CELEX: 51996PC0312
Language: en
Date: 1996-06-24
Title: Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE concerning the placing of biocidal products on the market

COMMISSION OF THE EUROPEAN COMMUNITIES
                                         Brussels, 24.06.1996
                                         COM(96) 312 final - COD 465
                   Amended proposal for a
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
  concerning the placing of biocidal products on the market
(presented by the Commission pursuant to Article 189 a (2)
                      of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                                EXPLANATORY MEMORANDUM
 Pursuant to Article 189(a) paragraph 2 of the EC treaty, the Commission submits an amended
 proposal for a European Parliament and Council Directive concerning the placing of biocidal
 products on the market. The amended proposal takes account of a number of amendments
 from the European Parliament, adopted at its plenary session on 18 April 19961.
 A large number of amendments were proposed by Parliament, grouped essentially as follows:
 to limit the use of laboratory animals, to alter the scope, to clarify the text, to introduce
 simplified procedures, to modify the data requirements, to alter the operation in certain areas
 (eg labelling, treatment of anti-fouling products) and to introduce a system to charge fees.
 Amendment 5 contains a proposal that a new recital, number 20a, be introduced stating that
 this directive assists in reducing the number of tests carried out on laboratory animals; the
 Commission agrees with this important addition.
 As this proposal is designed to fill a gap in the existing European chemicals legislation the
 scope is critical - it needs to cover all relevant products not covered by other legislation but
at the same time must avoid any duplication with existing legislation. The Commission agrees
that reference needs to be made to additional relevant Community legislation, and accepts
amendment number 2. The suggested text has, however, been added to recital 20 rather than
recital 13 as this is a more logical place for it. Additions have also been made to article 1 as
proposed in amendments 9, 10 and 11. Proposals to restrict the scope would leave gaps in
the European legislation and so the Commission cannot accept amendment 12 which indirectly
alters the scope by modifying an important definition, that of harmful organisms. Amendment
 13 cannot be accepted as it would increase the scope unnecessarily by including products
which are for export only; amendment 15 is unacceptable as it would bring treated materials
under the scope of the proposal. The proposal is concerned with the placing of biocidal
products on the European market and does not include the manufacturing stage of the
biocidal products themselves nor the post treatment stage ie materials after they have been
treated with biocides (eg treated wood).
Amendments 4, 7, 42 and 43 propose the setting up of action plans or other measures to
reduce the usage of biocidal products. However, whilst these ideas are laudable and indeed
are in line with the 5th Environmental Action Programme they cannot be incorporated into
this proposal. The proposal is concerned with the assessment of individual active substances
and biocidal products and not with the setting of an overall strategy for their use. For similar
reasons the Commission cannot accept the part of amendment 38 which proposes that all
product labels advise that the biocidal product should be used moderately.
The Commission recognizes that this is a very technical proposal and welcomes any relevant
clarification. Amendments 3 and 92 (grouped together), which clarify certain basic principles,
     1
         Reference- minutes of the session of 18 April 1996, provisional edition, PE 198.355.
                                                      L
 ---pagebreak---  have therefore been incorporated into recital 19 as suggested. A new recital, number 20b,
 has been introduced as proposed in amendment 6; this explains that a guidance document will
 be produced to assist in the implementation of annex VI (the common principles).
 The Commission agrees with the introduction of the concept of "frame-formulations" in
 article 2, as suggested in amendment 14, as this will simplify certain procedures.
 Another very useful clarification which has been accepted by the Commission is the principle
 of grouping all pertinent references to mutual recognition together in the manner suggested
by amendments 19 and 20. This has resulted in a restructuring of the text in article 3 which
 is now split into two parts, a new article 3 which contains the general requirements for
authorization and a new article 3a which contains the text dealing with mutual recognition.
The rewording suggested in amendment 17 clarifies the time period stipulated for applications
to be processed and this has been incorporated into the text of article 3.2. Amendment 18
has also been incorporated into the text in the new article 3 as the Commission agrees that
biocidal products to which the concept of frame formulations has been applied should be
processed within 60 days.
