Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE concerning the placing of biocidal products on the market
Date: 1996-06-24
Institutions: European Commission
Subjects: chemical product, environmental impact, marketing, plant health product, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.06.1996 
COM(96) 312 final - COD 465 

Amended proposal  for a 

EUROPEAN PARLIAMENT  AND COUNCIL DIRECTIVE 

concerning  the  placing  of  biocidal  products  on  the  market 

(presented by the Commission pursuant to Article  189 a (2) 
of the EC-Treaty) 

EXPLANATORY  MEMORANDUM 

Pursuant to Article  189(a) paragraph 2 of the EC treaty, the Commission submits an amended 
proposal  for a European Parliament and Council Directive concerning  the placing of biocidal 
products  on  the  market.  The  amended  proposal  takes  account  of  a  number  of  amendments 
from  the  European  Parliament,  adopted  at  its  plenary  session  on  18 April  19961. 

A large number of amendments were proposed by Parliament,  grouped essentially as follows: 
to  limit  the  use  of  laboratory  animals,  to  alter  the  scope,  to  clarify  the  text,  to  introduce 
simplified  procedures,  to modify  the data requirements,  to alter the operation  in certain areas 
(eg  labelling,  treatment  of  anti-fouling  products)  and  to  introduce  a system  to charge  fees. 

Amendment 5 contains a proposal  that a new recital,  number 20a,  be  introduced  stating that 
this  directive  assists  in  reducing  the  number  of  tests  carried  out  on  laboratory  animals;  the 
Commission  agrees  with  this  important  addition. 

As this  proposal  is designed  to fill  a gap  in the existing  European  chemicals  legislation  the 
scope  is critical  - it needs  to cover  all  relevant  products  not covered  by  other  legislation  but 
at the same time must avoid any duplication with existing legislation. The Commission agrees 
that  reference  needs  to  be  made  to  additional  relevant  Community  legislation,  and  accepts 
amendment  number 2. The suggested  text has, however,  been added  to recital  20 rather  than 
recital  13 as this  is a more  logical place for  it.  Additions  have  also been made to article  1 as 
proposed  in  amendments  9,  10 and  11.  Proposals  to  restrict  the  scope  would  leave  gaps  in 
the European legislation and so the Commission cannot accept amendment  12 which indirectly 
alters the scope by modifying  an important definition,  that of harmful  organisms.  Amendment 
13  cannot  be  accepted  as  it  would  increase  the  scope  unnecessarily  by  including  products 
which are  for  export only;  amendment  15 is unacceptable  as it would  bring treated  materials 
under  the  scope  of  the  proposal.  The  proposal  is  concerned  with  the  placing  of  biocidal 
products  on  the  European  market  and  does  not  include  the  manufacturing  stage  of  the 
biocidal  products  themselves  nor  the  post  treatment  stage  ie  materials  after  they  have  been 
treated  with  biocides  (eg  treated  wood). 

Amendments  4,  7,  42  and  43  propose  the  setting  up  of  action  plans  or  other  measures  to 
reduce  the usage  of biocidal  products.  However,  whilst  these  ideas  are  laudable  and  indeed 
are  in  line  with  the  5th  Environmental  Action  Programme  they  cannot  be  incorporated  into 
this proposal.  The proposal  is concerned  with the assessment of individual  active  substances 
and biocidal products and not with the setting of an overall strategy  for  their use.  For  similar 
reasons  the  Commission  cannot  accept  the  part  of  amendment  38  which  proposes  that  all 
product  labels  advise  that  the  biocidal  product  should  be  used  moderately. 

The Commission  recognizes that this is a very technical proposal  and welcomes any  relevant 
clarification.  Amendments 3 and 92 (grouped together), which clarify  certain basic principles, 

1  Reference-  minutes of the session of  18 April  1996, provisional edition,  PE  198.355. 

L 

have  therefore  been  incorporated  into  recital  19 as  suggested.  A  new  recital,  number  20b, 
has been introduced as proposed  in amendment 6; this explains that a guidance document  will 
be  produced  to  assist  in the  implementation  of  annex  VI  (the  common  principles). 

The  Commission  agrees  with  the  introduction  of  the  concept  of  "frame-formulations"  in 
article  2,  as  suggested  in amendment  14,  as  this  will  simplify  certain  procedures. 

Another very useful  clarification  which has been accepted by the Commission is the principle 
of grouping  all  pertinent  references  to mutual  recognition  together  in the manner  suggested 
by  amendments  19 and 20. This has resulted  in a restructuring  of the text  in article  3 which 
is  now  split  into  two  parts,  a  new  article  3  which  contains  the  general  requirements  for 
authorization  and  a  new  article  3a which contains  the  text dealing  with  mutual  recognition. 
The rewording suggested in amendment  17 clarifies the time period stipulated for  applications 
to be  processed  and  this  has been  incorporated  into  the  text  of article  3.2.  Amendment  18 
has  also  been  incorporated  into  the  text  in the  new  article  3 as the  Commission  agrees  that 
biocidal  products  to  which  the  concept  of  frame  formulations  has  been  applied  should  be 
processed  within  60 days. 

