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 Member States 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; 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; i.e. in cases where the 
requisite safety for humans and 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 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; 
G 
Recital 20 
Whereas active substances used in biocidal 
products may also be used in other 
preparations which have under other 
Community legislation, been tested on 
animals, whereas double testing on animals 
must be avoided; whereas, 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 Whereas active substances used in biocidal 
products may also be used in other 
preparations which have under other 
Community legislation, been tested on 
animals, whereas double testing on animals 
must be avoided; whereas, 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 
technical notes for guidance on the 
implementation of Annex VI: 
^ 
Article l(2)(aa) and (ab)(new) and (b) 
(aa) Council directive 81/851/EEC on the 
approximation of the laws of the Member 
States relating to veterinary medicinal 
products :(1) 
(ab) Council Directive 90/677/EEC on 
extending the scope of Directive. 
81/851/EEC on the approximation of the 
laws of the Member States relating to 
veterinary medicinal products and laying 
down additional provisions for 
immunological 
products:f2V veterinary medicinal 
(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)OJL 317.6.11.1981. p.82. 
(2) OJL 373. 31.12.1990 p.26 
(3)OJL32. 3.2.1977 p.l 
Article 1.2 (g) new 
(g) Council Directive 90/385/EEC on the 
approximation of the laws of the Member 
States on active implantable medicinal 
devices (1), 
(h) Council Directive 89/109/EEC of 21 
December 1988 on the approximation of the 
laws of the Member States relating to 
materials and articles intended to come into 
contact with foodstuffs (2) and subsequent 
follow-up Directives, 
m OJL 189. 20.7.1990. p.17 
(2)OJL40. 11.2.1989. P. 38 
Article l(3)(ea)(new) 
(galCouncil directive 84/450/EEC on the 
approximation of the laws, regulations or 
administrative provisions of the Member 
States relating to misleading advertising 
OJL 250. 19.09.1984. p. 17 
Article 2 (l)(ea)(new) 
(ea) Frame-Formulations 
Specifications for a group of biocidal 
products having the same use and user type. 
This group of products must contain the 
same active substances of the same 
specifications and their compositions must 
present only variations from a previously 
authorized biocidal product which do not 
affect the level of risk associated with them 
and their efficacy: 
In this context, a variation is the allowance 
of a reduction in the percentage of the 
active substance and/or an alteration in 
percentage composition of one or more 
non active substances and/or the 
replacement of one or more pigments, dyes, 
perfumes by other presenting the same or a 
lower risk, and which do not decrease its 
efficacy. 
Article 3 (2) 
2. Every application for authorization shall 2. Every application for authorization shall 
be decided upon within a reasonable be decided upon without undue delay, 
period. 
3 
Article 3 (par 4,5,6,7,8) 
3.A biocidal product that has already been deleted 
authorized in one Member State shall be 
authorized, in another Member State within 
60 days of an application being received by 
the other Member State, providing that the 
active substance of the biocidal product 
conforms to the entry in Annex 1. 
4.If complying with Article 4 a Member 
State establishes that: 
(a) unacceptable resistance of the target 
organism to the biocidal product is proven 
or 
(b) the relevant circumstances of use, such 
as climate or breeding period of the target 
species, differ significantly from those in 
the Member State where biocidal product 
was first authorized, and an unchanged 
authorization may therefore present 
unacceptable risks to man or the 
environment; 
the Member State may request that the 
directions for use and the dose rate referred 
to in Article 18(3)(e) are adjusted to the 
different circumstances, or, if the risk 
cannot be prevented in any other way, the 
Member State may request changes to be 
made to the biocidal product itself so that 
conditions for issue of an authorization 
provided for in article 4 are satisfied. 
5. Notwithstanding paragraph 4 where a 
Member State believes a biocidal product 
cannot meet the conditions set out under 
article 4 and consequently proposes to 
refuse authorization, it shall notify the 
Commission, other Member States and the 
applicant and shall provide them with an 
explanatory document giving details of the 
product and setting out the grounds on 
which it proposes to refuse the 
authorization. 
The Commission shall prepare a proposal deleted 
on these matters in accordance with Article 
24 for decision in accordance with the 
procedure laid down in Article 25(3). 
