Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products (Text with EEA relevance) {SEC(2009) 773} {SEC(2009) 774}
Date: 2009-06-12
Institutions: European Commission
Subjects: chemical product, market approval, marketing, pesticide

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.6.2009 
COM(2009) 267 final 

2009/0076 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the placing on the market and use of biocidal products  

(Text with EEA relevance) 

{SEC(2009) 773} 
{SEC(2009) 774} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Grounds for and objectives of the proposal 

Directive  98/8/EC  of  the  European  Parliament  and  the  Council  of  16  February  1998 
concerning  the  placing  of  biocidal  products  on  the  market  (hereinafter  'the  Directive') 
establishes  a  harmonised  regulatory  framework  for  the  authorisation  and  the  placing  on  the 
market  of  biocidal  products,  the  mutual  recognition  of  these  authorisations  within  the 
Community and the establishment at Community level of a positive list of active substances 
that  may  be  used  in  biocidal  products.  In  its  Article  18(5),  the  Directive  requires  the 
Commission to draw up a report seven years after its entry into force and to submit the report 
to  the  Council.  The  report  shall  address  the  implementation  of  the  Directive  and  the 
functioning up to that date of the simplified procedures (frame formulations, low-risk biocidal 
products and commodity substances). In accordance with the same provision, the Commission 
may accompany its report, if necessary, by proposals for amendment of the Directive.  

The Commission submitted the report on 8 October 2008 (COM(2008)620) and proposed at 
this occasion to extend the review programme, the transitional period, and certain provisions 
on data protection that accompany this period for an additional three years.  

Further to the proposal already presented, and based on the conclusions of the ‘seven years’ 
report,  the  present  proposal  for  revision  of  Directive  98/8/EC  aims  to  tackle  the  identified 
weaknesses of the regulatory framework during the first eight years of its implementation, to 
improve and update certain elements of the system and to avoid problems anticipated in the 
future.  

1.2. 

General context 

The  review  of  the  implementation  of  the  Directive  has  indicated  that  for  the  evaluation  of 
active substances, the simplified procedures provided for in the Directive, notably for low-risk 
products  (Annex  IA  to  the  Directive),  have  no  real  effect,  and  that  in  addition  the  data 
requirements and data waiving provisions may be unclear or inconsistently applied or lead to 
a disproportionate burden in some circumstances.  

In  addition,  although  product  authorisation  has  not  yet  started,  simplification  of  the 
procedures  concerning  the  authorisation  of  biocidal  products  in  the  Member  States  may  be 
beneficial  in  reducing  costs  and  administrative  burden  for  companies  and  public  authorities 
alike. The proposal is seeking to improve the existing regulatory framework, without reducing 
the high level of protection for the environment and human and animal health. 

The proposal also intends to simplify the data protection rules, to avoid duplicating vertebrate 
animal studies through mandatory data-sharing, increase harmonisation of fees systems in the 
Member  States,  establish  rules  for  parallel  trade  of  biocidal  products,  and  cover  articles  or 
materials treated with biocidal products.  

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1.3. 

130Existing provisions in the area of the proposal 

The current regulatory framework for biocidal products is established by Directive 98/8/EC of 
the  European  Parliament  and  the  Council  of  16  February  1998  concerning  the  placing  of 
biocidal products on the market and a number of implementing Commission Regulations, in 
particular  Commission  Regulation  (EC)  No  1451/2007  on  the  second  phase  of  the  10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament 
and of the Council concerning the placing of biocidal products on the market. .  

1.4. 

140Consistency with the other policies and objectives of the Union 

The  proposal  to  revise  the  Directive  takes  into  consideration  the  recent  revision  of  EU 
legislation  on  Chemicals  with  the  adoption  of  Regulation  (EC)  No  1907/2006  (REACH)  as 
well  as  Regulation  (EC)  No  1272/2008  on  classification,  labelling  and  packaging  of 
substances  and  mixtures,  amending  and  repealing  Directives  67/548/EEC  and  1999/45/EC, 
and amending Regulation (EC) No 1907/2006.  

Due note is also taken of changes in horizontal legislation that affect the biocides regulatory 
framework, such as those related to the procedures for the exercise of implementing powers 
conferred on the Commission (recent amendment of Decision 1999/468/EC). Furthermore, it 
also  takes  into  consideration  the  general  rules  and  the  obligations  for  Member  States  under 
Regulation (EC) No 765/2008 organising the market surveillance relating to the marketing of 
products. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

2.1. 

Consultation of interested parties 

2.1.1. 

211Consultation methods, main sectors targeted and general profile of respondents 

1. 

2. 

3. 

A first consultation workshop was held on 21-22 January 2008 in Ljubljana under the 
auspices of the Slovenian Presidency of the EU. The objective of this workshop was 
to allow a first informal exchange of views between Member States and Commission 
representatives on issues to be addressed in the revision of the Directive. An outline 
of 
at: 
http://ec.europa.eu/environment/biocides/workshop.htm 

available 

issues 

these 

is 

An additional discussion was organised in Bonn on 7-8 April 2008 gathering more 
than  140  representatives  of  industry,  NGOs  and  competent  authorities.  Participants 
debated  about  the  need  to  streamline  the  scope  of  the  Directive,  among  others  by 
clarifying border cases and product-types definition, about the product authorisation 
(e.g.  frame  formulation,  central  versus  mutual  recognition),  about  data  protection 
rules, as well as simplified or more flexible data requirements approach.  

A wider consultation of stakeholders was organised through a conference hosted by 
the Commission in Brussels on 23 May 2008 with the participation of representatives 
from different sectors of the biocides industry, individual companies, consultants and 
national governments. After the participants were informed about the key issues for 
the revision  (presentations given by Commission officers) they had the opportunity 
to comment and debate specific issues of interest. 

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4. 

A targeted stakeholder consultation was also carried out in the framework of a study 
in  preparation  of  the  impact  assessment  for  the  revision  of  the  Directive.  The 
consultation involved interviews with representatives of the industry (including small 
and  medium-sized  enterprises),  national  administrations/controlling  bodies, 
environmental  protection  and  consumers'  associations  and  others,  based  on 
questionnaires  that  were  previously  sent  to  these  stakeholders  to  prepare  the 
discussions. 

2.1.2. 

212Summary of responses and how they have been taken into account 

1. 

The  consultation  conference  in  Ljubljana  (Commission  &  Member  States)  and  the 
succeeding  conference  in  Bonn  (Member  States  &  Industry)  focused  on  numerous 
topics of interest for the revision, the most prominent of those being:  

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

the revision of the data protection provisions and (mandatory) data-sharing;  

the scope of the regulatory framework (to include or not the use phase; to add 
provisions about in-situ generated substances and active substance precursors; 
the relationship with other pieces of Community legislation; reduction or not of 
the number of product-types; definition of a biocidal product and definition of 
placing on the market; how to regulate articles/materials containing biocides); 

the  lack  of  harmonised  provisions  in  the  current  Directive  regarding  product 
authorisation  or  the  procedure  to  follow  after  the  inclusion  of  an  active 
substance in the Community positive list;  

the possibility to have a single Community authorisation for biocidal products; 
the role of a centralised Agency for biocides; effectiveness of implementation 
and enforcement at Member State level;  

how to facilitate the (future) mutual recognition procedure;  

the harmonisation and proportionality of fees charged by Member States, and 
ways to alleviate the financial burden of compliance for SMEs;  

the  performance  so  far  of  the  Directive's  simplified  procedures  (Annex  IA; 
Annex IB; prospects for frame formulation concept);  

the need to clarify the possibility for waiving data requirements; the use in the 
new  instrument  of  data-waiving  provisions  from  the  REACH  Regulation;  the 
establishment of a tiered system of data requirements (as was the original idea 
when the Directive was adopted);  

specific rules for low-volume or 'niche' market biocides;  

the need to develop harmonised efficacy requirements.  

Finally, the appropriateness of adopting specific provisions on parallel trade; and the 
pros  and  cons  of  turning  the  Directive  into  a  Regulation  were  also  discussed.  The 
Commission has taken into consideration all the - sometimes conflicting - opinions 
expressed by the Member States in the development of its proposal, while trying to 

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identify  the  best  elements  amongst  them  that  would  contribute  to  a  coherent  and 
workable regulatory framework.  

2. 

During  the  consultation  event  in  May  2008  in  Brussels  (participation  of  various 
stakeholders, mostly industry and enterprises' representatives), the participants had a 
chance  to  express  their  opinions  on  simplified  procedures;  data  requirements;  data 
protection and data-sharing; the procedure for biocidal product authorisation; the fees 
applied by Member States and articles or materials containing biocides.  

In general (although many varying opinions were voiced), the simplified procedures 
of  Annex  IA  and  Annex  IB  were  considered  a  failure;  the  frame  formulation 
procedure has not been tried yet but there seems to be some confusion as to how it 
would  work  and  different  expectations  as  to  what  it  would  offer;  the  data 
requirements are seen as particularly strict and in some cases as non-proportionate or 
inflexible;  the  data  protection  system  could  be  further  clarified  and  simplified,  and 
certain elements of it should be amended; the industry seems to have come to terms 
with  introducing  mandatory  sharing  of  vertebrate  animal  studies;  providing  for 
harmonised  authorisation  procedures  is  seen  as  a  plus  by  the  industry,  and  even 
better if a centralised procedure were adopted; the fees or at least the fee systems will 
need to be harmonised; and a solution should be found for articles or materials that 
are  containing  biocidal  products,  in  particular  those  articles  or  materials  imported 
from  third  countries.  All  these  concerns  were  taken  into  consideration  and  are 
reflected in the proposal. 

3. 

