EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 12.6.2009 
SEC(2009) 773 final 
  
COMMISSION STAFF WORKING DOCUMENT 
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 
 
IMPACT ASSESSMENT 
 
{COM(2009)267} 
{SEC(2009)774}  
EN 2   EN COMMISSION STAFF WORKING DOCUMENT 
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 
 
IMPACT ASSESSMENT 
  
            Lead DG: DG ENV Other involved services DG's ENTR, SANCO, AGRI, JRC, RELEX, TRADE, COMP, 
MARKT, SJ, SG. 
Agenda planning: 2008/ENV/003       The report commits only the Comm ission's services involved in th e preparation and the text is 
prepared as a basis for comment and does not prej udice the final form of any decision to be 
taken by the Commission 
EN 3   EN TABLE OF CONTENTS 
Executive summary.............................................................................................................. ...... 4 
1. Procedural issues and consulta tion of interested parties.............................................. 8 
2. Problem definition...................................................................................................... 11 3. Objectives.................................................................................................................. . 22 
4. Policy options............................................................................................................. 2 3 
5. Analysis of impacts.................................................................................................... 32 6. Comparing the options ............................................................................................... 46 7. Monitoring and evaluation ......................................................................................... 55 
ANNEX I: REFERENCES ...................................................................................................... 57 ANNEX II: Background information on Directive 98/8/ EC of the European Parliament and of 
the Council concerning the placing of biocidal products on the market.................................. 60 
ANNEX III: GLOSSARY........................................................................................................ 63 ANNEX IV: TABLES TO COMPARE THE OPTIONS ........................................................ 65 ANNEX V: STANDARD ASSUMPTIONS ON MARKETS FOR BIOCIDAL PRODUCTS 
AND ACTIVE SUBSTANCES............................................................................................... 82 
ANNEX VI: STANDARD ASSUMPTIONS ON COSTS...................................................... 85 ANNEX VII: DELIMITA TION OF COSTS........................................................................... 87 
ANNEX VIII: EU STANDARD COST MODEL REPORTING SHEET .............................. 88 
EN 4   EN Executive summary 
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 in clude 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 protectio n 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  
– 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 assessment  concluded that includ ing treated materials 
in the scope of the Directive would significantly in crease the costs to industry. However, 
                                                 
1 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. 
EN 5   EN although the equal treatment of industry, and e nvironmental and human health benefits are 
difficult to quantify, they are like ly 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 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 woul d 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 centr alisation 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 pr oducts with the strengt hening 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 authoris ation 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.  
POLICY ISSUE 4: DATA REQUIREMENTS  
– Unchanged policy; 
                                                 
2 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 us ed on food of plant origin, this would include the 
national legislation, where available, and the Biocides Directive. 
EN 6   EN – 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 concluded that all th e options have significa nt 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 for biocides would result in  very high costs for 
the industry in order to comply  with the provisions on the eval uation 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 
and cover the costs of including additional active 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 billion
4 over a period of 10 years . Due to reasons described in detail in Section 6 
                                                 
3 Net present value € 162.2 million to 591.6 million 
4 Net present value € 2.3 billion to 4.8 billion 
EN 7   EN (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. 
EN 8   EN 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Overview 
The revision of Directive 98/8/EC (3)  concerning the placing of biocidal products on 
the market (the Directive) is part of  the 2008 Commission Legislative and Work 
Programme (1)  and is included in the Comm ission strategy for simplifying the 
regulatory environment (2) . 
A number of stakeholders, experts and comp etent authorities of the Member States 
have been consulted. An Inter-Service Steering Group to support the work on the 
Impact Assessment was established. The need  for a revision addressing the scope of 
the Directive, product authoris ation, data sharin g, data requirements and fees was 
highlighted during the consultation process. 
This Impact Assessment follows the structure given in the Commission guidelines 
(4). It aims to consider the environmental, economic and social aspects of the 
revision of the Directive in an integrated and proportionate way. 
1.2. Inter-Service Steering Group 
Within the Commission, internal consulta tion has been pursued through an Inter-
Service Steering Group (ISSG) set up in December 2007. The ISSG was led by the Directorate-General Environment with the participation of DG's Enterprise and 
Industry, Health and Consum er Protection, Agriculture,  Joint Research Centre, 
External Relations, Trade, Competition, In ternal Market, Legal Service and the 
Secretariat General. The ISSG met on 3 December 2007, 5 June 2008 and 18 July 2008. 
1.3. Preparatory work 
To support this impact assessment, severa l studies were carried out by external 
contractors: 
• a study to assess the impact of the revision of Direct ive 98/8/EC concerning the 
placing of biocidal produ cts on the market (5)
; 
• a study on the impacts of the implementa tion of Directive 98/8/EC on biocidal 
products (6) ;  
• a study on impacts of possible measures to manage articles or  materials treated 
with biocides, in partic ular when imported (7) ; and  
• a study on the assessment of different options  to address risks from the use phase 
of biocides (8) . 
1.4. Stakeholder consultations 
During these studies, stakeholders (cons ultants, individual companies, industry 
associations, NGOs, Member State competen t authorities) were consulted through 
EN 9   EN several questionnaires and interviews. A Stakeholder Consultation Meeting was also 
held on 23 May 2008 in Brussels.  
In addition, an expert workshop was orga nised on 23 April 2008 to discuss the use 
phase of biocides. 
Concerning the consultation of the competent authorities, a first workshop dedicated 
to the revision of the Directive was orga nised by the Presidency of the EU in 
Slovenia in January 2008. Representatives of  Member States competent authorities 
then dealt in detail with the key issues fo r the revision during a meeting held on 28 – 
30 May 2008. In addition, several bilatera l meetings were held between the 
Commission services and representatives of  Member States competent authorities. 
Stakeholders were very supportive to the extension of the scope with respect to 
treated materials. In particular, the indus try demanded that a level playing field is 
created concerning materials treated with bi ocidal products that are placed on the EU 
market. The industry as well as the Member States were also in favour of a labelling 
system that would facilitate  the enforcement and inform consumers about the use of 
biocidal products in treated materials. 
Regarding product authorisation, the indus try was clearly in favour of a fully 
centralised Community-wide authorisation system. However, the Member States 
opposed this and argued that the role of Member States  in the authorisation process 
should be retained.  
All stakeholders agreed on the changes concerning data sharing and data 
requirements. The Member States had some  concerns about the implementation of 
the concept on low risk biocidal products, in  particular the definition and the details 
of the screening pro cess (see section 4.4.3). 
Finally, with respect to fees, the industr y fully supported the proposal to introduce a 
partially harmonised fee structure. The pr ovisions aimed at SMEs were welcome in 
particular by SMEs. The Member States we re in favour of keeping the decision on 
fees at national level. 
1.5. The Impact Assessment Board 
This Impact Assessment was submitted to the Board on 1 August 2008 and discussed 
at the Board meeting of 27 August 2008. The Board submitted its opinion on 3rd 
September 2008 proposing the followi ng changes to the assessment: 
– inserting more information on the market with biocidal products; 
– clarifying the relevance of th e subsidiarity principle; 
– inserting a section on methodology, in pa rticular clarifying the assumptions 
underlying the assessment; 
– detailing the impacts on the differe nt users of biocidal products; 
EN 10   EN – inserting more information on the situation concerning imports of treated 
materials; 
– including more information on how the costs of the different policy options 
compare to the value of the market; 
– setting out the advantages of the hybrid  system (mutual recognition for most 
products and centralised Community author isation at EU level for some products) 
compared to the current situation;  
– calculating the total costs and benefits  of the final policy package; and 
– reflecting better the results of  the stakeholde r consultation. 
All these recommendations have been introduced in the relevant sections. The 
modified impact assessment was re-submitted on 9th September 2008. The Board 
issued a new opinion on 2nd October 2008 in which it recommended:  
– to strengthen the subsidiarity analysis in particular as regards the policy issue on 
fees. This has been done in section 5.5.2.; 
– to clarify the structure of the options. The difference between options (a) and (b) 
for policy issues 1 (scope) and 2 (product au thorisation) has been  clarified in the 
relevant sections. Additionally, the pr oblems described under sections 4.2 and 
4.5.1 have been transferred to the problem definition section.; 
– to further assess the impacts of  the proposed options, notably 
(1) to provide more information on impacts of various types of affected parties 
(big companies versus SMEs, substance producers versus product manufacturers) and show how benefits/c osts evolve over time. See section 5. 
(2) to be more specific about the level of  data confidence and more transparent 
about uncertainty when aggregating da ta: Annex V sets out the standard 
assumptions on markets and numbers of products and substances used in the analysis of the various po licy options, indicating the source of the estimate 
and noting any particular areas of uncertainty. Annex VI sets out the 
assumptions on costs of product authorisation and support of active substances. The assumptions have been validated with stak eholders; however 
a high degree of uncertainty remains.  
(3) to provide a clear definition of ma rket value and to delimit business 
compliance and administrative costs. In section 5.1.3. 'market value' has been 
replaced by 'annual market turnover'. Business compliance and administrative 
costs have been delimited in Annex VII. 
(4) to quantify the effects on employment. See section 5. 
– to use the EU Standard Cost Model and to include the EU Standard Cost Model 
reporting sheet. The reporting sheet has been included in Annex VIII. The estimates are consistent with the European  Standard Cost Model in the sense that 
they examine the costs associated with different information obligations. The 
EN 11   EN "time-based" methodology could not be used because most of the costs in the 
report are charged on a fixed-price basis. 
2. PROBLEM DEFINITION  
2.1. Background 
Background information on the requirements of  the Directive is pr ovided in Annex II 
of this document. 
Biocidal products refer to a wide categor y of products divided into 23 product types 
including disinfectants, pest control pr oducts, wood preservatives, anti-fouling 
products and embalming products. Profes sional users are prevalent in all 
preservatives, in particular wood preservati ves, some pest control products (avicides 
and piscicides), anti-fouling products a nd embalming and taxidermist products. Non-
professional users (consumers) prevail in some pest control products (rodenticides, 
insecticides, repellents and attr actants) and some disinfectants. 
The value of the global biocidal products  market was in 2000 estimated at around € 3 
billion per year, with North America repr esenting about 43% a nd Europe 27% (the 
latter approximately worth € 890 million per year and volume s estimated at 89,000 
tonnes of products placed on the market per year)5. The European biocides market is 
dominated by three large companies that hol d 25% of the market, while the presence 
of small and medium-sized companies is also  quite important, especially with regard 
to the manufacture of "niche" or speciality biocides. Within the biocides market, one 
can distinguish producers of active substa nces, formulators of finished biocidal 
products, and companies that are active in both markets. As a result of the 
implementation of the Directive in Eur ope, there is currently a tendency for 
consolidation of the market and in particular, of active ingredients' producers to buy 
companies that formulate finished products.  
The Directive sets out a two-tiered system  of evaluating active substances at the 
Community level and authoris ing biocidal products cont aining these substances at 
the national level. The product authorisation stage of the Directive has not yet been 
implemented. It will be implemented gra dually following the inclusion of active 
substances in Annex I6. In case the companies intend to place their product on the 
market in several Member States, they can apply for a mutual recognition of the 
original product authorisation.  
This system has the objective to ensure a functioning internal market in biocidal 
products and a high level of  protection of human health  and the environment. The 
protection of human health and the environment is very important with respect to the use of biocidal products as biocidal produc ts can pose risks to humans, animals and 
the environment in a variety of ways due to  their intrinsic prope rties and associated 
use patterns. For example, the use of wood preservative s or anti-fouling products 
                                                
 
5 For more details see http://www.icis.com/Articles/2002/05/21/170110/biocide-deadline-comes-and-
goes.html  and http://www.personalcaremagazine.com/Story.aspx?Story=2644; the information was 
confirmed with representa tives of the industry;  
6 One biocidal product can contain several active substances. However, an authorisation for a biocidal 
product can only be issued once all active substance(s)  contained therein have been included in Annex I 
or IA.  
EN 12   EN often implies a direct contact of the bi ocidal product with aquatic or marine 
environment. In addition, biocidal produc ts may have negative effects on non-target 
organisms. With respect to human hea lth, biocidal products may leave residues 
which may have negative impact on human or animal health (e.g. through drinking 
water, food or feed, indoor air or co nsequences in the place of work).  
The above-mentioned studies and the report  on the functioning of the Directive 
highlighted the following issues: 
– Impacts on the market remain to be seen. However, the main lesson from the first 
years of implementation of the Directive is that seve ral substances and products 
have been removed from the market not b ecause of public health or environmental 
concerns but because the co sts of producing data for m eeting the requirements of 
the Directive were felt to be prohibitive (6) . 
– High costs of the active substance dossiers already had a significant impact on the 
number of substances participating in the Review Programme. Over 60% of active 
substances which were on the market in May 2000 were no t supported under the 
Review Programme and therefore, their marketing was discontinued in September 
2006. The impacts of the withdrawal7 on products are difficult to assess but some 
Member States indicate that up to 18 % of products had to be phased out8. High 
costs of the product authorisation applica tion, in particular when multiplied by the 
number of countries where a particular product is market ed or including the costs 
of the mutual recognition, may lead to similar impacts with  respect to the 
products.  
– Price increases for biocidal products of  between 10% to 30 % are anticipated by 
the industry because of the extensive da ta requirements for dossier preparation 
necessitating significant investments. Small and medium-sized enterprises 
(SMEs), as defined in the Commissi on Recommendation of 6 May 2003 (9)  are 
particularly affected, while larger companie s are more likely to be able to bear the 
costs of dossier preparation. High costs of  the dossier preparation are likely to 
have negative impact on the product avai lability which in return increases the 
risks of resistance development9. The lesser the choice of products, the more they 
will be used which increases the risk of resistance development.  
– The industry indicates that the devel opment of new active substances with 
potentially better risk or efficacy profile s is discouraged by the Directive because 
company resources are currently focused on defensive research in order to comply with the Review Programme requirements. In particular, the development of low 
risk active substances or basic substan ces is not supported because of the low 
attractiveness of simplified procedures
10. 
                                                 
7 Examples include the use of lavender oil as repellent, copper sulphate as wood preservatives, 
phenothrin as insecticide, zinc as anti-fouling product, etc. 
8 Study on Impact of the implementation of Directive 98/8/EC concerning the placing on the market of 
biocidal products 
9 Resistance is the capacity of bacteria to with stand the effects of a ha rmful chemical agent. 
10 Simplified procedures include for example the registration of a low risk biocidal product (as opposed to 
authorisation of 'normal' biocidal products) on the basis of a reduced data package with precise 
deadlines for the issuing of the registration and mutual recognition of the registration. 
EN 13   EN – The implementation of neighbouring legisl ation such as the REACH Regulation 
or the forthcoming Regulation on plant pr otection products is unlikely to have a 
significant impact on biocides. The REACH Regulation may have some impact on 
the evaluation of non-active substances11 which may be required under the 
Directive but will have very limited implications for the evaluation of active substances and authorisation of biocidal  products. The interac tion with the legal 
framework on plant protecti on products is largely limited to solving borderline 
issues concerning scope. With respect to the rules on mutual recognition of 
products, it should be clar ified that Regulation (EC) No 764/2008 laying down 
procedures relating to the application of certain national technical rules to 
products lawfully marketed in another Member State and repealing Decision No 
3052/95/EC does not apply to the mutual recognition process under the Biocides Directive
12. 
– The implementation of the Directive is too recent for evidence to be available on 
impacts on pest control and on the level of human/animal health and environmental protection. Some active s ubstances with highly hazardous profiles 
(e.g. strychnine, arsenic compounds) have b een taken off the market, representing 
a clear environmental and health benefit. However, some stakeholders fear that a 
reduced variety of active substances may lead to future treatment gaps and the 
development of tolerance and resistance of target organisms . 
The main reasons for these impacts  are: 
– the delimitation of the scope, in particular the loophole related to treated materials 
places EU producers at a disadvantage and is also a consumer and environmental 
protection issue; 
– the lack of expertise in dossier preparation and evaluation; 
– the uncertainty regarding the application of the Directive in particular in relation 
to data-protection, data waiving possi bilities, technical guidance for risk 
assessments and efficacy testing;  
– the low attractiveness of simplified pro cedures such as Annex IA (low-risk 
substances) and Annex IB (basic substances);  
– the extensive data requirements for dossier  preparation leading to high costs; the 
costs for product authorisation must be, in addition, multiplied by the number of markets on which the product shall be placed or it must include the costs of the mutual recognition including po ssible repetition of tests; 
– the high and heterogeneous fees fo r approval of active substances and 
authorisation of products. 
                                                
 
11 Non-active substances are substances which do not have general or specific action on or against harmful 
organisms. They include pigments, dyes, perfumes, so lvents, etc. Non-active su bstances fall within the 
scope of REACH and thus have to be registered and evaluated under the REACH Regulation. The 
results of this evaluation may be later used during the product authorisation stage under the Biocides Directive. 
12 The Regulation does not apply to technical rules which are subject of harmonisation at Community 
level. 
EN 14   EN While there are a large number of issues of  varying importance th at are likely to be 
addressed in the revision of the Directive, there are a few where it has been identified 
that there might be signifi cant impacts. These are set out  in section 2.3 and are the 
subject of this Impact Assessment.  
In cooperation with the stakeholders, various ways have been identified to 
significantly reduce costs related to the substance evaluation and, in particular to 
product authorisation and mu tual recognition. These incl ude for example obligatory 
sharing of vertebrate animal data, revisi on of the concept for low risk biocidal 
products or improved rules on data waiving. These measures which are presented in 
the impact assessment have high potential to reduce the costs. This would lead to the 
situation where more products would re main on the market and innovation with 
respect to new products would be encourag ed. Importantly, if no action is taken, 
many companies are, due to high costs of  the product authoris ation and mutual 
recognition, likely to stop marketing their products which will le ad to problems with 
product availability. Product availability is decisive for example for the development of resistance in target organisms. This ma y be a problem mainly for Member States 
with smaller markets where companies with  low turnover will not be able to cover 
the expenses linked with the product authoris ation or mutual recognition and will no 
longer find it economically viab le to supply such products.  
In addition, the changes to the Directive could make it simpler to understand which 
would facilitate the regulatory compliance.  This would mainly benefit SMEs which 
often lack the human resources to ensure regulatory compliance. Simplification would also reduce the need for human resources on the side of the Member States' authorities and would f acilitate enforcement. 
Given the potential cost savings to the industry that could be achieved with the 
actions described in this assessment, it seems appropriate to act now and not to 
postpone the changes. 
2.2. Methodology 
The following basic assumptions were used in the impact assessment: 
Number of biocidal products to be pla ced on the market over the next 10 years 
– Minimum number of products: 4 500 
– Maximum number of products: 9 000
13 
Total costs of an active substance evaluation14 
                                                 