An  addition  to  the  text  in  article  14 has  been  made,  as  suggested  in amendment  31  as  this 
clarifies  certain  aspects  of what happens  in the  transitional  period.  Amendment  57 has  been 
accepted  and  the  deletion  of  some  text  in paragraph  59  of  annex  VI  clarifies  the  meaning. 

The  Commission  cannot  accept  the  proposal,  contained  in  amendment  8,  to  delete  the 
reference  to  the  5th  Environmental  Action  Programme  in  recital  24  since  the  proposed 
directive  underpins  a  key  part  of  this  Programme  and  so  a  reference  to  it  is  important. 

A  number  of  amendments  were  proposed  which  alter  the  data  requirements;  some  of  these 
have  been  incorporated  into  the  text  but  others,  which  remove  certain  provisions  for 
flexibility,  are  not  acceptable.  This  flexibility  is  needed  to  ensure  that  only  data  which  is 
really  needed  for  the purposes  of carrying  out a risk assessment  is submitted  and  evaluated; 
this  flexibility  does,  of  course,  not  result  in a  reduction  in the  level  of  protection  afforded 
to  humans  or  the  environment.  Amendments  23,  25,  27,  28,  44,  50,  51,  53  and  54  are 
therefore  not  acceptable.  Other  amendments  propose  adding  to  the  data  requirements 
regardless  as to whether  or not they are necessary  for  the purposes  of the risk assessment  eg 
requesting  data  on  all  degradation  products  of  the  active  substances  or  decreasing  the 
acceptable  concentration  limits in water.  Amendment  numbers 45, 46, 47, 48, 49, 52 and  60 
fall  into  this  category  and  are  therefore  unacceptable.  The  amendments  relating  to  data 
requirements  which  have  been  incorporated  into  the  modified  text  are  numbers  79,  80, 81, 
and 83; these state that the dossier  requirements  must be in line with technical  development. 

Combining  an  alteration  in  the  data  requirements  with  a  change  in  operation  of  the 
authorization  conditions  the  Commission  has  incorporated  amendments  21 and  24  into  the 
text  of  article  4  and  amendment  59  into paragraph  80 of  annex  VI;  these  now  stipulate  that 
effects  on  air  and  on  surface  water  must  be  specifically  considered  and  that  application 
methods must be incorporated  into the conditions of authorization.  Amendment 56 states that 
only  where  appropriate  should  certain  types  of  tests  be used  for  efficacy  purposes;  this  is a 
helpful  amendment  and  the text  in paragraph  51 of  annex  VI has been  altered  accordingly. 

3 

A  number  of  amendments  were  concerned  with  labelling.  Amendment  37 proposes  that  all 
biocides  be  labelled  according  to the Preparations  Directive  (88/379/EEC);  the  Commission 
agrees  with  this  in principle  but  as  Directive  88/379/EEC  is currently  being  revised  cannot 
implement  this amendment yet.  Amendment  37 will be acted upon once the modifications  to 
Directive  88/379/EEC  have been completed;  article  18.4 has been amended  slightly  insofar 
as  the  reference  to  other  Community  provisions  has  been  deleted.  Amendment  36  also 
proposes  modifications  to  the  product  label;  the  part  which  states  that  labels  must  not  be 
misleading  is acceptable  but the request  not to have claims on the label cannot be  supported. 
Part of amendment  38 proposed  that labelling  should  be clearly  legible; this is not  necessary 
as  this point  is  already  covered  in Directive  88/379/EEC  under  which all biocidal  products 
will be labelled.  Directive 88/379/EEC also contains  requirements  as to when safety  lids  are 
required  and  so  amendment  35 has  not  been  accepted. 
Part  of  amendments  29  & 95  (grouped  together)  clarifies  that  the principle  of  comparative 
assessment  will  not  be  applied  to  biocidal  products,  this  helpful  clarification  has  been 
incorporated  into article 9.5.  In contrast amendment  58 cannot be accepted  as it implies  that 
comparative  assessment  would  be  applied  to biocidal  products.  The part  of  amendments  29 
and  95  which  is  not  acceptable  relates  to  the  request  to  have  a  5  year  phasing  out  period 
based on the procedure  in article  10 of the proposal; this cannot be accepted  as the  reference 
to  article  10  is  not  relevant  and  the  5 year  period  proposed  is too  long. 

