Directive 2008/31/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 98/8/EC concerning the placing of biocidal products on the market, as regards the implementing powers conferred on the Commission
Date: 2008-03-11
Institutions: Council of the European Union, European Parliament
Subjects: European Commission, animal health, chemical product, environmental protection, labelling, marketing, powers of the institutions (EU), public health

20.3.2008

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Official Journal of the European Union

L 81/57

DIRECTIVE 2008/31/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2008

amending Directive 98/8/EC concerning the placing of biocidal products on the market, as regards
the implementing powers conferred on the Commission

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty
Community, and in particular Article 95 thereof,

establishing the European

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

(5)

(6)

Whereas:

The Commission should be
empowered to adopt
common conditions on research and development, to
adapt the annexes and to adopt the review programme.
Since those measures are of general scope and are
designed to amend non-essential elements of Directive
inter alia, by supplementing it with new non-
98/8/EC,
essential elements, they must be adopted in accordance
with the regulatory procedure with scrutiny provided for
in Article 5a of Decision 1999/468/EC.

Directive
accordingly.

98/8/EC should

therefore

be

amended

Since the amendments made to Directive 98/8/EC by this
Directive are technical in nature and concern committee
procedure only, they do not need to be transposed by
the Member States. It is therefore not necessary to lay
down provisions to that effect,

(1)

(2)

(3)

Directive 98/8/EC of the European Parliament and of the
Council (3) provides that certain measures are to be
Council Decision
adopted
1999/468/EC of 28 June 1999 laying down the
procedures for
implementing powers
the exercise of
conferred on the Commission (4).

accordance with

in

the

introduced

Decision 1999/468/EC has been amended by Decision
2006/512/EC, which
regulatory
procedure with scrutiny for the adoption of measures
of general scope and designed to amend non-essential
elements of a basic instrument adopted in accordance
with the procedure referred to in Article 251 of the
Treaty, inter alia, by deleting some of those elements or
by supplementing the instrument with new non-essential
elements.

and

the Council

In accordance with the statement by the European
the Commission (5)
Parliament,
for the regulatory
concerning Decision 2006/512/EC,
procedure with scrutiny to be applicable to instruments
adopted in accordance with the procedure referred to in
Article 251 of the Treaty which are already in force,
those instruments must be adjusted in accordance with
the applicable procedures.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments

Directive 98/8/EC is hereby amended as follows:

1. Article 10(5) shall be amended as follows:

(a)

the third subparagraph of point (i) shall be replaced by
the following:

‘The assessment shall be circulated in accordance with
Article 11(2)
for a decision to be adopted by the
Commission in accordance with the procedure laid
down in Article 27. That decision, designed to amend
non-essential elements of this Directive, shall be adopted
in accordance with the
regulatory procedure with
scrutiny referred to in Article 28(4).’;

(1) OJ C 161, 13.7.2007, p. 45.
(2) Opinion of the European Parliament of 14 November 2007 (not yet
published in the Official Journal) and Council Decision of 3 March
2008.

(3) OJ L 123, 24.4.1998, p. 1. Directive as

last amended by

Commission Directive 2008/16/EC (OJ L 42, 16.2.2008, p. 48).
(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(5) OJ C 255, 21.10.2006, p. 1.

(b) point 5 of point (ii) shall be replaced by the following:

‘5. the complete data dossiers of the evaluation serving
or having served for entry in Annexes I, IA or IB
shall be put at the disposal of the committee referred
to in Article 28(1).’;

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Official Journal of the European Union

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2. Article 11(4) shall be replaced by the following:

adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 28(4).’;

‘4.
On receipt of the evaluation, the Commission shall, in
accordance with Article 27, prepare a proposal without
undue delay for a decision to be taken at the latest 12
months after the receipt of the evaluation referred to in
paragraph 2. That decision, designed to amend non-
this Directive, shall be adopted in
essential elements of
accordance with the regulatory procedure with scrutiny
referred to in Article 28(4).’;

5. Article 27(2) shall be replaced by the following:

At

the

end of

‘2.
comment,
the
a decision in
Commission shall prepare
accordance with the relevant procedure referred to in
Article 28(2) or
the following
elements:

the period for
for
a draft

(4) on the basis of all

3. Article 16(2) shall be replaced by the following:

(a)

the documents received from the Member State eval-
uating the dossiers;

the

Following

this Directive,

‘2.
the
adoption of
Commission shall commence a 10-year work programme
for
the systematic examination of all active substances
referred to in
already on the market on the date
Article 34(1) as active substances of a biocidal product for
purposes other than those defined in Article 2(2)(c) and (d).
Regulations shall provide for the establishment and imple-
mentation of the programme, including the setting of prio-
rities for the evaluation of the different active substances and
a timetable. Those regulations, designed to amend non-
this Directive by supplementing it,
essential elements of
shall be
regulatory
adopted in accordance with the
procedure with scrutiny referred to in Article 28(4). No
the work
later
programme,
the
European Parliament and the Council a report on progress
achieved with the programme.

than two years before completion of

the Commission

forward

shall

to

IA or
in cases where

During that 10-year period and from the date referred to in
Article 34(1), it may be decided that an active substance will
IB and under which
be included in Annexes I,
conditions, or,
requirements of
the
Article 10 are not satisfied or the requisite information
and data have not been submitted within the prescribed
period, that such active substance will not be included in
Annexes I, IA or IB. Such measures, designed to amend non-
essential elements of this Directive by supplementing it, shall
be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 28(4).’;

(b) any advice obtained from advisory scientific committees;

(c) comments received from other Member States and the

applicants; and

(d) any other relevant information.’;

6. Article 28 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

The Commission shall be assisted by a Standing

‘1.
Committee on Biocidal Products.’;

(b) paragraph 2 shall be replaced by the following:

‘2. Where reference is made to this paragraph, Articles
4 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision
1999/468/EC shall be set at three months.’;

4. Article 17(5) shall be replaced by the following:

(c) paragraph 3 shall be replaced by the following:

‘5.
Common conditions for the application of this Article,
in particular the maximum quantities of active substances or
biocidal products that may be released during experiments
and the minimum data to be submitted in order to permit
an assessment
in accordance with paragraph 2, shall be
adopted. Those measures, designed to amend non-essential
this Directive by supplementing it, shall be
elements of

‘3. Where reference is made to this paragraph, Articles
5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision
1999/468/EC shall be set at three months.’;

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(d) the following paragraph shall be added:

reference
to (4)

‘4. Where
Article 5a(1)
1999/468/EC shall
provisions of Article 8 thereof.’;

is made
to this paragraph,
and Article 7 of Decision
to the

apply, having

regard

7. Article 29 shall be replaced by the following:

‘Article 29

Adaptation to technical progress

Measures necessary to adapt Annexes IIA, IIB, IIIA, IIIB, IVA
or IVB or the descriptions of product types in Annex V to
technical progress or to specify data requirements for each of
these product
shall be adopted. Those measures,
designed to amend non-essential elements of this Directive,
inter alia, by supplementing it, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 28(4).’

types

Article 2

Entry into force

This Directive shall enter into force on the day following its
publication in the Official Journal of the European Union.

Article 3

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 11 March 2008.

For the European Parliament
The President

H.-G. PÖTTERING

For the Council
The President
J. LENARČIČ