Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products (Text with EEA relevance)
Date: 2000-09-07
Institutions: European Commission
Subjects: EU programme, animal health, chemical product, environmental protection, labelling, marketing, producer organisation, public health

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COMMISSION REGULATION (EC) No 1896/2000

of 7 September 2000

on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the
European Parliament and of the Council on biocidal products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

submit all the requisite information for a proper evalu-
ation of, and decision on, that active substance.

Having regard to the Treaty establishing the European
Community,

Having regard to 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 (1), and in particular
Article 16(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Pursuant to Directive 98/8/EC (hereinafter referred to as
‘the Directive’), a programme of work is to be initiated
for the review of all active substances of biocidal prod-
ucts already on the market on 14 May 2000 (hereinafter
referred to as ‘existing active substances’).

The first phase of the review programme is intended to
enable the Commission to identify existing active
substances of biocidal products and specify those which
should be evaluated for a possible inclusion in Annex I,
Annex IA or Annex IB to the Directive. Given the
expected high number of existing active substances
which are candidates for such inclusion, information is
needed to set priorities for a further phase of the review
programme, which is planned to be initiated in 2002.

It is necessary to specify the relationship between produ-
cers, formulators, Member States and the Commission
and the obligation on each of the parties for the imple-
mentation of the review programme.

In order to establish an exhaustive list of existing active
substances, an identification procedure should be laid
down by which all producers are to submit information
on existing active substances of biocidal products to the
Commission. Formulators should also have the oppor-
tunity of identifying existing active substances.

A notification procedure should be laid down by which
producers and formulators have the right to inform the
Commission of their interest in securing the possible
inclusion of an existing active substance in Annex I,
Annex IA or Annex IB to the Directive for one or more
to
specific product

their commitment

types and of

(1) OJ L 123, 24.4.1998, p. 1.

(6)

(7)

(8)

(9)

(10)

(11)

The information submitted with the notification on
active substances should be linked to one or more
specific product types or subgroups of product types
and should be the minimum necessary for priority
setting.

Member States should have the opportunity of indi-
cating an interest in the inclusion in Annex I or Annex
IA to the Directive of essential existing active substances
that have not been notified by producers or formulators.
Member States which have indicated such an interest
should carry out all the duties of a notifier.

Existing active substances notified in one or more
product
types should be allowed to remain on the
market in accordance with Article 16(1) of the Directive
for those notified product types until a date to be set in
the decision on inclusion or non-inclusion of the active
substance for that product type in Annex I or Annex IA
to the Directive.

For existing active substances not notified in specific
product types, decisions should be adopted, in accord-
ance with the procedure laid down in Article 28(3) of
the Directive, stating that those substances cannot be
included in Annex I or Annex IA to the Directive for
those product types under the review programme. A
reasonable phase-out period should be allowed for those
existing active substances and for biocidal products
containing them.

identified within the time
For active substances not
limits laid down in this Regulation, as well as for
biocidal products containing them, no further phase-out
period should be allowed after the establishment of the
list of existing active substances.

In view of the time limit for the transitional period of 10
years and the time needed to compile complete dossiers,
the identification of the first existing active substances to
be evaluated should not be delayed until the general
priorities are set. In the interests of successful
imple-
mentation of the Directive, it is advisable to start the
evaluation of existing active substances in product types
for which experience is already available.

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(12)

(13)

(14)

(15)

Some existing active substances used in wood preserva-
tives which are used in large volumes in the Community
are known to pose potential risks for humans and the
environment. The need to establish a harmonised market
for wood preservatives was one of the main reasons for
the adoption of the Directive. Having regard to national
rules in some Member States, the necessary experience
to evaluate wood preservatives is available. Experience
regarding rodenticides is available in many Member
States. The existing active substances in those two
specific product types should, therefore, be included in
the first list of existing active substances to be evaluated.

The evaluation of the first active substances should also
be used to gain experience on the risk assessment
process and on the appropriateness of the data require-
ments in order to carry out an adequate risk assessment.
Among other issues, it is necessary to ensure that the
risk assessment is carried out in a cost-effective way. For
this purpose, notifiers should be encouraged to provide
information on the costs of compiling a complete
dossier. This information, together with any appropriate
recommendations, should be integrated in the report
referred to in Article 18(5) of the Directive. However
this should not prevent earlier modifications of data
requirements or procedures.

