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}
Date: 2009-06-12
Institutions: European Commission
Subjects: chemical product, market approval, marketing, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.6.2009 
SEC(2009) 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} 

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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 
MARKT, SJ, SG. 

DG's  ENTR,  SANCO,  AGRI,  JRC,  RELEX,  TRADE,  COMP, 

Agenda planning: 

2008/ENV/003 

The report commits only the Commission's services involved in the preparation and the text is 
prepared as a basis for comment and does not prejudice the final form of any decision to be 
taken by the Commission 

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TABLE OF CONTENTS 

Executive summary .................................................................................................................... 4 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Procedural issues and consultation of interested parties .............................................. 8 

Problem definition...................................................................................................... 11 

Objectives................................................................................................................... 22 

Policy options............................................................................................................. 23 

Analysis of impacts .................................................................................................... 32 

Comparing the options ............................................................................................... 46 

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: DELIMITATION OF COSTS........................................................................... 87 

ANNEX VIII: EU STANDARD COST MODEL REPORTING SHEET .............................. 88 

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Executive summary 

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

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

The main reasons for these consequences are:  

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

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

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

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

protection and data waiving possibilities; and  

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

products.  

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

The Impact Assessment addresses five policy issues that require action: 

POLICY ISSUE 1: SCOPE 

–  Unchanged policy; 

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

–  Extend scope to cover treated materials. 

The policy options are cumulative. The assessment concluded that including treated materials 
in  the  scope  of  the  Directive  would  significantly  increase  the  costs  to  industry.  However, 

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. 

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

POLICY ISSUE 2: PRODUCT AUTHORISATION 

–  Unchanged policy; 

–  Strengthening of mutual recognition; 

–  Single Member State authorisation; 

–  Community authorisation. 

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

POLICY ISSUE 3: DATA SHARING 

–  Unchanged policy; 

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

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

substance approval stage. 

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

POLICY ISSUE 4: DATA REQUIREMENTS 

–  Unchanged policy; 

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

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

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

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

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

PROCEDURES OF THE DIRECTIVE 

–  Unchanged policy; 

–  Partially harmonised fee structure; 

–  Centralised fee system; 

–  Specific provisions for SMEs. 

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

OVERALL COSTS AND BENEFITS 

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

The impact assessment shows that the combined overall costs of all preferred options to the 
industry  would  amount  to  a  range  from  €193.6  to  706  million 3  over  a  period  of  10  years. 
These costs are attributable to the extension of the scope of the Directive to treated materials 
and  cover  the  costs  of  including  additional  active  substances  in  Annex  I,  the  costs  of  the 
authorisation of additional products and the labelling costs of treated materials. 

The  overall  cost  savings  of  all  the  preferred  options  for  the  industry  could  range  from 
€2.7 to 5.7 billion 4 over a period of 10 years. Due to reasons described in detail in Section 6 

3 
4 

Net present value € 162.2 million to 591.6 million 
Net present value € 2.3 billion to 4.8 billion 

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(Comparing  the  options),  it  is,  however,  unlikely  that  the  cost  savings  would  materialise  in 
such  scale.  The  actual  savings  are  likely  be  closer  to  the  lower  end  of  the  range  but  would 
certainly outweigh the total costs. 

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

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

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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  Commission  strategy  for  simplifying  the 
regulatory environment (2). 

A number of stakeholders, experts and competent 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  authorisation,  data  sharing,  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  consultation  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  Consumer  Protection,  Agriculture,  Joint  Research  Centre, 
External  Relations,  Trade,  Competition,  Internal  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,  several  studies  were  carried  out  by  external 
contractors: 

•  a study to assess the impact of the revision of Directive 98/8/EC concerning the 

placing of biocidal products on the market (5); 

•  a  study  on  the  impacts  of  the  implementation  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 particular 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  (consultants,  individual  companies,  industry 
associations,  NGOs,  Member  State  competent  authorities)  were  consulted  through 

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several questionnaires and interviews. A Stakeholder Consultation Meeting was also 
held on 23 May 2008 in Brussels.  

In addition, an expert workshop was organised 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  organised  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 for the revision during a meeting held on 28 – 
30  May  2008.  In  addition,  several  bilateral  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  industry  demanded  that  a  level  playing  field  is 
created concerning materials treated with biocidal 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  industry  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 process (see section 4.4.3). 

Finally, with respect to fees, the industry fully supported the proposal to introduce a 
partially harmonised fee structure. The provisions aimed at SMEs were welcome in 
particular by SMEs. The Member States were 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 following changes to the assessment: 

–  inserting more information on the market with biocidal products; 

–  clarifying the relevance of the subsidiarity principle; 

–  inserting  a  section  on  methodology,  in  particular  clarifying  the  assumptions 

underlying the assessment; 

–  detailing the impacts on the different users of biocidal products; 

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–  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 authorisation 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 stakeholder 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 authorisation) has been clarified in the 
relevant  sections.  Additionally,  the  problems  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) 

(2) 

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/costs evolve over time. See section 5. 

to be more specific about the level of data confidence and more transparent 
about  uncertainty  when  aggregating  data:  Annex  V  sets  out  the  standard 
assumptions on markets and numbers of products and substances used in the 
analysis  of  the  various  policy  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 stakeholders; however 
a high degree of uncertainty remains.  

(3) 

to  provide  a  clear  definition  of  market  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 

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"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 provided in Annex II 
of this document. 

Biocidal products refer to a wide category of products divided into 23 product types 
including  disinfectants,  pest  control  products,  wood  preservatives,  anti-fouling 
in  all 
products  and  embalming  products.  Professional  users  are  prevalent 
preservatives, in particular wood preservatives, some pest control products (avicides 
and piscicides), anti-fouling products and embalming and taxidermist products. Non-
professional  users  (consumers)  prevail  in  some  pest  control  products  (rodenticides, 
insecticides, repellents and attractants) and some disinfectants. 

The value of the global biocidal products market was in 2000 estimated at around € 3 
billion per year, with North America representing about 43% and Europe 27% (the 
latter approximately worth € 890 million  per year and volumes 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 hold 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  substances,  formulators  of  finished  biocidal 
products,  and  companies  that  are  active  in  both  markets.  As  a  result  of  the 
implementation  of  the  Directive  in  Europe,  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  authorising  biocidal  products  containing  these  substances  at 
the national level. The product authorisation stage of the Directive has not yet been 
implemented.  It  will  be  implemented  gradually  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 products can pose risks to humans, animals and 
the environment in a variety of ways due to their intrinsic properties and associated 
use  patterns.  For  example,  the  use  of  wood  preservatives  or  anti-fouling  products 

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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 representatives of the industry;  
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.  

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often  implies  a  direct  contact  of  the  biocidal  product  with  aquatic  or  marine 
environment. In addition, biocidal products may have negative effects on non-target 
organisms.  With  respect  to  human  health,  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 consequences 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  several  substances  and  products 
have been removed from the market not because of public health or environmental 
concerns but because the costs of producing data for meeting 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 not 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 application, in particular when multiplied by the 
number of countries where a particular product is marketed 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  data  requirements  for  dossier  preparation 
necessitating  significant 
investments.  Small  and  medium-sized  enterprises 
(SMEs), as defined in the Commission Recommendation of  6  May 2003  (9) are 
particularly affected, while larger companies 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  availability  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  development  of  new  active  substances  with 
potentially better risk or efficacy profiles 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  substances  is  not  supported  because  of  the  low 
attractiveness of simplified procedures10. 

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Examples  include  the  use  of  lavender  oil  as  repellent,  copper  sulphate  as  wood  preservatives, 
phenothrin as insecticide, zinc as anti-fouling product, etc. 
Study on Impact of the implementation of Directive 98/8/EC concerning the placing on the market of 
biocidal products 
Resistance is the capacity of bacteria to withstand the effects of a harmful chemical agent. 
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. 

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–  The  implementation  of  neighbouring  legislation  such  as  the  REACH  Regulation 
or the forthcoming Regulation on plant protection 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  interaction  with  the  legal 
framework  on  plant  protection  products  is  largely  limited  to  solving  borderline 
issues  concerning  scope.  With  respect  to  the  rules  on  mutual  recognition  of 
products,  it  should  be  clarified  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 
Directive12. 

–  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 substances with highly hazardous profiles 
(e.g. strychnine, arsenic compounds) have been 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  possibilities,  technical  guidance  for  risk 
assessments and efficacy testing;  

–  the  low  attractiveness  of  simplified  procedures  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 possible repetition of tests; 

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

authorisation of products. 

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12 

Non-active substances are substances which do not have general or specific action on or against harmful 
organisms. They include pigments, dyes, perfumes, solvents, etc. Non-active substances 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. 
The  Regulation  does  not  apply  to  technical  rules  which  are  subject  of  harmonisation  at  Community 
level. 

EN 

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While there are a large number of issues of varying importance that are likely to be 
addressed in the revision of the Directive, there are a few where it has been identified 
that there might be significant 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 mutual recognition. These include for example obligatory 
sharing  of  vertebrate  animal  data,  revision  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  remain  on  the  market  and  innovation  with 
respect  to  new  products  would  be  encouraged.  Importantly,  if  no  action  is  taken, 
many  companies  are,  due  to  high  costs  of  the  product  authorisation  and  mutual 
recognition, likely to stop marketing their products which will lead to problems with 
product availability. Product availability is decisive for example for the development 
of resistance in target organisms. This may 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 authorisation or mutual recognition and will no 
longer find it economically viable 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 facilitate 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 placed on the market over the next 10 years 

–  Minimum number of products: 4 500 

–  Maximum number of products: 9 00013 

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  duplicate  entries.  In  addition,  it  is  expected  that  the  market  will  consolidate 
after the end of the Review Programme. 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 

14 

   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 further assumptions including the number of cases 
where mutual recognition is sought, the rate of referral to the Commission in cases of 
disagreements  over  mutual  recognition,  the  average  number  of  markets  on  which 
biocidal products are placed, the average number of active substances on the market, 
etc.  These  assumptions  were  validated  with  the  stakeholders  (i.e.  individual 
companies,  industry  federations  and  Member  States)  to  make  them  as  robust  as 
possible. Because of the high degree of uncertainty 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 the Commission in case of disagreements over 
mutual recognition;  

–  the  pessimistic  scenario  refers  to  situations  where  there  will  be  fewer 
applications for product authorisations combined with a lower incidence 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 policy options are laid down in ranges which 
are direct consequences of using the scenario approach. The lower 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 the 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  European  Standard  Cost  Model  in  that  they 
examine  the  costs  associated  with  different  information  obligation.  This  was  done 
using the best available data and including 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 authorisation and mutual recognition were not 
yet  implemented.  There  is  no  practical  experience  on  product  authorisation  and 
mutual recognition available. This has implications for all policy options presented in 

14 

It is assumed that the costs of an active substance dossier are one-off 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 

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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 different ways by the Member States; 

–  problems with the functioning of mutual recognition provisions encountered in the 
context  of  Directive  91/414/EEC  concerning  the  placing  of  plant  protection 
products on the market which, mutatis mutandis, could also occur in the present 
case. 

–  concerns raised by all stakeholders, in particular the industry, with regards to the 

smooth functioning of the 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  intentionally  added  to  food  to  fulfil  a  certain 
technological  purpose  (17).  Some  of  these  substances,  although  they  are  clearly 
acting as biocidal active substances, are currently not covered by the Directive. This 
raises the question of coherence with respect to the scope of the Directive. 

