CELEX: 51993PC0351
Language: en
Date: 1993-07-27
Title: Proposal for a COUNCIL DIRECTIVE concerning the placing of biocidal products on the market

3. 9. 93                               Official Journal of the European Communities                              No C 239/3
                                                               ii
                                                       (Preparatory Acts)
                                                 COMMISSION
                 Proposal for a Council Directive concerning the placing of biocidal products on the market
                                                        (93 / C 239/03)
                                               COM(93) 351 final — SYN 465
                                       (Submitted by the Commission on 27 July 1993)
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,                          Commission to examine the situation in Member States
                                                                   and the possibility for action at Community level ;
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100a                 Whereas the term 'non-agricultural pesticides' was
thereof,                                                           formerly used to make a distinction with plant protection
                                                                   products which are essentially agricultural pesticides ;
                                                                   whereas, however, biocidal product is now a more
                                                                   accurate and appropriate term to describe the products
Having regard to the proposal from the Commission,                 covered by this Directive ;
In cooperation with the European Parliament,                       Whereas biocidal products comprise a highly diverse
                                                                   group of products, including wood preservatives, roden­
                                                                   ticides, insecticides, anti-foulings, surface and water
Having regard to the opinion of the Economic and                   biocides, disinfectants, fumigants, preservatives for
Social Committee,                                                  technical and household materials, preservatives for
                                                                   works of art, and others ; whereas they can give rise to
                                                                   exposure of man and the environment in a great variety
                                                                   of ways ;
Whereas provisions relating to certain dangerous
substances and preparations have already been laid down
in Community directives ; whereas it is still necessary to
establish rules in respect of other products which contain         Whereas biocidal products are necessary for control of
dangerous substances and which may involve risks for               organisms that are harmful to human or animal health
man and the environment;                                           and for the control of organisms that cause damage to
                                                                   natural or manufactured products ;
Whereas, in 1989, at the time of the adoption of the               Whereas the Commission review showed a diverse regu­
eighth       Amendment (l)       to    Council     Directive       latory status in the Member States ; whereas there are
76/769/EEC (2) on the marketing and use of certain                 rules in a few of the Member States governing the
dangerous substances and preparations, the Council                 placing on the market for use of biocidal products and
invited the Commission to develop specific measures for            whereas these rules differ as to the conditions for such
Community action in the field of non-agricultural                  placing on the market and whereas such differences may
pesticides ;                                                       constitute not only barriers to trade in biocidal products
                                                                   but also to trade in products treated with them, thereby
                                                                   affecting the functioning of the internal market;
Whereas during the discussion in the Council on
Directive 91 /414/EEC (3), the Council expressed
concern at the lack of harmonized Community                        Whereas in consequence the Commission concluded
provisions for non-agricultural pesticides and invited the         there was a need for action at Community level to
                                                                   eliminate such barriers by harmonizing the rules relating
(') OJ No L 398 , 30. 12. 1989, p. 19.                             to the placing on the market for use of biocidal products,
O OJ No L 262, 27 . 9. 1976, p. 201 .                              taking as a condition a high level of protection for man
(3) OJ No L 230, 19. 8 . 1991 , p. 1 .                             and the environment ;
 ---pagebreak--- No C 239 / 4                          Official Journal of the European Communities                                   3 . 9 . 93
Whereas therefore, the Commission made a statement              Whereas in the light of the diversity of both the
towards the Council proposing the development of a              substances and products concerned, the test requirements
framework of rules ; whereas, having regard to the              should allow for some flexibility to suit the individual
principle of subsidiarity, decisions taken at Community         circumstances and should result in an overall risk
level should be restricted to those necessary for the            assessment ;
proper functioning of the common market and to avoid
duplication of work by Member States taking into
account the necessity to ensure a high degree of                Whereas it is in the interest of free circulation of biocidal
protection for man and the environment throughout the            products as well as of goods treated with them, that
Community and whereas a directive on biocidal products           authorization granted by one Member State, and tests
(non-agricultural pesticides) is the most appropriate way        carried out with a view to authorization, should be
of establishing such a framework;                                recognized by other Member States ;
                                                                Whereas it is therefore desirable that a system for the
Whereas such rules should provide that biocidal products         mutual exchange of information should be established
should not be placed on the market for use unless they           and that Member States and the Commission should
have been officially authorized ;                                make available to each other on request the particulars
                                                                 and scientific documentation submitted in connection
                                                                 with applications for authorization of biocidal products ;
Whereas such official authorization is appropriate as
biocidal products consist mostly of dangerous substances
and are preparations designed to have detrimental effects       Whereas, Member States must be able to authorize
on the organisms they are intended to control ; whereas          biocidal products not complying with the abovemen­
biocidal products may have consequences other than the           tioned conditions for a limited period of time, especially
intended effects on the target species, they were designed       in case of an unforeseen danger threatening man or the
for and whereas, therefore, they may especially involve          environment which cannot be contained by other means ;
risks for man and the environment;                               whereas such authorization should be reviewed by the
                                                                 Commission in close cooperation with the Member
                                                                 States ; whereas the Community procedure should not
Whereas it is appropriate that an applicant should submit        prevent Member States from authorizing for use in their
dossiers and whereas it is further appropriate that the          territory for a limited period of time biocidal products
dossiers shall contain only that information which is            containing an active substance not yet entered in the
necessary to evaluate the risks that will arise from             Community list, provided that a dossier meeting
proposed uses of the product;                                    Community requirements has been submitted and the
                                                                 Member State believes that the active substance and the
                                                                 biocidal products satisfy the Community conditions set in
Whereas it is necessary, at the time when biocidal               regard to them ;
products are authorized, to make sure that, when
properly used for the purpose intended, they are suffi­
ciently effective and have no unacceptable effect on their       Whereas active substances used in biocidal products may
target species (i.e. they do not cause undesirable               also be used in other preparations which have under
resistance   and   in  the  case   of vertebrate    animals      other Community legislation, been tested on animals ;
unnecessary suffering), and have in the light of current         whereas double testing on animals must be avoided ;
scientific and technical knowledge no unacceptable               whereas, close coordination should be ensured with
adverse influence on the environment and, in particular,         other Community legislation and in particular with
no harmful effect on human or animal health ;                    Directive 91 /414/EEC on the placing on the market of
                                                                 plant protection products ;
Whereas authorization should be limited to biocidal
                                                                 Whereas, in order to ensure that the requirements laid
products containing certain active substances evaluated          down in respect of authorized biocidal products are
on the basis of their physicochemical, toxicological and         satisfied when they are placed on the market, Member
ecotoxicological properties ;                                    States must make provision for appropriate control and
                                                                 inspection arrangements ;
Whereas it is necessary to establish a Community list of
active substances permitted for inclusion in biocidal            Whereas the implementation of this Directive, the adap­
products ; whereas a Community procedure must be laid            tation of its Annexes to the development of technical and
down for assessing whether or not an active substance            scientific knowledge, and the registration of
can be entered in the Community list; whereas the infor­         Community-approved active substances necessitate close
mation that interested parties must submit with a view to        cooperation between the Commission and the Member
admission of a substance to the list has to be specified ;       States and the applicant; whereas the procedure of the
whereas, in the interest of safety, substances on the list       Standing Committee on Biocidal Products offers a
should be reviewed periodically, to take account of              suitable basis for this cooperation ; whereas this entails
developments in science and technology;                          transparency of the administrative procedures ;
                                                                    /
 ---pagebreak--- 3 . 9. 93                              Official Journal of the European Communities                                No C 239 / 5
Whereas the full implementation of this Directive and                 law, regulation or administrative action relating to
especially of Article 14 (4) will not be achieved for                 proprietary medicinal products (2) ;
several years, Directive 76/769/EEC on the approxi­
mation of the laws, regulations and administrative               (b) Council          Directives         70/524/EEC (J)   and
provisions of the Member States relating to restrictions              82/47 1 /EEC (4) on additives and substances for
on the marketing and use of certain dangerous                         exclusive use in animal feedingstuffs ;
substances and preparations can provide for a framework
to complement the development of the positive list by            (c) Council Directive 76/768 /EEC (5) on cosmetic
limitations of the marketing and use of certain active                products ;
substances and products or groups of these ;
                                                                 (d) Council Directive 89/ 107/EEC of 21 December
Whereas the Council in its resolution of 1 February                   1988 on substances used exclusively as additives to
 1993 (') on a Community programme of policy and                      foodstuffs (6) and Council Directive 88 /388 /EEC of
action in relation to the environment and sustainable                 22 June 1988 on substances used exclusively as
development has approved the general approach and                     flavourings in foodstuffs (7);
strategy of the programme presented by the Commission                                                            i
which states that economic growth and environmental              (e) Council Directive 91 /414/EEC of 15 July 1991
quality must be viewed as mutually dependant; whereas                 concerning the placing of plant protection products
therefore the strengthening of environmental protection               on the market (8) ;
requires the maintenance of the economic competi­
tiveness of industry;                                            (f) Council Directive .../.. ./EEC concerning medical
                                                                      devices .
Whereas the review of active substances shall need to
take account of other work programmes within the                 3. This Directive shall apply without prejudice to the
framework of other Community legislations concerned              provisions of:
with the review or authorization of substances and
products ;                                                       (a) Council Directive 76/769/EEC of 27 July 1976 on
                                                                      the approximation of the laws, regulations and
Whereas minimum rules concerning the use of biocidal­                 administrative provisions of the Member States
products at work are already laid down under directives               relating to restrictions on the marketing and use of
on health and safety at work : whereas it is desirable to             certain dangerous substances and preparations ;
develop further these rules ;
                                                                 (b) Council Directive 79/ 117/EEC of 21 December
                                                                      1978 prohibiting the placing on the market and use
HAS ADOPTED THIS DIRECTIVE :
                                                                      of plant protection products containing certain active
                                                                      substances (') ;
                           Article 1                             (c) Council Regulation (EEC) No 1734/88 of 16 June
                                                                      1988 on the export from and import into the
                    Scope of applicability                            Community of certain dangerous chemicals (10) ;
1.     This Directive concerns                                   (d) Council Directive 80/ 1107/EEC of 27 November
                                                                      1980 on the protection of workers against dangers
(a) the authorization and the placing on the market for               from exposure to chemical, physical and biological
      use of biocidal products within the Member States ;             agents at work ("), and Council Directive
                                                                      89/391 /EEC of 12 July 1989 on the introduction of
(b) the mutual acceptance of authorizations within the                measures to encourage improvements in the safety
      Community ;                                                     and health of workers at work (12) and individual
                                                                      Directives based on these Directives ;
(c) the establishment at Community level of a positive
     list of active substances which may be used in
     biocidal products .
                                                                  O   OJ  No  22 , 9. 2 . 1965 , p. 369/65 .
                                                                  O   OJ  No  L  270, 14. 12. 1970, p. 1 .
2. This Directive shall apply to biocidal products as             O   OJ  No  L  213, 21 . 7. 1982, p. 8 .
defined in Article 2 ( 1 ) (a) but shall exclude products         O   OJ  No  L  262, 27. 9. 1976, p. 169
where they are covered by the following Directives for            (6) OJ  No  L  40, 12. 2. 1989, p. 27.
the purposes of these Directives :
                         r
                                                                  O   OJ  No  L  184, 15. 7. 1988, p. 61 .
                                                                  (•) OJ  No  L  230, 19. 8 . 1991 , p. 1 .
(a) Council Directive 65/65/EEC of 26 January 1965                O   OJ  No  L  33, 8 . 2. 1979, p. 36.
     on the approximation of provisions laid down by             (10) OJ No   L  155, 22. 6. 1988 , p. 2.
                                                                 (")  OJ  No  L  327, 3. 12. 1980, p. 8 .
O OJ No C 138 , 17. 5 . 1993, p. 1 .                             (")  OJ  No  L  183, 29. 6. 1989, p. 1 .
 ---pagebreak--- No C 239 /6                             Official Journal of the European Communities                                   3 . 9 . 93
(e) Council Directive 90/679/EEC of 26 November                   2.     For the purposes of this Directive the definitions
     1990 on the protection of workers from risks related         for
     to exposure to biological agents at work (seventh
     individual Directive within the meaning of Article 16        (a) substances ;
     ( 1 ) of Directive 89/391 /EEC) (').
                                                                  (b) preparations ;
4. Article 1 8 does not apply to the carriage of biocidal         (c) scientific research and development;
products by rail, road, inland waterway, sea or air.              (d) process-orientated research and development
                                                                  laid down in Article 2 of Directive 67 / 548 /EEC on the
                            Article 2
                                                                  classification, packaging and labelling of dangerous
                           Definitions                            substances (2) shall apply.
1 . For the purposes of this Directive the following                                        Article 3
definitions shall apply :
                             V
                                                                  Authorization for placing on the market of biocidal
(a) biocidal products :                                                                     products
     active substances and preparations containing one or
     more active substances, put up in the form in which           1 . Member States shall prescribe that a biocidal
     they are supplied to the user, intended to destroy,          product shall not be placed on the market and used in
     deter, render harmless, prevent the action of, or            their territory unless it has been authorized in
                                                                  accordance with this Directive .
     otherwise exert a controlling effect on any harmful
     organism.
                                                                  2, Every application for authorization shall be decided
    An indicative list of product types is at Annex V;            upon within a resonable period.
