropriate                    properties of the preparation necessary
 classification and labelling in accordance               for    appropriate     classification     and
 with the criteria in Annex VI to that                    labelling in accordance with criteria in
 Directive.                                               Annex VI to that Directive;
                                                          (c) by determining by means of the
                                                          methods not using vertebrate animals and
 ---pagebreak---                                                specified in part B of Annex V to
                                               Directive 67/548/EEC the toxicological
                                               properties of the preparation necessary
                                               for     appropriate     classification    and
                                               labelling in accordande with the criteria
                                               in Annex VI to that Directive.
2.      The    health     hazards      of    a 2. The health hazards of a preparation
preparation     covered      by     Directive  covered by Directive 91/414/EEC shall
9I/414/EEC shall be assessed by one or         be assessed by one or more of the
more of the following procedures :             following procedures:
(a)     by the conventional method             (a)       by the conventional method
described in Annex II parts A and B to         described in Annex II parts A and B to
this Directive using concentration limits;     this Directive using concentration limits;
(b)     by determining the health effect        (b) by determining, by means of the
properties of the preparation necessary         methods using vertebrate animals and
for     appropriate      classification     in  specified in part B of Annex V to
accordance with criteria of Annex VI to         Directive 67/548/EEC. unless other
Directive 67/548/EEC. These health              internationally recognised methods are
effect properties will be determined by         acceptable in accordance with the
means of the methods laid down in part          provisions of Annexes II and III of
B of Annex V to Directive 67/548/EEC            Directive 91/414/EEC, the toxicological
unless other internationally recognized         properties of the preparation necessary
methods are acceptable in accordance            for    appropriate      classification   and
with the provisions of Annexes II and III       labelling in accordance with the criteria
to Directive 91/414/EEC.                        in Annex VI to Directive 67/548/EEC:
                                                (c) by determining, by means of the methods
                                                not using vertebrate animals and specified in
                                                part B of Annex V to Directive 67/548/EEC.
                                                unless other internationally recognised
                                                methods are acceptable in accordance with
                                                the provisions of Annexes II and HI of
                                                Directive 91/414/EEC. the toxicological
                                                properties of the preparation necessary for
                                                appropriate classification and labelling in
                                                accordance with the criteria in Annex VI to
                                                Directive 67/548/EEC:
3.      When a toxicological property is        3. Where it can be demonstrated by the
established by method Kb) or 2fb) to obtain     person responsible for placing the
new data, the test shall be conducted in        preparation on the market that a
compliance with the principles of good          toxicological property of a preparation
laboratory practice provided for in Directive   cannot be determined by method 1 (a) or 1
87/18/EEC4 and with the provisions of           (c). or by method 2(a) or 2 (c). or on the
Directive 86/609/EEC.                           basis of existing test results on vertebrate
                                                animals, the methods 1 (b) or 2
       OJNo. L 15, 17.1.1987, p. 29
 ---pagebreak---                                                 (b) may be used.
Any of the toxicological properties of the       Where a health hazard has been assessed
preparation which are not assessed by the       by the test methods specified in
method set out in Kb) or 2(b) above shall       paragraphs 1(b) or 1(c). or 2(b) or 2(c).
be assessed in accordance with the              these methods shall be used for
conventional method.                            classifying the preparation instead of the
                                                conventional method, except in the case
Where a toxicological property has been         of carcinogenic, mutagenic effects and
established by both the methods above,          toxic effects for reproduction for which
the result of method Kb) or 2(b) shall be       only the conventional method described
used for classifying the preparation            in Annex II applies.
except in the case of carcinogenic.
mutagenic effects and toxic effects for         Where results of both methods Kb) and
reproduction for which only the                  1(c). or 2(b) and 2(c) are available-
conventional method described in Annex          method 1(b) or 2(b) shall normally be
II applies.                                     used for classifying the preparation.
