EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN 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}  
 
 
 
EN 2   EN 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 harm onise the placing of bi ocidal 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 incl ude the slow progress in  the active substance 
Review Programme, the high level of w ithdrawal of certain active substances1 and products 
and the lack of incentives for the de velopment of new active substances.  
The main reasons for these consequences are:  
– the loopholes and the lack of clarity re lating to the scope of the Directive; 
– the extensive data requirements for dossier  preparation leading to high costs;  
– the low attractiveness of simplified procedur es 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 Dir ective (policy issue 1). 
The Impact Assessment addresses five policy issues that require action: 
P
OLICY ISSUE 1: SCOPE  
                                                 
1 Withdrawal refers here to the situation when so me companies decided not to support existing active 
substances in the Review Programme or the information provided by them was not sufficient. 
 
EN 3   EN – Unchanged policy; 
– Extend scope to cover processing ai ds and food contact materials; 
– Extend scope to cover treated materials. 
The policy options are cumulative. The assessmen t concluded that includ ing treated materials 
in the scope of the Directive would significan tly increase the costs to industry. However, 
although the equal treatment of industry, and e nvironmental and human health benefits are 
difficult to quantify, they are likely to be signifi cant. Including, in part icular 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 duplicati on of efforts. The related costs 
are likely to outweigh the limited benefits re sulting 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 authoris ation 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 produc ts. However, as the Member States have 
expressed significant concerns about a full cent ralisation of the product authorisation or a 
single Member State authorisati on due to reduced role for the Member States, a combination 
of the Community authorisation for certain pr oducts with the strengthening of the mutual 
recognition process for other products appe ars to be the most realistic solution. 
POLICY ISSUE 3: DATA SHARING  
– Unchanged policy; 
– Mandatory sharing of vertebrate animal te st data at product au thorisation 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 mand atory data sharing at 
product authorisation and active substance approval stage imp lies the highest total cost 
savings to applicants, possibly the highest number of safer pr oducts remaining on the market 
and the highest number of animals saved.  
                                                 
2 For processing aids used on food of animal origin, this would include the Regulation (EC) No 853/2004 
and the Biocides Directive. For proc essing aids used on food of plant origin, this would include the 
national legislation, where available, and the Biocides Directive. 
 
EN 4   EN POLICY ISSUE 4: DATA REQUIREMENTS  
– Unchanged policy; 
– Rewording provisions concerning data waivi ng and the use of existing information; 
– Reformulating the system for low-risk substances/products. 
The policy options are cumulative and address tw o types of problems: high data requirements 
and low attractiveness of the simplified proce dures, in particular for low risk and basic 
substances. The assessment conclu ded 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 th e 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 ha rmonised 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 f ee system would raise questions concerning the 
subsidiarity principle as it would transfer the co mpetences over setting the levels of fees from 
the Member States to the Community. 
OVERALL COSTS AND BENEFITS  
If left unchanged, the current legal framework fo r biocides would result in very high costs for 
the industry in order to comply with the provi sions 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 million3 over a period of 10 years . 
These costs are attributable to the extension of the scope of the Directive to treated materials 
                                                 
3 Net present value € 162.2 million to 591.6 million 
 
EN 5   EN and cover the costs of including additional activ e substances in Annex I, the costs of the 
authorisation of additional products and th e 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 billion4 over a period of 10 years . Due to reasons describe d 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 cl oser to the lower end of the range but would 
certainly outweigh the total costs. 
Concerning the environment and human health imp acts, 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 en vironmental 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 an d the revised concept for low risk biocidal 
products may have positive impacts on employment. 
                                                
 
4 Net present value € 2.3 billion to 4.8 billion