Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market
Date: 1998-02-16
Institutions: Council of the European Union, European Parliament
Subjects: chemical product, health control, labelling, market approval, marketing standard, packaging

24.4.98

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L 123/1

I

(Acts  whose  publication  is  obligatory)

DIRECTIVE  98/8/EC  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL

of  16  February  1998

concerning  the  placing  of  biocidal  products  on  the  market

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF
THE  EUROPEAN  UNION,

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  100a  thereof,

Having  regard  to  the  proposal  from  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article 189b of the Treaty (3) in the light of the joint text
approved  on  16  December  1997  by  the  Conciliation
Committee,

to 

(1) Whereas,  in  their  resolution  of  1  February  1993  on
a  Community  programme  of  policy  and  action  in
sustainable
the  environment  and 
relation 
development (4),  the  Council  and  the  representatives
of  the  Governments  of  the  Member  States,  meeting
within  the  Council,  approved  the  general  approach
and  strategy  of  the  programme  presented  by  the
risk
Commission, 
management  of  non-agricultural  pesticides 
is
emphasised;

in  which 

the  need 

for 

(2) Whereas,  both  when  the  eighth  Amendment (5)  to
Council  Directive  76/769/EEC  of  27  July  1976,  on
the  approximation  of  the  laws,  regulations  and
administrative  provisions  of  the  Member  States
relating  to  restrictions  on  the  marketing  and  use  of

(1) OJ C 239, 3.9.1993, p. 3, OJ C 261, 6.10.1995, p. 5 and OJ

C  241,  20.8.1996,  p.  8.

(2) OJ  C  195,  18.7.1994,  p.  70  and  OJ  C  174,  17.6.1996,

p.  32.

(3) Opinion  of  the  European  Parliament  of  18  April  1996  (OJ
C  141,  13.5.1996,  p.  191),  Council  common  position  of
20 December 1996 (OJ C 69, 5.3.1997, p. 13) and Decision
of  the  European  Parliament  of  13  May  1997  (OJ  C  167,
2.6.1997,  p.  24).  Council  Decision  of  18  December  1997.
Decision  of  the  European  Parliament  of  14  January  1998.

(4) OJ  C  138,  17.5.1993,  p.  1.
(5) OJ  L  398,  30.12.1989,  p.  19.

dangerous  substances  and  preparations (6)  was
adopted  in  1989  and  during  the  discussion  in  the
Council  on  Directive  91/414/EEC  concerning  the
placing  of  plant  protection  products  on 
the
market (7), the Council expressed concern at the lack
of  harmonised  Community  provisions  for  biocides,
formerly  known  as  non-agricultural  pesticides,  and
invited  the  Commission  to  examine  the  situation  in
Member  States  and  the  possibility  for  action  at
Community  level;

(3) Whereas  biocidal  products  are  necessary  for  the
control  of  organisms  that  are  harmful  to  human  or
animal health and for the control of organisms that
cause  damage  to  natural  or  manufactured  products;
whereas biocidal products can pose risks to humans,
animals  and  the  environment  in  a  variety  of  ways
due  to  their  intrinsic  properties  and  associated  use
patterns;

the 

the  Commission 

(4) Whereas the Commission review showed differences
in  the  regulatory  situation  in  the  Member  States;
whereas such differences may constitute barriers not
only  to  trade  in  biocidal  products  but  also  to  trade
in  products  treated  with  them,  thereby  affecting  the
internal  market;  whereas,
functioning  of 
therefore, 
the
development of a framework of rules relating to the
placing  on  the  market  for  use  of  biocidal  products,
taking  as  a  condition  a  high  level  of  protection  for
humans,  animals  and  the  environment;  whereas,
having  regard  to  the  principle  of  subsidiarity,
decisions  taken  at  Community  level  should  be
restricted 
the  proper
functioning  of  the  common  market  and  to  avoid
duplication  of  work  by  Member  States;  whereas  a
the  most
directive  on  biocidal  products 
appropriate  way  of  establishing  such  a  framework;

those  necessary 

proposed 

for 

to 

is 

(6) OJ  L  262,  27.9.1976,  p.  201.  Directive  as  last  amended  by

Directive  97/16/EC  (OJ  L  116,  6.5.1997,  p.  31).

(7) OJ  L  230,  19.8.1991,  p.  1.  Directive  as  last  amended  by

Directive  96/68/EC  (OJ  L  277,  30.10.1996,  p.  25).

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(5) Whereas the framework of rules should provide that
biocidal  products  should  not  be  placed  on  the
market  for  use  unless  they  have  complied  with  the
relevant  procedures  of  this  Directive;

(6) Whereas,  to  take  account  of  the  specific  nature  of
some biocidal products and the risks associated with
their  proposed  use,  it  is  appropriate  to  provide  for
including
authorisation  procedures, 
simplified 
registration;

information  which 

(7) Whereas  it  is  appropriate  that  the  applicant  submit
dossiers  which  contain 
is
necessary  to  evaluate  the  risks  that  will  arise  from
proposed  uses  of  the  product;  whereas  a  common
core  data  set  for  active  substances  and  for  biocidal
products  in  which  they  are  contained  is  necessary
so  as 
the  applicants  seeking
authorisation  and  those  carrying  out  the  evaluation
to 
authorisation;  whereas,
furthermore,  specific  data  requirements  need  to  be
elaborated for each of the product types covered by
this  Directive;

to  assist  both 

decide 

the 

on 

(8) Whereas  it  is  necessary,  when  biocidal  products  are
being  authorised,  to  make  sure  that,  when  properly
used  for  the  purpose  intended,  they  are  sufficiently
effective  and  have  no  unacceptable  effect  on  the
target  organisms  such  as  resistance  or  unacceptable
tolerance,  and,  in  the  case  of  vertebrate  animals,
unnecessary  suffering  and  pain,  and  have,  in  the
light  of  current  scientific  and  technical  knowledge,
no  unacceptable  effect  on  the  environment  and,  in
particular,  on  human  or  animal  health;

(9) Whereas 

it 

is  necessary 

to  provide  common
principles  for  the  evaluation  and  authorisation  of
biocidal  products  to  ensure  a  harmonised  approach
by  Member  States;

(12) Whereas  it  is  necessary  to  establish  a  Community
list  of  active  substances  permitted  for  inclusion  in
biocidal  products;  whereas  a  Community  procedure
must  be  laid  down  for  assessing  whether  or  not  an
active  substance  can  be  entered  in  the  Community
list;  whereas  the  information  that  interested  parties
must  submit  with  a  view  to  admission  of  an  active
substance  to  the  list  has  to  be  specified;  whereas
active  substances  on  the  list  should  be  reviewed
periodically,  and,  if  appropriate,  compared  with
each  other  under  specific  conditions,  to  take
account 
and
technology;

developments 

science 

of 

in 

(13) Whereas,  when  due  account  is  taken  of  products
which  pose  only  a  low  risk,  their  active  substances
should be incorporated in a specific annex; whereas
substances  the  main  use  of  which  is  non-pesticidal
but  which  have  some  minor  use  as  a  biocide  either
directly,  or  in  a  product  consisting  of  an  active
substance  and  a 
should  be
incorporated  in  a  separate  specific  annex;

simple  diluent 

the 
provisions 

time  Directive  67/548/EEC  on 

(14) Whereas  when  an  active  substance  is  evaluated  for
its entry or otherwise in the relevant annexes of the
Directive,  it  is  necessary  for  such  an  evaluation  to
cover,  where  appropriate,  the  same  aspects  as  those
covered  by  the  evaluation  made  under  Directive
92/32/EEC  of  30  April  1992  amending  for  the
seventh 
the
regulations  and
approximation  of 
administrative 
the
to 
classification,  packaging  and  labelling  of  dangerous
substances (1)  and  Council  Regulation 
(EEC)
No 793/93 of 23 March 1993 on the evaluation and
control  of  the  risks  of  existing  substances (2)  as  far
as  the  risk  assessment 
is  concerned;  whereas,
therefore,  the  risks  associated  with  the  production,
use  and  disposal  of  the  active  substance  and
materials  treated  with  it  are  to  be  considered  in  a
similar  way  as  they  are  in  the  aforementioned
legislation;

relating 

laws, 

(10) Whereas  Member  States  should  not  be  prevented
from  imposing  additional  requirements  on  the  use
of  biocidal  products  in  so  far  as  these  additional
requirements  are  in  conformity  with  Community
law  and  in  particular  do  not  run  counter  to  the
provisions of this Directive; whereas such provisions
are intended to protect the environment and human
and  animal  health  by  means  such  as  epidemic
control  and  food  and  feedingstuff  protection;

substances  and 

(11) Whereas,  in  the  light  of  the  diversity  of  both  the
the  biocidal  products
active 
concerned,  the  data  and  test  requirements  should
suit  the  individual  circumstances  and  result  in  an
overall  risk  assessment;

(15) Whereas it is in the interest of the free circulation of
biocidal  products,  as  well  as  of  materials  treated
with  them,  that  authorisation  granted  by  one
Member  State  should  be  recognised  by  other
Member  States  subject  to  the  specific  conditions
contained  in  this  Directive;

(16) Whereas,  while  envisaging  harmonised  provisions
including  those
for  all  biocidal  product  types, 
intended  to  control  vertebrates,  the  actual  use  of
such  types  might  give  rise  to  concern;  whereas
therefore  Member  States  should  be  allowed,  subject

(1) OJ  L  154,  5.6.1992,  p.  1.
(2) OJ  L  84,  5.4.1993,  p.  1.

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to  the  Treaty,  to  derogate  from  the  principle  of
mutual  recognition  for  biocidal  products  falling
under  three  particular  types  of  biocides  whenever
intended  to  control  particular  kinds  of  vertebrates,
in  so  far  as  such  derogations  are  justified  and  do
not  jeopardise  the  purpose  of  this  Directive;

(17) Whereas  it  is  therefore  desirable  that  a  system  for
the  mutual  exchange  of  information  should  be
established  and 
the
Commission should make available to each other on
request  the  particulars  and  scientific  documentation
submitted 
in  connection  with  applications  for
authorisation  of  biocidal  products;

that  Member  States  and 

comply  with 

(18) Whereas it should be possible for Member States to
authorise,  for  a  limited  period  of  time,  biocidal
products  which  do  not 
the
abovementioned  conditions,  especially  in  the  event
of  an  unforeseen  danger 
threatening  humans,
animals  or  the  environment  which  cannot  be
contained  by  other  means;  whereas  the  Community
procedure  should  not  prevent  Member  States  from
authorising,  for  a  limited  period  of  time  for  use  in
their  territory,  biocidal  products  containing  an
active  substance  not  yet  entered  in  the  Community
list,  provided  that  a  dossier  meeting  Community
requirements  has  been  submitted  and  the  Member
State  concerned  believes  that  the  active  substance
and  the  biocidal  product  satisfy  the  Community
conditions  set  for  them;

(19) Whereas  it  is  essential  that  this  Directive  help  to
minimise  the  number  of  tests  on  animals  and  that
testing  should  be  made  dependent  on  the  purpose
and  use  of  a  product;

(20) Whereas  close  coordination  should  be  ensured  with
other  Community  legislation  and  in  particular  with
Directive 91/414/EEC, the Directives concerned with
the  protection  of  water  and  those  concerned  with
the  contained  use  and  deliberate 
release  of
genetically modified organisms;

for 

guidance 

in  particular  on 

(21) Whereas  the  Commission  is  to  draw  up  technical
notes 
the
implementation of the authorisation procedures, the
entry  of  active  substances 
in  the  appropriate
Annexes,  the  Annexes  relating  to  data  requirements
and 
common
principles;

the  Annex  dealing  with 

the 

are  satisfied  when  they  are  placed  on  the  market,
Member  States 
for
appropriate  control  and  inspection  arrangements;

should  make  provision 

(23) Whereas  the  implementation  of  this  Directive,  the
adaptation  of  its  Annexes  to  the  development  of
technical and scientific knowledge and the inclusion
of  active  substances  in  the  appropriate  Annexes
the
necessitate 
Commission, the Member States and the applicants;
whereas,  in  cases  where  the  procedure  of  the
Standing  Committee  on  Biocidal  Products  is  to  be
applied,  this  constitutes  a  suitable  basis  for  such
cooperation;

cooperation 

between 

close 

(24) Whereas an agreement on a modus vivendi between
the  European  Parliament,  the  Council  and  the
Commission  concerning  the  implementing  measures
for  acts  adopted  in  accordance  with  the  procedure
laid  down  in  Article  189b  of  the  EC  Treaty  was
reached  on  20  December  1994 (1);

(25) Whereas  the  Commission  will  apply  the  modus
vivendi  to  the  implementing  measures  flowing  from
this  Directive  that  it  envisages  adopting,  including
those  concerning  Annexes  IA  and  IB;

(26) Whereas,  since  the  full  implementation  of  this
Directive, and especially the review programme, will
not  be  achieved 
for  several  years,  Directive
76/769/EEC  provides  a  framework  to  complement
the development of the positive list by limitations of
the  marketing  and  use  of  certain  active  substances
and  products  or  groups  thereof;

to 

(27) Whereas the review programme on active substances
take  account  of  other  work
will  need 
programmes  within 
framework  of  other
the 
Community legislation concerned with the review or
authorisation of substances and products or relevant
international  Conventions;

(28) Whereas the costs of the procedures associated with
the  operation  of  the  Directive  need  to  be  recovered
from  those  seeking  to  place,  or  placing,  biocidal
products  on  the  market  and  from  those  supporting
the  entries  of  active  substances  in  the  relevant
Annexes;

(29) Whereas  minimum  rules  concerning  the  use  of
biocidal  products  at  work  are  laid  down  under
Directives  on  health  and  safety  at  work;  whereas  it
is  desirable  to  develop  further  rules  in  this  area,

(22) Whereas,  in  order  to  ensure  that  the  requirements
laid down in respect of authorised biocidal products

(1) OJ  C  102,  4.4.1996,  p.  1.

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HAVE  ADOPTED  THIS  DIRECTIVE:

Article  1

Scope

1.

This  Directive  concerns:

(a)

the  authorisation  and  the  placing  on  the  market  for
use  of  biocidal  products  within  the  Member  States;

(b)

the  mutual  recognition  of  authorisations  within  the
Community;

(c)

the  establishment  at  Community  level  of  a  positive
list  of  active  substances  which  may  be  used  in
biocidal  products.

This  Directive  shall  apply  to  biocidal  products  as
2.
defined  in  Article  2(1)(a)  but  shall  exclude  products  that
are  defined  or  within  the  scope  of  the  following
instruments  for  the  purposes  of  these  Directives:

(a) Council Directive 65/65/EEC of 26 January 1965 on
the  approximation  of  provisions  laid  down  by  law,
regulation  or  administrative  action  relating 
to
proprietary  medicinal  products (1),

laying  down
veterinary  medicinal  products  and 
additional  provisions  on  homeopathic  veterinary
medicinal  products (5),

(f) Council  Regulation  (EEC)  No  2309/93  of  22  July
1993  laying  down  Community  procedures  for  the
authorisation  and  supervision  of  medicinal  products
for  human  and  veterinary  use  and  establishing  a
European  Agency  for  the  Evaluation  of  Medicinal
Products (6),

(g) Council  Directive  90/385/EEC  of  20  June  1990  on
the approximation of the laws of the Member States
relating  to  active  implantable  medical  devices (7),

(h) Council  Directive  93/42/EEC  of  14  June  1993

concerning  medical  devices (8),

(i) Council Directive 89/107/EEC of 21 December 1988
on  the  approximation  of  the  laws  of  the  Member
States  concerning  food  additives  authorised  for  use
in  foodstuffs  intended  for  human  consumption (9),
Council  Directive  88/388/EEC  of  22  June  1988  on
the approximation of the laws of the Member States
relating  to  flavourings  for  use  in  foodstuffs  and  to
their  production (10)  and
source  materials 
European 
and  Council  Directive
No  95/2/EC  of  20  February  1995  on  food  additives
other  than  colours  and  sweeteners (11),

for 
Parliament 

(b) Council Directive 81/851/EEC of 28 September 1981
on  the  approximation  of  the  laws  of  the  Member
States  on  veterinary  medicinal  products (2),

(j) Council Directive 89/109/EEC of 21 December 1988
on  the  approximation  of  the  laws  of  the  Member
States  relating  to  materials  and  articles  intended  to
come  into  contact  with  foodstuffs (12),

(c) Council Directive 90/677/EEC of 13 December 1990
extending  the  scope  of  Directive  81/851/EEC  on  the
approximation  of  the  laws  of  the  Member  States
relating  to  veterinary  medicinal  products  and  laying
immunological
down  additional  provisions 
medicinal  products (3),

for 

(d) Council  Directive  92/73/EEC  of  22  September  1992
widening  the  scope  of  Directives  65/65/EEC  and
75/319/EEC on the approximation of provisions laid
down  by  law,  regulation  or  administrative  action
relating  to  medicinal  products  and  laying  down
additional  provisions  on  homeopathic  medicinal
products (4),

(e) Council  Directive  92/74/EEC  of  22  September  1992
widening  the  scope  of  Directive  81/851/EEC  on  the
approximation  of  provisions  laid  down  by  law,
to
regulation  or  administrative  action  relating 

(k) Council Directive 92/46/EEC of 16 June 1992 laying
down the health rules for the production and placing
on  the  market  of  raw  milk,  heat-treated  milk  and
milk  based  products (13),

(l) Council  Directive  89/437/EEC  of  20  June  1989  on
hygiene and health problems affecting the production
and  the  placing  on  the  market  of  egg  products (14),

(5) OJ  L  297,  13.10.1992,  p.  12.
(6) OJ  L  214,  24.8.1993,  p.  1.
(7) OJ  L  189,  20.7.1990,  p.  17.  Directive  as  last  amended  by

Directive  93/68/EEC  (OJ  L  220,  31.8.1993,  p.  1).

(8) OJ  L  169,  12.7.1993,  p.  1.
(9) OJ  L  40,  11.2.1989,  p.  27.  Directive  as  amended  by

Directive  94/34/EC  (OJ  L  237,  10.9.1994,  p.  1).

(10) OJ  L  184,  15.7.1988,  p.  61.  Directive  as  amended  by

Directive  91/71/EEC  (OJ  L  42,  15.2.1991,  p.  25).

(11) OJ L 61, 18.3.1995, p. 1. Directive as amended by Directive

(1) OJ  22,  9.2.1965,  p.  369.  Directive  as  last  amended  by

96/85/EC  (OJ  L  86,  28.3.1997,  p.  4).

Directive  93/39/EEC  (OJ  L  214,  24.8.1993,  p.  22).

(2) OJ  L  317,  6.11.1981,  p.  1.  Directive  as  last  amended  by

(12) OJ  L  40,  11.2.1989,  p.  38.
(13) OJ  L  268,  14.9.1992,  p.  1.  Directive  as  last  amended  by

Directive  93/40/EEC  (OJ  L  214,  24.8.1993,  p.  31).

Directive  94/71/EC  (OJ  L  368,  31.12.1994,  p.  33).

(3) OJ  L  373,  31.12.1990,  p.  26.
(4) OJ  L  297,  13.10.1992,  p.  8.

(14) OJ  L  212,  22.7.1989,  p.  87.  Directive  as  last  amended  by

the  1994  Act  of  Accession.

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(m) Council Directive 91/493/EEC of 22 July 1991 laying
down  the  health  conditions  for  the  production  and
the  placing  on  the  market  of  fishery  products (1),

(b) Directive  79/117/EEC  of  21  December  1978
prohibiting  the  placing  on  the  market  and  use  of
plant  protection  products  containing  certain  active
substances (10),

(n) Council  Directive  90/167/EEC  of  26  March  1990
laying  down 
the
preparation,  placing  on  the  market  and  use  of
medicated  feedingstuffs  in  the  Community (2),

conditions 

governing 

the 

(o) Council Directive 70/524/EEC of 23 November 1970
in  feedingstuffs (3),  Council
concerning  additives 
Directive  82/471/EEC  of  30  June  1982  on  certain
products  used  in  animal  nutrition (4)  and  Council
Directive  77/101/EEC  of  23  November  1976  on  the
marketing  of  straight  feedingstuffs (5),

(p) Council  Directive  76/768/EEC  of  27  July  1976  on
the approximation of the laws of the Member States
relating  to  cosmetic  products (6),

(q) Council  Directive  95/5/EC  of  27  February  1995
amending  Directive  92/120/EEC  on  the  conditions
for granting temporary and limited derogations from
specific  Community  health  rules  on  the  production
and  marketing  of  certain  products  of  animal
origin (7),

(r) Council  Directive  91/414/EEC  of  15  July  1991
concerning  the  placing  of  plant  protection  products
on  the  market (8).

(c) Council  Regulation  (EEC)  No  2455/92  of  23  July
1992  concerning  the  export  and  import  of  certain
dangerous chemicals (11),

(d) Council  Directive  80/1107/EEC  of  27  November
1980,  on  the  protection  of  workers  from  the  risks
related  to  exposure  to  chemical,  physical  and
biological  agents  at  work (12),  Council  Directive
89/391/EEC  of  12  June  1989  on  the  introduction  of
measures  to  encourage  improvements  in  the  safety
and  health  of  workers  at  work (13)  and  individual
Directives  based  on  these  Directives,

to 

(e) Council Directive 84/450/EEC of 10 September 1984
laws,
the
misleading

relating 
regulations  or  administrative  provisions  of 
Member 
advertising (14).

the  approximation  of 

concerning 

States 

the 

Article 20 shall not apply to the carriage of biocidal

4.
products  by  rail,  road,  inland  waterway,  sea  or  air.

