OPINION OF THE COMMISSIONpursuant to Article 294(7)(c) of the Treaty on the Functioning of the European Union,on the European Parliament's amendment[s]to the Council's position regarding the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILconcerning the placing on the market and use of biocidal products.
Date: 2012-03-20
Institutions: European Commission
Subjects: chemical product, labelling, market approval, nanotechnology, plant health product

EUROPEAN COMMISSION 

Brussels, 20.3.2012  
COM(2012) 135 final 

2009/0076 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 294(7)(c) of the Treaty on the Functioning of the European Union,
on the European Parliament's amendment[s] 
to the Council's position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
concerning the placing on the market and use of biocidal products. 

 
 
 
 
  
 
 
 
2009/0076 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 294(7)(c) of the Treaty on the Functioning of the European Union, 
on the European Parliament's amendment[s] 
to the Council's position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
concerning the placing on the market and use of biocidal products. 

1. 

INTRODUCTION 

Article  294(7)(c)  of  the  Treaty  on  the  Functioning  of  the  European  Union  provides  that  the 
Commission  is  to  deliver  an  opinion  on  the  amendments  proposed  by  the  European 
Parliament at second reading. The Commission sets out its opinion below on the amendments 
proposed by the Parliament. 

2. 

BACKGROUND 

On  12  June  2009  the  Commission  submitted  a  proposal  for  a  Regulation  concerning  the 
placing  on  the  market  and  use  of  biocidal  products  to  the  European  Parliament  and  the 
Council for adoption by co-decision procedure as laid down in Article 251 of the EC Treaty. 

The Economic and Social Committee gave its opinion on 17 February 2010. 

The European Parliament adopted its first reading position on 22 September 2010. 

The Council reached a political agreement on the proposal on 20 December 2010 and adopted 
its common position on 21 June 2011. 

COREPER gave its agreement on the second reading compromise on 23 November 2011. 

The European Parliament adopted its Legislative Resolution at second reading on 19 January 
2012. 

3. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

The objective of the proposed Regulation is to improve the functioning of the internal market 
in  biocidal  products  whilst  ensuring  a  high  level  of  environmental  and  human  health 
protection.  The  proposal  intends  to  remedy  a  number  of  weaknesses  that  were  identified 
during  the  first  8  years  of  the  implementation  of  Directive  98/8/EC,  to  reduce  compliance 
costs, to pre-empt problems with the upcoming product authorisation and mutual recognition 
procedure, and to update and adapt the instrument to recent policy developments 

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4. 

OPINION OF THE COMMISSION ON THE AMENDMENTS PROPOSED BY THE EUROPEAN 
PARLIAMENT 

At  its  Plenary  Session  of  19  January  2012,  the  European  Parliament  adopted  a  compromise 
package  which  had  been  agreed  with  the  Council  in  view  of  reaching  a  second  reading 
agreement. 

These amendments concern essentially: 

–  the criteria for the exclusion of active substances from the approval process; 

–  the scope of the EU centralized procedure for biocidal products, 

–  greater  flexibility  in  relation  to  the  data  requirements  and  a  reduction  in  the  testing  of 

vertebrate animals, 

–  the labelling requirements for treated articles;  

–  the publication of reports and the dissemination of information, 

–  the  tasks  attributed  of  the  European  Chemicals  Agency  and  the  basis  for  the  payment  of 

fees to that Agency. 

The Commission will not stand against the compromise package as it is generally in line with 
the  overall  purpose  and  the  general  characteristics  of  the  proposal.  Regarding  the  use  of 
implementing acts for the setting of the fees payable to the European Chemicals Agency, the 
definition of nanomaterial and the fees for mutual recognition applications, declarations have 
been made by the Commission and are annexed to the present opinion. 

5. 

CONCLUSION 

Pursuant  to  Article  293(2)  of  the  Treaty  on  the  Functioning  of  the  European  Union,  the 
Commission  will  not  stand  against  the  amendments  voted  by  the  Europan  Parliament  in 
second reading according to the above described compromise text. 

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Annex: Commission Declarations 

Commission declaration concerning the use of implementing acts for the setting of the 
fees 

The  Commission  considers  that  the  setting  of  the  fees  to  be  paid  to  ECHA  cannot  be 
determined via implementing acts. However, in a spirit of compromise, the Commission will 
not stand against the final text as agreed between the Council and the European Parliament. 
Nevertheless,  on  this  specific  issue,  the  Commission  reserves  its  right  to  avail  itself  of  the 
legal remedies provided by the Treaty with a view to seeking clarification by the Court on the 
issue of delimitation between Articles 290 and 291. 

Commission declaration concerning the definition of nanomaterial 

While  the  Commission  can  accept  the  final  text  as  agreed  between  the  Council  and  the 
European  Parliament,  it  continues  to  believe  that  a  direct  reference  to  the  Commission 
Recommendation  2011/696/EU  on  the  definition  of  nanomaterial  would  have  been  more 
appropriate  in  view  of  the  need  for  a  harmonised  definition  of  nanomaterial  to  apply 
throughout the EU legislation and the possibility to easily adapt it to technical and scientific 
developments. To this effect, the Commission will take the necessary steps to ensure that this 
is reflected in any future proposals. 

Commission declaration concerning the fee for mutual recognition applications 

In  making  its  proposal  for  a  Regulation  on  fees  in  accordance  with  Article  80(1),  the 
Commission  will  seek  to  ensure  that  the  level  of  the  fee  for  applications  for  mutual 
recognition  payable  to  the  European  Chemicals  Agency  takes  into  account  the  level  of  fees 
charged in the different Member States and does not constitute a disproportionate burden for 
companies, in particular SMEs. 

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   EN