In order to avoid duplication of work, and in particular
experiments involving vertebrate animals, specific provi-
sions should be adopted to encourage producers to act
collectively, in particular by submitting collective notifi-
cations and dossiers.

The need to address the concern for the possible effects
of existing active substances directly or
indirectly
entering the food chain will be considered when setting
priorities for the further phase of the review programme.

(16)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation lays down provisions for the establishment and
implementation of the first phase of the programme of work
for the systematic examination of all active substances already
on the market on 14 May 2000 as active substances of biocidal
products (hereinafter referred to as ‘the review programme’)
referred to in Article 16(2) of the Directive

Article 2

Definitions

For the purposes of this Regulation, the definitions in Article 2
of the Directive shall apply.

The following definitions shall also apply:

(a) ‘existing active substance’ means an active substance on the
market before 14 May 2000 as an active substance of a
biocidal product for purposes other than those referred to
in Article 2(2)(c) and (d) of the Directive;

(b) ‘producer’ means:

— in the case of an active substance produced within the
Community and placed on the market, the manufac-
turer of that active substance or a person established
within the Community designated by the manufacturer
as his sole representative for the purposes of this Regu-
lation,

the

person

— in the case of an active substance produced outside the
Community,
the
Community and designated by the manufacturer of that
active substance as his sole representative for
the
purposes of this Regulation or, where no such person
has been so designated,
into the
Community of that active substance,

established within

importer

the

the

person

— in the case of a biocidal product produced outside the
Community,
the
Community and designated by the manufacturer of that
biocidal product as his sole representative for the
purposes of this Regulation or, where no such person
has been so designated,
into the
Community of that biocidal product;

established within

importer

the

(c) ‘formulator’ means, in the case of a biocidal product manu-
factured within the Community, the manufacturer of that
biocidal product, or a person established within the
Community designated by the manufacturer as his sole
representative for the purposes of this Regulation;

(d) ‘identification’ of an active substance means the submission
to the Commission of the information referred to in Annex
I. The person or the association of producers/formulators
submitting the identification is an ‘identifier’;

(e) ‘notification’ of an active substance means the submission
to the Commission of the information referred to in Annex
II. The submitter of the notification is a ‘notifier’.

The notifier may be:

— the producer or the formulator who has made a noti-
fication in accordance with Article 4 or Article 8,

— the association of producer(s) and/or

formulator(s)
established within the Community and designated by
the producers and/or formulators for the purpose of
complying with this Regulation, which has made a joint
notification in accordance with Article 4 or Article 8.

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Article 3

Identification of existing active substances

Each producer of an existing active substance placed on
1.
the market for use in biocidal products shall identify that active
substance by submitting to the Commission the information
on the active substance referred to in Annex I to be received
not later than 18 months after this Regulation enters into
force. This requirement shall not apply to existing active
substances which are no longer on the market after 13 May
2000 either as such or in biocidal products.

Any formulator may identify an existing active substance in
accordance with the first subparagraph, except for the require-
ments in points 5 and 6 of Annex I.

In submitting the information,
the identifier shall use the
special software package made available free of charge by the
Commission.

Member States may require identifiers established in their terri-
tory to submit simultaneously to their competent authorities
the same information as is submitted to the Commission.

2.
Any producer or formulator who notifies an existing
active substance in accordance with Article 4 shall not make a
separate identification of that active substance in accordance
with paragraph 1 of this Article.

3.
A working document containing a non-exhaustive list
with examples of possible existing active substances shall be
made available by the Commission on its Internet website and
shall also be made available as a hard-copy at the competent
authorities of the Member States not later than 30 days after
this Regulation enters into force.

Article 4

Notification of existing active substances

1.
Producers, formulators and associations wishing to apply
for the inclusion in Annex I or Annex IA to the Directive of an
existing active substance in one or more product types shall
notify that active substance to the Commission by submitting
the information referred to in Annex II to this Regulation to be
received not later than 18 months after this Regulation enters
into force.

Whenever a formulator or a producer is aware of another
notifier's possible intention to notify the same active substance,
they shall undertake all reasonable efforts to present a common
notification, in whole or in part, in order to minimise animal
testing.

In submitting the notification, the notifier shall use the special
software package (IUCLID) made available free of charge by the
Commission.

Member States may require notifiers established in their terri-
tory to submit simultaneously to their competent authorities
the same information as is submitted to the Commission.