The  requirement  that  the  consultation  between  the  applicant  and  the  Commission  be  made 
mandatory,  as  proposed  in  amendment  39,  is  acceptable  with  the  proviso  that  such 
consultation  is  not  needed  when  a positive  authorization  decision  is envisaged,  article  24.3 
has been reworded accordingly.  However the suggestion that all requests for the composition 
of all product  formulations  be kept confidential  automatically,  as requested  in amendment  34 
is  not  acceptable  as  certain  components  of  the  formulation  may  have  to  be  named  on  the 
product  label  if  they  are  dangerous  to  humans  or  the  environment. 

A derogation  for  anti-fouling  products  used  for  specific  purposes  is proposed  in  amendment 
96;  this  is  acceptable  to  the  Commission  as  it  recognizes  the  special  requirements  of  these 
products.  Paragraph  86  of  annex  VI  has  been  amended  accordingly. 

Amendments  1, 22 and  55 propose  restricting  the types  of substance  which can be  included 
in  biocidal  products;  these  cannot  be  accepted  as  this  would  alter  one  of  the  fundamental 
principles  of  this  proposal  -  that  decisions  are  based  on  risk  assessment  (and  not  a  hazard 
assessment). The proposal attempts to balance the decisions made at Member States level  and 
at  Community  level  by,  as  far  as  possible,  leaving  decisions  on  the  biocidal  product  to 
Member States and taking decisions on the active substance at Community level.  Amendment 
33 is not acceptable  as the Commission considers  that the decision as to the completeness  of 
a dossier  on a biocidal product  should be left  to the Member  State. Amendment  32 proposes 
an alteration  in the committee  procedure  for  the  adoption of the Regulation which  will  deal 
with  the  review  work;  the  Commission  originally  proposed,  after  careful  consideration,  an 
advisory  committee  for  this  work  and  sees  no  reason  to  change  this. 
Other  proposed  procedural  changes  which  are  not  acceptable  are  numbers  41  and  63. 
Amendment 41 would automatically extend the application of the safety clause to all Member 
States  following  use  by  a  single  Member  State  and  63  is  against  the  Commission  rules  in 
attempting  to  define  the  composition  of  the  Standing  Committee 

Amendment  62  is  not  acceptable  as  it  proposes  that,  in  paragraph  92  of  annex  VI,  only 
environmental and economic benefits  should be considered rather than benefits  in general -
this would restrict the flexibility needed when deciding upon  the authorization of a biocidal 
product. 

Finally  amendment  26  proposes  that  fees  be  charged  for  the  authorization  of  biocidal 
products; this principle has been accepted by the Commission and a new article 7a introduced 
into the text. 

X 

ORIGINAL  PROPOSAL 

MODIFIED  PROPOSAL 

Recital  19 

Whereas  Member  States  must  be  able  to 
authorize  biocidal  products  not  complying 
with  the  above-mentioned  conditions  for  a 
limited  period  of time, especially  in case  of 
an  unforseen  danger  threatening  man  or the 
environment  which  cannot  be contained  by 
other  means;  whereas  such  authorization 
should  be  reviewed  by  the  Commission  in 
close  cooperation  with  the  Member  States; 
whereas  the  Community  procedure  should 
not  prevent 
from 
authorizing  for  use  in  their  territory  for  a 
limited  period  of  time  biocidal  products 
containing  an  active  substance  not  yet 
entered in the Community  list, provided that 
a  dossier  meeting  community  requirements 
has  been  submitted  and  the  Member  States 
believes  that  the  active  substance  and  the 
biocidal  products  satisfy 
the  Community 
conditions  set  in  regard  to  them; 

Member  States 

i.e. 

safety 

in  cases  where 
for  humans  and 

Whereas  Member  States  must  be  able  to 
authorize  biocidal  products  not  complying 
with  the  above-mentioned  conditions  for  a 
limited  period  of time, especially  in case  of 
an  unforseen  danger  threatening  man  or  the 
environment  which cannot  be contained by 
the 
other  means; 
requisite 
the 
environment  cannot  be  achieved  by  other 
means or with the  aid of the products  listed 
in Annex  V of this Directive: whereas  such 
authorization  must  accord  with  principles 
laid  down  in  Point  61  of  Annex  VI  to  this 
Directive  and  should  be  reviewed  by  the 
Commission  in  close  cooperation  with  the 
Member  States;  whereas  the  Community 
procedure  should  not  prevent  Member 
States  from  authorizing  for  use  in  their 
territory  for  a 
time 
biocidal  products  containing  an  active 
substance not yet entered  in the  Community 
that  a  dossier  meeting 
list,  provided 
community 
been 
requirements 
submitted  and  the  Member  States  believes 
that  the  active  substance  and  the  biocidal 
products  satisfy  the  Community  conditions 
set  in  regard  to  them; 