An addition to the text in article 14 has been made, as suggested in amendment 31 as this
clarifies certain aspects of what happens in the transitional period. Amendment 57 has been
accepted and the deletion of some text in paragraph 59 of annex VI clarifies the meaning.
The Commission cannot accept the proposal, contained in amendment 8, to delete the
reference to the 5th Environmental Action Programme in recital 24 since the proposed
directive underpins a key part of this Programme and so a reference to it is important.
A number of amendments were proposed which alter the data requirements; some of these
have been incorporated into the text but others, which remove certain provisions for
flexibility, are not acceptable. This flexibility is needed to ensure that only data which is
really needed for the purposes of carrying out a risk assessment is submitted and evaluated;
this flexibility does, of course, not result in a reduction in the level of protection afforded
to humans or the environment. Amendments 23, 25, 27, 28, 44, 50, 51, 53 and 54 are
therefore not acceptable. Other amendments propose adding to the data requirements
regardless as to whether or not they are necessary for the purposes of the risk assessment eg
requesting data on all degradation products of the active substances or decreasing the
acceptable concentration limits in water. Amendment numbers 45, 46, 47, 48, 49, 52 and 60
fall into this category and are therefore unacceptable. The amendments relating to data
requirements which have been incorporated into the modified text are numbers 79, 80, 81,
and 83; these state that the dossier requirements must be in line with technical development.
Combining an alteration in the data requirements with a change in operation of the
authorization conditions the Commission has incorporated amendments 21 and 24 into the
text of article 4 and amendment 59 into paragraph 80 of annex VI; these now stipulate that
effects on air and on surface water must be specifically considered and that application
methods must be incorporated into the conditions of authorization. Amendment 56 states that
only where appropriate should certain types of tests be used for efficacy purposes; this is a
helpful amendment and the text in paragraph 51 of annex VI has been altered accordingly.
                                                     3
 ---pagebreak---  A number of amendments were concerned with labelling. Amendment 37 proposes that all
 biocides be labelled according to the Preparations Directive (88/379/EEC); the Commission
 agrees with this in principle but as Directive 88/379/EEC is currently being revised cannot
 implement this amendment yet. Amendment 37 will be acted upon once the modifications to
 Directive 88/379/EEC have been completed; article 18.4 has been amended slightly insofar
 as the reference to other Community provisions has been deleted. Amendment 36 also
 proposes modifications to the product label; the part which states that labels must not be
 misleading is acceptable but the request not to have claims on the label cannot be supported.
 Part of amendment 38 proposed that labelling should be clearly legible; this is not necessary
 as this point is already covered in Directive 88/379/EEC under which all biocidal products
 will be labelled. Directive 88/379/EEC also contains requirements as to when safety lids are
required and so amendment 35 has not been accepted.
Part of amendments 29 & 95 (grouped together) clarifies that the principle of comparative
assessment will not be applied to biocidal products, this helpful clarification has been
incorporated into article 9.5. In contrast amendment 58 cannot be accepted as it implies that
comparative assessment would be applied to biocidal products. The part of amendments 29
and 95 which is not acceptable relates to the request to have a 5 year phasing out period
based on the procedure in article 10 of the proposal; this cannot be accepted as the reference
to article 10 is not relevant and the 5 year period proposed is too long.
The requirement that the consultation between the applicant and the Commission be made
mandatory, as proposed in amendment 39, is acceptable with the proviso that such
consultation is not needed when a positive authorization decision is envisaged, article 24.3
has been reworded accordingly. However the suggestion that all requests for the composition
of all product formulations be kept confidential automatically, as requested in amendment 34
is not acceptable as certain components of the formulation may have to be named on the
product label if they are dangerous to humans or the environment.
A derogation for anti-fouling products used for specific purposes is proposed in amendment
96; this is acceptable to the Commission as it recognizes the special requirements of these
products. Paragraph 86 of annex VI has been amended accordingly.