The  targeted  consultation  served  mostly  the  purpose  of  obtaining  the  necessary 
quantitative/qualitative  information  for  preparing  the  impact  assessment  report 
presented  in  support  to  this  proposal.  It  covered  all  the  issues  discussed  with  the 
Member States in Ljubljana, in Bonn and with the stakeholders in Brussels and the 
responses  were  mostly  the  same  with  those  expressed  in  the  three  consultation 
events. 

An  open  consultation  was  conducted  over  the  internet  from  15/11/2006  to 
15/01/2007.  The  Commission  received  250  response(s).  The  results  of  the  open 
internet consultation were incorporated in the Commission report on the impacts of 
at: 
Directive 
the 
http://ec.europa.eu/environment/biocides/study.htm . 

implementation 

available 

98/8/EC 

of 

2.2. 

Collection and use of expertise 

To support this proposal, 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; 

a study on impacts of possible measures to manage articles or materials treated with 
biocides, in particular when imported;  

a  study  on  the  impacts  of  the  implementation  of  Directive  98/8/EC  on  biocidal 
products; and  

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– 

a study on the assessment of different options to address risks from the use phase of 
biocides. 

These  studies  were  evaluated  by  the  Commission  and  taken  into  consideration  while 
preparing the current proposal. In particular, the study to assess the impact of the revision of 
Directive  98/8/EC  concerning  the  placing  of  biocidal  products  on  the  market  evaluated  the 
economic, social and environmental impacts of the different policy options. The conclusions 
of this study are directly reflected in the impact assessment described in the following section. 

information 

More 
http://ec.europa.eu/environment/biocides/study.htm 
http://ec.europa.eu/environment/biocides/revision.htm. 

the 

on 

studies 

is 

available 

at: 
and 

2.3. 

230Impact assessment 

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 containing biocides. 

The  assessment  concluded  that  including  materials  containing  biocides  in  the  scope  of  the 
Directive  would  significantly  increase  the  costs  to  industry.  However,  although  the  equal 
treatment of industry, and environmental and human health benefits are difficult to quantify, 
they are likely to be significant. Including, in particular food processing aids in the scope of 
the  Directive  is  likely  to  result  in  a  complicated  process  of  authorisation  under  two  legal 
frameworks  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  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 other 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 
acceptable solution. 

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POLICY ISSUE 3: DATA-SHARING 

– 

– 

– 

Unchanged policy; 

Mandatory sharing of vertebrate animal test data for product authorisation; 

Mandatory  sharing  of  vertebrate  animal  test  data  for  active  substance  approval  and 
for product authorisation. 

The assessment concluded that mandatory data-sharing for active substance approval and for 
product authorisation 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; 

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

Reformulating the system for low-risk substances/products. 

The  policy  options  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  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  approval  of  active  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. 

The Commission carried out an impact assessment which is attached to this proposal. 

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

305Summary of the proposed action 

The revision of the Biocides Directive intends to remedy a number of weaknesses that were 
identified  during  the  first  eight  years  of  its  implementation,  to  anticipate  problems  with  the 
upcoming  authorisation  and  mutual  recognition  procedure,  and  to  update  and  adapt  the 
instrument to recent policy developments. 

First,  the  Directive  is  turned  into  a  Regulation.  As  a  result,  there  will  be  no  need  for  a 
transposition period or for national transposition measures, which is also expected to ensure 
more harmonised implementation of the regulatory framework in the Member States. 

Among the proposed amendments of the scope, particularly relevant are the extension of the 
scope to biocides in materials that might come into contact with food and the new provisions 
on articles or materials containing biocidal products.  

In particular with regard to the latter, under the current situation, if an article is treated in the 
EU then only a biocidal product that is authorised for that purpose may be used. However, if 
the  article  is  treated  with  a  biocidal  product  outside  the  EU  and  then  imported,  there  is  no 
control over the substance it may incorporate. This could represent risks for human health or 
for the environment if active substances that are not assessed or even banned in the EU are 
incorporated in such goods which are then imported into the EU. In addition, this situation is 
discriminatory  to  the  EU  industry,  and  could  lead  to  the  production  of  treated  articles  or 
materials being moved out of the EU in order to circumvent restrictions on certain substances. 
As part of the revision of the Biocides Directive, it is proposed that all articles or materials 
must be treated only with biocidal products authorised for that purpose in at least one Member 
State. 

Labelling requirements are accompanying the provision on articles or materials treated with 
biocides. These have two objectives: to inform consumers that the article was treated with a 
biocidal product; and to alert competent and/or customs authorities in the Member States and 
trigger  any  existing  inspection  provisions  aimed  at  ensuring  compliance.  The  labelling 
provisions apply equally to EU and non EU manufacturers.  

The  proposed  Regulation  provides  also  for  harmonised  procedures  for  the  authorisation  of 
biocidal  products,  an  element  that  is  significantly  underdeveloped  in  the  current  Directive. 
The provisions regarding mutual recognition of authorisations are reworked and clarified, in 
particular the resolution of disputes between Member States, or between Member States and 
applicants.  This  is  expected  to  contribute  to  a  smooth  functioning  of  the  upcoming 
authorisations of biocidal products. 

Apart  from  the  case  of  authorisations  granted  by  the  Member  States,  a  centralised 
authorisation system is proposed. This will be available for products identified as low-risk - 
without  having  to  go  through  a  separate  evaluation  of  the  active  substance  first-  and  for 
products  containing  new  active  substances.  The  latter  is  expected  to  promote  research  and 
innovation in the biocides field.  

The technical and scientific tasks relevant to this centralised system will be carried out by the 
European  Chemicals  Agency  (ECHA).  To  this  end,  the  proposal  incorporates  the  necessary 
provisions  governing  the  procedural  and  organisational  details.  In  addition,  ECHA  will 

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undertake  the  coordination  of  organisational  and  technical  tasks  for  the  evaluation  of  all 
applications  for  inclusion  of  active  substances  in  Annex  I  (the  Community  positive  list  for 
active substances) which were until now attributed to the Commission Joint Research Centre.  

The simplified procedures involving the current Annex IA and IB are repealed, as very little 
or  no  use  of  them  has  been  made  so  far.  The  simplified  procedure  involving  frame 
formulations - which has not yet been put into practice - is modified so as to allow, within a 
group  of  products  belonging  to  the  same  frame  formulation,  the  replacement  of  any  non-
active  ingredient  by  other  non-active  ingredients.  Currently,  this  is  restricted  to  pigments, 
dyes, and perfumes. The Regulation will also incorporate rules governing the modalities and 
conditions to apply for modifications to authorisations that are already granted. 

The rules on comparative assessment are also modified, as the current system does not seem 
sufficiently  clear  -  for  instance,  it  is  rather  problematic  to  apply  comparative  assessment 
during  the  review  programme,  where  all  existing  substances  are  being  evaluated.  The 
proposed  system  comprises  a  first  stage  where  active  substances  that  even  though  overall 
acceptable still give rise to concern are listed in Annex I, but are also flagged for substitution. 
Biocidal  products  containing  these  active  substances  may  be  compared  with  others  that  are 
available on the market for the same or similar use pattern, and if they present significantly 
higher risk than those, their authorisations are refused or cancelled at Member State level. 

In line with recent policy developments in REACH and the draft Regulation on the placing of 
plant protection products on the market, sharing of vertebrate animal studies in exchange for 
equitable compensation becomes mandatory. This is expected to save costs and animal lives 
by prohibiting the duplication of these studies. 

The data protection system is significantly simplified, without cutting back on any acquired 
rights under the current system. It also grants protection to data submitted after the inclusion 
of the active substance in Annex I (mainly during product authorisation): these studies are not 
protected by the current legislation. The proposed data protection system also covers the case 
of newly generated studies that, contrary to the legislator's intention, do not benefit from data 
protection  because  certain  Member  States  required  their  submission  for  the  purposes  of 
national authorisation during the transitional period (only data submitted for the first time in 
support of the first inclusion of the active substance are protected by the current system). 

The  data  requirements  of  the  Directive  are  modified.  First,  the  principle  of  proposing  and 
accepting  adaptations  to  the  data  requirements  is  formalised  and  Member  States  have  to 
inform and if possible assist the applicants with their adaptation requests. Second, the grounds 
for data waiving provided for in REACH will apply also for the proposed Regulation. Third, 
the  core  data  requirements  are  modified  and  certain  long-term  animal  studies  are  only 
required when necessary - these happen to be the most costly data requirements, in terms of 
lives of test animals and in terms of money. 

The confidentiality provisions are slightly modified and aligned with those of REACH. This 
is to facilitate their application by ECHA, which would otherwise have to apply two different 
sets of confidentiality rules in its everyday operations. 

For  the  purpose  of  facilitating  the  movement  of  biocidal  products  in  the  EU  territory,  the 
proposal provides for specific parallel trade rules: authorised biocidal products that have the 
same  use,  contain  the  same  active  substance  and  have  essentially  identical  composition  to 

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products  authorised  in  another  Member  State  may  be  placed  on  the  market  of  that  other 
Member State via a simplified administrative procedure. 

Finally, the proposal provides for a number of transitional measures to facilitate the transition 
from the system of the Directive to that of the draft Regulation, to introduce ECHA into the 
biocides regulatory framework, and to safeguard any acquired rights under the current system. 

3.2. 

310Legal basis 

Article 95 of TEC. 

3.3. 

329Subsidiarity principle 

The purpose of this Regulation is to facilitate the free movement of biocidal products within 
the  Community.  In  order  to  ensure  the  functioning  of  the  internal  market  with  biocidal 
products, it is necessary to harmonise the conditions of their placing on the market at the level 
of the Community.  

Individual measures of Member States stemming from the different levels of protection could 
result  in  obstacles  to  trade  in  biocidal  products.  This  could  compromise  the  achievement  of 
objectives related to the internal market. The Community is, therefore, better placed to take 
action with regards to the conditions of placing on the market and use of biocidal products. 