13 These numbers are estimates provided in the RPA Report (5) . On the basis of stakeholder consultation, 
the total number of biocidal products currently on the market may be higher as some Member States, in 
particular Germany and France, report a total number of 18.000 biocidal products. This number may, 
however, contain many dupli cate entries. In addition, it is expect ed that the market will consolidate 
after the end of the Review Prog ramme. Some companies may leave the market or reduce the number 
of markets on which they are active in response to the costs of the product authorisation under the 
provisions of the Directive and non-inclusion decisions about certain substances. 
EN 15   EN – Minimum total costs of an active substance dossier: € 3 million per substance  
– Maximum total costs of an active substance dossier: € 5 million per substance  
Total costs of a product authorisation 
– Minimum average costs of product authorisation: € 90,000 per product  
– Maximum average costs of product authorisation: € 200,000 per product  
It should be noted that there are furthe r assumptions including the number of cases 
where mutual recognition is s ought, the rate of referral to  the Commission in cases of 
disagreements over mutual recognition, th e average number of markets on which 
biocidal products are placed, the average number of active substances on the market, 
etc. These assumptions were validated wi th the stakeholders  (i.e. individual 
companies, industry federations and Member States) to make them as robust as possible. Because of the high degree of un certainty involved, the costs and benefits 
of different options were calculated with  help of scenarios.  An optimistic and a 
pessimistic scenario were prepared: 
– the optimistic scenario  refers to situation where there are many applications for 
product authorisations combined with a high incidence of mutual recognition and 
a relatively low rate of referral to th e Commission in case of disagreements over 
mutual recognition;  
– the pessimistic scenario  refers to situations wh ere there will be fewer 
applications for product authorisations comb ined with a lower in cidence of mutual 
recognition and a higher number of cases referred to the Commission in case of 
disagreements over the mutual recognition;  
The costs and benefits of the outlined po licy options are laid down in ranges which 
are direct consequences of using the scenar io approach. The lowe r range of the cost 
savings refers normally to the pessimistic scenario and the upper range to the optimistic scenario. 
Most of the major costs in th e report such as data costs and competent authority fees 
are charged on a fixed-price basis, rather than incurred in the form of person-hours, 
so the number of person-hours is not relevant for assessing these costs. Nevertheless, these estimates are consistent with the Eur opean Standard Cost Model in that they 
examine the costs associated with different information obligation. This was done using the best available data and in cluding data provided by stakeholders.  
2.3. The issues/problems that require actions  
It should be noted that the impact assessment was prepared at a time when the 
provisions of the Directive on product author isation and mutual recognition were not 
yet implemented. There is no practical experience on product authorisation and mutual recognition available. This has impli cations for all policy options presented in 
                                                                                                                                                        
 
14 It is assumed that the costs of an active substance dossier are one-of f costs which are incurred once in a 
10-year period. This is explained through the fact that  the inclusion of an active substance is valid for a 
period not exceeding 10 years. 
EN 16   EN the impact assessment. Nevertheless, there are several indications that problems may 
be anticipated: 
– slow progress of the Review Program for the evaluation of existing active 
substances15; 
– current provisions of the Directive, in  particular on mutual  recognition lack 
precision and can be interpreted in di fferent ways by the Member States; 
– problems with the functioning of mutual recognition provisions encountered in the 
context of Directive 91/414/EEC concer ning the placing of plant protection 
products on the market which, mutatis muta ndis, could also occur in the present 
case. 
– concerns raised by all stakeholders, in pa rticular the industry, with regards to the 
smooth functioning of th e product authorisation and mutual recognition. 
It was concluded that in order to ensure  harmonised conditions for placing biocidal 
products on the market, changes to  the Directive are required. 
2.3.1.  Policy issue 1: The scope needs to be revised 
2.3.1.1.  Biocides used in food processing and food contact materials 
Food processing aids are substances intent ionally added to food to fulfil a certain 
technological purpose (17) . Some of these substances , although they are clearly 
acting as biocidal active substances, are cu rrently not covered by the Directive. This 
raises the question of coherence with re spect to the scope of the Directive. 
Some processing aids used on food of anim al origin with a biocidal activity are 
covered by Regulation (EC) No 853/2004 (18) . This Regulation indeed prohibits the 
use of any substance other than potable wa ter to remove surface contamination from 
products of animal origin unless the use of such a substance has received an 
approval. However, compared with the Directive, the approval procedure under 
Regulation (EC) No 853/2004 does not extensively addre ss environmental concerns 
despite the most recent efforts16.  
In addition, Regulation (EC) No 853/2004 doe s not apply to processing aids used on 
food of plant origin. There is no other Co mmunity legislation requiring an evaluation 
of processing aids used on food of plant orig in. This leaves it to the discretion of the 
Member States whether they take any ac tion to evaluate the human health and 
environmental concerns. 
                                                 
15 On 9 September 2008, i.e. 8 years after the implem entation of the Directive, only 13 active substances 
out of 320 substances were included in Annex I ('normal' active substances) and one active substance in 
Annex IA (low risk active s ubstances) of the Directive. 
16 In the draft Commission Regulation implementing Regulation (EC) N° 853/2004 of the European 
Parliament and of the Council as regards the use of four antimicrobial substances (chlorine dioxide, 
acidified sodium chlorite, trisodi um phosphate, peroxyacids) to re move surface decontamination of 
poultry carcases strict conditions for the management of waste water are provided for in order to ensure 
the protection of the environment. 
EN 17   EN The situation of food contact materials is similar to th at of food processing aids. 
Despite the fact that Community legisla tion on food contact materials exist, the 
evaluation of environmental e ffects associated w ith the use of bioc idal products in 
food contact materials is not fores een but Regulation 1935/2004/EC sets a 
framework for the regulation of  food contact materials (19) . A series of 
implementing measures cover specific types of contact materials (e.g. ceramics, regenerated cellulose film, plastic materials). 
The Guidelines of the Scientific Committee on Food for the submission of an 
application for safety assessment of a substa nce to be used in food contact materials 
prior to its authorisation "do not include any considerat ion of environmental aspects 
such as persistence in the environment, ecological impact of their constituents and 
their fate after the food contact material has been submitted to waste disposal 
treatment. ” (20)
. 
Industry has submitted approximately 10 a pplications for the use of so-called 
“surface biocides” in food packaging, mainly  for silver compounds and triclosan to 
be embedded in packaging walls. None as yet have received approval.  
2.3.1.2.  Treated materials 
A major legislative loophole was identified with respect to mate rials treated with 
biocidal products in order to protect the material itself. The Directive presently does 
not cover the placing on the market of this type of treated materials. Therefore, 
nothing – apart from the case-by-case m easures adopted within the scope of 
Directive 76/769/EEC (11) , prevents the placing of mate rials treated with biocidal 
products containing not approve d or even banned active substances on the market.  
For example, wooden poles for electricity  which are manufactur ed in the EU can 
only be placed on the market if they are treate d with authorised biocidal products 
(containing approved active substances). Howe ver, imported electricity poles can be 
treated with any biocidal product. Concrete cases incl ude the imports of wooden 
electricity poles treated with products containing arsenic or chromated copper 
arsenate (CCA).  
There are no statistics available on the am ounts of imported treated materials placed 
on the EU market containing unauthorised  or banned active substances. Even though 
some treated articles may be found in the RAPEX notifications17, it is very difficult 
to identify them as these cases are not put in connection with bi ocidal products. Non-
EU producers represent a non-negligible sh are of the EU mark et with treated 
materials which is estimated at €22.2 billion per year; for example imports amount to 10-20% of the EU market for treated wood a nd 25 to 40% of the EU market for wool 
carpets (5). 
Apart from the possible negative environm ental and human health impacts, this 
situation places in particular the EU produ cers at a disadvantage with respect to the 
                                                
 
17 RAPEX is the EU rapid alert system for all dangerous consumer products, with the exception of food, 
pharmaceutical and medical devices. It  allows for the rapid exchange of information between Member 
States via central contact points  and the Commission of measures taken to prevent or restrict the 
marketing or use of products posing a serious risk to the health and safety of consumers. 
EN 18   EN EU market. This is due to the fact that  EU producers of treated materials can only 
buy authorised biocidal produc ts containing approved active substances as only these 
can be lawfully placed on the EU market. Non-EU producers of tr eated articles do 
not have to bear the costs of  compliance with the Directive and to participate in the 
cost of the evaluation of active substances  and authorisation of biocidal products 
used in the treated materials. This effectively renders the EU producers of treated materials less competitive compared with non-EU producers of these materials. 
2.3.2.  Policy issue 2: Product aut horisation is too complex 
The evaluation of active substances is done at Community level  and the subsequent 
authorisation of products containing the appr oved substances (i.e.: those listed in 
Annex I of the Direc tive) is done at the national level , by Member States. As 
mentioned above, the product authorisati on stage has not yet been implemented. 
Until it is implemented, some Member Stat es operate national product authorisation 
schemes based on their national legislation. However, it should be noted that some 
Member States with high estimated number s of products do not have authorisation 
procedures in place at the moment (e.g. Fran ce, Germany). There are no statistics on 
the lengths of the national proceedings or  the appeal options available to the 
applicants. 
An important element of the Directive is the principle of mutual recognition  of 
authorisations. In accordance with that prin ciple, a company, once it has obtained for 
a product a first authorisation in a Memb er State, may apply for the mutual 
recognition of that first author isation by other Member States. 
As mentioned above, because the product authorisation  has not yet started, no 
practical experience of the authorisati on and mutual recognition procedures is 
available. However, experience from othe r regulatory frameworks such as plant 
protection products (14)
, indicates that some change s might help in anticipating 
future problems.  
Mutual recognition of product au thorisations is considered as the major benefit of the 
Directive. However, stakeholders expre ssed concerns regarding the effective and 
homogenous application of mutual recogniti on. Concerns relate to the difficulty for 
Member States to trust each other's assessment of a dossier, due to divergent interpretation of data requirements, or to  different national approaches regarding the 
level of protection on the nati onal market, resulting in requ ests for additional tests. 
The representatives of the industry expres sed their concerns that some Member 
States may systematically require additional information including testing and repetition of the efficacy st udies for the purposes of the mutual recognition. This 
would render the pr ocess very time and cost intensiv e for the industry as well as for 
the competent authorities which would have  to evaluate the additional information. 
In addition, the negative past experience w ith mutual recognition of Plant Protection 
Products is the basis for thes e concerns. This c oncerns mainly the lack of mutual 
trust among the Member States. An exam ple of a functioning system of mutual 
recognition exists under the Medicinal Produc ts legislation, which has now been in 
operation for more than 10 years. The success there was built gradually on basis of informal cooperation between Member Stat es, the use of guidance documents and 
the experience gained through disagreemen ts concerning the mutual recognition. 
EN 19   EN 2.3.3.  Policy issue 3: Rules for dat a sharing are insufficient 
The Directive provides for a system of da ta protection, which prevents Competent 
Authorities from using data submitted by a first applicant for the benefit of a 
subsequent applicant, unless the first appl icant has agreed to it. This system is 
intended to ensure that data owners can r ecuperate the costs of their investments.  
The Directive urges applicants to co-opera te in compiling the necessary data for the 
evaluation of both active substances and bi ocidal products, but it does not explicitly 
provide for a system of mandatory data sh aring. Instead, the data owner may decide 
– but is not obliged – to give  a subsequent applicant the ri ght to refer to its data by 
granting a 'letter of access' . Whenever an agreement cannot be reached between the 
data owner and the subsequent applicant, th e latter may be either obliged to duplicate 
the studies (particularly unde sirable where animal studies  are concerned), or to 
abandon the market. 
The fact that data sharing is not obligat ory has given rise to  problems for industry 
and competent authorities.  
Data sharing aims at avoiding the submissi on of multiple dossiers for the same active 
substance. This was particularly relevant for the Review Programme, to limit duplication of work and comp lication of the evaluation process. Data sharing aims 
also to avoid the duplication of testing on vertebrate animals. 
Data sharing is primarily relevant for the tests done with the  active substances . The 
issue of data sharing will howev er also arise in relation to biocidal products  as 
dossiers for product authorisation must cont ain data on the active substance. In the 
absence of a mechanism of forced data sh aring, companies unable to obtain a letter 
of access would need to re-generate cert ain key data or abandon the market. 
There is a concern amongst stakeholders that under the existi ng rules manufacturers 
of active substances who are also biocidal product manufacturers would refuse letters 
of access to competing product manufacturers, thus restricting new entrants access to 
the market.  
2.3.4.  Policy issue 4: Data requir ements are too extensive 
The requirements of the Directive in terms of  toxicity and ecotoxicity studies aim at 
guaranteeing a high level of protection fo r human and animal health and for the 
environment and do so effectively.  
These data requirements are however a ma jor burden for companies that intend to 
support active substances. The costs of perf orming all the studies required are high, 
estimated at maximum
 3-5 million EUR (6) , and the active substances would need to 
be marketed over a long time to recover these costs. This has led industry to focus its 
resources on supporting existing active subs tances within the Review Programme 
rather than on the development of new one s; second to abandon its  support of certain 
existing active substances, when there was no prospect of an economic return on the investments to be made. Furthermore, th ese data requirements are perceived as 
excessive for certain substances that are considered to be of low risk. Data waiving is, therefore, a crucial issue, espe cially for very low exposure products. 
EN 20   EN The possibility to waive data requirements is provided for under the Directive. There 
is however no clear guidance on  data waiving and the application of this principle is 
left to the discretion of the Member States , which can lead to different approaches 
and entails the risk of  unequal treatment.  
2.3.5.  Policy issue 5: Fees charged by Member St ates for carrying out the procedures of 
the Directive are high and varying and the conditions for payment are unclear 
The main problem with the cu rrent provisions on fees is that they contribute to the 
heterogenous fee structure and significant di fferences in the levels of fees applied 
currently by Member States. Furthermore, it should be noted that the conditions of 
payment currently also vary among the Member States. 
Varying and high fees 
According to the existing provisions, it is currently the Member States who are 
responsible for deciding on the structur e and level of fees. The Directive only 
requires that the fees correspond as far as  possible to costs in curred by the Member 
States in carrying out all the different procedures associated with the provisions of 
this Directive. Some Member States underst and this in a way that "all procedures 
associated with the implementation of the Directive" shall also include for example 
enforcement. As a consequence, the fees in some Member States may reflect a much wider scope of costs than those linked to the individu al product authorisation 
application. In addition, the rules for setting fees differ significantly. In some Member States, the fee is determined according to a model calculation which takes into account the risk profile  of the product. In others, the risk profile will not be 
considered at all.  
There are differences in the structure and level of fees from one Member State to 
another: fees vary by a factor of more th an 10 for product  authorisation, by almost as 
much for active substance evaluation (Figur e 1) and by a factor of more than 100 for 
mutual recognition (5)
.  
The fee may account for a significant portion  of the total costs of supporting an 
active substance (from 5% to 75%). In dustry has indicated that fees are 
disproportionately high for SMEs and act as  a disincentive to the development of 
new active substances. This may hinder the i nnovation, in particular with respect to 
low risk biocidal products. 
EN 21   EN BE EL DK EE LV DE CY ES SI IE PT FR IT UK SK AT HU FI PL SE LU NL 050100150200250300350400
Member StateFee (Thousand EURO)
(Lines Indicate MS Fee Ranges)
 
Figure 1: Member State Fees and Fee Ranges for Active Substance Evaluation 
It is likely that the main reasons for the di fferences in the level of fee are the national 
attitude to cost recovery. In some Member  States, the competent authorities directly 
finance their activities (and thus their costs) through the f ees. In others, the 
competent authorities receive  a contribution from the national budget independent of 
the fees received.  
The fact that fees differ between Member States might encourage industry to submit 
product dossiers in Member States applyi ng lower fees, leading potentially to an 
overload of work for these Member States  and a loss of re venue for the more 
expensive ones. In practice, the level of fees is, howev er, only one factor in the 
industry choice of which Member State to submit a dossier, others include 
competence, responsiveness and a pproach towards data waiving.  
Unclear conditions for the payment of fees 
There are also variations in the conditions of payment. Some Member States enable 
payment in instalments and reimburse the fee or its part after a negative result of the 
completeness check. Other Member States require an upfront payment and do not 
reimburse the fee or its part if the applic ation does not pass the completeness check. 
This is mainly a problem for SMEs for which paying the enti re fee upfront may 
represent a significant financial burden. 
2.4. It should be noted that the structure of  the fees, the fee levels and the payment 
conditions may have an adverse impact  on the decision as on how many 
countries the company will intend to place its products. This may lead to problems with product availability in count ries with relatively small market and 
high fees. High fees may also have a negative impact on the innovation, in 
particular of SMEs.The pr inciple of subsidiarity 
According to the subsidiarity principle, in  areas which do not fall within its exclusive 
competence, the Community shall take action only if and in so far as the objectives 
of the proposed action cannot be sufficiently achieved by the Member States and can 
EN 22   EN be better achieved by the Community. This prin ciple is of high relevance to all policy 
areas discussed under this impact assessment.  
Currently, the granting of product authorisat ions is in the competence of Member 
States whereas the evaluation of active substances is done  at the Community level. 
With respect to data sharing, Member St ates have currently the possibility to 
introduce national measures obliging th e applicant and hol ders of former 
authorisations located within their territory  to share the data on vertebrate animals. 
The Member States are also currently re sponsible for setting the fees for the 
procedures under the Directive. Any change s to this division of tasks between the 
Commission and the Member St ates would have to comply  with the subsidiarity 
principle. More on the individual policy options and their compatibility with the 
subsidiarity principle can be found in Section 5 (Analysis of impacts). 
3. OBJECTIVES  
The aim of the revision is in line with the Commission's strategic objectives and 
better regulation principles (24) ,(25) ,(26) ,(27) , to improve and make the regulatory 
provisions more effective and efficient,  reducing unnecessary burden for Member 
States and industry whilst maintaining a high level of prot ection of human and 
animal health and the environment. 
The general objective is to review the Directive in order to: 
• Facilitate the harmonisation of the EU market for biocidal products; 
• Continue to provide a hi gh level of protection for humans, animals and the 
environment; 
• Increase the competitiveness of the EU industries affected by this Directive. 
In order to achieve the general object ives and address the different problems 
identified, the following specific objectives  have been established: 
• Ensure coherence of the scope of the Dire ctive, in particular with respect to 
treated materials; 
• Simplify the product authorisation system; 
• Avoid duplication of tests on vertebrate animals and reduce the number of animal 
lives used in the tests; 
• Improve the provisions for low risk bioc idal products in order to encourage 
development of such products; 
• Provide clarifications and increase legal certain ty on waiving of data 
requirements; 
• Improve the proportionality of fees  and clarify payment conditions. 
EN 23   EN 4. POLICY OPTIONS  
4.1. Policy issue 1: Scope 
The policy options presented below are cumula tive. In fact, they look at whether the 
scope should be extended and if so, to what extent, to ensure an overall coherence in 
the approach towards delimiting the scope. Different options are considered including the extension to food processing aids, food cont act materials and treated 
materials. 
4.1.1.  Option (a): Unchanged policy 
In this option only the list of Community legislation men tioned in Article 1 of the 
Directive would be updated to take account of developm ents in other Community 
legislation. This option does not  imply regulatory changes. 
4.1.2.  Option (b): Extend scope to cover pro cessing aids and food contact materials 
This option would imply regulatory change s to include processing aids and food 
contact materials in the scope of the Directive. 
Extension of the scope of the Directive to include food processing aids  could be 
achieved by amending Article 1(2), which a ddresses the interaction with other EU 
legislation and also by amending Annex V, the list and definition of different product 
types. Further provisions may be needed to  incorporate biocides used to remove 
surface contamination of animal carcasses, as these are addressed in Regulation (EC) No 853/2004 (28)
. This would have the objective to coordinate the procedure for 
approval of processing aids other than pot able water under this Regulation with the 
procedures provided for under the Directive. 
Placing on the market of  food contact materials  is not within the scope of the 
Directive under Article 1(2). If surface bi ocides for food contact materials were 
brought under the scope of the Directive,  the question arises  under which product 
types18 they would be evaluated. The most su itable product types seem to be product 
type 7 or 9 (film and plastic preservative s). This is because surface biocides are 
intended to protect the material itself. Assigning food contact materials to product-
type 7 or 9 might reduce the efforts requi red for dossier preparation and evaluation, 
as substances used as surface biocides will have already been assessed for very similar types of use
19. 
4.1.3.  Option (c): Extend scope to cover treated materials 
The option would consist of the adoption of a general obligation that only materials 
treated with biocidal products  authorised under the Directiv e in order to protect the 
material itself could be placed on the EU market. If a company wishes to place on the 
                                                 