Some  processing  aids  used  on  food  of  animal  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 water 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 address environmental concerns 
despite the most recent efforts16.  

In addition, Regulation (EC) No 853/2004 does not apply to processing aids used on 
food of plant origin. There is no other Community legislation requiring an evaluation 
of processing aids used on food of plant origin. This leaves it to the discretion of the 
Member  States  whether  they  take  any  action  to  evaluate  the  human  health  and 
environmental concerns. 

15 

16 

On 9 September 2008, i.e. 8 years after the implementation 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 substances) of the Directive. 
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,  trisodium  phosphate,  peroxyacids)  to  remove  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 

16 

   EN 

                                                 
The  situation  of  food  contact  materials  is  similar  to  that  of  food  processing  aids. 
Despite  the  fact  that  Community  legislation  on  food  contact  materials  exist,  the 
evaluation  of  environmental  effects  associated  with  the  use  of  biocidal  products  in 
food  contact  materials  is  not  foreseen  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 substance to be used in food contact materials 
prior to its authorisation "do not include any consideration 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  applications  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  materials  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  measures  adopted  within  the  scope  of 
Directive  76/769/EEC  (11),  prevents  the  placing  of  materials  treated  with  biocidal 
products containing not approved or even banned active substances on the market.  

For  example,  wooden  poles  for  electricity  which  are  manufactured  in  the  EU  can 
only  be  placed  on  the  market  if  they  are  treated  with  authorised  biocidal  products 
(containing approved active substances). However, imported electricity poles can be 
treated  with  any  biocidal  product.  Concrete  cases  include  the  imports  of  wooden 
electricity  poles  treated  with  products  containing  arsenic  or  chromated  copper 
arsenate (CCA).  

There are no statistics available on the amounts 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 biocidal products. Non-
EU  producers  represent  a  non-negligible  share  of  the  EU  market  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 and 25 to 40% of the EU market for wool 
carpets (5). 

Apart  from  the  possible  negative  environmental  and  human  health  impacts,  this 
situation places in particular the EU producers 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 

17 

   EN 

                                                 
EU  market.  This  is  due  to  the  fact  that  EU  producers  of  treated  materials  can  only 
buy authorised biocidal products containing approved active substances as only these 
can  be  lawfully  placed  on  the  EU  market.  Non-EU  producers  of  treated  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 authorisation is too complex 

The evaluation of active substances is done at Community level and the subsequent 
authorisation  of  products  containing  the  approved  substances  (i.e.:  those  listed  in 
Annex  I  of  the  Directive)  is  done  at  the  national  level,  by  Member  States.  As 
mentioned  above,  the  product  authorisation  stage  has  not  yet  been  implemented. 
Until it is implemented, some Member States operate national product authorisation 
schemes  based on their  national  legislation. However, it should be  noted that  some 
Member  States  with  high  estimated  numbers  of  products  do  not  have  authorisation 
procedures in place at the moment (e.g. France, 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 principle, a company, once it has obtained for 
a  product  a  first  authorisation  in  a  Member  State,  may  apply  for  the  mutual 
recognition of that first authorisation by other Member States. 

As  mentioned  above,  because  the  product  authorisation  has  not  yet  started,  no 
practical  experience  of  the  authorisation  and  mutual  recognition  procedures  is 
available.  However,  experience  from  other  regulatory  frameworks  such  as  plant 
protection  products  (14),  indicates  that  some  changes  might  help  in  anticipating 
future problems.  

Mutual recognition of product authorisations is considered as the major benefit of the 
Directive.  However,  stakeholders  expressed  concerns  regarding  the  effective  and 
homogenous application of mutual recognition. 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 national market, resulting in requests for additional tests. 
The  representatives  of  the  industry  expressed  their  concerns  that  some  Member 
States  may  systematically  require  additional  information  including  testing  and 
repetition  of  the  efficacy  studies  for  the  purposes  of  the  mutual  recognition.  This 
would render the process very time and cost intensive for the industry as well as for 
the competent authorities which would have to evaluate the additional information. 

In addition, the negative past experience with mutual recognition of Plant Protection 
Products  is  the  basis  for  these  concerns.  This  concerns  mainly  the  lack  of  mutual 
trust  among  the  Member  States.  An  example  of  a  functioning  system  of  mutual 
recognition exists under the Medicinal Products 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  States,  the  use  of  guidance  documents  and 
the experience gained through disagreements concerning the mutual recognition. 

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2.3.3.  Policy issue 3: Rules for data sharing are insufficient 

The  Directive  provides  for  a  system  of  data  protection,  which  prevents  Competent 
Authorities  from  using  data  submitted  by  a  first  applicant  for  the  benefit  of  a 
subsequent  applicant,  unless  the  first  applicant  has  agreed  to  it.  This  system  is 
intended to ensure that data owners can recuperate the costs of their investments.  

The Directive urges applicants to co-operate in compiling the necessary data for the 
evaluation of both active substances and biocidal products, but it does not explicitly 
provide for a system of mandatory data sharing. Instead, the data owner may decide 
– but is not obliged – to give a subsequent applicant the right 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, the latter may be either obliged to duplicate 
the  studies  (particularly  undesirable  where  animal  studies  are  concerned),  or  to 
abandon the market. 

The  fact  that  data  sharing  is  not  obligatory  has  given  rise  to  problems  for  industry 
and competent authorities.  

Data sharing aims at avoiding the submission of multiple dossiers for the same active 
substance.  This  was  particularly  relevant  for  the  Review  Programme,  to  limit 
duplication  of  work  and  complication  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  however  also  arise  in  relation  to  biocidal  products  as 
dossiers  for  product  authorisation  must  contain  data  on  the  active  substance.  In  the 
absence of a mechanism of forced data sharing, companies unable to obtain a letter 
of access would need to re-generate certain key data or abandon the market. 

There is a concern amongst stakeholders that under the existing 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 requirements are too extensive 

The requirements of the Directive in terms of toxicity and ecotoxicity studies aim at 
guaranteeing  a  high  level  of  protection  for  human  and  animal  health  and  for  the 
environment and do so effectively.  

These  data  requirements  are  however  a  major  burden  for  companies  that  intend  to 
support active substances. The costs of performing 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  substances  within  the  Review  Programme 
rather than on the development of new ones; 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,  these  data  requirements  are  perceived  as 
excessive for certain substances that are considered to be of low risk. Data waiving 
is, therefore, a crucial issue, especially for very low exposure products. 

EN 

19 

   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  States  for  carrying  out  the  procedures  of 
the Directive are high and varying and the conditions for payment are unclear 

The main problem with the current provisions on fees is that they contribute to the 
heterogenous  fee  structure  and  significant  differences  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  structure  and  level  of  fees.  The  Directive  only 
requires that the fees correspond as far as possible to costs incurred by the Member 
States  in  carrying  out  all  the  different  procedures  associated  with  the  provisions  of 
this  Directive.  Some  Member  States  understand  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  individual  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 than 10 for product authorisation, by almost as 
much for active substance evaluation (Figure 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%).  Industry  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 innovation, in particular with respect to 
low risk biocidal products. 

EN 

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)

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250

200

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BE EL DK EE LV  DE CY ES  SI  IE  PT  FR IT  UK SK AT HU  FI  PL 

LU  NL 

SE 

Member State

Figure 1: Member State Fees and Fee Ranges for Active Substance Evaluation 

It is likely that the main reasons for the differences 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  fees.  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  applying  lower  fees,  leading  potentially  to  an 
overload  of  work  for  these  Member  States  and  a  loss  of  revenue  for  the  more 
expensive  ones.  In  practice,  the  level  of  fees  is,  however,  only  one  factor  in  the 
industry  choice  of  which  Member  State  to  submit  a  dossier,  others  include 
competence, responsiveness and approach 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 application does not pass the completeness check. 
This  is  mainly  a  problem  for  SMEs  for  which  paying  the  entire  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 countries with relatively small market and 
high  fees.  High  fees  may  also  have  a  negative  impact  on  the  innovation,  in 
particular of SMEs.The principle 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 

21 

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be better achieved by the Community. This principle is of high relevance to all policy 
areas discussed under this impact assessment.  

Currently,  the  granting  of  product  authorisations  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  States  have  currently  the  possibility  to 
introduce  national  measures  obliging 
the  applicant  and  holders  of  former 
authorisations  located  within  their  territory  to  share  the  data  on  vertebrate  animals. 
The  Member  States  are  also  currently  responsible  for  setting  the  fees  for  the 
procedures  under  the  Directive.  Any  changes  to  this  division  of  tasks  between  the 
Commission  and  the  Member  States  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  protection  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  high  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  objectives  and  address  the  different  problems 
identified, the following specific objectives have been established: 

•  Ensure  coherence  of  the  scope  of  the  Directive,  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  biocidal  products  in  order  to  encourage 

development of such products; 

•  Provide  clarifications  and 

increase 

legal  certainty  on  waiving  of  data 

requirements; 

•  Improve the proportionality of fees and clarify payment conditions. 

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4.  POLICY OPTIONS 

4.1. 

Policy issue 1: Scope 

The policy options presented below are cumulative. 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  contact  materials  and  treated 
materials. 

4.1.1.  Option (a): Unchanged policy 

In  this  option  only  the  list  of  Community  legislation  mentioned  in  Article  1  of  the 
Directive  would  be  updated  to  take  account  of  developments  in  other  Community 
legislation. This option does not imply regulatory changes. 

4.1.2.  Option (b): Extend scope to cover processing aids and food contact materials 

This  option  would  imply  regulatory  changes  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  addresses  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 potable 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  biocides  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 suitable product types seem to be product 
type  7  or  9  (film  and  plastic  preservatives).  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 required for dossier preparation and evaluation, 
as  substances  used  as  surface  biocides  will  have  already  been  assessed  for  very 
similar types of use19. 

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 Directive in order to protect the 
material itself could be placed on the EU market. If a company wishes to place on the 

18 

19 

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  certain  product  type  (e.g. 
carbon dioxide for product type 14 (rodenticides)). 
This  refers  to  a  situation  when  an  active  substance  used  in  food  contact  material  has  been  already 
evaluated under the Biocides Directive, for example for its use as a film preservative in plastics. 

EN 

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EU  market  a  material  treated  with  a  biocidal  product  that  has  not  been  previously 
authorised in the EU, a full assessment of that product under 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 product-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  approach  in  Article  15  of  Regulation  (EC) 
1935/2004 (19), including:  

–  the  indication  “treated  with  approved  biocide”  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 manufacturer, processor, or seller responsible 

for placing the treated material on the market. 

As  an  alternative,  companies  placing  treated  materials  on  the  EU  market  could  be 
required  to  undertake  self-certification.  The  self-certification  could  be  modelled  on 
the system which exists under the ROHS Directive (21) . Producers and importers of 
electrical and electronic equipment voluntarily label their products as not containing 
any  of  the  hazardous  substances  prohibited  under  the  ROHS  Directive  by  using 
material compliance declarations. Alternatively, a system of third-party certification 
could  be  envisaged  where  companies  placing  treated  materials  on  the  EU  market 
would be required to obtain a certificate from a designated body. 

The  option  would  require  Member  States  to  ensure  adequate  enforcement  of  its 
provisions  through  market  surveillance  mechanisms  so  as  to  ensure  that  treated 
materials sold in the EU contain authorised biocides only. 

4.2. 