limited  period  of 

has 

G 

Recital  20 

Whereas  active  substances  used  in  biocidal 
products  may  also  be  used 
in  other 
preparations  which  have  under  other 
Community 
tested  on 
legislation,  been 
animals,  whereas  double  testing  on  animals 
must 
close 
coordination  should  be  ensured  with  other 
Community 
legislation  and  in  particular 
with  Directive  91/414/EEC  on  the  placing 
on  the  market  of  plant  protection  products 

avoided;  whereas, 

be 

be 

avoided;  whereas, 

Whereas  active  substances  used  in  biocidal 
products  may  also  be  used 
in  other 
preparations  which  have  under  other 
Community 
tested  on 
legislation,  been 
animals,  whereas  double  testing  on  animals 
must 
close 
coordination  should  be  ensured  with  other 
Community  legislation  and  in  particular 
with  Directive  91/414/EEC  on  the  placing 
on  the  market  of  plant  protection  products 
and  those  Directives  concerned  with  the 
protection  of  water,  and 
those  concerned 
with  the  contained  use  and  release  of 
genetically  modified  organism. 

Recital  20a  (new) 

Whereas  it  is  essential  that  this  Directive 
helps  to  reduce  the  number  of  tests  on 
animals  and  that  testing  should  be  made 
dependant  on  the  purpose  and  use  of  a 
product: 

Recital  20b  (new) 

Whereas  the  Commission  is  to  draw  up 
the 
technical  notes 
implementation  of  Annex  VI: 

for  guidance  on 

^ 

Article  l(2)(aa)  and 

(ab)(new)  and  (b) 

(aa)  Council  directive  81/851/EEC  on  the 
approximation  of  the  laws  of  the  Member 
States 
to  veterinary  medicinal 
products :(1) 

relating 

the 

Council  Directive  90/677/EEC  on 
(ab) 
extending 
of  Directive. 
scope 
81/851/EEC  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to 
veterinary  medicinal  products  and  laying 
down 
for 
provisions 
immunological 
veterinary  medicinal 
products:f2V 

additional 

(b) 
Council  Directives  70/524/EEC  and 
82/471/EEC on additives and substances  for 
exclusive  use  in  animal  feedingstuffs; 

(b) 
Council  Directives  70/524/EEC  and 
82/471/EEC on additives and substances  for 
exclusive  use  in  animal  feedingstuffs  and 
Directive  77/101/EEC  (3)  on  the  marketing 
of  straight  feedingstuffs: 

( l ) O JL  317.6.11.1981.  p.82. 
(2)  OJL  373.  31.12.1990  p.26 
( 3 ) O J L 3 2.  3.2.1977  p.l 

Article  1.2  (g)  new 

(g)  Council  Directive  90/385/EEC  on  the 
approximation  of  the  laws  of  the  Member 
implantable  medicinal 
States  on  active 
devices  (1), 
(h)  Council  Directive  89/109/EEC  of  21 
December  1988 on the approximation  of the 
laws  of  the  Member  States  relating 
to 
materials  and articles  intended  to  come  into 
contact  with  foodstuffs  (2)  and  subsequent 
follow-up  Directives, 
m  OJL  189. 20.7.1990. p.17 
(2)OJL40.  11.2.1989.  P.  38 

Article  l(3)(ea)(new) 

(galCouncil  directive  84/450/EEC  on  the 
approximation  of  the  laws,  regulations  or 
administrative  provisions  of  the  Member 
States  relating  to  misleading  advertising 
OJL  250.  19.09.1984. p. 17 

Article  2  (l)(ea)(new) 

(ea)  Frame-Formulations 

the 

substances  of 

for  a  group  of  biocidal 
Specifications 
products having the same use and user type. 
the 
This  group  of  products  must  contain 
same  active 
same 
specifications  and  their  compositions  must 
present  only  variations  from  a  previously 
authorized  biocidal  product  which  do  not 
affect  the  level of risk associated  with  them 
and  their  efficacy: 
In this  context,  a variation  is the  allowance 
of  a  reduction  in  the  percentage  of  the 
active  substance  and/or  an  alteration  in 
percentage  composition  of  one  or  more 
non 
the 
substances 
replacement  of one or more pigments, dyes, 
perfumes  by  other  presenting  the  same  or  a 
lower  risk,  and  which  do  not  decrease  its 
efficacy. 

and/or 

active 

Article  3 (2) 

2. Every application  for  authorization  shall 
be  decided  upon  within  a  reasonable 
period. 

2. Every application  for  authorization  shall 
be  decided  upon  without  undue  delay, 

3 

Article  3 

(par  4,5,6,7,8) 