18 Biocidal products are classified in 23 product types. These product types are also used at the stage of 
evaluating active substances – active substances are always evaluated for a cer tain product type (e.g. 
carbon dioxide for product type 14 (rodenticides)). 
19 This refers to a situation when an active substan ce used in food contact material has been already 
evaluated under the Biocides Directive, for exampl e for its use as a film preservative in plastics. 
EN 24   EN EU market a material treated with a bioc idal product that has not been previously 
authorised in the EU, a full assessment of that product und er the Directive would be 
required. The US has a system similar to this (7) .  
This option would also require labelling  for all or the most relevant treated materials, 
to facilitate enforcement and to enable informed choices by consumers. Quality labels are already in place for several produc t-types, e.g. ecolabels, national labels of 
industrial organisations and in Sweden and Germany, a system for labelling treated 
wood. Such labelling could follow the approa ch in Article 15 of Regulation (EC) 
1935/2004 (19)
, including:  
– the indication “treated with approved bioc ide” or a symbol illustrating this (one 
would have to be developed for this purpose). 
– the name of the active substance and the number of product authorisation could 
also be included;  
– if necessary, any special instructions to be observed for safe and appropriate use 
and disposal; 
– name or trade name and address of manufact urer, processor, or seller responsible 
for placing the treated material on the market. 
As an alternative, companies placing trea ted materials on the EU market could be 
required to undertake self-cer tification. The self-certifi cation could be modelled on 
the system which exists under the ROHS Directive (21)  . Producers and importers of 
electrical and electronic equipment voluntar ily label their produc ts as not containing 
any of the hazardous substa nces prohibited under the ROHS Directive by using 
material compliance declarations. Alternativ ely, a system of thir d-party certification 
could be envisaged where companies plac ing treated materials on the EU market 
would be required to obtain a ce rtificate from a designated body. 
The option would require Member States to ensure adequate enforcement  of its 
provisions through market surveillance mechan isms so as to ensure that treated 
materials sold in the EU cont ain authorised biocides only. 
4.2. Policy issue 2: Product authorisation 
The policy options concerning the product authorisation as pr esented below are 
alternatives but within them certain elem ents could be combined (e.g. strengthening 
of mutual recognition with Singl e Member State authorisation or strengthening of 
mutual recognition with Co mmunity authorisation). 
Mutual recognition as it exists today coul d provide significant benefits by enabling 
biocidal products to be sold  in all Member States without  the need for re-formulation 
and at lower costs than seeking separate  authorisation in each Member State. 
The options presented below provide solutions for the problems outlined in section 
2.3.2. In addition, they aim to provide incentiv es for innovation directed at low risk 
biocidal products and products based on new active substances. 
EN 25   EN 4.2.1.  Option (a): Unchanged policy 
In this option, the Commission would contin ue to facilitate mutual recognition by 
providing support to the informal group, composed of Member States 
representatives. This group has been set up to provide a forum to discuss general 
issues of mutual recognition, to devel op guidance documents on mutual recognition 
and to discuss specific products that could be considered problematic during mutual 
recognition procedures. This option doe s not imply regulatory changes. 
4.2.2.  Option (b): Strengthening  of mutual recognition 
This option would include regulatory change s to clarify and improve the provisions 
on mutual recognition and on conflic t resolution in particular.  
Mutual recognition would be improved in two ways:(1) Applicants could submit in 
parallel the application for the first author isation and the application for the mutual 
recognition of that first aut horisation. This would allow th e different Member States 
concerned to interact during the assessment of the dossier by the Reference Member 
State and would thus streamline and facilit ate the process of mutual recognition. (2) 
Member States could take th e initiative to laun ch a mutual recognition procedure, 
when they receive an application for the au thorisation of a produc t already authorised 
in another Member State. In that case, the second Member State would not assess the 
application and would wait to receive the as sessment report of the first Member State 
before granting the authorisation on the ba sis of the conclusions of that assessment 
report. 
These modifications are based on sim ilar provisions under other Community 
legislation (12) ,(13) ,(14) . At present, neither is possible. 
4.2.3.  Option (c): Single Member State authorisation 
A biocidal product authorised in one Member  State could be placed on the entire EU 
market, without the need for any furthe r administrative pro cedures, other than 
complying with labelling rules. 
The system would include a clause sta ting that Member States may object to 
authorisation within a certain time peri od. The conditions for objections would be 
described in a detailed and clear way. Objections would be notified to the 
Commission and dealt with in the Standing Committee. 
If there are no objections and the product is  authorised, the applicant would then 
notify any other Member State that it wish es to market the product, and submit a 
proposed label, packaging and safety data sh eet for approval (i.e. in particular, in the 
national language). 
During stakeholders' consultation, Memb er States opposed this system on the 
grounds that it reduces the role of the indivi dual Member States in the authorisation 
process. To take accoun t of it, this option c ould work as part of a dual system: certain 
categories of biocidal products would rece ive single Member State authorisation, 
while others would go through Member Stat e authorisation and mutual recognition 
(options (a) and (b)). 
EN 26   EN 4.2.4.  Option (d): Community authorisation 
Community authorisation, directly valid in the 27 EU Member States, would be 
issued at the Community level. 
A specific procedure for product authorisation would be created, carried out either by 
a central agency or modelled on the curren t procedure for the assessment of active 
substances. As no central agency exists unde r the current Directiv e, the role would 
have to be given to an existing agency set up under other Community legislation. The 
agency would be involved in the risk as sessment of biocidal products either by 
preparing the assessment or giving an opinion on the Rapporteur Member State 
assessment. 
Some stakeholders, in particular represen tatives of the industry, expressed a support 
for a fully centralised system of Community authorisations applicable to all biocidal 
products. This option was initially consider ed but due to the following reasons not 
further pursued: 
– the operation of a fully centralised syst em of Community authorisations would 
require significant financ ial and human resources (e .g. operative costs of the 
Agency, costs of organising the meetings of experts, etc.) 
– the total number of biocidal product s is high – between 4.500 to 9000 products20 – 
and all of them would have to pass th rough the centralised system in a limited 
time (around 10 years) after the en try into force of the proposal; 
– the sensitivity of some Member States with  regards to the aut horisation of certain 
product types (e.g. disinfect ancts) should be taken into consideration.  
As a complete centralisation may not be possible due to the above-stated reasons, a 
partial centralisation could be propos ed for just two types of products: 
(1) Biocidal products base d on new active substances; 
(2) Low risk biocidal products, potentially without a prior active substance approval  
– this will also need to in clude a screening phase to assess whether the products 
submitted do indeed match specified criter ia for low risk (see section 4.4.3). 
This option could also work as part of a dual system : certain categories of biocidal 
products (low risk products and products  based on new active substances) would 
receive Community authorisation, while others would go through Member State 
authorisation and mutual rec ognition (options (a) and (b)).  This option would include 
measures aimed at increasing the efficiency  of the mutual recognition system. This 
would maintain the current role of Member States w ith respect to the product 
authorisation in accordance with the subsidiarity principle.  
                                                 
20 This number is an estimate provided in the RPA Report. On the basis of stakeholder consultation, the 
total number of biocidal products may be higher as some Member States, in particular Germany, report 
a total number of 18.000 biocidal products. This number may, however, contain many duplicate entries. 
In addition, it is expected that the market will consolidate after the end of the Review Programme. 
EN 27   EN It should be noted that the Community au thorisation scheme would be optional – 
companies would have a choice to go thr ough the Community authorisation system 
or apply for an individual Member Stat e authorisation. The latter may be more 
interesting for companies which want to market their products only in a limited number of Member States. 
4.3. Policy issue 3: Data sharing 
The policy options presented below are mutually exclusive. They all address the 
same problem and offer different solutions to it. 
4.3.1.  Option (a): Unchanged policy 
The current system of voluntary data shari ng at the product author isation stage, with 
the possibility for Member States to intr oduce rules requiring mandatory sharing at 
national level, would be maintained. It is  foreseen to clarify the requirements and 
further encourage data sharing. These impr ovements would not re sult in changes to 
the current policy on data sharing. 
4.3.2.  Option (b): Mandatory sharing of verte brate animal test data at product 
authorisation stage 
This option would make the sharing of (and compensation for) vertebrate animal test 
data mandatory at the product authorisation  level. A company requesting a product 
authorisation would be re quired to contact the Competent Authority to get a 
permission to carry out the tests or to fi nd out who holds the data before undertaking 
any animal testing. 
Applying the "REACH model"
21, the Competent Authorities would inform the 
applicant of the names and addresses of the company which previously carried out 
any relevant studies which are still protecte d by data protection provisions. To ensure 
that data sharing works properl y, a centralised inventory of  studies could be set up by 
the Commission, along the lines envisaged und er REACH, to ensu re that all the 
information needed is accessible. Wher e a study involving tests on vertebrate 
animals has been carried out while they were still protecte d by data protection 
provisions, the applicant would be required to request from the previous company the 
information he needs in order to make its  application for authorisation. The data 
holder would then have to share its data with the applicant, with an effective 
compensation procedure for the costs to be shared on a fair and transparent basis.  
A clause on dispute resolution by arbitrat ion would also be added. The provision 
could indicate that the data holder and the applicants shall “make every effort to reach an agreement” on the sharing of the information requested by the potential applicant(s), or the issue may be submitted to arbitration. They shall also “make 
every effort to ensure that the costs of sharing the information are determined in a 
fair, transparent and non-discriminatory way”. If there is a failure to reach an agreement, the potential applicant(s) w ould inform the Commission/Agency, which 
                                                
 
21 See Title III of the REACH Regulation (EC) No 19 07/2006 – obligatory data sharing of vertebrate 
animal data in exchange of compensation and equal sharing as default compensation mechanism in case 
of disagreement 
EN 28   EN would have the ability to give the applic ant the authorisation to use the data upon 
payment of a share of the cost s (this would be subject to the possibility of appeal). 
4.3.3.  Option (c): Mandatory sharing of ver tebrate animal test data at product 
authorisation stage and active substance approval stage 
The obligation to share data would be expanded to cover the evaluation of active 
substances as well as the product authorisation stage . This would mean that if an 
applicant for example wished to apply for an  inclusion of a subs tance in Annex I for 
a new product type, he/she would be able to obtain the data from the previous 
applicant in exchange for compensation. Th e procedure could be similar to that 
outlined for the sharing of data at the pr oduct authorisation stage (see Option b)). 
In order to stimulate innovation and en courage companies to invest in the 
development of better and safer chemicals an exception might be proposed for new active substances where for the first 10 y ears (out of 15) of data protection, the 
sharing of vertebrate animal tests w ould be voluntary and not compulsory.  
4.4. Policy issue 4: Data requirements 
The three policy options presented below are cumulative. The options address two 
types of problems: high data requiremen ts and low attractiveness of the existing 
simplified procedures, in particular Annex IA (low risk substances) and Annex IB 
(basic substances). 
4.4.1.  Option (a): Unchanged policy 
This option retains the existing provisions and the current system. As part of the 
business as usual approach, the wording of the Directive w ould be made more 
precise, to clarify the concept of waiving in order to avoid obstacles linked to the 
existing uncertainties. It is important to not e that these clarifica tions would not entail 
changes to the current policy on data waiving. 
It is also foreseen to prepare detailed a ppropriate guidance in the form of Notes for 
Guidance, published in the Official Journal.  
4.4.2.  Option (b): Rewording provisions concer ning data waiving and the use of existing 
information 
It should be noted that the measures  proposed below have similar objectives; 
however, they look at the issues from different angles. There are strong links 
between the different measures (e.g. revisi ng the core/additional data may lead to 
tiered data requirements). 
Strengthen data waiving provisions
: this option proposes to take into consideration 
the waiving grounds set out in Article 13 of REACH in the biocides methodology. The REACH text contains in Annex XI fu rther guidance on the application of the 
waiving provisions, which coul d be used to provide higher certainty with regard to 
the interpretation of the waiving provisi ons in the Directive. This could be 
complemented by the use of official and more binding implementing rules.  
EN 29   EN An obligation for Member States could be incl uded to inform applicants of their right 
to request a waiver includi ng the grounds for such a waiv er and provide assistance to 
applicants in this respect. These change s would significantly modify the current 
policy approach towards data waiving. 
Revise the proportion of core data/additional data : for the evaluation of an active 
substance under existing provisions the a pplicant is required to submit a dossier 
satisfying the requirements of Annex IIA (cor e data which are identical for all active 
substances) and, where specified, the releva nt parts of Annex IIIA (additional data). 
All data (core and additional data requirements) can be waived if appropriate justification is provided. However, some Memb er States have been reluctant to waive 
core data arguing that this data is core data and, therefore has to be submitted in all cases. This situation could be clarified by renaming Anne x IIA and IIIA, specifying 
that waiving provisions are applicable to all data requirements or moving some core 
data to the additional data. In additi on, the core data set could be thoroughly 
reviewed and data requirements could be tiered as below. 
Use of existing information
: more guidance on the possibility of using, where 
available, existing information (e.g. test s and studies devel oped under other legal 
frameworks) could be considered. This is  similar to REACH, which also provides 
guidance on how to evaluate the informati on in terms of validity and reliability. The 
use of existing information could be extende d by including a clause in the Directive 
stating that assessments carried out under other Community legislation shall be taken 
into account, where such legislation appr opriately covers the objectives of the 
Directive. In addition, data requirements  for product authorisa tion could also be 
reduced where the product has already been authorised unde r other Community 
legislation (with similar exposure scenario s and analysis of risks). The assessment 
carried out within the framework of the Dire ctive could then be limited to aspects not 
assessed under these other pieces of le gislation e.g. exposur e and efficiency.  
Tiered data requirements : using tiered data requiremen ts would mean that only a 
limited set of data would be required upfront. If remaini ng concerns justify it, the 
competent authorities would be  allowed to request additiona l data from the applicant. 
It might also be possible to link data re quirements specifically to product-type; this 
would mean that product-types associat ed with use patterns which involve only 
reduced exposure would benefit from reduced  data requirements. This would allow a 
more systematic data waiving or a tiered approach in determining the data set.  
4.4.3.  Option (c): Reformulating the system for low-risk substances 
The key issue in revising the concept of lo w-risk substances is to define such 
substances. This may prove difficult as, while  various substances could be potentially 
considered low risk, in fact, risk al ways depends on the product formulation, 
exposure and use conditions, which are difficu lt to assess at the substance level 
alone. Around 50 biocidal active substances supported so far unde r the Directive are 
included in positive lists under other legislation22, which are considered to indicate 
low risk.  
                                                 