Policy issue 2: Product authorisation 

The  policy  options  concerning  the  product  authorisation  as  presented  below  are 
alternatives but within them certain elements could be combined (e.g. strengthening 
of  mutual  recognition  with  Single  Member  State  authorisation  or  strengthening  of 
mutual recognition with Community authorisation). 

Mutual recognition as it exists today could 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 incentives for innovation directed at low risk 
biocidal products and products based on new active substances. 

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4.2.1.  Option (a): Unchanged policy 

to 

In  this  option,  the  Commission  would  continue  to  facilitate  mutual  recognition  by 
providing  support 
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 develop guidance documents on mutual recognition 
and to discuss specific products that could be considered problematic during mutual 
recognition procedures. This option does not imply regulatory changes. 

the 

4.2.2.  Option (b): Strengthening of mutual recognition 

This option would include regulatory changes to clarify and improve the provisions 
on mutual recognition and on conflict resolution in particular.  

Mutual recognition would be improved in two ways:(1) Applicants could submit in 
parallel the application for the first authorisation and the application for the mutual 
recognition of that first authorisation. This would allow the different Member States 
concerned to interact during the assessment of the dossier by the Reference Member 
State and would thus streamline and facilitate the process of mutual recognition. (2) 
Member  States  could  take  the  initiative  to  launch  a  mutual  recognition  procedure, 
when they receive an application for the authorisation of a product already authorised 
in another Member State. In that case, the second Member State would not assess the 
application and would wait to receive the assessment report of the first Member State 
before granting the authorisation on the basis of the conclusions of that assessment 
report. 

These  modifications  are  based  on  similar  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  further  administrative  procedures,  other  than 
complying with labelling rules. 

The  system  would  include  a  clause  stating  that  Member  States  may  object  to 
authorisation  within  a  certain  time  period.  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  wishes  to  market  the  product,  and  submit  a 
proposed label, packaging and safety data sheet for approval (i.e. in particular, in the 
national language). 

During  stakeholders'  consultation,  Member  States  opposed  this  system  on  the 
grounds that it reduces the role of the individual Member States in the authorisation 
process. To take account of it, this option could work as part of a dual system: certain 
categories  of  biocidal  products  would  receive  single  Member  State  authorisation, 
while  others  would  go  through  Member  State  authorisation  and  mutual  recognition 
(options (a) and (b)). 

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25 

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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  current  procedure  for  the  assessment  of  active 
substances. As no central agency exists under the current Directive, 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  assessment  of  biocidal  products  either  by 
preparing  the  assessment  or  giving  an  opinion  on  the  Rapporteur  Member  State 
assessment. 

Some stakeholders, in particular representatives of the industry, expressed a support 
for a fully centralised system of Community authorisations applicable to all biocidal 
products.  This  option  was  initially  considered  but  due  to  the  following  reasons  not 
further pursued: 

–  the  operation  of  a  fully  centralised  system  of  Community  authorisations  would 
require  significant  financial  and  human  resources  (e.g.  operative  costs  of  the 
Agency, costs of organising the meetings of experts, etc.) 

–  the total number of biocidal products is high – between 4.500 to 9000 products20 – 
and  all  of  them  would  have  to  pass  through  the  centralised  system  in  a  limited 
time (around 10 years) after the entry into force of the proposal; 

–  the sensitivity of some Member States with regards to the authorisation of certain 

product types (e.g. disinfectancts) should be taken into consideration.  

As a complete centralisation may not be possible due to the above-stated reasons, a 
partial centralisation could be proposed for just two types of products: 

(1) Biocidal products based on new active substances; 

(2) Low risk biocidal products, potentially without a prior active substance approval  

–  this  will  also  need  to  include  a  screening  phase  to  assess  whether  the  products 
submitted do indeed match specified criteria 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 recognition (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  with  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 

26 

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It  should  be  noted  that  the  Community  authorisation  scheme  would  be  optional  – 
companies would have a choice to go through the Community authorisation system 
or  apply  for  an  individual  Member  State  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 sharing at the product authorisation stage, with 
the possibility for Member States to introduce rules requiring mandatory sharing at 
national  level,  would  be  maintained.  It  is  foreseen  to  clarify  the  requirements  and 
further encourage data sharing. These improvements would not result in changes to 
the current policy on data sharing. 

4.3.2.  Option  (b):  Mandatory  sharing  of  vertebrate  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  required  to  contact  the  Competent  Authority  to  get  a 
permission to carry out the tests or to find 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 protected by data protection provisions. To ensure 
that data sharing works properly, a centralised inventory of studies could be set up by 
the  Commission,  along  the  lines  envisaged  under  REACH,  to  ensure  that  all  the 
information  needed  is  accessible.  Where  a  study  involving  tests  on  vertebrate 
animals  has  been  carried  out  while  they  were  still  protected  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  arbitration  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) would inform the Commission/Agency, which 

21 

See  Title  III  of  the  REACH  Regulation  (EC)  No  1907/2006  –  obligatory  data  sharing  of  vertebrate 
animal data in exchange of compensation and equal sharing as default compensation mechanism in case 
of disagreement 

EN 

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would  have  the  ability  to  give  the  applicant  the  authorisation  to  use  the  data  upon 
payment of a share of the costs (this would be subject to the possibility of appeal). 

4.3.3.  Option  (c):  Mandatory  sharing  of  vertebrate  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 substance 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.  The  procedure  could  be  similar  to  that 
outlined for the sharing of data at the product authorisation stage (see Option b)). 

In  order  to  stimulate  innovation  and  encourage  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  years  (out  of  15)  of  data  protection,  the 
sharing of vertebrate animal tests would 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  requirements  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  would  be  made  more 
precise,  to  clarify  the  concept  of  waiving  in  order  to  avoid  obstacles  linked  to  the 
existing uncertainties. It is important to note that these clarifications would not entail 
changes to the current policy on data waiving. 

It is also foreseen to prepare detailed appropriate guidance in the form of Notes for 
Guidance, published in the Official Journal.  

4.4.2.  Option  (b):  Rewording  provisions  concerning  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.  revising  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  further  guidance  on  the  application  of  the 
waiving provisions,  which could be used to provide higher certainty with regard to 
the  interpretation  of  the  waiving  provisions  in  the  Directive.  This  could  be 
complemented by the use of official and more binding implementing rules.  

EN 

28 

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An obligation for Member States could be included to inform applicants of their right 
to request a waiver including the grounds for such a waiver and provide assistance to 
applicants  in  this  respect.  These  changes  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  applicant  is  required  to  submit  a  dossier 
satisfying the requirements of Annex IIA (core data which are identical for all active 
substances) and, where specified, the relevant parts of Annex IIIA (additional data). 
All  data  (core  and  additional  data  requirements)  can  be  waived  if  appropriate 
justification is provided. However, some Member 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 Annex IIA and IIIA, specifying 
that waiving provisions are applicable to all data requirements or moving some core 
data  to  the  additional  data.  In  addition,  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.  tests  and  studies  developed  under  other  legal 
frameworks)  could  be  considered.  This  is  similar  to  REACH,  which  also  provides 
guidance on how to evaluate the information in terms of validity and reliability. The 
use of existing information could be extended by including a clause in the Directive 
stating that assessments carried out under other Community legislation shall be taken 
into  account,  where  such  legislation  appropriately  covers  the  objectives  of  the 
Directive.  In  addition,  data  requirements  for  product  authorisation  could  also  be 
reduced  where  the  product  has  already  been  authorised  under  other  Community 
legislation  (with  similar  exposure  scenarios  and  analysis  of  risks).  The  assessment 
carried out within the framework of the Directive could then be limited to aspects not 
assessed under these other pieces of legislation e.g. exposure and efficiency.  

Tiered  data  requirements:  using  tiered  data  requirements  would  mean  that  only  a 
limited  set  of  data  would  be  required  upfront.  If  remaining  concerns  justify  it,  the 
competent authorities would be allowed to request additional data from the applicant. 
It might also be possible to link data requirements specifically to product-type; this 
would  mean  that  product-types  associated  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  low-risk  substances  is  to  define  such 
substances. This may prove difficult as, while various substances could be potentially 
considered  low  risk,  in  fact,  risk  always  depends  on  the  product  formulation, 
exposure  and  use  conditions,  which  are  difficult  to  assess  at  the  substance  level 
alone. Around 50 biocidal active substances supported so far under 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. 

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29 

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Substances  could  be  identified  as  being  low-risk  based  on  expert  judgment  (e.g. 
standing  expert  group)  or  available  information  (such  as  in  Annex  IV  or  V  of 
REACH). For these substances, a simple notification 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  products  without  their  active 
substances  being  previously  approved  at  EU  level.  This  would  avoid  some  of  the 
major  costs  linked  to  the  active  substance  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 Community level on whether the product would 
be  eligible  as  a  low  risk  product.  The  screening  process  could  be  organised  by  the 
Agency  which  would  decide  on  whether  a  concrete  product  qualifies  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 applied 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  alternatives  but  within  them  certain  elements 
could  be  combined  (e.g.  harmonised  fee  structure  with  specific  provisions  for 
SMEs).  In  particular,  the  last  option  (Specific  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 clarifications 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 fees 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 all 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 set for simplified or "accelerated" reviews 
of  similar  authorisation  cases,  such  as  re-authorisation  and  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 development of products, or active substances, 
that are low risk or where there is a shortage of products/substances on the market.  

EN 

30 

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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 returned to the company if an evaluation 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  the  EU  level  by  specifying  the 
amount of fees to be charged by Member States or by levying the fees centrally 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 provided 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 provisions for SMEs 

Reduced fees could be charged for SMEs, since 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  reductions  on  annual  fees  as  is  done  in  the 
legislation  on  medicinal  products  for  products  authorised  by  the  Community.  The 
annual fee would apply during the validity of the product authorisation. 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  Directive  and  place  all  biocidal  products  under  the 
REACH  Regulation  or  the  Plant  Protection  Products  Directive  was  not  pursued 
further.  This  is  mainly  due  to  the  fact  that  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 substance. In addition, there was 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 substances is ongoing, it 
was deemed too late to realistically pursue this option. 

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The issue of the use phase of biocides was briefly 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. 

ANALYSIS OF IMPACTS  

It  should  be  noted  that  the  policy  options  in  the  five  policy  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  unchanged  policy  on  data  requirements  or  a 
centralised  fee  system  with  unchanged  policy  on  product  authorisation.  The  only 
exception  is  the  combination  of  a  fully  centralised  authorisation  scheme  with  an 
unchanged policy on fees (Member  States  being  completely responsible  for the fee 
structure, the levels of fees and the payment conditions) or partially harmonised fee 
structure.  A  fully  centralised  authorisation  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  combination  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 determined for all Member States centrally at 
the Community level, some Member States would 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 types of affected parties (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 should 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 

32 

   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 processing aids within the scope of the Directive 
would give rise to administrative costs for industry in preparing applications for the 
authorisation  of  about  3-7  active  substances  and  an  unknown  number  of  biocidal 
products used as food processing aids, as well 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  over  a  longer  period  of  time  necessary  for 
the implementation of such provisions (around 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. For 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 substance evaluation and product authorisation combined with 
mutual  recognition,  where  appropriate.  They  will  not  face  any  net  costs,  however, 
assuming that the level of fees 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  control  of  processing  aids  and 
possibly  a  reduction  in  their  use  or  a  shift  towards  lower  risk  products  and  uses. 
However, a quantification is not possible due to uncertainty about the risk profile of 
the aids and actual responses to the proposed policy change. 