6. Member States shall prescribe that 
biocidal products shall be classified, 
packaged and labelled in accordance with 
the provisions of this Directive. 
7. Authorizations shall be granted for a 
fixed period of 10 years from the date of 
first entry of the active substance onto 
Annex ; they may be renewed after 
verification that the conditions imposed in 
paragraphs 1 and 2 are still satisfied. 
Renewal may, where necessary, be granted 
only for the period necessary to allow the 
competent authorities of the Member States, 
to make such verification, where an 
application for renewal has been made. 
8. Member States shall prescribe that 
biocidal products must be properly used. 
Proper use shall include compliance with 
conditions established under Article 4 and 
specified under the labelling provisions of 
this directive. Proper use shall also involve 
the rational application of a combination of 
physical, biological, chemical or other 
measures a s appropriate whereby the use 
of biocidal products is limited to the 
minimum necessary. Where biocidal are 
used at work use shall also be in 
accordance with requirements of directives 
for the protection of workers. 
S\ 1 
Article 3 par. 3,4,5,6 new 
3.Without prejudice to Articles 7 and 11 
and providing that the applicant has a right 
of access to it. when a subsequent 
application for authorization for a new 
biocidal product is -based upon a frame-
formulation, the competent authority shall 
take a decision with regard to this 
application within a period of 60 days. 
4. Member States shall prescribe that 
biocidal products shall be classified, 
packaged and labelled in accordance with 
the provisions of this Directive. 
5. Without prejudice to Article 6(1). 
authorizations shall be granted for a 
maximum period of 10 years from the date 
of first or renewed inclusion of the active 
substance onto Annex I for the product 
type, without exceeding the deadline 
specified for the active substance in Annex 
I. they may be renewed after verification 
that the conditions imposed in Article 4(1) 
and (2) are still satisfied. Renewal may, 
where necessary, be granted only for the 
period necessary to allow the competent 
authority of the Member States to make 
such verification, where an application for 
renewal has been made. 
6. Member States shall prescribe that 
biocidal products must be properly used-
Proper use shall include compliance with 
conditions established under Article 4 and 
specified under the labelling provisions of 
this directive. Proper use shall also involve 
the rational application of a combination of 
physical, biological, chemical or other 
measures as appropriate whereby the use of 
biocidal products is limited to the minimum 
necessary. Where biocidal products are used 
at work use shall also be in accordance 
with the requirements of directives for the 
protection of workers. 
f\t 
Article 3a (new) 
1. Without prejudice to Article 11. a 
biocidal product that has already been 
authorized in one Member State shall be 
authorized in another Member States within 
60 days of an application being received 
by the other Member State, provided that 
the active substance of the biocidal product 
is included in Annex I and conforms to the 
requirements thereof. The application shall 
include a summary of the dossier as 
required in Article 7(2)(a) and Annex 1ID. 
Section X and a certified copy of the first 
authorization granted. 
The authorization may be subject to 
provisions resulting from the 
implementation oi' other measures in 
accordance with Community law, relating to 
the conditions for distribution and use o\" 
biocidal products intended to protect the 
health of the distributors, users and workers 
concerned. 
2.11'. in accordance with Article 4. a 
Member State establishes that: 
(aa) the target species can be assured not to 
occur on its territory. 
(a) unacceptable resistance of the target 
organism to the biocidal product is 
demonstrated, or 
(b) the relevant circumstances o\" use, such 
as climate or breeding period of the target 
species, differ significantly from those in 
the Member States where the biocidal 
product was first authorized, and an 
unchanged authorization may therefore 
present unacceptable risks to humans or the 
environment. 
the Member States may request that certain 
conditions referred to in Article 
lS(3)(e).(f).(h).(j) and (1) be adjusted to the 
different circumstances, so that conditions 
for issue oï an authorization laid down in 
Article 4 are satisfied. 
>J 
3.Notwithstanding paragraph 2 where a 
Member State believes a biocidal product 
cannot meet the conditions set out under 
article 4 and consequently proposes to 
refuse or to restrict the authorization under 
certain conditions, it shall notify the 
Commission, other Member States and the 
applicant and shall provide them with an 
explanatory document containing the name 
of the product and its specification and 
setting out the grounds on which it 
proposes to refuse or to restrict the 
authorization. 