(b) active substances
     substances, fungi and micro-organisms including
                                                                  3.    A biocidal product that has already been authorized
                                                                  in one Member State shall be authorized, in another
    viruses having general or specific action on or               Member State within 60 days of an application being
     against harmful organisms ;                                  received by the other Member State, providing that the
(c) harmful organism                                              active substance of the biocidal product conforms to the
                                                                  entry in Annex I.
     any organism which has an unwanted presence or a
     detrimental effect for man, his activities or the
    products he uses or produces, or for animals or for           4.    If in complying with Article 4 a Member State
    the environment;                                              establishes that :
(d) placing on the market                                         (a) unacceptable resistance of the target organism to the
                                                                       biocidal product is proven or
    any supply, whether in return for payment or free of
    charge, other than for storage followed by                    (b) the relevant circumstances of use, such as climate or
    consignment from the territory of the Community or                 breeding period of the target species, differ signifi­
    disposal. Importation of a biocidal product into the               cantly from those in the Member State where the
    territory of the Community shall be deemed to                      biocidal product was first authorized, and an
    constitute placing on the market for the purposes of               unchanged authorization may therefore present
    this Directive ;                                                   unacceptable risks to man or the environment,
(e) authorization                                                 the Member State may request that the directions for use
    administrative act by which the competent authority           and the dose rate referred to in Article 1 8 (3) (e) are
    of a Member State authorizes, following an                    adjusted to the different circumstances, or, if the risk can
    application submitted by an applicant, the placing on         not be prevented in any other way, the Member State
    the market of a biocidal product in its territory or in       may request changes to be made to the biocidal product
                                                                  itself so that conditions for issue of an authorization
    a part thereof;
                                                                  provided for in Article 4 are satisfied.
(f) residues
    One or more of the substances present in a biocidal           5. Notwithstanding paragraph 4 where a Member
    product which remains as a result of its use including        State believes a biocidal product cannot meet the
    the metabolites of such substances and products               conditions set out under Article 4 and consequently
    resulting from their degradation or reaction.                 proposes to refuse authorization, it shall notify the
                                                                  Commission, other Member States and the applicant and
(') OJ No L 374, 31 . 12. 1990, p. 1 .                            ( ) OJ No L 196, 16. 8 . 1967, p. 1 (as amended).
 ---pagebreak--- 3 . 9 . 93                              Official Journal of the European Communities                                No C 239/7
shall provide them with an explanatory document giving                   — the consequences from use and disposal,
details of the product and setting out the grounds on
which it proposes to refuse the authorization.                           the biocidal product :
                                                                           (i) is sufficiently effective ;
The Commission shall prepare a proposal on these
matters in accordance with Article 24 for decision in                     (ii) has no unacceptable effect on the target
accordance with the procedure laid down in Article 25                          organism ;
(3­
                                                                         (iii) has no harmful effects itself or as a result of its
                                                                               residues, on human or animal health, directly or
6. Member States shall prescribe that biocidal                                 indirectly (e.g. through drinking water, food or
products shall be classified, packaged and labelled in                         feed) or on groundwater;
accordance with the provisions of this Directive.
                                                                         (iv) has no unacceptable effects on the environment
                                                                               having particular regard to the following
                                                                               considerations :
7. Authorizations shall be granted for a fixed period
of 10 years from the date of first entry of the active
substance onto Annex I ; they may be renewed after veri­                       — its fate and distribution in the environment ;
fication that the conditions imposed in paragraphs 1 and                           particularly      contamination   of water
2 are still satisfied. Renewal may, where necessary, be                            including drinking water and groundwater,
granted only for the period necessary to allow the                             — its impact on non-target organisms ;
competent authorities of the Member States, to make
such verification, where an application for renewal has                   (v) does not cause unnecessary suffering and pain
been made.
                                                                               to vertebrates to be controlled ;
8 . Member States shall prescribe that biocidal product            (c) the nature and quantity of its active substances and,
must be properly used. Proper use shall include                          where appropriate, any toxicologically or ecotoxico­
compliance with conditions established under Article 4                   logically significant impurities and co-formulants,
and specified under the labelling provisions of this                     and its residues of toxicological or environmental
Directive. Proper use shall also involve the rational                    significance, which result from authorized uses, can
application of a combination of physical, biological,                    be dermined according to the relevant requirements
chemical or other measures as appropriate whereby the                    in Annexes II, III and IV ;
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               (d) its physical and chemical properties have been
directives for the protection of workers.                                dertermined and deemed acceptable for purposes of
                                                                         the appropriate use, storage and transport of the
                                                                         product.
                            A rticle 4
            Conditions for issue of an authorization               2. A biocidal product classified according to Article 1 8
                                                                   ( 1 ) as very toxic or as a category 1 or 2 qarcinogen, or
                                                                   mutagen or classified as toxic for reproduction category
 1 . Member States shall authorize a biocidal product              1 or 2, shall not be authorized for marketing to, or use
only if                                                            by the general public.
(a) the active substance(s) included therein are listed in
       Annex I and any conditions laid down in the Annex           3. Authorization may be conditional on requirements
       are fulfilled ;                                             relating to marketing and use necessary to ensure
                                                                   compliance with the provisions of paragraph 1 .
(b) it is established, in the light of current scientific and                        t
       technical knowledge and it is shown from appraisal
       of the dossier provided for in Annex III and, where         4. Where other Community provisions impose
       specified, the relevant parts of Annex IV according         requirements relevant to the conditions for the issue of
       to the common principles for the evaluation of              an authorization and particularly where these are
       dossiers, that when used as authorized and having           intended to protect the health of distributors, users,
       regard to :                                                 workers and consumers or animal health of distributors,
                                                                   users, workers and consumers or animal health or the
       — all normal conditions under which the biocidal            environment, the competent authority shall take these
           product may be used,                                    into account when issuing an authorization and where
                                                                   necessary shall issue the authorization subject to those
       — how the material treated with it may be used,             requirements.
 ---pagebreak--- No C 239/ 8                           Official Journal of the European Communities                                   3 . 9 . 93
                         Article 5                              the proposed changes, in accordance with the procedures
                                                                laid down in Article 10 .
                Review of an authorization
Authorization may be reviewed at any time if there are           8.     Modification shall only be granted if it is estab­
indications that any of the requirements referred to in         lished that the conditions under Article 4 continue to be
Article 4 are no longer satisfied. In such instances the        satisfied .
Member States may require the applicant for authori­
zation or the applicant to whom a modification of auth­
orization has been granted in accordance with Article 6                                     Article 7
to submit further information necessary for the review.
Renewal may, where necessary, be granted only for the                            Requirements for authorization
period necessary to complete a review, and shall be
granted for the period necessary to provide such further
information .                                                    1 . Application for authorization shall be made by or
                                                                on behalf of the person who will be responsible for the
                                                                first placing on the marktet of a biocidal product in a
                         Article 6                              particular Member State and shall be to the competent
                                                                authority of that Member State. Every applicant shall be
     Cancellation or modification of an authorization
                                                                required to have a permanent office within the
                                                                Community.
 1.   An authorization shall be cancelled if :
(a) the active substance is no longer included in An­           2. Member States shall require that applicants for
     nex I ;                                                    authorization of a biocidal product shall submit to the
(b) the conditions under Article 4 ( 1 ) for obtaining the      competent authority:
     authorization are no longer satisfied ;
                                                                (a) a dossier on the biocidal product satisfying, in the
(c) it is discovered that false or misleading particulars             light of current scientific and technical knowledge,
    were supplied concerning the facts on the basis of                the requirements set out in Annex III and, where
    which the authorization was granted.                              specified, the relevant parts of Annex IX; and
                                                                               I
2 . An authorization may also be cancelled if the auth­         (b) for each active substance in the biocidal product, a
orization holder requests it and states the reasons for the
                                                                      dossier satisfying, in the light of current scientific
cancellation.                                                         and technical knowledge, the requirements set out in
                                                                      Annex II and, where specified, the relevant parts of
                                                                      Annex IV.
3.    Where a Member State cancels an authorization, it
shall inform the authorization holder and it may grant a
period of grace for the disposal or for storage, marketing      3.      The dossiers shall include a detailed and full
and use of existing stocks, of a length in accordance with      decription of the studies conducted and of the methods
the reason for the cancellation without prejudice to any        used or a bibliographical reference to those methods.
period provided for by decision taken under Directive           The information in the dossiers supplied according to
76/769/EEC or in connection with paragraph 1 (a).               Article 7 (2) shall be sufficient for an evaluation to be
                                                                made of the effects and properties referred to in Article 4
4.    An authorization shall be modified if, on the basis
                                                                ( 1 ) (b), (c) and (d). It shall be submitted to the
of developments in scientific and technical knowledge,          competent authority in the form of technical dossiers,
the conditions of use and, in particular, manner of use or      containing the information and results of the studies
amounts used can be modified .
                                                                referred to in Annex II and Annex III and, where
                                                                specified, the relevant parts of Annex IV.
5. An authorization may also be modified if the auth­
orization holder requests it and states the reasons for the     4. Information, which is not necessary owing to the
modification .                                                  nature of the biocidal product or of its proposed uses
                                                                need not be supplied. The same applies where it is not
6.    Where a proposed modification concerns an                 scientifically necessary or technically possible to supply
extention of uses, Member States shall extend the auth­         the information. In such cases, a justification, acceptable
orization subject to the particular conditions placed on        to the competent authority must be submitted.
the active substance in Annex I.
                                                                5.      If the evaluation of the dossier shows that further
7. Where a proposed modification of an authorization            information including information and results from
involves changes to the particular conditions placed on         further testing is necessary to evaluate the risks of the
the active substance in Annex I, these can be made only         biocidal product, the competent authority shall ask the
after evaluation of the active substance, with regard to        applicant to submit such information.
 ---pagebreak--- 3 . 9. 93                               Official Journal of the European Communities                               No C 239/9
6. The name of an active substance must be given as                     a dossier has been forwarded to a Member State,
registered in the list contained in Annex I to Directive                which satisfies the requirements of Article 10 ( 1 ),
67/548 /EEC or, if not included therein, as given in the                and is accompanied by the declaration that the active
European Inventory of Existing Chemical Substances                      substance is intended for inclusion in a biocidal
(Einecs) (x), or if not included therein, it must be given              product. This shall not apply to substances for use
its International Standards Organization (ISO) common                   under Article 1 5 ;
name . If the latter is not available, the substance must be
designated by its chemical designation according to               (b) it is classified, packaged and labelled in accordance
IUPAC rules .                                                           with the provisions of Directive 67/548 /EEC.
                                                                                               Article 9
7.     Tests must be conducted according to the methods
described in Annex V of Directive 67 / 548 / EEC . In the                  Inclusion of an active substance in Annex I
event of a method being inappropriate or not descirbed,
other methods used should, whenever possible, be inter­            1 . In the light of current sientific and technical
nationally recognized and must be justified. Tests must           knowledge, an active substance shall be included in
be conducted in accordance with the provisions laid               Annex I for an initial period not exceeding 10 years if it
down in Directive 86/609/EEC on the protection of                 may be expected that biocidal products containing the
animals used for experimental and other scientific                acitve substance will fulfil the conditions laid down in
purposes and Council Directive 87/ 18 /ECC (2) of 18              Article 4 ( 1 ) (b), (c) and (d).
December 1986 on the harmonization of laws, regu­
lations and administrative provisions for the application
of the principles of Good Laboratory Practice and the             2.      Inclusion of an active substance in Annex I shall,
verification of their applications for tests on chemical          where appropriate, be subject to the following :
substances .
                                                                    (i) requirements on :
8 . Competent authorities as referred to under Article                  (a) the minimum degree of purity of the active
23 shall ensure that a file is complied on each                              substance ;
application. Each file shall contain at least a copy of the
application, a record of the administrative decisions                   (b) the nature and maximum content of certain
taken by the Member State concerning the application                         impurities ;
and concerning the dossiers submitted in accordance
with paragraph 2 together with a summary of the latter.                 (c) product type in which it may be used ;
Member States shall on request make available to the
                                                                        (d) manner of use ;
other competent authorities and to the Commission the
files provided for in this paragraph ; they shall supply to             (e) designation of categories of users (e.g. industrial,
them on request all information necessary for full                           professional or non-professional) ;
comprehension of applications, and shall where
requested ensure that applicants provide a copy of the                  (f) other particular conditions from the evaluation
technical documentation laid down in Article 7 .
                                                                             of the information referred to in Article 10 (2) ;
                                                                  (ii) the establishment of the following :
9.     Member States may require that samples of the
preparation and of its ingredients be provided.                         (a) a suitable standard of user protection ;
                                                                        (b) where relevant, an acceptable daily intake for
                                                                             man (ADI);
                           Article 8
                                                                        (c) fate and behaviour in the environment and
         Placing on the market of active substances
                                                                             impact on non-target organisms.
                                    i
Member States shall prescribe that where a substance is           3.     The inclsusion in Annex I of an active substance
an active substance for use in biocidal products it may           shall be restricted to those product types in Annex V for
not be placed on the market for such use unless                   which       acceptable    data   have  been    submitted      in
                                r
                                                             i
                                                                  accordance with Article 7 .