Including  biocides  used  in  food  contact  materials  within  the  Directive  would 
require inclusion  in  Annex I  of the Directive of the active substances they contain; 
this could cost industry a range from €5 million to €50 million 25 for the inclusion 
of active substances, depending on the assumptions adopted, and from €8.3 million 
to  €73  million 26  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): Extend 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  treated  wood.  These  sectors  were 
chosen  because  they  have  quite  different  characteristics  and  thus  the  analysis 
provided a broad range of potential impacts.  

23 

24 
25 
26 

Net present value €3.8 million to € 29.3 million disc
rate. 
Net present value €4.1 million to €42.7 million 
Net present value € 4.2 million to € 41.9 million 
Net present value € 6.9 million to € 61.2 million 

ounted to the start of the period using 4% discount 

EN 

33 

   EN 

                                                 
The total costs of the inclusion of additional active substances for importers27 of 
all treated materials would be in a range between €36 million and €140 million 28 
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  biocidal  products  for  imported  treated 
materials  would  be  in  a  range  from  €3.6  million  to  €52  million 29  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 imported 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 million 30 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 market in the EU spread over 10 years (5). An 
alternative to labelling would be self-certification, which would impose lesser costs 
for  industry  but  would  generate  lesser  consumer  benefits  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  product  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  playing  field  with  third-country 
manufacturers of treated materials. This may 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 

28 
29 
30 

As  mentioned  in  Section  3.2.1.3,  EU  manufacturers  of  treated  materials  already  use  only  authorised 
biocidal products. 
Net present value € 30.2 million to € 117.3 million 
Net present value € 3.0 million to € 43.6 million 
Net present value € 129.0 million to € 430.1 million 

EN 

34 

   EN 

                                                 
improve the situation of SMEs, which produce 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 health benefits are, however, difficult to quantify due to 
missing evidence linking the use of biocidal products to quantified impacts on health 
and the environment. However, some anecdotal evidence on the benefits is available. 
This  evidence  mainly  concerns  imported  products  such  as  treated  wood  or  treated 
textiles which contained unauthorised substances. The exposure to these substances 
can  lead  to  severe  allergic  reactions,  in  particular  in  cases  of  old  people,  children, 
people  with 
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 organisms and the local ecosystems.  

system,  etc.  The  consequences 

immunity 

reduced 

In addition, it would also provide for an improved protection of workers' health with 
respect to intermediate goods (e.g. leather used for the 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 industry would be € 2.9 billion 31 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 recognition. In addition, it 
assumes that companies intend to place their products on a high number of markets. 
In reality, companies may choose to limit the 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  failure  of  the  mutual  recognition 
process. The failure of mutual recognition is likely to be particularly problematic for 
SMEs  which  cannot  afford  the  costs  of  additional  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 unlikely to change significantly, market losses 
for some companies will be balanced by gains for others.  

31 

Net present value € 2.4 billion 

EN 

35 

   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 depend on the number of products, which will be 
authorised  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 baseline 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  option  both  the  Commission  and  Competent  Authorities  will  face 
direct costs associated to facilitating the process of mutual recognition similarly to 
Option (a). 

For  Competent  Authorities  in  charge  of  product  dossiers,  this  option  may  pose 
additional  administrative  costs  for  co-ordination  with  other  Member  States.  This 
cost  may  fall  disproportionately  on  a  small  number  of  “respected”  Competent 
Authorities. This cost could be compensated for by an increase in the fee payable to 
the  authority  in  charge  of  the  dossier  assessment.  By  reducing  the  administrative 
costs  of  product  authorisation,  this  option  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 depend, as for Option (a) on the 
number of products, which will be authorised 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 

36 

   EN 

                                                 
Costs of authorisation to Industry
(Relative costs compared to current regime)

Table 1 

100

90

80

70

60

50

40

30

20

10

0

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 
billion33  spread  over  a  period  of  10  years.  The  administrative  costs  would  be 
below  40%  of  those  of  Option  (a)  (see  table  1);  the  reduction  in  costs  would  be 
particularly significant for SMEs placing products on several Member State markets. 
The  costs  again  depend  mainly  on  the  rate  of  referral  of  applications  to  the 
Community level, which has been estimated 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  possibly  delays.  Other  Member  States  may 
receive  few  applications,  generating  insufficient  revenue  from  fees  to  retain  the 
necessary expertise in dossier assessment. This option could imply a high number of 
objections from the other Member States which have not assessed 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 

37 

   EN 

 
                                                 
might not take full account of potential health and environmental impacts across the 
EU.  

5.2.4.  Costs and benefits of Option (d): Community authorisation 

A  system  of  Community  authorisation  for  product  authorisation  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  recovered  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 years 35, and 
at less than 40% of the costs of Option (a) (see table 1).  

A system of Community authorisation would likely improve the product availability 
as  the  costs  of  the  Community  authorisation  would  be  lower  than  the  costs  of 
Member State authorisations combined with the costs for the mutual recognition. 

There could be additional benefits to health and the environment as the assessment 
by a central authority would improve the overall consistency.  

However,  as  explained  above  (see  sections  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  which  only  certain  products  would  be 
eligible  for  a  Community  authorisation.  The  rest  of  the  products  would  obtain  a 
Member  State  authorisation  and  could  go  through  a  mutual  recognition  process  if 
there  is  an  interest  to  market  them  in  more  than  one  Member  State.  Such  a  dual 
system would better reflect the 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 centralisation, 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 the centralised system. However, it would 
provide some efficiency gains compared to Option a). The efficiency gains would 
stem  from  the  different  measures  described  under  Option  b)  aimed  to  improve 
mutual  recognition  and  the  centralised  Community  authorisation  for  certain 
categories  of  products  under  Option  d).  The  functioning  of  the  dual  system  could 
however be revised after a certain period and additional products potentially included 
in the Community authorisation system. 

34 
35 

Net present value € 15.1 million to €16.8 million 
Net present value € 0.8 billion 

EN 

38 

   EN 

                                                 
5.3. 

Policy issue 3: Data sharing 

The  main  scope  for  data  sharing  is  likely  to  be  between  applicants  for  product 
authorisation  and  holders  of  data  on  the  active  substance(s)  contained  within  the 
product.  Most  stakeholders  who  were  consulted  believed  that  data  sharing  would 
work reasonably well, although some concerns were expressed. 

The  three  options  presented  below  address  the  problem  related  to  high  costs  of 
compiling  a  dossier,  in  particular  the  dossier  on  the  active  substance,  and  the 
objective of reducing vertebrate 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 guidance prepared for REACH and for the 
proposed Regulation on Plant Protection Products (22). 

There  would  also  be  additional  costs  to  Competent  Authorities  in  setting  up  and 
maintaining  registers  of  test  and  study  reports  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  range  from  €675  millio n  to  €2.6  billion 36 
spread over a period of 10 years 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 sets 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  approach  of  sharing  costs  equally  as  a 
default option in cases of disagreements was adopted.  

36 
37 

Net present value € 565.6 million to € 2.2 billion 
It should be noted that cost savings in such scale are unlikely to materialise because they are based on 
the  assumption  that  under  the  existing  framework  the  companies  would  regenerate  parts  of  the  data 
package. In reality, many companies, particular SMEs, would be unable to face such costs and would 
stop marketing their products in the EU. 

EN 

39 

   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  they  should  be  greater  than  for  Option  a) 
because of the obligatory nature of data sharing in Option b). 

Furthermore, it would become easier to extend 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  SMEs,  which  generally  have  fewer  resources 
available for up-front payments. However, as the option encourages data owners and 
applicants  to  reach  agreement  on  cost  sharing,  it  should  be  possible  for  “staged” 
payment of this type to continue.  

There could also be some costs to 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 market share for generic products. The impact assessment 
for  the  proposed  Plant  Protection  Products  Regulation  (16)  considered  that  this 
impact  could  be  significant,  but  stakeholders  consulted  have  indicated  that  other 
factors are more significant in determining the profitability of biocidal products. 

In  case  of  disagreements  over  data  sharing  (e.g.  disputes  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 therefore, 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, for example, the costs could be similar 
to those for the ECHA classification and labelling inventory, at around €130,000 to 
€260,000 per year. 

EN 

40 

   EN 

5.3.3.  Costs and benefits of Option (c): Mandatory sharing of vertebrate animal test data at 

product authorisation stage and active substance approval stage 

Option c) could generate additional benefits to industry, compared to Option a), 
in  the  range  between  €1.4  billion  and  €2.7  billion 38  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  saving  in  the  range  between  €  150 
million and € 760 million 39 spread over a period of 10 years.  

Nevertheless,  it  should  be  noted  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 product authorisation. Companies, in particular 
SMEs,  would  unlikely  be  able  to  incur  the  costs  for  such  regeneration  and  would 
probably  stop  marketing  their  products  in  the  EU.  The  cost  savings  of  Option  c) 
would rather have the form of maintaining 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 significant 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 Community level by the 
time an amendment to the Directive is adopted, 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 protection) in order to stimulate 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 market share for generic products. The impact 
assessment  for  the  proposed  Plant  Protection  Products  Regulation  (16)  considered 
that this impact could be significant; there would also be issues of fairness, because 
of the lower costs faced by these new entrants to the market. 

38 
39 

Net present value € 1.2 billion to € 2.3 billion 
Net present value € 125.7 million to € 636.8 million 

EN 

41 

   EN 

                                                 
In  case  of  disagreements  over  data  sharing  (e.g.  costs  of  studies,  identity  of  the 
substance),  there  would  be  additional  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  animal  tests  at  both  the  product  authorisation 
and  active  substance  stages  will  be  removed.  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 animals40. 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  clarity  regarding  the  data  requirements  of  the 
Directive, there is the potential for the waiving 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  billion 41  spread  over  a  period  of  10  years.  This  saving  is  based  on  two 
scenarios with 4,500 and 9,000 estimated applications across the EU 27 over the next 
10 years. 

The  harmonisation  of  data  requirements,  including  efficacy  testing,  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 offset 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  would  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  protection  should  not  be  affected  and  there  should  be  no 
adverse environmental impacts.  

40 

41 

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. 
Net present value € 584.9 million to € 1.2 billion 

EN 

42 

   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 data requirements of the Directive could be 
reworded,  to  minimise  animal  testing  and  to  reduce  costs  as  far  as  possible.  These 
include  strengthening  of  provisions  on  waiving;  clarifying  the  use  of  existing 
information and the introduction of a common 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  efficacy  testing  in  every 
Member State). 

Based  on  theoretical  modelling,  data  waiving  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 substances and in the range from 
€341 million to €682 million 43 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  applications  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 evaluate 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 authorities, 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): Reformulating 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  preferred  alternative  to  other  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  risk  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 approval and product authorisation 
under  the  current  system.  The  costs  savings  are  greatest  where  low  risk  active 

42 
43 
44 

Net present value € 71.2 million 
Net present value € 285.7 million to € 571.4 million 
Net present value € 285.7 million to € 571.4 million 

EN 

43 

   EN 

                                                 
substances  are  included  in  Annex  IA,  as  this  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  testing:  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  substances  would  have  to  be  evaluated,  but  Competent 
Authorities  would  save  time  and  effort  that  would  have  been  used  to  evaluate 
additional tests. Reduced requirements for low risk products could have a significant 
positive  impact  on  product  availability  and  could  increase  the  numbers  of  safe 
products placed on the EU market, giving public health and environmental benefits. 