The Commission shall prepare a proposal 
on these matters in accordance with Article 
24 for a decision in accordance with the 
procedures laid down in Article 25(3). 
Article 4(1 )(b)(iii)and (iv) 
(iii) has no harmful effects itself or as a 
result of its residues, on human or animal 
health, directly or indirectly (e.g. through 
drinking water, food or feed) or on 
groundwater; 
(iv) has no unacceptable effect on the 
environment having particular regard to the 
following considerations: 
- its fate and distribution n the environment; 
particularly contamination of water 
including drinking water and groundwater, 
-its impact on non-target organisms; (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; 
particularly contamination of water 
including drinking water, groundwater and 
surface water. 
-its impact on non-target organisms; 
» H 
Article 4.4 
4. Where other Community provisions 
impose requirements relevant to the 
conditions for the issue of an authorization 
and particularly where these are intended to 
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 and where 
necessary shall issue the authorization 
subject to those requirements. 4. Where other Community provisions 
impose requirements relevant to the 
conditions for the issue of an authorization 
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 environment , the competent authority 
shall take these into account when issuing 
an authorization and where necessary shall 
issue the authorization subject to those 
requirements. 
Article 7.a new 
Member States shall establish a system 
obliging those seeking to place or having 
placed biocidal products on the market and 
those supporting entries for active 
substances on Annexes I. la and lb to pay 
charges, globally covering the costs of all 
different procedures associated with the 
provisions of this directive. 
Article 9(5) 
5. The inclusion of an active substance in 
Annex I may be refused or reviewed, if 
there is another active substance in Annex I 
for the same product type, or another 
method of control exists, which in the light 
of scientific or technical 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 in accordance with common 
principles for the evaluation of dossiers, to 
demonstrate they can be used with the same 
effect on the target organism without 
significant economic and 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). 5. The inclusion of an active substance in 
Annex I may be refused or reviewed, if 
there is another active substance in Annex I 
for the same product type, or another 
method of control exists, which in the light 
of scientific or technical 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 product containing active 
substances not listed in Annex I that are on 
the market on the date of entry into force of 
this Directive. 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 product containing 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. 
Article 18(3), introduction 
3. Biocidal products shall be labelled 3. Biocidal products shall be labelled 
according to the provisions of Directive 
88/379/EEC concerning labelling. In 
addition the label must show clearly and 
indelibly the following: 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) 
4.By way of derogation from paragraph 1 
and 2 and the first sentence of paragraph 3 
biocidal products authorised as insecticides, 
acaricides, rodenticides, avicides 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. 4.By way of derogation from paragraph 1 
and 2 and the first sentence of paragraph 3 
biocidal products authorised as insecticides, 
acaricides, rodenticides, avicides 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) 
1 OJL 206. 29.7.1978. p. 13. 
K 
Article 24 (3) 
3.The applicant or his authorized 
representative may be asked by the 
Commission to submit remarks to it, in 
particular whenever an unfavourable 
decision is envisaged. 3.The applicant or his authorized 
representative shall be asked by 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 
"Dossier requirements". Responses are 
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 
"Dossier requirements". Responses are 
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 
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 
is in order of 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 
80. The Member State shall not authorize 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 relevant 
metabolites or breakdown or reaction 
products in the groundwater exceeds the 
lower of the following concentrations: 80. The Member State shall not authorize 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 relevant 
metabolites or breakdown or reaction 
products in the surface water or 
groundwater exceeds the lower of the 
following concentrations: 
U 
Annex VI (86) new 
86. The Member States shall not authorize 
a biocidal product where there is a 
reasonably foreseeable possibility of aquatic 
organisms being exposed to the biocidal 
product if for any active substance or 
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 according to the proposed 
conditions of use. 86. The Member States shall not authorize 
a biocidal product where there is a 
reasonably foreseeable possibility of aquatic 
organisms being exposed to the biocidal 
product if for any active substance or 
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 according to the proposed 
conditions of use. 
- the bioconcentration factor (BCF) is 
greater than 1000 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 after use of the 
biocidal product according to the proposed 
conditions of use. - the bioconcentration factor (BCF) is 
greater than 1000 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 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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