(a) where the active substance was not on the market
     before the date of entry into force of this Directive,       4 . The inclusion of a substance in Annex I may be
                                                                  renewed on one or more occasions for periods not
(') OJ No C 146, 15 . 6. 1990, p. 1 ;                             exceeding 10 years. The initial inclusion as well as any
O OJ No L 15, 17. 1 . 1987, p. 29.                                renewed inclusion may be reviewed at any time if there
 ---pagebreak--- No C 239 / 10                         Official Journal of the European Communities                                    3 . 9 . 93
are indications that any of the requirements referred to        recommendation for the inclusion, or otherwise, of the
in paragraph 1 are no longer satisfied. Renewal may,            active substance in Annex I.
where necessary, be granted only for the period
necessary to complete a review, where an application has        If during the evaluation of the dossiers it appears that
been made for such renewal and shall be granted for the         further information is necessary for full evaluation to be
period necessary to provide information requested in            made, the receiving competent authority shall ask that
accordance with Article 10 (2).                                 the applicant submit such information. The six-month
                                                                period shall be suspended from the date of issue of the
                                                                competent authority's request until the date the infor­
5.    The inclusion of an active substance in Annex I           mation is received. The competent authority shall inform
may be refused or reviewed, if there is another active          the other Member States and the Commission of its
substance on Annex I for the same product type, or              action at the same time as it informs the applicant.
another method of control exists, which in the light of
scientific or technical knowledge present significantly less    3 . On receipt of the evaluation, the Commission shall,
risk to health or to the environment. When considering          in accordance with in Article 24, prepare a proposal
such a refusal, an evaluation of the alternative active
                                                                without undue delay for decision in accordance with the
substances or methods shall be produced in accordance           procedures laid down in Article 25 (3). The decision
with common principles for the evaluation of dossiers, to       shall be taken at the latest 15 months after the receipt by
demonstrate they can be used with the same effect on the        the    Commission      of the     evaluation referred   to    in
target organism without significant economic and                paragraph 2 .
practical disadvantages to the user. The evaluation shall
be circulated in accordance with the procedures in
Article 10 (2) for decision in accordance with the                                          Article 11
procedures laid down in Articles 24 and 25 (3).
                                                                Use of data held by competent authorities for other
                                                                                            applicants
                          Article 10
                                                                 1.    Member States shall not make use of the infor­
Procedure for inclusion of an active substance in Annex I       mation referred to in Annex II and the relevant parts of
                                                                Annex IV for the benefit of a second or subsequent
                                                                applicant :
 1.   An active substance will be considered for inclusion
in Annex I, and any changes to Annex I will be                  (a) unless the second or subsequent applicant has the
considered when :                                                   written agreement of the first applicant that use may
                                                                     be made of such information ; or
(a) an applicant has forwarded to the competent                 (b) in the case of an active substance not on the market
    authority of one of the Member States :                         on the date of coming into force of this Directive,
                                                                    for a period of 15 years from the date of first
                                                                    inclusion in Annex I ; or
     (i) a dossier for the active substance satisfying the
         requirements of Annex II and, where specified,         (c) in the case of an active substance already on the
         the relevant parts of Annex IV ;                           market on the date of coming into force of this
                                                                    Directive ;
    (ii) a dossier for at least one biocidal product
         containing the active substances satisfying the              (i) for a period of 10 years from the date of coming
         requirements of Annex III an, where specified,                   into force of this Directive for any information
         the relevant parts of Annex IV ;                                 submitted for the purposes of this Directive
                                                                          except where such information is already
                                                                          protected under existing national rules relating
(b) the receiving competent authority has checked the                     to biocidal products. In such cases the infor­
    dossiers and believes them to satisfy the requirements                mation shall continue to be protected in that
    of Annex II and Annex III and where relevant Annex                    Member State until the expiry of any remaining
    IV, accepts them and agrees to the applicant                          period of data protection provided for under
    forwarding a summary of the dossiers to the                           national rules, up to a maximum of 10 years
    Commission and the other Member States .                              from the date or coming into force of this
                                                                          Directive ;
                                                                     (ii) for a period of 10 years from the date of entry
2. The receiving competent authority shall, within six                    of an active substance onto Annex I for infor­
months of accepting the dossiers carry out an evaluation                  mation submitted for the first time in support of
thereof. A copy of the evaluation shall be sent by the                    the first inclusion in Annex I of either the active
competent authority to the Commission, the other                          substance or an additional product type for that
Member States and to the applicant, together with a                       active substance ;
 ---pagebreak--- 3 . 9 . 93                                Official Journal of the European Communities                               No C 239 / 11
(d) in the case of any further information submitted for            (d) in the case of any data submitted for the first time
       the first time for any of the following :                          for either of the following :
        (i) variation of the conditions of the entry on An­                (i) variation of the conditions of authorization of a
            nex I ;                                                            biocidal product;
       (ii) maintenance of the entry on Annex I                           (ii) submission of data necessary to maintain entry
                                                                               of an active substance onto Annex I :
            for a period of five years from the date of
            decision following receipt of further information                  for a period of five years from the date of first
            unless the five-year period expires before the                     receipt of further information unless the
            period provided for in paragraph 1 (b) and (c),                    five-year period expires before the period in
            in which case the period of five years shall be                    paragraph 2 (b) and (c) above in which case the
            extended so as to expire on the same data as                       period of five years shall be extended so as to
            those periods.                                                     expire on the same date as those periods.
            Where an active substance is included in Annex I
            of this Directive and also in Annex I of Directive
                                                                    Where a biocidal product contains an active substance
                                                                    which is included in Annex I of this Directive and also in
            91 / 414/EEC, the information referred to in
                                                                    Annex I of Directive 91 /414/EEC, the information
            Annex II and relevant parts of Annex IV, which          referred to in Annex III and relevant parts of Annex IV,
            is required under both Directives and has been          which is required under both Directives and has been
            provided under both Directives, shall benefit           provided under both Directives, shall benefit only from
            only from the periods of data protection                the periods of data protection provided for under
            provided for under Directive 91 /414/EEC.                Directive 91 /414 /EEC .
2.       Member States shall not make use of the infor­
                                                                                                 Article 12
mation referred to in Annex III and the relevant parts of
Annex IV, for the benefit of a second or subsequent                     Second and subsequent applications for authorization
applicant :
(a) unless the ( second or subsequent applicant has the              1.     In the case of a biocidal product which has already
                                                                    been authorized in accordance with Articles 3 and 4 , and
       written agreement of the first applicant that use may
       be made of such information ; or                             without prejudice to the obligations imposed under
                                                                    Article 11 , the competent authority may agree that a
                                                                    second or subsequent applicant for authorization may
(b) in the case of a biocidal product containing an active          refer to data provided by the first applicant insofar as the
       substance not on the market on the date of coming            second or subsequent applicant can provide evidence that
       into force of this Directive ; for a period of 10 years      the biocidal product and its active substances is the same
       from the date of first authorization in any Member           as the one previously authorized, including degree of
       State ; or                                                   purity and nature of impurities.
(c) in the case of a biocidal product containing an active
       substance already on the market on the date of               2.      Notwithstanding Article 7 (2) where the active
       coming into force of this Directive ;                        substance is listed in Annex I :
                                i
        (i) for a period of 10 years from the date of coming         (a) applicants for authorization of biocidal products
            into force of this Directive for any information              shall, before carrying out experiments involving
            submitted for the purposes of this Directive,                 vertebrate animals, enquire of the competent
            except in the case where data are already                     authority of the Member State to which they intend
            protected according to existing national rules                making application :
            relating to biocidal products, in which case such
            data shall be protected in that Member State                  — whether the biocidal product for which an
            until the expiry of any remaining period of data                   application is to be made is the same as a biocidal
            protection provided for under those national                       product for which authorization has been
            rules, up to a maximum of 10 years from the                        granted, and
            date of coming into force of this Directive ;
                                             r
                                                                          — as to the name and address of the holder or
       (ii) for a period of 10 years from the date of entry                    holders of the authorization or authorizations .
            of an active substance onto Annex I, for infor­
            mation which is submitted for the first time in               The enquiry shall be supported by evidence that the
            support of the inclusion in Annex I either of the             prospective applicant intends to apply for auth­
            active substance or of an additional product type             orization on his own behalf and that the other infor­
            for that active substance ;                                   mation specified in Article 7 (2) is available ;
 ---pagebreak--- No C 239/ 12                          Official Journal of the European Communities                                       3 . 9. 93
(b) the competent authority of the Member State, if             mation they receive concerning potentially harmful
    satisfied that the applicant intends to apply, shall        effects for man or the environment of a biocidal product,
    provide the name and address of the holder or               its active substances, impurities, co-formulants or
    holders of previous relevant authorizations and shall       residues .
    at the time inform the holders of the authorizations
    of the name und address of the applicant.
                                                                                            Article 14
    The holder or holders of previous authorizations and        Transitional      measures and derogations            from     the
    the applicant shall take all reasonable steps to reach                               requirements
    agreement on the sharing of information so as to
    avoid the duplication of testing on vertebrate
    animals .                                                    1 . By way of derogation from Article 3 and 4, a
                                                                Member State may authorize temporarily for a period
                                                                not exceeding 1 20 days the placing on the market of
    Where data is requested with a view to inclusion in         biocidal products not complying with the provisions of
    Annex I of an active substance already on the market        this Directive for a limited and controlled use if such a
    on the date of entry into force of this Directive, the      measure appears necessary because of an unforseen
    competent authorities of the Member States shall            danger which cannot be contained by other means. In
    encourage data holders to cooperate in the provision        this case, the Member State concerned shall immediately
    of the requested data, with a view to limiting the          inform the other Member States and the Commission of
    duplication of testing on vertebrate animals.               its action and the justification for it. The Commission
                                                                 shall make a proposal and it shall be decided without
    If the applicant and holders of previous author­            delay, in accordance with the procedure laid down in
    izations of the same product can still not reach an         Article 25 , whether and under which conditions the
    agreement on the sharing of data, Member States              action taken by the Member State may be extended for a
    may introduce national measures obliging the                period to be determined, be repeated, or be revoked.
                                                                                    I
    applicant and holders of previous authorizations                                           >       •
    located within their territory to share the data with a                                  I
    view to avoiding duplicative testing on vertebrate           2.     By way of derogation from Article 4 ( 1 ) (a) and
    animals and determine both the procedure for                until an active substance is listed in Annex I a Member
    utilizing information, and the reasonable balance of         State may authorize provisionally, for a period not
    the interests of the parties concerned.                      exceeeding three years, the placing on the market of a
                                                                biocidal product containing an active substance not listed
                                                                in Annex I and not yet available on the market on the
                                                                 date of coming into force of this Directive. Such an
                          Article 13                             authorization may only be issued if, after evaluation of
                                                                 dossiers in accordance with the Article 10 the Member
                      New infor ation                            State believes that :
                                                                                  \
                                                                — the active substance satisfies the requirements of
                                                                      Article 9 and,
1 . Member States shall prescribe that the holder of an
authorization for a biocidal product shall immediately          — the biocidal product may be expected to satisfy the
notify the competent authority of information which                   conditions of Article d ( 1 ) (b), (c) and (d),
they may reasonably be expected to be aware concerning
an active substance or a biocidal product containing it                                          »
and which may affect continuing authorization. In                and no other Member State, on the basis of the summary
particular the following shall be notified :                     it receives, makes legitimate objection in accordance with
                                                                 Article 16 (2) to the completeness of the dossiers. Where
— new knowledge or information on the effects of the             an objection is made a decision on the completeness of
    active substance or biocidal product for man or the          dossiers shall be taken in accordance with the procedures
    environment,                                                 laid down in Article 25 (3) without undue delay.
                                                                                                                       /
— changes in the source or composition of an active                                        <
                                                                 If following the procedures laid down in Article 24 and
    substance,                                                   25 (3), it is decided, that the active substance does not
                                                                 satisfy the requirements specified in Article 9, the
— changes in composition of a biocidal product.                  Member State shall ensure that the provisional author­
                                                                 ization is cancelled .
                                                                                                   i '
2. Member States shall immediately notify other                  In cases where evaluation of dossiers for the purposes of
Member States and the Commission of any such infor­              inclusion of an active substance in Annex I is not
 ---pagebreak--- 3 . 9. 93                             Official Journal of the European Communities                             No C 239/ 13
completed when the period of three years expires, the           (b), (c) and (d) on the basis of dossiers which address the
competent authority may further provisionally authorize         requirements in Annex II and III.
the product for a period i^ot exceeding one year,
providing there are good reasons to believe the active
substance will satisfy the requirements of Article 9.
Member States shall inform other Member States and the                                    Article 15
Commission of such action.
                                                                                 Research and development
3. By way of further derogation from Article 4 ( 1 ),            ( 1)    Member States shall prescribe that any experiment
Article 7 (2) and Article 7 (3) and without prejudice to        or test for the purposes of research or development
paragraph 4 and paragraph 6, a Member State may, for            involving placing on the market of an unauthorized
a period of 10 years from the date of entry into force of       biocidal product or an active substance intended exclu­
this Directive, authorize the placing on the market in its      sively for use in a biocidal product shall not take place
territory of a biocidal product containing active               unless :
substances not listed in Annex I that are on the market
on the date of entry into force of this Directive.