3.A  biocidal  product  that  has  already  been 
authorized  in  one  Member  State  shall  be 
authorized,  in  another  Member  State  within 
60 days of an  application  being  received  by 
the  other  Member  State,  providing  that  the 
active  substance  of  the  biocidal  product 
conforms  to  the  entry  in  Annex  1. 

deleted 

4.If  complying  with  Article  4  a  Member 
State  establishes  that: 
(a)  unacceptable  resistance  of  the  target 
organism  to  the  biocidal  product  is  proven 
or 
(b)  the  relevant  circumstances  of  use,  such 
as  climate  or  breeding  period  of  the  target 
species,  differ  significantly  from  those  in 
the  Member  State  where  biocidal  product 
was  first  authorized,  and  an  unchanged 
present 
authorization  may 
unacceptable 
the 
or 
risks 
environment; 
the  Member  State  may  request  that  the 
directions  for  use and the  dose  rate  referred 
to  in  Article  18(3)(e)  are  adjusted  to  the 
different  circumstances,  or, 
the  risk 
cannot  be  prevented  in  any  other  way,  the 
Member  State  may  request  changes  to  be 
made  to  the  biocidal  product  itself  so  that 
conditions  for  issue  of  an  authorization 
provided  for  in  article  4  are  satisfied. 

therefore 
to  man 

if 

5.  Notwithstanding  paragraph  4  where  a 
Member  State  believes  a  biocidal  product 
cannot  meet  the  conditions  set  out  under 
to 
article  4  and  consequently  proposes 
refuse 
authorization,  it  shall  notify  the 
Commission,  other  Member  States  and  the 
applicant  and  shall  provide  them  with  an 
explanatory  document  giving  details  of  the 
product  and  setting  out  the  grounds  on 
which 
the 
authorization. 

proposes 

refuse 

to 

it 

deleted 

The  Commission  shall  prepare  a  proposal 
on these  matters  in  accordance  with  Article 
24  for  decision  in  accordance  with  the 
procedure  laid  down  in  Article  25(3). 

that 
6.  Member  States  shall  prescribe 
biocidal  products 
classified, 
packaged  and  labelled  in  accordance  with 
the  provisions  of  this  Directive. 

shall  be 

; 

7.  Authorizations  shall  be  granted  for  a 
fixed  period  of  10  years  from  the  date  of 
first  entry  of  the  active  substance  onto 
Annex 
they  may  be  renewed  after 
verification  that  the  conditions  imposed  in 
paragraphs  1  and  2  are  still  satisfied. 
Renewal  may,  where  necessary,  be  granted 
only  for  the  period  necessary  to  allow  the 
competent  authorities of the Member States, 
to  make 
such  verification,  where  an 
application  for  renewal  has  been  made. 

that 
8.  Member  States  shall  prescribe 
biocidal  products  must  be  properly  used. 
Proper  use  shall  include  compliance  with 
conditions  established  under  Article  4  and 
specified  under  the  labelling  provisions  of 
this  directive.  Proper  use  shall  also  involve 
the  rational  application  of  a combination  of 
physical,  biological,  chemical  or  other 
measures  a  s  appropriate  whereby  the  use 
of  biocidal  products 
the 
minimum  necessary.  Where  biocidal  are 
used  at  work  use  shall  also  be 
in 
accordance  with  requirements  of  directives 
for  the  protection  of  workers. 

limited 

to 

is 

S\  1 

Article  3  par.  3,4,5,6  new 

3.Without  prejudice  to  Articles  7  and  11 
and  providing  that  the  applicant  has  a  right 
subsequent 
to 
of 
a 
it.  when 
access 
application 
for  a  new 
for  authorization 
biocidal  product  is  -based  upon  a  frame-
formulation,  the  competent  authority  shall 
take 
this 
application  within  a  period  of  60  days. 

a  decision  with 

regard 

to 

that 
4. Member  States 
biocidal 
classified, 
products 
packaged  and  labelled  in  accordance  with 
the  provisions  of  this  Directive. 

prescribe 
be 

shall 
shall 

for 

the 

shall  be  granted 

to  Article  6(1). 
5.  Without  prejudice 
a 
authorizations 
maximum  period  of  10  years  from  the  date 
of  first  or  renewed  inclusion  of  the  active 
substance  onto  Annex  I  for  the  product 
deadline 
exceeding 
type,  without 
specified  for  the  active  substance  in  Annex 
I.  they  may  be  renewed  after  verification 
that  the  conditions  imposed  in  Article  4(1) 
and  (2)  are  still  satisfied.  Renewal  may, 
where  necessary,  be  granted  only  for  the 
period  necessary  to  allow  the  competent 
authority  of  the  Member  States  to  make 
such  verification,  where  an  application  for 
renewal  has  been  made. 