Article  2

Definitions

This  Directive  shall  apply,  without  prejudice  to
3.
relevant  Community  provisions  or  measures  taken  in
accordance  with  them,  in  particular,  to:

For  the  purposes  of  this  Directive  the  following

1.
definitions  shall  apply:

(a) Council  Directive  76/769/EEC  of  27  July  1976  on
the  approximation  of  the  laws,  regulations  and
administrative  provisions  of  the  Member  States
relating  to  restrictions  on  the  marketing  and  use  of
certain  dangerous  substances  and  preparations (9),

(1) OJ  L  268,  24.9.1991,  p.  15.  Directive  as  last  amended  by

Directive  95/71/EC  (OJ  L  332,  30.12.1995,  p.  40).

(2) OJ  L  92,  7.4.1990,  p.  42.
(3) OJ  L  270,  14.12.1970,  p.  1.  Directive  as  last  amended  by

Directive  97/6/EC  (OJ  L  35,  5.2.1997,  p.  11).

(4) OJ  L  213,  21.7.1982,  p.  8.  Directive  as  last  amended  by

Directive  96/25/EC  (OJ  L  125,  23.5.1996,  p.  35).

(a) Biocidal  products

Active substances and preparations containing one or
more  active  substances,  put  up  in  the  form  in  which
they  are  supplied  to  the  user,  intended  to  destroy,
deter,  render  harmless,  prevent  the  action  of,  or
otherwise  exert  a  controlling  effect  on  any  harmful
organism  by  chemical  or  biological  means.

An  exhaustive  list  of  23  product  types  with  an
indicative  set  of  descriptions  within  each  type  is
given  in  Annex  V.

(5) OJ  L  32,  3.2.1977,  p.  1.  Directive  as  last  amended  by  the

(10) OJ  L  33,  8.2.1979,  p.  36.  Directive  as  last  amended  by  the

1994  Act  of  Accession.

1994  Act  of  Accession.

(6) OJ  L  262,  27.9.1976,  p.  169.  Directive  as  last  amended  by

Directive  97/18/EC  (OJ  L  114,  11.5.1997,  p.  43).

(7) OJ  L  51,  8.3.1995,  p.  12.
(8) OJ  L  230,  19.8.1991,  p.  1.  Directive  as  last  amended  by

Directive  96/68/EC  (OJ  L  277,  30.10.1996,  p.  25).

(9) OJ  L  262,  27.9.1976,  p.  201.  Directive  as  last  amended  by

Directive  97/16/EC  (OJ  L  116,  6.5.1997,  p.  31).

(11) OJ  L  251,  29.8.1992,  p.  13.  Regulation  as  last  amended
by  Regulation  (EC)  No  1492/96  (OJ  L  189,  30.7.1996,
p.  19).

(12) OJ L 327, 3.12.1980, p. 8. Directive as last amended by the

1994  Act  of  Accession.
(13) OJ  L  183,  29.6.1989,  p.  1.
(14) OJ  L  250,  19.9.1984,  p.  17.

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(b) Low-risk  biocidal  product

(f) Harmful  organism

A  biocidal  product  which  contains  as  active
substance(s)  only  one  or  more  of  those  listed  in
Annex 
I A  and  which  does  not  contain  any
substance(s)  of  concern.

Under  the  conditions  of  use,  the  biocidal  product
shall  pose  only  a  low  risk  to  humans,  animals  and
the  environment.

(c) Basic  substance

A  substance  which  is  listed  in  Annex  I B,  whose
major  use  is  non-pesticidal  but  which  has  some
minor use as a biocide either directly or in a product
consisting  of  the  substance  and  a  simple  diluent
which itself is not a substance of concern and which
is  not  directly  marketed  for  this  biocidal  use.

The  substances,  which  could  potentially  enter
Annex  IB  in  accordance  with  the  procedure  laid
down  in  Articles  10  and  11,  are  inter  alia  the
following:

— carbon  dioxide,

— nitrogen,

— ethanol,

— 2-propanol,

— acetic acid,

— kieselguhr.

(d) Active  substance

A substance or micro-organism including a virus or a
fungus having general or specific action on or against
harmful  organisms.

(e) Substance  of  concern

Any  substance,  other  than  the  active  substance,
which  has  an  inherent  capacity  to  cause  an  adverse
effect on humans, animals or the environment and is
present  or  is  produced  in  a  biocidal  product  in
sufficient  concentration  to  create  such  an  effect.

Such  a  substance,  unless  there  are  other  grounds  for
concern,  would  be  normally  a  substance  classified
as  dangerous  according 
to  Council  Directive
67/548/EEC  of  27  June  1967  on  the  approximation
of  laws,  regulations  and  administrative  provisions
relating  to  the  classification,  packaging  and  labelling
of  dangerous  substances (1),  and  present 
in  the
biocidal  product  at  a  concentration  leading  the
product  to  be  regarded  as  dangerous  within  the
meaning  of  Article  3  of  Council  Directive
88/379/EEC of 7 June 1988 on the approximation of
the laws, regulations and administrative provisions of
the  Member  States  relating  to  the  classification,
packaging 
dangerous
labelling 
preparations (2).

and 

of 

Any  organism  which  has  an  unwanted  presence  or  a
detrimental  effect  for  humans,  their  activities  or  the
products  they  use  or  produce,  or  for  animals  or  for
the  environment.

(g) Residues

One  or  more  of  the  substances  present  in  a  biocidal
product which remains as a result of its use including
the  metabolites  of  such  substances  and  products
resulting  from  their  degradation  or  reaction.

(h) Placing  on  the  market

Any supply, whether in return for payment or free of
charge,  or  subsequent  storage  other  than  storage
followed  by  consignment  from  the  customs  territory
of  the  Community  or  disposal.  Importation  of  a
biocidal  product  into  the  customs  territory  of  the
Community shall be deemed to constitute placing on
the  market  for  the  purposes  of  this  Directive.

(i) Authorisation

An  administrative  act  by  which  the  competent
authority of a Member State authorises, following an
application submitted by an applicant, the placing on
the market of a biocidal product in its territory or in
a  part  thereof.

(j) Frame-formulation

Specifications  for  a  group  of  biocidal  products
having  the  same  use  and  user  type.

This group of products must contain the same active
substances  of  the  same  specifications,  and  their
compositions  must  present  only  variations  from  a
previously  authorised  biocidal  product  which  do  not
affect the level of risk associated with them and their
efficacy.

In  this  context,  a  variation  is  the  allowance  of  a
reduction  in  the  percentage  of  the  active  substance
and/or  an  alteration  in  percentage  composition  of
one  or  more  non-active  substances  and/or  the
replacement of one or more pigments, dyes, perfumes
by  others  presenting  the  same  or  a  lower  risk,  and
which  do  not  decrease  its  efficacy.

(k) Registration

An  administrative  act  by  which  the  competent
authority  of  a  Member  State, 
following  an
application 
submitted  by  an  applicant,  after
verification  that  the  dossier  meets  the  relevant
requirements  of  this  Directive,  allows  the  placing  on
the  market  of  a  low-risk  biocidal  product  in  its
territory  or  in  a  part  thereof.

(1) OJ  196,  16.8.1967.  Directive  as  last  amended  by  Directive

94/69/EC  (OJ  L  381,  31.12.1994,  p.  1).

(2) OJ  L  187,  16.7.1988,  p.  14).

A  document,  signed  by  the  owner  or  owners  of
relevant  data  protected  under  the  provisions  of  this

(l) Letter  of  access

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Directive,  which  states  that  these  data  may  be  used
by  the  competent  authority  for  the  purpose  of
granting  an  authorisation  or  a  registration  of  a
biocidal  product  under  this  Directive.

For  the  purposes  of  this  Directive  the  definitions

2.
for:

Without  prejudice  to  Articles  8  and  12  and  providing
that  the  applicant  has  a  right  of  access  to  the
frame-formulation in the form of a letter of access, when
a  subsequent  application  for  authorisation  for  a  new
biocidal  product  is  based  on  this  frame-formulation,  the
competent  authority  shall  take  a  decision  with  regard  to
this  application  within  a  period  of  60  days.

(a)

substance,

(b) preparation,

(c)

scientific  research  and  development,

(d) process-orientated  research  and  development

laid  down  in  Article  2  of  Council  Directive  67/548/EEC
shall apply.

Article  3

Authorisation  for  placing  on  the  market  of  biocidal
products

1. Member  States  shall  prescribe  that  a  biocidal
product  shall  not  be  placed  on  the  market  and  used  in
their territory unless it has been authorised in accordance
with  this  Directive.

2.

By  way  of  derogation  from  paragraph  1:

(i) Member  States  shall,  subject  to  registration,  allow
the  placing  on  the  market  and  use  of  a  low-risk
biocidal  product,  provided 
in
accordance with Article 8(3) has been submitted and
verified  by  the  competent  authorities.

that  a  dossier 

Unless  otherwise  specified,  all  provisions  relating  to
authorisation under this Directive shall also apply to
registration.

(ii) Member States shall allow the placing on the market
and  use  of  commodity  substances  for  biocidal
purposes  once  they  have  been  entered  in  Annex  IB.

3.

(i) Every  application  for  authorisation  shall  be

decided  on  without  undue  delay.

(ii) For  applications  for  biocidal  products  that
require  registration,  the  competent  authority
shall  take  a  decision  within  a  period  of  60
days.

4. Member  States  shall,  on  request,  or  may,  on
their  own  initiative,  and  where  relevant,  establish  a
frame-formulation  and  communicate  it  to  the  applicant
when  issuing  an  authorisation  for  a  particular  biocidal
product.

5. Member  States 
that  biocidal
products  are  to  be  classified,  packaged  and  labelled  in
accordance  with  the  provisions  of  this  Directive.

shall  prescribe 

6. Without  prejudice  to  Article  7(1),  authorisations
shall be granted for a maximum period of 10 years from
the  date  of  first  or  renewed  inclusion  of  the  active
substance in Annex I or I A for the product type, without
exceeding  the  deadline  specified  for  the  active  substance
in Annex I or I A; they may be renewed after verification
that  the  conditions  imposed  in  Article  5(1)  and  (2)  are
still  satisfied.  Renewal  may,  where  necessary,  be  granted
only  for  the  period  necessary  to  allow  the  competent
authorities  of 
to  make  such
the  Member  States 
verification,  where  an  application  for  renewal  has  been
made.

shall  prescribe 

that  biocidal
7. Member  States 
products are to be properly used. Proper use shall include
compliance  with  conditions  established  pursuant  to
Article  5  and  specified  under  the  labelling  provisions  of
this  Directive.  Proper  use  shall  also  involve  the  rational
application  of  a  combination  of  physical,  biological,
chemical  or  other  measures  as  appropriate,  whereby  the
use  of  biocidal  products  is  limited  to  the  minimum
necessary. Where biocidal products are used at work, use
shall  also  be  in  accordance  with  the  requirements  of
Directives  for  the  protection  of  workers.

Article  4

Mutual  recognition  of  authorisations

1. Without  prejudice  to  Article  12,  a  biocidal  product
that  has  already  been  authorised  or  registered  in  one
Member State shall be authorised or registered in another
Member  State  within  120  days,  or  60  days  respectively,
of  an  application  being  received  by  the  other  Member
State,  provided  that  the  active  substance  of  the  biocidal
product  is  included  in  Annex  I  or  I  A  and  conforms  to
the  requirements  thereof.  For  the  mutual  recognition  of
authorisations,  the  application  shall  include  a  summary
of  the  dossier  as  required 
in  Article  8(2)(a)  and
Annex  II  B,  Section  X  and  a  certified  copy  of  the  first
recognition  of
authorisation  granted.  For  mutual 
registration of low-risk biocidal products, the application
shall include the data requirements of Article 8(3), except
for  the  efficacy  data  for  which  a  summary  shall  suffice.

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The  authorisation  may  be  subject  to  provisions  resulting
from the implementation of other measures in accordance
with  Community  law,  relating  to  the  conditions  for
distribution  and  use  of  biocidal  products  intended  to
protect  the  health  of  the  distributors,  users  and  workers
concerned.

This  mutual  recognition  procedure  shall  be  without
prejudice  to  measures  taken  by  Member  States  pursuant
to  Community  law  intended  to  protect  the  health  of
workers.

If,  in  accordance  with  Article  5,  a  Member  State

2.
establishes  that:

(a)

target  species 

the 
quantities,

is  not  present 

in  harmful

(b) unacceptable  tolerance  or  resistance  of  the  target
organism  to  the  biocidal  product  is  demonstrated,
or

(c)

the  relevant  circumstances  of  use,  such  as  climate  or
breeding  period  of 
species,  differ
the 
significantly  from  those  in  the  Member  State  where
the  biocidal  product  was  first  authorised,  and  an
unchanged  authorisation  may 
therefore  present
unacceptable  risks  to  humans  or  the  environment,

target 

the  Member  State  may  request  that  certain  conditions
referred  to  in  Article  20(3)(e),  (f),  (h),  (j)  and  (l)  be
adjusted to the different circumstances, so that conditions
for  issue  of  an  authorisation  laid  down  in  Article  5  are
satisfied.

If  the  procedure  laid  down  in  paragraph  4  leads  to
5.
the  confirmation  of  a  refusal  of  a  second  or  subsequent
registration  by  a  Member  State,  the  Member  State  that
had  previously  registered  the  low-risk  biocidal  product
shall,  where  deemed  appropriate  by 
the  Standing
Committee,  take  this  refusal  into  consideration  and
review  its  registration  according  to  Article  6.

If  this  procedure  confirms  the  initial  registration,  the
Member  State  having  introduced  the  procedure  shall
register  the  low-risk  biocidal  product  concerned.

By  way  of  derogation  from  paragraph  1,  Member
6.
the  Treaty,  mutual
States  may  refuse,  subject 
recognition  of  authorisations  granted 
for  product
types  15,  17  and  23  of  Annex  V  provided  that  such  a
limitation  can  be  justified  and  does  not  jeopardise  the
purpose  of  the  Directive.

to 

Member  States  shall 
the
Commission  of  any  decision  taken  in  this  respect  and
indicate  the  reasons  therefor.

inform  each  other  and 

Article  5

Conditions  for  issue  of  an  authorisation

1. Member  States  shall  authorise  a  biocidal  product
only  if

3. Where  a  Member  State  believes  that  a  low-risk
biocidal  product  which  has  been  registered  by  another
Member  State  does  not  comply  with  the  definition
provided for in Article 2(1)(b), it may provisionally refuse
registration  thereof  and  shall  immediately  communicate
its  concerns  to  the  competent  authority  responsible  for
the  verification  of  the  dossier.

(a)

(b)

If, within a maximum period of 90 days, an agreement is
not  reached  between  the  authorities  concerned,  the
matter  will  be  forwarded  to  the  Commission  for  a
decision  in  accordance  with  the  procedure  laid  down  in
paragraph  4.

4. Notwithstanding  paragraphs  2  and  3,  where  a
Member  State  believes  a  biocidal  product  authorised  by
another Member State cannot meet the conditions set out
pursuant  to  Article  5(1)  and  consequently  proposes  to
refuse  the  authorisation  or  the  registration  or  to  restrict
the  authorisation  under  certain  conditions,  it  shall  notify
the  Commission,  other  Member  States  and  the  applicant
and  shall  provide  them  with  an  explanatory  document
containing  the  name  of  the  product  and  its  specification
and  setting  out  the  grounds  on  which  it  proposes  to
refuse  or  to  restrict  the  authorisation.

The  Commission  shall  prepare  a  proposal  on  these
matters  in  accordance  with  Article  27  for  a  decision
in  accordance  with 
in
Article  28(2).

the  procedure 

laid  down 

the  active  substance(s)  included  therein  are  listed  in
Annex  I  or  IA  and  any  requirements  laid  down  in
these  Annexes  are  fulfilled;

it  is  established,  in  the  light  of  current  scientific  and
technical knowledge, and is shown from appraisal of
the dossier provided for in Article 8, according to the
common  principles  for  the  evaluation  of  dossiers  as
laid  down 
in  Annex  VI,  that,  when  used  as
authorised  and  having  regard  to:

— all  normal  conditions  under  which  the  biocidal

product  may  be  used,

— how  the  material  treated  with  it  may  be  used,

— the  consequences  from  use  and  disposal,

the  biocidal  product:

(i)

is  sufficiently  effective,

(ii) has  no  unacceptable  effects  on  the  target
organisms,  such  as  unacceptable  resistance  or
cross-resistance  or  unnecessary  suffering  and
pain  for  vertebrates,

(iii) has  no  unacceptable  effects  itself  or  as  a  result
of  its  residues,  on  human  or  animal  health,
directly  or  indirectly  (e.g.  through  drinking

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water, food or feed, indoor air or consequences
in  the  place  of  work)  or  on  surface  water  and
groundwater,

(iv) has  no  unacceptable  effect 

itself,  or  as  a
its  residues,  on  the  environment
following
to 

the 

result  of 
having  particular  regard 
considerations:

— its  fate  and  distribution  in  the  environment;
particularly contamination of surface waters
(including 
seawater),
groundwater  and  drinking  water,

estuarian 

and 

information  received  according  to  Article  14,  if  there  are
indications  that  any  of  the  conditions  referred  to  in
Article  5  are  no  longer  satisfied.  In  such  instances  the
Member  States  may  require  the  authorisation  holder,
or  the  applicant  to  whom  a  modification  of  the
in  accordance  with
authorisation  has  been  granted 
Article 7, to submit further information necessary for the
review.  If  need  be,  the  authorisation  may  be  prolonged
only for the period necessary to complete the review, but
shall be prolonged for the period necessary to provide for
further  information.

— its  impact  on  non-target  organisms;

Article  7

(c)

the  nature  and  quantity  of  its  active  substances
and,  where  appropriate,  any  toxicologically  or
ecotoxicologically 
and
significant 
co-formulants,  and  its  residues  of  toxicological  or
environmental 
from
significance,  which 
authorised  uses,  can  be  determined  according  to  the
relevant  requirements  in  Annex  IIA,  IIB,  IIIA,  IIIB,
IVA  or  IVB;

impurities 

result 

(d)

its  physical  and  chemical  properties  have  been
determined  and  deemed  acceptable  for  purposes  of
the  appropriate  use,  storage  and  transport  of  the
product.

classified  according 

A  biocidal  product 

2.
to
Article  20(1)  as  toxic,  very  toxic  or  as  a  category  1  or  2
carcinogen, or as a category 1 or 2 mutagen or classified
as  toxic  for  reproduction  category  1  or  2,  shall  not  be
authorised  for  marketing  to,  or  use  by  the  general
public.

3.
Authorisation  may  be  conditional  on,  and  must
stipulate  the  conditions  relating  to  marketing  and  use
necessary  to  ensure  compliance  with  the  provisions  of
paragraph  1.

4. Where  other  Community  provisions 
impose
requirements relevant to the conditions for the issue of an
authorisation  and  for  use  of  the  biocidal  product,  and
particularly  where  these  are  intended  to  protect  the
health  of  distributors,  users,  workers  and  consumers  or
animal  health  or 
the  competent
authority  shall  take  these  into  account  when  issuing  an
the
authorisation  and  where  necessary  shall 
authorisation  subject  to  those  requirements.

the  environment, 

issue 

Article  6

Review  of  an  authorisation

Cancellation  or  modification  of  an  authorisation

1.

An  authorisation  shall  be  cancelled  if:

(a)

the active substance is no longer included in Annex I
or  IA  as  required  by  Article  5(1)(a);

(b)

the conditions within the meaning of Article 5(1) for
obtaining  the  authorisation  are  no  longer  satisfied;

(c)

it  is  discovered  that  false  or  misleading  particulars
were  supplied  concerning  the  facts  on  the  basis  of
which  the  authorisation  was  granted.

2.
An  authorisation  may  also  be  cancelled  if  the
authorisation  holder  so  requests  and  states  the  reasons
for  the  cancellation.

3. When  a  Member  State 
intends  to  cancel  an
authorisation,  it  shall  inform  and  hear  the  authorisation
holder.  When  cancelling  the  authorisation,  the  Member
State  may  grant  a  period  of  grace  for  the  disposal  or  for
the  storage,  marketing  and  use  of  existing  stocks,  of  a
length  in  accordance  with  the  reason  for  the  cancellation
without  prejudice  to  any  period  provided  for  by  decision
taken pursuant to Directive 76/769/EEC or in connection
with  paragraph  1(a).

4. Where  a  Member  State  considers  it  necessary,  on
the  basis  of  developments  in  scientific  and  technical
knowledge  and  to  protect  health  and  the  environment,  it
shall  modify  the  conditions  of  use  of  an  authorisation
and,  in  particular,  the  manner  of  use  or  the  amounts
used.

5.
An  authorisation  may  also  be  modified  if  the
authorisation holder requests it and states the reasons for
the  modification.

6. Where  a  proposed  modification  concerns  an
extension  of  uses,  a  Member  State  shall  extend  the
authorisation  subject  to  the  particular  conditions  placed
on  the  active  substance  listed  in  Annex  I  or  IA.

During  the  period  for  which  an  authorisation  has  been
granted,  it  may  be  reviewed  at  any  time,  e.g.  following

7. Where  a  proposed  modification  of  an  authorisation
involves  changes  to  the  particular  conditions  placed  on

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the active substance listed in Annex I or IA, such changes
can be made only after evaluation of the active substance,
with  regard  to  the  proposed  changes,  in  accordance  with
the  procedures  laid  down  in  Article  11.