                                                                 (a in the case of scientific research and development the
                                                                      persons concerned draw up and maintain written
                                                                      records detailing the identity of the product or
4. Following the adoption of this Directive, the                      substance, labelling data, quantities supplied and the
Commission shall commence a 10-year programme of                      names and addresses of those persons receiving the
work for the systematic examination of active substances              product or substance and compiles a dossier
not on Annex I. A regulation, adopted according to the                containing all available data on possible effects on
procedure laid down in Article 25 (2), will provide for all           human or animal health or impact on the
provisions necessary for the establishment and implemen­              environment. This information shall, as requested, be
tation of the programme. No later than two years before               made available to the competent authority;
completion of the work programme, the Commission
shall forward to the Council and the European
Parliament a report on the progress achieved with the            (b) in the case of process-orientated research and devel­
programme.
                                                                      opment the information required in (a) is notified to
                                                                      the competent authority where and before placing on
                                                                      the market occurs and to the competent authority of
                                                                      the Member State where the experiment or test is to
During this 10-year period, it may be decided under the               be conducted .
procedure laid down in Article 25 (3) that an active
substance shall be included in Annex I and under which
conditions, or, in cases where the requirements of Article
9 are not satisfied or the requisite information and data       2. Member States shall prescribe that an unauthorized
have not been submitted within the prescribed period,           biocidal product or an active substance for exclusive use
that such active substance shall not be included in An­         in a biocidal product may not be placed on the market
nex I.                                                          for the purpose of trials which may involve or result in
                                                                release into the environment unless the competent
                                                                authority has assessed the available data and issued an
                                                                 authorization for trials purposes which limits the quan­
Following a decision, the Member States shall ensure            tities to be used and the areas to be treated and may
that authorizations for biocidal products containing the         impose further conditions .
active substances are modified or cancelled as appro­
priate.
                                                                 3 . Where trials take place in a Member State other
                          review of an active substance it
                                                                 than the Member State where placing on the market
5.     Where following a                                         occurs, the applicant shall obtain trials authorization
is concluded that the substance does not meet the
                                                                 from the competent authority of the Member State in
requirements of Article 9 and consequently cannot be            whose territory the trials are to be conducted.
included in Annex I, the Commission shall bring forward
proposals for restricting the marketing and use of that
substance in accordance with Directive 76/769/ EEC .
                                                                 If the proposed experiments or tests referred to in
                                                                 paragraph 1 and 2 are liable to have harmful effects on
                                                                 human or animal health or to have an unacceptable
6.     When authorizing biocidal products containing an          adverse influence on the environment, the Member State
active substance to be reviewed in accordance with               concerned may either prohibit them or only permit them
paragraph 4 and before such review has taken place,              subject to such conditions as it considers necessary to
Member States shall apply the conditions in Article 4 ( 1)      prevent those consequences.
 ---pagebreak---   No C 239/ 14                           Official Journal of the European Communities                                    3. 9. 93
  4. Paragraph 2 shall not apply if the Member State                                         Article 17
  has granted the person concerned the right to undertake
  certain experiments and tests and has determined the                                    Confidentiality
  conditions under which the experiments and tests have to
  be undertaken .                                                   1.    Without     prejudice      to    Council    Directive
                                      i
                                                                   90 / 313 /EEC on the freedom of access to information on
                                                                   the environment O an applicant may indicate to the
  5 . Common conditions for the application of this                competent authority the information which he considers
  Article, in particular the maximum quantities of active          to be commercially sensitive and disclosure of which
  substances or biocidal products that may be released             might harm him industrially or commercially and which
  during experiments, and the minimum data to be                   he therefore wishes to be kept confidential from all
  submitted in accordance with paragraph 2, shall be               persons other than the competent authorities and the
  adopted in accordance with the procedure laid down in            Commission. Full justification will be required in each
  Article 25 (3).                                                  case .
                            A rticle 1 6                           (2)     The competent authority receiving the application
                                                                   shall decide which information shall be confidential
                      Information exchange
                                                                   within the terms of paragraph 1 .
   1 . Within a period of one month from the end of each
  quarter Member States shall inform each other and the            Information accepted as being confidential by the
  Commission of any biocidal products which have been              receiving competent authority shall be treated as being
  authorized within their territory or for which an authori­       confidential by the other competent authorities, Member
                                                                   States and the Commission.
  zation has been refused, modified, renewed or cancelled,
  indicating at least :
  (a) the name or business name of the holder of the auth­         3.     Confidentiality shall not in any case apply to :
       orization ;
                                                                   (a) the name of the applicant;
                                                          \
  (b) the trade name of the biocidal product ;
                                                                   (b) the name of the biocidal product manufacturer;
  (c) the name and amount of each active substance which
       it contains ;                                               (c) the name of the active substance manufacturer;
  (d) the product type and the use or uses for which it is         (d) the names and content of the active substances or
       authorized ;                                                     substances in the biological product and the name of
                                                                        the biocidal product;
  (e) the type of formulation ;
                                                                   (e) the name of other substances which are regarded as
  (f) any proposed limits on residues which have been                   dangerous under Directives 67/548 /EEC               and
       established ;                                                    contribute to the classification of the product;
  (g) limitations, conditions and requirements of the auth­        (f) physico-chemical data concering the active substance
       orization and where relevant, the reasons for the                and biocidal product;
       modification or cancellation of an authorization.
                                                                   (g) any ways of rendering the active substance or
                                                                        biocidal product harmless ;
  2. Where a Member State receives a summary of the
  dossiers in accordance with Article 10 ( 1 ) (b) and has         (h) a summary of the results of the tests required under
  legitimate reason to believe the dossiers are incomplete it           Article 7 to establish the substance's or product's
  shall immediately communicate its concerns to the                     efficacy and effects on humans, animals and the
  competent authority responsible for the evaluation of the             environment ;
  dossiers and shall immediately inform the Commission
  and other Member States of its concerns .                        (i) recommended methods and precautions to reduce
                                                                        dangers from handling, storage, transport and use as
                                                             0
                                                                        well as from fire or other hazards ;
  3. Each Member State shall draw up an annual list of
  the biocidal products authorized in its territory and shall      (j) methods of analysis referred to in Article 4 ( 1) (c) ;
  communicate that list to the other Member States and
  the Commission .
                                                                   (k) methods of disposal of the product and of its
                                                                        packaging ;
  4. In accordance with the procedure laid down in
  Article 25 (2) a standardized information system shall be
  set up to facilitate the application of paragraphs 1 and 2.      (') OJ No L 158, 23. 6. 1990, p. 56.
«
 ---pagebreak--- 3 . 9 . 93                                     Official Journal of the European Communities                            No C 239 / 15
                                                                                  '
(1) decontamination procedures to be followed in the                     (e) directions for use and the dose rate, expressed in
       case of accidental spillage or leakage ;                                metric units, for each use provided for under the
                                                                 t
                                                                               terms of the authorization ;
(m) first aid and medical treatment to be given in the
       case of injury to persons.                                         (f) particulars of likely or indirect adverse side effects
                                                                               and any directions for first aid;
If the applicant or manufacturer or importer of the
                                                                                                                                     i
biocidal product or active substance should later disclose                (g) if accompanied by a leaflet the sentence 'Read
previously confidential information, the competent                             attached instructions before use';
authority shall be informed accordingly.
                                                                          (h) directions for safe disposal of the biocidal product
                             i
                                                                               and its packaging; including where relevant any
4. The detailed provisions and format for making                              prohibition on re-use of packaging;
information publicly available shall be decided in
accordance with the procedures set out in Article 25 (2).
                                                                          (i) the formulation batch number or designation and the
                                                                               expiry date relevant to normal conditions of storage ;
                                 A rticle 1 8
                                                                         and where applicable :
            Classification, packaging and labelling of                          v
                          biocidal products                               (j) the interval to be observed between applications of
                                                                               the biocidal product or between application and the
1 . Biocidal products shall be classified according to                         next use of the product treated, or the next access by
                                                                               man or animals to the area where the biocidal
the provisions relating to classification in Directive
88/379/EEC on the classification, packaging and                                product has been used ;
labelling of dangerous preparations (1).
                                                                          (k) the categories of users to which the biocidal product
                                                                               is restricted ;
2.       Biocidal products shall be packaged according to
Article 6 of Directive 88 / 379/EEC . In addition :                       (1) information on any specific dangers to the
                      i
                                                                               environment particularly concerning protection of
(a) products which may be mistaken for food or drink                           non-target species and avoidance of contamination
       shall be packaged to minimize the likelihood of such                    of water.
       a mistake being made ;
(b) products available to the general public which may                    Member States shall require that items 3 (a), (b), (d) and
       be   mistaken     for      food    or  drink   shall  contain     where applicable (g) and (k) always be carried on the
       components to discourage their consumption.                       label of the product.
                                                    t
3. Biocidal products shall be labelled according to the                  Member States shall permit items 3 (c), (e), (f), (h), (i),
provisions of Directive 88/379/EEC concerning                             (j) and (1) to be carried elsewhere on the packaging or
labelling. In addition the label must show clearly and                   on an accompanying leaflet integral to the packaging.
indelibly the following :                                                These items of information shall be regarded as label
         I                                                                information for the purposes of this Directive.
(a) the identity of the active substance and its concen­
       tration in metric units ;
                                                                          4. By way of derogation from paragraphs 1 and 2 and
(b) the authorization number allocated to the biocidal                    the first sentence of paragraph 3, biocidal products auth­
       product by the competent authority;                                orized as insecticides, acaricides, rodenticides, avicides
                                                                          or molluscicides shall be classified packaged and labelled
                                                                          in accordance with Directive 78 /631 /EEC on the
(c) the type of preparation (e.g. liquid concentrates,                    approximation of the laws of the Member States relating
       granules, powders, solids, etc.);                                 to the classification, packaging and labelling of
                               «                                          dangerous preparations (pesticides) (*) insofar as there is
(d) the uses for which the biocidal product is authorized                no other Community provisions specifically covering
       (e.g. wood preservation, disinfection, surface biocide,           these matters for such products.
       anti-fouling, etc);
O OJ No L 187, 16. 7. 1988 , p. 14.                                       (l) OJ lyo L 206, 29. 7. 1978, p. 13.
 ---pagebreak--- s
  No C 239 / 16                          Official Journal of the European Communities                                   3 . 9 . 93
  5.     Where a biocidal product identified in paragraph 4                                Article 21
  is authorized under this Directive and is also subject to
                                                                                         Poison control
  classification, packaging and labelling according to
  Directive 78 /631 /EEC by virtue of other Community
  provisions, Member States shall permit changes to the            Member States shall appoint the body or bodies
  packaging and labelling of that product which may be             responsible for receiving information on biocidal
  required as a consequence of those provisions, insofar as        products which have been placed on the market,
  they do not conflict with the requirements of an                 including information on the chemical composition, of
  authorization issued under this Directive .                      such products, and for making such information
                                                                   available in cases where suspected poisoning arises from
                                                                   the use of biocidal products. Such information may only
  6. Member States may require the provision of                    be used to meet any medical demand by formulating
  samples, models or drafts of the packaging, labelling and        preventive and curative measures, in particular in emer­
  leaflets .                                                       gencies. Member States shall ensure that the information
                                                                   is not used for other purposes.
                             Article 19
                                                                   Member States shall take the necessary steps to ensure
                        Safety data sheets                         that the appointed bodies provide all the requisite guar­
                                                                   antees for maintaining the confidentiality of the infor­
                                                                   mation received. Member States shall ensure that the
  Member States shall ensure that a system of specific             appointed bodies shall have at their disposal all the infor­
  information (in safety-data-sheet form) is established to        mation required to carry out the tasks for which they are
  enable professional and industrial users of biocidal             responsible from the manufacturers or persons
  products to take the necessary measure for the                   responsible for marketing.
  protection of the environment and health safety at the
  workplace.                                                 v
                                                                   For biocidal products already on the market, Member
                                                       \
                                                                   States shall take measures to comply with this Directive
  For active substances used exclusively in biocidal               within three years from the adoption thereof.
  products safety data sheets shall be prepared in
  accordance with the requirements of Article 27 of
  Directive 67 / 548 / EEC .                                                               Article 22
                                                -
                                                                                 Compliance with requirements
  For biocidal products safety data sheets shall be prepared
  in accordance with Article 10 of Directive 88 / 379 /EEC .
                                                                   Member States shall make suitable arrangements for
                                                                   biocidal products which have been placed on the market
                                                                   to be officially monitored to establish whether they
                             Article 20                            comply with the requirements of this Directive.
                           Advertising
                                                                   Every three years after the entry into force of this
                                                                   Directive,   Member     States   shall  forward     to      the
  1 . Member States shall require that every adver­                Commission by the 30 November of the third year a
  tisement for a biocidal product is accompanied by the            report on their action in these matters together with
  sentences 'Use biocides safely. Always read the label and        information on any poisonings involving biocidal
  product information before use'.                                 products. The Commission shall within one year of
                                                                   receipt of this information prepare and publish a
        t
  The sentences shall be clearly distinguishable in relation       composite report.
  to the whole advertisement.
                                                                                           A rticle 23
  Member States shall prescribe that advertisers may
  replace the word 'biocides' in the prescribed sentences                            Competent authorities
  with an accurate description of the product type being
  advertised e.g. wood preservatives, disinfectants, surface        1 . Member States shall designate a competent
  biocides, anti-fouling products, etc.                            authority responsible for carrying out the duties imposed
                                                                   on Member States under this Directive .