The Commission in cooperation with Member States
2.
shall check that a notification submitted to it complies with the
requirements of paragraph 1.

the notification complies with those requirements,

If
Commission shall accept it.

the

If the notification does not comply with those requirements,
the Commission shall grant the notifier a period of 30 days in
If, after the
which to complete or correct his notification.
expiry of that 30-day period, the notification fails to comply
with those requirements, the Commission shall
inform the
notifier that his notification has been rejected and give the
reasons therefor.

Where a notification has been rejected, the notifier may within
30 days address a request to the Commission for a Decision to
be taken in accordance with the procedure laid down in Article
28(3) of the Directive.

3.
If a notification is accepted by the Commission, the noti-
fier shall provide to the Commission all data and information
necessary for the evaluation of the existing active substance
with a view to its possible inclusion in Annex I or Annex IA to
the Directive during the
review
programme.

second phase of

the

A notifier may only withdraw his notification if an objec-
4.
tive change in the assumptions for the notification justifies the
withdrawal. The notifier shall inform the Commission without
delay, mentioning the reasons. If the Commission accepts the
withdrawal,
to the
requirement set out in paragraph 3.

the notifier shall no longer be subject

Where a withdrawal has been rejected, the notifier may within
30 days address a request to the Commission for a Decision to
be taken in accordance with the procedure laid down in Article
28(3) of the Directive.

A Decision shall be taken in accordance with the procedure
laid down in Article 28(3) of the Directive not to include in
Annex I or Annex IA to the Directive an active substance for
which the notification has been withdrawn and for which no
other notification has been accepted with the consequences
referred to in Article 6(3) of this Regulation.

this
In the event of non-compliance with paragraph 3 of
Article in relation to any product type, a Decision may be
taken in accordance with the procedure laid down in Article
28(3) of the Directive with the consequences referred to in
Article 6(3) of this Regulation for the placing of the active
substance on the market in other product types according to
Annex V to the Directive.

Article 5

Indication of interest by Member States

The Commission shall communicate to the Member
1.
States a list of all active substances which have been identified
as existing active substances under Article 3 or Article 4,
indicating those in respect of which a notification has been
submitted in accordance with Article 4(1) and accepted by the
Commission.

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2. Within three months after receiving the list referred to in
paragraph 1 and in accordance with the procedure laid down
in Article 3(1), Member States may identify additional existing
active substances.

3. Within three months after receiving the list referred to in
paragraph 1, Member States, alone or collectively, may indicate
their interest in the possible inclusion in Annex I or Annex IA
to the Directive of an existing active substance in product types
where it has uses which the Member State considers essential in
particular for the protection of human health or the environ-
ment, and for which no notification has been accepted by the
Commission.

By indicating such an interest a Member State shall be deemed
to carry out the duties of an applicant as set out in the
Directive, and the active substance shall without notification in
accordance with Article 4(1) of this Regulation, be included in
the list referred to in Article 6(1)(b).

Article 6

Consequences of identification and notification

In accordance with the procedure laid down in Article
the Directive, a Regulation shall be adopted

1.
28(3) of
containing:

(a) an exhaustive list of existing active substances placed on
the market
for which
for use in biocidal products,
substances at least one identification complies with the
requirements of Article 3(1) or Article 5(2) or equivalent
information submitted in a notification according to Article
4(1); and

(b) an exhaustive list of existing active substances to be
review

reviewed during
programme containing those existing active substances

second phase of

the

the

(i) for which the Commission has accepted at least one
notification in accordance with Article 4(1) or Article
8(1); or

(ii) that Member States have indicated in accordance with

Article 5(3); or

(iii) for which, following indications in accordance with
Article 8(3) or (4), Member States, alone or collectively,
have agreed to provide the necessary data to carry out
evaluations for possible inclusion in Annex IB to the
Directive
review
programme.

second phase of

in the

the

The Commission shall make the lists publicly available by
electronic means.

biocidal products, in the product type or types for which the
Commission has accepted at least one notification.

3.
In accordance with the procedure laid down in Article
28(3) of the Directive, Decisions addressed to Member States
shall be adopted stating that the following active substances
shall not be included in Annex I, Annex IA or Annex IB to the
Directive under the review programme and that these active
substances, solely or in biocidal products, shall no longer be
placed on the market for biocidal purposes:

(a) active substances not included in the list referred to in

paragraph 1(b);

(b) active substances included in the list referred to in para-
graph 1(b) in product types for which the Commission has
not accepted at least one notification.