(iii)

intended  uses:

3.1. product  type  (Annex  V)  and  field  of  use,

is
8. Modifications  shall  be  granted  only 
established  that  the  conditions  within  the  meaning  of
Article  5  remain  satisfied.

it 

if 

3.2. category  of  users,

3.3. method  of  use,

(iv) efficacy data,

Article  8

(v) analytical methods,

Requirements  for  authorisation

(vi) classification,  packaging  and  labelling,  including  a

draft  label,  according  to  Article  20,

1.
Application  for  authorisation  shall  be  made  by,  or
on  behalf  of,  the  person  who  will  be  responsible  for  the
first  placing  on  the  market  of  a  biocidal  product  in  a
particular  Member  State  and  shall  be  to  the  competent
authority  of  that  Member  State.  Every  applicant  shall
be  required  to  have  a  permanent  office  within  the
Community.

2. Member  States  shall  require  that  an  applicant  for
authorisation  of  a  biocidal  product  shall  submit  to  the
competent  authority:

(a) a dossier or a letter of access for the biocidal product
satisfying,  in  the  light  of  current  scientific  and
technical  knowledge,  the  requirements  set  out  in
Annex IIB and, where specified, the relevant parts of
Annex  IIIB,  and

(b)

for  each  active  substance  in  the  biocidal  product,  a
dossier  or  a  letter  of  access  satisfying,  in  the  light  of
current  scientific  and  technical  knowledge,  the
requirements  set  out  in  Annex  IIA  and,  where
specified,  the  relevant  parts  of  Annex  IIIA.

3.
By way of derogating from paragraph 2(a), Member
States  shall  require  a  dossier  comprising  the  following
data  for  a  low-risk  biocidal  product:

(i) applicant:

1.1. name  and  address,

(vii)

safety  data  sheet  prepared  in  accordance  with
Article  10  of  Council  Directive  88/379/EEC  of
7  June  1988  on  the  approximation  of  the  laws,
regulations,  and  administrative  provisions  of  the
Member  States  relating 
the  classification,
packaging and labelling of dangerous substances (1),
or  Article  27  of  Directive  67/548/EEC.

to 

4.
The  dossiers  shall  include  a  detailed  and  full
description  of  the  studies  conducted  and  of  the  methods
used or a bibliographical reference to those methods. The
information  in  the  dossiers  supplied  in  accordance  with
Article  8(2)  shall  be  sufficient  for  an  evaluation  to  be
made  of  the  effects  and  properties  referred  to 
in
Article  5(1)(b),  (c)  and  (d).  It  shall  be  submitted  to  the
competent  authority  in  the  form  of  technical  dossiers,
containing  the  information  and  results  of  the  studies
referred  to  in  Annexes  IIA  and  IIB  and,  where  specified,
the  relevant  parts  of  Annexes  IIIA  and  IIIB.

5.
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.  Such  a
justification  may  be  the  existence  of  a  frame-formulation
which  the  applicant  has  the  right  to  access.

1.2. manufacturers of the biocidal product and the

active substances,
(names  and  addresses  including  location  of
manufacturer  of  the  active  substance)

1.3. where  appropriate,  a  letter  of  access  to  any

relevant  data  needed,

6.
If  the  evaluation  of  the  dossier  shows  that  further
information,  including  data  and  results  from  further
testing,  is  necessary  to  evaluate  the  risks  of  the  biocidal
product,  the  competent  authority  shall  ask  the  applicant
to  submit  such  information.  The  time  period  for  the
evaluation of the dossier shall start only after the dossier
is  complete.

(ii)

identity  of  the  biocidal  product:

2.1.

trade  name,

2.2.

full  composition  of  the  biocidal  product,

7.
The  name  of  an  active  substance  must  be  given  as
registered  in  the  list  contained  in  Annex  I  to  Directive

2.3. physical and chemical properties as referred to

in  Article  5(1)(d),

(1) OJ  L  187,  16.7.1988,  p.  14.  Directive  as  amended  by

Directive  93/18/EEC  (OJ  L  104,  29.4.1993,  p.  46).

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the  active 

67/548/EEC  or,  if  the  name  is  not  included  therein,  as
given  in  the  European  Inventory  of  Existing  Chemical
Substances  (Einecs),  or,  if  the  name  is  not  included
therein, 
its
International  Standards  Organisation  (ISO)  common
name. If the latter is not available, the substance must be
designated  by  its  chemical  designation  according  to
International  Union  of  Pure  and  Applied  Chemistry
(IUPAC)  rules.

substance  must  be  given 

8.
As  a  general  principle,  tests  must  be  conducted
according  to  the  methods  described  in  Annex  V  to
Directive  67/548/EEC.  In  the  event  of  a  method  being
inappropriate  or  not  described,  other  methods  used
should,  whenever  possible,  be  internationally  recognised
and  must  be  justified.  Where  appropriate,  tests  must  be
conducted  in  accordance  with  the  provisions  laid  down
in  Council  Directive  86/609/EEC  of  24  November  1986
on 
regulations  and
administrative provisions of the Member States regarding
the protection of animals used for experimental and other
scientific purposes (1) and Council Directive 87/18/EEC of
18  December  1986  on  the  harmonisation  of  laws,
regulations  and  administrative  provisions  relating  to  the
application  of  the  principles  of  good  laboratory  practice
and  the  verification  of  their  applications  for  tests  on
chemical  substances (2).

the  approximation  of 

laws, 

those 

laid  down 

9. Where  test  data  exist  that  have  been  generated
before  the  adoption  of  this  Directive  by  methods  other
than 
to  Directive
67/548/EEC,  the  adequacy  of  such  data  for  the  purposes
of  this  Directive  and  the  need  to  conduct  new  tests
according to Annex V must be decided on a case-by-case
basis, taking into account, among other factors, the need
to  minimise  testing  on  vertebrate  animals.

in  Annex  V 

10.
Competent  authorities  as  referred  to  within  the
meaning of Article 26 shall ensure that a file is compiled
on each application. Each file shall contain at least a copy
of  the  application,  a  record  of  the  administrative
decisions  taken  by  the  Member  State  concerning  the
application  and  concerning  the  dossiers  submitted  in
accordance  with  paragraph  2,  together  with  a  summary
of  the  latter.  On  request,  Member  States  shall  make
available  to  the  other  competent  authorities  and  to  the
Commission the files provided for in this paragraph; they
shall  supply  to  them,  on  request,  all 
information
necessary  for  full  comprehension  of  applications  and
shall,  where  requested,  ensure  that  applicants  provide  a
copy  of  the  technical  documentation  laid  down  in
paragraph  2.

Article  9

Placing  on  the  market  of  active  substances

Member  States  shall  prescribe  that  where  a  substance  is
an  active  substance  for  use  in  biocidal  products  it  may
not  be  placed  on  the  market  for  such  use  unless:

(a) where  the  active  substance  was  not  on  the  market
before the date referred to in Article 34(1), a dossier
has  been  forwarded  to  a  Member  State,  which
satisfies  the  requirements  of  Article  11(1)  and  is
accompanied  by  the  declaration  that  the  active
substance  is  intended  for  inclusion  in  a  biocidal
product.  This  shall  not  apply  to  substances  for  use
pursuant  to  Article  17;

(b)

it  is  classified,  packaged  and  labelled  in  accordance
with  the  provisions  of  Directive  67/548/EEC.

Article  10

Inclusion  of  an  active  substance  in  Annexes  I,
IA  or  IB

In  the  light  of  current  scientific  and  technical
1.
knowledge,  an  active  substance  shall  be  included  in
Annex  I,  Annex  IA  or  IB  for  an  initial  period  not
exceeding  10  years  if  it  may  be  expected  that

— biocidal  products  containing  the  active  substance,

— low-risk  biocidal  products  complying  with 

the

definition  in  Article  2(1)(b),

— commodity  substances  complying  with  the  definition

in  Article  2(1)(c),

will  fulfil  the  conditions  laid  down  in  Article  5(1)(b),  (c)
and  (d),  taking  into  account,  where  relevant,  cumulation
effects  from  the  use  of  biocidal  products  containing  the
same  active  substances.

An active substance cannot be included in Annex IA if it
is  classified  according  to  Directive  67/548/EEC  as:

— carcinogenic,

— mutagenic,

11. Member  States  my  require  that  samples  of  the
preparation  and  of  its  ingredients  be  provided.

— toxic  for  reproduction,

— sensitising,  or

12. Member  States  may  require  that  applications  for
authorisation  be  submitted  in  their  national  or  official
languages  or  one  of  these  languages.

(1) OJ  L  358,  18.12.1986,  p.  1.
(2) OJ  L  15,  17.1.1987,  p.  29.

— is  bioaccumulative  and  does  not  readily  degrade.

Where  appropriate,  the  entry  of  an  active  substance  in
Annex IA shall refer to the concentration ranges between
which  the  substance  can  be  used.

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Inclusion of an active substance in Annexes I, IA or
2.
IB  shall,  where  appropriate,  be  subject  to  the  following:

be used in authorised biocidal products, risks
to  health  or  the  environment  still  give  rise  to
concern,  and

(i)

requirements  on:

(a)

the  minimum  degree  of  purity  of  the  active
substance,

(b)

the  nature  and  maximum  content  of  certain
impurities,

(c) product  type  in  which  it  may  be  used,

(d) manner  and  area  of  use,

(e) designation of categories of users (e.g. industrial,

professional  or  non-professional),

(f) other  particular  conditions  from  the  evaluation
information  which  has  been  made

of  the 
available  in  the  context  of  this  Directive;

(ii)

the  establishment  of  the  following:

(a) acceptable  operator  exposure  level  (AOEL),  if

necessary,

(b) where  relevant,  an  acceptable  daily  intake  for
man  (ADI)  and  a  maximum  residue 
limit
(MRL),

(c)

fate  and  behaviour  in  the  environment  and
impact  on  non-target  organisms.

The  inclusion  in  Annex  I,  IA  or  IB  of  an  active
3.
substance  shall  be  restricted  to  those  product  types  in
Annex V for which relevant data have been submitted in
accordance  with  Article  8.

4.
The inclusion of an active substance in Annex I, IA
or  IB  may  be  renewed  on  one  or  more  occasions  for
periods  not  exceeding  10  years.  The  initial  inclusion,  as
well  as  any  renewed  inclusion,  may  be  reviewed  at  any
time  if  there  are  indications  that  any  of  the  requirements
referred  to  in  paragraph  1  are  not  longer  satisfied.
Renewal  may,  where  necessary,  be  granted  only  for  the
minimum  period  necessary  to  complete  a  review,  where
an application has been made for such renewal, and shall
be  granted  for  the  period  necessary  to  provide  further
information  requested  in  accordance  with  Article  11(2).

5.

(i) An  entry  of  an  active  substance  in  Annex  I  and,
where  relevant,  IA  or  IB  may  be  refused  or
removed,

— if  there 

is  another  active  substance  on
Annex  I  for  the  same  product  type  which,  in
the  light  of  scientific  or  technical  knowledge,
presents  significantly  less  risk  to  health  or  to
the  environment.

When such a refusal or removal is considered, an
assessment  of  an  alternative  active  substance  or
substances shall take place to demonstrate that it
can  be  used  with  similar  effect  on  the  target
organism  without  significant  economic  and
practical  disadvantages  for  the  user  and  without
an 
the
environment.

for  health  or 

increased 

risk 

for 

The  assessment  shall  be  circulated  in  accordance
with  the  procedures  in  Article  11(2)  for  decision
in  accordance  with  the  procedures  laid  down  in
Articles  27  and  28(3).

(ii) The refusal or removal of an Annex I and, where
relevant,  IA  or  IB  entry  shall  be  carried  out
under  the  following  conditions:

1.

2.

the chemical diversity of the active substances
should be adequate to minimise occurrence of
resistance  in  the  target  organism;

it should be applied only to active substances
which, when used under normal conditions in
authorised  biocidal  products,  present  a
significantly  different  level  of  risk;

3.

it should be applied only to active substances
used  in  products  of  the  same  product  type;

4.

5.

it  should  be  applied  only  after  allowing  the
possibility,  where  necessary,  of  acquiring
experience  from  use  in  practice,  if  it  is  not
already available;

the  complete  data  dossiers  of  the  evaluation
serving or having served for entry in Annex I,
IA  or  IB  shall  be  put  at  the  disposal  of  the
Committee  referred  to  in  Article  28(3).

— if  the  evaluation  of  the  active  substance  in
accordance  with  Article  11(2)  shows  that,
under  normal  conditions  under  which  it  may

(iii) A  decision  to  remove  an  Annex  I  entry  shall  not
have  immediate  effect  but  shall  be  delayed  for  a
period  of  up  to  a  maximum  of  four  years  from
the  date  of  that  decision.

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Article  11

Procedure for inclusion of an active substance in Annex I,
IA  or  IB

1.
Inclusion, or subsequent changes to the inclusion, of
an  active  substance  in  Annex  I,  IA  or  IB  shall  be
considered  when:

(a) an  applicant  has  forwarded  to  the  competent

authority  of  one  of  the  Member  States:

(i) a  dossier  for  the  active  substance  satisfying  the
requirements  of  Annex  IVA  or  the  requirements
of  Annex  IIA  and,  where  specified,  the  relevant
parts  of  Annex  IIIA;

(ii) a  dossier  for  at  least  one  biocidal  product
containing  the  active  substance  satisfying  the
requirements  of  Article  8,  with  the  exception  of
paragraph  3  thereof;

(b)

the  receiving  competent  authority  has  verified  the
dossiers and believes them to satisfy the requirements
of Annex IVA and Annex IVB or the requirements of
Annex  IIA  and  Annex  IIB  and,  where  relevant,
Annexes  IIIA  and  IIIB,  accepts  them  and  agrees  to
the  applicant  forwarding  a  summary  of  the  dossiers
to  the  Commission  and  the  other  Member  States.

2.
The  receiving  competent  authority  shall,  within  12
months of accepting the dossiers, carry out an evaluation
thereof.  A  copy  of  the  evaluation  shall  be  sent  by  the
competent  authority  to  the  Commission,  the  other
Member  States  and  to  the  applicant,  together  with  a
recommendation  for  the  inclusion,  or  otherwise,  of  the
active  substance  in  Annex  I,  IA  or  IB.

If, when the dossiers are evaluated, it appears that further
information  is  necessary  for  full  evaluation  to  be  made,
the  receiving  competent  authority  shall  ask  that  the
applicant submit such information. The 12-month period
shall  be  suspended  from  the  date  of  issue  of  the
competent  authority’s 
the
information  is  received.  The  competent  authority  shall
inform  the  other  Member  States  and  the  Commission  of
its  action  when  it  informs  the  applicant.

request  until 

the  date 

3.
To  avoid  dossiers  being  evaluated  by  only  a  few
Member  States,  the  evaluation  can  be  carried  out  by
Member  States  other  than  the  receiving  one.  A  request
for this shall be given when the dossiers are accepted, and
the  decision  shall  be  taken  in  accordance  with  the
procedure  laid  down  in  Article  28(2).  The  decision  shall
be  taken  at  the  latest  one  month  after  receipt  by  the
Commission  of  the  request.

4. On receipt of the evaluation, the Commission shall,
in accordance with the procedure in Article 27, prepare a
proposal  without  undue  delay  for  decision  in  accordance
with  the  procedure  laid  down  in  Article  28(3).  The

decision  shall  be  taken  at  the  latest  12  months  after  the
receipt  by  the  Commission  of  the  evaluation  referred  to
in  paragraph  2.

Article  12

Use  of  data  held  by  competent  authorities  for  other
applicants

1. Member  States  shall  not  make  use  of 
the
information  referred  to  in  Article  8  for  the  benefit  of  a
second  or  subsequent  applicant:

(a) unless  the  second  or  subsequent  applicant  has  the
written agreement in the form of a letter of access of
the  first  applicant  that  use  may  be  made  of  such
information,  or

(b)

in  the  case  of  an  active  substance  not  on  the  market
on  the  date  referred  to  in  Article  34(1),  for  a  period
of  15  years  from  the  date  of  first  inclusion  in
Annex  I  or  IA,  or

(c)

in  the  case  of  an  active  substance  already  on  the
market  on  the  date  referred  to  in  Article  34(1):

(i)

for  any 

information 

in  Article  34(1) 

for  a  period  of  10  years  from  the  date  referred
to 
information
submitted  for  the  purposes  of  this  Directive,
is  already
except  where  such 
protected  under  existing  national  rules  relating
to  biocidal  products. 
the
information  shall  continue  to  be  protected  in
that  Member  State  until  the  expiry  of  any
remaining  period  of  data  protection  provided
for  under  national  rules,  up  to  a  maximum  of
10  years 
in
the  date 
Article  34(1);

In  such  cases, 

referred 

from 

to 

(ii)

for  a  period  of  10  years  from  the  date  of  entry
of  an  active  substance  onto  Annex  I  or  IA  for
information  submitted  for  the  first  time  in
support of the first inclusion in Annex I or IA of
either  the  active  substance  or  an  additional
product  type  for  that  active  substance,

(d)

in  the  case  of  any  further  information  submitted  for
the  first  time  for  any  of  the  following:

(i) variation  of  the  requirements  of  the  entry  on

Annex  I  or  IA;

(ii) maintenance  of  the  entry  of  Annex  I  or  IA

for  a  period  of  five  years  from  the  date  of  decision
following  receipt  of  further  information  unless  the
five-year  period  expires  before  the  period  provided
for  in  paragraphs  1(b)  and  (c),  in  which  case  the
period of five years shall be extended so as to expire
on  the  same  date  as  those  periods.

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the
2. Member  States  shall  not  make  use  of 
information  referred  to  in  Article  8,  for  the  benefit  of  a
second  or  subsequent  applicant:

Article  13

(a) unless  the  second  or  subsequent  applicant  has  the
written agreement in the form of a letter of access of
the  first  applicant  that  use  may  be  made  of  such
information;  or

(b)

in the case of a biocidal product containing an active
substance  not  on  the  market  on  the  date  referred
to  in  Article  34(1)  for  a  period  of  10  years  from
the  date  of  first  authorisation  in  any  Member  State,
or;

Cooperation in the use of data for second and subsequent
applications  for  authorisation

1.
In  the  case  of  a  biocidal  product  which  has  already
been authorised in accordance with Articles 3 and 5, and
without prejudice to the obligations imposed pursuant to
Article  12,  the  competent  authority  may  agree  that  a
second  or  subsequent  applicant  for  authorisation  may
refer  to  data  provided  by  the  first  applicant  in  so  far  as
the  second  or  subsequent  applicant  can  provide  evidence
that  the  biocidal  product  is  similar  and  its  active
substances  are  the  same  as  the  one  formerly  authorised,
including  degree  of  purity  and  nature  of  impurities.

(c)

in the case of a biocidal product containing an active
substance already on the market on the date referred
to  in  Article  34(1);

2. Notwithstanding  Article  8(2):

(i)

for  any 

in  Article  34(1) 

for  a  period  of  10  years  from  the  date  referred
to 
information
submitted  for  the  purposes  of  this  Directive,
except  in  the  case  where  data  are  already
protected  according  to  existing  national  rules
relating to biocidal products, in which case such
data  shall  be  protected  in  that  Member  State
until the expiry of any remaining period of data
protection  provided  for  under  those  national
rules,  up  to  a  maximum  of  10  years  from  the
date  referred  to  in  Article  34(1);

(ii)

for  a  period  of  10  years  from  the  date  of  entry
of  an  active  substance  onto  Annex  I  or  IA,  for
information which is submitted for the first time
in  support  of  the  inclusion  in  Annex  I  or  IA
either of the active substance or of an additional
product  type  for  that  active  substance;

(d)

in  the  case  of  any  data  submitted  for  the  first  time
for  either  of  the  following:

(i) variation of the conditions of authorisation of a

biocidal  product;

(ii)

submission  of  data  necessary  to  maintain  entry
of  an  active  substance  onto  Annex  I  or  IA

for  a  period  of  five  years  from  the  date  of  first
receipt  of  further  information,  unless  the  five-year
period  expires  before  the  period  in  paragraphs  (b)
and  (c),  in  which  case  the  period  of  five  years  shall
be  extended  so  as  to  expire  on  the  same  date  as
those  periods.

(a) an  applicant  for  authorisation  of  biocidal  products
shall,  before  carrying  out  experiments  involving
the  competent
vertebrate  animals,  enquire  of 
authority  of  the  Member  State  to  which  he  intends
making application:

— whether  the  biocidal  product  for  which  an
application  is  to  be  made  is  similar  to  a  biocidal
product 
for  which  authorisation  has  been
granted,  and

— as  to  the  name  and  address  of  the  holder  or
holders  of  the  authorisation  or  authorisations.

The  enquiry  shall  be  supported  by  evidence  that  the
prospective 
for
authorisation  on  his  own  behalf  and  that  the  other
information  specified  in  Article  8(2)  is  available;

applicant 

intends 

apply 

to 

(b)

the  competent  authority  of  the  Member  State,  if
satisfied  that  the  applicant  intends  to  apply,  shall
provide  the  name  and  address  of  the  holder  or
holders of former relevant authorisations and shall at
the  time  inform  the  holders  of  the  authorisations  of
the  name  and  address  of  the  applicant.

The  holder  or  holders  of  former  authorisations  and
the  applicant  shall  take  all  reasonable  steps  to  reach
agreement  on  the  sharing  of  information,  so  as  to
avoid,  if  possible,  the  duplication  of  testing  on
vertebrate animals.