The  impacts  on  public  authorities  will  depend  largely  upon  the  definition  of  low 
risk  products  adopted  and  upon  the  data  requirements  for  their  authorisation.  The 
Commission  Services  and  Competent  Authorities  would  have  to  develop  guidance 
and  the  effort  required  to  achieve  a  harmonised  approach  could  be  considerable. 
Some active substance perceived as being low risk, which have not been supported 
for  Annex  IA  inclusion,  might  be  re-introduced  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,  the  main  change  from  increasing  the 
transparency of the current system, with fees 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  transparency  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 mutual recognition to parallel 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 the 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 

44 

   EN 

–  Variation in fees by product-types: the scale of impact will be determined by the 
number of applications for product authorisations 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  overall  revenue  they 
receive  is  maintained,  the  overall  effect  on  industry  will  be  cost-neutral. 
Instead, there would be a transfer of costs 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  check,  and  might  encourage  industry  to 
seek the evaluation of active substances not previously supported.  

It is likely that Member States would adjust the level of their 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 subsidiarity principle: Member States 
are best placed to set the levels 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  would  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 than 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 increased 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 law to the level needed to recover costs.  

Any  distortion  of  the  market  caused  by  varying  fee  rates  across  the  EU  would, 
however, be removed; this could 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 

45 

   EN 

A  fully  centralised  fee  system  would  raise  questions  concerning  the  subsidiarity 
principle  as  it  would  transfer  the  competences  over  setting  fees  from  the  Member 
States to the Community. A full harmonisation would mean that the fees applicable 
to  all  Member  States  would  be  decided  at  Community  level.  This  may  lead  to  a 
situation that in some Member States the fees levied will not cover the costs linked to 
processing  the  individual  applications.  In  other  Member  States  the  fees  would  go 
beyond  what  may  be  necessary  to  cover  the  costs.  Material  and  human  resources 
costs  of  the  services  can  not  be  harmonised  in  all  Member  States  unless  a  fully 
centralised authorisation scheme is put in place. 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  the  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. 
45 spread over a period of 
Cost can be reduced by a range of €75,600 to €639,000
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, placed 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  evaluation  stage  and  the  product  authorisation  stage).  All  other 
policy  areas  require  a  combination  of  various  options  in  order  to  adequately 
address  the  problem  and  adapt  the  solution  to  the  current  situation  on  the  market 
with  biocidal  products.  In  particular,  with  regard  to  product  authorisation,  the 
Member  States  have  expressed  serious  concerns  about  a  full  centralisation  of  the 
product  authorisation  under  the  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 principle. The same applies to fees where the harmonised fee 
structure should be accompanied with specific provisions to SMEs. With respect to 
the scope issues and data requirements, the 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 

46 

   EN 

                                                 
The  impact  assessment  shows  that  the  total  costs  of  all  preferred  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 preferred options for the industry could 
range from €2.7 bill ion to 5.7 billion spread over a period of 10 years47. The cost 
savings  (compared  to  Unchanged  Policy  option)  would  be  achieved  through  the 
options  concerning  product  authorisation,  data  sharing,  data  requirements  and  fees. 
In practice, these cost savings are very unlikely 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  calculated  in  comparison  to  the  Unchanged 
Policy  (Option  a))  which  assumes  that  companies  would  regenerate  significant 
parts of the data package for the purposes of the product authorisation under the 
existing legal framework. As already explained in Section 5.3.3, many companies, 
in  particular  SMEs,  are  unlikely  to  bear  such  costs  and  would  rather  stop 
marketing their products; 

–  with respect to the product authorisation and mutual recognition, the Unchanged 
Policy  (Option  a))  is  based  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 thus also the benefits that 
could be achieved by an obligatory data sharing scheme. It is, however, difficult to 
quantify  the  impacts  of  such  linkages.  The  calculations  also  do  not  consider  the 
numerous  uncertainties  mentioned  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 savings 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 

47 

Based on the overall EU market with treated materials of €22.2 billion per year (€222 billion over 10 
years). 
The  cost  savings  include  the  cost  savings  achieved  through  improvement  of  mutual  recognition  and 
partial centralisation of product authorisation, introduction of obligatory data sharing at substance and 
product authorisation stage, strengthening of the waiving provisions, revision of the concept relating to 
low risk biocidal products and reductions of the fees for SMEs. 

EN 

47 

   EN 

                                                 
savings were included. A detailed overview of the costs and cost savings is available 
in Annex IV of this document. 

Preferred option 

Total costs / cost savings 

extend 
Scope: 
treated materials 

scope 

to 

€193.6  and 
Costs  between 
706  million  spread  over  10 
years 

authorisation: 
Product 
Facilitation, 
improvement 
and  strengthening  of  mutual 
recognition 

Product 
authorisation: 
Community  authorisation  for 
certain categories of products 

Data 
sharing:  Mandatory 
sharing  of  vertebrate  animal 
product 
data 
test 
authorisation 
active 
substance approval stage 

at 
and 

requirements: 
Data 
Rewording 
provisions 
concerning  data  waiving  and 
existing 
use 
the 
information 

of 

Cost  savings  up 
million 
years48 

to 

€700 

spread  over  10 

Cost  savings  up 
€1.9 
billion spread over 10 years49 

to 

Cost  savings  between  €1.4 
and 2.7 billion spread over 10 
years 

Cost  savings  between  €426 
and  767  million  spread  over 
10 years50 

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 
€75,600  and  639,000  spread 

between 

48 

49 

50 

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.. 
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. 
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 

48 

   EN 

                                                 
SMEs 

Total costs  

Total cost savings 

over 10 years 

Between 
million 
years  

€193.6  and  706 
spread  over  10 

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  scope  to  treated  materials  could  be  much 
lower than this, as manufacturers are likely to switch to substances on Annex I and 
authorised  products  where  possible,  avoiding  these  costs.  The  environmental  and 
human health benefits resulting from extending 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  environmental  benefit  but  they  are  likely  to  be 
significant.  The  same  applies  to  the  competitiveness  benefits  for  the  EU  industry 
with respect to their position on the EU market. In addition, 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 product 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 authorisation 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 requirements require an existing 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,  data  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  environment.  This  may  benefit  particularly 
SMEs which often lack human and financial resources to ensure compliance with the 
requirements  of  the  Directive.  For  example,  the  obligatory  sharing  of  vertebrate 
animal  data  will  mean  that  the  formulators  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 authorisation. In addition, 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 reduction in the costs of authorisation to the 
industry,  encouraging  authorisation  of  more  products  or  authorisation  in  more 

EN 

49 

   EN 

markets.  This  will  benefit  mainly  consumers  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  preferred  options  in  all  policy  areas  could  have 
positive  impacts  on  employment.  In  particular,  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.  With  respect  to  scope,  the 
producers of treated materials will be affected most significantly. Examples include 
the  chemicals  sector  (water  resistant  and  fungi-based  paint  manufacture),  timber 
processing and leather industries. The changes may also lead to increased prices of 
imported treated materials, which might however 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  formulators  of  biocidal  products.  However, 
given  the  ongoing  implementation  of  the  Review  Programme  for  the  evaluation  of 
existing  active  substances,  the  changes  will  have  more  impact  on  the  formulators 
than  the  active  substance  producers.  The  options  concerning  product  authorisations 
will have impact only on biocidal product formulators. The changes concerning the 
scope  may  have  implications  for  both  active  substance  producers  and  biocidal 
product formulators. 

Improved data waiving and obligatory data sharing may particularly benefit SMEs as 
they  often  lack  financial  and  human  resources  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  particular,  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  market  throughout  the  Community  without  the 
need  to  request  an  authorisation  in  all  Member  States  or  go  through  the  mutual 
recognition  process.  They  will  also  benefit  from  the  improved  data  waiving  and 
obligatory  data  sharing.  Concerning  the  fees,  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 

50 

   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  products  are  considered  a  preferred  alternative  to  other 
biocidal  products.  The  environmental  and  human  health  benefits  of  using  low  risk 
products are, however, not easily quantifiable due to the missing information on the 
risk  profiles  of  low  risk  biocidal  products  and  the  number  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  would  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 active 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  achieve  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. 

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51 

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SCOPE 

(a) Unchanged policy 

(b) Include borderline issues 

(c) Include treated materials 

Food processing aids 

Food contact materials 

Minor  costs  associated  with 
updating the Directive 

Administrative  costs  between  €4.5 
million and €35 million spread over 
for  active 
10  years 
evaluation;  

substance 

Administrative  costs  of  a  range 
between  €5  million  and  €50  million 
spread  over  10  years 
substance evaluation;  

in  active 

Administrative  costs  of  a 
between €36 million and €140 million 
spread  over  10  years  for  Annex  1 
inclusion of active substances;  

range 

€5  million  to  €51  million  spread 
over  10  years  for  biocidal  product 
authorisation. 

€8.3  million  to  €73  million  spread 
over  10  years  for  biocidal  product 
authorisation. 

€3.6  million  to  €52  million  spread 
years 
over 
authorisation;  

for 

10 

product 

PRODUCT AUTHORISATION 

(a) Unchanged  

(b)  Strengthening  of  mutual 
recognition 

Single  Member 

(c) 
authorisation 

State 

(d) Community authorisation 

€154  million  to  €514  million  spread 
over 10 years for labelling.  

Improved  protection  of  environment, 
consumer and workers health 

Total  administrative  costs 
industry: 
over 10 years 

€  2.9  billion  spread 

to 

administrative 

Total 
industry: € 2.2 billion spread over 10 
years 

costs 

to 

administrative 

Total 
industry:€  1  billion  spread  over  10 
years 

costs 

to 

Cost  savings  to  industry:  0.7  billion 
spread over 10 years 

Cost  savings  to  industry:  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 

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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  testing  with  vertebrate 
animals not fully addressed 

Additional theoretical cost savings on top of basic 
functioning  of  mutual  recognition  to  applicants 
for  product  authorisation  compared  to  option  (a) 
by a range between € 675 million and €2.6 billion 
spread over 10 years 

Additional theoretical cost savings on top of basic 
functioning of mutual recognition to applicants for 
product  authorisation  compared  to  option  (a)  by  a 
range between €1.4 billion and €2.7 billion spread 
over 10 years 

Number  of  animals  saved:  between  450,000  and 
844,000 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 saved: 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 

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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 
structure 

fee 

(c) Centralised fees system 

(d) Specific Provisions for SMEs 

Minor increase in clarity 

in 

Reduction 
for 
inclusion/authorisation  of  several 
PTs; 

costs 

More  effective  budget  planning  by 
Competent Authorities. 

May  encourage  more  new  active 
substances  and  retention  of  more 
existing active substances. 

Increased 
products especially from SMEs 

availability  of 

some 

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 
helping them to stay on the market 

for  SMEs, 

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7. 

MONITORING AND EVALUATION 

Monitoring and evaluation will be on the basis of measurements against the general 
objectives set out in Section 4. The core indicators for the general policy objectives 
are shown in the table below. 

There are a number of sources of information 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.  Every  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  information  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 exchange 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  cancelled.  The  register  will  be  operable  by 
the  end  of  2009.  The  overall  goal  of  the  R4BP  system  is  to  provide  a  notification 
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 Member 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  initiated  procedures  to  all  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  available  information  in  the  system  and  to 
provide a status report of pending and finalised procedures upon demand. 