However if
the active substance is included in the list of
existing active substances referred to in paragraph 1(a), a
reasonable phase-out period shall be allowed of not more than
three years from the date on which the Decision referred to in
the first subparagraph takes effect.

4.
The following applications for inclusion of existing active
substances in Annex I, Annex IA or Annex IB to the Directive
shall be treated as if the substance was not placed on the
market for use in biocidal products before 14 May 2000:

(a) an application for inclusion of an active substance not

included in the list referred to in paragraph 1(b);

(b) an application for inclusion of an active substance in
product types other than those for which it is included in
the list referred to in paragraph 1(b).

Article 7

Submission of dossiers for the inclusion in Annex I,
Annex IA or Annex IB to the Directive of active
substances in certain product types

1.
Existing active substances of biocidal product types 8
(wood preservatives) and 14 (rodenticides) according to Annex
V to the Directive that are included in the list referred to in
Article 6(1)(b) of this Regulation shall be included in the first
list of existing active substances to be reviewed. Notifiers whose
notifications have been accepted by the Commission in accord-
ance with Article 4(2) of this Regulation shall submit complete
dossiers
the Directive
concerning the inclusion in Annex I, Annex IA or Annex IB to
the Directive of active substances in those product types. The
dossiers referred to in Article 11(1)(a)(ii) of the Directive shall
cover representative uses in particular with respect to exposure
of humans and the environment to the active substance.

according to Article 11(1)(a) of

2. Without prejudice to Article 16(1),
(2) or (3) of the
Directive, all producers of an active substance included in the
list referred to in paragraph 1(b) and all formulators of biocidal
products containing that active substance may start or continue
to place on the market the active substance, as such or in

2. Member States may require that advance payment of a
charge according to Article 25 of the Directive covering the
costs of the work resulting from the requirement set out in
Article 11(1)(b) of the Directive concerning the acceptance of
the dossier shall be part of a complete dossier.

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In order to minimise both animal testing and the costs of
the applicant may ask
justifications

3.
compilation of complete dossiers,
Member States' advice on the acceptability of
submitted by the applicant to waive certain studies.

Decision shall be adopted, in accordance with the procedure
laid down in Article 28(3) of the Directive, not to include that
active substance in Annex I or Annex IA to the Directive.

The advice shall not predetermine the verification in accord-
ance with Article 11(1)(b) of the Directive on whether the
dossier can be regarded as complete.

To provide information on the costs related to the application
of the Directive's requirements, the notifier may submit to the
competent authority together with the complete dossier a
breakdown of the costs of the respective actions and studies
carried out. The competent authority shall submit this informa-
tion to the Commission when submitting the evaluation report
referred to in Article 11(2) of the Directive.

The Commission shall
include in the report referred to in
Article 18(5) of the Directive information on the costs related
to compilation of complete dossiers, together with any appro-
priate recommendations concerning modifications of data
requirements in order to ensure cost effectiveness.

4. Whenever several notifiers have notified the same active
substance, they shall undertake all reasonable efforts to present
a collective dossier. Where a collective dossier is not presented
by all the notifiers concerned with that active substance, the
dossier shall detail the efforts made to secure their participation
and the reasons for their non-participation.

5.
The dossiers shall be received by the competent authority
of the designated Member State not later than 42 months after
this Regulation enters into force. The designation shall be
carried out by the Commission when the list referred to in
Article 6(1)(b) of this Regulation is established.

6. Within a reasonable period after the receipt of the dossier
and in any event not later than 45 months after this Regulation
enters into force, Member States shall complete the steps
referred to in Article 11(1)(b) of the Directive concerning the
acceptance of the dossiers for which they have been designated.

If a complete dossier as referred to in paragraph 1 is not
received within the time limit referred to in pararaph 5, the
designated Member State shall inform the Commission, giving
the reasons pleaded by the notifier.

In exceptional cases and on the basis of the report of the
designated Member State, a new time limit may be established
in accordance with the procedure laid down in Article 28(3) of
the Directive, where the notifier demonstrates that the delay
was due to force majeure.

Article 8

Basic substances

1.
Any person wishing to apply for the inclusion of an
existing active substance in Annex IB to the Directive in one or
more specific product types shall notify the substance to the
Commission in accordance with the procedure laid down in
Article 4(1) and (2).