The  competent  authorities  of  the  Member  States  shall
encourage  data-holders  to  cooperate  in  the  provision  of
the
the  requested  data,  with  a  view 
duplication  of  testing  on  vertebrate  animals.

limiting 

to 

3.
For  decisions  to  be  taken  in  accordance  with
Article 10(5), the information referred to in paragraphs 1
and  2  can  be  used  by  the  Commission,  the  Scientific
Committees  as  referred  to  in  Article  27  and  the  Member
States.

If  it  is  still  not  possible  for  the  applicant  and  holders  of
former  authorisations  of  the  same  product  to  reach  an
agreement  on  the  sharing  of  data,  Member  States  may
introduce  national  measures  obliging  the  applicant  and
holders  of  former  authorisations  located  within  their

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territory  to  share  the  data  with  a  view  to  avoiding
duplicative  testing  on  vertebrate  animals  and  determine
both  the  procedure  for  utilising  information,  and  the
reasonable  balance  of  the 
interests  of  the  parties
concerned.

if  so,  under  what
in  Article  28(2),  whether,  and, 
conditions, the action taken by the Member State may be
extended  for  a  period  to  be  determined,  be  repeated,  or
be  revoked.

Article  14

New  information

1. Member States shall  prescribe that  the holder of an
authorisation  for  a  biocidal  product  shall  immediately
notify  the  competent  authority  of  information  of  which
he or she is aware or of which he or she may reasonably
be  expected  to  be  aware  concerning  an  active  substance
or a biocidal product containing it and which may affect
continuing  authorisation.  In  particular,  the  following
shall  be  notified:

— new  knowledge  or  information  on  the  effects  of  the
active  substance  or  biocidal  product  for  humans  or
the  environment,

— changes  in  the  source  or  composition  of  the  active

substance,

— changes  in  composition  of  a  biocidal  product,

— development  of  resistance,

— changes  of  an  administrative  nature  or  other  aspects,

such  as  the  nature  of  the  packaging.

immediately  notify  other
2. Member  States  shall 
Member  States  and  the  Commission  of  any  such
information  they  receive  concerning  potentially  harmful
effects  for  humans  or  the  environment  or  the  new
composition  of  a  biocidal  product,  its  active  substances,
impurities,  co-formulants  or  residues.

Article  15

Derogation  from  the  requirements

1.
By  way  of  derogating  from  Articles  3  and  5,  a
Member State may authorise temporarily for a period not
exceeding 120 days, the placing on the market of biocidal
products  not  complying  with  the  provisions  of  this
Directive  for  a  limited  and  controlled  use  if  such  a
measure  appears  necessary  because  of  an  unforseen
danger  which  cannot  be  contained  by  other  means.  In
this  case,  the  Member  State  concerned  shall  immediately
inform  the  other  Member  States  and  the  Commission  of
its  action  and  the  justification  for  it.  The  Commission
shall  make  a  proposal  and  it  shall  be  decided  without
delay,  in  accordance  with  the  procedure  laid  down

2.
By way of derogation from Article 5(1)(a) and until
an active substance is listed in Annex I or IA, a Member
State  may  authorise  provisionally,  for  a  period  not
exceeding  three  years,  the  placing  on  the  market  of  a
biocidal product containing an active substance not listed
in Annex I or IA and not yet available on the market on
the  date  referred  to  in  Article  34(1)  for  purposes  other
than  those  defined  in  Article  2(2)(c)  and  (d).  Such  an
authorisation  may  be  issued  only  if,  after  dossiers  have
in  accordance  with  Article  11,  the
been  evaluated 
Member  State  believes  that:

— the  active  substance  satisfies  the  requirements  of

Article  10  and,

— the  biocidal  product  may  be  expected  to  satisfy  the

conditions  of  Articles  5(1)(b),  (c)  and  (d),

and no other Member State, on the basis of the summary
it receives, makes legitimate objection, in accordance with
Article  18(2),  to  the  completeness  of  the  dossiers.  Where
an  objection  is  made,  a  decision  on  the  completeness  of
dossiers  shall  be  taken  in  accordance  with  the  procedure
laid  down  in  Article  28(2)  without  undue  delay.

If, following the procedures laid down in Articles 27 and
28(2),  it  is  decided  that  the  active  substance  does  not
satisfy  the  requirements  specified  in  Article  10,  the
Member  State 
the  provisional
authorisation  is  cancelled.

shall  ensure 

that 

In  cases  where  evaluation  of  dossiers  for  the  purposes  of
inclusion  of  an  active  substance  in  Annex  I  or  IA  is  not
completed  when  the  period  of  three  years  expires,  the
competent  authority  may  further  provisionally  authorise
the  product  for  a  period  not  exceeding  one  year,
providing  there  are  good  reasons  to  believe  the  active
substance  will  satisfy  the  requirements  of  Article  10.
Member States shall inform other Member States and the
Commission  of  such  action.

Article  16

Transitional  measures

By  way  of  further  derogating  from  Articles  3(1),
1.
5(1),  8(2)  and  8(4),  and  without  prejudice 
to
paragraphs 2 and 3, a Member State may, for a period of
10  years  from  the  date  referred  to  in  Article  34(1),
continue to apply its current system or practice of placing
biocidal  products  on  the  market.  It  may,  in  particular,
according  to  its  national  rules,  authorise  the  placing  on
its  territory  of  a  biocidal  product
the  market 

in 

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24.4.98

containing  active  substances  not  listed  in  Annex  I  or  IA
for  that  product  type.  Such  active  substances  must  be  on
the  market  on  the  date  referred  to  in  Article  34(1)  as
active substances of a biocidal product for purposes other
than  those  defined  in  Article  2(2)(c)  and  (d).

Article  17

Research  and  development

2.
Following  the  adoption  of  this  Directive,  the
Commission  shall  commence  at  10-year  programme  of
work  for  the  systematic  examination  of  all  active
substances  already  on  the  market  on  the  date  referred  to
in Article 34(1) as active substances of a biocidal product
for  purposes  other  than  those  defined  in  Article  2(2)(c)
and  (d).  A  Regulation,  adopted  according  to  the
procedure  laid  down  in  Article  28(3),  will  provide  for
all  provisions  necessary  for  the  establishment  and
implementation of the programme including the setting of
priorities  for  the  evaluation  of  the  different  active
substances  and  a  timetable.  No  later  than  two  years
the
before  completion  of 
Commission  shall  forward  to  the  European  Parliament
and  the  Council  a  report  on  the  progress  achieved  with
the  programme.

the  work  programme, 

During that 10-year period and from the date referred to
in  Article  34(1),  it  may  be  decided  pursuant  to  the
procedure  laid  down  in  Article  28(3)  that  an  active
substance  shall  be  included  in  Annexes  I,  IA  or  IB  and
under  which  conditions,  or, 
the
requirements  of  Article  10  are  not  satisfied  or  the
requisite  information  and  data  have  not  been  submitted
within  the  prescribed  period,  that  such  active  substance
shall  not  be  included  in  Annex  I,  IA  or  IB.

in  cases  where 

3.
Following  such  a  decision  to  include  or  not  to
include an active substance in Annex I, IA or IB, Member
States shall ensure that authorisations or, where relevant,
registrations  for  biocidal  products  containing  the  active
substances  and  complying  with  the  provisions  of  this
Directive  are  granted,  modified  or  cancelled  as
appropriate.

4. Where, following a review of an active substance, it
is  concluded  that  the  substance  does  not  meet  the
requirements  of  Article  10  and  consequently  cannot  be
included  in  Annex  I,  IA  or  IB,  the  Commission  shall
bring forward proposals for restricting the marketing and
use  of  that  substance  in  accordance  with  Directive
76/769/EEC.

5.
The  provisions  of  Council  Directive  83/189/EEC  of
28  March  1983  laying  down  a  procedure  for  the
in  the  field  of  technical
provision  of 
standards  and  Regulations (1)  shall  continue  to  apply
during 
in
the 
paragraph  2.

transitional  period 

information 

referred 

to 

(1) OJ  L  109,  26.4.1983,  p.  8.  Directive  as  last  amended  by

Directive  94/10/EC  (OJ  L  100,  19.4.1994,  p.  30).

1.
By  way  of  derogation  from  Article  3,  Member
States  shall  prescribe  that  any  experiment  or  test  for  the
involving  the
purposes  of  research  or  development 
placing  on  the  market  of  an  unauthorized  biocidal
product  or  an  active  substance  intended  exclusively  for
use  in  a  biocidal  product  shall  not  take  place  unless:

(a)

substance, 

in  the  case  of  scientific  research  and  development,
the persons concerned draw up and maintain written
records  detailing  the  identity  of  the  biocidal  product
or  active 
labelling  data,  quantities
supplied  and  the  names  and  addresses  of  those
persons  receiving  the  biocidal  product  or  active
substance  and  compile  a  dossier  containing  all
available  data  on  possible  effects  on  human  or
animal  health  or  impact  on  the  environment.  This
information  shall,  if  requested,  be  made  available  to
the  competent  authority,

(b)

the  case  of  process-oriented  research  and
in 
development,  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  be  conducted.

2. Member  States  shall  prescribe  that  an  unauthorised
biocidal  product  or  an  active  substance  for  exclusive  use
in  a  biocidal  product  may  not  be  placed  on  the  market
for  the  purpose  of  any  experiment  or  test  which  may
involve,  or  result  in,  release  into  the  environment  unless
the  competent  authority  has  assessed  the  available  data
and issued an authorisation for this purpose which limits
the  quantities  to  be  used  and  the  areas  to  be  treated  and
may  impose  further  conditions.

3. Where  any  experiment  or  test  takes  place  in  a
Member  State  other  than  the  Member  State  where
placing  on  the  market  occurs,  the  applicant  shall  obtain
experiments  or  tests  authorisation  from  the  competent
authority  of  the  Member  State  in  the  territory  of  which
the  experiments  or  tests  are  to  be  conducted.

If  the  proposed  experiments  or  tests  referred  to  in
paragraphs  1  and  2  are  liable  to  have  harmful  effects  on
human  or  animal  health  or  to  have  an  unacceptable
adverse  influence  on  the  environment,  the  Member  State
concerned  may  either  prohibit  them  or  only  allow  them
subject  to  such  conditions  as  it  considers  necessary  to
prevent  those  consequences.

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Paragraph 2 shall not apply if the Member State has
4.
granted  the  person  concerned  the  right  to  undertake
certain  experiments  and  tests  and  has  determined  the
conditions under which the experiments and tests have to
be  undertaken.

5.
Common  conditions  for  the  application  of  this
Article,  in  particular  the  maximum  quantities  of  active
substances  or  biocidal  products  that  may  be  released
during  experiments,  and  the  minimum  data  to  be
submitted  in  accordance  with  paragraph  2,  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  28(2).

Article  18

Information  exchange

1. Within a period of one month from the end of each
quarter,  Member  States  shall  inform  each  other  and  the
Commission  of  any  biocidal  products  which  have  been
authorised  or  registered  within  their  territory  or  for
which  an  authorisation  or  registration  has  been  refused,
modified,  renewed  or  cancelled,  indicating  at  least:

(a)

the  name  or  business  name  of  the  applicant  for,  or
the  holder  of,  the  authorisation  or  registration;

(b)

the  trade  name  of  the  biocidal  product;

(c)

the name and amount of each active substance which
it  contains,  as  well  as  the  name  and  amount  of  each
dangerous  substance  in  the  meaning  of  Article  2(2)
of  Directive  67/548/EEC  and  their  classification;

(d)

the  product-type  and  the  use  or  uses  for  which  it  is
authorised;

(e)

the  type  of  formulation;

(f) any  proposed  limits  on  residues  which  have  been

established;

(g) conditions  of  the  authorisation  and  where  relevant,
the reasons for the modification or cancellation of an
authorisation;

(h) an  indication  of  whether  the  product  is  of  a  special
low-risk

type  (e.g.  within  a  frame-formulation, 
biocidal  product).

2. Where  a  Member  State  receives  a  summary  of  the
dossiers  in  accordance  with  Articles  11(1)(b)  and  15(2)
and  has  legitimate  reason  to  believe  the  dossiers  are
incomplete, 
its
concerns  to  the  competent  authority  responsible  for  the
evaluation  of  the  dossiers  and  shall  without  undue  delay
inform  the  Commission  and  other  Member  States  of  its
concerns.

immediately  communicate 

shall 

it 

Each  Member  State  shall  draw  up  an  annual  list  of
3.
the  biocidal  products  authorised  or  registered  in  its
territory  and  shall  communicate  that  list  to  the  other
Member  States  and  the  Commission.

In  accordance  with  the  procedure  laid  down  in
4.
Article  28(2),  a  standardised  information  system  shall  be
set  up  to  facilitate  the  application  of  paragraphs  1  and
2.

the 

functioning  of 

The  Commission  shall  draw  up  a  report  on  the
5.
implementation  of  this  Directive  and,  in  particular,
on 
simplified  procedures
low-risk  biocidal  products  and
(frame-formulations, 
the  date
commodity  substances)  seven  years  after 
mentioned in Article 34(1). The Commission shall submit
the  report  to  the  Council,  accompanied  by  proposals  if
necessary.

the 

Article  19

Confidentiality

1. Without prejudice to Council Directive 90/313/EEC
of  7  June  1990  on  the  freedom  of  access  to  information
on  the  environment (1),  an  applicant  may  indicate  to  the
competent  authority  the  information  which  he  considers
to  be  commercially  sensitive  and  disclosure  of  which
might  harm  him  industrially  or  commercially  and  which
he  therefore  wishes  to  be  kept  confidential  from  all
persons  other  than  the  competent  authorities  and  the
Commission.  Full  justification  will  be  required  in  each
case.  Without  prejudice  to  the  information  referred  to  in
paragraph 3 and the provisions of Directives 67/548/EEC
and  88/379/EEC,  Member  States  shall  take  the  necessary
steps to ensure the confidentiality of the full composition
of  product  formulations  if  requested  by  the  applicant.

2.
The  competent  authority  receiving  the  application
shall  decide,  on  the  basis  of  documentary  evidence
produced  by  the  applicant,  which  information  shall  be
confidential  within  the  terms  of  paragraph  1.

Information  accepted  as  being  confidential  by  the
receiving  competent  authority  shall  be  treated  as  being
confidential  by  the  other  competent  authorities,  Member
States  and  the  Commission.

After 

3.
confidentiality  shall  not  in  any  case  apply  to:

authorisation  has  been 

the 

granted,

(a)

the  name  and  address  of  the  applicant;

(b)

the  name  and  address  of  the  biocidal  product
manufacturer;

(c)

the  name  and  address  of  the  active  substance
manufacturer;

(d)

the  names  and  content  of  the  active  substance  or
substances  in  the  biocidal  product  and  the  name  of
the  biocidal  product;

(1) OJ  L  158,  6.10.1990,  p.  40.

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24.4.98

(e)

the  names  of  other  substances  which  are  regarded
as  dangerous  within  the  meaning  of  Directive
67/548/EEC  and  contribute  to  the  classification  of
the  product;

(b) products  available  to  the  general  public  which
may  be  mistaken  for  food,  drink  or  feedingstuff
shall  contain  components 
their
consumption.

to  discourage 

(f) physical  and  chemical  data  concerning  the  active

substance  and  biocidal  product;

(g) any  ways  of  rendering  the  active  substance  or

biocidal  product  harmless;

(h) a  summary  of  the  results  of  the  tests  required
pursuant  to  Article  8  to  establish  the  substance’s  or
product’s  efficacy  and  effects  on  humans,  animals
and  the  environment  and,  where  applicable,  its
ability  to  promote  resistance;

(i)

recommended  methods  and  precautions  to  reduce
dangers from handling, storage, transport and use as
well  as  from  fire  or  other  hazards;

(j)

safety  data  sheets;

(k) methods  of  analysis  referred  to  in  Article  5(1)(c);

(l) methods  of  disposal  of  the  product  and  of  its

packaging;

(m) procedures  to  be  followed  and  measures  to  be  taken

in  the  case  of  spillage  or  leakage;

(n)

first aid and medical advice to be given in the case of
injury  to  persons.

If  the  applicant  or  manufacturer  or  importer  of  the
biocidal product or active substance should later  disclose
the  competent
information, 
previously  confidential 
authority  shall  be  informed  accordingly.

4.
The  detailed  provisions  and  format  for  making
information  publicly  available  and  for  implementing  this
the
Article  shall  be  decided 
procedures  set  out  in  Article  28(2).

in  accordance  with 

Article  20

Classification,  packaging  and  labelling  of  biocidal
products

1.
Biocidal  products  shall  be  classified  in  accordance
with  the  provisions  relating  to  classification  in  Directive
88/379/EEC.

Biocidal  products  shall  be  packaged  in  accordance

2.
with  Article  6  of  Directive  88/379/EEC.  In  addition:

(a) products  which  may  be  mistaken  for  food,  drink  or
feedingstuff  shall  be  packaged  to  minimize  the
likelihood  of  such  a  mistake  being  made;

3.
Biocidal  products  shall  be  labelled  in  accordance
with  the  provisions  relating  to  labelling  in  Directive
88/379/EEC.  Labels  shall  not  be  misleading  or  give  an
exaggerated  impression  of  the  product  and,  in  any  case,
not  mention  the  indications  ‘low-risk  biocidal  product’,
‘non-toxic’, ‘harmless’ or similar indications. In addition,
the  label  must  show  clearly  and  indelibly  the  following:

(a)

identity  of  every  active  substance  and 

the 
concentration  in  metric  units;

its

(b)

the  authorisation  number  allocated  to  the  biocidal
product  by  the  competent  authority;

(c)

the  type  of  preparation  (e.g.  liquid  concentrates,
granules,  powders,  solids,  etc.);

(d)

the uses for which the biocidal product is authorised
(e.g. wood preservation, disinfection, surface biocide,
anti-fouling,  etc.);

(e) directions  for  use  and  the  dose  rate,  expressed  in
metric  units,  for  each  use  provided  for  under  the
terms  of  the  authorisation;

(f) particulars  of  likely  direct  or  indirect  adverse  side

effects  and  any  directions  for  first  aid;

(g)

if  accompanied  by  a  leaflet,  the  sentence  ‘Read
attached  instructions  before  use’;

(h) directions  for  safe  disposal  of  the  biocidal  product
and  its  packaging,  including,  where  relevant,  any
prohibition  on  reuse  of  packaging;

(i)

(j)

the formulation batch number or designation and the
expiry  date  relevant 
to  normal  conditions  of
storage;

the  period  of  time  needed  for  the  biocidal  effect,  the
interval  to  be  observed  between  applications  of  the
biocidal product or between application and the next
use of the product treated, or the next access by man
or  animals  to  the  area  where  the  biocidal  product
has  been  used, 
including  particulars  concerning
decontamination  means  and  measures  and  duration
of  necessary  ventilation  of  treated  areas;  particulars
for  adequate  cleaning  of  equipment;  particulars
concerning  precautionary  measures  during  use,
storage  and 
(e.g.  personal  protective
clothing  and  equipment,  measures  for  protection

transport 

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against  fire,  covering  of  furniture,  removal  of  food
and  feedingstuff  and  directions  to  prevent  animals
from  being  exposed);

Article  21

Safety-data  sheets

and  where  applicable:

(k)

the categories of users to which the biocidal product
is  restricted;

(l)

information  on  any 
environment  particularly 
of  non-target  organisms 
contamination  of  water;

specific  danger 

the
concerning  protection
avoidance  of

and 

to 

(m) for  microbiological  biocidal  products, 

labelling
requirements 
to  Council  Directive
90/679/EEC of 26 November 1990 on the protection
of  workers  from  risks  related  to  exposure  to
biological  agents  at  work (1).

according 

Member  States  shall  require  that  items  3(a),  (b),  (d)  and
where  applicable  (g)  and  (k)  always  be  carried  on  the
label  of  the  product.

Member States shall permit items 3(c), (e), (f), (h), (i), (j)
and (l) to be carried elsewhere on the packaging or on an
accompanying  leaflet  integral  to  the  packaging.  These
items  of 
label
information  for  the  purposes  of  this  Directive.

information  shall  be  regarded  as 

rodenticide,  avicide  or  molluscicide 

4. Where  a  biocidal  product  identified  as  insecticide,
acaricide, 
is
authorised  pursuant  to  this  Directive  and  is  also  subject
to  classification,  packaging  and  labelling  according  to
Council  Directive  78/631/EEC  of  26  June  1978  on  the
approximation of the laws of the Member States relating
to the classification, packaging and labelling of dangerous
preparations (pesticides) (2) by virtue of other Community
provisions,  Member  States  shall  permit  changes  to  the
packaging  and  labelling  of  that  product  which  may  be
required as a consequence of those provisions in so far as
the  conditions  of  an
they  do  not  conflict  with 
authorisation  issued  under  this  Directive.

5. Member  States  may  require  the  provision  of
samples, models or drafts of the packaging, labelling and
leaflets.

6. Member  States  shall  make  the  placing  of  biocidal
products on the market in their territories subject to them
being  labelled  in  their  national  language  or  languages.

(1) OJ  L  374,  31.12.1990,  p.  1.  Directive  as  last  amended  by

Directive  95/30/EC  (OJ  L  155,  6.7.1995,  p.  5).

(2) OJ  L  206,  29.7.1978,  p.  13.  Directive  as  last  amended  by

Directive  92/32/EEC  (OJ  L  154,  5.6.1992,  p.  1).

Member  States  shall  take  the  necessary  measures  to
ensure that a system of specific information is established
to  enable  professional  and  industrial  users  and,  as
appropriate,  other  users  of  biocidal  products  to  take  the
necessary measures for the protection of the environment
and health as well as health and safety at the workplace.
This  shall  be  done  in  the  form  of  a  safety-data  sheet
provided  by  those  responsible  for  the  placing  on  the
market  of  the  product.