Amendments 1, 22 and 55 propose restricting the types of substance which can be included
in biocidal products; these cannot be accepted as this would alter one of the fundamental
principles of this proposal - that decisions are based on risk assessment (and not a hazard
assessment). The proposal attempts to balance the decisions made at Member States level and
at Community level by, as far as possible, leaving decisions on the biocidal product to
Member States and taking decisions on the active substance at Community level. Amendment
33 is not acceptable as the Commission considers that the decision as to the completeness of
a dossier on a biocidal product should be left to the Member State. Amendment 32 proposes
an alteration in the committee procedure for the adoption of the Regulation which will deal
with the review work; the Commission originally proposed, after careful consideration, an
advisory committee for this work and sees no reason to change this.
Other proposed procedural changes which are not acceptable are numbers 41 and 63.
Amendment 41 would automatically extend the application of the safety clause to all Member
States following use by a single Member State and 63 is against the Commission rules in
attempting to define the composition of the Standing Committee
 ---pagebreak--- Amendment 62 is not acceptable as it proposes that, in paragraph 92 of annex VI, only
environmental and economic benefits should be considered rather than benefits in general -
this would restrict the flexibility needed when deciding upon the authorization of a biocidal
product.
Finally amendment 26 proposes that fees be charged for the authorization of biocidal
products; this principle has been accepted by the Commission and a new article 7a introduced
into the text.
                                                       X
 ---pagebreak---          ORIGINAL PROPOSAL                              MODIFIED PROPOSAL
                                         Recital 19
Whereas Member States must be able to          Whereas Member States must be able to
authorize biocidal products not complying      authorize biocidal products not complying
with the above-mentioned conditions for a      with the above-mentioned conditions for a
limited period of time, especially in case of  limited period of time, especially in case of
an unforseen danger threatening man or the     an unforseen danger threatening man or the
environment which cannot be contained by       environment which cannot be contained by
other means; whereas such authorization        other means; i.e. in cases where the
should be reviewed by the Commission in        requisite safety for humans and the
close cooperation with the Member States;      environment cannot be achieved by other
whereas the Community procedure should         means or with the aid of the products listed
not prevent         Member States from         in Annex V of this Directive: whereas such
authorizing for use in their territory for a   authorization must accord with principles
limited period of time biocidal products       laid down in Point 61 of Annex VI to this
containing an active substance not yet         Directive and should be reviewed by the
entered in the Community list, provided that   Commission in close cooperation with the
a dossier meeting community requirements       Member States; whereas the Community
has been submitted and the Member States       procedure should not prevent         Member
believes that the active substance and the     States from authorizing for use in their
biocidal products satisfy the Community        territory for a limited period of time
conditions set in regard to them;              biocidal products containing an active
                                               substance not yet entered in the Community
                                               list, provided that a dossier meeting
                                               community requirements has been
                                               submitted and the Member States believes
                                               that the active substance and the biocidal
                                               products satisfy the Community conditions
                                               set in regard to them;
                                                         G
 ---pagebreak---                                         Recital 20
Whereas active substances used in biocidal     Whereas active substances used in biocidal
products may also be used in other             products may also be used in other
preparations which have under other           preparations which have under other
Community legislation, been tested on          Community legislation, been tested on
animals, whereas double testing on animals    animals, whereas double testing on animals
must be avoided; whereas, close               must be avoided; whereas, close
coordination should be ensured with other     coordination should be ensured with other
Community legislation and in particular       Community legislation and in particular
with Directive 91/414/EEC on the placing      with Directive 91/414/EEC on the placing
on the market of plant protection products    on the market of plant protection products
                                              and those Directives concerned with the
                                              protection of water, and those concerned
                                              with the contained use and release of
                                              genetically modified organism.