22 For example substances included in Annex IV and V of REACH Regulation (EC) No 1907/2006, US 
GRAS List, US minimum risk pesticides, etc. 
EN 30   EN Substances could be identified as being low-risk ba sed on expert judgment (e.g. 
standing expert group) or available inform ation (such as in Annex IV or V of 
REACH). For these substances, a simple no tification of placing on the market would 
suffice.  
Alternatively, the definition of low-risk biocidal products would be introduced in 
combination with a direct authorisation of these pr oducts without their active 
substances being previously approved at EU level. This would avoid some of the 
major costs linked to the active substan ce approval and would make qualifying for 
low risk status much more attractive. A screening stage would be needed, whereby a 
rapid decision would be taken at the Comm unity level on whether the product would 
be eligible as a low risk product. The sc reening process could be organised by the 
Agency which would decide on whether a c oncrete product qualif ies as a low risk 
biocidal product. The final approval of the low risk products could either be made at 
the EU level (centralised procedure) or at the national level. In that latter case, mutual recognition could be appl ied to national authorisations. 
4.5. Policy issue 5: Fees charged by Member States for carrying out the procedures 
of the Directive 
The policy options set out below are alternat ives but within them certain elements 
could be combined (e.g. harmonised fee st ructure with specific provisions for 
SMEs). In particular, the last option (S pecific provisions for SMEs) is a rather 
horizontal option which can be combined  with any system of setting fees. 
4.5.1.  Option (a): Unchanged policy  
Under this option, the current system, with fees and conditions set at Member State 
level, would be retained with minor clarif ications of the payment conditions, such as 
the timing of payment. 
4.5.2.  Option (b): Partially harmonised fee structure 
This option would involve the partial harmonisation of fee structures in the Member 
States; Member States would remain free to set the level of fees, but the structure of 
fees would be mandatory. Three aspects of  such a partial harmonisation have been 
considered in more details: (a) reduced f ees for multiple submissions; (b) variation in 
fees by product-type; (c) payment by instalments. 
Reduced fees for multiple submissions:
 the full fee would be charged for the first 
product-type only, with a reduced fee for a ll subsequent product-types for the same 
active substance. Those Member States that  already apply reductions for subsequent 
product-types apply discounts of approximately  30% on average, of  their initial fee 
(9). In addition, lower fees could also be se t for simplified or "accelerated" reviews 
of similar authorisation cases, such as  re-authorisation a nd minor changes in 
composition, as well as for low-risk products.  
Variation in fees by product-type  could be introduced if different data requirements 
for different product-types were adopted, to reflect the level of analysis needed. It 
could also be used to encourage the deve lopment of products, or active substances, 
that are low risk or where there is a s hortage of products/subs tances on the market.  
EN 31   EN Instalment system for payments  to spread the costs for industry over the period of the 
evaluation procedure, with a separate fee levied for a completeness check. This 
might consist of charging a part of the fee at the beginning and the rest of the fee at 
the end of the process. It could also be specified that any unused fees, paid in 
advance, should be retu rned to the company if an eval uation could not be finalised. 
For example, if an application does not  pass the completeness check and is not 
evaluated, the fees for dossier  evaluation would be repaid.  
4.5.3.  Option (c): Centralised fee system 
In this option, the standard  fees would be set at th e EU level by specifying the 
amount of fees to be charged by Member St ates or by levying th e fees centr ally and 
refunding Member States for the actual work  they have carried out. It should be 
noted that the Member States were opposed to such system on grounds of subsidiarity principle. The fees provide d for under the REACH Regulation are set out 
by Commission Regulation (EC) No 340/2008 (15)
 and this Regulation applies to all 
Member States and may therefore provide a possible indicator of standard fees under 
the Directive.  
4.5.4.  Option (d): Specific pr ovisions for SMEs 
Reduced fees could be charged for SMEs, si nce high fees are more  often an obstacle 
for SMEs to support substances or to keep their products on the market. Such fee reductions are offered by REACH: 30% for medium companies; 60% for small sized 
companies; and 90% for micro enterprises. 
Another possibility is to introduce reduc tions on annual fees as is done in the 
legislation on medicinal products for pr oducts authorised by the Community. The 
annual fee would apply during the validity of the product au thorisation. SMEs would 
then be eligible for a reduction of the annual fee. 
4.6. Options discarded at an early stage 
It should be noted that some policy options were discarded at an early stage of the 
impact assessment process.  
Firstly, the option to repeal the Directiv e and place all biocidal products under the 
REACH Regulation or the Plant Protecti on Products Directive was not pursued 
further. This is mainly due to the fact th at the Directive is a specialised legal act, 
adapted to the needs of this particular  sector. For example the tiered tonnage 
approaches of the REACH Regulation are not well-suited to biocides, where some of 
the most dangerous products (e.g. rodenticides) may be produced using small quantities of the active subs tance. In addition, there wa s no support for these options 
from either the stakeholders or the Member States. 
Secondly, the option to reduce (and combine)  different product types was looked at 
in context of the product authorisation. However, the classification according to 
products types has an important impact on the evaluation of the active substance. As the Review Programme for the evaluation of  existing active subs tances is ongoing, it 
was deemed too late to real istically pursue this option. 
EN 32   EN The issue of the use phase of biocides was br iefly considered in the initial stages of 
the impact assessment. However, it was found that the issue of the use phase of biocides was not significant when taken in the overall context of  the revision of the 
Directive. It was therefore decided not to pursue this further in the framework of this impact assessment.  
5. A
NALYSIS OF IMPACTS  
It should be noted that the policy opti ons in the five polic y areas are largely 
compatible from the perspective of an overall policy package. For example, it would be possible to combine mandatory sharing of vertebrate animal test data at the product authorisation stage with uncha nged policy on data requirements or a 
centralised fee system with unchanged  policy on product aut horisation. The only 
exception is the combination of a fully cen tralised authorisation scheme with an 
unchanged policy on fees (Member States being completely responsible for the fee structure, the levels of fees and the pa yment conditions) or partially harmonised fee 
structure. A fully centralised authorisati on scheme would require  a centralised fee 
system in which the fee structure, the levels of fees and the payment conditions are decided at Community level. An example for this is the REACH system operated 
with help of the European Chemicals Agency where the fees were set by means of Commission Regulation (EC) No 340/2008 on the fees and charges payable to the 
European Chemicals Agency pursuant to the REACH Regulation.  
Despite the fact that the policy options in all five areas are largely compatible, their 
simultaneous implementation may have impact on the costs and cost savings. For example, the above-cited combinati on of an unchanged policy on product 
authorisation and a centralised fee system may result into difficulties for some Member States. As the fees would be determ ined for all Member States centrally at 
the Community level, some Member States wo uld be faced with a situation that their 
costs of evaluating a product authorisation application are not fully covered by 
revenues from the fees. On the other hand, in  other Member States the revenue from 
fees may outweigh the costs of the application evaluation. For companies this would 
mean that they would have to pay more  than necessary to review their product 
authorisation application. 
Due to the lack of data it is not possible to include in the impact assessment 
information concerning impacts on various type s of affected part ies (big companies 
versus SMEs, substance producers versus product manufacturers) and to show how 
benefits/costs evolve over time. 
It was not possible to quantify the impacts on employment due to the lack of basic 
market data on the biocides sector. 
5.1. Policy issue 1: Scope 
The three options introduced with respect to the scope of the Directive concern the 
question as to whether additional products s hould be included within its scope or not. 
5.1.1.  Costs and benefits of Option (a): Unchanged policy 
This option implies no additional costs and no significant benefits. 
EN 33   EN 5.1.2.  Costs and benefits of Option (b): Extend scope to cover processing aids and food 
contact materials 
Including biocides used as food processi ng aids within the scope of the Directive  
would give rise to administrative costs  for industry in prepari ng applications for the 
authorisation of about 3-7 active substances and an unkn own number of biocidal 
products used as food processing aids, as we ll as the costs of the mutual recognition 
of these products. The costs for industry  could range from €4.5 million to €35 
million23 for the inclusion of active substances  and from €5 million to €51 
million24 for the authorisation of biocidal products , depending on the assumptions 
adopted. These costs would be incurred ove r a longer period of time necessary for 
the implementation of such provisions (ar ound 10 years). For the inclusion of active 
substances, the figures are based on two scenarios with respectively 3 and 7 active 
substances to be supported for inclusion. Fo r the authorisation of biocidal products, 
two scenarios were developed for 42 and 196 additional biocidal products to be 
authorised.  
Competent authorities will face administrative costs  for the assessment of 
applications for active subs tance evaluation and product au thorisation combined with 
mutual recognition, where appropriate. They  will not face any net costs, however, 
assuming that the level of f ees they charge are sufficient to meet their costs.  
On the other hand, bringing food processing  aids under the Directive may provide a  
benefit of a greater regulatory certainty  to industry . It is also likely to bring about 
some environmental benefits , due to increased contro l of processing aids and 
possibly a reduction in their use or a shif t towards lower risk products and uses. 
However, a quantification is not possible du e to uncertainty about the risk profile of 
the aids and actual responses to the proposed policy change. 
Including biocides used in food co ntact materials within the Directive  would 
require inclusion in Annex I of the Directiv e of the active substances they contain; 
this could cost industry a range from  €5 million to €50 million25 for the inclusion 
of active substances , depending on the assumptions adopted, and from €8.3 million 
to €73 million26 in biocidal product authorisation spread over a period of 10 
years . The costs of active substance inclusions  are based on two scenarios with 5 and 
10 substances to be included. For product authorisations, the costs are based on 70 
and 280 additional biocidal products to be authorised. 
5.1.3.  Costs and benefits of Option (c): Exte nd scope to cover treated materials 
The cost and benefit evaluation focused on two types of treated materials: water-
based paints containing in- can preservatives and treate d wood. These sectors were 
chosen because they have quite different  characteristics and thus the analysis 
provided a broad range of potential impacts.  
                                                 
23 Net present value €3.8 million to € 29.3 million disc ounted to the start of the period using 4% discount 
rate. 
24 Net present value €4.1 million to €42.7 million 
25 Net present value € 4.2 million to € 41.9 million 
26 Net present value € 6.9 million to € 61.2 million 
EN 34   EN The total costs of the inclusion of additi onal active substances for importers27 of 
all treated materials would be in a range between €36 million and €140 million28 
spread over a period of 10 years . These costs depend on the number of additional 
active substances to be included in Annex I and the average cost of Annex I inclusion 
per substance (between €3 and 5 million). 
The total costs of authorisation of bioc idal products for imported treated 
materials  would be in a range from €3.6 million to €52 million29 spread over a 
period of 10 years . The costs depend on the number of biocidal products applying 
for product authorisation and the average costs of the authorisation (between €90,000 
and €200,000). In practice, switching to biocid al products that are already authorised 
under the Directive may be a less costly  option for concerned third-country 
producers. This would also mean that the trade implications would be minimal. 
However, it should be stressed that the cost is rather low when compared to the value 
of the sales. For example, the costs of  Annex I inclusion of additional active 
substances with regard to imported water-based paints are 0,5 to 1,7% of the value 
of imported paints spread over 10 years . For imported treated wood, these costs 
would reach 0,8 to 2,1% of the value of imported timber spread over 10 years . 
Similarly, the costs of the authorisation of additional biocidal products would be 0,04 
to 0,15% of the value of imported water-based paints spread over 10 years  and 
0,1 to 2,4% of the value of impo rted timber spread over 10 years .  
This option would also pose costs to both importers and EU  manufacturers for 
labelling of treated materials. The total costs of labelling could range from €154 
million to €514 million30 for all treated materials (5) . The costs would be incurred 
over a period of 10 years to allow for the implementation of these provisions. These 
costs represent 0.07 to 0,23% of the estimated total market turnover of all 
treated materials placed on the ma rket in the EU spread over 10 years (5). An 
alternative to labelling w ould be self-certification, wh ich would impose lesser costs 
for industry but would genera te lesser consumer benef its and could make market 
surveillance more costly and difficult.  
It will also imply additional costs with regard to ensuring that only authorised 
biocidal products are used; and some additional costs to the  Commission and 
Competent Authorities , in relation to additional produc t authorisations  as well as 
the need to train customs officials to ensure understanding of the enforcement issues such as the new labelling requirements as well as the product identification and testing.  
Extending the scope of the Directive to include treated materials will imply benefits 
to EU industry  in the creation of a level pl aying field with third-country 
manufacturers of treated materials. This ma y in particular improve the position of EU 
industry on the EU market with treated wood (imports  amount to 10-20% of the 
market) and wool carpet (imports amount to 25-45% of the market). This may also 
                                                
 
27 As mentioned in Section 3.2.1.3, EU manufacturers of treated materials already use only authorised 
biocidal products. 
28 Net present value € 30.2 million to € 117.3 million 
29 Net present value € 3.0 million to € 43.6 million 
30 Net present value € 129.0 million to € 430.1 million 
EN 35   EN improve the situation of SMEs, which pr oduce and place treated materials on the EU 
market. 
By ensuring that all active substances and biocidal products in treated materials are 
subject to strict testing and authorisation procedures, this option is expected to have 
potentially significant benefits in terms of the health and environmental impact  
of materials placed on the EU market. The environmental and human health impacts 
are likely to be significant given the size of  the market with treated materials in the 
EU. The environmental and heal th benefits are, however, difficult to quantify due to 
missing evidence linking the use of biocidal products to quantifie d impacts on health 
and the environment. However, some anecdot al evidence on the benefits is available. 
This evidence mainly concerns imported pr oducts such as treated wood or treated 
textiles which contained unauthorised substa nces. The exposure to these substances 
can lead to severe allergic reactions, in pa rticular in cases of old people, children, 
people with reduced immunity system , etc. The consequences include 
hospitalisation, the costs of medical treatment,  the costs of missed days at work, etc. 
Environmental impacts include leaching of  such hazardous substances to soil and 
groundwater, impacts on aquatic organi sms and the local ecosystems.  
In addition, it would also provide for an impr oved protection of wo rkers' health with 
respect to intermedia te goods (e.g. leather used for th e production of textiles or wood 
used for furniture) and allow consumers to make informed choices. 
5.2. Policy issue 2: Product Authorisation 
5.2.1.  Costs and benefits of Option (a): Unchanged policy  
Compared to the current situation,  this option imposes negligible administrative 
costs on the Commission, Competent Authorities and possibly selected industry  
representatives in terms of organising additional meetings to prepare guidance 
documents and discussing specific product issues.  
Under current legal framework, the overall administrative costs of product 
authorisation to the indus try would be € 2.9 billion31 spread over a period of 10 
years.  These costs are based mainly on the number of products, the frequency of 
mutual recognition and the rate of referral to the Commission in case of disagreement 
about the mutual recognition. These costs are based on the assumption that Member States may require additional information during mutual recogniti on. In addition, it 
assumes that companies intend to place their products on a high number of markets. In reality, companies may choose to limit th e number of markets in which they are 
active. 
The most important costs would be those of the current situation and would be 
associated with possible delays and even a failu re of the mutual recognition 
process . The failure of mutual recognition is likely to be particularly problematic for 
SMEs which cannot afford the costs of add itional full product authorisation fees if 
they intend to market their products in more  than one Member State. However, as the 
overall market for biocidal products is unlik ely to change signif icantly, market losses 
for some companies will be balanced by gains for others.  
                                                
 
31 Net present value € 2.4 billion 
EN 36   EN The costs of mutual recognition to Member States are assumed to be covered by the 
fees charged. However, there is a risk that some Member States could face an 
overload of dossiers for review, resulting in  delays in authorisation decisions. The 
failure of mutual recognition could result in reduced product availability  in 
some Member States with smaller markets. 
The costs of this baseline scenario depe nd on the number of products, which will be 
authorised via mutual recognition, and th e number of cases where Member States 
will not be able to agree and where the matter will have to be referred to the Community level for settlement. For this base line scenario, it has been assumed that 
between 10 and 50% of all products would be  authorised via mutual recognition and 
that the rate of referral would be 30%. 
5.2.2.  Costs and benefits of Option (b): Strengthening of mutual recognition 
Under this op tion both the Commission and Competent Authorities will face 
direct costs  associated to facilitating the proces s of mutual recognition similarly to 
Option (a). 
For Competent Authorities  in charge of product do ssiers, this option may pose 
additional administrative costs  for co-ordination  with other Member States. This 
cost may fall disproportionately on a sm all number of “res pected” Competent 
Authorities. This cost coul d be compensated for by an in crease in the fee payable to 
the authority in charge of the dossier assessment. By reducing the administrative costs of product authorisation, this opti on may encourage industry to increase the 
number of products that it places on the market, and/or to place each product on a 
larger number of markets. It could also  result in a larger number of products 
remaining on the market. 
Improving and strengthening the mutual recognition  procedure should create greater 
legal certainty. The total administrative costs to industry  under Option (b) are 
estimated at € 2.2 billion
32 spread over a period of 10 years . They are at around 
75% of those of Option (a)  (see Table 1). The costs depe nd, as for Option (a) on the 
number of products, which will be authoris ed via mutual recognition, and the number 
of cases where Member States will not be  able to agree and where the matter will 
have to be referred to the Community level for settlement. For this scenario, it has been assumed that between 30 and 70% of  all products would be authorised via 
mutual recognition and that the rate of referral would be 10%. 
Table 1 compares the costs expressed in percentages to  industry of the different 
product authorisation options. 
                                                
 
32 Net present value € 1.8 billion 
EN 37   EN Table 1 
Costs of authorisation to Industry
(Relative costs compared to current regime)
0102030405060708090100
Current regime Improving MR Single MS authorisation Community authorisation
 
5.2.3.  Costs and benefits of Option (c): Single Member State authorisation 
A single Member State authorisation, where  a biocidal product authorised in one 
Member State could be placed freely on the EU market, would reduce costs for industry because only a single application for authorisation would be needed. The 
total administrative costs  of this option to the industry are estimated at € 1 
billion
33 spread over a period of 10 years . The administrative costs would be 
below 40% of those of Option (a)  (see table 1); the redu ction in costs would be 
particularly significant for SMEs placing products on several Memb er State markets. 
The costs again depend mainly on the rate  of referral of a pplications to the 
Community level, which has been esti mated at 10% of all applications. 
The option should also significantly reduce costs to  Competent Authorities as only 
one Member State would review the dossier. However, there is  a risk that due to easy 
access some Member States will experience a high number of applications leading to 
potential problems with resources and po ssibly delays. Other Member States may 
receive few applications, generating insufficient revenue from fees to retain the necessary expertise in dossier  assessment. This option c ould imply a high number of 
objections from the other Member States wh ich have not assesse d the dossier, which 
would increase the administrative costs  for dispute resolution. These costs would not 
be covered by product authorisation fees.  
A single Member State authorisation should not result in any impacts on  public 
health , as the data requirements would not change. However, a number of Member 
States have expressed concerns that assessment by one Competent Authority only 
                                                
 
33 Net present value € 0.84 billion 
EN 38   EN might not take full account of potential hea lth and environmental impacts across the 
EU.  
5.2.4.  Costs and benefits of Option (d): Community authorisation 
A system of Community authorisation fo r product authorisa tion would require  the 
role to be given to an existing agency set up under other Community legislation. The 
agency would require 100-150 staff, with operating costs of €18 million to €20 
million34 per year , which would be in part recove red in fees. For comparison, the 
European Chemicals Agency (ECHA) is expected to have around 450 staff and the budget of €90million per year. The Europe an Agency for the Evaluation of 
Medicinal Products (EMEA) operates with 500 members of staff and an annual 
budget of more than € 160 million (23)
. 
There would be a net saving in costs to public authorities, because of reduced 
duplication of work. The costs to industry  would be similar to the costs of a single 
Member State authorisation, at € 1 billion spread over a period of 10 years35, and 
at less than 40% of the costs of Option (a)  (see table 1).  
A system of Community authorisation woul d likely improve the product availability 
as the costs of the Community authorisat ion would be lower than the costs of 
Member State authorisations combined w ith the costs for the mutual recognition. 
There could be additional benefits to health and the environment  as the assessment 
by a central authority would im prove the overall consistency.  
However, as explained above (see s ections 4.2.3 and 4.2.4) both a Community 
authorisation and a single Member State authorisation scheme on its own are 
unlikely to be supported by the Member States.  
A dual system  could however be applied in whic h only certain products would be 
eligible for a Community authorisation. The rest of the pr oducts would obtain a 
Member State authorisation and could go th rough a mutual rec ognition process if 
there is an interest to market them in more than one Member State. Such a dual 
system would better reflect th e principle of subsidiarity  by maintaining the role of 
Member States with respect to the product authorisation of a majority of products.  
Compared to Option d) and a full centralis ation, such a dual system would not offer 
the same magnitude of efficiency gains to the costs of industry as only certain categories of products would pass through th e centralised system. However, it would 
provide some efficiency gains compared to Option a) . The efficiency gains would 
stem from the different measures desc ribed under Option b) aimed to improve 
mutual recognition and the centralised Community authorisation for certain 
categories of products under Option d). Th e functioning of the dual system could 
however be revised after a certain period and additional products potentially included in the Community authorisation system. 
                                                
 
34 Net present value € 15.1 million to €16.8 million 
35 Net present value € 0.8 billion 
EN 39   EN 5.3. Policy issue 3: Data sharing 
The main scope for data sharing is likel y to be between applicants for product 
authorisation and holders of data on the active substance(s) contained within the 
product. Most stakeholders who were cons ulted believed that data sharing would 
work reasonably well, although so me concerns were expressed. 
The three options presented below addre ss the problem related to high costs of 
compiling a dossier, in particular the dos sier on the active substance, and the 
objective of reducing vert ebrate animal testing. 
5.3.1.  Costs and benefits of Option (a): Unchanged policy  
There will be some cost savings to applicants  for product authorisation through a 
basic functioning of mutual recognition.  
Developing improved guidance on data sharing would incur some limited costs for 
the Commission services and Member States . However, the data sharing guidance 
under the Directive could draw upon the gui dance prepared for REACH and for the 
proposed Regulation on Plan t Protection Products (22) . 
There would also be additional costs to  Competent Authorities  in setting up and 
maintaining registers of test and study re ports for active substances. These costs 
would be offset by reduced duplication of assessment. There are no data available at present to estimate the scale of these benefits  to public authorities . However, the 
impact assessment on the proposed Plant Protection Products Regulation (16)
 
identified significant potential reductions  in staff days needed per application 
through data sharing. 
Increased data sharing could also help to  ensure that a larger number of products 
remains on the market and reduce the numbers of vertebrate animal tests carried out. 
There would also be benefits to data holders , who would gain some return on their 
costs for data generation. 
5.3.2.  Costs and benefits of Option (b): Mandatory sharing of vertebrate animal test data at 
product authorisation stage 
Mandatory sharing of vertebrate animal test  data at the product authorisation stage 
could save applicants costs in the ra nge from €675 millio n to €2.6 billion36 
spread over a period of 10 ye ars compared to Option a)37. The savings depend on 
the number of submitted product authorisation dossiers, the average number of active 
substances per dossier, the number of data se ts needed, the percentage of vertebrate 
animal tests required to be repeated, and total costs of data sharing. These savings 
could be reduced, however, if the REACH ap proach of sharing costs equally as a 
default option in cases of disagreements was adopted.  
                                                 