The  subsidiarity  principle  was  also  closely  considered  when  deciding  on  the  distribution  of 
tasks between the competent authorities of Member States, the Agency and the Commission, 
in particular with respect to the authorisation of biocidal products. 

3.4. 

Proportionality principle 

The proposal complies with the proportionality principle for the following reason(s). 

The proposed Regulation aims to harmonise the conditions for placing biocidal products on 
the  market  but  with  respect  to  the  majority  of  biocidal  products  it  leaves  it  to  the  Member 
States  to  authorise  these  products  in  accordance  with  these  conditions.  The  centralised 
procedure  in  which  the  Commission  grants  a  Community  authorisation  will  be  restricted  to 
two  categories  of  biocidal  products:  products  based  on  new  active  substances  and  low-risk 
biocidal products. For these categories of biocidal products centralisation is justified because 
of its positive impact on innovation and instant access to the entire Community market. 

The  proportionality  principle  was  also  respected  with  respect  to  the  fees.  The  Commission 
will adopt another Regulation setting out a harmonised structure for fees but the decision on 
the amount of the fees will remain within the competence of the Member States. 

Furthermore, the proposed Regulation does not go further than what is necessary with respect 
to its scope and the administrative burden on the industry as well as the competent authorities. 
In fact, the administrative and financial burden on the industry and the competent authorities 
will be reduced compared to Directive 98/8/EC because of the following reasons: 

– 

the  provision  of  strict  deadlines  for  each  procedural  step  will  increase  the 
predictability and facilitate the access of biocidal products to the market; 

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– 

– 

– 

the  centralised  authorisation  will  save  time  and  costs  for  both  the  industry  and 
competent authorities;  

the  possibility  of  a  mutual  recognition  in  parallel  will  provide  for  a  closer 
cooperation  among  the  Member  States  concerning  the  evaluation  of  a  biocidal 
product while saving financial and human resources; 

the mandatory data sharing with respect to vertebrate animal data will save the costs 
for  the  industry  and  avoid  repeated  evaluating  of  the  same  data  by  the  competent 
authorities. 

3.5. 

Choice of instruments 

Proposed instruments: Regulation. 

Other means would not be adequate for the following reason(s). 

The  current  regulatory  framework  for  the  placing  on  the  market  of  biocidal  products  is 
Directive  98/8/EC.  The  Commission  -  in  line  with  recent  proposals  concerning  the  plant 
protection products legislation and general chemicals legislation (the REACH Regulation and 
the  Regulation  on  classification,  labelling  and  packaging  of  substances  and  mixtures)  -  is 
proposing  to  replace  that  Directive  with  a  Regulation.  This  will  eliminate  the  need  for  a 
transitional  period  and  will  advance  the  implementation  of  urgently  needed  provisions  by 
approximately  two  years.  A  Regulation  will  also  ensure  the  uniform  application  of  the  new 
instrument throughout the EU, in particular the procedures and deadlines for authorisation of 
biocidal  products  and  mutual  recognition  of  those  authorisations.  Differences  in  the 
transposition  of  measures  and/or  the  implementation  would  have  very  serious  consequences 
for the functioning of the internal market in biocidal products. 

The choice of the legal instrument will also reduce the administrative burden and ensure the 
clarity for the industry. 

4. 

BUDGETARY IMPLICATION 

The  proposal  will  have  budgetary  implications  as  there  is  a  need  to  support  the  European 
Chemicals  Agency  (the  Agency)  in  taking  up  the  additional  tasks  related  to  the  assessment 
and inclusion of active substances used in biocidal products in Annex I of the Regulation and 
the  centralised  authorisation  of  certain  biocidal  products.  The  Agency  will  receive  specific 
fees  from  applicants  for  certain  of  these  activities  as  well  as  an  annual  fee  on  products 
centrally  authorised  by  the  Community.  The  revenue  from  the  fees  will  have  to  be 
supplemented  by  a  subsidy  from  the  Community.  It  is,  however,  expected  that  this  support 
from  the  Community  will  be  limited  in  time  as  the  activities  of  the  Agency  should  be  self-
funding  through  fee  revenues  after  a  number  of  years.  Detailed  rules  on  the  budget  of  the 
Agency  and  its  implementation  are  already  laid  down  in  REACH  Regulation  (EC)  No. 
1907/2006. These rules shall apply accordingly in the context of this Regulation. 

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5. 

ADDITIONAL INFORMATION 

5.1. 

510Simplification 

The  proposal  provides  for  simplification  of  legislation,  simplification  of  administrative 
procedures for public authorities (EU or national), and for private parties. 

Apart  from  the  obvious  economy  of  dispensing  with  transposition  measures,  transposition 
periods  and  transposition  conformity  controls  that  is  achieved  by  replacing  the  current 
Directive with a Regulation, the proposal clarifies in much greater detail than in the present 
text the procedures to be followed for granting authorisations by the Member States and the 
procedures for mutual recognition of those authorisations.  

In  particular,  the  acceptable  grounds  for  opposing  mutual  recognition  are  made  clear  and 
procedural steps are provided for the resolution of disputes. 

In addition, the grounds for waiving data requirements are set out in more detail, enhancing 
legal  certainty  for  the  applicants.  In  the  current  system,  while  the  principle  of  waiving  data 
requirements is recognised, little is provided as conditions for implementing the principle. As 
a result, Member States are sometimes reluctant to allow that certain studies listed in the core 
data  set  need  not  be  submitted  by  the  applicant  as  the  safety  of  a  substance  is  sufficiently 
established by other available information.  

The  data  protection  provisions  are  simplified  and  better  aligned  with  the  objectives  of  the 
Community policy (recovery of costs - protection for newly generated data). 

Lastly, the establishment of a centralised system for the authorisation of certain products is an 
obvious simplification as the products concerned will not need individual authorisation in all 
or some of the 27 Member States.  

The  Member  States  competent  authorities  will  have  a  more  harmonised  framework  for 
granting  authorisations  (e.g.  harmonised  content  of  an  authorisation  document).  They  will 
also  have  specific  deadlines  and  procedures  for  all  the  tasks  related  to  authorisation  and 
mutual recognition. 

With  the  handling  of  the  procedure  for  the  evaluation  of  active  substances  by  ECHA  there 
will  be  greater  transparency,  co-ordination  and  efficiency  of  the  process  compared  to  the 
current  system.  This  will  among  others  avoid  the  same  active  substance  being  evaluated  in 
parallel by two different Member States.  

The proposal foresees that Member States will have a common structure on the basis of which 
they can rationally develop their fees' systems. 

Enterprises supporting the placing on the market of a low-risk product or a product containing 
a new active substance will be able to obtain only one (Community) authorisation valid for 
the  whole  EU  territory.  Consequently,  the  Member  States  will  not  need  to  carry  out  an 
evaluation as those products will be approved via centralised authorisations. There will also 
be no need for mutual recognition or multiple provisional authorisation procedures for these 
products, as those will be handled at Community level by ECHA. 

Enterprises will now have to consult only one legal text that applies in the EU instead of 27 
national transposition instruments. 

EN 

12 

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Authorisation  and  mutual  recognition  procedures  are  better  defined  and  predictable  and 
specific deadlines are added.  

The legal certainty is increased with regard to the protection afforded to studies submitted in 
support of an application. 

The  proposal  is  included  in  the  Commission's  rolling  programme  for  up-date  and 
simplification  of  the  acquis  communautaire  and  its  Work  and  Legislative  Programme  under 
the reference COM(2007) 640. 

5.2. 

520Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation, in particular 
Directive 98/8/EC. 

5.3. 

Review/revision/sunset clause 

The proposal includes a review clause.  

5.4. 

540Recasting 

The proposal does not involve recasting.  

5.5. 

560European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the European 
Economic Area.

EN 

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2009/0076 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the placing on the market and use of biocidal products  

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

(3) 

Biocidal products are necessary for the control of organisms that are harmful to human 
or  animal  health  and  for  the  control  of  organisms  that  cause  damage  to  natural  or 
manufactured products. However, biocidal products can pose risks to humans, animals 
and the environment due to their intrinsic properties and associated use patterns. 

Biocidal products should not be placed on the market or used unless they comply with 
the authorisation granted in accordance with this Regulation.  

The purpose of this Regulation is to increase the free movement of biocidal products 
within  the  Community.  In  order  to  remove  as  far  as  possible  obstacles  to  trade  in 
biocidal  products  stemming  from  the  different  levels  of  protection  in  the  Member 
States, harmonised rules should be laid down for the approval of active substances and 
the  placing  on  the  market  and  use  of  biocidal  products,  including  the  rules  on  the 
mutual recognition of authorisations and on parallel trade.  

(4) 

Rules  concerning  the  placing  on  the  market  of  biocidal  products  in  the  Community 
were  initially  adopted  in  Directive  98/8/EC  of  the  European  Parliament  and  of  the 
Council  of  16  February  1998  concerning  the  placing  of  biocidal  products  on  the 

1 
2 
3 
4 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 

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14 

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(5) 

(6) 

(7) 

(8) 

(9) 

market5. It is necessary to adapt that system on the basis of a report on the first seven 
years of its implementation submitted by the Commission to the European Parliament 
and the Council6, which analyses problems and weaknesses of that Directive. 

Taking  into  account  the  main  adaptations  which  are  introduced  in  the  existing 
regulatory system, a Regulation is the appropriate legal instrument to replace Directive 
98/8/EC as it imposes clear and detailed rules which do not give room for diverging 
transposition  by  Member  States.  Moreover,  a  Regulation  ensures  that  legal 
requirements are implemented at the same time throughout the Community. 