shall  prescribe 

6.  Member  States 
that 
biocidal  products  must  be  properly  used-
Proper  use  shall  include  compliance  with 
conditions  established  under  Article  4  and 
specified  under  the  labelling  provisions  of 
this  directive.  Proper  use  shall  also  involve 
the  rational  application  of  a  combination  of 
physical,  biological,  chemical  or  other 
measures  as  appropriate  whereby  the  use  of 
biocidal  products  is  limited  to  the  minimum 
necessary.  Where  biocidal  products  are  used 
at  work  use  shall  also  be  in  accordance 
with  the  requirements  of  directives  for  the 
protection  of  workers. 

f \t 

Article  3a  (new) 

1.  Without  prejudice 
to  Article 
11.  a 
that  has  already  been 
biocidal  product 
authorized  in  one  Member  State  shall  be 
authorized  in  another  Member  States  within 
60  days  of  an  application  being  received 
by  the  other  Member  State,  provided  that 
the  active  substance  of  the  biocidal  product 
is  included  in  Annex  I  and  conforms  to  the 
requirements  thereof.  The  application  shall 
include  a  summary  of 
the  dossier  as 
required  in  Article  7(2)(a)  and  Annex  1ID. 
Section  X  and  a  certified  copy  of  the  first 
authorization  granted. 
to 
The  authorization  may  be 
t he 
p r o v i s i o ns 
in 
implementation 
accordance  with  Community  law, relating  to 
the  conditions  for  distribution  and  use  o\" 
biocidal  products  intended 
the 
health  of  the  distributors,  users  and  workers 
concerned. 

oi'  other  measures 

r e s u l t i ng 

to  protect 

subject 

from 

in  accordance  with  Article  4.  a 

2.11'. 
Member  State  establishes  that: 

(aa)  the  target  species  can  be  assured  not  to 
occur  on  its  territory. 

(a)  unacceptable  resistance  of 
organism 
demonstrated,  or 

the  biocidal 

to 

the 
product 

target 
is 

(b)  the  relevant  circumstances  o\" use,  such 
as  climate  or  breeding  period  of  the  target 
species,  differ  significantly  from  those  in 
the  biocidal 
the  Member  States  where 
product  was 
an 
therefore 
authorization  may 
unchanged 
present  unacceptable  risks  to  humans  or  the 
environment. 

authorized,  and 

first 

referred 

the  Member  States  may  request  that  certain 
conditions 
Article 
lS(3)(e).(f).(h).(j)  and  (1)  be  adjusted  to  the 
different  circumstances,  so  that  conditions 
for  issue  oï  an  authorization  laid  down  in 
Article  4  are  satisfied. 

in 

to 

>J 

3.Notwithstanding  paragraph  2  where  a 
Member  State  believes  a  biocidal  product 
cannot  meet  the  conditions  set  out  under 
to 
article  4  and  consequently  proposes 
the  authorization  under 
refuse  or  to  restrict 
certain  conditions, 
the 
shall  notify 
it 
Commission,  other  Member  States  and  the 
applicant  and  shall  provide  them  with  an 
explanatory  document  containing  the  name 
its  specification  and 
of  the  product  and 
it 
setting  out 
proposes 
the 
to 
authorization. 

the  grounds  on  which 
refuse  or 

restrict 

to 

The  Commission  shall  prepare  a  proposal 
on  these  matters  in  accordance  with  Article 
24  for  a  decision  in  accordance  with  the 
procedures  laid  down  in  Article  25(3). 

Article  4(1 )(b)(iii)and  (iv) 

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

food  or 

(iii)  has  no  harmful  effects  itself  or  as  a 
result  of  its  residues,  on  human  or  animal 
health,  directly  or  indirectly  (e.g.  through 
air,  drinking  water,  food  or  feed)  or  on 
groundwater  and  surface  water; 

(iv)  has  no  unacceptable  effect  on 
the 
environment  having  particular  regard  to  the 
following  considerations: 
-  its  fate  and  distribution  n the  environment; 
of  water 
contamination 
particularly 
including  drinking  water  and  groundwater, 
-its  impact  on  non-target  organisms; 

(iv)  has  no  unacceptable  effect  on 
the 
environment  having  particular  regard  to  the 
following  considerations: 
-  its  fate  and  distribution  n the  environment; 
of  water 
contamination 
particularly 
including  drinking  water,  groundwater  and 
surface  water. 
-its  impact  on  non-target  organisms; 

»  H 

Article 

4.4 

to 

relevant 

requirements 

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

authorization 

issue 

the 

the 

to 

relevant 

requirements 

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

intended 

Article  7.a  new 

supporting 

Member  States  shall  establish  a  system 
obliging  those  seeking  to  place  or  having 
placed  biocidal  products  on  the  market  and 
those 
active 
substances  on  Annexes  I.  la  and  lb  to  pay 
charges,  globally  covering  the  costs  of  all 
different  procedures  associated  with 
the 
provisions  of  this  directive. 

