Commission staff working document - Summary of the impact assessment : accompanying document to the Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products {COM(2009)267} {SEC(2009)773}
Date: 2009-06-12
Institutions: European Commission
Subjects: chemical product, market approval, marketing, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.6.2009 
SEC(2009) 774 final 

COMMISSION STAFF WORKING DOCUMENT 

SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying document to the 

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

{COM(2009)267} 
{SEC(2009)773} 

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COMMISSION STAFF WORKING DOCUMENT 

SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying document to the 

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

Directive 98/8/EC (the Directive) seeks to harmonise the placing of biocidal products on the 
market  whilst  guaranteeing  a  high  level  of  protection  for  humans,  animals  and  the 
environment.  

Although  the  Directive  has  been  successful  in  removing  a  number  of  undesirable  products 
from the EU market, and in bringing structure to an area that was regulated in a fragmented 
way in the Member States, during the first eight years of the implementation of the Directive, 
several problems have been identified. These include the slow progress in the active substance 
Review Programme, the high level of withdrawal of certain active substances1 and products 
and the lack of incentives for the development of new active substances.  

The main reasons for these consequences are:  

–  the loopholes and the lack of clarity relating to the scope of the Directive; 

–  the extensive data requirements for dossier preparation leading to high costs;  

–  the low attractiveness of simplified procedures for low-risk and basic substances;  

–  the  uncertainty  regarding  the  application  of  the  Directive  in  particular  in  relation  to  data 

protection and data waiving possibilities; and  

–  the  high  and  heterogeneous  fees  for  approval  of  active  substances  and  authorisation  of 

products.  

It appears, therefore, necessary to modify certain provisions of the Directive (policy issues 2 
to  5)  in  order  to  make  it  more  effective  and  efficient,  reducing  unnecessary  burdens  for 
Member States and industry whilst maintaining a high level of protection of human health and 
environment. In addition, the need to ensure coherence and to establish a level playing field 
between EU producers and third-country producers of treated materials necessitates a change 
of the scope of the Directive (policy issue 1). 

The Impact Assessment addresses five policy issues that require action: 

POLICY ISSUE 1: SCOPE 

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Withdrawal  refers  here  to  the  situation  when  some  companies  decided  not  to  support  existing  active 
substances in the Review Programme or the information provided by them was not sufficient. 

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–  Unchanged policy; 

–  Extend scope to cover processing aids and food contact materials; 

–  Extend scope to cover treated materials. 

The policy options are cumulative. The assessment concluded that including treated materials 
in  the  scope  of  the  Directive  would  significantly  increase  the  costs  to  industry.  However, 
although  the  equal  treatment  of  industry,  and  environmental  and  human  health  benefits  are 
difficult to quantify, they are likely to be significant. Including, in particular food processing 
aids in the scope of the Directive is likely to result in a complicated process of authorisation 
under two legal frameworks2 which may lead to some duplication of efforts. The related costs 
are  likely  to  outweigh  the  limited  benefits  resulting  from  better  control  of  environmental 
impacts and greater regulatory certainty. 

POLICY ISSUE 2: PRODUCT AUTHORISATION 

–  Unchanged policy; 

–  Strengthening of mutual recognition; 

–  Single Member State authorisation; 

–  Community authorisation. 

The policy options are alternatives but within them certain elements could be combined. The 
assessment concluded that a Community authorisation or a single Member State authorisation 
would be the most efficient systems and would provide incentives for innovation of products 
based  on  new  active  substances/low  risk  products.  However,  as  the  Member  States  have 
expressed  significant  concerns  about  a  full  centralisation  of  the  product  authorisation  or  a 
single Member State authorisation due to reduced role for the Member States, a combination 
of  the  Community  authorisation  for  certain  products  with  the  strengthening  of  the  mutual 
recognition process for other products appears to be the most realistic solution. 

POLICY ISSUE 3: DATA SHARING 

–  Unchanged policy; 

–  Mandatory sharing of vertebrate animal test data at product authorisation stage; 

–  Mandatory sharing of vertebrate animal test data at product authorisation stage and active 

substance approval stage. 