A  difference  should  be  made  between  existing  active  substances  which  were  on  the 
market  in  biocidal  products  on  14  May  2000  and  new  active  substances  which  were 
not yet on the market in biocidal products by this date. That date was initially set in 
Directive  98/8/EC  as  the  date  by  which  that  Directive  had  to  be  transposed  into 
national  legislation.  That  date  made  a  difference  between  substances  which  were  on 
the market on that date and those which were not. A work programme is carried out 
for  the  review  of  all  existing  substances  with  view  to  their  inclusion  in  Annex  I  to 
Directive  98/8/EC.  During  that  review,  biocidal  products  containing  existing 
substances  can  continue  being  placed  on  the  market  in  order  to  prevent  a  situation 
where no biocidal products would be available on the market. New active substances 
should be reviewed before biocidal products containing them could be placed on the 
market so as to ensure that only safe new products could be placed on the market. 

During  the  work  programme,  and  at  most  up  until  the  decision  on  inclusion  of  the 
active  substance  in  Annex  I  to  Directive  98/8/EC,  Member  States  may  temporarily 
authorise biocidal products not complying with the provisions of this Regulation under 
certain conditions. Following the decision on inclusion, Member States should grant, 
cancel or modify authorisations in accordance with this Regulation. 

In order to ensure legal certainty, it is necessary to establish a Community list of active 
substances permitted for use in biocidal products. A procedure should be laid down for 
assessing  whether  or  not  an  active  substance  can  be  entered  in  the  Community  list. 
The information that interested parties should submit in support of an inclusion of an 
active substance in the Community list should be specified.  

The  risks  associated  with  the  production,  use  and  disposal  of  a  chemically  active 
substance and materials and articles treated with it are to be assessed and managed in a 
similar way as they are in Regulation (EC) No 1907/2006 of the European Parliament 
and  of  the  Council  of  18  December  2006  concerning  the  Registration,  Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (REACH),  establishing  a  European 
Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation 
(EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC, 
93/105/EC and 2000/21/EC7. 

(10)  With  view  to  achieving  a  high  level  of  environmental  and  human  health  protection, 
active  substances  with  the  worst  hazard  profiles  should  not  be  approved  for  use  in 

5 
6 
7 

OJ L 123, 24. 04. 1998, p.1. 
COM(2008)620   
OJ L 396, 30.12.2006, p. 1 

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15 

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biocidal  products  except  in  specific  situations.  These  should  include  situations  when 
the approval is justified because of a negligible exposure of humans to the substance, 
public health reasons or disproportionate negative impacts of a possible non-inclusion 
provided no alternatives exist.  

(11) 

In  order  to  prevent  the  use  of  active  substances  with  the  worst  hazard  profiles,  in 
particular  when  their  use  is  not  authorised  under  Regulation  (EC)  No  XXX/2009  of 
the  European  Parliament  and  of  the  Council  of  .....  2009  concerning  the  placing  of 
plant protection products on the market and repealing Council Directives 79/117/EEC 
and  91/414/EEC8,  it  is  appropriate  to  restrict  their  approval  to  situations  when  the 
exposure  of  humans  to  the  substance  is  negligible  or  the  substance  is  necessary  for 
public health reasons. 

(12)  The  active  substances  in  the  Community  list  should  be  regularly  examined  to  take 
account  of  developments  in  science  and  technology.  Where  there  are  serious 
indications  that  an  active  substance  used  in  biocidal  products  may  pose  higher  risk 
than previously thought, the Commission should be able to review an inclusion of the 
active substance.  

(13)  Active substances can, on basis of their intrinsic hazardous properties, be designated 
as candidates for substitution with other active substances, whenever such substances 
considered  as  efficient  towards  the  targeted  harmful  organisms  become  available  in 
sufficient variety to avoid the development of resistances amongst harmful organisms. 
In order to allow for a regular examination of substances identified as candidates for 
substitution, the inclusion period for these substances should not, even in the case of 
renewal,  exceed  ten  years.  Furthermore,  the  identification  of  substances  which  are 
considered  as  candidates  for  substitution  should  be  considered  as  a  first  step  of  a 
comparative assessment. 

(14) 

In course of the authorisation or renewal of biocidal product authorisations, it should 
be  possible  to  compare  two  or  more  biocidal  products  with  regard  to  risks  posed  by 
them  and  benefits  accrued  through  their  use.  As  a  result  of  such  a  comparative 
assessment,  authorised  biocidal  products  containing  active  substances  indicated  as 
candidates for substitution could be replaced with others that present significantly less 
risk  to  health  or  to  the  environment  and  where  there  are  no  significant  adverse 
economic  or  practical  impacts.  Appropriate  phase-out  periods  should  be  foreseen  in 
such cases. 

(15) 

In order to avoid unnecessary administrative and financial burden for the industry as 
well as competent authorities, a full in-depth evaluation of an application to renew the 
inclusion of an active substance in the Community list or the authorisation should only 
be carried out if the competent authority that was responsible for the initial evaluation 
decides so on basis of the available information.  

(16)  There  is  a  need  to  ensure  effective  coordination  and  management  of  the  technical, 
scientific  and  administrative  aspects  of  this  Regulation  at  Community  level.  The 
European  Chemicals  Agency  set  up  under  Regulation  (EC)  No  1907/2006  should 
carry out specified tasks with regard to the evaluation of active substances as well as 

8 

OJ L , , p. . 

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16 

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the  authorisation  of  certain  categories  of  biocidal  products  and  related  tasks  in  the 
Community  territory.  Consequently,  a  Biocidal  Products  Committee  should  be 
established  within  the  Agency  to  carry  out  the  tasks  attributed  to  the  European 
Chemicals Agency by this Regulation. 

(17) 

It is recognised that biocidal products intended to be used not only for purposes of this 
Regulation but also in connection with medical devices, such as disinfectants used for 
the  disinfection  of  surfaces  in  hospitals  as  well  as  medical  devices,  may  pose  risks 
different from those covered by this Regulation. Therefore, it should be required that 
such  biocidal  products  comply,  in  addition  to  the  requirements  laid  down  in  this 
Regulation, with the relevant essential requirements of Council Directive 90/385/EEC 
of  20  June  1990  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
active  implantable  medical  devices9,  Council  Directive  93/42/EEC  of  14  June  1993 
concerning  medical  devices10  or  Directive  98/79/EC  of  the  European  Parliament  and 
of the Council of 27 October 1998 on in vitro diagnostic medical devices11. 

(18)  As  the  costs  of  the  application  of  this  Regulation  to  food  or  feedingstuffs  used  for 
biocidal  purposes  would  be  disproportionate  to  the  benefits  thereof,  food  and 
feedingstuffs  used  for  biocidal  purposes  should  not  be  covered  by  this  Regulation. 
Furthermore, the safety of food and feedingstuffs is subject to Community legislation, 
in  particular  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the 
Council  of  28  January  2002  laying  down  the  general  principles  and  requirements  of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures in matters of food safety12. 

(19)  Processing aids are covered by existing Community legislation in particular, Council 
Directive 89/107/EEC 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 consumption13 and Regulation (EC) No 1831/2003 of the European Parliament 
and  of  the  Council  of  22  September  2003  on  additives  for  use  in  animal  nutrition14. 
Therefore, it is appropriate to exclude them from the scope of this Regulation. 

(20)  As products used for the preservation of food or feedstocks by the control of harmful 
organisms, previously covered by product type 20, are covered by Council Directive 
89/107/EEC  and  Regulation  (EC)  No  1831/2003  of  the  European  Parliament  and  of 
the Council, it is not appropriate to maintain this product type. 

(21)  As  the  International  Convention  for  the  Control  and  Management  of  Ships'  Ballast 
Water and Sediments provides for an effective assessment of the risks posed by ballast 
water management systems, the final approval and subsequent type approval of such 
systems  should  be  considered  equivalent  to  the  product  authorisation  required  under 
this Regulation. 

9 
10 
11 
12 
13 
14 

OJ L 189, 20.7.1990, p. 17. 
OJ L 169, 12.7.1993, p. 1. 
OJ L 331, 7.12.1998, p. 1. 
OJ L 31, 1.2.2002, p. 1 
OJ L 40, 11.2.1989, p. 27 
OJ L 268, 18.10.2003, p. 29 

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(22)  To take account of the specific nature of some biocidal products and the low level of 
risk associated with their proposed use, and to encourage the development of biocidal 
products  containing  new  active  substances,  it  is  appropriate  to  provide  for  a 
Community authorisation of those products. 

(23) 

(24) 

In order to ensure that only biocidal products that comply with the relevant provisions 
of  this  Regulation  are  placed  on  the  market,  biocidal  products  should  be  subject  to 
authorisation  either  by  competent  authorities  for  placing  on  the  market  or  use  in  a 
territory of a Member State, or a part of it, or by the Commission for placing on the 
market or use in the Community.  

In order to facilitate access to the internal market and to avoid the additional costs and 
time involved in obtaining separate national authorisations in separate Member States, 
the  Commission,  taking  into  account  the  experience  with  the  provisions  on 
Community  authorisations,  may  decide  to  extend  the  scope  of  the  Community 
authorisation procedure to other biocidal products.  

(25)  To ensure a harmonised application of the low-risk criteria by competent authorities, it 
is necessary to specify those criteria in the Regulation as far as possible. The criteria 
should be based on the hazard characteristics of the biocidal products and the exposure 
to the product associated with its use. The use of low-risk biocidal products should not 
lead to a high risk of developing resistance in target organisms. 

(26) 

(27) 

(28) 

(29) 

(30) 

In  order  to  encourage  the  use  of  low-risk  biocidal  products  with  more  favourable 
environmental or human health profile compared to other biocidal products, it should 
be allowed to authorise low-risk biocidal products without prior approval of the active 
substances contained therein. 

In  view  of  the  provisions  on  low-risk  biocidal  products  in  this  Regulation,  it  seems 
appropriate  to  exempt  active  substances  contained  in  those  products  from  the 
registration  obligations  under  Regulation  (EC)  1907/2006.  This  is,  in  particular, 
necessary because these substances do not fulfil the conditions in Article 15(2) of that 
Regulation.  