36 Net present value € 565.6 million to € 2.2 billion 
37 It should be noted that cost savi ngs in such scale are unlikely to ma terialise because they are based on 
the assumption that under the existing framework th e companies would regenerate parts of the data 
package. In reality, many companie s, particular SMEs, would be unab le to face such costs and would 
stop marketing their products in the EU. 
EN 40   EN There could also be benefits to public authorities  from data sharing, because they 
would not have to review new data sets. There are no data available at present to 
estimate the scale of these benefits, but th ey should be greater than for Option a) 
because of the obligatory nature of data sharing in Option b). 
Furthermore, it would become easier to exte nd the inclusions of an active substance 
in Annex I to additional product types because  the data sharing would facilitate the 
access to existing vertebrate animal data on the active substance. Mandatory data sharing could also help to ensure that a higher number of safer products remain on 
the market, with potential benefits for health and the environment. It will also prevent duplication of vertebrate animal tests at the product authorisation stage, which would result in a reduction of the numbers of vertebrate animals required 
for repeated tests between 450,000 and 844,000 animals over a period of 10 
years . Thus, a great number of animal lives  could be saved by this Option. 
This option could have a potential cost for some applicants  under the default for 
cost sharing, if it resulted in a requirement  to pay for access to data up-front, rather 
than over a period of time through long-term  supply contracts. If this happened, it 
could be particularly problematic for SM Es, which generally have fewer resources 
available for up-front payments. However, as  the option encourages data owners and 
applicants to reach agreement on cost sh aring, it should be possible for “staged” 
payment of this type to continue.  
There could also be some costs to those involved in pl acing biocidal products on 
the market  if data sharing led to an increased number of products on the market and, 
in particular, an increased market share for generic products. The impact assessment 
for the proposed Plant Prot ection Products Regulation (16)
 considered that this 
impact could be significant, but stakeholde rs consulted have in dicated that other 
factors are more significant in determini ng the profitability of biocidal products. 
In case of disagreements ove r data sharing (e.g. disput es on the costs of studies, 
identity of the substance), there would be additional costs to the applicants linked to 
the court proceedings or arbitration. However, there is an uncertainty as to the frequency of such disagreements and therefor e, the quantification of potential costs is 
difficult. It is likely that companies will prefer out-of-court settlement of cases involving disagreements.  
This Option could give rise to additional costs for the  Commission,  in preparing 
guidance on data sharing , similar to those of Option (a). There would also be 
additional costs to  Competent Authorities  in setting up and maintaining registers 
of test and study reports  for active substances, similar to  Option (a). If a centralised 
data system was set up, by the Commission, fo r example, the costs could be similar 
to those for the ECHA classification a nd labelling inventory, at around €130,000 to 
€260,000 per year. 
EN 41   EN 5.3.3.  Costs and benefits of Option (c): Mandatory sh aring of vertebrate animal test data at 
product authorisation stage and active substance approval stage 
Option c) could generate additional benefits to indus try, compared to Option a), 
in the range between  €1.4 billion and €2.7 billion38 spread over a period of 10 
years . The savings depend on the number of active substances reintroduced as a 
result of the mandatory data sharing, the average costs of active substance vertebrate animal test data and the number  of manufacturers per substance. 
Compared to Option (b) , this means a net savi ng in the range between € 150 
million and € 760 million
39 spread over a period of 10 years .  
Nevertheless, it should be not ed that such high savings  are unlikely because they 
assume that under existing legal framework companies would regenerate large parts 
of the studies for the purposes of the produc t authorisation. Compan ies, in particular 
SMEs, would unlikely be able to incur th e costs for such regeneration and would 
probably stop marketing their products in the EU. The co st savings of Option c) 
would rather have the form of maintaini ng a wider choice of products on the market 
compared to Option a). 
Compared to Option (b), it is unlikely that extending the requirement for data sharing 
to active substances would result in signifi cant additional costs to  public authorities, 
although some additional costs might be incurred in extending guidance on data 
sharing to include active substances. 
There could also be benefits to public authorities  from data sharing, because they 
would not have to review new data sets. There are no data available at present to 
estimate the scale of these benefits, but they should be greater than  for options a) and 
b) because of the higher level of data sharing. 
There would also be additional benefits for  active substances manufacturers . 
Since most existing substances will have been evaluated at Co mmunity level by the 
time an amendment to the Directive is adopt ed, these benefits will only affect active 
substances evaluated after the change.  
However, it is unlikely that completely new active substances will be introduced by 
more than one company, so there would be no possibility of data sharing. In addition, 
the proposal to exempt new substances from obligatory data sharing requirements for 10 years (out of 15 years of data protecti on) in order to stimu late innovation would 
limit the benefits.  
There could also be some revenue losses for those involved in  placing biocidal 
products on the market if data sharing led to an increased number of products on the 
market and, in particular, an increased mark et share for generic products. The impact 
assessment for the proposed Plant Protecti on Products Regulation (16) considered 
that this impact could be significant; there would also be issues of fairness, because 
of the lower costs faced by thes e new entrants to the market. 
                                                
 
38 Net present value € 1.2 billion to € 2.3 billion 
39 Net present value € 125.7 million to € 636.8 million 
EN 42   EN In case of disagreements over data sharing (e.g. costs of studies, identity of the 
substance), there would be ad ditional costs to the applicants linked to the court 
proceedings or arbitration. As mentioned in Option b), there is an uncertainty as to 
the frequency of such disagreements and therefore, the quantification of potential 
costs is difficult. It is likely that companies will prefer out-of-court settlement of cases involving disagreements. 
The risk of duplication of vertebrate anim al tests at both the product authorisation 
and active substance stages will be re moved. The reduction in the numbers of 
animals through reduced duplication at the products authorisation stage will be the same as in Option b). In addition, the number of animals used at the active substance 
stage will be reduced by a number between 170,000 to 480,000 animals
40. Therefore, 
this option will reduce the numbers of animals used in duplicated tests by 
around 1 million in total over 10 years . 
5.4. Policy issue 4: Data requirements 
5.4.1.  Costs and benefits of Option (a):  Unchanged policy – clarification 
With further guidance and increased clarit y regarding the data requirements of the 
Directive, there is the potential for the wa iving of many tests and the routine use of 
data generated under other legislation. This could reduce the costs to industry of 
testing for the purposes of product authorisation by a range from €698 million 
to €1.4 billion41 spread over a period of 10 years . This saving is based on two 
scenarios with 4,500 and 9,000 estimated applic ations across the EU 27 over the next 
10 years. 
The harmonisation of data requirements, in cluding efficacy tes ting, also has the 
potential to reduce the likelihood of mutual  recognition applications being refused by 
Competent Authorities. 
The development of guidance would require some additional resources and 
discussions among Competent Authorities , but this would be o ffset by reductions in 
the time and effort that would have been used to evaluate additional tests. It is likely that SMEs in particular would benefit from improved guidance because they do not 
have the relevant information. There woul d also be potentially positive impacts on 
product availability .  
If the assessment of waiving arguments based on existing guidance is carried out 
carefully, the level of pr otection should not be affected and there should be no 
adverse  environmental impacts .  
                                                
 
40 It should be noted that the numbers are only estimates based on assumptions including the number of 
products, percentages of vertebrate data required to  be repeated and the number of vertebrate animals 
per test. These assumptions do not take into account potential data waiving and specific data 
requirements for certain product types. 
41 Net present value € 584.9 million to € 1.2 billion 
EN 43   EN 5.4.2.  Costs and benefits Option (b): Rewording provisions concerning data waiving and 
the use of existing information 
There are a number of ways in which the da ta requirements of the Directive could be 
reworded, to minimise animal testing and to reduce costs as far as possible. These include strengthening of pr ovisions on waiving; clarif ying the use of existing 
information and the introduction of a comm on procedure to challenge requests from 
authorities for extra data that were not necessarily required to establish risk, but which could give rise to excessive cost (e.g. repeating effic acy testing in every 
Member State). 
Based on theoretical modelling, data waiv ing has the potential to reduce active 
substance testing costs by 75% and product testing costs by 66%, giving savings to 
industry of €85 million
42 for additional active substa nces and in the range from 
€341 million to €682 million43 for product authorisations  spread over a period of 
10 years . The savings are based on two scenarios with 4,500 and 9,000 estimated 
applications for product authorisation. This  should provide an economic incentive for 
industry to increase the number of app lications for product authorisation, in 
particular for new substances, with potential  benefits for health and the environment. 
An increased number of products on the market would imply positive impact on the employment. In addition, Competent Authorities  would save the time and effort 
that would have been used to evalua te the results of additional tests. 
However, it should be noted that in practice,  it may be difficult to realise savings of 
this scale. This is mainly due to the elements of uncertainty which require further data to support certain conclusions in the process of assessing the risks of biocidal 
products. Some degree of uncertainty linked to  the risks of the biocidal products may 
be acceptable to the competent authorit ies, but the exact extent will vary. 
There would also be a reduction between 350,000 and 1.5 million vertebrate 
animals used for testing spread over the next 10 years.  
5.4.3.  Costs and benefits Option (c): Reformulati ng the system for low-risk substances 
The most significant benefit to  industry may result from the retention of additional 
low-risk biocidal products, which would otherwise not be supported . It should be 
noted that low-risk products are a prefe rred alternative to ot her biocidal products 
because of the lower risk posed to human health and the environment. The benefits to human health and the environment can not  be quantified because of the missing 
information on the risk profiles of low ri sk biocidal products and the number of 
products which may qualify as low risk biocidal products. 
Positive listing of low risk substances could result in cost savings to industry 
ranging between €159 million and €340 million
44 spread over a period of 10 
years , compared to the costs of active substance approva l and product authorisation 
under the current system. The costs saving s are greatest wher e low risk active 
                                                 
42 Net present value € 71.2 million 
43 Net present value € 285.7 million to € 571.4 million 
44 Net present value € 285.7 million to € 571.4 million 
EN 44   EN substances are included in Annex IA, as th is removes the need for testing at the 
product authorisation stage.  
Reducing the requirements for low risk substances could also reduce the numbers 
of vertebrate animals used for te sting: a number between 30,000 and 343,750 
vertebrate animals used over a period of 10 years .  
The impact for public authorities would be that dossiers and/or literature data on 
potential low-risk s ubstances would have to be evaluated, but Competent 
Authorities would save time and effort  that would have been  used to evaluate 
additional tests. Reduced requirement s for low risk products could have a significant 
positive impact on  product availability  and could increase th e numbers of safe 
products placed on the EU market, giving publ ic health and environmental benefits. 
The impacts on  public authorities  will depend largely upon the definition of low 
risk products adopted and upon the data re quirements for their authorisation. The 
Commission Services and Competent Author ities would have to develop guidance 
and the effort required to achieve a ha rmonised approach could be considerable. 
Some active substance perceived as being low risk, which have not been supported 
for Annex IA inclusion, might be re-intr oduced through direct  authorisation of 
products containing them.  
5.5. Policy issue 5: Fees charged by Member States for carrying out the procedures 
of the Directive 
5.5.1.  Costs and benefits of Option (a): Unchanged policy  
As fee levels are already published, th e main change from increasing the 
transparency of the current system, with f ees and conditions still set at Member State 
level, would be to clarify the conditions for payment of fees. The direct impact on 
Member States  across the EU27 of increased transp arency on fees is likely to be 
negligible. Greater clarity may make it easier for companies  to plan ahead. However, 
it is not clear whether such planning will result in authorisation being sought for 
more or fewer products. There are unlikely to be significant  social or 
environmental impacts . 
In addition, companies may tend to prefer mu tual recognition to pa rallel applications 
in different Member States where they intend to place their products on the market. 
This may increase the number of cases going through the mutual recognition which may in return cause some Member States to  increase their fees for mutual recognition 
(rather than the authorisation fees). 
5.5.2.  Costs and benefits of Option (b): Partially harmonised fee structure 
The partial harmonisation of the fee structure
 would contain the following impacts: 
– Reduced active substance evaluation fees for multiple submissions would have a 
limited impact on manufacturers  of existing active substances , as the review 
programme will be largely complete by th e time that any changes are introduced. 
However, it could encourage industry to  add more product-types to new active 
substance dossiers and the potential benefits to formulators of biocidal 
products  could be significant.  
EN 45   EN – Variation in fees by product- types: the scale of impact will be determined by the 
number of applications for product authoris ations that would fall into the different 
categories. At present, there is no information available on this. However, assuming that Member States adjust their fees so that the ove rall revenue they 
receive is maintained, the overall effect on industry will be  cost-neutral . 
Instead, there would be a transfer of cost s within industry, with  certain companies 
paying higher fees and others paying lower fees. 
– Refund of unused fees could result in  significant savings to companies  whose 
dossier does not pass the completeness ch eck, and might encourage industry to 
seek the evaluation of active substa nces not previously supported.  
It is likely that Member States  would adjust the level of th eir fees so that there would 
be no overall reduction in revenue as a result of harmonisation of structures. 
However, there could be limited administrative costs for Member States  in 
modifying their fees in line with a harmonised fee structure. There are unlikely to be 
significant social or environmental impacts .  
The current role of the Member  States with respect to the setting of the levels of fees
 
would remain. This is in  accordance with the s ubsidiarity principle: Member States 
are best placed to set the leve ls of fees because the costs to cover the work to be done 
are not the same in the different Member States. However, Member States would be 
free to set the fee levels but only within the framework of the partially harmonised 
fee structure. The structure would harmonise  the criteria on basis of which the fee 
would be set. A full authorisation w ould cost more than a renewal of the 
authorisation in all Member States; an authorisation of a low risk biocidal product 
would cost less than an authorisation of  other products in all Member States. 
Concerning the level of fees, there will likely be differences in the level of the fees 
among Member States in the future. However, these will be related to the costs of the 
services to that Member State rather th an the structure of setting the fee.  
5.5.3.  Costs and benefits of Option (c): Centralised fee system 
The impact of this option would clearly depend upon the level at which the range of 
fees is set. Industry would benefit from in creased market harmonisation  across 
the EU and from the reduction of the high level of fees charged by some Member 
States. Conversely, industry would not be able to reduce costs by choosing to apply 
for authorisation only in Member States with very low fees.  
For example, limiting fees to 25% above or  below the current average would mean 
that 6 to 9 Member States  would have to reduce their fees; this could mean that 
staffing and other costs would not be recovered. By contrast, 11 to 17 Member States 
would have to increase their fees to fit within this range. This may cause a problem 
in Member States where fees are limited by la w to the level needed to recover costs.  
Any distortion of the market caused by va rying fee rates across the EU would, 
however, be removed; this coul d potentially result in greater product availability  in 
Member States with high current fee levels, especially if the market in these Member 
States is small. There are unlikely to be significant social or environmental 
impacts .  
EN 46   EN A fully centralised fee system would rais e questions concerning the subsidiarity 
principle as it would transfer the compet ences over setting fees from the Member 
States to the Community. A full harmonisati on would mean that the fees applicable 
to all Member States would be decided at Community le vel. This may lead to a 
situation that in some Member States the f ees levied will not c over the costs linked to 
processing the individual applications. In  other Member States the fees would go 
beyond what may be necessary to cover th e costs. Material and human resources 
costs of the services can not be harmoni sed in all Member States unless a fully 
centralised authorisation scheme is put in pl ace. As this has been  refused in sections 
4.2.3, 4.2.4 and 5.2.4, a centralised system of fees  including the setting of the fees 
level is only proposed with respect to th e Community authorisations of certain 
biocidal products. For those products the Agency will be responsible for assessing 
the application and, therefore, a fully centralised fee system is justified. 
5.5.4.  Costs and benefits of Option (d): Specific provisions for SMEs 
Reduced fees for SMEs could benefit them significantly, as high fees are more often 
an obstacle for SMEs to support substances or to keep their products on the market. 
Cost can be reduced by a range of €75,600 to €639,00045 spread over a period of 
10 years  if fee reductions would be offered to SME's following the REACH model. 
Such reductions would likely have positive impact on the employment by SMEs. 
If Member States took steps to ensure that  their revenue from fees remains the same 
(by charging higher fees to large companies), there would be a significant transfer 
of costs from SMEs to large companies . 
The availability of products  formulated by SMEs, including safer products,  is likely 
to increase . However, increased costs to larger companies could reduce the numbers 
of products, including safer products, pl aced on the market by these companies. 
6. COMPARING THE OPTIONS  
See Tables 2.21, 3.18, 4.10, 5.13, and 6.11. The preferred options are marked in grey. 
It should be noted that only  in one policy area, namely the data sharing, it is possible 
to choose one policy option ( mandatory sharing of vertebrate animal data at the 
active substance evalua tion stage and the product authorisation stage ). All other 
policy areas require a combination of various opti ons in order to adequately 
address the problem and adapt the solution to the cu rrent situation on the market 
with biocidal product s. In particular, with regard  to product au thorisation, the 
Member States have expressed serious c oncerns about a full centralisation of the 
product authorisation under th e Directive. Thus, the combination of a partial 
centralisation for certain biocidal products  with a strengthening of the mutual 
recognition process seems the best variant under these circumstances and taking into 
account the subsidiarity princi ple. The same applies to fees where the harmonised fee 
structure should be accompanied with specif ic provisions to SMEs . With respect to 
the scope issues and data requirements, th e assessed options did not always address 
the same problem. This means that more than one option may be suitable for these policy areas. 
                                                
 
45 Net present value €63.300 to € 535.400 
EN 47   EN The impact assessment shows that the total costs of all pref erred options to the 
industry would amount to a range from €193.6 to 706 million  spread  over a 
period of 10 years . They represent between 0.09% and 0.32% of the overall value 
of the EU market with treated materials spread over 10 years46. These costs are 
attributable to the extension of the scope of the Directive to treated materials. The 
costs 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. 
In theory the total cost savings of all the prefer red options for the industry could 
range from €2.7 bill ion to 5.7 billion  spread  over a period of 10 years
47. The cost 
savings (compared to Unchanged Policy option) would be achieved through the options concerning product authorisation, da ta sharing, data re quirements and fees. 
In practice, these cost savings are very un likely to materialise in such scale and are 
expected to be closer to the lower end of  the range because of the following reasons: 
– the majority of the savings would be achieved under obligatory data sharing of 
tests involving vertebrate animals at  the substance evaluation and product 
authorisation stage. The savings are calcu lated in comparison to the Unchanged 
Policy (Option a)) which assumes that co mpanies would regenerate significant 
parts of the data package for the purposes of the pr oduct authorisation under the 
existing legal framework. As already e xplained in Section 5.3.3, many companies, 
in particular SMEs, are unlikely to be ar such costs and would rather stop 
marketing their products; 
– with respect to the product authorisati on and mutual recogn ition, the Unchanged 
Policy (Option a)) is base d on the assumption that the Member States could 
potentially request significant amount of additional information including testing. This remote eventuality would be a failure of the mutual recognition as foreseen by the current Directive.  
These calculations also do not take into account the various links between the 
different policy areas (e.g. between data waiving and data sharing, between product 
authorisation and fees). Such links cover for example the situation when a well functioning data waiving system reduces the efficiency and t hus also the benefits that 
could be achieved by an oblig atory data sharing scheme. It is, however, difficult to 
quantify the impacts of such linkages. Th e calculations also do not consider the 
numerous uncertainties me ntioned throughout this assessment. Nevertheless, the 
calculation of the overall costs and benefits clearly shows that the cost savings, 
mainly to the benefit of the industry,  largely outweigh the costs of the proposed 
options .  
The total costs and cost savi ngs of all preferred options for the industry are presented 
in Table 7.1 below. It should be, however, noted that only quantifiable costs and cost 
                                                