2.
If a notification is accepted by the Commission, the noti-
fier shall provide to the Commission all data and information
necessary for the evaluation of the existing active substance
with a view to its possible inclusion in Annex IB to the
Directive during the second phase of the review programme.

A notifier may only withdraw his notification, if an objective
change in the assumptions for the notification justifies the
withdrawal. The notifier shall inform the Commission thereof
without delay mentioning the reasons.
the Commission
accepts the withdrawal, the notifier shall no longer be subject
to the requirement set out in the first subparagraph.

If

Where a withdrawal has been rejected, the notifier may within
30 days address a request to the Commission for a Decision to
be taken in accordance with the procedure laid down in Article
28(3) of the Directive.

3. Member States may indicate existing active substances as
potential basic substances for inclusion in Annex IB to the
Directive. To this end they shall submit to the Commission not
later than six months after the entry into force of this Regula-
tion their indication together with the information referred to
in Annex I to this Regulation.

4.
The Commission shall communicate to the Member
States a list of potential basic substances which have been
indicated as existing basic substances. Within three months
after receiving that list, Member States may indicate further
existing basic substances in accordance with the requirements
of paragraph 3.

Article 9

Entry into force

If, on the expiry of the time limit, a dossier on an active
substance is incomplete and no other dossier concerning that
active substance in the same product type has been accepted, a

This Regulation shall enter
into force on the 20th day
following that of its publication in the Official Journal of the
European Communities.

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This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 September 2000.

For the Commission

Margot WALLSTRÖM

Member of the Commission

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ANNEX I

INFORMATION REQUIRED FOR IDENTIFICATION IN ACCORDANCE WITH ARTICLE 3 OR INDICATION IN
ACCORDANCE WITH ARTICLE 8(3) OR (4)

1.

Identity of the identifier (1) etc.:

1.1. Name and address etc. of the identifier and his status as producer, formulator or Member State.

1.2. If the identifier is a producer who is not the manufacturer of the active substance: the authorisation by the

manufacturer of the identifier to act as his sole representative within the Community.

1.3. If the identifier is not the manufacturer of the active substance: the name and address of that manufacturer.

2.

Identity of the substance:

2.1. Common name proposed or accepted by ISO and synonyms.

2.2. Chemical name (IUPAC nomenclature).

2.3. Manufacturer's development code number(s) (if available).

2.4. CAS and EC numbers.

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

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

3.

Proof that the substance was already on the market as an active substance of a biocidal product before 14 May 2000.
Apart from EC number also evidence that the substance was used as an active substance in at least one biocidal
product, e.g.

in form of an invoice ant the composition of a product and/or a label.

4. Member States where the active substance is placed on the market. For basic substances the Member States where the

basic substance is used.

5.

6.

If the identifier is a producer: average annual quantities of the active substance placed on the market for the years
1998-2000 per product type according to Annex V to the Directive. If relevant, quantities shall be specified by
subgroup as listed below. If statistics are not available, estimation shall be sufficient.

By way of derogation from paragraph 5 for potential basic substances: annual quantities placed on the market in
total and used as biocidal products per product type according to Annex V to the Directive. If relevant the quantities
shall be specified by subgroups as listed below.

Product type according to Annex V to the Directive and subgroups relevant for the priority setting

Product type 1: Human hygiene biocidal products

Product type 2: Private area and public health area disinfectants and other biocidal products

2.01. Disinfectants for medical equipment, biocidal products for accommodation for man or in industrial areas

2.02. Biocidal products to be used in swimming pools etc.

2.03. Biocidal products to be used in air-conditioning system

2.04. Biocidal products for chemical toilets, treatment of waste water or treatment of hospital waste.

2.05. Other biocidal products within product type 2

Product type 3: Veterinary hygiene biocidal products

Product type 4: Food and feed area disinfectants

Product type 5: Drinking water disinfectants

Product type 6: In-can preservatives

6.01. Preservatives for detergents

6.02. Other in-can preservatives

(1) In the case of identification in accordance with Article 5 or indication in accordance with Article 8: the identity of the Member

State.