It  is  necessary  to  provide  common  principles  for  the  evaluation  and  authorisation  of 
biocidal products to ensure a harmonised approach by competent authorities. 

In  order  to  evaluate  the  risks  that  would  arise  from  the  proposed  uses  of  biocidal 
products,  it  is  appropriate  that  the  applicants  submit  dossiers  which  contain  the 
necessary  information.  Defining  a  data  set  for  active  substances  and  for  biocidal 
products  in  which  they  are  contained  is  necessary  so  as  to  assist  both  the  applicants 
seeking authorisation and competent authorities carrying out the evaluation to decide 
on the authorisation.  

In the light of the diversity of both the active substances and the biocidal products, the 
data  and  test  requirements  should  suit  the  individual  circumstances  and  allow  an 
overall risk assessment. Therefore, an applicant should be able to request adaptations 
of  the  data  requirements,  as  appropriate,  including  the  waiving  of  data  requirements 
which are not necessary or impossible to submit in view of the nature or the proposed 
uses of the product. Applicants should provide the appropriate technical and scientific 
justification to support their requests. 

EN 

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(31) 

(32) 

In  order  to  ensure  that  the  applicant  can  effectively  exercise  his  right  to  request  an 
adaptation  of  the  data  requirements,  the  competent  authorities  should  inform  the 
applicant about this possibility and the grounds on which such request could be made. 
Furthermore, in order to facilitate the preparation of the request, in particular by small- 
and  medium-sized  enterprises  (SMEs),  the  competent  authority  should  assist  the 
applicant, where possible, in preparing such a request. 

In order to facilitate access to the market of biocidal products belonging to one group 
of  products,  it  should  be  possible  to  authorise  such  groups  of  biocidal  products  with 
similar  uses  and  allow  for  limited  variations  with  regard  to  the  reference  biocidal 
product provided that those changes do not affect the level of the risk and the efficacy 
of the products. 

(33)  When  biocidal  products  are  being  authorised,  it  is  necessary  to  ensure  that,  when 
properly  used  for  the  purpose  intended,  they  are  sufficiently  effective  and  have  no 
unacceptable  effect  on  the  target  organisms  such  as  resistance,  and,  in  the  case  of 
vertebrate  animals,  unnecessary  suffering  and  pain,  and  have,  in  the  light  of  current 
scientific and technical knowledge, no unacceptable effect on the environment and on 
human  or  animal  health.  When  deciding  whether  a  biocidal  product  should  be 
authorised, due consideration should be given to the benefits from its use.  

(34) 

In  order  to  avoid  duplication  of  the  evaluation  procedures  and  to  ensure  free 
movement of biocidal products, as well as of materials and articles treated with them, 
within the Community, procedures should be established to ensure that authorisations 
of products granted in one Member States are recognised in all other Member States.  

(35)  Specific  provisions  should  lay  down  procedures  to  ensure  the  smooth  operation  of 
mutual recognition of authorisations granted by Member States, and in particular the 
resolution of any disagreements without undue delay. 

(36) 

In order to enable Member States to co-operate in the evaluation of biocidal products 
and to facilitate the access of biocidal products to the market, it should be possible to 
launch the process of the mutual recognition together with the application for the first 
authorisation. 

(37)  There is a need to provide for a dispute settlement mechanism at Community level to 
ensure an effective functioning of mutual recognition. If a competent authority refuses 
to  mutually  recognise  an  authorisation  or  proposes  to  restrict  it,  the  Commission 
should  be  empowered  to  take  a  decision.  In case  of  technical  or  scientific  questions, 
the Commission may consult the Agency before preparing the decision. 

(38)  While envisaging harmonised provisions for all biocidal product types, including those 
intended to control vertebrates, the actual use of such product types might give rise to 
concern. Therefore, Member States should be allowed to derogate from the principle 
of  mutual  recognition  for  biocidal  products  falling  under  certain  particular  types  of 
biocides  when  intended  to  control  particular  kinds  of  vertebrates,  in  so  far  as  such 
derogations  are  justified  and  do  not  jeopardise  the  purpose  of  this  Regulation 
regarding an appropriate level of protection of the internal market. 

(39) 

In  order  to  facilitate  the  functioning  of  the  authorisation  and  mutual  recognition 
procedures,  it  is  appropriate  to  establish  a  system  for  the  mutual  exchange  of 

EN 

19 

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(40) 

(41) 

(42) 

(43) 

information  and  Member  States,  the  Commission  and  the  Agency  should  make 
available  to  each  other  on  request  the  particulars  and  scientific  documentation 
submitted in connection with applications for authorisation of biocidal products. 

If  the  use  of  a  biocidal  product  is  in  the  interest  of  a  Member  State,  but  there  is  no 
applicant interested in the placing of the market of such product in the Member State, 
pest control bodies and other professional organisations should be allowed to apply for 
an authorisation. In the case they are granted an authorisation, they should possess the 
same rights and obligations as any other authorisation holder. 

In  order  to  take  account  of  the  scientific  and  technical  developments  as  well  as  the 
needs  of  the  authorisation  holders,  it  should  be  specified  under  which  conditions 
authorisations can be cancelled, reviewed or amended. Provisions on the notification 
and exchange of information which may affect the authorisations should be set out so 
as to enable the competent authorities and the Commission to take appropriate action.  

In  the  event  of  an  unforeseen  danger  threatening  public  health  or  the  environment 
which cannot be contained by other means, it should be possible for Member States to 
authorise, for a limited period of time, biocidal products which do not comply with the 
requirements laid down in this Regulation.  

In order to encourage the development of new active substances, the procedure for the 
evaluation of a newly developed active substance should not prevent Member States or 
the  Community  from  authorising,  for  a  limited  period  of  time,  biocidal  products 
containing that active substance before the latter is entered in Annex I, provided that a 
dossier meeting all requirements has been submitted and it is believed that the active 
substance and the biocidal product satisfy the conditions set for them.  

(44) 

In order to encourage the research and development in active substances and biocidal 
products, it is necessary to establish rules under which unauthorised biocidal products 
or  active  substances  may  be  placed  on  the  market  for  the  purposes  of  research  and 
development.  

(45) 

In view of the benefits for the internal market and for the consumer, it is desirable to 
establish harmonised rules for parallel trade of substantially identical biocidal products 
that are authorised in different Member States. 

(46)  For purposes of the protection of human and animal health and of the environment, as 
well  as  for  the  non-discrimination  between  articles  or  materials  originating  in  the 
Community and articles or materials imported from third countries, all treated articles 
or  materials  placed  on  the  internal  market  should  contain  only  authorised  biocidal 
products. 

(47)  For the purpose of enabling consumers to make informed choices and facilitating the 
enforcement of this Regulation by competent authorities, articles or materials treated 
with biocidal products should be appropriately labelled. 

(48)  Applicants  that  have  invested  in  supporting  the  inclusion  of  an  active  substance  in 
Annex I or in the authorisation of a biocidal product in accordance with the provisions 
of  this  Regulation  should  be  able  to  recover  part  of  their  investment  by  receiving 
equitable compensation whenever use of proprietary information which they submitted 

EN 

20 

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(49) 

(50) 

(51) 

in  support  of  such  inclusions  or  authorisations  is  made  for  the  benefit  of  subsequent 
applicants.  

In  view  of  ensuring  that  all  proprietary  information  submitted  in  support  of  an 
inclusion of an active substance or an authorisation of a biocidal product is protected 
from the moment of its submission and to prevent situations where some information 
is  without  protection,  the  provision  on  information  protection  periods  should  also 
apply to information submitted for the purposes of Directive 98/8/EC. 

In order to encourage the development of new active substances and biocidal products 
containing them, it is necessary to provide for a period of protection with respect to the 
proprietary  information  submitted  in  support  of  the  inclusion  of  active  substances  or 
authorisations of products which is longer than the period of protection for information 
concerning existing active substances and products containing them. 

It  is  essential  to  minimise  the  number  of  tests  on  animals  and  to  ensure  that  testing 
should  be  made  dependent  on  the  purpose  and  use  of  a  product.  Applicants  should 
share,  and  not  duplicate,  vertebrate  animal  studies  in  exchange  for  equitable 
compensation.  In  absence  of  an  agreement  on  sharing  of  vertebrate  animal  studies 
between  the  data  owner  and  the  prospective  applicant,  the  Agency  should  allow  the 
use of the studies by the prospective applicant without prejudice to the decision on the 
compensation  made  by  national  courts.  A  Community  register  listing  the  contact 
details of the owners of such studies should be established and put at the disposal of all 
authorities to inform prospective applicants. 

(52)  The  generation  of  information  by  alternative  means  not  involving  tests  on  animals 
which are equivalent to prescribed tests and test methods should also be encouraged. 
In addition, the adaptation of data requirements should be used to prevent unnecessary 
costs related to testing. 

(53) 

(54) 

(55) 

In  order  to  ensure  that  the  requirements  laid  down  in  respect  of  authorised  biocidal 
products are satisfied when they are placed on the market, the Member States should 
take measures for appropriate control and inspection arrangements. 

It  is  necessary  to  provide  for  the  effective  communication  of  information  on  risks 
resulting  from  biocidal  products  and  risk  management  measures  as  it  forms  an 
essential part of the system established by this Regulation. While facilitating access to 
information,  competent  authorities,  the  Agency  and  the  Commission  should  respect 
the principle of confidentiality and avoid any disclosure of information which could be 
harmful for the commercial interests of the person concerned. 

In  order  to  increase  the  efficiency  of  monitoring  and  control,  and  to  provide 
information relevant for addressing the risks of biocidal products, producers, importers 
and  professional  users  should  be  required  to  keep  records  of  the  products  they 
produce,  place  on  the  market  or  use.  The  Commission  should  adopt  implementing 
rules on data collection, transmission and processing. 