 
46 Based on the overall EU market with treated mate rials of €22.2 billion per year (€222 billion over 10 
years). 
47 The cost savings include the cost savings achieved through improvement of mutual recognition and 
partial centralisation of product authorisation, intr oduction of obligatory data sharing at substance and 
product authorisation stage, strengthening of the wa iving provisions, revision of the concept relating to 
low risk biocidal products and reductions of the fees for SMEs. 
EN 48   EN savings were included. A detail ed overview of the costs and cost savings is available 
in Annex IV of this document. 
Preferred option Total costs / cost savings 
Scope: extend scope to 
treated materials Costs between €193.6 and 
706 million spread over 10 years 
Product authorisation: Facilitation, improvement and strengthening of mutual 
recognition Cost savings up to €700 
million spread over 10 years
48 
Product authorisation: Community authorisation for certain categories of products Cost savings up to €1.9 
billion spread over 10 years
49 
Data sharing: Mandatory sharing of vertebrate animal test data at product authorisation and active substance approval stage Cost savings between €1.4 
and 2.7 billion spread over 10 years 
Data requirements: Rewording provisions concerning data waiving and the use of existing information Cost savings between €426 
and 767 million spread over 10 years
50 
Data requirements: Reformulating the system for low risk biocidal products Cost savings between €159 
million and 340 million spread over 10 years 
Fees: Partially harmonised fee structure N/A 
Fees: Specific provisions for Cost savings between 
€75,600 and 639,000 spread 
                                                 
48 The total cost savings from the combined options in product authorisation (Option b) and Option d)) 
will be in the range between €700 million and €1.9 billion. These savings cannot be added up in the total costs because the two options would be combined. The measures in the options will interact and 
therefore, the savings will go beyond what would only be achieved with just one of the options but will 
remain less than the sum of the individual savings.. 
49 The total cost savings from the combined options in product authorisation (Option b) and Option d)) 
will be in the range between €700 million and €1.9 billion. These savings cannot be added up in the 
total costs because the two options would be combined. The measures in the options will interact and 
therefore, the savings will go beyond what would only be achieved with just one of the options but will 
remain less than the sum of the individual savings. 
50 The figure has been calculated by adding up €85million for additional active substance inclusions 
spread over 10 years and a range between €341 million and 682 million for additional product 
authorisations spread  over 10 years. 
EN 49   EN SMEs over 10 years 
Total costs  Between €193.6 and 706 
million spread over 10 years  
Total cost savings Between €2.7 billion and 5.7 
billion spread over 10 years 
When comparing the costs and benefits of the different options,  the only option 
which could give rise to a significant cost increase for industry is the extension 
of the scope to treated materials . In all other policy areas, the options will  
reduce costs for industry  compared to the continuing the current policies. In 
practice, the final costs of extending the sc ope to treated materials could be much 
lower than this, as manufacturers are likel y to switch to substances on Annex I and 
authorised products where possible, avoi ding these costs. Th e environmental and 
human health benefits resulting from exte nding the scope to treated materials cannot 
be easily quantified partially due to the missing evidence linking the use of biocidal 
products with quantified health and environm ental benefit but they are likely to be 
significant. The same applies to the comp etitiveness benefits for the EU industry 
with respect to their positi on on the EU market. In additi on, the labelling would have 
benefits with respect to consumer protection. 
The costs and benefits will be incurred gradually over a period of ten years. Both the 
inclusion of active substances and the produc t authorisations are granted for a period 
of ten years. The timing will be postponed for provisions which will require a transitional period (e.g. treated materials). 
The options on scope, product authorisat ion and data sharing will require additional 
work by public authorities  linked with the development of guidance documents. 
The related costs are, however, likely to be minor. Furthermore, the preferred options 
in product authorisation and data requiremen ts require an existi ng Agency to play a 
role in the product authorisation process and the screening process with regard to low 
risk biocidal products. 
Policy options in product authorisation, da ta sharing and data waiving have the 
potential to simplify the Directive. This  would be in line with the Commission's 
strategy for simplifying the regulatory enviro nment. This may benefit particularly 
SMEs which often lack human and financial resources to ensure compliance with the 
requirements of the Directive. For exampl e, the obligatory sharing of vertebrate 
animal data will mean that the formulator s of biocidal products will no longer be 
allowed to repeat studies for the purpose of product authorisation. This will reduce 
the costs of the product author isation. In additi on, the review of product authorisation 
applications will become simpler and less resource intensive for the competent authorities.  
Apart from the options on the scope of the Directive, most of the other options are 
likely to increase the product availability  compared to the current policy. This is 
mainly because the options will lead to a re duction in the costs of  authorisation to the 
industry, encouraging author isation of more products or  authorisation in more 
EN 50   EN markets. This will benefit mainly consumer s as they will have a wider choice of 
products to choose from. 
No significant overall impacts on employment  are anticipated as the overall market 
remains the same. Potentially, the preferre d options in all policy areas could have 
positive impacts on employment. In partic ular, changes in product authorisation, 
obligatory data sharing, improved waiving provisions and a revised concept for low 
risk biocidal products could lead to incentives for development of new products and 
thus to an increased employment relative to  the baseline. However, there may be job 
losses as some companies may be forced  out of the market due to increased 
competition. 
The different users of biocidal products will be affected in the same manner by the 
preferred policy options in all policy areas but scope. W ith respect to scope, the 
producers of treated materials will be aff ected most significantly. Examples include 
the chemicals sector (water resistant a nd fungi-based paint manufacture), timber 
processing and leather industries. The change s may also lead to increased prices of 
imported treated materials, which might how ever be reduced if  producers switch to 
already authorised products. 
The policy options concerning data requirements, data sharing and fees will benefit 
both active substance producers and formulat ors of biocidal products. However, 
given the ongoing implementation of the Re view Programme for the evaluation of 
existing active substances, the changes will have more impact on the formulators than the active substance producers. The op tions concerning product authorisations 
will have impact only on biocidal product fo rmulators. The changes concerning the 
scope may have implications for both active substance producers and biocidal 
product formulators. 
Improved data waiving and obligatory data sh aring may particularly  benefit SMEs as 
they often lack financial and human res ources necessary for ensuring regulatory 
compliance. SMEs may also profit the most  from the special provisions for SMEs 
outlined under fees.  
Big companies which place their products on the market in all or a majority of 
Member States may benefit, in particul ar, from the possibility to apply for a 
Community authorisation for certain types of biocidal products. This will enable 
them to place their products on the ma rket throughout the Community without the 
need to request an authorisation in all Member States or go through the mutual 
recognition process. They will also bene fit from the improved data waiving and 
obligatory data sharing. Concerning the f ees, the reductions for SMEs will likely 
have to be compensated by higher fees for big companies. 
Professional and non-professional users will  be affected similarly. The preferred 
options would lead to a wider choice of biocidal products on the market, more low 
risk biocidal products and improved safety with respect to the treated materials. 
The options on scope of the directive are likely to have positive impacts on both 
health and the environment  because they extend controls to products not fully 
regulated at present, and thus  remove the risks that these products may pose to health 
or the environment. The options in other policy areas may have indirect 
EN 51   EN environmental and health benefits, because they encourage industry to retain or 
introduce more low risk products on the market, by reducing the costs of the 
authorisation. Low risk produc ts are considered a prefe rred alternativ e to other 
biocidal products. The environmental and hum an health benefits of using low risk 
products are, however, not eas ily quantifiable du e to the missing information on the 
risk profiles of low risk biocidal products and the num ber of products which may 
qualify as low risk biocidal products. The options on data sharing and data 
requirements also significantly  reduce the numbers of vertebrate animal tests .  
With respect to the subsidiarity principle , Member States will retain their roles with 
respect to the mutual recognition which w ould be applicable to the majority of 
products on the market while the Community  authorisation would apply only to low 
risk products and products based on new activ e substances. Similarly, with regards to 
the fees, Member States will continue to set the amount of the fees. Thus, none of the 
options goes beyond what is necessary to ach ieve the objectives of the Directive 
including the functioning of the internal market with biocidal  products and the high 
level of environmental and human health protection. 
Table 7.2 presents a summary of benefits and costs to stakeholders of all the 
considered options. The preferred options are marked in grey. 
 
EN 52   EN SCOPE 
(a) Unchanged policy (b) Include borderline issues 
 Food processing aids Food contact materials (c) Include treated materials 
Minor costs associated with 
updating the Directive Administrative costs between €4.5 
million and €35 million spread over 10 years  for active substance 
evaluation;  
€5 million to €51 million spread 
over 10 years  for biocidal product 
authorisation. Administrative costs of a range 
between €5 million and €50 million spread over 10 years  in active 
substance evaluation;  
€8.3 million to €73 million spread 
over 10 years  for biocidal product 
authorisation. Administrative costs of a range 
between €36 million and €140 million 
spread over 10 years  for Annex 1 
inclusion of active substances;  
€3.6 million to €52 million spread 
over 10 years  for product 
authorisation;  
€154 million to €514 million spread 
over 10 years for labelling.  
Improved protection of environment, 
consumer and workers health 
PRODUCT AUTHORISATION 
(a) Unchanged  (b) Strengthening of mutual 
recognition (c) Single Member State 
authorisation (d) Community authorisation 
Total administrative costs to 
industry: € 2.9 billion spread over 10 years Total administrative costs to 
industry: € 2.2 billion spread over 10 
years 
Cost savings to i ndustry: 0.7 billion 
spread over 10 years Total administrative costs to 
industry:€ 1 billion spread over 10 years 
Cost savings to i ndustry: 1.9 billion 
spread over 10 years Total administrative costs to industry: 
€ 1 billion spread over 10 years;  
Incentives for innovation of products 
based on new active substances / low 
risk products 
 
EN 53   EN Cost savings to industry: 1.9 billion 
spread over 10 years 
DATA SHARING 
(a) Unchanged policy – clarification and 
encouragement (b) Mandatory sharing of vertebrate animal 
test data at product authorisation stage (c) Mandatory sharing of vertebrate animal test 
data at product authorisation and active 
substance stage 
Some cost savings to applicants for product 
authorisation through a basic functioning of 
mutual recognition 
Risk of duplication of te sting with vertebrate 
animals not fully addressed Additional theoretical cost  savings on top of basic 
functioning of mutual r ecognition to applicants 
for product authorisation compared to option (a) 
by a range between € 675 million and €2.6 billion spread over 10 years 
Number of animals sa ved: between 450,000 and 
844,000 spread over 10 years Additional theoretical cost  savings on top of basic 
functioning of mutual rec ognition to applicants for 
product authorisation compar ed to option (a) by a 
range between €1.4 billion and €2.7 billion spread 
over 10 years 
Possibly a higher number of  safer products will 
remain on the market than under options (a) or (b) 
Number of animals save d: around 1 million spread 
over 10 years. 
DATA REQUIREMENTS 
(a) Unchanged policy - clarification  (b) Data waiving and use of existing 
information Option (c) Low-risk substances 
 
EN 54   EN Theoretical benefits of 100% waiving: 
between €698 million and €1.4 billion spread over 10 years, but unlikely  to be realised in 
practice Potential reduction in testing costs of €85 million 
over 10 years  (active substances); a range 
between €341 million and €682 million spread 
over 10 years (products) from increased waiving, 
+ benefits from use of existing data. 
Number of animals saved: between 350,000 and 
1,5 million spread over 10 years.  Potential cost savings from positive listing of low 
risk substances: a range between €159 million and 
€340 million spread over 10 years. 
Number of animals saved : between 30,000 and 
343,750 spread over 10 years  
FEES 
(a) Unchanged policy - more 
transparency  (b) Partially harmonised fee 
structure  (c) Centralised fees system (d) Specific Provisions for SMEs  
Minor increase in clarity Reduction in costs for 
inclusion/authorisation of several 
PTs; 
More effective budget planning by 
Competent Authorities. 
May encourage more new active 
substances and retention of more 
existing active substances. 
Increased availability of some 
products especially from SMEs 11-17 MS may have to increase 
current fees. 
6-9 MS may have to reduce current 
fees. Cost reductions: a range between 
€75,600 and €639,000 spread over 10 
years 
More products on the market from 
SMEs 
Procedure less costly for SMEs, 
helping them to stay on the market 
 
 
EN 55   EN 7. MONITORING AND EVALUATION  
Monitoring and evaluation will be on the ba sis of measurements against the general 
objectives set out in Section 4. The core i ndicators for the general policy objectives 
are shown in the table below. 
There are a number of sources of informa tion in place or under development that can 
be used to obtain information on the core indicators. 
According to Article 24  of the Directive Member States  have to take the necessary 
arrangements to monitor whether biocidal products placed on the market comply with the requirements of the Directive. Ev ery three years Member States have to 
submit to the Commission by 30 November of the third year a report on their action 
in these matters together with inform ation on any poisonings involving biocidal 
products. The Commission within one year of  receipt of this information prepares 
and publishes a composite report.  
The Commission is in the process of preparing a Community Register for Biocidal 
Products (R4BP)  to facilitate the information excha nge as foreseen in Article 18.1 of 
the Directive, which stipulates that Member  States shall on a quarterly basis inform 
each other and the Commission of biocidal products for which an authorisation was 
granted, refused, modified, renewed or ca ncelled. The register will be operable by 
the end of 2009. The overall goal of the R4BP  system is to pr ovide a no tification 
system to signal that a company intends to initiate an authorisation procedure for a product in a Member State, or a mutual recognition procedure for a product and to 
signal that a Member State has taken certain decisions on procedures or 
authorisations. It also aims to allow Memb er States and companies to keep track of 
the main milestones of procedures (i.e. dates of dossier submission, of dossier 
acceptance, start of evaluation, end of evaluation and authorisation) and to 
communicate information about all initiate d procedures to a ll concerned Member 
States. The R4BP will help Member States identify which products are authorised on 
other Member States respective markets, which substances these products contain and for which product-types they are authorised  and it will collect standardised data 
on the products concerned. Finally it aims to offer assistance  to the Member States to 
fulfil their quarterly and annual information reporting obligations and to allow the Commission to analyse and query the availa ble information in the system and to 
provide a status report of pending an d finalised procedures upon demand. 
A new reporting article  related to the use phase coul d be included in the revised 
Directive and could provide important info rmation on quantities of biocidal products 
placed on the market. 
As for the evaluation, the Commission will  review the Compos ite Reports due in 
2010 and 2013 to assess the impact of the revision of the Directive. 
Objective Indicator Data source 
Facilitate the harmonisation 
of the EU market for Number of active substances 
evaluated Progress report extracted 
from DG ENV's database 
 
EN 56   EN Speed of product authorisation Community Register For 
Biocidal Products biocidal products 
Number of conflicts in Mutual 
Recognition that require resolution at Community level The Commission/Agency 
will keep track of the number of conflict resolutions 
Number of biocidal products on the market Reporting obligation from 
MS to the Commission. 
Community Register for 
Biocidal Products 
Number of poisoning incident s Reporting obligation from 
MS to the Commission under Article 24 of the Directive. 
Number of low risk biocidal products The Agency will keep 
track of the decisions about low risk biocidal products Continue to provide high 
level of protection for 
humans, animals and the 
environment 
Number of data sharing failures 
(linked to animal testing) The Commission/Agency 
are informed when there is no agreement. 
Increase the competitiveness 
of the EU industries affected 
by this Directive Number of new active 
substances  Agency 
 Number of unfavourable 
controls/inspections in the market surveillance  activities in 
particular for the treated materials Member States 
 
EN 57   EN ANNEX I  
REFERENCES  
(1) Communication from the Comm ission to the European Parliament, the Council, the 
European Economic and Social Committ ee and the Committee of the Regions - 
Commission Legislative and Work Programme 2008 (Brussels, 23.10.2007 - COM(2007) 640) 
(2) Second progress report on the strategy fo r simplifying the regulatory environment 
(Brussels, 30.01.2008 - COM(2008) 33 final 
(3) Directive 98/8/EC of the European Parliame nt and of the Council of 16 February 1998 
concerning the placing of biocidal products on the market ( Official Journal  L 123, 24 
April 1998, p.1 ). All relevant information regarding the Biocidal Products Directive 
98/8/EC and its implementing Regulations can be found at: http://europa.eu.int/comm/e nvironment/biocides/index.htm 
(4) Commission Impact Assessment guidelines of 15 June 2005 (SEC 2005 - 791). 
(5) Study to assess the impact of the revision of  Directive 98/8/EC concerning the placing 
of biocidal products on the mark et (final report submitted on 14
th August 2008 – when 
approved available at: ht tp://ec.europa.eu/environment/biocides/study.htm). 
(6) Study on the impacts of the implementation of  Directive 98/8/EC on biocidal products 
(2007 - available at: http://ec.europa .eu/environment/biocides/study.htm)  
(7) Study on impacts of possible measures to mana ge articles or materials treated with 
biocides, in particular when  imported (2006 - available at: 
http://ec.europa.eu/environment/biocides/study.htm)  
(8) Study on the assessment of different options to address risks from the use phase of 
biocides (ongoing) 
(9) Commission Recommendation of 6 May 2003 concerning the definition of micro, 
small and medium-sized ente rprises (OJ L 124 of 20.5.2003, p. 36) 
(10) Second composite report prepared in accordan ce with the provisions of Article 24 of 
Directive 98/8/EC and covering the peri od from December 2003 to November 2006 
(2008 - available at  http://ec.europa.eu/environment/b iocides/pdf/composite_report_2006.pdf
).  
(11) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, 
regulations and administrative pr ovisions of the Member States relating to restrictions 
on the marketing and use of certain dange rous substances and preparations ( Official 
Journal L 262, 27.9.1976, p. 201–203 ) 
(12) Directive 2001/83/EC of the European Parl iament and of the Council of 6 November 
2001 on the Community code relating to medicinal products for human use (Official 
Journal L 311, 28/11/2001 p. 67 - 128) .  
 