                                    Recital 20a (new)
                                              Whereas it is essential that this Directive
                                              helps to reduce the number of tests on
                                              animals and that testing should be made
                                              dependant on the purpose and use of a
                                              product:
                                   Recital 20b (new)
                                              Whereas the Commission is to draw up
                                              technical notes for guidance on the
                                              implementation of Annex VI:
                                               ^
 ---pagebreak---                         Article l(2)(aa) and     (ab)(new) and (b)
                                                (aa) Council directive 81/851/EEC on the
                                                approximation of the laws of the Member
                                                 States relating to veterinary medicinal
                                                products :(1)
                                                (ab)         Council Directive 90/677/EEC on
                                                extending the scope of Directive.
                                                81/851/EEC on the approximation of the
                                                laws of the Member States relating to
                                                veterinary medicinal products and laying
                                                down         additional      provisions   for
                                                immunological veterinary            medicinal
                                                products:f2V
(b)     Council Directives 70/524/EEC and       (b)       Council Directives 70/524/EEC and
82/471/EEC on additives and substances for      82/471/EEC on additives and substances for
exclusive use in animal feedingstuffs;          exclusive use in animal feedingstuffs and
                                                Directive 77/101/EEC (3) on the marketing
                                                of straight feedingstuffs:
                                                ( l ) O J L 317.6.11.1981. p.82.
                                                (2) OJL 373. 31.12.1990 p.26
                                                ( 3 ) O J L 3 2 . 3.2.1977 p.l
                                    Article 1.2 (g) new
                                               (g) Council Directive 90/385/EEC on the
                                                approximation of the laws of the Member
                                                States on active implantable medicinal
                                                devices (1),
                                               (h) Council Directive 89/109/EEC of 21
                                                December 1988 on the approximation of the
                                                laws of the Member States relating to
                                                materials and articles intended to come into
                                                contact with foodstuffs (2) and subsequent
                                                follow-up Directives,
                                                m OJL 189. 20.7.1990. p.17
                                                (2)OJL40. 11.2.1989. P. 38
                                   Article l(3)(ea)(new)
                                              (galCouncil directive 84/450/EEC on the
                                                approximation of the laws, regulations or
                                                administrative provisions of the Member
                                                States relating to misleading advertising
                                                OJL 250. 19.09.1984. p. 17
 ---pagebreak---                                      Article 2 (l)(ea)(new)
                                                  (ea) Frame-Formulations
                                                  Specifications for a group of biocidal
                                                  products having the same use and user type.
                                                  This group of products must contain the
                                                  same active substances of the same
                                                  specifications and their compositions must
                                                  present only variations from a previously
                                                  authorized biocidal product which do not
                                                  affect the level of risk associated with them
                                                  and their efficacy:
                                                  In this context, a variation is the allowance
                                                  of a reduction in the percentage of the
                                                  active substance and/or an alteration in
                                                  percentage composition of one or more
                                                  non active substances and/or the
                                                  replacement of one or more pigments, dyes,
                                                  perfumes by other presenting the same or a
                                                  lower risk, and which do not decrease its
                                                  efficacy.
                                          Article 3 (2)
2. Every application for authorization shall         2. Every application for authorization shall
be decided upon within a reasonable                  be decided upon without undue delay,
period.
                                             3
 ---pagebreak---                                       Article 3 (par 4,5,6,7,8)
 3.A biocidal product that has already been                     deleted
 authorized in one Member State shall be
 authorized, in another Member State within
 60 days of an application being received by
 the other Member State, providing that the
 active substance of the biocidal product
 conforms to the entry in Annex 1.
 4.If complying with Article 4 a Member
 State establishes that:
(a) unacceptable resistance of the target
organism to the biocidal product is proven
or
(b) the relevant circumstances of use, such
as climate or breeding period of the target
species, differ significantly from those in
the Member State where biocidal product
was first authorized, and an unchanged
authorization may therefore            present
unacceptable risks to man or the
environment;
the Member State may request that the
directions for use and the dose rate referred
to in Article 18(3)(e) are adjusted to the
different circumstances, or, if the risk
cannot be prevented in any other way, the
Member State may request changes to be
made to the biocidal product itself so that
conditions for issue of an authorization
provided for in article 4 are satisfied.