The policy options are mutually exclusive; they address the same problem and offer different 
solutions  to  it.  The  assessment  concluded  that  the  last  option  of  mandatory  data  sharing  at 
product  authorisation  and  active  substance  approval  stage  implies  the  highest  total  cost 
savings to applicants, possibly the highest number of safer products remaining on the market 
and the highest number of animals saved.  

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For processing aids used on food of animal origin, this would include the Regulation (EC) No 853/2004 
and  the  Biocides  Directive.  For  processing  aids  used  on  food  of  plant  origin,  this  would  include  the 
national legislation, where available, and the Biocides Directive. 

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POLICY ISSUE 4: DATA REQUIREMENTS 

–  Unchanged policy; 

–  Rewording provisions concerning data waiving and the use of existing information; 

–  Reformulating the system for low-risk substances/products. 

The policy options are cumulative and address two types of problems: high data requirements 
and  low  attractiveness  of  the  simplified  procedures,  in  particular  for  low  risk  and  basic 
substances. The assessment concluded that all the options have significant potential to reduce 
costs for industry and that the last two options would also significantly reduce the numbers of 
vertebrate animal tests. In order to meet the objectives of the revision, the best option seems 
to be a combination of data waiving with the use of existing information and a new approach 
to low risk biocidal products. 

POLICY  ISSUE  5:  FEES  CHARGED  BY  MEMBER  STATES  FOR  CARRYING  OUT  THE 

PROCEDURES OF THE DIRECTIVE 

–  Unchanged policy; 

–  Partially harmonised fee structure; 

–  Centralised fee system; 

–  Specific provisions for SMEs. 

The policy options are alternatives but within them certain elements could be combined. The 
assessment  concluded  that  a  partially  harmonised  fee  structure  may  encourage  the 
development  of  more  new  active  substances  and  the  retention  of  more  existing  active 
substances. It should also reduce the costs for the inclusion of substances for several product 
types. The last option will make the procedure less costly for SMEs, which should help them 
to  stay  on  the  market.  A  fully  centralised  fee  system  would  raise  questions  concerning  the 
subsidiarity principle as it would transfer the competences over setting the levels of fees from 
the Member States to the Community. 

OVERALL COSTS AND BENEFITS 

If left unchanged, the current legal framework for biocides would result in very high costs for 
the industry in order to comply with the provisions on the evaluation of active substances and 
authorisation of biocidal products. The total costs and benefits of the policy options presented 
in the impact assessment should be seen in light of this fact.  

The impact assessment shows that the combined overall costs of all preferred options to the 
industry  would  amount  to  a  range  from  €193.6  to  706  million 3  over  a  period  of  10  years. 
These costs are attributable to the extension of the scope of the Directive to treated materials 

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Net present value € 162.2 million to 591.6 million 

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and  cover  the  costs  of  including  additional  active  substances  in  Annex  I,  the  costs  of  the 
authorisation of additional products and the labelling costs of treated materials. 

The  overall  cost  savings  of  all  the  preferred  options  for  the  industry  could  range  from 
€2.7 to 5.7 billion 4 over a period of 10 years. Due to reasons described in detail in Section 6 
(Comparing  the  options),  it  is,  however,  unlikely  that  the  cost  savings  would  materialise  in 
such  scale.  The  actual  savings  are  likely  be  closer  to  the  lower  end  of  the  range  but  would 
certainly outweigh the total costs. 

Concerning the environment and human health impacts, the impact assessment shows that the 
extension of the scope to treated materials will result in significant environmental and human 
benefits  even  though  these  are  difficult  to  quantify.  The  other  policy  options  will  help 
maintain the current high level of environmental and human health protection. 

Regarding the social impacts, no significant impacts on employment are expected. However, 
the  individual  policy  options,  in  particular  the  changes  in  product  authorisation,  obligatory 
data  sharing,  improved  waiving  provisions  and  the  revised  concept  for  low  risk  biocidal 
products may have positive impacts on employment. 

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Net present value € 2.3 billion to 4.8 billion 

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