The  safety-data  sheets  shall  be  prepared:

— for  biocidal  products  classified  as  dangerous  and  in
accordance  with  Article  10  of  Directive  88/379/EEC,

— for  active  substancess  used  exclusively  in  biocidal
products  in  accordance  with  the  requirements  of
Article  27  of  Directive  67/548/EEC.

Article  22

Advertising

States 

1. Member 
every
shall 
advertisement  for  a  biocidal  product  is  accompanied  by
the  sentences  ‘Use  biocides  safely.  Always  read  the  label
and  product  information  before  use’.

require 

that 

The  sentences  shall  be  clearly  distinguishable  in  relation
to  the  whole  advertisement.

Member  States  shall  prescribe  that  advertisers  may
replace  the  word  ‘Biocides’  in  the  prescribed  sentences
with  an  accurate  description  of  the  product-type  being
advertised, for example wood preservatives, disinfectants,
surface  biocides,  anti-fouling  products,  etc.

2. Member States shall require that advertisements for
biocidal products do not refer to the product in a manner
which  is  misleading  in  respect  of  the  risks  from  the
product  to  man  or  the  environment.

Under no circumstances may the advertising of a biocidal
product  mention  ‘low-risk  biocidal  product’,  ‘non-toxic’,
‘harmless’  or  any  similar  indications.

Article  23

Poison  control

Member States shall appoint a body or bodies responsible
for  receiving  information  on  biocidal  products  which

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information  available 

have  been  placed  on  the  market,  including  information
on  the  chemical  composition  of  such  products,  and  for
making  such 
in  cases  where
suspected  poisoning  arises  from  biocidal  products.  Such
information  may  only  be  used  to  meet  any  medical
demand by formulating preventive and curative measures,
in  particular  in  emergencies.  Member  States  shall  ensure
that  the  information  is  not  used  for  other  purposes.

Member  States  shall  take  the  necessary  steps  to  ensure
that  the  appointed  bodies  provide  all  the  requisite
guarantees  for  maintaining  the  confidentiality  of  the
information received. Member States shall ensure that the
the
appointed  bodies  have  at 
information  required  to  carry  out  the  tasks  for  which
they  are  responsible  from  the  manufacturers  or  persons
responsible  for  marketing.

their  disposal  all 

For  biocidal  products  already  on  the  market  on  the  date
referred  to  in  Article  34(1),  Member  States  shall  take
measures to comply with this Article within three years of
the  date  referred  to  Article  34(1).

Article  24

Compliance  with  requirements

Member  States  shall  take  the  necessary  arrangements  for
biocidal  products  which  have  been  placed  on  the  market
to  be  monitored  to  establish  whether  they  comply  with
the  requirements  of  this  Directive.

three  years  after 

the  date  referred 

Every 
in
Article  34(1),  Member  States  shall  forward  to  the
Commission  by  30  November  of  the  third  year  a  report
on their action in these matters together with information
on  any  poisonings  involving  biocidal  products.  The
Commission  shall  within  one  year  of  receipt  of  this
information  prepare  and  publish  a  composite  report.

to 

Article  25

Charges

Member  States  shall  establish  systems  obliging  those
having  placed  or  seeking  to  place  biocidal  products  on
the  market  and  those  supporting  entries  for  active
substances  on  Annexes  I,  IA  or  IB  to  pay  charges,
corresponding as far as possible to their costs in carrying
out  all  the  different  procedures  associated  with  the
provisions  of  this  Directive.

Article  26

Competent  authorities

1. Member  States 
shall  designate  a  competent
for
authority  or  competent  authorities  responsible 
carrying  out  the  duties  imposed  on  Member  States
pursuant  to  this  Directive.

2. Member  States  shall  inform  the  Commission  of  the
identity  of  their  competent  authority  or  competent
authorities,  not 
in
Article  34(1).

later  than  the  date  referred  to 

Article  27

Commission  procedures

1. When  the  Commission  receives  from  a  Member
State  either:

(a) an  evaluation  and  recommendations  concerning  an
active  substance  in  accordance  with  Article  11(2)
and/or  an  assessment  according  to  Article  10(5),  or

(b) a  proposal 

to  refuse  an  authorisation  or  a
in

registration  and  an  explanatory  document 
accordance  with  Article  4(4),

it  shall  allow  a  period  of  90  days  during  which  other
Member  States  and  the  applicant  may  submit  comments
to  it  in  writing.

At  the  end  of  the  period  for  comment,  the

2.
Commission  shall,  on  the  basis  of:

— the  documents  received  from  the  Member  State

evaluating  the  dossiers  and,

— any  advice  obtained 

from  advisory 

scientific

committees,

— comments received from other Member States and the

applicants and,

— any  other  relevant  information,

prepare  a  draft  for  decision  in  accordance  with  the
relevant  procedures  laid  down  in  Article  28(2)  or  28(3).

3.
The  Commission  shall  ask  the  applicant  and/or  his
authorised  representative  to  submit  remarks  to  it,  unless
a  favourable  decision  is  envisaged.

Article  28

Committees  and  procedures

1.
Committee  on  Biocidal  Products 

The  Commission  shall  be  assisted  by  a  Standing
Standing

(the 

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Committee).  The  Standing  Committee  shall  be  composed
of representatives of the Member States and chaired by a
representative  of 
the  Commission.  The  Standing
Committee  shall  adopt  its  own  rules  of  procedure.

IVB, 

IVA  and 

the  representative  of 

2.
For  matters  referred  to  the  Standing  Committee  by
virtue  of  Articles  4,  11(3),  15,  17,  18,  19,  27(1)(b),  29
and  33  and  the  elaboration  of  specific  data  by  product
type  referred  to 
in  Annex  V,  to  be  drawn  from
Annexes  IIIA  and  IIIB  and,  as  appropriate,  from
Annexes 
the
Commission shall submit to the committee a draft of the
measures  to  be  taken.  The  committee  shall  deliver  its
opinion  on  the  draft  within  a  time  limit  which  the
chairman  may  lay  down  according  to  the  urgency  of  the
matter.  The  opinion  shall  be  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.  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.

The  Commission  shall  adopt  the  measures  envisaged
which  shall  apply 
these
measures  are  not  in  accordance  with  the  opinion  of  the
Committee, 
the
shall  be  communicated  by 
Commission  to  the  Council  forthwith.  In  that  event:

immediately.  However, 

they 

if 

The  Commission  shall  defer  application  of  the  measures
which  it  has  decided  for  a  period  of  three  months  from
the  date  of  communication.

The  Council,  acting  by  a  qualified  majority,  may  take  a
different  decision  within  the  time  limit  referred  to  in  the
previous subparagraph.

3.
For  matters  referred  to  the  Standing  Committee  by
virtue of Articles 10, 11(4), 16, 27(1)(a) and (2), and 32,
the  representative  of  the  Commission  shall  submit  to  the
committee  a  draft  of  the  measures  to  be  taken.  The
committee  shall  deliver  its  opinion  on  the  draft  within  a
time  limit  which  the  chairman  may  lay  down  according
to  the  urgency  of  the  matter.  The  opinion  shall  be
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.
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.

The  Commission  shall  adopt  the  measures  envisaged  if
they  are 
the
committee.

in  accordance  with 

the  opinion  of 

If  the  measures  envisaged  are  not  in  accordance  with  the
opinion  of  the  committee,  or  if  no  opinion  is  delivered,
the  Commission  shall,  without  delay,  submit  to  the

Council  a  proposal  relating  to  the  measures  to  be  taken.
The  Council  shall  act  by  a  qualified  majority.

If, on the expiry of three months from the date of referral
to  the  Council,  the  Council  has  not  acted,  the  proposed
measures  shall  be  adopted  by  the  Commission,  save
where  the  Council  has  decided  against  the  said  measures
by  a  simple  majority.

Article  29

Adaptation  to  technical  progress

The  amendments  necessary  for  adapting  Annexes  IIA,
IIB,  IIIA,  IIIB,  IVA  and  IVB,  the  descriptions  of  the
product-types  in  Annex  V  to  technical  progress  and  for
specifying  data  requirements  for  each  of  these  product
types, shall be adopted in accordance with the procedure
laid  down  in  Article  28(2).

Article  30

Modification  or  adaptation  of  Annexes  V  and  VI

Acting  on  a  proposal  from  the  Commission,  the  Council
and  the  European  Parliament  shall,  in  accordance  with
the  procedures  laid  down  in  the  Treaty,  modify  or  adapt
to  technical  progress  the  titles  of  the  product-types  of
Annex  V  and  the  provisions  of  Annex  VI.

Article  31

Civil and criminal liability

The  granting  of  authorisation  and  all  other  measures  in
conformity  with  this  Directive  shall  be  without  prejudice
to  general  civil  and  criminal  liability  in  the  Member
States  of  the  manufacturer  and,  where  applicable,  of  the
person responsible for placing the biocidal product on the
market  or  using  it.

Article  32

Safeguard clause

Where a Member State has valid reasons to consider that
a  biocidal  product  which  it  has  authorised,  registered  or
is bound to authorise or register pursuant to Articles 3 or
4,  constitutes  an  unacceptable  risk  to  human  or  animal
health or the environment, it may provisionally restrict or
prohibit the use or sale of that product on its territory. It
shall  immediately  inform  the  Commission  and  the  other
Member  States  of  such  action  and  give  reasons  for  its

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decision.  A  decision  shall  be  taken  on  the  matter  within
90  days  in  accordance  with  the  procedure  laid  down  in
Article  28(3).

accompanied  by  such  reference  on  the  occasion  of  their
official  publication.  The  methods  of  making  such  a
reference  shall  be  laid  down  by  the  Member  States.

Article  33

Technical  notes  for  guidance

The  Commission,  in  accordance  with  the  procedure  laid
down  in  Article  28(2),  shall  draw  up  technical  notes  for
guidance  to  facilitate  the  day-to-day  implementation  of
this  Directive.

These  technical  notes  shall  be  published  in  the  ‘C’  series
of  the  Official  Journal  of  the  European  Communities.

Article  34

Implementation  of  the  Directive

1. Member  States  shall  bring  into  force  the  laws,
regulations  and  administrative  provisions  necessary  to
comply with this Directive not later than 24 months after
its  entry  into  force.  They  shall  forthwith  inform  the
Commission  thereof.

2. When  Member  States  adopt  these  measures,  they
shall  contain  a  reference  to  this  Directive  or  shall  be

3. Member 
the
shall 
Commission  the  texts  of  the  provisions  of  national  law
which  they  adopt  in  the  field  covered  by  this  Directive.

communicate 

States 

to 

Article  35

This  Directive  shall  enter  into  force  on  the  20th  day
following  its  publication.

Article  36

This  Directive  is  addressed  to  the  Member  States.

Done  at  Brussels,  16  February  1998.

For  the  European  Parliament

For  the  Council

The  President

The  President

J.  M.  GIL-ROBLES

J.  CUNNINGHAM

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ANNEX  I

LIST  OF  ACTIVE  SUBSTANCES  WITH  REQUIREMENTS  AGREED  AT  COMMUNITY  LEVEL  FOR
INCLUSION  IN  BIOCIDAL  PRODUCTS

ANNEX  IA

LIST  OF  ACTIVE  SUBSTANCES  WITH  REQUIREMENTS  AGREED  AT  COMMUNITY  LEVEL  FOR
INCLUSION  IN  LOW-RISK  BIOCIDAL  PRODUCTS

ANNEX  IB

LIST  OF  BASIC  SUBSTANCES  WITH  REQUIREMENTS  AGREED  AT  COMMUNITY  LEVEL

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ANNEX  IIA

COMMON  CORE  DATA  SET  FOR  ACTIVE  SUBSTANCES

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. The dossier requirements must be in line
with  technical  development.

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.  Such  a  justification  may  be  the  existence  of  a  frame-formulation  to  which  the  applicant  has
the  right  of  access.

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  Sections  II  to  IX

The  following  data  will  be  required  to  support  submission  on  the  above  points.

I. APPLICANT

1.1.

Name  and  address,  etc.

1.2.

Active  substance  manufacturer  (name,  address,  location  of  plant)

II.

IDENTITY

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  EC  numbers  (if  available)

2.5.

Molecular  and  structural  formula  (including  full  details  of  any  isomeric  composition),  molecular
mass

2.6.

Method  of  manufacture  (syntheses  pathway  in  brief  terms)  of  active  substance

2.7.

Specification  of  purity  of  the  active  substance  in  g/kg  or  g/l,  as  appropriate

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2.8.

2.9.

Identity  of  impurities  and  additives  (e.g.  stabilisers),  together  with  the  structural  formula  and  the
possible  range  expressed  as  g/kg  or  g/l,  as  appropriate

The  origin  of  the  natural  active  substance  or  the  precursor(s)  of  the  active  substance,  e.g.  an
extract  of  a  flower

2.10.

Exposure  data  in  conformity  with  Annex  VIIA  to  Directive  92/32/EEC (*).

III. PHYSICAL  AND  CHEMICAL  PROPERTIES

3.1.

Melting  point,  boiling  point,  relative  density (1)

3.2.

Vapour  pressure  (in  Pa) (1)

3.3.

Appearance  (physical  state,  colour) (2)

3.4.

3.5.

Absorption  spectra  (UV/VIS,  IR,  NMR),  and  a  mass  spectrum,  molar  extinction  at  relevant
wavelengths,  where  relevant (1)

Solubility  in  water  including  effect  of  pH  (5  to  9)  and  temperature  on  solubility,  where
relevant (1)

3.6.

Partition  coefficient  n-octanol/water  including  effect  of  pH  (5  to  9)  and  temperature (1)

3.7.

Thermal  stability,  identity  of  relevant  breakdown  products

3.8.

Flammability  including  auto-flammability  and  identity  of  combustion  products

3.9.

Flash-point

3.10.

Surface  tension

3.11.

Explosive  properties

3.12.

Oxidising  properties

3.13.

Reactivity  towards  container  material

IV. ANALYTICAL  METHODS  FOR  DETECTION  AND  IDENTIFICATION

4.1.

4.2.

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.
stabilisers)

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

(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  to
Council  Directive  80/778/EEC  of  15  July  1980  relating  to  the  quality  of  water  intended  for
human  consumption (**)  can  be  estimated  with  adequate  reliability  at  the  MAC  specified  in
that  Directive  for  individual  pesticides

(d) Animal  and  human  body  fluids  and  tissues

(*) OJ  L  154,  5.6.1992,  p.  1.

(**) OJ  L  229,  30.8.1980,  p.  11.  Directive  as  last  amended  by  Directive  91/692/EEC  (OJ  L  377,  31.12.1991,  p.  48).

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V. EFFECTIVENESS  AGAINST  TARGET  ORGANISMS  AND  INTENDED  USES

5.1.

Function,  e.g.  fungicide,  rodenticide,  insecticide,  bactericide

5.2.

Organism(s)  to  be  controlled  and  products,  organisms  or  objects  to  be  protected

5.3.

Effects  on  target  organisms,  and  likely  concentration  at  which  the  active  substance  will  be  used

5.4.

Mode  of  action  (including  time  delay)

5.5.

Field  of  use  envisaged

5.6.

User:  industrial,  professional,  general  public  (non-professional)

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

VI. TOXICOLOGICAL  AND  METABOLIC  STUDIES

6.1.

Acute  toxicity

For  studies  6.1.1  to  6.1.3,  substances  other  than  gases  shall  be  administered  via  at  least  two
routes, one of which should be the oral route. The choice of the second route will depend on the
nature of the substance and the likely route of human exposure. Gases and volatile liquids should
be  administered  by  the  inhalation  route.

6.1.1. Oral

6.1.2.

Dermal

6.1.3.

Inhalation

6.1.4.

Skin  and  eye  irritation (3)

6.1.5.

Skin  sensitisation

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
appropriate

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.

Subchronic  toxicity  90-day  study,  two  species,  one  rodent  and  one  non-rodent

6.5.

Chronic  toxicity (4)

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  cells

6.6.3.

In-vitro  gene  mutation  assay  in  mammalian  cells

6.6.4.

6.6.5.

If  positive  in  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)

If  negative  in  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

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6.6.6.

If  positive  in  6.6.4  then  a  test  to  assess  possible  germ  cell  effects  may  be  required

6.7.

Carcinogenicity study (4)

One  rodent  and  one  other  mammalian  species.  These  studies  may  be  combined  with  those  in
6.5

6.8.

Reproductive  toxicity (5)

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.

Medical  data  in  anonymous  form

6.9.1. Medical  surveillance  data  on  manufacturing  plant  personnel  if  available

6.9.2.

Direct  observation,  e.g.  clinical  cases,  poisoning  incidents  if  available

6.9.3. Health  records,  both  from  industry  and  any  other  available  sources

6.9.4.

Epidemiological  studies  on  the  general  population,  if  available

6.9.5.

Diagnosis  of  poisoning  including  specific  signs  of  poisoning  and  clinical  tests,  if  available

6.9.6.

Sensitisation/allergenicity observations, if available

6.9.7.

Specific  treatment  in  case  of  an  accident  or  poisoning:  first  aid  measures,  antidotes  and  medical
treatment,  if  known

6.9.8.

Prognosis  following  poisoning

6.10.

Summary  of  mammalian  toxicology  and  conclusions,  including  no  observed  adverse  effect  level
(NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological data
and any other information concerning the active substances. Where possible any suggested worker
protection  measures  should  be  included  in  summary  form

VII. ECOTOXICOLOGICAL  STUDIES

7.1.

Acute  toxicity  to  fish

7.2.

Acute  toxicity  to  Daphnia magna

7.3.

Growth  inhibition  test  on  algae

7.4.

Inhibition  to  microbiological  activity

7.5.

Bioconcentration

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

7.6.2.

Abiotic

7.6.2.1. Hydrolysis  as  a  function  of  pH  and  identification  of  breakdown  products

7.6.2.2. Phototransformation  in  water  including  identity  of  the  products  of  transformation (1)

7.7.

Adsorption/desorption  screening  test

Where the results of this test indicate the need to do so, the test described in Annex IIIA Part XII.1
in  Annex  IIIA  Part  XII.2
paragraph  1.2  shall  be  required,  and/or  the  test  described 
paragraph 2.2

7.8.

Summary  of  ecotoxicological  effects  and  fate  and  behaviour  in  the  environment

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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.

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.

Procedures  for  waste  management  of  the  active  substance  for  industry  or  professional  users

8.5.1.

Possibility  of  reuse  or  recycling

8.5.2.

Possibility  of  neutralisation  of  effects

8.5.3.

Conditions  for  controlled  discharge  including  leachate  qualities  on  disposal

8.5.4.

Conditions  for  controlled  incineration

8.6.

Observations  on  undesirable  or  unintended  side-effects,  e.g.  on  beneficial  and  other  non-target
organisms

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  SECTIONS  II  TO  IX

Notes

(1) These  data  must  be  submitted  for  the  purified  active  substance  of  stated  specification.
(2) These  data  must  be  submitted  for  the  active  substance  of  stated  specification.
(3) Eye  irritation  test  shall  not  be  necessary  where  the  active  substance  has  been  shown  to  have  potential

corrosive  properties.

(4) The  long-term  toxicity  and  carcinogenicity  of  an  active  substance  may  not  be  required  where  a  full

justification  demonstrates  that  these  tests  are  not  necessary.

(5) If,  in  exceptional  circumstances,  it  is  claimed  that  such  testing  is  unnecessary,  that  claim  must  be  fully

justified.

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ANNEX  IIB

COMMON  CORE  DATA  SET  FOR  BIOCIDAL  PRODUCTS

CHEMICAL  PRODUCTS

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. The dossier requirements must be in line
with  technical  development.

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.  Such  a  justification  may  be  the  existence  of  a  frame-formulation  to  which  the  applicant  has
the  right  of  access.

3.

Information  may  be  derived  from  existing  data  where  a  justification  acceptable  to  the  competent
authority  is  provided.  In  particular,  the  provisions  of  Directive  88/379/EEC  should  be  used  wherever
possible  to  minimise  animal  testing.

Dossier  requirements

I. Applicant

II.

Identity  of  the  biocidal  product

III. Physical  and  chemical  properties  of  the  biocidal  product

IV. Methods  for  identification  and  analysis  of  the  biocidal  product

V.

Intended  uses  of  the  biocidal  product  and  efficacy  for  these  uses

VI. Toxicology  data  for  the  biocidal  product  (additional  to  that  for  the  active  substance)

VII. Ecotoxicology  data  for  the  biocidal  product  (additional  to  that  for  the  active  substance)

VIII. Measures  necessary  to  protect  man,  animals  and  the  environment

IX. Classification, packaging and labelling

X. Summary  and  evaluation  of  Sections  II  to  IX

The  following  data  will  be  required  to  support  submission  on  the  above  points.

I. APPLICANT

1.1. Name  and  address,  etc.

1.2.

Formulator of the biocidal product and the active substance(s) (names, addresses, including location
of  plant(s))

II.

IDENTITY

2.1.

2.2.

2.3.

Trade  name  or  proposed  trade  name,  and  manufacturer’s  development  code  number  of  the
preparation,  if  appropriate

Detailed  quantitative  and  qualitative  information  on  the  composition  of  the  biocidal  product,  e.g.
active  substance(s),  impurities,  adjutants,  inert  components

Physical  state  and  nature  of  the  biocidal  product,  e.g.  emulsifiable  concentrate,  wettable  powder,
solution

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III. PHYSICAL,  CHEMICAL  AND  TECHNICAL  PROPERTIES

3.1.