5. Notwithstanding paragraph 4 where a
Member State believes a biocidal product
cannot meet the conditions set out under
article 4 and consequently proposes to
refuse authorization, it shall notify the
Commission, other Member States and the
applicant and shall provide them with an
explanatory document giving details of the
product and setting out the grounds on
which it proposes to refuse the
authorization.
 ---pagebreak---  The Commission shall prepare a proposal          deleted
 on these matters in accordance with Article
 24 for decision in accordance with the
 procedure laid down in Article 25(3).
 6. Member States shall prescribe that
 biocidal products shall be classified,
 packaged and labelled in accordance with
 the provisions of this Directive.
 7. Authorizations shall be granted for a
 fixed period of 10 years from the date of
first entry of the active substance onto
Annex ; they may be renewed after
verification that the conditions imposed in
paragraphs 1 and 2 are still satisfied.
Renewal may, where necessary, be granted
only for the period necessary to allow the
competent authorities of the Member States,
to make such verification, where an
application for renewal has been made.
8. Member States shall prescribe that
biocidal products must be properly used.
Proper use shall include compliance with
conditions established under Article 4 and
specified under the labelling provisions of
this directive. Proper use shall also involve
the rational application of a combination of
physical, biological, chemical or other
measures a s appropriate whereby the use
of biocidal products is limited to the
minimum necessary. Where biocidal are
used at work use shall also be in
accordance with requirements of directives
for the protection of workers.
                                             S\ 1
 ---pagebreak--- Article 3 par. 3,4,5,6 new
          3.Without prejudice to Articles 7 and 11
          and providing that the applicant has a right
          of access to it. when a subsequent
          application for authorization for a new
          biocidal product is -based upon a frame-
          formulation, the competent authority shall
          take a decision with regard to this
          application within a period of 60 days.
          4. Member States shall prescribe that
          biocidal products shall be classified,
          packaged and labelled in accordance with
          the provisions of this Directive.
          5. Without prejudice to Article 6(1).
          authorizations shall be granted for a
          maximum period of 10 years from the date
          of first or renewed inclusion of the active
          substance onto Annex I for the product
          type, without exceeding the deadline
          specified for the active substance in Annex
          I. they may be renewed after verification
          that the conditions imposed in Article 4(1)
          and (2) are still satisfied. Renewal may,
          where necessary, be granted only for the
          period necessary to allow the competent
          authority of the Member States to make
          such verification, where an application for
          renewal has been made.
          6. Member States shall prescribe that
          biocidal products must be properly used-
          Proper use shall include compliance with
          conditions established under Article 4 and
          specified under the labelling provisions of
          this directive. Proper use shall also involve
          the rational application of a combination of
          physical, biological, chemical or other
          measures as appropriate whereby the use of
          biocidal products is limited to the minimum
          necessary. Where biocidal products are used
          at work use shall also be in accordance
          with the requirements of directives for the
          protection of workers.
                  f\t
 ---pagebreak--- Article 3a (new)
         1. Without prejudice to Article 11. a
        biocidal product that has already been
        authorized in one Member State shall be
        authorized in another Member States within
        60 days of an application being received
        by the other Member State, provided that
        the active substance of the biocidal product
        is included in Annex I and conforms to the
        requirements thereof. The application shall
        include a summary of the dossier as
        required in Article 7(2)(a) and Annex 1ID.
        Section X and a certified copy of the first
        authorization granted.
        The authorization may be subject to
        provisions          resulting      from      the
        implementation oi' other measures in
        accordance with Community law, relating to
        the conditions for distribution and use o\"
        biocidal products intended to protect the
        health of the distributors, users and workers
        concerned.
        2.11'. in accordance with Article          4. a
        Member State establishes that:
        (aa) the target species can be assured not to
        occur on its territory.