Furthermore,      where      it    can    be    Furthermore,      where      it     can    be
demonstrated that :                             demonstrated:
- toxicological effects on man differ from           by epidemiological         studies, by
those suggested by a toxicological              scientifically valid case studies based on
determination      or    a      conventional    the use of preparations               or   by
assessment, then the preparation shall be       statistically-backed experience, such as
classified according to its effects on man,     the assessment of data from poison
                                                information      units   or      occupational
                                                diseases that toxicological effects on man
                                                differ     from    those    suggested     In-
                                                application of methods provided for in
                                                paragraphs 1 or 2. then the preparation
                                                shall be classified according to its effects
                                                on man.
- owing to effects such as potentiation a       - that owing to effects such as
conventional        assessment         would    potentiation a conventional assessment
underestimate the toxicological hazard,         would underestimate the toxicological
these effects shall be taken into account       hazard, these effects shall be taken into
in classifying the preparation,                 account in classifying the preparation.
- owing to effects such as antagonism, a        - that owing to effects such as
conventional        assessment         would    antagonism, a conventional assessment
overestimate the toxicological hazard,          would overestimate the toxicological
these effects shall be taken into account       hazard, these effects shall be taken into
in classifying the preparation.                 account in classifying the preparation.
                                             10
 ---pagebreak---                               Article 9, 2nd paragraph (new)
                                                         2. Preparations shall be deemed to satisfy
                                                         the requirements of point 1. first to third
                                                         indents, if their packaging complies with
                                                         the requirements for carriage by rail-
                                                         road, inland waterway, sea or air.
                              Article 10(2.3.3) (2.3.4(a) (new)
2.3.3. for preparations classified as                    2.3.3. for preparations classified as
sensitizing, in accordance with Article 6,               sensitizing, in accordance with Article 6,
only the sensitizing substances present in               only the sensitizing substances present in
concentrations equal to or greater than                  concentrations equal to or greater than
their respective limits laid down in Annex               their respective limits laid down in Annex
I to Directive 67/548/EEC or, failing that,              I to Directive 67/548/EEC or, failing that.
Annex II B of this Directive have to be                  Annex II B of this Directive have to be
taken into consideration.                                taken into consideration.
As a general rule a maximum of four
chemical names shall suffice to identify
the substances primarily responsible for
the major health hazards which have
given rise to the classification and the
choice of the corresponding phrases
referring to the risk involved. In some
cases, more than four chemical names
may be necessary.
                                                         2.3.4 (a) As a general rule a maximum of
                                                         four chemical names shall suffice to
                                                         identify     the    substances     primarily
                                                         responsible for the major health hazards
                                                         which have given rise to the classification
                                                         and the choice of the corresponding
                                                         phrases referring to the risk involved. In
                                                         some cases, more than four chemical
                                                         names may be necessary.
                                  Article 10(4), first indent
         in the case of irritant, highly                          in the case of irritant, highly
flammable and oxidizing preparations                      flammable,           oxidizing         and
with the exception of those assigned the                 environmentally dangerous preparations
phrase R41, there is no need to indicate                 with the exception of those assigned the
the special risks (R phrases) or the safety               phrase R41, there is no need to indicate
advice (S phrases);                                       the special risks (R phrases) or the safety
                                                          advice (S phrases);
                                              11
 ---pagebreak---                                      Article 10(5)
5.      Information such as 'non-toxic',           5.      Information such as 'non-toxic'.
'non-harmful' or any other statement               'non-harmful', 'environmentally-friendly',
indicating that the preparation is not             'eco' or any other statement indicating
dangerous must not appear on the                   that the preparation is not dangerous or
packaging or labelling of the preparations         which might lead to an underestimation
subject to this Directive.                         of the hazards of such preparations must
                                                   not appear on the packaging or labelling
                                                   of the preparations subject to this
                                                   Directive.
                                       Article 15
              Advertisements                                    Distance selling
Any advertisement for a preparation                Any advertisement for a preparation
within the meaning of this Directive               within the meaning of this Directive
communicated           exclusively      by         communicated          exclusively       by
correspondence or catalogue which                  correspondence or catalogue which
imposes an obligation on the buyer shall           imposes an obligation on the buyer shall
be prohibited if no mention is made                be prohibited if no mention is made
therein of the type or types of hazard             therein of the type or types of hazard
indicated on the label.                            indicated on the label.