(56) 

In  order  to  facilitate  the  exchange  of  information  between  competent  authorities,  the 
Agency and the Commission, the Community Register for Biocidal Products should be 
established. 

EN 

21 

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(57) 

It  is  necessary  to  specify  that  provisions  concerning  the  Agency  laid  down  in 
Regulation  (EC)  No  1907/2006  should  apply  accordingly  in  the  context  of  biocidal 
active  substances  and  products.  Where  separate  provisions  need  to  be  made  with 
respect to the tasks and functioning of the Agency under this Regulation, it should be 
specified in the provisions of this Regulation.  

(58)  The costs of the procedures associated with the operation of this Regulation need to be 
recovered from those seeking to place or placing biocidal products on the market and 
from those supporting the entries of active substances in Annex I. In order to promote 
the smooth operation of the internal market, the Commission should adopt measures to 
harmonise  the  structure  of  fee  systems  established  by  the  Member  States  and  the 
Agency taking into account the special needs of SMEs.  

(59) 

It is necessary to provide for the possibility of an appeal against certain decisions of 
the  Agency.  The  Board  of  Appeal  set  up  within  the  Agency  by  Regulation  (EC)  No 
1907/2006  should  also  guarantee  processing  of  appeals  against  decisions  adopted  by 
the Agency under this Regulation.  

(60)  The measures necessary for the implementation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the 
procedures for the exercise of implementing powers conferred on the Commission15. 

(61) 

In  particular,  the  Commission  should  be  empowered  to  adopt  measures  to  decide  on 
the  application  to  include  the  active  substance  in  Annex  I  or  to  renew  or  review  the 
inclusion, to specify the procedures related to the renewal and review of an inclusion 
of  an  active  substance  in  Annex  I,  to  extend  the  provisions  on  Community 
authorisations  to  other  categories  of  biocidal  products,  to  specify  the  criteria  and 
procedures  related  to  a  cancellation  of  an  authorisation  or  amendments  of  the  terms 
and  conditions  of  an  authorisation,  including  a  dispute  settlement  mechanism,  to 
specify  the  overall  applicable  maximum  quantities  of  active  substances  or  biocidal 
products  that  may  be  released  during  experiments  and  the  minimum  data  to  be 
submitted, to establish a harmonised structure of fees and other rules concerning the 
payment of fees and charges to the competent authorities and the Agency, to adapt the 
Annexes to scientific and technical progress, to carry out the work programme and to 
specify  the  related  rights  and  obligations  of  the  competent  authorities  and  the 
participants in the programme and to extend the duration of the work programme for a 
determined  period.  Since  those  measures  are  of  general  scope  and  are  designed  to 
amend  non-essential  elements  of  this  Regulation,  inter  alia,  by  supplementing  this 
Regulation with new non-essential elements, they must be adopted in accordance with 
the  regulatory  procedure  with  scrutiny  provided  for  in  Article  5a  of  Decision 
1999/468/EC. 

(62)  When,  on  imperative  grounds  of  urgency,  the  normal  time  limits  for  the  regulatory 
procedure with scrutiny cannot be complied with, the Commission should be able to 
apply  the  urgency  procedure  provided  for  in  Article  5a(6)  of  Decision  1999/468/EC 
for the adoption of decisions to amend the inclusion of an active substance in Annex I 
or to remove it from that Annex on basis of Article 13. 

15 

OJ L 184, 17.7.1999, p. 23. 

EN 

22 

   EN 

 
                                                 
(63) 

It  is  appropriate  to  provide  for  a  deferred  application  of  this  Regulation  so  as  to 
facilitate  the  smooth  transition  to  the  new  system  applied  to  the  inclusion  of  active 
substances in Annex I and authorisation of biocidal products.  

(64)  Due to the limited number of new submissions of applications for inclusion of active 
substances in Annex I, the Agency should take over the co-ordination and facilitation 
tasks for new submissions as of the date of applicability of this Regulation. However, 
in view of the high number of historical dossiers and in order to allow some time for 
the Agency to prepare for the new role, it should take over the tasks related to dossiers 
submitted under Directive 98/8/EC as of 1 January 2014. 

(65) 

In order to respect the legitimate expectations of companies with respect to the placing 
on the market and use of low-risk biocidal products covered Directive 98/8/EC, those 
companies should be allowed to place such products on the market if they comply with 
the  rules  on  the  registration  of  low-risk  biocidal  products  under  that  Directive. 
However, this Regulation should apply after the expiry of the first registration. 

(66)  Taking  into  consideration  that  some  products  were  not  previously  covered  by  the 
Community legislation in the field of biocidal products, it is appropriate to allow for a 
transitional period for the companies to be  prepared to apply the  rules concerning  in 
situ  generated  active  substances,  treated  articles  and  materials  and  food  contact 
materials. 

(67) 

In  order  to  ensure  an  equal  treatment  of  persons  placing  on  the  market  biocidal 
products containing one or more existing active substances, they should be required to 
hold  a  dossier  or  have  a  letter  of  access  to  a  dossier,  or  to  each  component  of  the 
dossier, for each of the active substances contained in the product. Those persons who 
will not comply with this obligation by 1 January 2014 should no longer be allowed to 
place their products on the market. Appropriate phase-out periods for disposal, storage 
and use of existing stocks of biocidal products should be foreseen in such cases. 

(68)  This  Regulation  should  take  account,  as  appropriate,  of  other  work  programmes 
concerned  with  the  review  or  authorisation  of  substances  and  products,  or  relevant 
international Conventions, 

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
SCOPE AND DEFINITIONS 

Article 1 
Subject matter 

This Regulation lays down rules for: 

(1) 

the placing on the market and use of biocidal products within the Member States or 
the Community; 

(2) 

the mutual recognition of authorisations within the Community;  

EN 

23 

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(3) 

the  establishment  at  Community  level  of  a  list  of  active  substances  which  may  be 
used in biocidal products. 

Article 2 
Scope 

1. 

2. 

This  Regulation  shall  apply  to  biocidal  products  as  defined  in  point  (a)  of  Article 
3(1).  

A  list  of  the  types  of  biocidal  products  covered  by  this  Regulation  and  their 
descriptions is set out in Annex V.  

This Regulation shall not apply to biocidal products that are within the scope of the 
following instruments: 

(a)  Council  Directive  76/768/EEC  of  27  July  1976  on  the  approximation  of  the 

laws of the Member States relating to cosmetic products16; 

(b)  Council  Directive  82/471/EEC  of  30  June  1982  concerning  certain  products 

used in animal nutrition17; 

(c)  Council  Directive  88/388/EEC  of  22  June  1988  on  the  approximation  of  the 
laws of the Member States relating to flavourings for use in foodstuffs and to 
source materials for their production18; 

(d)  Regulation (EC) No 1333/2008 of the European Parliament and of the Council 

of 16 December 2008 on food additives19; 

(e)  Council  Directive 90/167/EEC of 26 March 1990 laying down the conditions 
governing  the  preparation,  placing  on  the  market  and  use  of  medicated 
feedingstuffs in the Community20; 

(f)  Council  Directive  90/385/EEC  of  20  June  1990  on  the  approximation  of  the 
laws of the Member States relating to active implantable medical devices21; 

(g)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant 

protection products on the market22; 

(h)  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices23; 

(i)  European Parliament and Council Directive No 95/2/EC of 20 February 1995 

on food additives other than colours and sweeteners24; 

16 
17 
18 
19 
20 
21 
22 
23 
24 

OJ L 262, 27.9.1976, p. 169.  
OJ L 213, 21.7.1982, p. 8.  
OJ L 184, 15.7.1988, p. 61.  
OJ L 354, 31.12.2008, p. 16. 
OJ L 92, 7.4.1990, p. 42. 
OJ L 7, 11.1.1994, p. 20 
OJ L 230, 19.8.1991, p. 1.  
OJ L 169, 12.7.1993, p. 1 
OJ L 61, 18.3.1995, p. 1.  

EN 

24 

   EN 

 
                                                 
(j)  Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed 
materials,  amending  Directives  70/524/EEC,  74/63/EEC,  82/471/EEC  and 
93/74/EEC and repealing Directive 77/101/EEC25; 

(k)  Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27 

October 1998 on in vitro diagnostic medical devices26; 

(l)  Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  of  6 
November  2001  on  the  Community  code  relating  to  veterinary  medicinal 
products27; 

(m)  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 use28;  

(n)  Regulation (EC) No 1831/2003 of the European Parliament and of the Council 

of 22 September 2003 on additives for use in animal nutrition29;  

(o)  Regulation (EC) No 852/2004 of the European Parliament and of the Council 

of 29 April 2004 on the hygiene of foodstuffs30; 

(p)  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 
origin31. 

3. 

Subject  to  any  explicit  provision  to  the  contrary,  this  Regulation  shall  be  without 
prejudice to the following instruments: 

(a)  Council  Directive  67/548/EEC  27  June  1967  on  the  approximation  of  laws, 
regulations  and  administrative  provisions  relating  to  the  classification, 
packaging and labelling of dangerous substances32; 

(b)  Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on 
the  market  and  use  of  plant  protection  products  containing  certain  active 
substances33; 

(c)  Council  Directive  89/391/EEC  of  12  June  1989  on  the  introduction  of 
measures  to  encourage  improvements  in  the  safety  and  health  of  workers  at 
work34; 

25 
26 
27 
28 
29 
30 
31 
32 
33 
34 

OJ L 125, 23.5.1996, p. 35.  
OJ L 331, 7.12.1998, p. 1 
OJ L 311 , 28.11.2001, p. 1. 
OJ L 311 , 28.11.2001, p. 67. 
OJ L 268, 18.10.2003, p. 29.  
OJ L 139, 30.4.2004, p. 1. 
OJ L 139, 30.4.2004, p. 55.  
OJ 196, 16.8.1967, p. 1. 
OJ L 33, 8.2.1979, p. 36.  
OJ L 183, 29.6.1989, p. 1.  