        (a) unacceptable resistance of the target
        organism to the biocidal product is
        demonstrated, or
        (b) the relevant circumstances o\" use, such
        as climate or breeding period of the target
        species, differ significantly from those in
        the Member States where the biocidal
        product was first authorized, and an
        unchanged authorization may therefore
        present unacceptable risks to humans or the
        environment.
        the Member States may request that certain
        conditions       referred     to   in    Article
         lS(3)(e).(f).(h).(j) and (1) be adjusted to the
        different circumstances, so that conditions
        for issue oï an authorization laid down in
        Article 4 are satisfied.
               >J
 ---pagebreak---                                                    3.Notwithstanding paragraph 2 where a
                                                  Member State believes a biocidal product
                                                  cannot meet the conditions set out under
                                                  article 4 and consequently proposes to
                                                  refuse or to restrict the authorization under
                                                  certain conditions, it shall notify the
                                                  Commission, other Member States and the
                                                  applicant and shall provide them with an
                                                  explanatory document containing the name
                                                  of the product and its specification and
                                                  setting out the grounds on which it
                                                  proposes to refuse or to restrict the
                                                  authorization.
                                                  The Commission shall prepare a proposal
                                                  on these matters in accordance with Article
                                                  24 for a decision in accordance with the
                                                  procedures laid down in Article 25(3).
                                       Article 4(1 )(b)(iii)and (iv)
(iii) has no harmful effects itself or as a       (iii) has no harmful effects itself or as a
result of its residues, on human or animal        result of its residues, on human or animal
health, directly or indirectly (e.g. through      health, directly or indirectly (e.g. through
drinking water, food or feed) or on               air, drinking water, food or feed) or on
groundwater;                                      groundwater and surface water;
(iv) has no unacceptable effect on the            (iv) has no unacceptable effect on the
environment having particular regard to the       environment having particular regard to the
following considerations:                         following considerations:
- its fate and distribution n the environment;    - its fate and distribution n the environment;
particularly     contamination      of   water    particularly     contamination      of   water
including drinking water and groundwater,         including drinking water, groundwater and
-its impact on non-target organisms;              surface water.
                                                  -its impact on non-target organisms;
                                                     » H
 ---pagebreak---                                       Article     4.4
4. Where other Community provisions              4. Where other Community provisions
 impose requirements relevant to the             impose requirements relevant to the
conditions for the issue of an authorization     conditions for the issue of an authorization
and particularly where these are intended to     and for use of the biocidal product and
protect the health of distributors, users,       particularly where these are intended to
workers and consumers or animal health or        protect the health of distributors, users,
the environment , the competent authority        workers and consumers or animal health or
shall take these into account when issuing       the environment , the competent authority
an authorization and where necessary shall       shall take these into account when issuing
issue the authorization          and where       an authorization and where necessary shall
necessary shall issue the authorization          issue the authorization subject to those
subject to those requirements.                   requirements.
                                      Article 7.a new
                                                 Member States shall establish a system
                                                obliging those seeking to place or having
                                                placed biocidal products on the market and
                                                those     supporting    entries  for   active
                                                substances on Annexes I. la and lb to pay
                                                charges, globally covering the costs of all
                                                different procedures associated with the
                                                provisions of this directive.
                                         Article 9(5)
5. The inclusion of an active substance in      5. The inclusion of an active substance in
Annex I may be refused or reviewed, if          Annex I may be refused or reviewed, if
there is another active substance in Annex I    there is another active substance in Annex I
for the same product type, or another           for the same product type, or another
method of control exists, which in the light    method of control exists, which in the light
of scientific or technical knowledge            of scientific or technical knowledge
presents significantly less risk to health or   presents significantly less risk to health or
to the environment. When considering such       to the environment. When considering such
a refusal, an evaluation of the alternative     a refusal, an evaluation of the alternative
active substances or methods shall be           active substances or methods shall be
produced in accordance with common              produced to demonstrate they can be used
principles for the evaluation of dossiers, to   with the same effect on the target organism
demonstrate they can be used with the same      without significant economic an d practical
effect on the target organism without           disadvantages to the user; The evaluation
significant    economic      and    practical   shall be circulated in accordance with the
disadvantages to the user. The evaluation       procedures in Article 10(2) for decision in
shall be circulated in accordance with the      accordance with the procedures laid down
procedures in Article 10(2) for decision in      in Articles 24 and 25(3).
accordance with the procedures laid down
in Articles 24 and 25 (3).