  2. Member States shall require that advertisements for
  biocidal products shall not refer to the product in a            2.    Member States shall inform the Commission of the
  manner which is misleading in respect of the effects of          identity of their competent authority six months before
  the substance on man or the environment.                         the entry into force of this Directive.
 ---pagebreak--- 3 . 9 . 93                             Official Journal of the European Communities                             No C 239 / 17
                          Article 24                             Committee) to assist it. The Standing Committee shall be
                                                                 composed of representatives of the Member States and
                    Commission procedures                        chaired by a representative of the Commission. The
                                                                 Standing Committee shall adopt its own rules of
1.      When the Commission receives from a Member               procedure.
State either :
(a) an evaluation and recommendations concerning an
       active substance as foreseen in Article 10 (2) and         2. For matters referred to the Standing Committee by
      Article 9 (5); or                                          virtue of Articles 14 (4), 16 (4) and 17 (4) the represen­
                                                                 tative of the Commission shall submit to the Committee
                                                                  a draft of the measures to be taken . The Committee shall
(b) a proposal to refuse an authorization and an expla­           deliver its opinion on the draft, within a time limit which
       natory document as foreseen in Article 3 ( 5") :
                                                                  the chairman may lay down according to the urgency of
                                                                  the matter, if necessary by taking a vote.
it shall allow a period of 45 days during which other
Member States and the applicant may submit comments
              • •
to it in writing
                                                                 The opinion shall be recorded in the minutes ; in
                                                                  addition, each Member State shall have the right to ask
2.      At the end of the period for comment, the                 to have its position recorded in the minutes.
Commission shall, on the basis of:
      the documents received from the Member State
                                                                 The Commission shall take the utmost account of the
      evaluating the dossiers and,
                                                                  opinion delivered by the Committee. It shall inform the
      any advice obtained from advisory committees in             Committee of the manner in which its opinion has been
                                                                  taken into account.
      particular the Scientific Advisory Committee on the
      toxicology and ecotoxicology of chemical substances
      as     established    by      Commission         Decision
      78/61 8 /EEC (') and in the case of active substances
      included in insecticides, acaricides, rodenticides,         3.    For all other matters referred to the Committee in
      avicides and molluscicides which are also authorized        accordance with the requirements of this Directive the
      under the requirements of Directive 91 /414/EEC,            representative of the Commission shall submit to the
                                                                  Committee a draft of the measures to be taken . The
      the Scientific Committee for Pesticides, as established
      by Commission Decision 78 /436/EEC (2),                     Committee shall deliver its opinion on the draft within a
                                                                  time limit which the chairman may lay down according
      comments received from other Member States and              to the urgency of the matter. The opinion shall be
      the applicants and,
                                                                  delivered by the majority laid down in Article 148 (2) of
                                                                  the Treaty in the case of decisions which the Council is
                                                                  required to adopt on a proposal from the Commission.
      any other relevant information,                             The votes of the representatives of the Member States
                                                                  within the Committee shall be weighted in the manner
                                                                  set out in that Article . The chairman shall not vote .
prepare a proposal for decision in accordance with the
procedures laid down in Article 25 (3).
                                                                  The Commission shall adopt the measures envisaged if
3. The applicant or his authorized representative may             they are in accordance with the opinion of the
be asked by the Commission to submit remarks to it, in            Committee .
particular whenever an unfavourable decision is
envisaged.
                                                                  If the measures envisaged are not in accordance with the
                           Article 25                             opinion of the Committee, or if no opinion is delivered,
                                                                  the Commission shall, without delay, submit to the
                  Committees and procedures                       Council a proposal relating to the measures to be taken.
                                                                  The Council shall act by a qualified majority.
 1 . The Commission shall establish a                  Standing
Committee on Biocidal Products (the                    Standing
                                                                  If, on the expiry of a period of 30 days the Council has
O OJ No L 198 , 22. 7. 1978 , p. 17.                              not acted, the proposed measures shall be adopted by the
O OJ No L 124, 12. 5 . 1978 , p. 16.                              Commission .
 ---pagebreak--- No C 239 / 18                            Official Journal of the European Communities                                      3. 9. 93
                           Article 26                                                            Article 29
     Common principles for the evaluation of dossiers                                        Safeguard clause
                                                                       Where a Member State has valid reasons to consider that
The common principles for evaluation of dossiers                        a biocidal product which it has authorized or is bound to
referred to in Article 4 ( 1 ) (b) above, shall be adopted in          authorize under Article 3 constitutes an unacceptable
accordance with the procedure laid down in Article 25                  risk to human or animal health or the environment, it
(3). These principles shall be regularly reviewed and                   may provisionally restrict or prohibit the use or sale of
where appropriate revised, in accordance with the same                 that product on its territory. It shall immediately inform
procedure.                                                              the Commission and the other Member States of such
                                                                        action and give reasons for its decision. A decision shall
                                                                       be taken on the matter within 90 days in accordance
                           Article 27                                  with the procedure laid down in Article 25 (3).
             Adaptation to technical progress
                                                                                                 Article 30
The amendments necessary for adapting Annexes II, III,                               Implementation of the Directive
IV and V to technical progress shall be adopted in                      1.    Not later than 18 months after the date of the
accordance with the procedure laid down in Article 25                   adoption of the Directive Member States shall adopt and
(3).                                                                   publish the laws, regulations and administrative
                                                                       provisions necessary to comply with this Directive. They
                                                                        shall forthwith inform the Commission thereof.
                           Article 28
                  Civil and criminal liability                          2.    When Member States adopt these measures, they
                                                                        shall contain a reference to this Directive or shall be
                                                                        accompanied by such reference on the occasion of their
The granting of authorization and all other measures in                 official publication. The methods of making such a
conformity with this Directive shall be without prejudice              reference shall be laid down by the Member States.
to general civil and criminal liability in the Member
States of the manufacturer and, where applicable, of the                                         Article 31
person responsible for placing the biocidal product on
the market or using it.                                                This Directive is addressed to the Member States .
                                                               ANNEX I
              LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL
                                          FOR INCLUSION IN BIOCIDAL PRODUCTS
                                                             i
                                                               ANNEX II
                           REQUIREMENTS FOR THE DOSSIER TO BE INTRODUCED FOR THE
                                    INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I
                                                                PART A
                                                          Chemical substances
              1 . Dossiers on active substances are required to address at least all the points listed under 'Dossier
                  requirements'. Responses are required to be supported by data.
                                                                                               /
 ---pagebreak--- 3. 9. 93                              Official Journal of the European Communities                                       No C 239/ 19
         2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
             need not be supplied. The same applies where it is not scientifically necessary or technically possible to
             supply the information. In such cases, a justification, acceptable to the competent authority must be
             submitted .
         Dossier requirements
                                                                                 >                                  »
                                            /
                                        >
               I Applicant
            II Identity of the active substance
           III Physical and chemical properties of the active substance
           IV Methods of detection and identification
            V Effectiveness against target organisms and intended uses
           VI Toxicological profile for man and animals including metabolism
          VII Ecotoxicological profile including environmental fate and behaviour
         VIII Measures necessary to protect man, animals and the environment
           IX Classification and labelling
            X Summary and evaluation of II to IX
                                                                           i
         The following data will be required to support submission on the above points.
         I APPLICANT
         1.1 .       Name 4- address .
         1.2.        Active substance manufacturer (name, address, location of plant).
         II IDENTITY OF THE ACTIVE SUBSTANCE
         2.1 .       Common name proposed or accepted by ISO and synonyms.
         2.2.        Chemical name (IUPAC nomenclature).
         2.3.        Manufacturer's development code number(s).
         2.4.        CAS and EEC numbers (if available).
         2.5.        Empirical and structural formula (including full details of any isomeric composition), molecular
                     mass .
         2.6.        Method of manufacture (synthesis pathway in brief terms) of active substance.
         2.7.        Specification of purity of the active in g/kg or g/1, as appropriate.
         2.8 .       Identity of impurities and additives (e.g. stabilizers), together with the structural formula and the
                     possible range expressed as g/kg or g/1, as appropriate.
         2.9.        The origin of the natural active substance or the precursor(s) of the active substance, e.g. an
                     extract of a flower.
 ---pagebreak---                   0
No C 239 /20                             Official Journal of the European Communities                                      3 . 9 . 93
           III PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE
           3.1 .      Melting point, boiling point, relative density (').
           3.2.       Vapour pressure (in Pa) (').
           3.3.       Appearance (physical state, colour) (2).
           3.4.       Absorption spectra (UV/VIS, IR, NMR), and a mass spectrum, molar extinction at relevant
                      wavelengths, where relevant (').
           3.5 .      Solubility in water including effect of pH (5 to 9) and temperature on solubility, where
                      relevant (').
           3.6.       Solubility in organic solvents, including effect of temperature on solubility (').
           3.7.       Partition coefficient n-octanol/water including effect of pH (5 to 9) and temperature (').
           3.8 .      Stability in organic solvents used in preparations and identity of relevant breakdown products (2).
           3.9.       Thermal stability, identity of relevant breakdown products.
           3.10.      Flammability including auto-flammability and identity of combustion products.
           3.11 .     Flashpoint.
           3.12 .     Surface tension.
           3.13.      Explosive properties.
           3.14.      Oxidizing properties.
           3.15 .     Reactivity towards container material.
           IV ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
           4. 1 .     Analytical methods for the determination of pure active substance and, where appropriate, for
                      relevant degradation products, isomers and impurities of the active substance and additives (e.g.
                      stabilizers).
           4.2 .      Analytical methods including recovery rates and the limits of determination for the active
                      substance, and for residues thereof, and where relevant in/on the following :
                      (a) soil ;
                                                                 i ,
                      (b) air;
                      (c) water : the applicant should confirm that the substance itself and any of its degradation
                           products which fall within the definition of pesticides given for parameter 55 in Annex I of
                           Directive 80/778 /EEC on the quality of water intended for human consumption (OJ No
                           L 229, 30. 8 . 1980, p. 11 ) can be estimated with adequate reliability at the MAC specified in
                           that Directive for individual pesticides ;
                      (d) animal and human body fluids and tissues ;
                      (e) food or feedingstuffs and other products where relevant.
           (') These data must be submitted for the purified active substance of stated specification.
           (J) These data must be submitted for the active substance of stated specification.
 ---pagebreak--- 3 . 9 . 93                            Official Journal of the European Communities                                     No C 239 / 21
           V EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USES
           5.1 .    Function, e.g. fungicide, rodenticide, insecticide, bacteriocide.
           5.2.     Organism(s) controlled and products, organisms or objects to be protected.
           5.3 .    Effects on target organisms, e.g. contact, inhalation or stomach poison, fungitoxic, or fungistatic.
           5.4 .    Mode of action.
           5.5.     Field of use envisaged.
           5.6.     User, professional or non-professional, general public.
           5.7.     Information on the occurrence or possible occurrence of the development of resistance and
                    appropriate management strategies.
           5.8 .    Likely tonnage to be placed on the market per year.
           5.9.     Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target
                    organisms.
           VI TOXICOLOGICAL AND METABOLIC STUDIES
           6.1 .    Acute toxicity.
           6.1.1 .  Oral.
           6.1.2 .  Dermal
           6.1.3 .  Inhalation.
           6.1.4.   Skin and eye irritation.
           6.1.5 .  Skin sensitization.
           6.2 .    Metabolism studies in mammals.
                    Basic toxicokinetics, including a dermal absorption study.
                    For the following studies 6.3 (where necessary), 6.4, 6.5, 6.7 and 6.8 , the required route of
                    administration is the oral route unless it can be justified that an alternative route is more appro­
                    priate.
           6.3.     Short term repeated dose toxicity (28 days).
                    This study is not required when a sub-chronic toxicity study is available in a rodent.
           6.4.     Sub-chronic toxicity.
                                                I
                    90-day study, two species, one rodent and one non-rodent.
           6.5 .    Chronic toxicity.
            #
                                              «
                    One rodent and one other mammalian species.
           6.6.     Mutagenicity studies.
           6.6. 1 . In vitro gene mutation study in bacteria.
           6.6.2.   In vitro cytogenicity study in mammalian ceils.
           6.6.3 .  In vitro gene mutation assay in mammalian ceils.
           6.6.4.   If positive in points 6.6.1 , 6.6.2 or 6.6.3, then an in vivo mutagenicity study will be required
                    (bone marrow assay for chromosomal damage or a micronucleus test).
 ---pagebreak--- No C 239/22                           Official Journal of the European Communities                                         3. 9. 93
          6.6.5.    If negative in point 6.6.4 but positive in vitro tests then undertake a second in vivo study to
                    examine whether mutagenicity or evidence of DNA damage can be demonstrated in tissue other
                    than bone marrow.
          6.6.6.    If positive in point 6.6.4 then a test to assess possible germ cell effects may be required.
          6.7.      Carcinogenicity study.
                    One rodent and one other mammalian species. These studies may be combined with those in
                    point 6.5 .
           6.8 .    Reproductive toxicity.
           6.8.1 .  Teratogenicity test — rabbit and one rodent species
           6.8.2.   Fertility study — at least two generations, one species, male and female
           6.9.     Neurotoxicity study.
                    If the active substance is an organophosphorus compound or if there are any other indications
                    that the test substance may have neurotoxic properties then neurotoxicity studies will be required.