A  new  reporting  article  related  to  the  use  phase  could  be  included  in  the  revised 
Directive and could provide important information on quantities of biocidal products 
placed on the market. 

As  for  the  evaluation,  the  Commission  will  review  the  Composite  Reports  due  in 
2010 and 2013 to assess the impact of the revision of the Directive. 

Objective 

Indicator 

Data source 

Facilitate  the  harmonisation 
for 
the  EU  market 
of 

Number  of  active  substances 
evaluated 

Progress  report  extracted 
from DG ENV's database 

EN 

55 

   EN 

 
biocidal products 

Speed of product authorisation  Community  Register  For 

Continue  to  provide  high 
level 
for 
of  protection 
humans,  animals  and  the 
environment 

Number  of  conflicts  in  Mutual 
require 
Recognition 
resolution at Community level 

that 

Biocidal Products 

The  Commission/Agency 
the 
will  keep 
number 
conflict 
resolutions 

track  of 
of 

Number of biocidal products on 
the market 

Reporting  obligation  from 
MS to the Commission. 

Community  Register  for 
Biocidal Products 

Number of poisoning incidents  Reporting  obligation  from 
MS  to  the  Commission 
under  Article  24  of  the 
Directive. 

Number  of  low  risk  biocidal 
products 

Number of data sharing failures 
(linked to animal testing) 

The  Agency  will  keep 
track  of 
the  decisions 
about  low  risk  biocidal 
products 

The  Commission/Agency 
are informed when there is 
no agreement. 

Increase the competitiveness 
of the EU industries affected 
by this Directive 

Number 
substances  

of 

new 

active 

Agency 

of 

unfavourable 
Number 
controls/inspections 
the 
in 
market surveillance activities in 
particular 
treated 
materials 

the 

for 

Member States 

EN 

56 

   EN 

 
 
ANNEX I 
REFERENCES 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  - 
Commission  Legislative  and  Work  Programme  2008  (Brussels,  23.10.2007  - 
COM(2007) 640) 

Second  progress  report  on  the  strategy  for  simplifying  the  regulatory  environment 
(Brussels, 30.01.2008 - COM(2008) 33 final 

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 (Official Journal L 123, 24 
April  1998,  p.1).  All  relevant  information  regarding  the  Biocidal  Products  Directive 
98/8/EC 
at: 
http://europa.eu.int/comm/environment/biocides/index.htm 

implementing 

Regulations 

found 

and 

can 

its 

be 

Commission Impact Assessment guidelines of 15 June 2005 (SEC 2005 - 791). 

Study to assess the impact of the revision of Directive 98/8/EC concerning the placing 
of biocidal products on the market (final report submitted on 14th August 2008 – when 
approved available at: http://ec.europa.eu/environment/biocides/study.htm). 

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)  

Study  on  impacts  of  possible  measures  to  manage  articles  or  materials  treated  with 
at: 
imported 
biocides, 
http://ec.europa.eu/environment/biocides/study.htm)  

particular 

available 

(2006 

when 

in 

- 

Study  on  the  assessment  of  different  options  to  address  risks  from  the  use  phase  of 
biocides (ongoing) 

Commission  Recommendation  of  6  May  2003  concerning  the  definition  of  micro, 
small and medium-sized enterprises (OJ L 124 of 20.5.2003, p. 36) 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10)  Second composite report prepared in accordance with the provisions of Article 24 of 
Directive  98/8/EC  and  covering  the  period  from  December  2003  to  November  2006 
(2008 - available at 
http://ec.europa.eu/environment/biocides/pdf/composite_report_2006.pdf).  

(11)  Council  Directive  76/769/EEC  of  27  July  1976  on  the  approximation  of  the  laws, 
regulations and administrative provisions of the Member States relating to restrictions 
on  the  marketing  and  use  of  certain  dangerous  substances  and  preparations  (Official 
Journal L 262, 27.9.1976, p. 201–203) 

(12)  Directive 2001/83/EC of the European Parliament 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 

57 

   EN 

 
 
(13)  Directive 2001/82/EC of the European Parliament 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  Agency  pursuant  to  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH). 

(16)  Commission  Staff  Working  Document  Report  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  the  approximation  of  the  laws  of  the 
Member States concerning food additives authorized 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 intended to come into contact 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 Food for the presentation of an application 
for  safety  assessment  of  a  substance  to  be  used  in  food  contact  materials  prior  to  its 
authorisation (http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf) 

(21)  Directive  2002/95/EC  of  the  European  Parliament  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 Parliament and of the Council concerning 
the placing of plant protection products on the market (COM(2006) 388 final) 

(23) 

2007  annual 
EMEA/MB/17464/2008) 

report  of 

the  European  Medicines  Agency 

(May  2008 

- 

(24)  Communication from the Commission 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 Security - Communication from the President in agreement 
with Vice-President Wallström (26.1.2005 - COM(2005) 12 )  

(26)  Communication  to  the  Spring  European  Council  -  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 

58 

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(27)  Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  - 
Proposal  for  a  joint  declaration  by  the  Council,  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 

59 

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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  "the  Directive")  was  adopted  on  16th  February  1998.  It  aims  to 
harmonise the European market for biocidal products and their active substances; at the same 
time it aims to provide a high level of protection for humans, animals and the environment.  

What is a biocidal product?  

Biocidal  products  are  active  substances  or  preparations  containing  one  or  more  active 
substances,  intended  to  destroy,  deter,  render  harmless,  prevent  the  action  of,  or  exert  a 
controlling  effect  on  harmful  organisms,  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, covering 23 different  product-types. These include 
disinfectants  used  in  different  areas,  chemicals  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 already covered by other Community legislation, 
such as plant protection products, medicines, and 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  the  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  system,  based  on  the  evaluation  and 
approval  of  the  active  ingredients  at  Community  level,  and  the  subsequent  authorisation  of 
biocidal products containing these ingredients 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 into 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  can  be  found  at: 
http://europa.eu.int/comm/environment/biocides/index.htm 

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60 

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•  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  order  to  allow  for  their  risk  and  efficacy  assessment,  and 
ultimately  their  inclusion  in  the  above-mentioned  positive  list  (Annexes  I,  IA  or  IB  to  the 
Directive). During this 10-year period, Member States may continue to apply their systems or 
practices for the placing of biocidal products on the market ('the transitional period').  

In  a  first  step,  industry  was  invited  in  2000  to  identify  all  existing  active  substances  and  to 
notify to the Commission those substances 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  principle  of  mutual  recognition  of  authorisations. 
Under this principle, a biocidal product that has already been authorised or registered in one 
Member  State  must  be  authorised  in  another  Member  State  within  120  days  or  registered 
within 60 days of an application being received by the other Member State.  

Product Authorisation stage 

The product authorisation stage has not yet started. 

A  Product  Authorisation  and  Mutual  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 recognition of authorisations and registrations in 
particular.  

What should a "Active Substance 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 
53 

From 14 May 2000 to 14 May 2010. 
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 

61 

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–  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 including 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 

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ANNEX III: GLOSSARY 

PT: Product-type 

PT 1: Product-type 1: Human hygiene biocidal products 

PT  2:  Product-type  2:  Private  area  and  public  health  area  disinfectants  and  other  biocidal 
products 

PT 3: Product-type 3: Veterinary hygiene biocidal products 

PT 4: Product-type 4: Food and feed area disinfectants 

PT 5: Product-type 5: Drinking 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, rubber and polymerised materials preservatives 

PT 10: Product-type 10: Masonry preservatives 

PT 11: Product-type 11: Preservatives for liquid-cooling and processing systems 

PT  12:  Product-type  12:  Slimicides,  Products  used  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: Metalworking-fluid preservatives 

PT  14:  Product-type  14:  Rodenticides,  Products  used  for  the  control  of  mice,  rats  or  other 
rodents. 

PT 15: Product-type 15: Avicides, Products used for the control of birds. 

PT 16: Product-type 16: Molluscicides, Products used for the control of molluscs. 

PT  17:  Product-type  17:  Piscicides,  Products  used  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  attractants,  Products  used  to  control  harmful 
organisms  (invertebrates  such  as  fleas,  vertebrates  such  as  birds),  by  repelling  or  attracting, 
including those that are used for human or veterinary hygiene either directly or indirectly. 

PT 20: Product-type 20: Preservatives for food or feedstocks 

EN 

63 

   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 other structures used in water. 

PT 22: Product-type 22: Embalming and taxidermist fluids, Products 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 

64 

   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 

(a) Unchanged policy 

(b) Include borderline issues 

(c) Include treated materials 

EU industry 

Benefits 
Minor 
increase 
borderline issues 

in 

clarity  over 

Benefits 
Clearer  and  more  harmonised 
regulatory regime 

Benefits 
Possibly 
certainty 

increased 

regulatory 

Food processing aids 

Food contact materials 

Costs 
Minor  costs  associated  with  updating 
the Directive 

costs54 

Costs 
Administrative 
between 
million  spread  over  10  years  for 
active substance evaluation. 

€4.5  million  and 

ranging 
€35 

Costs 
Administrative  costs  of  a  range 
between 
million  spread  over  10  years  in 
active substance evaluation. 

€5  million  and 

€50 

Administrative  costs  of  a  range 
between 
million  spread  over  10  years  for 
biocidal product authorisation. 

€5  million  and 

€51 

Administrative  costs  of  a  range 
between 
million  spread  over  10  years  in 
biocidal product authorisation. 

€8.3  million  and 

€73 

Benefits 
Harmonisation  of  rules  and  level  playing 
field with third country producers 

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 

65 

EN 

 
  
 
                                                 
Table 2.21: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Scope 

Stakeholders 

Option 

(b) Include borderline issues 

Administration 
(implementation 
enforcement) 

and 

Benefits 
Minor 
increase 
borderline issues 

in 

clarity  over 

Benefits 
Clearer  and  more  harmonised 
regulatory regime 

Benefits 
Clearer  and  more  harmonised 
regulatory regime 

Benefits 
Greater regulatory certainty. 

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 

Framework  for  addressing  risks  from 
imported treated materials 

Costs 
Administrative  cost  in  additional  active 
substance  and  product  authorisations. 
Should be off-set by fees. 

related 

training  and 
Some  costs 
improvement  in  customs  controls,  and 
labelling requirement 

to 

Product availability 

Benefits 
Not applicable 

Benefits 
Not applicable 

Benefits 
Not applicable  

Benefits 

Costs 
Not applicable 

Possibly  more  substances  supported  and 
thus  more  products  available  on  the 
market 

Costs 
Possibly 
materials 

increased  prices  of 

treated 

the  number  of 
of 

costs 

to 

the  number  of 
of 

costs 

to 

reduce 

Costs 
May 
products, 
authorisation 

due 

reduce 

Costs 
May 
products, 
authorisation 

due 

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 

66 

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 

Environmental impacts 

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  over  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  

Costs 
Not applicable 

Costs 
Not applicable  

Costs 
Not applicable 

Costs 
Not applicable 

EN 

67 

EN 

 
  
 
Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 

PRODUCT AUTHORISATION 

Stakeholder
s 

Option 

(a) Unchanged policy  

Strengthening 

(b) 
recognition 

of  mutual 

(c) Single Member State authorisation 

(d) Community authorisation 

EU industry 

Benefits: 
Increase 
recognition  would 
authorisation 

in  effectiveness  of  mutual 
reduce  costs  of 

Benefits: 
Potential benefits due to greater certainty 
about mutual recognition. 