EN 58   EN (13) Directive 2001/82/EC of the European Parl iament and of the Council of 6 November 
2001 on the Community code relating to  veterinary medicinal products ( Official 
Journal L 311, 28/11/2001 p. 1 - 66 ). 
(14) Council Directive 91/414/EEC  of 15 July 1991 concerning the placing of plant 
protection products on the market ( Official Journal L 230, 19.8.1991, p. 1 ). 
(15) Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges 
payable to the European Chemicals Ag ency pursuant to Regulation (EC) No 
1907/2006 of the European Parliament a nd of the Council on the Registration, 
Evaluation, Authorisation and Rest riction of Chemicals (REACH). 
(16) Commission Staff Working Document Re port on the Impact Assessment for a 
Regulation Replacing Directive 91/414/EEC on Plant Protection Products Annex 2, 
part 5 {COM(2006) 388 final} {SEC(2006) 930} 
(17) Council Directive of 21 December 1988 on th e approximation of the laws of the 
Member States concerning food additives aut horized for use in foodstuffs intended for 
human consumption (OJ L 40, 11.2.1989, p. 27)  
(18) Regulation (EC) No 853/2004 of the European  Parliament and of the Council of 29 
April 2004 laying down specific hygiene rules for food of animal origin (Official 
Journal of the European Union L 139 of 30 April 2004)  
(19) Regulation (EC) No 1935/2004 of the European  Parliament and of the Council of 
27 October 2004 on materials and articles intend ed to come into c ontact with food and 
repealing Directives 80/590/EEC  and 89/109/EEC (OJ L 338, 13.11.2004, p. 4.) 
(20) Guidelines of the Scientific Committee on F ood for the presentation of an application 
for safety assessment of a substance to be used in food contact ma terials prior to its 
authorisation ( http://ec.europa.eu/fo od/fs/sc/scf/out82_en.pdf ) 
(21) Directive 2002/95/EC of the European Par liament and of the Council of 27 January 
2003 on the restriction of the use of certain  hazardous substances in electrical and 
electronic equipment ( OJ L 37, 13.2.2003, p. 19–23)  
(22) Proposal for a Regulation of the European Pa rliament and of the Council concerning 
the placing of plant protection product s on the market (COM(2006) 388 final) 
(23) 2007 annual report of the European  Medicines Agency (May 2008 - 
EMEA/MB/17464/2008) 
(24) Communication from the Comm ission of 5 June 2002 - Action plan "Simplifying and 
improving the regulatory environment" COM(2002) 278 final 
(25) Strategic Objectives 2005 – 2009 - Europe 2010: A Partnership for European Renewal 
Prosperity, Solidarity and S ecurity - Communication from the President in agreement 
with Vice-President Wallström (26.1.2005 - COM(2005) 12 )  
(26) Communication to the Spring European Counc il - Working together for growth and 
jobs - A new start for the Lisbon Strategy - Communication from President Barroso in 
agreement with Vice-President Verheugen (2.2.2005 - COM(2005) 24) 
 
EN 59   EN (27) Communication from the Comm ission to the Council, the European Parliament, the 
European Economic and Social Committ ee and the Committee of the Regions - 
Proposal for a joint declaration by the C ouncil, the European Parliament and the 
Commission on the European Union Development Policy - “The European Consensus” (13.7.2005 - COM(2005) 311) 
(28) Regulation (EC) No 853/2004 of the European  Parliament and of the Council laying 
down specific hygiene rules for food of animal origin 
 
EN 60   EN ANNEX II  
 
Background information on  
Directive 98/8/EC of the European Parliament  and of the Council concerning the placing 
of biocidal products on the market  
Aims of the Biocidal Products Directive 
The European Parliament and Council Directive 98/8/EC51 on the placing on the market of 
biocidal products (hereafter "t he Directive") was adopted on 16th February 1998. It aims to 
harmonise the European market for biocidal pro ducts and their active substances; at the same 
time it aims to provide a high level of protecti on for humans, animals and the environment.  
What is a biocidal product?  
Biocidal products are active substances or preparations containi ng one or more active 
substances, intended to destroy,  deter, render harmless, prev ent the action of, or exert a 
controlling effect on harmful orga nisms, such as microbes, insects, mice, rats, etc. For 
example, a repellent used to ‘deter ’ a mosquito is a biocidal product. 
The scope of the Directive is very wide, c overing 23 different product -types. These include 
disinfectants used in different areas, chem icals used for preservation of products and 
materials, non-agricultural pesticides and anti -fouling products used on hulls of vessels. The 
Directive does not apply to certain products al ready covered by other Community legislation, 
such as plant protection products, medicines, an d cosmetics. Moreover, the Directive does not 
apply to articles (e.g. textiles and clothes, wood, plastic objects)  treated for internal effect 
with biocides imported from the third countries. 
How does the Directive work? 
The Directive sets out a Community harmonised system for the authorisation and placing on 
the market  of biocidal products; for the mutual recognition  of these authorisations within the 
Community; and for the establishment at Community level of a positive list of active 
substances  which may be used in biocidal products.  
The Directive was modelled on Directive 91 /414/EEC concerning th e placing of plant 
protection products on the market, and takes a similar approach to the authorisation 
procedure, in the sense that it provides for a two-tier syst em, based on the evaluation and 
approval of the active ingredient s at Community level, and the subsequent authorisation of 
biocidal products containing these in gredients at Member State level.  
The basic principles of the Directive are the following:  
• Active substances  have to be assessed and the decision on their inclusion in to Annex I, IA 
or IB of the Directive shall be taken at Community level. 
                                                 
51 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products  on the market (OJ L 123, 24 
April 1998, p.1). All relevant information regarding the Biocidal Products Directive 98/8/EC and its implementing Regulations c an be found at: 
http://europa.eu.int/comm/environment/biocides/index.htm 
 
EN 61   EN • Member States shall authorise the biocidal products  in accordance with the rules and 
procedures set in Annex VI of the Directive. They can only authorise products which 
contain active substances included in Annex I. 
• A biocidal product authorised in one Member  State shall be authorised upon application 
also in other Member States in the process of mutual recognition  unless there are specific 
derogation grounds. 
10-Year Review Programme 
The Directive established a 10-year review programme52 for the systematic examination of 
active substances used in biocidal products that  were present on the market before its entry 
into force (14 May 2000), in or der to allow for their risk and efficacy assessment, and 
ultimately their inclusion in the above-mentione d positive list (Annexes I, IA or IB to the 
Directive). During this 10-year period, Member St ates may continue to apply their systems or 
practices for the placing of bi ocidal products on the market (' the transitional period').  
In a first step, industry was invited in 2000 to identify all existing activ e substances and to 
notify to the Commission those subs tances that they would intend to defend within the review 
programme53. 
In a second step, four priority lists were established for the evaluation of the defended 
substances and the evaluation work distributed among Member States.  
Mutual Recognition of Authorisations 
The authorisation system is based on the princi ple of mutual recognition of authorisations. 
Under this principle, a biocidal product that ha s already been authorised or registered in one 
Member State must be authorised in another Member State within 1 20 days or registered 
within 60 days of an app lication being received by the other Member State.  
Product Authorisation stage 
The product authorisation st age has not yet started. 
A Product Authorisation and Mu tual Recognition Facilitation Group has been set up with 
Member States and Stakeholders in order to smooth the working of the product authorisation 
stage and anticipate issues with the mutual rec ognition of authorisations  and registrations in 
particular.  
What should a "Active Subs tance Dossier" include ? 
Dossiers on active substances are required to address at least the following points:  
– I. Applicant: name, address, etc. 
– II. Identity of the active substance 
                                                 
52 From 14 May 2000 to 14 May 2010. 
53 See Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2 ) of Directive 98/8/EC of 
the European Parliament and of the Council on biocidal products. (OJ L 228, 8.9.2000, p.6 - Regulation as amended by Regulation  (EC) No 2032/2003) 
 
EN 62   EN – III. Physical and chemical properties of the active substance 
– IV. Methods of detection and identification 
– V. Effectiveness against target organisms and intended uses 
– VI. Toxicological profile for man and animals including metabolism 
– VII. Ecotoxicological profile includi ng environmental fate and behaviour 
– VIII. Measures necessary to protect man, animals and the environment 
– IX. Classification and labelling 
– X. Summary and evaluation of Sections II to IX 
 
EN 63   EN ANNEX III: GLOSSARY  
PT: Product-type 
PT 1: Product-type 1: Huma n hygiene biocidal products 
PT 2: Product-type 2: Private area and public health area disi nfectants and other biocidal 
products 
PT 3: Product-type 3: Veterina ry hygiene biocidal products 
PT 4: Product-type 4: Food and feed area disinfectants PT 5: Product-type 5: Dr inking water disinfectants 
PT 6: Product-type 6: In-can preservatives 
PT 7: Product-type 7: Film preservatives PT 8: Product-type 8: Wood preservatives PT 9: Product-type 9: Fibre, leather, r ubber and polymerised materials preservatives 
PT 10: Product-type 10: Masonry preservatives 
PT 11: Product-type 11: Pr eservatives for liquid-coo ling and processing systems 
PT 12: Product-type 12: Slimicides, Products us ed for the prevention or control of slime 
growth on materials, equipment and structures, used in industrial processes, e.g. on wood and 
paper pulp, porous sand strata in oil extraction. 
PT 13: Product-type 13: Meta lworking-fluid preservatives 
PT 14: Product-type 14: Rodenticides, Products us ed for the control of mice, rats or other 
rodents. 
PT 15: Product-type 15: Avicides, Produc ts used for the control of birds. 
PT 16: Product-type 16: Mollu scicides, Products used for the control of molluscs. 
PT 17: Product-type 17: Piscicides, Products us ed for the control of fish; these products 
exclude products for the treatment of fish diseases. 
PT 18: Product-type 18: Insecticides, acaricides and products to control other arthropods (e.g. 
insects, arachnids and crustaceans). 
PT 19: Product-type 19: Repellents and attract ants, Products used to control harmful 
organisms (invertebrates such as fleas, vertebra tes such as birds), by repelling or attracting, 
including those that are used for human or vete rinary hygiene either di rectly or indirectly. 
PT 20: Product-type 20: Preserva tives for food or feedstocks 
 
EN 64   EN PT 21: Product-type 21: Antifouling products, Products used to control the growth and 
settlement of fouling organisms (microbes and higher forms of plant or animal species) on 
vessels, aquaculture equipment or ot her structures used in water. 
PT 22: Product-type 22: Embalm ing and taxidermist fluids, Produc ts used for the disinfection 
and preservation of human or animal corpses, or parts thereof. 
PT 23: Product-type 23: Control of  other vertebrates, Products used for the control of vermin. 
 
EN 65   EN ANNEX IV: TABLES TO COMPARE THE OPTIONS  
SCOPE  
Table 2.21: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Scope 
Stakeholders Option 
(b) Include borderline issues  (a) Unchanged policy 
Food processing aids Food contact materials (c) Include treated materials 
Benefits 
Minor increase in clarity over 
borderline issues Benefits 
Clearer and more harmonised 
regulatory regime Benefits 
Possibly increased regulatory 
certainty Benefits 
Harmonisation of rules and level playing 
field with third country producers EU industry 
Costs 
Minor costs associat ed with updating 
the Directive Costs 
Administrative costs54 ranging 
between €4.5 million and €35 
million  spread  over 10 years  for 
active substance evaluation. 
Administrative costs of a range 
between €5 million and €51 
million  spread  over 10 years  for 
biocidal product authorisation. Costs 
Administrative costs of a range 
between €5 million and €50 
million  spread  over 10 years  in 
active substance evaluation. 
Administrative costs of a range 
between €8.3 million and €73 
million  spread  over 10 years  in 
biocidal product authorisation. Costs 
Administrative costs of a range between 
€36 million and €140 million  spread  
over 10 years  for inclusion of active 
substances in Annex 1 
Administrative costs of a range between 
€3.6 million and €52 million  spread  
over 10 years  in biocidal product 
authorisation. 
Labelling cost of a range between €154 
million and €514 million spread  over 10 
years.  
                                                 
54 See section 2.2 why the EU Standard Cost Model was not used. 
 
EN 66   EN Table 2.21: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Scope 
Stakeholders Option 
(b) Include borderline issues 
Benefits 
Minor increase in clarity over 
borderline issues Benefits 
Clearer and more harmonised 
regulatory regime Benefits 
Clearer and more harmonised 
regulatory regime Benefits 
Greater regulatory certainty. 
Framework for addressing risks from 
imported treated materials Administration 
(implementation and 
enforcement) 
Costs 
No significant impacts Costs 
Possible duplication of effort, as 
both food safety and biocidal product regulators would review 
requests Costs 
Possible duplication of effort, as 
both food safety and biocidal product regulators would review 
requests Costs 
Administrative cost in additional active 
substance and product authorisations. 
Should be off-set by fees. 
Some costs related to training and 
improvement in customs controls, and 
labelling requirement 
Benefits 
Not applicable Benefits 
Not applicable Benefits 
Not applicable  Benefits 
Possibly more substances supported and 
thus more products available on the 
market Product availability 
Costs 
Not applicable Costs 
May reduce the number of products, due to costs of 
authorisation Costs 
May reduce the number of products, due to costs of 
authorisation Costs 
Possibly increased prices of treated 
materials 
Social impacts Benefits 
Not applicable Benefits 
Potential health benefits to workers using the products which will be 
included Benefits 
Not applicable Benefits 
Improved protection of consumer health, 
as risks related to substances in imported 
treated materials are assessed 
 
EN 67   EN Table 2.21: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Scope 
Stakeholders Option 
(b) Include borderline issues 
Improved protection of worker health for 
intermediate goods (e.g. wet-blue tanned 
leather) 
With labelling, consumers better able to 
make informed choices 
Costs 
Not applicable Costs 
New products covered may increase costs on SMEs and lead to loss of 
jobs Costs 
New products covered may increase costs on SMEs and lead to loss of 
jobs Costs 
Not applicable 
Benefits 
Limited – possibly better information 
due to clearer regulatory framework Benefits 
Environmental benefits, due to 
increased control and possible 
reduction in use or switch to lower risk products and uses. Benefits 
Greater control ove r environmental 
impacts of use and disposal of food 
contact materials Benefits 
Improved environmental protection, as 
risks related to biocides in imported 
treated materials are assessed  Environmental impacts 
Costs 
Not applicable Costs 
Not applicable  Costs 
Not applicable Costs 
Not applicable 
 
 
EN 68   EN PRODUCT AUTHORISATION 
Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 
Option Stakeholder
s 
(a) Unchanged policy  (b) Strengthening of mutual 
recognition (c) Single Member State authorisation (d) Community authorisation 
Benefits: 
Increase in effectiveness of mutual recognition would reduce costs of 
authorisation Benefits: 
Potential benefits due to greater certainty 
about mutual recognition. 
Reduction of administrative costs 
compared to option (a) Benefits: 
Potential benefits due to automatic ability to sell products across EU 
Significant reduction of administrative 
costs compared to Option 1 + 2 
Benefits significantly reduced under dual 
system Benefits: 
Potential benefits due to automatic ability 
to sell products across EU. 
Significant reduction of administrative 
costs compared to Option 1 + 2 
Benefits significantly reduced under dual 
system  EU industry 
Costs 
Total administrative cost of product 
authorisation €2.9 billion spread over 10 
years . Costs 
Total administrative costs of €2.2 billion 
spread over 10 years ( = 75% of option 
(a) ) Costs 
Total administrative costs €1 billion 
spread over 10 years  
( = below 40% of option (a) ) . Costs 
Total administrative costs €1 billion 
spread over 10 years . 
( = below 40% of option (a) ) . 
Administrat
ion 
(implement
ation and enforcemen
t) Benefits 
No changes in the legislation to 
implement 
Greater clarity on operation of 
authorisation and mutual recognition Benefits 
Potential to share the burden of 
evaluation. 
Better information exchange. 
Possibility to initiate mutual recognition 
and to authorise a product without 
application. Benefits 
Efficiency savings due to reduced 
duplication. 
Benefits reduced under dual system Benefits 
Overall efficiency savings due to the 
ending of duplication 
Benefits significantly reduced under dual 
system 
 
 
EN 69   EN Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 
Option Stakeholder
s 
(a) Unchanged policy  (b) Strengthening of mutual 
recognition (c) Single Member State authorisation (d) Community authorisation 
Costs 
Limited costs of in preparing guidance (<€350,000) and possibly holding 
workshops Costs 
Limited costs of preparing guidance 
(<€350,000) and possibly of holding 
workshops. 
Potential increase in administrative costs 
for a small number of MS. 
Potential loss of fees. Costs 
Potential costs associated with dispute resolution which may not be covered by 
fees 
Costs increased under dual system Costs 
A central agency would require 
significant financial resources and 
experienced staff 
Potential costs associated with dispute 
resolution which may not be covered by 
fees 
Benefits 
More efficient operation of mutual 
recognition could reduce the numbers of 
products lost to the market  Benefits 
Could reduce the numbers of products 
lost to the market and facilitate placing 
on the market of safer products Benefits 
Reducing costs of authorisation, could 
significantly reduce the numbers of 
products lost to the market for economic reasons and facilitate placing on the 
market of safer products 
Benefits reduced under dual system Benefits 
Reducing costs of authorisation, could 
significantly reduce the numbers of 
products lost to the market and facilitate 
placing on the market of safer products 
Benefits reduced under dual system Product 
availability 
Costs 
No changes Costs 
No changes Costs 
Not applicable Costs 
Not applicable 
 
EN 70   EN Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 
Option Stakeholder
s 
(a) Unchanged policy  (b) Strengthening of mutual 
recognition (c) Single Member State authorisation (d) Community authorisation 
Benefits 
None Benefits 
Potentially reduced loss of safer products 
for economic reasons. Benefits 
Potentially reduced loss of safer products for economic reasons. 
Impacts on employment unclear, as 
overall market is unlikely to grow. 
Impacts would be reduced under dual 
system Benefits 
Potentially reduced loss of safer products 
for economic reasons. 
Guarantee of harmonised requirements, 
leading to more reliable assessment. 
Impacts would be reduced under dual 
system Social 
impacts 
Costs 
Potential loss of some safer products if 
mutual recognition fails. 
Impacts on employment unclear Costs 
Employment impacts unclear. Costs 
MS concerns about possible effects from 
failure to consider localised health 
impacts 
Fewer staff needed by Competent 
Authorities for authorisation procedures  
Impacts would be reduced under dual 
system Costs 
Fewer staff needed by Competent 
Authorities. 
Impacts would be reduced under dual 
system  
 
EN 71   EN Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 
Option Stakeholder
s 
(a) Unchanged policy  (b) Strengthening of mutual 
recognition (c) Single Member State authorisation (d) Community authorisation 
Benefits 
None Benefits 
Reduced loss of safer products for 
economic reasons. Benefits 
Reduced loss of safer products for economic reasons 
Impacts would be reduced under dual 
system Benefits 
Reduced loss of safer products for 
economic reasons. 
More incentives for innovation with 
respect to biocidal products based on new 
active substances and low risk biocidal 
products 
Impacts would be reduced under dual 
system Environmental impacts 
Costs 
Potential loss of some safer products if mutual recognition fails Costs 
None Costs 
MS concerns about possible effects from failure to consider localised 
environmental impacts 
Impacts would be reduced under dual 
system Costs 
None 
 
EN 72   EN DATA SHARING 
Table 4.10: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Sharing 
Options Stakeholders 
(a) Unchanged policy – clarification and 
encouragement (b) Mandatory sharing of vertebrate animal 
test data at product authorisation stage (c) Mandatory sharing of vertebrate animal 
test data at product authorisation stage and 
active substance approval stage 
Benefits: 
Some cost savings to applicants for product 
authorisation through a basic functioning of 
mutual recognition. 
Data holders would recover 58% to 85% of their 
animal testing costs Benefits: 
Additional theoretical cost savings  to applicants 
for product authorisation, compared to Option 
(a) of a range between €675 million and €2.6 
billion spread over 10 years ;  
Benefits would be significantly reduced under the 
REACH default of equal cost sharing. Data 
holders would recover 64% to 107% of their costs 
(or 100% under the REACH cost sharing default)  Benefits: 
Compared to option (b): potential savings to 
manufacturers of reintroduced active substances of 
a range between €150 million and €760 million 
spread over 10 years  
Compared to Option (a): total additional 
benefits of a range between €1.4 billion and € 
2.7 billion spread over 10 years . EU industry 
Costs 
No direct costs, but no guarantee that data will be 
shared more effectively.  
Risk of use of data protection to provide an 
obstacle to new market entrants remains  Costs 
Potential costs to formulators of biocidal products 
from increased competition, if more products are 
placed on the market 
Costs of litigation in case of disagreement over 
data sharing Costs 
Potential costs to manufacturers of active 
substances and formulators of biocidal products 
from increased competition, if more products are 
placed on the market 
Costs of litigation in case of disagreement over 
data sharing 
Administration 
(implementation and 
enforcement)   Benefits 
Potential cost savings from reduced numbers of 
data sets to review and easier interpretation of EU 
legislation due to clarification and guidance Benefits 
Potential cost savings from reduced numbers of 
data sets to review; savings likely to be greater 
than for Option (a) Benefits 
Potential cost savings from reduced numbers of 
data sets to review; savings likely to be greater 
than for Option (a) or (b) 
 
EN 73   EN Table 4.10: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Sharing 
Options Stakeholders 
(a) Unchanged policy – clarification and 
encouragement (b) Mandatory sharing of vertebrate animal 
test data at product authorisation stage (c) Mandatory sharing of vertebrate animal 
test data at product authorisation stage and 
active substance approval stage 
Costs 
Commission: preparation of guidance on data 
sharing (<€350,000) 
CAs: development and maintenance of registers of 
test and study reports: between €160,000 and 
€310,000 per year Costs 
Commission: preparation of guidance on data 
sharing (<€350,000) 
CAs: development and maintenance of registers of 
test and study reports: between €160,000 and 
€310,000 per year 
Costs for national courts or arbitration bodies – 
however, will be offset by the fees Costs 
Commission: preparation of guidance on data 
sharing (<€350,000) 
CAs: development and maintenance of registers of 
test and study reports: between €160,000 and 
€310,000 per year 
Costs for national courts or arbitration bodies – 
however, will be offset by the fees 
Benefits: 
Improved guidance could help to ensure that the number of products remaining on the market is at 
the higher rather than lower end of the range Benefits: 
Potentially more products will remain on the market than under Option 1, as increased data 
sharing will reduce the costs Benefits: 
Potentially more products will remain on the 
market than under Option 1 and 2, as increased 
data sharing will reduce the costs and more active 
substances may be re-introduced Product availability 
Costs 
No change Costs 
Not applicable Costs 
Not applicable. 
Benefits: 
May help to ensure that a higher number of safer 
products remains on the market Benefits: 
May help to ensure that a higher number of safer 
products remains on the market than Option (a). 
Reduced costs for industry could help maintain 
employment. Benefits: 
May help to ensure that a higher number of safer 
products remains on the market than Options (a) 
or (b). 
Reduced costs for industry could help maintain 
employment Social impacts 
Costs Costs Costs 
 
EN 74   EN Table 4.10: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Sharing 
Options Stakeholders 
(a) Unchanged policy – clarification and 
encouragement (b) Mandatory sharing of vertebrate animal 
test data at product authorisation stage (c) Mandatory sharing of vertebrate animal 
test data at product authorisation stage and 
active substance approval stage 
No change  Not applicable  Not applicable 
Benefits 
No change Benefits 
Potentially more environmentally-safe products on 
the market due to improved data sharing rules and 
thus less barriers for new entrants 
Reduced number of vertebrate animals used 
for repeated test: between 450,000 and 844,000 
spread over 10 years  Benefits 
Potentially more products on the market due to 
improved data sharing rules and thus fewer 
barriers for new entrants.  
Benefits should be greater than for Option (b) 
Reduced number of vertebrate animals used in 
duplicated tests: around 1 million spread over 
10 years Environmental Impacts 
Costs 
Risk of duplication of testing with vertebrate animals not fully addressed  Costs 
Not applicable. Costs 
Not applicable. 
 