entries 

for 

Article  9(5) 

or 

technical 

scientific 

the  same  product 

5.  The  inclusion  of  an  active  substance  in 
Annex  I  may  be  refused  or  reviewed,  if 
there  is  another  active  substance  in  Annex  I 
type,  or  another 
for 
method  of  control  exists,  which  in  the  light 
of 
knowledge 
presents  significantly  less  risk  to  health  or 
to  the  environment.  When  considering  such 
a  refusal,  an  evaluation  of  the  alternative 
shall  be 
active  substances  or  methods 
common 
in  accordance  with 
produced 
principles  for  the  evaluation  of  dossiers,  to 
demonstrate  they  can  be  used  with  the  same 
target  organism  without 
effect  on 
practical 
and 
significant 
disadvantages  to  the  user.  The  evaluation 
shall  be  circulated  in  accordance  with  the 
procedures  in  Article  10(2)  for  decision  in 
accordance  with  the  procedures  laid  down 
in  Articles  24  and  25  (3). 

economic 

the 

or 

technical 

scientific 

the  same  product 

5.  The  inclusion  of  an  active  substance  in 
Annex  I  may  be  refused  or  reviewed,  if 
there  is  another  active  substance  in  Annex  I 
type,  or  another 
for 
method  of  control  exists,  which  in  the  light 
of 
knowledge 
presents  significantly  less  risk  to  health  or 
to  the  environment.  When  considering  such 
a  refusal,  an  evaluation  of  the  alternative 
active  substances  or  methods  shall  be 
produced  to  demonstrate  they  can  be  used 
with  the  same  effect  on  the  target  organism 
without  significant  economic  an  d  practical 
disadvantages  to  the  user;  The  evaluation 
shall  be  circulated  in  accordance  with  the 
procedures  in  Article  10(2)  for  decision  in 
accordance  with  the  procedures  laid  down 
in  Articles  24  and  25(3). 

/ir 

Article  14(3) 

3.By way  of further  derogation  from  Article 
4(1),  Article  7(2)  and  Article  7(3)  and 
without  prejudice 
to  paragraph  4  and 
paragraph  6,  a  Member  State  may,  for  a 
period  of  10  years  from  the  date  of  entry 
into  force  of  this  Directive,  authorize  the 
placing  on  the  market  in  its  territory  of  a 
biocidal 
active 
substances  not  listed  in Annex  I that  are  on 
the market  on the date of entry  into  force  of 
this  Directive. 

containing 

product 

3.By way of further  derogation  from  Article 
3(1).  Article  4(1)  Article  7(2)  and  Article 
7(3)  and  without  prejudice  to  paragraph  4 
and  paragraph  6,  a  Member  State  may,  for 
a  period  of  10 years  from  the date of  entry 
into  force  of  this  Directive,  authorize  the 
placing  on  the  market  in  its  territory  of  a 
biocidal 
active 
substances  not  listed  in  Annex  I, but  which 
have been used  in biocidal  products  and  are 
on  the  market  on  the  date  of  entry  into 
force  of  this  Directive. 

containing 

product 

Article  18(3),  introduction 

3.  Biocidal  products  shall  be 
according  to  the  provisions  of  Directive 
88/379/EEC 
In 
concerning 
addition  the  label  must  show  clearly  and 
indelibly  the  following: 

labelling. 

labelled  3.  Biocidal  products  shall  be 

labelled 
according  to  the  provisions  of  Directive 
88/379/EEC  concerning  labelling.  Labels 
shall  not  be  misleading  or  give  an 
exaggerated  impression  of  the  product.  In 
addition  the  label  must  show  clearly  and 
indelibly  the  following: 

Article  18 (4) 

avicides 

rodenticides, 

4.By  way  of  derogation  from  paragraph  1 
and  2  and  the  first  sentence  of  paragraph  3 
biocidal  products  authorised  as  insecticides, 
acaricides, 
or 
molluscicides  shall  be  classified,  packaged 
and  labelled  in  accordance  with  Directive 
78/631/EEC  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to  the 
classification,  packaging  and  labelling  of 
dangerous  preparations  (pesticides)  (1) 
insofar  as  there  is  no  other  Community 
provision specifically  covering these matters 
for  such  products. 
1  OJ  L  206.  29.7.1978.  p.  13. 

rodenticides, 

4.By  way  of  derogation  from  paragraph  1 
and  2 and  the  first  sentence  of  paragraph  3 
biocidal  products  authorised  as  insecticides, 
acaricides, 
or 
molluscicides  shall  be  classified,  packaged 
and  labelled  in  accordance  with  Directive 
78/631/EEC  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to  the 
classification,  packaging  and  labelling  of 
dangerous  preparations  (pesticides).(l) 

avicides 

1  OJL  206. 29.7.1978.  p. 13. 

K 

Article  24  (3) 

or 

his 

applicant 

authorized 
3.The 
representative  may  be  asked  by 
the 
Commission  to  submit  remarks  to  it,  in 
particular  whenever 
unfavourable 
decision  is  envisaged. 

an 

or 

applicant 

his 
shall  be  asked  by 

authorized 
3.The 
representative 
the 
Commission  to  submit  remarks  to  it,  unless 
a  favourable  decision  is  envisaged. 