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Product type 7: Film preservatives

Product type 8: Wood preservatives

8.01. Pre-treatment in industrial premises (pressure and vacuum impregnation and dipping)

8.02. Other wood preservatives

Product type 9: Fibre,

leather, rubber and polymerised materials preservatives

9.01. Preservatives for textiles and leather

9.02. Preservatives for paper

9.03. Preservatives for rubber and polymerised materials and other biocidal products covered by product type 09

Product type 10: Masonry preservatives

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

11.01. Preservatives used in once-through systems

11.02. Preservatives used in recirculating systems

Product type 12: Slimicides

12.01. Slimicides for paperpulp

12.02. Slimicides for mineral oil extraction

12.03. Other slimicides

Product type 13: Metalworking-fluid preservatives

Product type 14: Rodenticides

Product type 15: Avicides

Product type 16: Molluscicides

Product type 17: Piscicides

Product type 18: Insecticides, acaricides and products to control other arthropods

18.01. Used by professionals

18.02. Used by non-professionals

Product type 19: Repellents and attractants

19.01. Repellents applied directly on human or animal skin

19.02. Attractants and repellents not applied directly on human or animal skin

Product type 20: Preservatives for food or feedstocks

Product type 21: Anti-fouling products

Product type 22: Embalming and taxidermist fluids

Product type 23: Control of other vertebrate

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ANNEX II

INFORMATION REQUIRED FOR NOTIFICATION IN ACCORDANCE WITH ARTICLE 4 OR ARTICLE 8(1)

1. Product type(s) according to Annex V to the Directive for which the notification is submitted.

2. Summary studies,

information, relevant endpoints and information on the date of completion of ongoing or
committed studies as specified in Table 1 of Annex II. Only information which has to be included in the complete
dossier for the use and the nature of the biocidal product shall be submitted.

3. Proof that the substance was already on the market as an active substance of a biocidal product before 14 May 2000.
Apart from EC number also evidence that the substance was used as an active substance in at least one biocidal
product, e.g.

in form of an invoice and the composition of a product and/or a label.

4. Member States where the active substance is placed on the market. For substances applied for as basic substances the

Member States where the basic substance is used.

5. If the identifier is a producer. The information shall also include information on quantities in product types not

notified:

(a) average annual quantities of the active substance placed on the market for the years 1998-2000 per product type
according to Annex V to the Directive. If relevant, quantities shall be specified by subgroup as listed in Annex I. If
statistics are not available, estimation shall be sufficient;

(b) an estimation of the notifier's market share percentage for the years 1998-2000 in the EU of:

(i) the total use of the active substance for that product type,
(ii) the total use of the substance within the EU.

if relevant specified by subgroups; and of

6. By way of derogation from paragraph 5 for potential basic substances: annual quantities placed on the market in total
and used as biocidal products per product type according to Annex V to the Directive and subgroups as listed in
Annex I.

7. Declaration confirming that the information provided is honest and correct and that the notifier commits to submit to
the competent authorities of the designated reporting Member State the complete dossiers according to Article 11(1)(a)
of the Directive within the time period laid down by the Commission. He confirms that the information submitted the
notification is based on studies which are available to the notifier and which will be submitted to the rapporteur
Member State as part of the dossier referred to in Article 11(1).

Table (1)

Number (2)

Issue

Mandatory
information (3)

To be
submitted
if available

State of
finalisation
of dossier:
(IA, Fin. Date,
NR) (4)

I d e n t i t y o f t h e n o t i f i e r

Name and address etc. of the notifier and his status as
producer or not-producer according to the definition in
Article 2

If the notifier is a producer who is not the manufacturer of
the active substance: the authorisation by the manufacturer
of the notifier to act as his sole representative within the
Community

the notifier

If
substance: the name and address of that manufacturer

the manufacturer of

the active

is not

I d e n t i t y o f t h e a c t i v e s u b s t a n c e

Common name proposed or accepted by ISO and
synonyms

Chemical name (IUPAC-nomenclature)

×

×

×

×

×

1.1.

1.1.

1.2.

2.1.

2.2.

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Official Journal of the European Communities

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Number (2)

Issue

Mandatory
information (3)

To be
submitted
if available

State of
finalisation
of dossier:
(IA, Fin. Date,
NR) (4)

2.3.

2.4.

2.5.

2.6.

2.7.

2.8.

2.9.

3.1.

3.2.

3.5.

3.6.
(3.9.)