                                       Article 21
Amendments required to adapt to                    Amendments required to adapt to
technical progress the Annexes to this             technical progress the Annexes to this
Directive shall be adopted in accordance           Directive shall be adopted in accordance
with the procedure laid down in Article            with the procedure laid down in Article
29 of Directive 67/548/EEC.                        29 paragraph 4 (a) of Directive
                                                   67/548/EEC.
                  ANNEX III, Introduction, paragraphs 1A to IE (new)
 Ihe systematic assessment of all the               The systematic assessment of all the
dangerous properties for the environment           dangerous properties for the environment
is expressed by means of concentration             is expressed by means of concentration
limits, expressed as a weight/weight               limits, expressed as a weight/weight
 percentage      except     for    gaseous         percentage      except     for     gaseous
 preparations where they are expressed as           preparations where they are expressed as
 a volume/volume percentage and in                  a volume/volume percentage and in
 conjunction with the classification of a           conjunction with the classification of a
 substance.                                         substance.
                                            12
 ---pagebreak---                                                    Part A gives the calculation procedure
                                                   according to Article 7(l)(a) and 7(2)(a)
                                                   and gives the R phrases to be assigned to
                                                   the classification of the preparation.
                                                   Part B gives the concentration limits to be
                                                   used when applying the conventional
                                                   method and the relevant symbols and R
                                                   phrases for classification.
                                                   Part C gives the test methods for the
                                                   evaluation of the hazards for the aquatic
                                                   environment-
                                                   Part D gives the R phrases to use on the
                                                   label
                                                   Part E gives the indications concerning
                                                   safety advice to put on the label.
                  ANNEX III, Part B, Table V, second column, first line
concentration > 0.5%                               concentration >QJ_%
                       ANNEX IV, Part B, 2nd paragraph (new)
                                                   This provision shall not apply to aerosols
                                                   classified and labelled only as extremely
                                                   flammable or highly flammable.
                                 ANNEX V, Part C(l)
1.       Preparations containing at least          1.       Preparations containing at least
one dangerous substance but not                    one dangerous substance but not
classified within the meaning of Articles          classified within the meaning of Articles
5, 6 and 7.                                        5, 6 and 7.
The label on the packaging of                      The label on the packaging               of
preparations containing at least one               preparations containing at least one
substance classified as sensitizing and            substance classified as sensitizing and
accompanied by a specific note under               accompanied by a specific note under
Annex I to Directive 67/548/EEC must               Annex I to Directive 67/548/EEC must
bear the inscription:                              bear the inscription:
"Contains 'name of sensitizing substance'.         "Contains 'name of sensitizing substance'.
May produce an allergic reaction in                May produce an allergic reaction/"
persons already sensitized"
                                           13
 ---pagebreak---                                   ANNEX V, Part C(2)
2.      Preparations not intended for the         2.       Preparations not intended, for the
general public.                                   general public.
The label on the packaging of the                 The label on the packaging of the
preparations referred to in Article 16.2          preparations referred to in Article 16.2
must bear the following inscription:              must bear the following inscription:
'Safety data sheet available on request'          'Contains dangerous substances in such
                                                  amounts that warning label is not
                                                  justified. Safety data sheet available on
                                                  request.'
                                 ANNEX V, Part D (new)
                                                   D.      Special        provisions       for
                                                   preparations placed on the market solely
                                                   as authorized plant protection products
                                                   pursuant to Directive 91/414/EEC.
                 ANNEX VIII, Part A, 2nd indent, 3rd subindent a (new)
 Directive      88/379/EEC       on      the       Directive       88/379/EEC       on     the
 approximation of the laws of the Member           approximation of the laws of the Member
 States relating to the classification,            States relating to the classification,
 packaging and labelling of dangerous              packaging and labelling of dangerous
 preparations and                                  preparations and
 its following adaptations to technical            its following adaptations to technical
 progress:                                         progress:
         -Directive 89/178/EEC                              -Directive  89/178/EEC
         - Directive 90/492/EEC                             - Directive 90/492/EEC
         -Directive 93/18/EEC                               -Directive  93/18/EEC
                                                            - Directive 96/65/EC
                                             14
 ---pagebreak---                                                                   ISSN 0254-1475
                                                           COM(97) 462 final
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                                                             ISBN 92-78-24908-4
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