Appearance  (physical  state,  colour)

3.2.

Explosive  properties

3.3. Oxidising  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.

3.8.

3.9.

Storage  stability  —  stability  and  shelf-life.  Effects  of  light,  temperature  and  humidity  on  technical
characteristics  of  the  biocidal  product;  reactivity  towards  container  material

Technical  characteristics  of  the  biocidal  product,  e.g.  wettability,  persistent  foaming,  flowability,
pourability  and  dustability

Physical  and  chemical  compatibility  with  other  products  including  other  biocidal  products  with
which  its  use  is  to  be  authorised

IV. METHODS  OF  IDENTIFICATION  AND  ANALYSIS

4.1.

4.2.

Analytical  method  for  determining  the  concentration  of  the  active  substance(s)  in  the  biocidal
product

In  so  far  as  not  covered  by  Annex  IIA,  paragraph  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

V.

INTENDED  USES  AND  EFFICACY

5.1.

Product  type  and  field  of  use  envisaged

5.2. Method  of  application  including  description  of  system  used

5.3.

Application  rate  and  if  appropriate,  the  final  concentration  of  the  biocidal  product  and  active
substance  in  the  system  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
animals

5.5.

Function,  e.g.  fungicide,  rodenticide,  insecticide,  bactericide

5.6.

Pest  organism(s)  to  be  controlled  and  products,  organisms  or  objects  to  be  protected

5.7.

Effects  on  target  organisms

5.8. Mode  of  action  (including  time  delay)  in  so  far  as  not  covered  by  Annex  IIA,  paragraph  5.4

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5.9.

User:  industrial,  professsional,  general  public  (non-professional)

Efficacy  data

5.10. The  proposed  label  claims  for  the  product  and  efficacy  data  to  support  these  claims,  including  any

available  standard  protocols  used,  laboratory  tests,  or  field  trials,  where  appropriate

5.11. Any  other  known  limitations  on  efficacy  including  resistance

VI. TOXICOLOGICAL  STUDIES

6.1.

Acute  toxicity

For  studies  6.1.1  to  6.1.3,  biocidal  products  other  than  gases  shall  be  administered  via  at  least  two
routes,  one  of  which  should  be  the  oral  route.  The  choice  of  the  second  route  will  depend  on  the
nature of the product and the likely route of human exposure. Gases and volatile liquids should be
administered  by  the  inhalation  route

6.1.1. Oral

6.1.2. Dermal

6.1.3.

Inhalation

6.1.4. For  biocidal  products  that  are  intended  to  be  authorised  for  use  with  other  biocidal  products,  the
mixture  of  products,  where  possible,  shall  be  tested  for  acute  dermal  toxicity  and  skin  and  eye
irritation,  as  appropriate

6.2.

Skin  and  eye  irritation (1)

6.3.

Skin  sensitisation

6.4.

Information  on  dermal  absorption

6.5.

Available toxicological data relating to toxicologically relevant non-active substances (i.e. substances
of  concern)

6.6.

Information  related  to  the  exposure  of  the  biocidal  product  to  man  and  the  operator

Where necessary, the test(s) described in Annex IIA, shall be required for the toxicologically relevant
non-active  substances  of  the  preparation

VII. ECOTOXICOLOGICAL  STUDIES

7.1.

Foreseeable  routes  of  entry  into  the  environment  on  the  basis  of  the  use  envisaged

7.2.

7.3.

Information  on  the  ecotoxicology  of  the  active  substance  in  the  product,  where  this  cannot  be
extrapolated  from  the  information  on  the  active  substance  itself

Available  ecotoxicological  information  relating  to  exotoxicological  relevant  non-active  substances
(i.e.  substances  of  concern),  such  as  information  from  safety  data  sheets

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.

Specific  treatment  in  case  of  an  accident,  e.g.  first-aid  measures,  antidotes,  medical  treatment  if
available;  emergency  measures  to  protect  the  environment;  in  so  far  as  not  covered  by  Annex  IIA,
paragraph 8.3

8.3.

Procedures,  if  any,  for  cleaning  application  equipment

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8.4.

Identity  of  relevant  combustion  products  in  cases  of  fire

8.5.

Procedures  for  waste  management  of  the  biocidal  product  and  its  packaging  for  industry,
professional  users  and  the  general  public  (non-professional  users),  e.g.  possibility  of  reuse  or
recycling,  neutralisation,  conditions  for  controlled  discharge,  and  incineration

8.6.

Possibility  of  destruction  or  decontamination  following  release  in  or  on  the  following:

(a) Air

(b) Water,  including  drinking  water

(c) Soil

8.7. Observations  on  undesirable  or  unintended  side-effects,  e.g.  on  beneficial  and  other  non-target

organisms

8.8.

Specify  any  repellents  or  poison  control  measures  included  in  the  preparation  that  are  present  to
prevent  action  against  non-target  organisms

IX. CLASSIFICATION,  PACKAGING  AND  LABELLING

— Proposals  for  packaging  and  labelling

— Proposals  for  safety-data  sheets,  where  appropriate

— Justification  for  the  classification  and  labelling  according  to  the  principles  of  Article  20  of  this

Directive

— Hazard  symbol(s)

— Indications  of  danger

— Risk  phrases

— Safety phrases

— Packaging  (type,  materials,  size,  etc.),  compatibility  of  the  preparation  with  proposed  packaging

materials  to  be  included

X. SUMMARY  AND  EVALUATION  OF  SECTIONS  II  TO  IX

Notes

(1) Eye-irritation  test  shall  not  be  necessary  where  the  biocidal  product  has  been  shown  to  have  potential

corrosive  properties.

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ANNEX  IIIA

ADDITIONAL  DATA  SET  FOR  ACTIVE  SUBSTANCES

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. The dossier requirements must be in line
with  technical  development.

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.  Such  a  justification  may  be  the  existence  of  a  frame-formulation  to  which  the  applicant  has
the  right  of  access.

III. PHYSICAL  AND  CHEMICAL  PROPERTIES

1.

2.

Solubility  in  organic  solvents,  including  effect  of  temperature  on  solubility (1)

Stability  in  organic  solvents  used  in  biocidal  products  and  identity  of  relevant  breakdown
products (2)

IV. ANALYTICAL  METHODS  FOR  DETECTION  AND  IDENTIFICATION

1.

Analytical  methods  including  recovery  rates  and  the  limits  of  determination  for  the  active  substance,
and  for  residues  thereof,  in/on  food  or  feedstuffs  and  other  products  where  relevant

VI. TOXICOLOGICAL  AND  METABOLIC  STUDIES

1. Neurotoxicity  study

If the active substance is an organophosphorus compound or if there are any other indications that the
active  substance  may  have  neurotoxic  properties  then  neurotoxicity  studies  will  be  required.  The  test
species  is  the  adult  hen  unless  another  test  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

2.

3.

4.

5.

6.

Toxic  effects  on  livestock  and  pets

Studies  related  to  the  exposure  of  the  active  substance  to  humans

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  Section  XI,  part  1  shall  be  required

If  any  other  tests  related  to  the  exposure  of  the  active  substance  to  humans,  in  its  proposed  biocidal
products,  are  considered  necessary,  then  the  test(s)  referred  to  in  Section  XI,  part  2  shall  be
required

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

7. Mechanistic  study  —  any  studies  necessary  to  clarify  effects  reported  in  toxicity  studies

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VII. ECOTOXICOLOGICAL  STUDIES

1.

2.

3.

4.

5.

6.

Acute  toxicity  test  on  one  other,  non-aquatic,  non-target  organism

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  Sections  XII  and  XIII  shall  be  required

If the result of the test in paragraph 7.6.1.2 of Annex IIA is negative and if the likely route of disposal
of the active substance is by sewage treatment then the test described in Section XIII, part 4.1 shall be
required

Any other biodegradability tests that are relevant from the results in paragraphs 7.6.1.1 and 7.6.1.2 of
Annex  IIA

Phototransformation  in  air  (estimation  method),  including  identification  of  breakdown  products (1)

If the results from paragraphs 7.6.1.2 in Annex IIA or from paragraph 4, above, indicate the need to
do  so,  or  the  active  substance  has  an  overall  low  or  absent  abiotic  degradation,  then  the  tests
described  in  Section  XII,  part  1.1,  part  2.1  and,  where  appropriate,  part  3  shall  be  required

VIII. MEASURES  NECESSARY  TO  PROTECT  HUMANS,  ANIMALS  AND  THE  ENVIRONMENT

1.

Identification  of  any  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 (*)

Notes

(1) These  data  must  be  submitted  for  the  purified  active  substance  of  stated  specification.
(2) These  data  must  be  submitted  for  the  active  substance  of  stated  specification.

XI. FURTHER  HUMAN  HEALTH-RELATED  STUDIES

1.

Food  and  feedingstuffs  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
including  the  kinetics  of

metabolites  on  the  treated  or  contaminated  food  or  feedstuffs 
disappearance

1.3. Overall  material  balance  for  the  active  substance.  Sufficient  residue  data  from  supervised  trials  to
demonstrate that residues likely to arise from the proposed use would not be of concern for human or
animal health

1.4. Estimation  of  potential  or  actual  exposure  of  the  active  substance  to  humans  through  diet  and  other

means

1.5.

If residues of the active substance remain 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  residues

of  the  active  substance

1.7. Proposed  acceptable  residues  and  the  justification  of  their  acceptability

1.8. Any  other  available  information  that  is  relevant

(*) OJ  L  20,  26.1.1980,  p.  43.

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1.9. Summary  and  evaluation  of  data  submitted  under  1.1  to  1.8

2. Other  test(s)  related  to  the  exposure  to  humans

Suitable  test(s)  and  a  reasoned  case  will  be  required

XII. FURTHER  STUDIES  ON  FATE  AND  BEHAVIOUR  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. Absorption and desorption in at least three soil types and, where relevant, absorption 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

2.

Fate  and  behaviour  in  water

2.1. Rate  and  route  of  degradation  in  aquatic  systems  (as  far  as  is  not  covered  by  Annex  IIA,

paragraph  7.6)  including  identification  of  metabolites  and  degradation  products

2.2. Absorption  and  desorption  in  water  (soil  sediment  systems)  and,  where  relevant,  absorption  and

desorption  of  metabolites  and  degradation  products

3.

Fate  and  behaviour  in  air

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  Section  VII,  part  5

4.

Summary  and  evaluation  of  parts  1,  2  and  3

XIII. FURTHER  ECOTOXICOLOGICAL  STUDIES

1.

Effects  on  birds

1.1. Acute oral toxicity — this need not be done if an avian species was selected for study in Section VII,

part  1

1.2. Short-term  toxicity  —  eight-day  dietary  study  in  at  least  one  species  (other  than  chickens)

1.3. Effects  on  reproduction

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

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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  Section  VII,  part  1

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  of  parts  1,  2,  3  and  4

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ANNEX  IIIB

ADDITIONAL  DATA  SET  FOR  BIOCIDAL  PRODUCTS

CHEMICAL  PRODUCTS

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. The dossier requirements must be in line
with  technical  development.

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.  Such  a  justification  may  be  the  existence  of  a  frame-formulation  to  which  the  applicant  has
the  right  of  access.

3.

Information  may  be  derived  from  existing  data  where  a  justification  acceptable  to  the  competent
authority  is  provided.  In  particular,  the  provisions  of  Directive  88/379/EEC  should  be  used  wherever
possible  to  minimise  animal  testing.

XI. FURTHER  HUMAN  HEALTH-RELATED  STUDIES

1.

Food  and  feedingstuffs  studies

1.1.

If  residues  of  the  biocidal  product  remain  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

1.2.

Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues
of  the  biocidal  product

2.

Other  test(s)  related  to  the  exposure  to  humans

Suitable  test(s)  and  a  reasoned  case  will  be  required  for  the  biocidal  product

XII. FURTHER  STUDIES  ON  FATE  AND  BEHAVIOUR  IN  THE  ENVIRONMENT

1.

2.

Where  relevant  all  the  information  required  in  Annex  IIIA,  Section  XII

Testing  for  distribution  and  dissipation  in  the  following:

(a) Soil

(b) Water

(c) Air

Test  requirements  1  and  2  above  are  applicable  only  to  ecotoxicologically  relevant  components  of
the  biocidal  product

XIII. FURTHER  ECOTOXICOLOGICAL  STUDIES

1.

Effects  on  birds

1.1.

Acute  oral  toxicity,  if  not  already  done  in  accordance  with  Annex  IIB,  Section  VII

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2.

Effects  on  aquatic  organisms

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

metabolites

2.1.3. The studies referred to in Annex IIIA, Section XIII, parts 2.1, 2.2, 2.3 and 2.4 may be required for

relevant  components  of  the  biocidal  product

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

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

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

4.

Summary  and  evaluation  of  parts  1,  2,  and  3

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ANNEX  IVA

DATA  SET  FOR  ACTIVE  SUBSTANCES

FUNGI,  MICRO-ORGANISMS  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. The dossier requirements must be
in  line  with  technical  development.

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.  Such  a  justification  may  be  the  existence  of  a  frame-formulation  to  which  the  applicant  has
the  right  of  access.

Dossier  requirements

I. Applicant  details

II.

Identity  of  the  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

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  organisms  and  the  environment

X. Classification and labelling

XI. Summary  and  evaluation  of  Sections  II  to  X

The  following  data  will  be  required  to  support  submissions  on  the  above  points.

I. APPLICANT

1.1.

Applicant  (name,  address,  etc.)

1.2. Manufacturer  (name,  address,  plant  location)

II.

IDENTITY  OF  THE  ORGANISM

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.)

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III. SOURCE  OF  THE  ORGANISM

3.1. Occurrence  in  nature  or  otherwise

3.2.

Isolation  methods  for  organism  or  active  strain

3.3.

Culture  methods

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

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

4.3. Methods  to  show  the  microbiological  purity  of  the  final  product  and  showing  that  contaminants

have  been  controlled  to  an  acceptable  level,  the  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.

5.4.

Effects  on  target  organism.  Pathogenicity  or  kind  of  antagonism  to  the  host.  Details  of  host
specificity  range  should  be  included

Transmissibility,  infective  dose  and  mode  of  action  including  information  on  presence,  absence  or
production  of  toxins  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  infectivity,
pathogenicity,  and  transmissibility

5.6.

Transmissibility  to  other  non-target  organisms

5.7.

Any  other  biological  effects  on  non-target  organisms  when  properly  used

5.8.

Infectivity  and  physical  stability  when  properly  used

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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

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  product,  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

3.

inhalation

4.

skin  and  where  necessary  eye  irritation

5.

skin  sensitisation  and,  where  necessary,  respiratory  sensitisation  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  another  route  is  more
appropriate

7.4.

Carcinogenicity study

May  be  combined  with  studies  in  6.3.  One  rodent  and  one  other  mammal

7.5. Mutagenicity  studies

As  specified  in  Annex  IIA,  Section  VI,  part  6.6

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7.6.

Reproductive  toxicity

Teratogenicity test — rabbit and one rodent species. Fertility study — one species, minimum of two
generations,  male  and  female

7.7. Metabolism  studies

Basic  toxicokinetics,  absorption  (including  dermal  absorption)  distribution  and  excretion  in
mammals  including  elucidation  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

7.11. 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

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  appropriate
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  algae  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.

In  cases  where  toxins  are  produced,  data  as  outlined  in  Annex  IIA,  Section  VII,  parts  7.1  to  7.5
should  be  produced

Fate  and  behaviour  in  the  environment

8.9.

Spread,  mobility,  multiplication  and  persistence  in  air,  soil  and  water

8.10.

In  cases  where  toxins  are  produced,  data  as  outlined  in  Annex  IIA,  Section  VII,  parts  7.6  to  7.8

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IX. MEASURES  NECESSARY  TO  PROTECT  HUMANS,  NON-TARGET  ORGANISMS  AND  THE

ENVIRONMENT

9.1. Methods and precautions to be taken for storage, handling, transport and use; or in the event of fire

or  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  non-infective  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

X. CLASSIFICATION  AND  LABELLING

Proposals  for  allocation  to  one  of  the  risk  groups  outlined  in  Article  2(d)  of  Directive  90/679/EEC
with  justifications  for  the  proposal  together  with  indications  on  the  need  for  products  to  carry  the
biohazard  sign  specified  in  Annex  II  to  Directive  90/679/EEC

XI. SUMMARY  AND  EVALUATION  OF  SECTIONS  II  TO  X

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ANNEX  IVB

DATA  SET  FOR  BIOCIDAL  PRODUCTS

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. The dossier requirements must be in line
with  technical  development.

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.  Such  a  justification  may  be  the  existence  of  a  frame-formulation  to  which  the  applicant  has
the  right  of  access.

3.

Information  may  be  derived  from  existing  data  where  a  justification  acceptable  to  the  competent
authority  is  provided.  In  particular,  the  provisions  of  Directive  88/379/EEC  should  be  used  wherever
possible  to  minimise  animal  testing.

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  humans,  non-target  organisms  and  the  environment

IX. Classification,  packaging  and  labelling  of  the  biocidal  product

X. Summary  of  Sections  II  to  IX

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.

2.2.

Trade  name  or  proposed  trade  name  and  manufacturer’s  development  code  number  for  biocidal
product,  if  appropriate

Detailed quantitative and qualitative information on the composition of the biocidal product (active
organisms,  inert  components,  extraneous  organisms,  etc.)

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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  biocidal  product

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. Emulsifiability, 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  authorised

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

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

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  standardisation

V.

INTENDED  USES  AND  EFFICACY  FOR  THESE  USES

5.1.

Use

Product-type  (e.g.  wood  preservative,  insecticide,  etc.)

5.2.

Details  of  intended  use,  (e.g.  types  of  harmful  organism  controlled,  materials  to  be  treated,  etc.)

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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

5.6. Number  and  timing  of  applications

5.7.

Proposed  instructions  for  use

Efficacy  data

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 
ORGANISM

INFORMATION  ADDITIONAL  TO  THAT  REQUIRED  FOR  THE  ACTIVE

6.1. Oral  single  dose

6.2.

Percutaneous  single  dose

6.3.

Inhalation

6.4.

Skin  and  where  relevant  eye  irritation

6.5.

Skin  sensitisation

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

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

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

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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 biocidal product with proposed packaging
materials

9.3.

Specimens  of  proposed  packaging

X. SUMMARY  OF  SECTIONS  II  to  IX

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ANNEX  V

BIOCIDAL  PRODUCT-TYPES  AND  THEIR  DESCRIPTIONS  AS  REFERRED  TO  IN  ARTICLE  2(1)(a)
OF  THIS  DIRECTIVE

These product-types exclude products where they are covered by the Directives mentioned in Article 1(2) of
this  Directive  for  the  purposes  of  these  Directives  and  their  subsequent  modifications.

MAIN  GROUP  1: Disinfectants  and  general  biocidal  products

These  product  types  exclude  cleaning  products  that  are  not  intended  to  have  a  biocidal  effect,  including
washing  liquids,  powders  and  similar  products.

Product-type  1: Human  hygiene  biocidal  products

Products  in  this  group  are  biocidal  products  used  for  human  hygiene  purposes.

Product-type  2:

Private  area  and  public  health  area  disinfectants  and  other  biocidal  products

Products used for the disinfection of air, surfaces, materials, equipment and furniture which are not used for
direct  food  or  feed  contact  in  private,  public  and  industrial  areas,  including  hospitals,  as  well  as  products
used  as  algaecides.

Usage  areas  include,  inter  alia,  swimming  pools,  aquariums,  bathing  and  other  waters;  air-conditioning
systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil
or  other  substrates  (in  playgrounds).

Product-type  3: Veterinary  hygiene  biocidal  products

Products in this group are biocidal products used for veterinary hygiene purposes including products used in
areas  in  which  animals  are  housed,  kept  or  transported.

Product-type  4:

Food  and  feed  area  disinfectants

Products  used  for  the  disinfection  of  equipment,  containers,  consumption  utensils,  surfaces  or  pipework
associated with the production, transport, storage or consumption of food, feed or drink (including drinking
water)  for  humans  and  animals.

Product-type  5: Drinking  water  disinfectants

Products  used  for  the  disinfection  of  drinking  water  (for  both  humans  and  animals).

MAIN  GROUP  2: Preservatives

Product-type  6:

In-can  preservatives

Products  used  for  the  preservation  of  manufactured  products,  other  than  foodstuffs  or  feedingstuffs,  in
containers  by  the  control  of  microbial  deterioration  to  ensure  their  shelf  life.

Product-type  7:

Film preservatives

Products used for the preservation of films or coatings by the control of microbial deterioration in order to
protect  the  initial  properties  of  the  surface  of  materials  or  objects  such  as  paints,  plastics,  sealants,  wall
adhesives,  binders,  papers,  art  works.

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Product-type  8: Wood  preservatives

Products  used  for  the  preservation  of  wood,  from  and  including  the  saw-mill  stage,  or  wood  products  by
the  control  of  wood-destroying  or  wood-disfiguring  organisms.

This  product  type  includes  both  preventive  and  curative  products.

Product-type  9:

Fibre,  leather,  rubber  and  polymerised  materials  preservatives

Products  used  for  the  preservation  of  fibrous  or  polymerised  materials,  such  as  leather,  rubber  or  paper  or
textile  products  and  rubber  by  the  control  of  microbiological  deterioration.

Product-type  10: Masonry preservatives

Products  used  for  preservation  and  remedial  treatment  of  masonry  or  other  construction  materials  other
than  wood  by  the  control  of  microbiological  and  algal  attack.