Benefits: 
Potential benefits due to automatic ability 
to sell products across EU 

Benefits: 
Potential benefits due to automatic ability 
to sell products across EU. 

Reduction 
compared to option (a) 

of 

administrative 

costs 

Significant  reduction  of  administrative 
costs compared to Option 1 + 2 

Significant  reduction  of  administrative 
costs compared to Option 1 + 2 

Benefits significantly reduced under dual 
system 

Benefits significantly reduced under dual 
system 

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 
spread over 10 years  

€1  billion 

Costs 
Total  administrative  costs 
spread over 10 years. 

€1  billion 

( = below 40% of option (a) ). 

( = below 40% of option (a) ). 

Benefits 
No  changes 
implement 

in 

the 

legislation 

to 

Benefits 
Potential 
evaluation. 

to 

share 

the  burden  of 

Benefits 
Efficiency 
duplication. 

savings  due 

to 

reduced 

Greater 
operation 
authorisation and mutual recognition 

clarity 

on 

of 

Better information exchange. 

Benefits reduced under dual system 

Possibility  to  initiate  mutual  recognition 
and 
to  authorise  a  product  without 
application. 

Benefits 
Overall  efficiency  savings  due  to  the 
ending of duplication 

Benefits significantly reduced under dual 
system 

68 

EN 

Administrat
ion 
(implement
ation 
enforcemen
t) 

and 

EN 

 
  
 
Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 

Stakeholder
s 

Option 

(a) Unchanged policy  

Strengthening 

(b) 
recognition 

of  mutual 

(c) Single Member State authorisation 

(d) Community authorisation 

Costs 
Limited  costs  of  in  preparing  guidance 
(<€350,000) 
workshops 

possibly 

holding 

and 

Costs 
Limited  costs  of  preparing  guidance 
(<€350,000)  and  possibly  of  holding 
workshops. 

Costs 
Potential  costs  associated  with  dispute 
resolution  which  may  not  be  covered  by 
fees 

central 

Costs 
A 
significant 
experienced staff 

agency  would 

financial 

resources 

require 
and 

Potential  increase  in  administrative  costs 
for a small number of MS. 

Costs increased under dual system 

Potential  costs  associated  with  dispute 
resolution  which  may  not  be  covered  by 
fees 

Potential loss of fees. 

Product 
availability 

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 
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 

Benefits reduced under dual system 

Costs 
No changes 

Costs 
No changes 

Costs 
Not applicable 

Costs 
Not applicable 

EN 

69 

EN 

 
  
Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 

Stakeholder
s 

Option 

(a) Unchanged policy  

Social 
impacts 

Benefits 
None 

Strengthening 

(b) 
recognition 

of  mutual 

(c) Single Member State authorisation 

(d) Community authorisation 

Benefits 
Potentially reduced loss of safer products 
for economic reasons. 

Benefits 
Potentially reduced loss of safer products 
for economic reasons. 

Benefits 
Potentially reduced loss of safer products 
for economic reasons. 

Costs 
Potential  loss  of  some  safer  products  if 
mutual recognition fails. 

Costs 
Employment impacts unclear. 

Impacts on employment unclear 

Impacts  on  employment  unclear,  as 
overall market is unlikely to grow. 

Guarantee  of  harmonised  requirements, 
leading to more reliable assessment. 

Impacts  would  be  reduced  under  dual 
system 

Impacts  would  be  reduced  under  dual 
system 

Costs 
MS concerns about possible effects from 
failure 
localised  health 
impacts 

to  consider 

Fewer 
staff  needed  by  Competent 
Authorities for authorisation procedures  

Impacts  would  be  reduced  under  dual 
system 

Costs 
Fewer 
Authorities. 

staff  needed  by  Competent 

Impacts  would  be  reduced  under  dual 
system 

EN 

70 

EN 

 
  
Table 3.18: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Product Authorisation 

Stakeholder
s 

Option 

(a) Unchanged policy  

Environme
ntal impacts 

Benefits 
None 

Strengthening 

(b) 
recognition 

of  mutual 

(c) Single Member State authorisation 

(d) Community authorisation 

Benefits 
Reduced 
economic reasons. 

loss  of  safer  products  for 

Benefits 
Reduced 
economic reasons 

loss  of  safer  products  for 

Benefits 
Reduced 
economic reasons. 

loss  of  safer  products  for 

Impacts  would  be  reduced  under  dual 
system 

Costs 
Potential  loss  of  some  safer  products  if 
mutual recognition fails 

Costs 
None 

Costs 
MS concerns about possible effects from 
localised 
failure 
environmental impacts 

consider 

to 

incentives  for 

More 
innovation  with 
respect to biocidal products based on new 
active  substances  and  low  risk  biocidal 
products 

Impacts  would  be  reduced  under  dual 
system 

Costs 
None 

Impacts  would  be  reduced  under  dual 
system 

EN 

71 

EN 

 
  
Table 4.10: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Sharing 

Stakeholders 

Options 

DATA SHARING 

EU industry 

(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: 
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 

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) 

Compared  to  Option  (a):  total  additional 
benefits  of  a  range  between  €1.4  billion  and  € 
2.7 billion spread over 10 years. 

Costs 
No direct costs, but no guarantee that data will be 
shared more effectively. 

Costs 
Potential costs to formulators of biocidal products 
from  increased  competition,  if  more  products  are 
placed on the market 

Risk  of  use  of  data  protection  to  provide  an 
obstacle to new market entrants remains 

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 
enforcement)  

and 

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 

72 

EN 

 
  
Table 4.10: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Sharing 

Stakeholders 

Options 

(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) 

Costs 
Commission:  preparation  of  guidance  on  data 
sharing (<€350,000) 

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 

CAs: development and maintenance of registers of 
test  and  study  reports:  between  €160,000  and 
€310,000 per year 

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  for  national  courts  or  arbitration  bodies  – 
however, will be offset by the fees 

Product availability 

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 

Costs 
No change 

Costs 
Not applicable 

Costs 
Not applicable. 

Social impacts 

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 

Costs 

Costs 

Costs 

EN 

73 

EN 

 
  
Table 4.10: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Sharing 

Stakeholders 

Options 

(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 

Environmental Impacts 

No change 

Benefits 
No change 

Not applicable  

Not applicable 

Benefits 
Potentially more environmentally-safe products on 
the market due to improved data sharing rules and 
thus less barriers for new entrants 

Benefits 
Potentially  more  products  on  the  market  due  to 
improved  data  sharing  rules  and  thus  fewer 
barriers for new entrants.  

Reduced  number  of  vertebrate  animals  used 
for repeated test: between 450,000 and 844,000 
spread over 10 years 

Benefits should be greater than for Option (b) 

Reduced number of vertebrate animals used in 
duplicated  tests:  around  1  million  spread  over 
10 years 

Costs 
Risk  of  duplication  of  testing  with  vertebrate 
animals not fully addressed 

Costs 
Not applicable. 

Costs 
Not applicable. 

EN 

74 

EN 

 
  
Table 5.13: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Requirements 

Stakeholders 

Options 

DATA REQUIREMENTS 

(a)  Unchanged 
clarification 

policy 

- 

(b)Rewording  provisions 
waiving and use of existing information 

concerning  data 

Option (c) Reformulating the system for low-risk 
substances 

EU Industry 

Benefits: 
Less  uncertainty  related  to  data 
requirements; 

Benefits: 
Improved flexibility, differences in substance risks 
better addressed; 

Benefits: 
Reduced  costs 
for  manufacturers  of 
substances and products containing them; 

low-risk 

Improved 
option 
operational; 

flexibility:  waiving 
be  made 

would 

Maximum  potential  reduction  in  testing  costs  of 
€85  million  spread  over  10  years  for  active 
substances ; 

Potential  increase  in  business  from  more  active 
substances and the products that contain them; 

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. 

data 
Harmonisation 
requirements  amongst  national 
authorities. 

of 

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 

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/costs  compared  to  full 
assessment of the active substance; 

Product  authorisation  not  delayed  during 
approval of the active substance; 

the 

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 

75 

EN 

 
  
Table 5.13: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Requirements 

Stakeholders 

Options 

(a)  Unchanged 
clarification 

policy 

- 

(b)Rewording  provisions 
waiving and use of existing information 

concerning  data 

Option (c) Reformulating the system for low-risk 
substances 

Administration 
(Implementation 
Enforcement) 

and 

Benefits: 
Less  uncertainty  related  to  data 
requirements; 

Benefits: 
More targeted evaluation; 

Less data to be assessed; 

Benefits: 
More  targeted  evaluation  at  product  authorisation 
stage where use conditions are known.  

Moderate  cost  savings 
reduction in workload 

from 

Moderate cost savings from reduction in workload. 

Some  potential  low  risk  active  substances  available 
on the market without their Annex IA inclusion. 

Costs: 
Time  and  resources  required  to 
develop 
upon 
guidance. 

agree 

and 

Costs: 
Could 
among 
Competent  Authorities  within  a  MS  to  share 
information; 

require  greater 

coordination 

Justification 
decisions 
workload 

of 
might 

waiving 
increase 

More  resources  and  coordination  required  to 
inform  the  applicant  about  waiving  grounds  and 
provide any necessary assistance to the applicant. 

Workload  depends  on  number  of  low  risk  products 
to  be  assesses  compared  to  the  number  of  active 
substances re-introduced 

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 
the 
who  have 
authorisation for ASs that are defined as low risk 

incurred 

already 

costs 

for 

Product Availability 

Benefits: 
Potential 
product 
applications, 
certainty. 

incentive 

for  more 
authorisation 
through  greater 

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. 

low  risk  products  with  distinct  active 

More 
substances on the market. t 

EN 

76 

EN 

 
  
Table 5.13: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Requirements 

Stakeholders 

Options 

Social Impacts 

(a)  Unchanged 
clarification 

policy 

- 

(b)Rewording  provisions 
waiving and use of existing information 

concerning  data 

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 
increased 
if 
employment 
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 

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 

Substitution  of  higher  risk  products  might  lead  to 
improvement of health of professional users 

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 

77 

EN 

 
  
Table 5.13: Comparison of the Benefits and Costs to Stakeholders of Options Relating to Data Requirements 

Stakeholders 

Options 

(a)  Unchanged 
clarification 

policy 

- 

(b)Rewording  provisions 
waiving and use of existing information 

concerning  data 

Option (c) Reformulating the system for low-risk 
substances 

Costs: 
Loss of potential low risk active 
substances  and  products  not 
addressed 

Costs: 
Reduced 
uncertainties 
impacts. 

data 

requirements  might 

cause 
in  evaluation  of  environmental 

Costs: 
Unknown  risks  of  “low  risk  active  substances” 
might  not  become  apparent  during  product 
authorisation 

EN 

78 

EN 

 
  
Table 6.11: Comparison of the Benefits and Costs to Stakeholders of Options Related to Fees 

Stakeholders 

Options 

FEES 

(a)  Unchanged  policy  -increased 
transparency 

(b)  Partially  harmonised 
structure 

fee 

(c) Centralised fees system 

(d) Specific Provisions for SMEs 

EU industry 

Benefits: 
Publication  would  facilitate  budget 
planning  for  companies  and  may 
reduce differences between MS due 
to open comparison. 

Cost-neutral 

Costs 
Fees  cost  between  €180  million  to 
€520 million. 