Manufacturer's development code number(s) (if available)

CAS and EC numbers

Molecular and structural formula

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

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

Identity of impurities and additives, together with the struc-
tural formula and the possible range expressed as g/kg or
g/l, as appropriate

The origin of
active
precursor(s) of the active substance

the natural

substance or

the

P h y s i c a l a n d c h e m i c a l p r o p e r t i e s

Melting point, boiling point, relative density

Vapour pressure (in Pa)

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

if relevant

Partition coefficient n-octanol/water

T o x i c o l o g i c a l a n d m e t a b o l i c s t u d i e s

6.1.1.

Acute toxicity — Oral

6.1.2.-6.1.3.

Acute toxicity — Dermal or inhalation

6.1.4.

6.1.5.

6.2.

6.3.-6.4.

6.5.

6.6.1.

6.6.2.

6.6.3.

Acute toxicity — Skin and eye irritation

Acute toxicity — Skin sensitisation

Metabolism studies in mammals

Subchronic toxicity 90-day study or a short-term repeated
dose toxicity study (28 days). The 90-day study shall be
submitted if available. The 28-day-study shall not be
conducted if not available

Chronic toxicity

In vitro gene mutation study in bacteria

In vitro cytogenicity study in mammalian cells

In vitro gene mutation assay in mammalian cells

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

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Official Journal of the European Communities

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Number (2)

Issue

Mandatory
information (3)

To be
submitted
if available

State of
finalisation
of dossier:
(IA, Fin. Date,
NR) (4)

6.6.4.

6.6.5.

6.6.6.

6.7.

6.8.1.

6.8.2.

In vivo genotoxicity study (if positive in 6.6.1, 6.6.2 or
6.6.3)

A second in vivo genotoxicity study (if negative in 6.6.4 but
positive in vitro tests)

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

Carcinogenicity study

Teratogenicity tests

Fertility study

6.9.4.
(6.12.4.)

Epidemiological
available

studies on the general population,

if

E c o t o x i c o l o g i c a l s t u d i e s

7.1.1.
(7.4.1.1.)

7.2.
(7.4.1.2.)

7.3.
(7.4.1.3.)

7.4.
(7.4.1.4.)

7.5.
(7.4.2.)

7.6.1.1.
(7.1.1.2.1.)

Acute toxicity to fish

Acute toxicity to Daphnia magna/invertebrates

Growth inhibition test on algae

Inhibition to microbiological activity

Bioconcentration

Degradation — Biotic — Ready biodegradability

7.6.1.2.
(7.1.1.2.2.)

Degradation — Biotic — Inherent biodegradability, where
appropriate

7.6.2.1.
(7.1.1.1.1.)

Degradation — Abiotic — Hydrolysis as a function of pH
and identification of breakdown products

7.6.2.2.
(7.1.1.1.2.)

Degradation — Abiotic — Phototransformation in water
including identity of the products of transformation

7.7.
(7.1.3.)

Adsorption/desorption screening test

Proposals including justification for the proposals for the
classification and labelling of
substance
according to Directive 67/548/EEC

active

the

Risk phrases

Other information related to Annex IIA and IIIA to the Directive relevant
for the decision on when the complete dossier on the active substance
should be submitted in the review programme

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

×

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Official Journal of the European Communities

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Number (2)

Issue

Mandatory
information (3)

To be
submitted
if available

State of
finalisation
of dossier:
(IA, Fin. Date,
NR) (4)

Information on the result of studies which might give rise for concern and
which is not included above

Information on the duration of studies necessary for a proper risk assess-
ment that can not be submitted to the designated Member State within 42
months from the date when the list referred to in Article 6(1)(b) of this
Regulation is published

×

×

(1) Information on active substances which are micro-organisms shall be given when appropriate in accordance with Annex IVA to the

Directive.

(2) The numbering in the table follows the Directive 98/8/EC, Annex IIA. Brackets are used if the number differs from that of the
corresponding number in the ‘Technical guidance document in support of the Directive 98/8/EC concerning the placing of biocidal
products on the market — Part I — Guidance on data requirements for active substances and biocidal products’, draft December 1999.
(3) Information on an endpoint is only mandatory if the endpoint is required for a complete dossier for the notified product type/field of
use. Justification shall be provided, if information on an endpoint is not submitted because it is not scientifically necessary or technically
possible to supply.

(4) IA: information available; Fin. Date: note the target finalisation date for ongoing or commissioned studies; NR: information which the
applicant does not believe is necessary for a proper risk assessment and for which a justification is provided; this shall not predetermine
the verification in accordance with Article 11(1)(b) of the Directive.