                                                       /ir
 ---pagebreak---                                         Article 14(3)
 3.By way of further derogation from Article    3.By way of further derogation from Article
4(1), Article 7(2) and Article 7(3) and         3(1). Article 4(1) Article 7(2) and Article
without prejudice to paragraph 4 and            7(3) and without prejudice to paragraph 4
paragraph 6, a Member State may, for a          and paragraph 6, a Member State may, for
period of 10 years from the date of entry       a period of 10 years from the date of entry
into force of this Directive, authorize the     into force of this Directive, authorize the
placing on the market in its territory of a     placing on the market in its territory of a
biocidal     product containing        active   biocidal product containing            active
substances not listed in Annex I that are on    substances not listed in Annex I, but which
the market on the date of entry into force of   have been used in biocidal products and are
this Directive.                                 on the market on the date of entry into
                                                force of this Directive.
                                 Article 18(3), introduction
3. Biocidal products shall be labelled 3. Biocidal products shall be labelled
according to the provisions of Directive according to the provisions of Directive
88/379/EEC concerning labelling. In 88/379/EEC concerning labelling. Labels
addition the label must show clearly and shall not be misleading or give an
indelibly the following:                        exaggerated impression of the product. In
                                                addition the label must show clearly and
                                                indelibly the following:
                                        Article 18 (4)
4.By way of derogation from paragraph 1         4.By way of derogation from paragraph 1
and 2 and the first sentence of paragraph 3     and 2 and the first sentence of paragraph 3
biocidal products authorised as insecticides,   biocidal products authorised as insecticides,
acaricides, rodenticides, avicides or           acaricides, rodenticides, avicides or
molluscicides shall be classified, packaged     molluscicides shall be classified, packaged
and labelled in accordance with Directive       and labelled in accordance with Directive
78/631/EEC on the approximation of the          78/631/EEC on the approximation of the
laws of the Member States relating to the       laws of the Member States relating to the
classification, packaging and labelling of      classification, packaging and labelling of
dangerous preparations (pesticides) (1)         dangerous preparations (pesticides).(l)
insofar as there is no other Community
provision specifically covering these matters
for such products.
1 OJ L 206. 29.7.1978. p. 13.                   1 OJL 206. 29.7.1978. p. 13.
                                                 K
 ---pagebreak---                                           Article   24 (3)
  3.The applicant or his authorized 3.The applicant or his authorized
 representative may be asked by the representative shall be asked by the
 Commission to submit remarks to it, in Commission to submit remarks to it, unless
 particular whenever an unfavourable a favourable decision is envisaged.
 decision is envisaged.
                                         Annex II (A) (1)
 1 .Dossiers on active substances are required      1 .Dossiers on active substances are required
 to address at least all the points listed under   to address at least all the points listed under
 "Dossier requirements". Responses are             "Dossier requirements". Responses are
 required to be supported by data.                 required to be supported by data. The
                                                   dossier requirements must be in line with
                                                   technical development.
                                          Annex 11(B) (1)
 1. Dossiers on active substances are required 1.Dossiers on active substances are required
to address at least all the points listed under to address at least all the points listed under
"Dossier requirements". Responses are "Dossier requirements". Responses are
required to be supported by data.                 required to be supported by data. The
                                                  dossiers requirements must be in line with
                                                  technical development.