EN 

25 

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(d)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and 
safety of workers from the risks related to chemical agents at work (fourteenth 
individual  Directive  within  the  meaning  of  Article  16(1)  of  Directive 
89/391/EEC)35;  

(e)  Directive  1999/45/EC  of  the  European  Parliament  and  of  the  Council  of  31 
May  1999  concerning  the  approximation  of  the  laws,  regulations  and 
administrative  provisions  of  the  Member  States  relating  to  the  classification, 
packaging and labelling of dangerous preparations36; 

(f)  Directive  2000/54/EC  of  the  European  Parliament  and  of  the  Council  of  18 
September 2000 on the protection of workers from risks related to exposure to 
biological agents at work37; 

(g)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
of  18  December  2006  concerning  the  Registration,  Evaluation,  Authorisation 
and  Restriction  of  Chemicals  (REACH),  establishing  a  European  Chemicals 
Agency,  amending  Directive  1999/45/EC  and  repealing  Council  Regulation 
(EEC)  No 793/93  and  Commission  Regulation  (EC)  No 1488/94  as  well  as 
Council  Directive  76/769/EEC  and  Commission  Directives  91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC38; 

(h)  Directive 2006/114/EC of 12 December 2006 of the European Parliament and 

of the Council concerning misleading and comparative advertising39; 

(i)  Regulation (EC) No 689/2008 of the European Parliament and of the Council 
of 17 June 2008 concerning the export and import of dangerous chemicals40; 

(j) 

[proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council 
establishing a framework for Community action to achieve the sustainable use 
of pesticides]; 

(k)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council 
of 16 December 2008 on classification, labelling and packaging of substances 
and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, 
and amending Regulation (EC) No 1907/200641. 

Article  58  shall  not  apply  to  the  carriage  of  biocidal  products  by  rail,  road,  inland 
waterway, sea or air. 

This  Regulation  shall  not  apply  to  food  or  feedingstuffs  that  are  used  for  biocidal 
purposes. 

This Regulation shall not apply to processing aids that are used for biocidal purposes. 

OJ L 131, 5.5.1998, p. 11.  
OJ L 200, 30.7.1999, p. 1. 
OJ L 262, 17.10.2000, p. 21 
OJ L 396, 30.12.2006, p. 1.  
OJ L 376, 27.12.2006, p. 21.  
OJ L 204, 31.7.2008, p. 1.  
OJ L 353, 31.12.2008, p. 1. 

4. 

5. 

6. 

35 
36 
37 
38 
39 
40 
41 

EN 

26 

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7. 

8. 

Where a biocidal product is intended by its manufacturer to be used for the purpose 
of exerting a controlling effect on any harmful organism present on medical devices 
and  for  other  purposes  covered  by  this  Regulation,  the  relevant  essential 
requirements  of  Directives  90/385/EEC,  93/42/EEC  or  98/79/EC  shall  also  be 
fulfilled. 

Biocidal  products  which  obtained  the  final  approval  under  the  International 
Convention for the Control and Management of Ships' Ballast Water and Sediments 
shall be considered as authorised under Chapter VII of this Regulation. Articles 38 
and 57 shall apply accordingly. 

Article 3 
Definitions 

1. 

For the purposes of this Regulation, the following definitions shall apply: 

(a) 

'biocidal products' means  

active substances or mixtures containing one or more active substances, put up in the 
form  in  which  they  are  supplied  to  the  user,  intended  to  destroy,  deter,  render 
harmless, prevent the action of, or otherwise exert a controlling effect on any harmful 
organism by chemical or biological means. 

All  substances,  mixtures  and  devices  placed  on  the  market  with  the  intention  to 
generate active substances shall also be considered biocidal products; 

(b) 

'micro-organism' means 

any  microbiological  entity,  cellular  or  non-cellular,  capable  of  replication  or  of 
transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, 
algae, protozoa and microscopic parasitic helminths;  

(c) 

'active substance' means 

a substance or a micro-organism having an action against harmful organisms;  

(d) 

'existing active substance' means 

a  substance  which  was  on  the  market  on  14  May  2000  as  an  active  substance  of  a 
biocidal product for purposes other than scientific or product and process-orientated 
research and development;  

(e) 

'new active substance' means 

a substance which was not on the market on 14 May 2000 as an active substance of a 
biocidal product for purposes other than scientific or product and process-orientated 
research and development;  

(f) 

'substance of concern' means 

any  substance,  other  than  the  active  substance,  which  has  an  inherent  capacity  to 
cause an adverse effect on humans, animals or the environment and is present or is 

EN 

27 

   EN 

 
produced in a biocidal product in sufficient concentration to present risks of such an 
effect; 

(g) 

'harmful organism' means 

organisms,  including  pathogenic  agents,  which  have  an  unwanted  presence  or  a 
detrimental effect on humans, their activities or the products they use or produce, or 
on animals or the environment;  

(h) 

'residues' means 

substances present in or on plants or products of plant origin, edible animal products, 
drinking  water  or  elsewhere  in  the  environment  and  resulting  from  the  use  of  a 
biocidal product, including their metabolites, breakdown or reaction products; 

(i) 

'placing on the market' means 

the  first  supply  of  a  biocidal  product  for  distribution  or  for  use  on  the  Community 
market in the course of a commercial activity, whether in return for payment or free 
of charge; 

(j) 

'use' means 

all operations carried out with a biocidal product, including storage, handling, mixing 
and  application,  except  any  such  operation  carried  out  with  view  to  export  of  the 
biocidal product outside the Community; 

(k) 

'treated material or article' means 

any  substance,  mixture,  material  or  article  which  was  treated  with  or  incorporates 
one  or  more  biocidal  products  with  the  intention  to  protect  the  substance,  mixture, 
material or article from deterioration caused by harmful organisms; 

(l) 

'national authorisation' means 

an administrative act by which the competent authority of a Member State authorises 
the placing on the market and the use of a biocidal product in its territory or in a part 
thereof;  

(m) 

'Community authorisation' means 

an administrative act by which the Commission authorises the placing on the market 
and  the  use  of  a  biocidal  product  in  the  territory  of  the  Community  or  in  a  part 
thereof; 

(n) 

'authorisation' means 

national authorisation or Community authorisation; 

(o) 

'unique product formulation' means 

EN 

28 

   EN 

 
a biocidal product with no variations as to the percentage of the active substance, the 
percentage  composition  of  the  non-active  substances,  or  the  perfumes,  dyes  or 
pigments it contains;  

(p) 

'frame formulation' means  

a group of biocidal products having similar uses and presenting limited variations in 
their composition with regard to a reference biocidal product belonging to that group 
which  contains  the  same  active  substances  of  the  same  specifications  where  such 
permitted variations do not adversely affect the level of risk or the efficacy of these 
products; 

(q) 

'letter of access' means 

an  original  document,  signed  by  the  owner  or  owners  of  information,  which  states 
that  the  information  may  be  used  by  the  competent  authorities,  the  European 
Chemicals  Agency,  or  the  Commission  for  the  purpose  of  evaluating  an  active 
substance or granting an authorisation; 

(r) 

'food and feedingstuff' means 

food  as  defined  in  Article  2  of  Regulation  (EC)  No  178/2002  of  the  European 
Parliament  and  of  the  Council42  and  feedingstuff  as  defined  in  Article  3(4)  of  that 
Regulation.  

(s) 

'food contact materials' means 

any material and article intended to come into contact with food which are covered 
by Regulation (EC) No 1935/200443;  

(t) 

'processing aid' means 

any substance which: 

(i) is not consumed as a food or feedingstuff by itself; 

(ii) is intentionally used in the processing of raw materials, foods or feedingstuff or 
their  ingredients,  to  fulfil  a  certain  technological  purpose  during  treatment  or 
processing; and 

(iii) may result in the unintentional but technically unavoidable presence in the final 
product of  residues of the substance or its derivatives provided they  do  not present 
any health risk and do not have any technological effect on the final product;.  

(u) 

'technical equivalence' means 

similarity  as  regards  the  chemical  composition  and  hazard  profile  of  a  substance 
produced  from  a  new  manufacturing  source,  compared  to  the  substance  of  the 
reference source with respect to which the initial risk assessment was carried out. 

42 
43 

OJ L 31, 1.2.2002, p. 1 
OJ L 338, 13.11.2004, p. 4 

EN 

29 

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2. 

For  the  purposes  of  this  Regulation,  the  definitions  laid  down  in  Article  3  of 
Regulation (EC) No 1907/2006 shall apply for the following terms: 

(a) 

substance; 

(b)  mixture; 

(c) 

article; 

(d)  product and process-orientated research and development; 

(e) 

scientific research and development. 

CHAPTER II 
INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I 

Article 4 
Conditions for inclusion 

1. 

2. 

3. 

An active substance shall be included in Annex I for an initial period not exceeding 
10 years if the biocidal products containing that active substance fulfil the conditions 
laid down in point (b) of Article 16(1). 

The inclusion in Annex I of an active substance shall be restricted to those product 
types  in  Annex  V  for  which  relevant  data  have  been  submitted  in  accordance  with 
Article 6. 

An active substance shall, where appropriate, be included in Annex I together with 
any of the following conditions: 

(a) 

the minimum degree of purity of the active substance; 

(b) 

the nature and maximum content of certain impurities; 

(c) 

the product type as outlined in Annex V; 

(d)  manner and area of use; 

(e) 

designation of categories of users; 

(f) 

other particular conditions based on the evaluation of the information related to 
that active substance. 

4. 

