Proposal for a Directive of the European Parliament and of the Council amending Directive 98/8/EC concerning the placing of biocidal products on the market, as regards the implementing powers conferred to the Commission
Date: 2006-12-22
Institutions: European Commission
Subjects: European Commission, animal health, chemical product, comitology, marketing, powers of the institutions (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2006 
COM(2006) 923 final 

2006/0288 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending 

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

(presented by the Commission) 

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   EN 

 
 
 
  
 
2006/0288 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending 

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4 

Whereas: 

(1) 

(2) 

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Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council5  provides  that 
certain measures are to be adopted in accordance with Council Decision 1999/468/EC 
of 28 June 1999 laying down the procedures for the exercise of implementing powers 
conferred on the Commission6. 

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

… 
… 
… 
… 
OJ L 123, 24.4.1998, p.1; corrigendum OJ L150, 8.6.2002, p.71. 
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 
11). 

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(3) 

(4) 

(5) 

In accordance with the joint statement of the European Parliament, the Council and the 
Commission7 on Decision 2006/512/EC, instruments which are already in force must 
be  adjusted  in  accordance  with  the  applicable  procedures.  That  statement  indicates  a 
list of instruments that should be adjusted as a matter of urgency, including Directive 
98/8/EC. 

In particular power should be conferred on the Commission to amend the Annexes and 
to  adopt  the  review  programme.  Since  such  measures  are  of  general  scope  and  are 
designed to amend non-essential elements of this Directive and to supplement it by the 
addition of new non-essential elements, they should be adopted in accordance with the 
regulatory  procedure  with  scrutiny  provided  for 
in  Article  5a  of  Decision 
1999/468/EC. 

On grounds of efficiency, and in particular with regard to the time limits imposed to 
the Commission by Article 11(4), the normal time-limits for the regulatory procedure 
with  scrutiny  should  be  curtailed  for  the  adoption  of  decisions  including  an  active 
substance in the Directive's positive list. 

(6) 

Directive 98/8/EC should therefore be amended accordingly. 

(7) 

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

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 98/8/EC is amended as follows: 

(1) Article 10 (5) is amended as follows: 

(a) In point (i) the third subparagraph is replaced by the following: 

"The assessment shall be circulated in accordance with Article 11(2) for 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)." 

(b) In point (ii), point (5) is replaced by the following: 

"5. the complete data dossiers of the evaluation serving or having served for entry in 
Annex I, IA or IB shall be put at the disposal of the Committee referred to in Article 
28(4)." 

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OJ C 255, 21.10.2006, p.1 

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(2) In Article 11, paragraph 4 is replaced by the following: 

"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-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 28(4)" 

(3) In Article 16, paragraph 2 is replaced by the following: 

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

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

(4) In Article 27 paragraph 2 is replaced by the following: 

"At  the  end  of  the  period  for  comment,  the  Commission  shall  prepare  a  draft  for 
decision  in  accordance  with  the  relevant  procedures  referred  to  in  Article  28(2)  or 
28(4) on the basis of all the following elements: 

(a) the documents received from the Member State evaluating the dossiers and; 

(b) any advice obtained from advisory scientific committees; 

(c) comments received from other Member States and the applicants; 

(d) any other relevant information. 

(5) Article 28 is amended as follows: 

(a) Paragraph 3 is replaced by the following: 

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" For matters referred to the Standing Committee by virtue of Article 32, 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." 

(b) The following paragraph 4 is added: 

"4.  For  matters  referred  to  the  Standing  Committee  by  virtue  of  Article  10,  Article 
11(4),Article16(2), and Article 27(1)(a) and (2), of this Directive,Article 5a(1) to (4) 
and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof.  

The time-limit laid down in Article 5a(3)(c), of Decision 1999/468/EC with regard to 
Article 11(4), Article 16(2) second subparagraph and Article 27(1)(a) and (2) of this 
Directive shall be set at one month." 

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

Article 2 

Article 3 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President   

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