Annex  II  (A)  (1) 

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. 

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. 

Annex  11(B) (1) 

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. 

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 
dossiers  requirements  must  be  in  line  with 
technical  development. 

Annex  III(A)  (1) 

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. 

1.Dossiers on active substances  are  required 
to address at least  all the points listed  under 
requirements".  Responses  are 
"Dossier 
required 
to  be  supported  by  data.  The 
dossier  requirements  must  be  in  line  with 
technical  development. 

Annex  III  (B)(1) 

1 .Dossiers on active  substances  are required 
to address at least all the points  listed  under 
"Dossier 
requirements".  Responses  are 
required  to  be  supported  by  data. 

1.Dossiers on active substances  are  required 
to address at least all the points  listed  under 
requirements".  Responses  are 
"Dossier 
required 
to  be  supported  by  data.  The 
dossier  requirements  must  be  in  line  with 
technical  development. 

1  ^ 

Annex  VI  (51)  introduction 

51.  Testing  should  be carried  out  according 
to  European  Union  guide-lines  if  these  are 
available  and  applicable.  In  the  absence  of 
these  other  methods  can  be  used  as  shown 
is  in  order  of 
in  the  list  below  which 
descending  preference: 

51.  Testing  should  be carried  out  according 
to  European  Union  guide-lines  if  these  are 
available  and applicable.  Where  appropriate 
other  methods  can  be  used  as  shown  in  the 
list  below  which  is  in  order  of  descending 
preference: 

Annex  VI  (59), 2nd  subparagraph 

In  the  case  of  active  substances  not  on  the 
market  on  the  implementation  date  of  the 
Directive  only  those  substances  listed  in 
Annex  I  of  the  Directive  can  be  used  in 
biocidal  products. 

Deleted 

Annex  VI  (80),  introduction 

of 

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

the 

of 

the 

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

in 

U 

Annex  VI  (86)  new 

there 

86.  The  Member  States  shall  not  authorize 
is  a 
a  biocidal  product  where 
reasonably  foreseeable  possibility  of aquatic 
organisms  being  exposed  to  the  biocidal 
if  for  any  active  substance  or 
product 
substance  of  concern  in  it: 
-  the  PEC/PNEC>  1  unless  it  is  clearly 
established  in the risk assessment  that under 
field  conditions  the  viability  of  aquatic 
organisms  is not  threatened  by the  biocidal 
product 
proposed 
conditions  of  use. 

according 

the 

to 

there 

86.  The  Member  States  shall  not  authorize 
is  a 
a  biocidal  product  where 
reasonably  foreseeable  possibility  of aquatic 
organisms  being  exposed  to  the  biocidal 
if  for  any  active  substance  or 
product 
substance  of  concern  in  it: 
-  the  PEC/PNEO  1  unless  it  is  clearly 
established  in the risk assessment  that  under 
field  conditions  the  viability  of  aquatic 
organisms  is not  threatened  by the  biocidal 
product 
proposed 
conditions  of  use. 

according 

the 

to 

are 

not 

factor 

(BCF) 

those  which 

the  bioconcentration 

- 
is 
greater  than  1000  for  substances  which  are 
readily  biodegradable  or  greater  than  100 
for 
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  after  use  of  the 
biocidal  product  according  to  the  proposed 
conditions  of  use. 

are 

not 

factor 

(BCF) 

those  which 

the  bioconcentration 

- 
is 
greater  than  1000  for  substances  which  are 
readily  biodegradable  or  greater  than  100 
for 
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  after  use  of  the 
biocidal  product  according  to  the  proposed 
conditions  of  use. 
Member  States  may,  however,  authorize 
anti-fouling  products  used  on  sea  going 
vessels  of over  25 metres  for  a period  of up 
to  10  years  from  the  date  on  which  this 
Directive  enters  into  force.  This  provision 
shall  lapse  if  appropriate  IMP  rules  are 
adopted  within  that  period. 

A-j> 

ISSN 0254-1475 

COM(96) 312 final 

OCUMENTS 

EN 

14  03  15 

Catalogue  number  :  CB-CO-96-320-EN-C 

ISBN  92-78-05897-1 

Office  for  Official  Publications  of  the European  Communities 

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