Product-type  11: Preservatives  for  liquid-cooling  and  processing  systems

Products  used  for  the  preservation  of  water  or  other  liquids  used  in  cooling  and  processing  systems  by  the
control  of  harmful  organisms  such  as  microbes,  algae  and  mussels.

Products  used  for  the  preservation  of  drinking  water  are  not  included  in  this  product  type.

Product-type  12: Slimicides

Products used for the prevention or control of slime growth on materials, equipment and structures, used in
industrial  processes,  e.g.  on  wood  and  paper  pulp,  porous  sand  strata  in  oil  extraction.

Product-type  13: Metalworking-fluid preservatives

Products  used  for  the  preservation  of  metalworking  fluids  by  the  control  of  microbial  deterioration.

MAIN  GROUP  3: Pest  control

Product-type  14: Rodenticides

Products  used  for  the  control  of  mice,  rats  or  other  rodents.

Product-type  15: Avicides

Products  used  for  the  control  of  birds.

Product-type  16: Molluscicides

Products  used  for  the  control  of  molluscs.

Product-type  17: Piscicides

Products  used  for  the  control  of  fish;  these  products  exclude  products  for  the  treatment  of  fish  diseases.

Product-type  18:

Insecticides,  acaricides  and  products  to  control  other  arthropods

Products  used  for  the  control  of  arthropods  (e.g.  insects,  arachnids  and  crustaceans).

Product-type  19: Repellents  and  attractants

Products  used  to  control  harmful  organisms  (invertebrates  such  as  fleas,  vertebrates  such  as  birds),  by
repelling  or  attracting,  including  those  that  are  used  for  human  or  veterinary  hygiene  either  directly  or
indirectly.

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MAIN  GROUP  4: Other  biocidal  products

Product-type  20: Preservatives  for  food  or  feedstocks

Products  used  for  the  preservation  of  food  or  feedstocks  by  the  control  of  harmful  organisms.

Product-type  21: Antifouling  products

Products  used  to  control  the  growth  and  settlement  of  fouling  organisms  (microbes  and  higher  forms  of
plant  or  animal  species)  on  vessels,  aquaculture  equipment  or  other  structures  used  in  water.

Product-type  22: Embalming  and  taxidermist  fluids

Products  used  for  the  disinfection  and  preservation  of  human  or  animal  corpses,  or  parts  thereof.

Product-type  23: Control  of  other  vertebrates

Products  used  for  the  control  of  vermin.

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ANNEX  VI

COMMON  PRINCIPLES  FOR  THE  EVALUATION  OF  DOSSIERS  FOR  BIOCIDAL  PRODUCTS

CONTENTS

Definitions

Introduction

Evaluation

— General principles

— Effects  on  humans

— Effects  on  animals

— Effects  on  the  environment

— Unacceptable  effects

— Efficacy

— Summary

Decision-making

— General principles

— Effects  on  humans

— Effects  on  animals

— Effects  on  the  environment

— Unacceptable  effects

— Efficacy

— Summary

Overall  integration  of  conclusions

DEFINITIONS

(a) Hazard  identification

This  is  the  identification  of  the  adverse  effects  which  a  biocidal  product  has  an  inherent  capacity  to
cause.

(b) Dose  (concentration)  —  response  (effect)  assessment

This is the estimate of the relationship between the dose, or level of exposure, of an active substance or
substance  of  concern  in  a  biocidal  product  and  the  incidence  and  severity  of  an  effect.

(c) Exposure  assessment

This is the determination of the emissions, pathways and rates of movement of an active substance or a
substance  of  concern  in  a  biocidal  product  and  its  transformation  or  degradation  in  order  to  estimate
the  concentration/doses  to  which  human  populations,  animals  or  environmental  compartments  are  or
may  be  exposed.

(d) Risk characterisation

This  is  the  estimation  of  the  incidence  and  severity  of  the  adverse  effects  likely  to  occur  in  a  human
population,  animals  or  environmental  compartments  due  to  actual  or  predicted  exposure  to  any  active
substance  or  substance  of  concern  in  a  biocidal  product.  This  may  include  ‘risk  estimation’  i.e.  the
quantification  of  that  likelihood.

(e) Environment

Water, including sediment, air, land, wild species of fauna and flora, and any interrelationship between
them,  as  well  as  any  relationship  with  living  organisms.

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INTRODUCTION

1. This  Annex  lays  down  principles  to  ensure  that  evaluations  made  and  decisions  taken  by  a  Member
State  concerning  the  authorisation  of  a  biocidal  product  providing  it  is  a  chemical  preparation  results
in a harmonised high level of protection for humans, animals and the environment in accordance with
Article  5(1)(b)  of  this  Directive.

2.

In  order  to  ensure  a  high  and  harmonised  level  of  protection  of  human  and  animal  health  and  of  the
environment, any risks arising from the use of a biocidal product shall be identified. To achieve this a
risk  assessment  shall  be  carried  out  to  determine  the  acceptability  or  otherwise  of  any  risks  identified
during the proposed normal use of the biocidal product. This is done by carrying out an assessment of
the  risks  associated  with  the  relevant  individual  components  of  the  biocidal  product.

3. A  risk  assessment  on  the  active  substance  or  substances  present  in  the  biocidal  product  is  always
required.  This  will  already  have  been  carried  out  for  the  purpose  of  Annexes  I,  IA  or  IB.  This  risk
assessment  shall  entail  hazard  identification,  and,  as  appropriate,  dose  (concentration)  —  response
(effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessment
cannot  be  made  a  qualitative  assessment  shall  be  produced.

4. Additional risk assessments shall be carried out, in the same manner as described above, on any other
substance  of  concern  present  in  the  biocidal  product  where  relevant  for  the  use  of  the  biocidal
product.

5.

In order to carry out a risk assessment data are required. These data are detailed in Annexes II, III and
IV and, recognising that there are a wide variety of product types, are flexible according to the product
type  and  associated  risks.  The  data  required  shall  be  the  minimum  necessary  to  carry  out  an
appropriate  risk  assessment.  Member  States  should  take  due  consideration  of  the  requirements  of
Articles  12  and  13  of  this  Directive  in  order  to  avoid  duplication  of  data  submissions.  The  minimum
set  of  data  required  for  an  active  substance  in  any  biocidal  product  type,  however,  shall  be  that
detailed  in  Annex  VIIA  to  Directive  67/548/EEC;  these  data  will  already  have  been  submitted  and
assessed as part of the risk assessment required for entry of the active substance into Annex I, IA or IB
to  this  Directive.  Data  may  also  be  required  on  a  substance  of  concern  present  in  a  biocidal
product.

6. The  results  of  the  risk  assessments  carried  out  on  an  active  substance  and  on  a  substance  of  concern
present  in  the  biocidal  product  shall  be  integrated  to  produce  an  overall  assessment  for  the  biocidal
product  itself.

7. When making evaluations and taking decisions concerning the authorisation of a biocidal product the

Member  State  shall:

(a)

take  into  consideration  other  relevant  technical  or  scientific  information  which  is  reasonably
available  to  them  with  regard  to  the  properties  of  the  biocidal  product,  its  components,
metabolites,  or  residues;

(b) evaluate,  where  relevant,  justifications  submitted  by  the  applicant  for  not  supplying  certain  data.

8. The Member State shall comply with the requirements of mutual recognition as stated in Articles 4(1),

(2)  and  (6)  of  this  Directive.

9.

It is known that many biocidal products present only minor differences in composition and this should
be  taken  into  account  when  evaluating  dossiers.  The  concept  of  ‘frame-formulations’  is  relevant  here.

10.

It  is  known  that  certain  biocidal  products  are  considered  as  posing  only  a  low  risk,  these  biocidal
products,  while  complying  with  the  requirements  of  this  Annex,  are  subject  to  a  simplified  procedure
as  detailed  in  Article  3  of  this  Directive.

11. The application of these common principles shall lead to the Member State deciding whether or not a
biocidal  product  can  be  authorised,  such  authorisation  may  include  restrictions  on  use  or  other
conditions.  In  certain  cases  the  Member  State  may  conclude  that  more  data  are  required  before  an
authorisation  decision  can  be  made.

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12. During the process of evaluation and decision-making, Member States and applicants shall cooperate in
order  to  resolve  any  questions  on  the  data  requirements  quickly  or  to  identify  at  an  early  stage  any
additional studies required, or to amend any proposed conditions for the use of the biocidal product or
to modify its nature or its composition in order to ensure full compliance with the requirements of this
Annex  or  of  this  Directive.  The  administrative  burden,  especially  for  small  and  medium-sized
enterprises (SMEs), shall be kept to the minimum necessary without prejudicing the level of protection
afforded  to  humans,  animals  and  the  environment.

13. The judgments made by the Member State during the evaluation and decision-making process must be
based on scientific principles, preferably recognised at international level, and be made with the benefit
of  expert  advice.

EVALUATION

General principles

14. The  data  submitted  in  support  of  an  application  for  authorisation  of  a  biocidal  product  shall  be
examined for completeness and overall scientific value by the receiving Member State. After acceptance
of  these  data  the  Member  State  shall  utilise  them  by  carrying  out  a  risk  assessment  based  on  the
proposed  use  of  the  biocidal  product.

15. A risk assessment on the active substance present in the biocidal product shall always be carried out. If
there are, in addition, any substances of concern present in the biocidal product then a risk assessment
shall  be  carried  out  for  each  of  these.  The  risk  assessment  shall  cover  the  proposed  normal  use  of  the
biocidal  product  together  with  a  realistic  worst-case  scenario  including  any  relevant  production  and
disposal  issue  either  of  the  biocidal  product  itself  or  any  material  treated  with  it.

16. For  each  active  substance  and  each  substance  of  concern  present  in  the  biocidal  product,  the  risk
assessment 
establishment  of  appropriate
identification  and 
no-observed-adverse-effect levels (NOAEL), where possible. It shall also include, as appropriate, a dose
(concentration)  —  response  (effect)  assessment,  together  with  an  exposure  assessment  and  a  risk
characterisation.

entail  a  hazard 

shall 

the 

17. The results arrived at from a comparison of the exposure to the no-effect level concentrations for each
of  the  active  substances  and  any  substances  of  concern  shall  be  integrated  to  produce  an  overall  risk
assessment  for  the  biocidal  product.  Where  quantitative  results  are  not  available  the  results  of  the
qualitative  assessments  shall  be  integrated  in  a  similar  manner.

18. The  risk  assessment  shall  determine:

(a)

the  risk  to  humans  and  animals,

(b)

the  risk  to  the  environment,

(c)

the  measures  necessary  to  protect  humans,  animals  and  the  general  environment  during  both  the
proposed  normal  use  of  the  biocidal  product  and  in  a  realistic  worst-case  situation.

19.

In  certain  cases  it  may  be  concluded  that  further  data  are  required  before  a  risk  assessment  can  be
finalised.  Any  such  additional  data  requested  shall  be  the  minimum  necessary  to  complete  such  a  risk
assessment.

Effects  on  humans

20. The  risk  assessment  shall  take  account  of  the  following  potential  effects  arising  from  the  use  of  the

biocidal  product  and  the  populations  liable  to  exposure.

21. The  effects  previously  mentioned  result  from  the  properties  of  the  active  substance  and  any  substance

of  concern  present.  They  are:

— acute  and  chronic  toxicity,

— irritation,

— corrosivity,

— sensitisation,

— repeated  dose  toxicity,

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— mutagenicity,

— carcinogenicity,

— reproduction  toxicity,

— neurotoxicity,

— any  other  special  properties  of  the  active  substance  or  substance  of  concern,

— other  effects  due  to  physico-chemical  properties.

22. The  populations  previously  mentioned  are:

— professional  users,

— non-professional  users,

— humans  exposed  indirectly  via  the  environment.

23. The  hazard  identification  shall  address  the  properties  and  potential  adverse  effects  of  the  active
substance and any substances of concern present in the biocidal product. If this results in the biocidal
product  being  classified  according  to  the  requirements  of  Article  20  of  this  Directive  then  dose
(concentration)  —  response  (effect)  assessment,  exposure  assessment  and  risk  characterisation  shall  be
required.

24.

In  those  cases  where  the  test  appropriate  to  hazard  identification  in  relation  to  a  particular  potential
effect  of  an  active  substance  or  a  substance  of  concern  present  in  a  biocidal  product  has  been
conducted  but  the  results  have  not  lead  to  classification  of  the  biocidal  product  then  risk
characterisation  in  relation  to  that  effect  shall  not  be  necessary  unless  there  are  other  reasonable
grounds  for  concern,  e.g.  adverse  environmental  effects  or  unacceptable  residues.

25. The  Member  State  shall  apply  paragraphs  26  to  29  when  carrying  out  a  dose  (concentration)  —
response  (effect)  assessment  on  an  active  substance  or  a  substance  of  concern  present  in  a  biocidal
product.

26. For repeated dose toxicity and reproductive toxicity the dose response relationship shall be assessed for
each active substance or substance of concern and, where possible, the no-observed-adverse-effect level
(NOAEL) identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level
(LOAEL)  shall  be  identified.

27. For  acute  toxicity,  corrosivity  and  irritation,  it  is  not  usually  possible  to  derive  a  NOAEL  or  LOAEL
on  the  basis  of  tests  conducted  in  accordance  with  the  requirements  of  this  Directive.  For  acute
toxicity,  the  LD50  (median  lethal  dose)  or  LC50  (median  lethal  concentration)  value  or,  where  the
fixed  dose  procedure  has  been  used,  the  discriminating  dose  shall  be  derived.  For  the  other  effects  it
shall  be  sufficient  to  determine  whether  the  active  substance  or  substance  of  concern  has  an  inherent
capacity  to  cause  such  effects  during  use  of  the  product.

28. For mutagenicity and carcinogenicity it shall be sufficient to determine whether the active substance or
substance of concern has an inherent capacity to cause such effects during use of the biocidal product.
However,  if  it  can  be  demonstrated  that  an  active  substance  or  a  substance  of  concern  identified  as  a
carcinogen  is  non-genotoxic,  it  will  be  appropriate  to  identify  a  N(L)OAEL  as  described  in
paragraph 26.

29. With respect to skin sensitisation and respiratory sensitisation, in so far as there is no consensus on the
possibility  of  identifying  a  dose/concentration  below  which  adverse  effects  are  unlikely  to  occur  in  a
subject  already  sensitised  to  a  given  substance,  it  shall  be  sufficient  to  evaluate  whether  the  active
substance  or  substance  of  concern  has  an  inherent  capacity  to  cause  such  effects  during  use  of  the
biocidal  product.

30. Where  toxicity  data  derived  from  observations  of  human  exposure,  e.g.  information  gained  from
manufacture, from poison centres or epidemiology surveys, are available special consideration shall be
given  to  those  data  when  carrying  out  the  risk  assessment.

31. An  exposure  assessment  shall  be  carried  out  for  each  of  the  human  populations  (professional  users,
non-professional  users  and  humans  exposed  indirectly  via  the  environment)  for  which  exposure  to  a
biocidal product occurs or can reasonably be foreseen. The objective of the assessment shall be to make

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a quantitative or qualitative estimate of the dose/concentration of each active substance or substance of
concern  to  which  a  population  is,  or  may  be  exposed  during  use  of  the  biocidal  product.

32. The  exposure  assessment  shall  be  based  on  the  information  in  the  technical  dossier  provided  in
conformity  with  Article  8  of  this  Directive  and  on  any  other  available  and  relevant  information.
Particular  account  shall  be  taken,  as  appropriate,  of:

— adequately  measured  exposure  data,

— the  form  in  which  the  product  is  marketed,

— the  type  of  biocidal  product,

— the  application  method  and  application  rate,

— the  physico-chemical  properties  of  the  product,

— the  likely  routes  of  exposure  and  potential  for  absorption,

— the  frequency  and  duration  of  exposure,

— the  type  and  size  of  specific  exposed  populations  where  such  information  is  available.

33. Where  adequately  measured,  representative  exposure  data  are  available,  special  consideration  shall  be
given  to  them  when  conducting  the  exposure  assessment.  Where  calculation  methods  are  used  for  the
estimation  of  exposure  levels,  adequate  models  shall  be  applied.

These  models  shall:

— make  a  best  possible  estimation  of  all  relevant  processes  taking  into  account  realistic  parameters

and  assumptions,

— be  subjected  to  an  analysis  taking  into  account  possible  elements  of  uncertainty,

— be reliably validated with measurements carried out under circumstances relevant for the use of the

model,

— be  relevant  to  the  conditions  in  the  area  of  use.

Relevant  monitoring  data  from  substances  with  analogous  use  and  exposure  patterns  or  analogous
properties  shall  also  be  considered.

34. Where,  for  any  of  the  effects  set  out  in  paragraph  21  a  NOAEL  or  LOAEL  had  been  identified,  the
risk  characterisation  shall  entail  comparison  of  the  NOAEL  or  LOAEL  with  the  evaluation  of  the
dose/concentration  to  which  the  population  will  be  exposed.  Where  a  NOAEL  or  LOAEL  cannot  be
established  a  qualitative  comparison  shall  be  made.

Effects  on  animals

35. Using  the  same  relevant  principles  as  described  in  the  section  dealing  with  effects  on  humans,  the

Member  State  shall  consider  the  risks  posed  to  animals  from  the  biocidal  product.

Effects  on  the  environment

36. The risk assessment shall take account of any adverse effects arising in any of the three environmental
compartments — air,  soil and water (including sediment) — and of the biota following the use of the
biocidal  product.

37. The  hazard  identification  shall  address  the  properties  and  potential  adverse  effects  of  the  active
substance and any substances of concern present in the biocidal product. If this results in the biocidal
product  being  classified  according  to  the  requirements  of  this  Directive  then  dose  (concentration)  —
response  (effect)  assessment,  exposure  assessment  and  risk  characterisation  shall  be  required.

38.

In  those  cases  where  the  test  appropriate  to  hazard  identification  in  relation  to  a  particular  potential
effect  of  an  active  substance  or  a  substance  of  concern  present  in  a  biocidal  product  has  been
conducted  but  the  results  have  not  led  to  classification  of  the  biocidal  product  then  risk

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characterisation  in  relation  to  that  effect  shall  not  be  necessary  unless  there  are  other  reasonable
grounds for concern. Such grounds may derive from the properties and effects of any active substance
or  substance  of  concern  in  the  biocidal  product,  in  particular:

— any  indications  of  bioaccumulation  potential,

— the  persistence  characteristics,

— the  shape  of  the  toxicity/time  curve  in  ecotoxicity  testing,

— indications  of  other  adverse  effects  on  the  basis  of  toxicity  studies  (e.g.  classification  as  a

mutagen),

— data  on  structurally  analogous  substances,

— endocrine  effects.

39. A  dose  (concentration)  —  response  (effect)  assessment  shall  be  carried  out  in  order  to  predict  the
concentration  below  which  adverse  effects  in  the  environmental  compartment  of  concern  are  not
expected to occur. This shall be carried out for the active substance and for any substance of concern
present  in  the  biocidal  product.  This  concentration  is  known  as  the  predicted  no-effect  concentration
(PNEC).  However,  in  some  cases,  it  may  not  be  possible  to  establish  a  PNEC  and  a  qualitative
estimation  of  the  dose  (concentration)  —  response  (effect)  then  has  to  be  made.

40. The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted
in  accordance  with  requirements  of  Article  8  of  this  Directive.  It  shall  be  calculated  by  applying  an
assessment  factor  to  the  values  resulting  from  tests  on  organisms,  e.g.  LD50  (median  lethal  dose),
LC50  (median  lethal  concentration),  EC50  (median  effective  concentration),  IC50  (concentration
causing  50 %  inhibition  of  a  given  parameter,  e.g.  growth),  NOEL(C)  (no-observed-effect  level
(concentration)),  or  LOEL(C)  (lowest-observed-effect  level  (concentration)).

41. An assessment factor is an expression of the degree of uncertainty in extrapolation from test data on a
limited  number  of  species  to  the  real  environment.  Therefore,  in  general,  the  more  extensive  the  data
and  the  longer  the  duration  of  the  tests,  the  smaller  is  the  degree  of  uncertainty  and  the  size  of  the
assessment  factor.

The  specifications  for  the  assessment  factors  shall  be  elaborated  in  the  notes  for  technical  guidance
which,  to  this  end,  shall  be  based  particularly  on  the  indications  given  in  Commission  Directive
93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and environment
from  substances  notified  in  accordance  with  Council  Directive  67/548/EEC (*).

42. For  each  environmental  compartment  an  exposure  assessment  shall  be  carried  out  in  order  to  predict
the  concentration  likely  to  be  found  of  each  active  substance  or  substance  of  concern  present  in  the
biocidal  product.  This  concentration  is  known  as  the  predicted  environmental  concentration  (PEC).
However in some cases it may not be possible to establish a PEC and a qualitative estimate of exposure
then  has  to  be  made.

43. A  PEC,  or  where  necessary  a  qualitative  estimate  of  exposure,  need  only  be  determined  for  the
environmental  compartments  to  which  emissions,  discharges,  disposal  or  distributions  including  any
relevant  contribution  from  material  treated  with  biocidal  products  are  known  or  are  reasonably
foreseeable.

44. The  PEC,  or  qualitative  estimation  of  exposure,  shall  be  determined  taking  account  of,  in  particular,

and  if  appropriate:

— adequately  measured  exposure  data,

— the  form  in  which  the  product  is  marketed,

— the  type  of  biocidal  product,

— the  application  method  and  application  rate,

— the  physico-chemical  properties,

(*) OJ  L  227,  8.9.1993,  p.  9.