High fees still a problem, especially 
for SMEs 

Cost-neutral 

Benefits: 
More  PTs  added  to  new  active 
substance dossiers. 

Benefits: 
Less  disparity  between  MS:  less 
risk of distortion of competition; 

Benefits: 
Cost  reductions:  a  range  between 
€75,600 and €639,000 spread over 
10 years 

Greater predictability of fees. 

Increased predictability will allow 
future planning. 

Reduction 
in 
authorisation across many PTs. 

costs 

for 

Installments could bring significant 
benefits to SMEs. 

Cost-neutral overall 

Costs 

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 
Significant  transfer  of  costs  from 
SME's to larger industries 

Administration 

Benefits 

Benefits 

Benefits 

Benefits 

EN 

79 

EN 

 
  
Table 6.11: Comparison of the Benefits and Costs to Stakeholders of Options Related to Fees 

Stakeholders 

Options 

(a)  Unchanged  policy  -increased 
transparency 

(b)  Partially  harmonised 
structure 

fee 

(c) Centralised fees system 

(d) Specific Provisions for SMEs 

(implementation 
enforcement) 

and 

Reduction  in  complaints  and  in  the 
cost of dealing with complaints. 

Potential  increase  in  revenue  for 
cheaper MS as well as companies. 

Clearer  information  may  enable 
more  effective  budget  planning  by 
CAs;  

Clarity  over  fees  to  be  charged  so 
fewer objections from companies. 

Potential  for  cheaper  MS  to  be 
overwhelmed 
authorisation 
by 
applications 

May  encourage  more  new  a/s  and 
retention of more existing a/s. 

Cost-neutral 

Costs  recovered  by  increased  fees 
therefore cost-neutral 

11  to  17  MS  would  have  to 
increase current fees. 

Needs  of  SMEs  can  better  be 
addressed by CAs. 

Reduced work load. 

Cost-neutral 

Costs 
for 
Potential 
expensive  MS  as  companies  switch 
to cheaper MS 

loss  of 

revenue 

Cost-neutral 

Costs 
Less flexibility. 

Costs 
6-9  MS  would  have  to  reduce 
current fees. 

Costs 
Cost-neutral 

Different  costs  of  national  staff 
might not be addressed adequately. 

Costs  recovered  by  increased  fees 
therefore cost-neutral. 

Possibly 
Member States. 

lower 

revenues 

for 

Product availability 

Benefits 
 No major change 

Benefits 
Potentially  improved  competition, 
more safe products on the market. 

Benefits 
Potentially improved competition, 
more safe products on the market. 

Benefits 
More  products  on  the  market  from 
SMEs. 

Increase  in  availability  of  some 
products  especially  from  SMEs 
and where AS has many PTs. 

Increase  in  availability  of  some 
products  especially  from  SMEs 
and where AS has many PTs 

EN 

80 

EN 

 
  
Table 6.11: Comparison of the Benefits and Costs to Stakeholders of Options Related to Fees 

Stakeholders 

Options 

(a)  Unchanged  policy  -increased 
transparency 

(b)  Partially  harmonised 
structure 

fee 

(c) Centralised fees system 

(d) Specific Provisions for SMEs 

Social impacts 

Costs 
No major change 

Benefits: 
No major change 

Costs 
No change 

Costs 
No change 

Benefits: 
Slight increase in safer products. 

Benefits: 
Slight increase in safer products. 

Costs 
Potential 
larger companies. 

loss  of  products  from 

Benefits: 
Procedure  less  costly  for  SMEs 
helping them to stay on the market 

increase 

in  employment 

Slight 
overall. 

increase 

Slight 
overall. 

in  employment 

Job increases in SME's. 

Costs 
No major change 

Costs 
No major impacts. 

Costs 
No major impacts. 

Costs 
ob losses in larger companies. 

Environmental impacts 

Benefits 
No change  

Costs 
No change 

Benefits 
More (safe) products on the market 
from SMEs. 

Benefits 
More 
market from SMEs 

(safe)  products  on 

the 

Benefits 
Increase  in  (safe)  products  on  the 
market from SMEs 

Costs 
No change 

Costs 
No change 

Costs 
Decrease  in  (safe)  products  on  the 
market from larger companies. 

EN 

81 

EN 

 
  
ANNEX V: STANDARD ASSUMPTIONS ON MARKETS FOR BIOCIDAL PRODUCTS AND ACTIVE SUBSTANCES 

Parameter 

Value 

Source 

Notes 

Low 

High 

€0.5 
billion  

€1.0 
billion 

Current Markets 

Total annual market for 
biocide active substance 
at 
the  manufacturer 
level 

UK  HSE  and  data  on  global 
market,  assuming  European 
contribution  of  30%  (used  in 
Study  on  the  Impacts  of  the 
BPD) 

data 

not 
Eurostat 
distinguish  between  BPD  and 
PPP substances 

does 

Total annual market for 
biocidal  products  at  the 
manufacturer level 

€1.5 
billion  

€3 billion  UK HSE (see above ) 

No.  biocidal  products 
currently on the market 

15,000  

18,000 

Consultation 
Composite Report1 

(industry)  and 

Average no. markets on 
which biocidal products 
are currently placed 

10 

15 

Consultation (industry) 

Eurostat 

data 

does 

not 

distinguish  between  BPD  and 
PPP substances.  

Not  necessarily 
with  MS  registers,  due 
duplication 

consistent 
to 

Very variable, with a range of 
1 to 27 

Markets Following Product Authorisation 

product 

4,500  

9,000 

Likely 
no. 
authorisation 
applications 

Consultation 
(industry) 
indicates  that  between  50% 
and  75%  of  products  will  not 
be authorised 

This  number 
change 
if 
becomes less onerous/ costly 

is 
to 
likely 
authorisation 

Average no. markets on 
which  each  biocidal 
product will be placed 

10  

20 

Consultation 
‘typical’ range 

(industry); 

Actual  range  is  1  to  27;  will 
depend  on  how  onerous 
mutual recognition is. 

EN 

82 

EN 

 
  
Parameter 

Value 

Source 

Notes 

Low 

High 

No.  active  substances 
per product 

1.5 

2 

Consultation (industry) 

Average  number  of 
product  types  for  each 
active substance 

No.  active  substances 
that 
be 
could 
reintroduced  as  new 
substances 

3.4 

and  Member  State 

ECB 
assessment reports 

25 

50 

Consultation (industry) 

No.  ‘me 
substances  

too’  active 

25 

50 

Consultation (industry) 

Average  no.  products 
per active substance 

13.8  

27.5 

Calculated  

Some  have  more  than  this; 
may  depend  on  definition  of 
active  substances  and  co-
formulants 

Will  depend  upon  market 
factors  and  data  requirement 
options. 
consultees 
Some 
considered  these  numbers  to 
be over-estimates 

Will  depend  upon  market 
factors  and  data  requirement 
consultees 
Some 
options. 
considered  these  numbers  to 
be over-estimates 

Likely  no.  of 
authorised 
products  divided  by  expected 
no. 
substances  on 
Annex 1 

active 

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 consultees, 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 variations with different trade names (i.e. for sale in specific 

EN 

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Parameter 

Value 

Source 

Notes 

countries) or with minor variations in the formulation 

Low 

High 

EN 

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EN 

 
  
Parameter 

Value 

Source 

Notes 

ANNEX VI: STANDARD ASSUMPTIONS ON COSTS 

Low 

High 

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 

Total  cost  of  product 
authorisation 
application 

€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  

€90,000  

€200,000  Consultation (industry) 

Based on average of responses 

Fee  –  1st  authorisation 
(average) 

€19,000 

Consultation 
Composite report2 

(CAs) 

and 

Average of responses 

Mutual  recognition  fee 
(average per market) 

€2,000 

Consultation 
composite report2 

(CAs) 

and 

Average of responses 

Active substance3 

Total 
(including 

testing 

costs 
vertebrate 

€2  

€2.4 

Study  on  impacts  of  the  BPD,  Derived  from  testing  cost  for 

full data package Confirmed by 

EN 

85 

EN 

 
  
 
 
 
 
 
 
animal testing) 

million 

million 

confirmed by consultation 

stakeholder information 

Vertebrate 
testing costs 

animal 

€1.5 
million  

€1.8 
million 

Study on impacts of the BPD - 
full  data 
testing  cost 
by 
package, 
consultation 

confirmed 

for 

75% of total testing cost.  

Total  cost  of  active 
substance dossier 

€3.0 
million  

€5.0 
million 

Study on impacts of the BPD 

Fees 

Notes 

€160,000 

Consultation 

(CAs) 

and 

Average 

composite report 

2. European Commission (2008): Composite Report in accordance with Article 24 of Directive 98/8/EC concerning the placing of 
biocidal products on the market Covering the period from December 2003 to November 2006 

3. Details of the derivation of cost estimates for active substances are given Hydrotox, Oekopol, RPA (2007). Study on Impact of 
the 
the  Market  of  Biocidal  Products 
concerning 
(http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/study_implementation/report_101007pdf/_EN_1.0_&a=d) 

Implementation  of  Directive  98/8/EC 

the  Placing  on 

EN 

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ANNEX VII: DELIMITATION OF COSTS 

Administrative 
costs (€) 

Testing 
costs (€) 

1.760.000 

7.040.000 

556.000 

2.224.000 

materials 

Treated 
inclusion 
substances in Annex I:  

of 

- 
active 

8.800.000 

Treated  materials  -  biocidal 
product autorisation 

2.780.000 

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 

Data requirements - product 
authorisation 

-51.150.000 

Data requirements - positive 
listing of low risk substances 

-24.950.000 

- 425.000 

- 8.075.000 

-2.557.500 

- 48.592.500 

-1.247.500 

- 23.702.500 

TOTAL COSTS (€) per year  

-374.620.000 

-139.514.000 

- 235.106.000 

EN 

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EN 

 
  
 
 
 
 
 
 
 
 
ANNEX VIII: EU STANDARD COST 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 

2 

3 

4 

5 

6 

7 

8 

Application for individual 
authorisation or 
exemption  

Producing new data 

Application for individual 
authorisation or 
exemption  

Information labelling for 
third parties 

Application for individual 
authorisation or 
exemption  
Application for individual 
authorisation or 
exemption  

Application for individual 
authorisation or 
exemption  

Application for individual 
authorisation or 
exemption  

Application for individual 
authorisation or 
exemption  

Producing new data 

Designing information 
material (leaflet 
conception…) 

Producing new data 

Producing new data 

Producing new data 

Producing new data 

Producing new data 

Treated 
materials - 
inclusion of 
Active 
Substances in 
Annex 1 
Treated 
materials - 
biocidal product 
autorisation 
Treated 
materials - 
labelling costs 
Product 
autorisation 

Data sharing - 
industry 

Data 
requirements - 
active 
substances 
Data 
requirements - 
product auth, 
Data 
requirements - 
positive listing of 
low risk 
substances 

0,0 

1 

N/A 

1.760.000 

100% 

0,0 

0,0 

0,0 

0,0 

0,0 

0,0 

1 

1 

1 

1 

1 

1 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

556.000 

100% 

33.400.000 

100% 

-130.000.000 

100% 

-41.000.000 

100% 

-425.000 

100% 

-2.557.000 

100% 

0,0 

1 

N/A 

-1.247.500 

100% 

Total Administrative costs (€) -139.514.000  

EN 

88 

EN