EN 75   EN DATA REQUIREMENTS 
Table 5.13: Comparison of the Benefi ts and Costs to Stakeholders of Op tions Relating to Data Requirements 
Options Stakeholders 
(a) Unchanged policy - 
clarification  (b)Rewording provisions concerning data 
waiving and use of existing information Option (c) Reformulating the system for low-risk 
substances 
Benefits: 
Less uncertainty related to data requirements; 
Improved flexibility: waiving 
option would be made 
operational; 
Harmonisation of data 
requirements amongst national 
authorities. 
Theoretical benefits of 100% 
waiving: a range between €698 
million and €1.4 billion spread 
over 10 years, but unlikely to be realized in practice Benefits: 
Improved flexibility, differences in substance risks 
better addressed; 
Maximum potential reduction in testing costs of 
€85 million spread over 10 years for active 
substances ; 
A range between €341 million and €682 million 
spread over 10 years for products from increased 
waiving, plus additional benefits from greater use 
of existing data. Benefits: 
Reduced costs for manufacturers of low-risk 
substances and products containing them; 
Potential increase in business from more active 
substances and the products that contain them; 
Potential cost savings from positive listing of low 
risk substances of a range between €159 million and 
€340 million spread over 10 years. 
More flexibility in product development encourages 
innovation; 
Lower data requirements/co sts compared to full 
assessment of the active substance; 
Product authorisation not delayed during the 
approval of the active substance; EU Industry 
Costs: 
Continued discretion of MS as to 
waiving of data Costs: 
More complex system of data requirements to 
understand. Costs: 
Difficulties may remain over definition of low-risk 
substances;  
Applying for product authorisation may be more 
complicated, time consuming. 
 
EN 76   EN Table 5.13: Comparison of the Benefi ts and Costs to Stakeholders of Op tions Relating to Data Requirements 
Options Stakeholders 
(a) Unchanged policy - 
clarification  (b)Rewording provisions concerning data 
waiving and use of existing information Option (c) Reformulating the system for low-risk 
substances 
Benefits: 
Less uncertainty related to data requirements; 
Moderate cost savings from 
reduction in workload Benefits: 
More targeted evaluation; 
Less data to be assessed; 
Moderate cost savings from reduction in workload. Benefits: 
More targeted evaluation at product authorisation 
stage where use conditions are known.  
Some potential low risk active substances available 
on the market without their Annex IA inclusion. 
Workload depends on number of low risk products 
to be assesses compared to the number of active 
substances re-introduced Administration 
(Implementation and Enforcement) 
Costs: 
Time and resources required to 
develop and agree upon guidance. 
Justification of waiving 
decisions might increase workload Costs: 
Could require greater coordination among 
Competent Authorities within a MS to share 
information; 
More resources and coordination required to 
inform the applicant about waiving grounds and 
provide any necessary assistance to the applicant. Costs: 
Effort for dossier and/or literature data evaluation of 
potential low risk products  
Lower data requirement could lead to uncertainty 
during the evaluation stage  
Compensation may be requested by manufacturers 
who have already incurred costs for the 
authorisation for ASs that are defined as low risk 
Product Availability Benefits: 
Potential incentive for more product authorisation 
applications, th rough greater 
certainty. Benefits: 
Reduced costs could lead to support of more 
substances by industry – more products available. Benefit: 
Facilitate support of more substances by industry - 
more products available. 
More low risk products with distinct active 
substances on the market. t 
 
EN 77   EN Table 5.13: Comparison of the Benefi ts and Costs to Stakeholders of Op tions Relating to Data Requirements 
Options Stakeholders 
(a) Unchanged policy - 
clarification  (b)Rewording provisions concerning data 
waiving and use of existing information Option (c) Reformulating the system for low-risk 
substances 
Costs: 
No change  Costs 
Potential low quality products remain on the 
market.  Costs: 
Potential low quality products remain on the market. 
Benefits: 
Possible positive impact on 
employment if increased guidance leads to support of 
more products, especially by 
SME's. Benefits: 
Reduced data cost for industry may encourage 
more products onto the market with potential 
employment benefits  
Substitution of higher risk products might lead to 
improvement of health of professional users Benefits:  
Reduced data cost for industry may encourage more 
products onto the market with potential employment 
benefits  
Substitution of higher risk products might lead to 
improvement of health of professional users  Social Impacts 
Costs: 
No change Costs: 
Unknown risks of substances where requirements 
are waived might not become apparent and are not 
assessed.  Costs: 
Unknown risks of “low risk active substances” 
might not become apparent during product 
authorisation 
Environmental Impacts Benefits: 
No change Benefits: 
Could reduce numbers of vertebrate animal used in 
testing by a range between 350,000 to 1,5 million 
spread over 10 years. Benefits: 
Could reduce numbers of vertebrate animal used in 
testing by a range between 30,000 and 343,750 
spread over 10 years  
Use of low risk products  might replace known high 
risk products. 
More low risk products to be encouraged onto the 
market. 
More flexibility in pest control 
 
EN 78   EN Table 5.13: Comparison of the Benefi ts and Costs to Stakeholders of Op tions Relating to Data Requirements 
Options Stakeholders 
(a) Unchanged policy - 
clarification  (b)Rewording provisions concerning data 
waiving and use of existing information Option (c) Reformulating the system for low-risk 
substances 
Costs: 
Loss of potential low risk active substances and products not 
addressed Costs: 
Reduced data requirements might cause 
uncertainties in evaluation of environmental 
impacts. Costs: 
Unknown risks of “low risk active substances” 
might not become apparent during product 
authorisation 
 
EN 79   EN FEES 
Table 6.11: Comparison of the Benefits and Costs to Stakeholders of Options Related to Fees 
Options Stakeholders 
(a) Unchanged policy -increased 
transparency  (b) Partially harmonised fee 
structure  (c) Centralised fees system (d) Specific Provisions for SMEs  
Benefits: 
Publication would facilitate budget planning for companies and may 
reduce differences between MS due 
to open comparison. 
Cost-neutral Benefits: 
More PTs added to new active 
substance dossiers. 
Greater predictability of fees. 
Reduction in costs for 
authorisation across many PTs. 
Installments could bring significant 
benefits to SMEs. 
Cost-neutral  overall Benefits: 
Less disparity between MS: less risk of distortion of competition; 
Increased predictability will allow 
future planning. Benefits: 
Cost reductions: a range between 
€75,600 and €639,000 spread over 
10 years  EU industry 
Costs 
Fees cost between €180 million to €520 million. 
High fees still a problem, especially 
for SMEs 
Cost-neutral Costs 
Fees might still be considered as 
too high for supporting active 
substance or products. 
Potentially, significant increase in 
costs for authorisation with one 
PT. 
Cost-neutral  overall Costs Costs 
Significant transfer of costs from 
SME's to larger industries 
Administration Benefits Benefits Benefits Benefits 
 
EN 80   EN Table 6.11: Comparison of the Benefits and Costs to Stakeholders of Options Related to Fees 
Options Stakeholders 
(a) Unchanged policy -increased 
transparency  (b) Partially harmonised fee 
structure  (c) Centralised fees system (d) Specific Provisions for SMEs  
Reduction in complaints and in the 
cost of dealing with complaints. 
Potential increase in revenue for 
cheaper MS as well as companies. 
Potential for cheaper MS to be 
overwhelmed by authorisation 
applications 
Cost-neutral Clearer information may enable 
more effective budget planning by 
CAs;  
Clarity over fees to be charged so 
fewer objections from companies. 
May encourage more new a/s and 
retention of more existing a/s. 
Costs recovered by increased fees 
therefore cost-neutral  11 to 17 MS would have to 
increase current fees. 
Reduced work load. Needs of SMEs can better be 
addressed by CAs. 
Cost-neutral  (implementation and 
enforcement) 
Costs 
Potential loss of revenue for expensive MS as companies switch 
to cheaper MS 
Cost-neutral Costs 
Less flexibility.  
Different costs of national staff 
might not be addressed adequately. 
Costs recovered by increased fees 
therefore cost-neutral.  Costs 
6-9 MS would have to reduce current fees. 
Possibly lower revenues for 
Member States.  Costs 
Cost-neutral 
Product availability Benefits 
 No major change Benefits 
Potentially improved competition, 
more safe products on the market. 
Increase in availability of some 
products especially from SMEs 
and where AS has many PTs. Benefits 
Potentially improved competition, 
more safe products on the market. 
Increase in availability of some 
products especially from SMEs 
and where AS has many PTs  Benefits 
More products on the market from 
SMEs.  
 
EN 81   EN Table 6.11: Comparison of the Benefits and Costs to Stakeholders of Options Related to Fees 
Options Stakeholders 
(a) Unchanged policy -increased 
transparency  (b) Partially harmonised fee 
structure  (c) Centralised fees system (d) Specific Provisions for SMEs  
Costs 
No major change  Costs 
No change Costs 
No change  Costs 
Potential loss of products from 
larger companies.  
Benefits: 
No major change Benefits: 
Slight increase in safer products. 
Slight increase in employment 
overall. Benefits: 
Slight increase in safer products. 
Slight increase in employment 
overall. Benefits: 
Procedure less costly for SMEs 
helping them to stay on the market 
Job increases in SME's. Social impacts 
Costs 
No major change  Costs 
No major impacts.  Costs 
No major impacts.  Costs 
ob losses in larger companies.  
Benefits 
No change  Benefits 
More (safe) products on the market 
from SMEs.  Benefits 
More (safe) products on the 
market from SMEs  Benefits 
Increase in (safe) products on the 
market from SMEs  Environmental impacts 
Costs 
No change  Costs 
No change Costs 
No change Costs 
Decrease in (safe) products on the 
market from larger companies. 
 
EN 82   EN ANNEX V: STANDARD ASSUMPTIONS ON MARKETS FOR BIOCIDAL PRODUCTS AND ACTIVE SUBSTANCES  
Value Parameter 
Low High Source Notes 
Current Markets 
Total annual market for 
biocide active substance 
at the manufacturer level €0.5 
billion  €1.0 
billion UK HSE and data on global 
market, assuming European 
contribution of 30% (used in Study on the Impacts of the 
BPD) Eurostat data does not 
distinguish between BPD and 
PPP substances 
Total annual market for biocidal products at the 
manufacturer level €1.5 
billion  €3 billion UK HSE (see above ) Eurostat data does not 
distinguish between BPD and 
PPP substances.  
No. biocidal products 
currently on the market 15,000  18,000 Consultation (industry) and 
Composite Report1 Not necessarily consistent with MS registers, due to duplication 
Average no. markets on 
which biocidal products 
are currently placed 10 15 Consultation (industry) Very variable, with a range of 
1 to 27 
Markets Following Product Authorisation 
Likely no. product 
authorisation 
applications 4,500  9,000 Consultation (industry) 
indicates that between 50% 
and 75% of products will not 
be authorised This number is likely to 
change if authorisation 
becomes less onerous/ costly 
Average no. markets on 
which each biocidal 
product will be placed 10  20 Consultation (industry); 
‘typical’ range Actual range is 1 to 27; will 
depend on how onerous 
mutual recognition is. 
 
EN 83   EN Value Parameter 
Low High Source Notes 
No. active substances 
per product 1.5 2 Consultation (industry) Some have more than this; 
may depend on definition of 
active substances and co-formulants 
Average number of 
product types for each 
active substance 3.4 ECB and Member State 
assessment reports  
No. active substances 
that could be 
reintroduced as new 
substances 25 50 Consultation (industry) Will depend upon market 
factors and data requirement 
options. Some consultees 
considered these numbers to 
be over-estimates 
No. ‘me too’ active 
substances  25 50 Consultation (industry) Will depend upon market 
factors and data requirement options. Some consultees 
considered these numbers to 
be over-estimates 
Average no. products per active substance 13.8  27.5 Calculated  Likely no. of authorised 
products divided by expected 
no. active substances on 
Annex 1 
No. manufacturers per additional active 
substance 3 5 Study on impacts of the BPD  REACH Impact Assessment 
used 5 – 16 manufacturers for 
up to 100t/y; from EUSES 
1. This was the consensus of the majority of industry cons ultees, but one company believed  that the totals could be 
much higher whilst another believed that the number of likely products authorisations appears to be high – unless this figure includes both the “core” biocides as well as vari ations with different trade names (i.e. for sale in specific 
 
EN 84   EN Value Parameter 
Low High Source Notes 
countries) or with minor variations in the formulation 
 
EN 85   EN   
ANNEX VI: STANDARD A SSUMPTIONS ON COSTS  
Value  Parameter 
Low High Source Notes 
Product authorisation 
Testing (average) €48,000 €60,000 Consultation (industry) Central estimate - actual cost 
estimates by industry ranged 
from €15,000 to over €150,000 
Dossier preparation €10,000  €70,000 Consultation (industry)  
Letter of access for use 
of data from the active 
substance dossier €32,000  €90,000 Consultation (industry) Most likely to be charged as % 
increase in active substance 
price (of below 5% to 50%) than a lump sum  
Total cost of product 
authorisation 
application €90,000  €200,000 Consultation (industry) 
 Based on average of responses 
Fee – 1st authorisation 
(average) €19,000 Consultation (CAs) and 
Composite report2 Average of responses 
 
Mutual recognition fee 
(average per market) €2,000 Consultation (CAs) and 
composite report2 Average of responses 
Active substance3 
Total testing costs 
(including vertebrate €2  €2.4 Study on impacts of the BPD, Derived from testing cost for 
full data package Confirmed by 
 
EN 86   EN animal testing) million million confirmed by consultation stakeholder information 
Vertebrate animal 
testing costs €1.5 
million  €1.8 
million Study on impacts of the BPD - 
testing cost for full data 
package, confirmed by consultation 75% of total testing cost.  
Total cost of active 
substance dossier €3.0 
million  €5.0 
million Study on impacts of the BPD  
Fees €160,000 Consultation (CAs) and 
composite report Average 
Notes  
2. European Commission (2008): Composite Re port in accordance with Article 24 of Di rective 98/8/EC concerning the placing of 
biocidal products on the market Covering th e period from December 2003 to November 2006 
3. Details of the derivation of cost es timates for active substances  are given Hydrotox, Oekopol, RPA (2007). Study on Impact o f 
the Implementation of Directive 98/8/EC concerning  the Placing on the Market of Biocidal Products  
(http://circa.europa.eu/Pub lic/irc/env/bio_reports/library?l=/study_i mplementation/report_101007pdf/_EN_1.0_&a=d)  
 
EN 87   EN  
ANNEX VII: DELIMITATION OF COSTS  
  
   Administrative 
costs (€) Testing 
costs (€) 
Treated materials - 
inclusion of active 
substances in Annex I:  8.800.000  
1.760.000  
7.040.000 
Treated materials - biocidal 
product autorisation 2.780.000 556.000 2.224.000 
Treated materials - labelling  33.400.000 33.400.000 - 
Product autorisation -130.000.000 -130.000.000 - 
Data sharing - industry -205.000.000 -41.000.000 -164.000.000 
Data requirements - active 
substances -8.500.000 - 425.000 - 8.075.000 
Data requirements - product 
authorisation -51.150.000 -2.557.500 - 48.592.500 
Data requirements - positive 
listing of low risk substances -24.950.000 -1.247.500 - 23.702.500 
TOTAL COSTS (€) per year  -374.620.000 -139.514.000 - 235.106.000 
 
EN 88   EN ANNEX VIII: EU STANDARD CO ST MODEL REPORTING SHEET  
Directive 98/8/EC concerning the placing of biocidal products on the market 
  Tariff 
(€ per 
hour)  
TIme  
(hour) Price 
(per 
action 
or 
equip) Freq 
(per 
year) Nbr  
of  
entities Total nbr
of  
actions Total cost Regulatory 
origin 
(%) 
No. Ass. 
Art. Orig. 
Art. Type of obligation Description of required 
action(s) Target group i e i e           Int EU Nat Reg 
1     Application for individual 
authorisation or 
exemption  Producing new data Treated 
materials - 
inclusion of 
Active Substances in Annex 1         0,0 1 N/A   1.760.000   100%     
2     Application for individual 
authorisation or exemption  Producing new data Treated 
materials - biocidal product autorisation         0,0 1 N/A   556.000   100%     
3     Information labelling for 
third parties Designing information 
material (leaflet conception…) Treated 
materials - labelling costs         0,0 1 N/A   33.400.000   100%     
4     Application for individual 
authorisation or 
exemption  Producing new data Product 
autorisation         0,0 1 N/A   -130.000.000   100%     
5     Application for individual 
authorisation or exemption  Producing new data Data sharing - 
industry         0,0 1 N/A   -41.000.000   100%     
6     Application for individual 
authorisation or exemption  Producing new data Data 
requirements - active substances         0,0 1 N/A   -425.000   100%     
7     Application for individual 
authorisation or exemption  Producing new data Data 
requirements - product auth,         0,0 1 N/A   -2.557.000   100%     
8     Application for individual 
authorisation or exemption  Producing new data Data 
requirements - positive listing of low risk substances         0,0 1 N/A   -1.247.500   100%     
Total Administrative costs (€) -139.514.000