                    The test species is the adult hen unless another species is justified to be more appropriate. If
                    appropriate, delayed neurotoxicity tests will be required. If anticholine esterase activity is
                    detected, a test for response to reactivating agents should be considered.
           6.10.    Toxic effects on livestock and, pets.
           6.11 .   Studies related to the exposure of the active substance to man.
           6.11.1 . Food and feedingstuffs — if the active substance is to be used in preparations for use where food
                    for human consumption is prepared, consumed or stored, or where feedingstuff for livestock is
                    prepared, consumed or stored the tests referred to in Annex IV, Part A, point 1 shall be required.
           6.11.2.  If any other tests related to the exposure of the active substance to man, in its proposed prepa
                    rations, are considered necessary, then the test(s) in Annex IV, Part A, point 2 shall be required.
           6.12.    Supplementary studies.
           6.12.1 . If the active substance is to be used in products for action against plants then tests to assess toxic
                    effects of metabolites from treated plants, if any, where different from those identified in animals
                    shall be required.
           6.12.2 . Mechanistic study — any studies necessary to clarify effects reported in toxicity studies
           6.13 .   Medical data in anonymous form.
           6.13.1 . Medical surveillance data on manufacturing plant personnel if available.
           6.13.2.  Direct observation, e.g. clinical cases, poisoning incidents if available.
           6.13.3.  Health records, both from industry and any other availabe sources
           6.13.4.  Epidemiological studies on the general population, if available.
           6.13.5.  Diagnosis of poisoning (determination of active substance, metabolites in body fluids or exhaled
                    air) specific signs of poisoning, clinical tests.
           6.13.6.  Sensitifcation/allergenicity observations, if available.
           6.13.7.  Proposed treatment : first aid measures, antidotes, medical treatment.
 ---pagebreak--- 3 . 9 . 93                               Official Journal of the European Communities                                        No C 239 /23
           6.13.8 .   Prognosis following poisoning.
           6.14.      Summary of mammalian toxicology and conclusions, including no observable adverse effect level
                      (NOAEL), no observable effect level (NOEL), overall evaluation with regard to all toxicological
                      data and any other information concerning active substance. Where possible any suggested
                      worker protection measures should be included in summary form.
           VII ECOTOXICOLOGICAL STUDIES ON THE ACTIVE SUBSTANCE
           7.1 .      Acute toxicity to fish.
           7.2.       Acute toxicity to Daphnia magna.
           7.3.       Growth inhibition test on algae.
           7.4.       Acute toxicity test on one other, non-aquatic, non-target organism.
           7.5 .      If the results of the ecotoxicological studies and the intended use(s) of the active substance
                      indicate a danger for the environment then the tests described in Annex IV, Parts B and C, shall
                      be required.
           Fate and behaviour in the environment
           7.6.       Degradation.
           7.6.1 . •  Biotic .
           7.6.1.1 .  Ready biodegradability.
           7.6.1.2.   Inherent biodegradability, where appropriate.
           7.6.1.3 .  If the result of the test in point 7.6.1.2 is negative and if the likely route of disposal of the active
                      substance and its preparations is by sewage treatment, then the test described in Annex IV,
                      Part C, point 4.1 shall be required.
           7.6.1.4.   Any other biodegradability tests that are relevant from the results in points 7.6.1.1 and 7.6.1.2 .
           7.6.2 .    Abiotic.
           7.6.2.1 .  Hydrolysis as a function of pH and identification of breakdown product(s).
           7.6.2.2.   Phototransformation in water including identity of the products of transformation (').
           7.6.2.3.   Phototransformation in air (estimation method), including identification of breakdown
                      products (').
           7.6.3.     If the results of point 7.6.1.2 or 7.6.1.4 indicate the need to do so, or the active substance has an
                      overall low or absent abiotic degradation, then the tests described in Annex IV, Part B, points
                      1.1 and 2.1 , and where appropriate the tests described in Annex IV, Part B, point 3 shall be
                      required.
           7.7.       Adsorption/desorption screening test.
                      Where the results of this test indicate the need to do so, the test described in Annex IV, Part B,
                      point 1.2 shall be required, and/or the test described in Annex IV, Part B, point 2.2.
           7.8 .      Summary of ecotoxicological effects and fate and behaviour in the environment.
           VIII MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT
           8.1 .      Recommended methods and precautions concerning handling, use, storage, transport or fire.
           8.2 .      In case of fire, nature of reaction products, combustion gases etc.
           (') These data must be submitted for the purified active substance of stated specification.
 ---pagebreak---   I
No C 239/24                              Official Journal of the European Communities                                       3. 9. 93
          8.3 .        Emergency measures in case of an accident.
          8.4 .        Possibility of destruction or decontamination following release in or on the following :
                                                                                                   \
                       (a) air;
                       (b) water, including drinking water;
                       (c) soil.
           8.5 .       Substances falling within the scope of List I or List II of the Annex to Directive 80/68 /EEC on
                       the protection of groundwater against pollution caused by certain dangerous substances (OJ No
                       L 20, 26. 1 . 1980, p. 43).
           8 .6 .      Procedures for waste management of the active substance for industry or professional users.
                                    i
           8.6.1 .     Possibility of re-use or recycling.
           8.6.2 .      Possibility of neutralization.
           8.6.3 .      Conditions for controlled discharge including leachate qualities on disposal.
           8.6.4 .      Conditions for controlled incineration.
                                                                                                            i
           8.6.5 .      Others, if appropriate.
           IX CLASSIFICATION AND LABELLING
           Proposals including justification for the proposals for the classification and labelling of the active substance
           according to Directive 67/548/EEC.
           — Hazard symbol(s).
           — Indications of danger.
           — Risk phrases.
           — Safety phrases.
           X SUMMARY AND EVALUATION OF II TO IX
                                                                PART B
                                                    Fungi, icro-organis s and viruses
           1 . Dossiers on active organisms are required to address at least all the points listed under 'Dossier
                requirements' below. Responses are required to be supported by data.
                                                                                         <
           2 . Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
                 need not be supplied. The same applies where it is not scientifically necessary or technically possible to
                 supply the information. In such cases, a justification, acceptable to the competent authority must be
                 submitted .
           Dossier requirements
                  I Applicants details
                II Identity of active organism
              III Source of active organism
              IV Methods of detection and identification
               V Biological properties of active organism including pathogenicity and infectivity for target and
                    non-target organisms including man
 ---pagebreak--- 3. 9. 93                            Official Journal of the European Communities                                      No C 239/25
           VI Effectiveness and intended uses
          VII Toxicological profile for man and animals including metabolism of toxins
         VIII Ecotoxicological profile including environmental fate and behaviour of the organisms and of toxins it
               produces
           IX Measures necessary to protect man, non-target organism and the environment
            X Classification and labelling
           XI Summary and evaluation of II to X
         The following data will be required to support submissions on the above points.
         I APPLICANT
         1.1 .     Applicant (name, address, etc.).
                                               s
         1.2.      Manufacturer (name, address, plant location).
         II IDENTITY OF THE ORGANISM
                                                                         a
         2.1 .     Common name of organism (including alternative and superseded names).
         2.2.      Taxonomic name and strain indicating whether it is a stock variant or a mutant strain ; for
                   viruses, taxonomic designation of the agent, serotype, strain or mutant.
         2.3 .     Collection and culture reference number where the culture is deposited.
         2.4.      Methods, procedures and criteria used to establish the presence and identity of the organism (e.g.
                   morphology, biochemistry, serology, etc.).
         Ill SOURCE OF THE ORGANISM
         3.1 .     Occurrence in nature or otherwise.
         3.2.      Isolation methods for organism or active strain.
                            /
         3.3 .     Culture methods.
                                                                       i
         3.4.      Production methods including details of containment and procedure to maintain quality and
                   ensure a uniform source of active organism. For mutant strains detailed information should be
                   provided on production and isolation, together with all known differences between the mutant
                   strains and parent and naturally occurring strains.
         3.5.      Composition of the final active organism material i.e. nature, purity, identity, properties, content
                   of any impurities and extraneous organisms.
         3.6.      Methods to prevent contamination of seed stock and loss of virulence of seed stock.
         3.7.      Procedures for waste management.
                                           i
         IV METHODS OF DETECTION AND IDENTIFICATION
         4.1 .     Methods for establishing the presence and identity of the organism.
         4.2.      Methods for establishing the identity and purity of seed stock from which batches are produced
                   and results obtained, including information on variability.
 ---pagebreak--- No C 239/26                         Official Journal of the European Communities                                      3. 9. 93
          4.3.   Methods to show microbiological purity of the final product and showing that contaminants
                 have been controlled to an acceptable level, results obtained and information on variability.
          4.4.   Methods used to show that there are no human or other mammalian pathogens as contaminants
                 in the active agent, including in the case of protozoa and fungi, the effects of temperature (35 °C
                 and other relevant temperatures).
          4.5.   Methods to determine viable and non-viable (e.g. toxins) residues in or on treated products,
                 foodstuffs, feedingstuffs, animal and human body fluids and tissues, soil, water and air, where
                 relevant.
          V BIOLOGICAL PROPERTIES OF THE ORGANISM
                                                                                      »
          5.1 .  History of the organism and its uses including as far as is known its general natural history and
                 if relevant its geographical distribution.
          5.2.   Relationship to existing pathogens of vertebrates, invertebrates, plants or other organisms.
          5.3.   Effects on target organism. Pathogenicity or kind of antagonism to the host. Details of host
                 specificity range should be included.
          5.4.   Transmissibility, infective dose and mode of action including information on presence, absence
                 or production of toxics with, if appropriate, information on their nature, identity, chemical
                 structure and stability and potency.
          5.5.   Possible effects on non-target organisms closely related to the target organism including infec­
                 tivity, pathogenicity, transmissibility.
           5.6.  Transmissibility to other non-target organisms.
                                              I
                                                  t
          5.7.   Any other biological effects on non-target organisms when properly used.
          5.8 .  Infectivity and physical stability when properly used.
          5.9.   Genetic stability under environmental conditions of proposed use.
           5.10. Any pathogenicity and infectivity to man and animals under conditions of immunosuppression.
          5.11 . Pathogenicity and infectivity for known parasites/predators of the target species.
          VI EFFECTIVENESS AND INTENDED USES
              J
          6. 1 . Harmful organisms controlled and materials, substances, organisms or products to be treated or
                 protected.
                                                                        <
          6.2.   Uses envisaged e.g. insecticide disinfectant, anti-fouling biocide, etc.
                                                                                                      \
          6.3 .  Information or observations on undesirable or unintended side effects.
                                                    <
          6.4.   Information on the occurrence or possible occurrence of the development of resistance and
                 possible management strategies to deal with this.
          6.5.   Effects on target organisms.
          6.6.   Category of user.
          VII TOXICOLOGICAL AND METABOLIC STUDIES
          7.1 .  Acute toxicity.
                 In cases where a single dose is not appropriate, a set of range finding tests must be carried out to
                 reveal highly toxic agents and infectivity:
                 ( 1) oral ;
                 (2) dermal ;
 ---pagebreak--- 3. 9. 93                             Official Journal of the European Communities                                      No C 239/27
                 (3) inhalation ;
                 (4) skin and where necessary eye irritation ;
                 (5) skin sensitization and where necessary respiratory sentization ; and
                 (6) for viruses and viroids, cell culture studies using purified infective virus and primary cell
                       cultures of mammalian, avian and fish cells .
         7.2.    Sub-chronic toxicity
                 40-day study, two species, one rodent, one non-rodent :
                 ( 1 ) oral administration ;
                 (2) other routes (inhalation, dermal) as appropriate ; and
                 (3) for viruses and viroids test for infectivity carried out by bio-assay or on a suitable cell culture
                       at least seven days after administration to test animals.
         7.3.    Chronic toxicity
                 Two species, rodent and one other mammal, oral administration unless other route more appro
                 priate.
         7.4.    Carcinogenicity study
                 May be combined with studies in point 6.3 . One rodent and on other mammal
         7.5.    Mutagenicity studies
                 As specified in Part A, point 6.6
         7.6.    Reproductive toxicity
                 Teratogenicity test — rabbit and one rodent species. Fertility study — one species, minimum two
                 generations, male and female.
         7.7 .   Metabolism studies
                 Basic toxicokinetics, absorption (including dermal absorption) distribution and excretion in
                 mammals including elucidatipn of metabolic pathways;
         7.8 .   Neurotoxicity studies : required where there is any indication of anticholinerterase activity or
                 other neurotoxic effects. Delayed neurotoxicity tests using adult hens should be performed where
                 appropriate.
         7.9.    Immunotoxicity studies e.g. allergenicity
         7.10.   Incidental exposure studies : required where the active substance will be in products for use where
                 human food or animal feedingstuffs are prepared, consumed or stored and where humans
                 livestock or pets are likely to be exposed to treated areas or materials.
         7.1 1 . Human exposure data including :
                 ( 1 ) medical data in anonymous form (if available);
                 (2) health records, medical surveillance data on manufacturing plants personnel (if available);
                 (3) epidemiological data (if available);
                 (4) poisoning incidents data ;
                                                                                                                                   »
 ---pagebreak--- No C 239 / 28                            Official Journal of the European Communities                                      3 . 9 . 93
                       (5) poisoning diagnosis (signs, symptoms) including details of any analytical tests ;
                       (6) proposed treatment of poisoning and prognoses.