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— breakdown/transformation  products,

— likely  pathways  to  environmental  compartments  and  potential  for  adsorption/desorption  and

degradation,

— the  frequency  and  duration  of  exposure.

45. Where  adequately  measured,  representative  exposure  data  are  available,  special  consideration  shall  be
given  to  them  when  conducting  the  exposure  assessment.  Where  calculation  methods  are  used  for  the
estimation  of  exposure  levels,  adequate  models  shall  be  applied.  The  characteristics  of  these  models
shall be as listed in paragraph 33. Where appropriate, on a case-by-case basis, relevant monitoring data
from  substances  with  analogous  use  and  exposure  patterns  or  analogous  properties  should  also  be
considered.

46. For  any  given  environmental  compartment,  the  risk  characterisation  shall,  as  far  as  possible,  entail

comparison  of  the  PEC  with  the  PNEC  so  that  a  PEC/PNEC  ratio  may  be  derived.

47.

If  it  has  not  been  possible  to  derive  a  PEC/PNEC  ratio,  the  risk  characterisation  shall  entail  a
qualitative  evaluation  of  the  likelihood  that  an  effect  is  occurring  under  the  current  conditions  of
exposure  or  will  occur  under  the  expected  conditions  of  exposure.

Unacceptable  effects

48. Data shall be submitted to and evaluated by the Member State to assess whether the biocidal product
does not cause unnecessary suffering in its effect on target vertebrates. This shall include an evaluation
of the mechanism by which the effect is obtained and the observed effects on the behaviour and health
of the target vertebrates; where the intended effect is to kill the target vertebrate the time necessary to
obtain  the  death  of  the  target  vertebrate  and  the  conditions  under  which  death  occurs  shall  be
evaluated.

49. The Member State shall, where relevant, evaluate the possibility of the development of resistance to an

active  substance  in  the  biocidal  product  by  the  target  organism.

50.

If there are indications that any other unacceptable effects may occur the Member State shall evaluate
the  possibility  of  such  effects  occurring.  An  example  of  such  an  unacceptable  effect  would  be  an
adverse  reaction  to  fastenings  and  fittings  used  in  wood  following  the  application  of  a  wood
preservative.

Efficacy

51. Data shall be submitted and evaluated to ascertain if the efficacy claims of the biocidal product can be
substantiated.  Data  submitted  by  the  applicant  or  held  by  the  Member  State  must  be  able  to
demonstrate  the  efficacy  of  the  biocidal  product  against  the  target  organism  when  used  normally  in
accordance  with  the  conditions  of  authorisation.

52. Testing should be carried out according to Community guidelines if these are available and applicable.
Where  appropriate,  other  methods  can  be  used  as  shown  in  the  list  below.  If  relevant  acceptable  field
data  exist,  these  can  be  used.

— ISO,  CEN  or  other  international  standard  method

— national  standard  method

— industry  standard  method  (accepted  by  Member  State)

— individual  producer  standard  method  (accepted  by  Member  State)

— data  from  the  actual  development  of  the  biocidal  product  (accepted  by  Member  State).

Summary

53.

In each of the areas where risk assessments have been carried out, i.e. effects on man, animals, and the
environment,  the  Member  State  shall  combine  the  results  for  the  active  substance  together  with  the
results  for  any  substance  of  concern  to  produce  an  overall  assessment  for  the  biocidal  product  itself.
This  should  take  account  of  any  likely  synergistic  effects  of  the  active  substance(s)  and  substances  of
concern  in  the  biocidal  product.

54. For  biocidal  products  containing  more  than  one  active  substance  any  adverse  effects  shall  also  be

combined  to  produce  an  overall  effect  for  the  biocidal  product  itself.

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DECISION  MAKING

General principles

55. Subject to paragraph 96, the Member State shall come to a decision regarding the authorisation for use
of  a  biocidal  product  as  a  result  of  the  integration  of  the  risks  arising  from  each  active  substance
together  with  the  risks  from  each  substance  of  concern  present  in  the  biocidal  product.  The  risk
assessments shall cover normal use of the biocidal product together with a realistic worst-case scenario
including  any  relevant  disposal  issue  either  of  the  biocidal  product  itself  or  any  material  treated  with
it.

56.

In  making  a  decision  concerning  authorisation,  the  Member  State  shall  arrive  at  one  of  the  following
conclusions  for  each  product  type  and  for  each  area  of  use  of  the  biocidal  product  for  which
application  has  been  made:

1.

the  biocidal  product  cannot  be  authorised;

2.

the  biocidal  product  can  be  authorised  subject  to  specific  conditions/restrictions;

3. more  data  is  required  before  a  decision  on  authorisation  can  be  made.

57.

If  the  conclusion  arrived  at  by  the  Member  State  is  that  additional  information  or  data  are  required
before an authorisation decision can be made, then the need for any such information or data shall be
justified.  This  additional  information  or  data  shall  be  the  minimum  necessary  to  carry  out  a  further
appropriate  risk  assessment.

58. The  Member  State  shall  comply  with  the  principles  of  mutual  recognition  as  detailed  in  Article  4  of

this  Directive.

59. The  Member  State  shall  apply  the  rules  concerning  the  concept  of  ‘frame  formulations’  when  making

an  authorisation  decision  on  a  biocidal  product.

60. The Member State shall apply the rules concerning the concept of ‘low risk’ products when making an

authorisation  decision  on  such  a  biocidal  product.

61. The  Member  State  shall  only  grant  authorisation  to  those  biocidal  products  which,  when  used
according to their conditions of authorisation, do not present an unacceptable risk to humans, animals
or the environment, are efficacious and which contain active substances permitted at Community level
to  be  used  in  such  biocidal  products.

62. The  Member  State  shall 

impose,  where  appropriate,  conditions  or  restrictions  when  giving
authorisations. The nature and severity of these shall be selected on the basis of, and be appropriate to,
the  nature  and  extent  of  the  expected  advantages  and  the  risks  likely  to  arise  from  the  use  of  the
biocidal  product.

63.

In  the  decision-making  process  the  Member  State  shall  take  into  consideration  the  following:

— the  results  of  the  risk  assessment,  in  particular  the  relationship  between  exposure  and  effect,

— the  nature  and  severity  of  the  effect,

— the  risk  management  which  can  be  applied,

— the  field  of  use  of  the  biocidal  product,

— the  efficacy  of  the  biocidal  product,

— the  physical  properties  of  the  biocidal  product,

— the  benefits  of  using  the  biocidal  product.

64. The  Member  State  shall,  when  taking  a  decision  concerning  the  authorisation  of  a  biocidal  product,
take  into  account  the  uncertainty  arising  from  the  variability  in  the  data  used  in  the  evaluation  and
decision-making  process.

65. The  Member  State  shall  prescribe  that  biocidal  products  shall  be  used  properly.  Proper  use  shall
include  application  at  an  efficacious  dose  and  minimisation  of  use  of  biocidal  products  where
possible.

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66. The Member State shall take the necessary measures to ensure that the applicant proposes a label, and,

where  relevant,  the  safety-data  sheet,  for  the  biocidal  product  which:

— fulfils  the  requirements  of  Articles  20  and  21  of  this  Directive,

— contains  the  information  on  the  protection  of  users  required  by  Community  legislation  on  worker

protection,

— specifies  in  particular  the  conditions  or  restrictions  under  which  the  biocidal  product  may  or  may

not  be  used.

Before  issuing  an  authorisation  the  Member  State  shall  confirm  that  these  requirements  must  be
satisfied.

67. The  Member  State  shall  take  the  necessary  measures  to  ensure  that  the  applicant  proposes  packaging
and, where appropriate, the procedures for destruction or decontamination of the biocidal product and
its  packaging  or  any  other  relevant  material  associated  with  the  biocidal  product,  which  conforms  to
the  relevant  regulatory  provisions.

Effects  on  humans

68. The  Member  State  shall  not  authorise  a  biocidal  product  if  the  risk  assessment  confirms  that,  in
foreseeable  application  including  a  realistic  worst  possible  scenario,  the  product  presents  an
unacceptable  risk  to  humans.

69. The Member State shall consider possible effects on all human populations, namely professional users,
non-professional  users  and  humans  exposed  directly  or  indirectly  through  the  environment  when
making  a  decision  on  the  authorisation  of  a  biocidal  product.

70. The Member State shall examine the relationship between the exposure and the effect, and use this in
the  decision-making  process.  A  number  of  factors  need  to  be  considered  when  examining  this
relationship  and  one  of  the  most  important  is  the  nature  of  the  adverse  effect  of  the  substance.  These
effects  include  acute  toxicity,  irritancy,  corrosivity,  sensitisation,  repeated  dose  toxicity,  mutagenicity,
carcinogenicity, neurotoxicity, reproduction toxicity together with physico-chemical properties, and any
other  adverse  properties  of  the  active  substance  or  substance  of  concern.

71. The  Member  State  shall,  where  possible,  compare  the  results  obtained  with  those  obtained  from
previous risk assessments for an identical or similar adverse effect and decide on an appropriate margin
of  safety  (MOS)  when  making  an  authorisation  decision.

An  appropriate  MOS  is  typically  100  but  an  MOS  higher  or  lower  than  this  may  be  appropriate
depending  on,  among  other  things,  the  nature  of  the  critical  toxicological  effect.

72. The  Member  State  shall,  if  appropriate,  impose,  as  a  condition  of  authorisation,  the  wearing  of
personal  protective  equipment  such  as  respirators,  breathing-masks,  overalls,  gloves  and  goggles  in
order  to  reduce  exposure  for  professional  operators.  Such  equipment  must  be  readily  available  to
them.

73.

If  for  non-professional  users  the  wearing  of  personal  protective  equipment  would  be  the  only  possible
method  for  reducing  exposure,  the  product  shall  not  normally  be  authorised.

74.

If  the  relationship  between  the  exposure  and  the  effect  cannot  be  reduced  to  an  acceptable  level  then
no  authorisation  can  be  given  by  the  Member  State  for  the  biocidal  product.

75. No  biocidal  product  classified  according  to  Article  20(1)  of  this  Directive  as  toxic,  very  toxic  or  as  a
category  1  or  2  carcinogen,  or  as  a  category  1  or  2  mutagen,  or  classified  as  toxic  for  reproduction
category  1  or  2,  shall  be  authorised  for  use  by  the  general  public.

Effects  on  animals

76. The Member State shall not authorise a biocidal product if the risk assessment confirms that, in normal

use,  the  biocidal  product  presents  an  unacceptable  risk  to  non-target  animals.

77. Using the same relevant criteria as described in the section dealing with effects on humans, the Member
State shall consider the risks posed to animals from the biocidal product when making an authorisation
decision.

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Effects  on  the  environment

78. The Member State shall not authorise a biocidal product if the risk assessment confirms that the active
substance,  or  any  substance  of  concern,  or  any  degradation,  or  reaction  product  presents  an
unacceptable  risk  in  any  of  the  environmental  compartments,  water  (including  sediment),  soil  and  air.
This  shall  include  the  assessment  of  risks  to  non-target  organisms  in  these  compartments.

In  considering  whether  there  is  an  unacceptable  risk  Member  States  shall,  when  coming  to  a  final
decision  in  accordance  with  paragraph  96,  take  into  account  the  criteria  in  paragraphs  81  to  91.

79. The  basic  tool  used  in  the  decision  making  is  the  PEC/PNEC  ratio  or,  if  this  is  not  available,  a
qualitative estimation. Due consideration shall be given to the accuracy of this ratio due to variability
in  the  data  used  both  in  measurements  of  concentration  and  of  estimation.

In  the  determination  of  the  PEC  the  most  appropriate  model  should  be  used  taking  into  account  the
environmental  fate  and  behaviour  of  the  biocidal  product.

80. For  any  given  environmental  compartment  if  the  PEC/PNEC  ratio  is  equal  to  or  less  than  1  the  risk

characterisation  shall  be  that  no  further  information  and/or  testing  are  necessary.

If the PEC/PNEC ratio is greater than 1 the Member State shall judge, on the basis of the size of that
ratio  and  on  other  relevant  factors,  if  further  information  and/or  testing  are  required  to  clarify  the
concern or if risk reduction measures are necessary or if the product cannot be given an authorisation
at  all.  Relevant  factors  to  be  considered  are  those  previously  mentioned  in  paragraph  38.

Water

81. The Member State shall not authorise a biocidal product, if under the proposed conditions of use, the
foreseeable  concentration  of  the  active  substance  or  of  any  other  substance  of  concern  or  of  relevant
metabolites or breakdown or reaction products in water (or its sediments) has an unacceptable impact
on  non-target  species  in  the  aquatic,  marine  or  estuarine  environment  unless  it  is  scientifically
demonstrated  that  under  relevant  field  conditions  there  is  no  unacceptable  effect.

82. The Member State shall not authorise a biocidal product if, under the proposed conditions of use, the
foreseeable  concentration  of  the  active  substance  or  of  any  other  substance  of  concern  or  of  relevant
metabolites  or  breakdown  or  reaction  products  in  groundwater  exceeds  the  lower  of  the  following
concentrations:

(a)

the  maximum  permissible  concentration  laid  down  by  Directive  80/778/EEC,  or

(b)

the  maximum  concentration  as  laid  down  following  the  procedure  for  including  the  active
substance  in  Annex  I,  IA  or  IB  to  this  Directive,  on  the  basis  of  appropriate  data,  in  particular
toxicological data

unless  it  is  scientifically  demonstrated  that  under  relevant  field  conditions  the  lower  concentration  is
not  exceeded.

83. The Member State shall not authorise a biocidal product if the foreseeable concentration of the active
substance or a substance of concern or of relevant metabolites, breakdown or reaction products to be
expected  in  surface  water  or  its  sediments  after  use  of  the  biocidal  product  under  the  proposed
conditions  of  use:

— exceeds,  where  the  surface  water  in  or  from  the  area  of  envisaged  use  is  intended  for  the

abstraction  of  drinking  water,  the  values  fixed  by

— Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water

intended  for  the  abstraction  of  drinking  water  in  the  Member  States (1),

— Directive  80/778/EEC  or

— has  an  impact  deemed  unacceptable  on  non-target  species

(1) OJ  L  194,  25.7.1975,  p.  26.  Directive  as  last  amended  by  Directive  91/692/EEC  (OJ  L  377,  31.12.1991,  p.  48).

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unless  it  is  scientifically  demonstrated  that  under  relevant  field  conditions  this  concentration  is  not
exceeded.

84. The  proposed  instructions  for  use  of  the  biocidal  product,  including  procedures  for  cleaning
application  equipment,  must  be  such  that  the  likelihood  of  accidental  contamination  of  water  or  its
sediments  is  minimised.

Soil

85. Where  unacceptable  contamination  of  soil  is  likely  to  occur,  the  Member  State  shall  not  authorise  a
biocidal product if the active substance or substance of concern contained in it, after use of the biocidal
product:

— during  tests  in  the  field,  persists  in  soil  for  more  than  one  year,  or

— during  laboratory  tests,  forms  non-extractable  residues  in  amounts  exceeding  70 %  of  the  initial

dose  after  100  days  with  a  mineralisation  rate  of  less  than  5 %  in  100  days,

— has  unacceptable  consequences  or  effects  on  non-target  organisms,

unless it is scientifically demonstrated that under field conditions there is no unacceptable accumulation
in  soil.

Air

86. The  Member  State  shall  not  authorise  a  biocidal  product  where  there  is  a  foreseeable  possibility  of
unacceptable effects on the air compartment unless it is scientifically demonstrated that under relevant
field  conditions  there  is  no  unacceptable  effect.

Effects  on  non-target  organisms

87. The  Member  State  shall  not  authorise  a  biocidal  product  where  there  is  a  reasonably  foreseeable
possibility of non-target organisms being exposed to the biocidal product if for any active substance or
substance  of  concern:

— the  PEC/PNEC  is  above  1  unless  it  is  clearly  established  in  the  risk  assessment  that  under  field
conditions no unacceptable effects occur after use of the biocidal product according to the proposed
conditions  of  use,  or

— the bioconcentration factor (BCF) related to fat tissues in non-target vertebrates is above 1 unless it
is  clearly  established  in  the  risk  assessment  that  under  field  conditions  no  unacceptable  effects
occur, either directly or indirectly, after use of the product according to the proposed conditions of
use.

88. The  Member  State  shall  not  authorise  a  biocidal  product  where  there  is  a  reasonably  foreseeable
possibility  of  aquatic  organisms  including  marine  and  estuarine  organisms  being  exposed  to  the
biocidal  product  if  for  any  active  substance  or  substance  of  concern  in  it:

— the  PEC/PNEC  is  above  1  unless  it  is  clearly  established  in  the  risk  assessment  that  under  field
conditions  the  viability  of  aquatic  organisms  including  marine  and  estuarine  organisms  is  not
threatened  by  the  biocidal  product  according  to  the  proposed  conditions  of  use,  or

— the  bioconcentration  factor  (BCF)  is  greater  than  1 000  for  substances  which  are  readily
biodegradable or greater than 100 for those which are not readily biodegradable unless it is clearly
established in the risk assessment that under field conditions no unacceptable impact, either directly
or  indirectly,  occurs  on  the  viability  of  exposed  organisms  including  marine  and  estuarine
organisms  after  use  of  the  biocidal  product  according  to  the  proposed  conditions  of  use.

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By  way  of  derogation  from  this  paragraph,  Member  States  may,  however,  authorise  an  anti-fouling
product  used  on  commercial,  public  service  and  naval  seagoing  vessels  for  a  period  of  up  to  10  years
from the date on which this Directive enters into force if similar fouling control cannot be achieved by
other  practicable  means.  When  implementing  this  provision,  Member  States  shall,  if  appropriate,  take
into  account  relevant  International  Maritime  Organisation  (IMO)  resolutions  and  recommendations.

89. The  Member  State  shall  not  authorise  a  biocidal  product  where  there  is  a  reasonably  foreseeable
possibility of micro-organisms in sewage treatment plants being exposed to the biocidal product if for
any  active  substance,  substance  of  concern,  relevant  metabolite,  breakdown  or  reaction  product  the
PEC/PNEC  ratio  is  above  1  unless  it  is  clearly  established  in  the  risk  assessment  that  under  field
conditions  no  unacceptable  impact,  either  directly  or  indirectly,  occurs  on  the  viability  of  such
micro-organisms.

Unacceptable  effects

90.

If  the  development  of  resistance  to  the  active  substance  in  the  biocidal  product  is  likely  the  Member
State shall take steps to minimise the consequences of this resistance. This may involve modification of
the  conditions  of  authorisation  or  even  refusal  of  any  authorisation.

91. An  authorisation  for  a  biocidal  product  intended  to  control  vertebrates  shall  not  be  given  unless:

— death  is  synchronous  with  the  extinction  of  consciousness,  or,

— death  occurs  immediately,  or,

— vital  functions  are  reduced  gradually  without  signs  of  obvious  suffering.

For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for
the  target  vertebrate.

Efficacy

92. Member States shall not authorise a biocidal product which does not possess acceptable efficacy when
used  in  accordance  with  the  conditions  specified  on  the  proposed  label  or  with  other  conditions  of
authorisation.

93. The  level,  consistency  and  duration  of  protection,  control  or  other  intended  effects  must,  as  a
minimum, be similar to those resulting from suitable reference products, where such products exist, or
to other means of control. Where no reference products exist, the biocidal product must give a defined
level  of  protection  or  control  in  the  areas  of  proposed  use.  Conclusions  as  to  the  performance  of  the
biocidal  product  must  be  valid  for  all  areas  of  proposed  use  and  for  all  areas  in  the  Member  State
except  where  the  proposed  label  prescribes  that  the  biocidal  product  is  intended  for  use  in  specific
circumstances. Member States shall evaluate dose response data generated in trials (which must include
an  untreated  control)  involving  dose  rates  lower  than  the  recommended  rate,  in  order  to  assess  if  the
recommended  dose  is  the  minimum  necessary  to  achieve  the  desired  effect.

Summary

94.

In each of the areas where risk assessments have been carried out, i.e. effects on humans, animals, and
the  environment,  the  Member  State  shall  combine  the  conclusions  arrived  at  for  the  active  substance
and  the  substances  of  concern  to  produce  an  overall  conclusion  for  the  biocidal  product  itself.  A
summary  should  also  be  made  of  the  efficacy  assessment  and  of  the  unacceptable  effects.

The  result  shall  be:

— a  summary  of  the  effects  of  the  biocidal  product  on  humans,

— a  summary  of  the  effects  of  the  biocidal  product  on  animals,

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— a  summary  of  the  effects  of  the  biocidal  product  on  the  environment,

— a  summary  of  the  efficacy  assessment,

— a  summary  of  the  unacceptable  effects.

OVERALL  INTEGRATION  OF  CONCLUSIONS

95. The  Member  State  shall  combine  the  individual  conclusions  arrived  at  with  regard  to  effects  of  the
biocidal  product  on  the  three  sectors  namely,  humans,  animals  and  the  environment  to  arrive  at  an
overall  conclusion  for  the  global  effect  of  the  biocidal  product.

96. The  Member  State  shall  then  take  due  consideration  of  any  relevant  unacceptable  effects,  the  efficacy
of  the  biocidal  product  and  the  benefits  of  using  the  biocidal  product  before  taking  an  authorisation
decision  on  the  biocidal  product.

97. The  Member  State  shall  ultimately  decide  whether  or  not  the  biocidal  product  can  be  authorised  and
whether  this  authorisation  shall  be  subject  to  any  restrictions  or  conditions  in  conformity  with  this
Annex  and  this  Directive.