                                         Annex III(A) (1)
 1 .Dossiers on active substances are required     1.Dossiers on active substances are required
to address at least all the points listed under   to address at least all the points listed under
"Dossier requirements". Responses are             "Dossier requirements". Responses are
required to be supported by data.                 required to be supported by data. The
                                                  dossier requirements must be in line with
                                                  technical development.
                                         Annex III (B)(1)
1 .Dossiers on active substances are required      1.Dossiers on active substances are required
to address at least all the points listed under   to address at least all the points listed under
"Dossier requirements". Responses are             "Dossier requirements". Responses are
required to be supported by data.                 required to be supported by data. The
                                                  dossier requirements must be in line with
                                                  technical development.
                                        1 ^
 ---pagebreak---                                 Annex VI (51) introduction
 51. Testing should be carried out according   51. Testing should be carried out according
 to European Union guide-lines if these are   to European Union guide-lines if these are
 available and applicable. In the absence of  available and applicable. Where appropriate
 these other methods can be used as shown     other methods can be used as shown in the
 in the list below which is in order of       list below which is in order of descending
descending preference:                        preference:
                             Annex VI (59), 2nd subparagraph
In the case of active substances not on the                      Deleted
market on the implementation date of the
Directive only those substances listed in
Annex I of the Directive can be used in
biocidal products.
                                Annex VI (80), introduction
80. The Member State shall not authorize a    80. The Member State shall not authorize a
biocidal product if, under the proposed       biocidal product if, under the proposed
conditions of use, the            foreseeable conditions of use, the           foreseeable
concentration of the active substance or of   concentration of the active substance or of
any other substance of concern or relevant    any other substance of concern or relevant
metabolites or breakdown or reaction          metabolites or breakdown or reaction
products in the groundwater exceeds the       products      in the surface water or
lower of the following concentrations:        groundwater exceeds the lower of the
                                              following concentrations:
                                                    U
 ---pagebreak---                                       Annex VI (86) new
 86. The Member States shall not authorize        86. The Member States shall not authorize
 a biocidal product where there is a              a biocidal product where there is a
 reasonably foreseeable possibility of aquatic    reasonably foreseeable possibility of aquatic
 organisms being exposed to the biocidal          organisms being exposed to the biocidal
 product if for any active substance or           product if for any active substance or
 substance of concern in it:                      substance of concern in it:
 - the PEC/PNEC> 1 unless it is clearly           - the PEC/PNEO 1 unless it is clearly
established in the risk assessment that under     established in the risk assessment that under
field conditions the viability of aquatic         field conditions the viability of aquatic
organisms is not threatened by the biocidal       organisms is not threatened by the biocidal
product according to the proposed                 product according to the proposed
conditions of use.                               conditions of use.
- the bioconcentration factor (BCF) is           - the bioconcentration factor (BCF) is
greater than 1000 for substances which are       greater than 1000 for substances which are
readily biodegradable or greater than 100        readily biodegradable or greater than 100
for those which are not readily                  for those which are not readily
biodegradable unless it is clearly established   biodegradable unless it is clearly established
in the risk assessment that under field          in the risk assessment that under field
conditions no unacceptable impact, either        conditions no unacceptable impact, either
directly or indirectly, occurs on the viability  directly or indirectly, occurs on the viability
of exposed organisms after use of the            of exposed organisms after use of the
biocidal product according to the proposed       biocidal product according to the proposed
conditions of use.                               conditions of use.
                                                 Member States may, however, authorize
                                                 anti-fouling products used on sea going
                                                 vessels of over 25 metres for a period of up
                                                 to 10 years from the date on which this
                                                 Directive enters into force. This provision
                                                 shall lapse if appropriate IMP rules are
                                                 adopted within that period.
                                                A-j>
 ---pagebreak---  ---pagebreak---                                                                   ISSN 0254-1475
                                                            COM(96) 312 final
                                                   OCUMENTS
EN                                                                  14 03 15
                                    Catalogue number : CB-CO-96-320-EN-C
                                                             ISBN 92-78-05897-1
Office for Official Publications of the European Communities
L 2985 Luxembourg