            7.12.      Summary of mammalian toxicology — conclusions (including NOAEL, NOEL and if appro­
                       priate ADI) overall evaluation with regard to all toxicological, pathogenicity and infectivity data
                       and any other information concerning the active organism. Where possible suggested user
                       protection measures should be included in summary form.
            VIII ECOTOXICOLOGICAL STUDIES
             8.1 .     Acute toxicity to fish.
             8.2.      Acute toxicity to Daphnia magna.
             8.3.      Effects on algal growth (inhibition test)
             8.4.      Acute toxicity on one other, non-aquatic, non-target organism.
             8.5 .     Pathogenicity and infectivity for honeybees and earthworms.
             8.6.      Acute toxicity and/or pathogenicity and infectivity for other non-target organisms believed to be
                       at risk.
             8.7.      Effects (if any) on other flora and fauna.
             8.8 .     Potential for indirect contamination of areas adjacent to treatment areas
        /
             8.9.      In cases where toxins are produced, data as outlined in Annex II, Part A, points 7.1 to 7.5 should
                       be produced.
             Fate and behaviour in the environment
             8.10.     Spread, mobility, multiplication and persistence in air, soil and water.
             8.11 .    In cases where toxins are produced, data as outlined in Annex II, Part A, points 7.6 to 7.8 .
             IX MEASURES NECESSARY TO PROTECT MAN, NON-TARGET ORGANISMS AND THE
                   ENVIRONMENT
             9.1 .     Methods and precautions, to be taken for storage, handling, transport and use ; or in event of fire
                       on other likely incident.
             9.2.      Any circumstances or environmental conditions under which the active organism should not be
                       used.
             9.3.      The possibility of rendering the active organism uninfective and any method for doing this.
             9.4.      Consequences of the contamination of air, soil and water, particularly drinking water.
            9.5.       Emergency measures in case of accident.
            9.6.       Procedures for waste management of the active organism including leachate qualities on disposal.
             9.7.      Possibility of destruction or decontamination following release in or into the following : air,
                       water, soil, others if appropriate.
 ---pagebreak--- 3. 9. 93                                Official Journal of the European Communities                                     No C 239/29
          X CLASSIFICATION AND LABELLING
          Proposals for allocation to one of the risk groups outlined in Article 2 (d) of Directive 90/679/CEE (')
         with justifications for the proposal. Together with indications on the need for products to carry the
          biohazard sign specified in Annex II of 90/679/EEC.
         XI SUMMARY AND EVALUATION OF II TO X
          (') OJ No L 374, 31 . 12 . 1990, p. 1 .
                                                            ANNEX III
                                                                                        s
          REQUIREMENTS FOR THE DOSSIER TO BE INTRODUCED FOR THE AUTHORIZATION OF
                                                    A BIOCIDAL PRODUCT
                                                                     V
                                                              PART A
                                                        Chemical products
          1 . Dossiers on biocidal products are required to address at least all the points listed under 'Dossiers
               requirements'. Responses are required to be supported by data.
         2. Information which is not necessary owing to the nature of the biocidal product or of this proposed uses
               need not be supplied. The same applies where it is not scientifically necessary or technically possible to
               supply the information. In such cases, a justification, acceptable to the competent authority must be
               submitted.
         Dossier requirements
                I Applicant
              II Identity and composition of the biocidal product
             III Physical, chemical and technical properties of the biocidal product
             IV Methods for identification and analysis of the biocidal product
              V Intended uses of the product and efficacy for these uses
            VI Toxicology data for the biocidal products (additional to that for the active substance)
           VII Ecotoxicological data for the biocidal products (additional to that for the active substance)
         VIII Measures to be adopted to protect man, animals and the environment
                                                            /
             IX Classification, packaging and labelling of the biocidal product
                                                                                                     «
              X Summary and evaluation of II to IX
         The following data will be required to support submissions on the above points.
         I APPLICANT
                                                                                              /
         1.1 .       Applicant (name and address etc).
         1.2.        Manufacturer of the preparation and the active substance(s) (names and addresses, including
                     location of piant(s)).
 ---pagebreak--- No C 239 / 30                            Official Journal of the European Communities                                       3 . 9 . 93
            II IDENTITY OF THE BIOCIDAL PRODUCT
                   i
            2.1 .    Trade name or proposed trade name, and manufacturer's development code number of the prepa­
                     ration, if appropriate.
            2.2.     Detailed quantitative and qualitative information on the composition of the preparation e.g. active
                     substance(s), impurities, adjuvants, inert components.
            2.3 .    Physical state and nature of the preparation, e.g. emulsifiable concentrate, wettable powder,
                     solution .
            Ill PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
            3.1 .    Appearance (physical state, colour).
             3.2 .   Explosive properties.
             3.3 .   Oxidizing properties.
             3.4.    Flash point and other indications of flammability or spontaneous ignition.
             3.5 .   Acidity/alkalinity and if necessary pH value (1 % in water).
             3.6.    Relative density.
             3.7.    Storage stability — stability and shelf-life. Effects of light, temperature and humidity on technical
                     characteristics of the biocidal product.
             3.8 .   Technical characteristics of the preparation.
             3.8.1 . Wettability.
                                                                                             9
             3.8.2 . Persistent foaming.
             3.8.3 . Flowability, pourability and dustability.
             3.8.4.  Suspensibility and suspension stability.
             3.8.5 . Wet sieve test and dry sieve test.
             3.8.6.  Particle size distribution, content of dust/fines, attrition and friability.
             3.8.7.  In the case of granules, sieve test and indication of weight distribution of the granules, at least of
                     the fraction with particle sizes bigger than 1 mm.
             3.8.8 . Emulsifiability, re-emulsifiability, emulsion stability.
             3.8.9.  Wetting, adherence and distribution to target organisms.
             3.9.    Physical and chemical compatibility with other products including other biocidal products with
                     which its use is to be authorized .
             3.10.   If the biocidal product is to be used in the form of a bait for granules, then specify any repellants
                     or poison control measures included with the preparation that are present to prevent action
                     against non-target organisms.
            IV METHODS OF IDENTIFICATION AND ANALYSIS
            4.1 .    Analytical method for determining the composition of the biocidal product
            4.2 .    In so far as not covered by Annex II, point 4.2 analytical methods including recovery rates and the
                     limits of determination for toxicologically and ecotoxicologically relevant components of the
                     biocidal product and/or residues thereof, where relevant in or on the following :
                     (a) soil ;
                     (b) air ;
                                                                  \
                     (c) water (including drinking water) ;
                     (d) animal and human body fluids and tissues ;
                     (e) treated food or feedingstuffs .
 ---pagebreak--- 3 . 9 . 93                             Official Journal of the European Communities                                    No C 239 / 31
           V INTENDED USES AND EFFICACY
           5.1 .    Field of use envisaged.
           5.2 .    Method of application.
           5.3 .    Application rate and if appropriate, the final concentration of biocidal product and active
                    substance in systems in which the preparation is to be used, e.g. cooling water, surface water,
                    water used for heating purposes.
           5.4.     Number and timing of applications, and where relevant, any particular information relating to
                    geographical variations, climatic variations, or necessary waiting periods to protect man and
                    livestock.
           5.5 .    Any other necessary information.
           5.6.     Function, e.g. fungicide, rodenticide, insecticide, bacteriocide.
           5.7.     Pest organism(s) controlled and products, organisms or objects to be protected.
           5.8 .    Effects on target organisms, e.g. contact, ingestion or stomach poison, fungitoxic, fungistatic.
           5.9.     Mode of action in so far as not covered by Annex II, point 5.4.
           5.10.    User, professional or non-professional.
           5.11 .   Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target
                    organisms.
           Efficacy data
           5.12.    Data to support the efficacy claims of the preparation label, including any available standard
                    protocols used, laboratory tests, or where appropriate field trials. For each application a reasoned
                    case will be required.
           5.13 .   The effect of factors such as climate, temperature, humidity, precipitation etc. in so far as not
                    covered by point 5.4.
           5.14.    Compatibility with different cultural practices and other measures that may be used against the
                    target organism under the conditions of use envisaged.
           5.15 .   Any other known limitations on efficacy.
           5.16.    Relative advantages of the preparation or its intended use compared to any existing preparations
                    or treatment methods .
           5.17.    Summary and evaluation of data presented under point 5.12 to 5.17.
           VI TOXICOLOGICAL STUDIES
           6.1 .    Acute toxicity.
           6.1.1 .  Oral .
           6.1.2 .  Dermal.
           6.1.3 .  Inhalation .
           6.1.4.   Skin and eye irritation.
 ---pagebreak--- No C 239/ 32                           Official Journal of the European Communities                                       3 . 9 . 93
           6.1.5.   For biocidal products that are intended to be authorized for use with other biocidal products, the
                    mixture of preparations, where possible, shall be tested for acute dermal toxicity and skin and eye
                    irritation, as appropriate.
           6.2.     Dermal absorption test, where necessary.
           6.3 .    Available toxicological data relating to toxicologically relevant non-active substances.
           6.4.     Studies related to the exposure of the preparation to man.
                                                                                      r
                    Where necessary, the test(s) described in Annex IV, Part A shall be required for the toxico­
                    logically relevant non-active substances of the preparation.
           6.5 .    If the biocidal product is in the form of a bait or granules, pet or livestock acceptance studies may
                    be required.
            6.6.    Summary and evaluation of data presented in point 6.1 to 6.6, including where possible any
                    suggested worker protection measures in summary form.
           VII ECOTOXICOLOGICAL STUDIES ON THE BIOCIDAL PRODUCT
                  v
            7.1 .   The information provided must, where relevant, include that referred to in Annex II, points 7.1
                    to 7.4 .
                               r
            7.2.    If the results of the ecotoxicological studies and the intended use(s) of the active substance
                    indicate a danger for the environment then the tests described in Annex IV, Parts D and E shall
                    be required.
            Fate and behaviour in the environment
            7.3.    The information provided must, where relevant, include that referred to in Annex II, point 7.6.
           VIII MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT
            8.1 .   Recommended methods and precautions concerning handling, use, storage, transport or fire.
            8.2.    Emergency measures in case of an accident.
            8.3 .   Procedures, if any, for cleaning application equipment.
            8.4.    Possible routes of entry into the environment.
            8.5.    Identity of relevant combustion products in cases of fire.
            8.6.    Procedures for waste management of the biocidal product and its packaging for industry,
                    professional users and the general public.
            8.6.1 . Possibility of re-use or recycling.
            8.6.2.  Possibility of neutralization.
            8.6.3 . Conditions for controlled discharge.
            8.6.4.  Conditions for controlled incineration.
            8.6.5.  Others, if appropriate.
            8.7.    Possibility of destruction or decontamination following release in or on the following :
                    (a) air;
                    (b) water, including drinking water;
                    (c) soil.
 ---pagebreak--- 3. 9. 93                                Official Journal of the European Communities                                    No C 239/33
         8.8 .        Leachate qualities on disposal, in so far as not covered by point 8.6.3 of Annex II.
         8.9.         Any information on authorization in other countries.
         IX CLASSIFICATION, PACKAGING AND LABELLING
         Proposals including justification for the classification and labelling according to Pirective 88 /379/EEC or,
         in the case of rodenticides, insecticides/acaricides, avicides and molluscicides Directive 78/631 /EEC :
                                                                            r
         — hazard symbol(s),
         — indications of danger,
         — risk phrases,
         — safety phrases,
         — instructions for use,
         — packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging                   f
                materials to include,
         — specimens of the proposed packaging and of the proposed label(s) if so required.
         X        SUMMARY         AND      EVALUATION           OF     ALL    ANNEX       III   INFORMATION         AND
                  REQUIREMENTS
                                                                                                                  \
                                                                 PART B
                                                 Fungi, micro-organisms and viruses
          1 . Dossiers on biocidal products are required to address at least all the points listed under 'Dossier
               requirements'. Responses are required to be supported by data.
         2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
               need not be supplied. The same applies where it is not scientifically necessary or technically possible to
               supply the information. In such cases, a justification acceptable to the competent authority must be
               submitted.
         Dossier requirements
                I Applicant
              II Identity and composition of the biocidal product
             III Technical properties of the biocidal product and any biocidal properties additional to those of the
                  active organism
             IV Methods for identification and analysis of the biocidal product
              V Intended uses and efficacy for those uses
             VI Toxicological information (additional to that for the active organism)
           VII Ecotoxicological information (additional to that for the active organism)
         VIII Measures to be adopted to protect man, non-target organisms and the environment
           IX Classification, packaging and labelling of the biocidal product
             X Summary of II to IX
 ---pagebreak--- No C 239/34                            Official Journal of the European Communities                                        3. 9. 93
          The following data will be required to support submission on the above points.
          I APPLICANT
           1.1 .   Name and address etc.
           1.2.    Manufacturers of biocidal products and active organisms including location of plants.
          II IDENTITY OF BIOCIDAL PRODUCT
          2.1 .    Trade name or proposed trade name and manufacturer's development code number for the
                   biocidal product, if appropriate.
           2.2.    Detailed quantitative and qualitative information, on the composition of the biocidal product
                   (active organisms, inert components, extraneous organisms, etc.).
           2.3.    Physical state and nature of the biocidal product (emulsifiable concentrate, wettable powder, etc.).
                                >
           2.4.    Concentration of active organism in material used.
           III TECHNICAL AND BIOLOGICAL PROPERTIES
           3.1 .   Appearance (colour and odour).
           3.2.    Storage — stability and shelf-life. Effects of temperature, method of packaging and storage, etc.
                   on retention of biological activity.
           3.3.    Methods for establishing storage and shelf-life stability.
           3.4.    Technical characteristics of the preparation.
           3.4.1 . Wettability.
           3.4.2.  Persistent foaming.
           3.4.3.  Suspensibility and suspension stability.
           3.4.4.  Wet sieve test and dry sieve test.
           3.4.5.  Particle size distribution, content of dust/fines, attrition and friability.
           3.4.6.  In the case of granules, sieve test and indications of weight distribution of the granules, at least of
                   the fraction with particle sizes bigger than 1 mm.
           3.4.7.  Content of active substance in or on bait particles, granules or treated material.
           3.4.8 . Emulsinability, re-emulsifiability, emulsion stability.
           3.4.9.  Flowability, pourability and dustability.
           3.5.    Physical and chemical compatibility with other products including biocidal products with which its
                   use is to be authorized.
           3.6.    Wetting, adherence and distribution following application.
           3.7.    Any changes to biological properties of the organism is a result of formulation. In particular
                   changes in pathogenicity on infectivity.
           IV METHOD FOR IDENTIFICATION AND ANALYSIS OF THE BIOCIDAL PRODUCT
           4.1 .   Analytical methods for determining the composition of the biocidal product.
                                                                                        «
           4.2.    Methods for determining residues (e.g. biotest).
           4.3.    Methods used to show microbiological purity of the biocidal product.
 ---pagebreak--- 3. 9. 93                              Official Journal of the European Communities                                    No C 239/35
         4.4.     Methods used to show the biocidal product to be free from any human and other mammalian
                  pathogens or, if need be, from pathogens harmful to non-target organisms and the environment.
         4.5.     Techniques used to ensure a uniform product and assay methods for its standardization.
         V INTENDED USES AND EFFICACY FOR THESE USES
         5.1 .    Use.
                  Product type (e.g. wood preservative, public hygiene biocide etc).
         5.2.      Details of intended use, e.g. types of harmful organism controlled, materials to be treated etc.
         5.3.     Application rate.
         5.4.     Where necessary, in the light of the test results, any specific circumstances or environmental
                   conditions under which the product may or may not be used.
         5.5.      Method of application.                                                                           t
         5.6.      Number and timing of applications.
                                                                *
         5.7.      Proposed instructions for use.
                                                                            s
                                                                                                             I
         Efficacy data
                                                                  j
         5.8 .     Preliminary range-finding tests.
         5.9.     Field experimentation.
         5.10.    Information on the possible occurrence of the development of resistance.
         5.11 .   Effects on the quality of materials or products treated.
         VI TOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR THE ACTIVE
               ORGANISM
         6.1 .    Oral single dose.
         6.2 .    Percutaneous single dose.
         6.3 .    Inhalation.
                                                            4
         6.4 .    Skin and where relevant eye irritation.
         6.5 .    Skin sensitization.
         6.6 .    Available toxicological data relating to non-active substances.
         6.7 .    Operator exposure.
         6.7.1 .  Percutaneous absorption/inhalation depending on formulation and method of application.
         6.7.2 .  Likely operator exposure under field conditions, including where relevant quantitative analysis of
                  operator exposure .
         VII ECOTOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR THE ACTIVE
                ORGANISM
         7.1 .    Observations concerning undesirable or unintended side-effects, e.g. on beneficial and other
                  non-target organisms or persistence in the environment.
 ---pagebreak--- No C 239/ 36                            Official Journal of the European Communities                                    3 . 9 . 93
           VIII MEASURES TO BE ADOPTED TO PROTECT MAN, NON-TARGET ORGANISMS AND
                  THE ENVIRONMENT
           8.1 .    Recommended methods and precautions concerning handling, storage, transport and use.
                                                                                           r
            8.2.    Re-entry periods, necessary waiting periods or other precautions to protect humans and animals.
           8.3.     Emergency measures in case of an accident.
            8.4.    Procedures for destruction or decontamination of the biocidal product and its packaging.
            8.5.    Procedures for cleaning application equipment.
            8.6.    Procedures for safe disposal of the concentrated biocidal product or diluted product.
           IX CLASSIFICATION, PACKAGING AND LABELLING
           9.1 .    Proposals including justification for the classification, packaging and labelling
                     (i) with regard to non-biological components of the product in accordance with Directive
                         88 / 379/EEC :
                         — hazard symbol(s),
                         — indications of danger,
                         — risk phrases,
                         — safety phrases ;
                    (ii) with regard to the active organisms labelling with the appropriate risk group as outlined in
                         Article 2 (d) of Directive 90/679/EEC together with the biohazard sign specified in that
                         Directive if appropriate.
            9.2.    Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging
                    materials.
           9.3.     Specimens of proposed packaging.
                                                                    I
           X SUMMARY OF II TO IX
                                                            ANNEX IV
            FURTHER REQUIREMENTS FOR THE DOSSIERS TO BE INTRODUCED FOR THE AUTH­
                                           ORIZATION OF BIOCIDAL PRODUCTS
                                                                           <
                                                              PART A
                                                                                                                      >
                       Further human health related studies on the active substance and/or the preparation
            1.      Food andfeedingstuffs studies
            1.1 .   Identification of degradation and reaction products and of metabolites of the active substance in
                    treated or contaminated foods or feedstuffs .
            1.2 .   Behaviour of the residue of the active substance, its degradation products and where relevant its
                    metabolites on the treated or contaminated food or feedstuffs including the kinetics of disap­
                    pearance .
            1.3.    Overall material balance of the active substance. Sufficient residue data from supervised trials to
                    demonstrate that residues likely to arise from proposed use would not be of concern for human or
                    animal health .
 ---pagebreak--- 3. 9. 93                            Official Journal of the European Communities                                       No C 239/37
         1.4.  Estimation of potential or actual exposure of the active substance to humans through diet and
               other means.
         1.5 . If the residue of the biocidal product remains on feedingstuffs for a significant period of time then
               feeding and metabolism studies in livestock shall be required to permit evaluation of residues in
               food of animal origin.
         1.6.  Effects of industrial processing and/or domestic preparation on the nature and magnitude of
               residue of the biocidal product or active substance.
         1.7.  Proposed acceptable residues and the justification of their acceptability.
         1.8 . Any other available information that is relevant.
         1.9.  Summary and evaluation of data submitted under 1.1 to 1.8 .
         2.     Other test(s) related to the exposure to man
               Suitable test(s) and a reasoned case will be required for the active substance or the preparation, as
               appropriate.
                                                           PART B
                 Further studies on the fate and behaviour of the active substance in the environment
         1.    Fate and behaviour in soil
         1.1 . Rate and route of degradation including identification of the processes involved and identification
               of any metabolites and degradation products in at least three soil types under appropriate
               conditions.
         1.2.  Adsorption and desorption in at least three soil types and where relevant adsorption and
               desorption of metabolites and degradation products.
         1.3.  Mobility in at least three soil types and where relevant mobility of metabolites and degradation
               products.
         1.4.  Extent and nature of bound residues .
                                                                                                                  k
         2.    Fate and behaviour in water
         2.1 . Rate and route of degradation in aquatic systems (as far as is not covered by Annex II, point 7.6)
               including identification of metabolites and degradation products.
         2.2.  Adsorption and desorption in water (soil sediment systems) and where relevant adsorption and
               desorption of metabolites and degradation products.
         3.    Fate and behaviour in air
                                   V
               If the active substance is to be used in preparations for fumigants, if it is to be applied by a spray
               method, if it is volatile, or if any other information indicates that this is relevant, then the rate and
               route of degradation in air shall be determined as far as is not covered by Annex II, point 7.6.2.3.
         4.     Summary and evaluation ofparts 1, 2 and 3
                                                           PART C
                                   Further ecotoxicological studies on the active substance
         1.    Effects on birds
         1.1 . Acute oral toxicity — this need not be done if an avian species was selected for study in Annex II,
               point 7.4.                                      >
         1.2.  Short-term toxicity — eight-day dietary study in at least one species (other than chicken).
         1.3.  Effects on reproduction.
 ---pagebreak--- No C 239/38                             Official Journal of the European Communities                                      3. 9. 93
          2.         Effects on aquatic organisms
          2.1 .      Prolonged toxicity to an appropriate species of fish.
          2.2.       Effects on reproduction and growth rate on an appropriate species of fish.
          2.3.       Bioaccumulation in an appropriate species of fish.
          2.4 .      Daphnia magna reproduction and growth rate.
           3.        Effects on other non-target organisms
           3.1 .     Acute toxicity to honeybees and other beneficial arthropods e.g. predators. A different test
                     organism shall be chosen from that used in Annex II, point 7.4.
                               i
           3.2.      Toxicity to earthworms and to other soil non-target macro-organisms.
  «
                         «
           3.3 .     Effects on soil non-target micro-organisms.
           3.4.      Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk.
        *
           4.         Other effects
          4.1 .      Activated sludge respiration inhibition test.
           5.         Summary and evaluation ofparts 1, 2 and 3.
                                                                                                                        I
                                                               PART D
           Further studies on the fate and behaviour of the environmentally relevant components of the biocidal
                                                      product in the environment
           1 . Where relevant all the information required in Annex IV, Part B.
           2. Testing for distribution and dissipation in the following :
               (a) soil ;
               (b) water;
               (c) air.
           Test requirements 1 and 2 are applicable only to ecotoxicologically relevant components of the preparation.
                                                               PART E
                                       Further ecotoxicological studies on the biocidal products
           1.        Effects on birds
           1.1 .     Acute oral toxicity, if not already done in accordance with Annex III, point 7.
           2.        Effects on aquatic organisms
                                                                              i
           2.1 .     In case of application on, in or near to surface waters.
           2.1.1 .   Particular studies with fish and other aquatic organisms.
           2.1.2 .   Residue data in fish concerning the active substance and including toxicologically relevant metab­
                     olites .
           2.1.3 .   The studies referred to in Annex IV, Part C points 2.1 , 2.2, 2.3 and 2.4 may be required for
                     relevant components of the preparation.
           2.2 .     If the biocidal product is to be sprayed near to surface waters then an overspray study may be
                     required to assess risks to aquatic organisms under field conditions.
 ---pagebreak--- 3 . 9 . 93                               Official Journal of the European Communities                                    No C 239 /39
           3.        Effects on other non-target organisms
           3.1 .    Toxicity to terrestrial vertebrates other than birds.
           3.2 .    Acute toxicity to honeybees.
           3.3 .     Effects on beneficial arthropods other than bees.
           3.4 .     Effects on earthworms and other soil non-target macro-organisms, believed to be at risk.
           3.5 .     Effects on soil non-target micro-organisms.
           3.6 .     Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk,
           3.7 .     If the biocidal product is in the form of bait or granules, the following will be required.
           3.7.1 .   Supervised trials to assess risks to non-target organisms under field conditions.
           3.7.2     Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought
                     to be at risk; in so far as not covered by Annex III, point 6.6.
           4.        Summary and evaluation ofParts 1, 2 and 3.
                                                               ANNEX V
           Biocidal products shall include those product types set out below which can be used for the purposes
           described :
           Product type                                              Description of use
           Disinfectant                                              Disinfection of skin (human or animal) and articles
                                                                    intended to come into contact with skin.
           Swimming pool disinfectant                                Disinfection of water used for public bathing.
           Food industry disinfectant                               Disinfection of containers surfaces and pipework
                                                                     associated with the production of food and drink for
                                                                     humans and animals .
           General biocide                                           Control of harmful micro-organisms in premises
                                                                    vehicles and areas used by humans and animals.
           Sanitary biocide                                         Control of harmful micro-organisms in sanitary
                                                                    convenancies and equipment.
           Air-conditioning biocide                                  Control of harmful organisms in air conditioning
                                                                     systems .
           Wood preservatives                                        Protection of sawn timber and timber products from
                                                                     harmful organisms.
           Textile preservatives                                     Protection of textiles from harmful organisms.
           Masonry preservatives                                     Protection of masonry and other construction
                                                                     materials (except wood) from harmful organisms.
           Consumer product preservatives                            Protection of products marketed to the consumer,
                                                                     other than food and feed, from harmful organisms.
           Industrial biocides                                       Control of harmful organisms affecting industrial
                                                                    processes .
           Specialist biocides                                       Control of harmful organisms in connection with
                                                                     specific products, substances, materials, articles on
                                                                     areas not covered by other product types.
 ---pagebreak--- No C 239/ 40                     Official Journal of the European Communities                                   3 . 9 . 93
           Product type                                  Description of use
           Rodenticide                                   Control of rats, mice or other rodents for purposes
                                                         of public health and well-being.
           Avicide                                       Control of birds for purposes of public health and
                                                         well-being.
           Molluscicide                                  Control of snails and other molluscs, both terrestrial
                                                         and aquatic for purposes of public health and well­
                                                         being.
           Insecticide/Acaricide                         Control of insects, mites and other arthropods for
                                                         purposes of public health and well-being.
           Anti-fouling biocide                          Control of fouling organisms on ships, boats, aquatic
                                                         structures and articles.