Where  appropriate,  maximum  residue  limits  shall  be  established  with  respect  to 
active  substances  included  in  Annex  I  in  accordance  with  Regulation  (EC)  No 
396/2005 of the European Parliament and of the Council44 [and Council Regulation 
(EEC) No 2377/90]. 

44 

OJ L 70, 16.3.2005, p. 1 

EN 

30 

   EN 

 
                                                 
Article 5 
Exclusion criteria 

1. 

Notwithstanding  Article  4(1),  active  substances  referred  to  in  paragraph  2  shall  be 
included in Annex I only if at least one of the following conditions is met: 

(a) 

(b) 

(c) 

the  exposure  of  humans  to  that  active  substance  in  a  biocidal  product,  under 
normal conditions of use, is negligible, in particular where the product is used 
in closed systems or strictly controlled conditions; 

it is shown that the active substance is necessary to control a serious danger to 
public health; 

it  is  shown  that  not  including  the  active  substance  in  Annex  I  would  cause 
disproportionate  negative  impacts  when  compared  with  the  risk  to  human 
health or the environment arising from the use of the substance and that there 
are no suitable alternative substances or technologies. 

Point (c) shall not apply to active substances for product types 4 and 14 to 19. 

2. 

The following active substances shall be included in Annex I where at least one of 
the conditions set out in paragraph 1 is met:  

(a) 

(b) 

(c) 

active  substances  which  have  been  classified  in  accordance  with  Regulation 
(EC)  No  1272/2008  as,  or  which  meets  the  criteria  to  be  classified  as, 
carcinogen category 1A or 1B; 

active  substances  which  have  been  classified  in  accordance  with  Regulation 
(EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen 
category 1A or 1B; 

active  substances  which  have  been  classified  in  accordance  with  Regulation 
(EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for 
reproduction category 1A or 1B; 

(d) 

active  substances  identified  under  Article  57(f)  of  Regulation  (EC)  No 
1907/2006 as having endocrine disrupting properties. 

Article 6 
Data requirements for an application 

1. 

An  application  to  include  an  active  substance  in  Annex  I  shall  contain  at  least  the 
following elements: 

(a) 

(b) 

a dossier for the active substance satisfying the requirements set out in Annex 
II; 

a dossier for at least one representative biocidal product that contains the active 
substance satisfying the requirements set out in Annex III.  

The application shall be accompanied by the fees payable under Article 70. 

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2. 

Notwithstanding paragraph 1, the applicant need not provide data required under that 
paragraph if any of the following grounds applies: 

(a) 

the  information  is  not  necessary  owing  to  the  exposure  associated  with  the 
proposed uses; 

3. 

4. 

1. 

2. 

3. 

(b) 

it is not scientifically necessary to supply the information;  

(c) 

it is not technically possible to supply the information.  

An applicant may propose to adapt the data required under paragraph 1 in accordance 
with  Annex  IV.  The  justification  for  the  proposed  adaptations  to  the  data 
requirements shall be clearly stated in the application with a reference to the specific 
rules in Annex IV.  

The competent authority shall inform the applicant about the possibility of proposing 
the adaptation of data requirements, the grounds on which such an adaptation can be 
requested and, where possible, shall provide assistance in preparing such a proposal.  

The Commission shall adopt the measures designed to set the criteria defining what 
constitutes adequate justification to adapt the data required under paragraph 1 on the 
ground referred to in paragraph 2(a).  

Those  measures  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 

Article 7 
Submission and validation of applications  

The applicant shall submit an application to include an active substance in Annex I, 
or  to  make  subsequent  amendments  to  the  conditions  of  inclusion  of  an  active 
substance,  to  the  European  Chemicals  Agency  (hereinafter  referred  to  as  'the 
Agency') and inform it of the name of the competent authority of the Member State 
that  he  chooses  to  evaluate  his  application.  That  competent  authority  (hereinafter 
referred  to  as  'the  evaluating  competent  authority')  shall  be  responsible  for  the 
evaluation of the application.  

The  Agency  shall,  within  one  month  from  the  receipt  of  the  application,  notify  the 
evaluating  competent  authority  that  the  application  is  available  in  the  Agency 
database. 

Within two months after the receipt of an application, the Agency shall validate the 
application if it complies with the following requirements: 

(a) 

dossiers referred to in points (a) and (b) of Article 6(1) have been submitted; 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 

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4. 

5. 

6. 

1. 

2. 

3. 

If  the  Agency  considers  that  the  application  is  incomplete,  it  shall  inform  the 
applicant  as  to  what  additional  information  is  required  for  the  validation  of  the 
application  and  shall  set  a  reasonable  time  limit  for  the  submission  of  that 
information.  

The Agency shall, within two months after the receipt of the additional information, 
determine  whether  the  additional  information  submitted  is  sufficient  to  validate  the 
application. 

The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and shall inform the applicant thereof. In such cases 
a  part  of  the  fee  paid  to  the  Agency  in  accordance  with  Article  70  shall  be 
reimbursed.  

An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 4.  

If the Agency, on the basis of the validation made pursuant to paragraph 3, considers 
that the application is complete, it shall without delay inform the applicant and the 
evaluating competent authority thereof. 

Article 8 
Evaluation of applications 

The  evaluating  competent  authority  shall,  within  12  months  after  the  validation, 
evaluate  the  dossiers  in  accordance  with  Article  4  including,  where  relevant,  any 
proposal to adapt data requirements submitted in accordance with Article 6(3).  

The evaluating competent authority shall provide the applicant with an opportunity to 
provide  written  or  oral  comments  on  the  conclusions  of  the  evaluation  within  two 
months.  The  evaluating  competent  authority  shall  take  due  account  of  these 
comments when finalising its evaluation. 

The  evaluating  competent  authority  shall  send  the  conclusions  of  the  evaluation  to 
the Agency.  

If, when the dossiers are evaluated, it appears that additional information is necessary 
to carry out the evaluation, the evaluating competent authority shall ask the applicant 
to submit such information within a specified time limit, and shall inform the Agency 
thereof.  

The 12-month period referred to in paragraph 1 shall be suspended from the date of 
issue of the request until the date the information is received.  

If the evaluating competent authority considers that there are concerns with regard to 
the cumulative effects from the use of biocidal products containing the same active 
substance, it shall document its concerns in accordance with the requirements of the 
relevant  parts  of  Section  II.3  of  Annex  XV  to  Regulation  (EC)  No  1907/2006  and 
include this as part of its conclusions. 

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4. 

5. 

6. 

Within nine months after the receipt of the conclusions of the evaluation, the Agency 
shall prepare and submit to the Commission an opinion on the inclusion of the active 
substance in Annex I.  

On receipt of the opinion of the Agency, the Commission shall adopt a decision on 
the application to include the active substance in Annex I. That decision, designed to 
amend  non-essential  elements  of  this  Regulation  by  supplementing  it,  shall  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 72(4). 

Notwithstanding Article 7(1), the evaluation of the application may be carried out by 
the  competent  authority  other  than  the  one  which  has  received  the  copy  of  the 
application.  

The competent authority that has been notified of the application for the evaluation 
may  submit  a  duly  substantiated  request  to  appoint  another  evaluating  competent 
authority  to  the  Commission  within  one  month  after  the  receipt  of  the  notification 
referred  to  in  Article  7(2).  The  Commission  shall  take  the  decision  in  accordance 
with  the  procedure  referred  to  in  Article  72(2).  The  12-month  period  referred  to  in 
paragraph 1 shall commence on the date when this decision is taken. 

Article 9 
Active substances which are candidates for substitution 

1. 

An active substance fulfilling at least one of the following criteria shall be considered 
a candidate for substitution in accordance with the procedure referred to in paragraph 
2: 

(a) 

(b) 

(c) 

its  acceptable  daily  intake,  acute  reference  dose  or  acceptable  operator 
exposure  level  is  significantly  lower  than  those  of  the  majority  of  the  active 
substances included in Annex I for the same product type; 

it  meets  two  of  the  criteria  to  be  considered  as  a  persistent,  bio-accumulative 
and  toxic  substance  as  set  out  in  Annex  XIII  of  Regulation  (EC)  No 
1907/2006; 

there  are  reasons  for  concern  linked  to  the  nature  of  the  critical  effects,  in 
particular  developmental  neurotoxic  or  immunotoxic  effects,  which,  in 
combination with the use patterns, amount to use that could still cause concern, 
even with very restrictive risk management measures; 

(d) 

it contains a significant proportion of non-active isomers; 

(e) 

(f) 

it  is  classified  or  meets  the  criteria  to  be  classified,  in  accordance  with 
Regulation  (EC)  No  1272/2008,  as  carcinogen  category  1A  or  1B,  mutagen 
category 1A or 1B or toxic for reproduction category 1A or 1B; 

it is considered to have endocrine disrupting properties that may cause adverse 
effect  on  humans  on  the  basis  of  the  assessment  of  Community  or 
internationally agreed test guidelines or other available data. 

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2. 

3. 

4. 

5. 

1. 

2. 

3. 

1. 

When preparing an opinion on the inclusion or renewal of the inclusion of an active 
substance in Annex I, the Agency shall examine whether the active substance fulfils 
any of the criteria listed in paragraph 1 and address the matter in its opinion.  

Prior  to  submitting  the  opinion  on  the  inclusion  or  renewal  of  the  inclusion  of  an 
active  substance  in  Annex  I  to  the  Commission,  the  Agency  shall  make  publicly 
available  information  on  potential  candidates  for  substitution  with  a  reasonable 
period  during  which  relevant  information,  including  information  on  available 
substitutes, may be submitted by interested third parties. The Agency shall take due 
account of the information received when finalising its opinion. 

By  way  of  derogation  from  Article  10(3),  the  inclusion  of  an  active  substance  in 
Annex  I  that  is  considered  as  a  candidate  for  substitution  shall  be  renewed  for  a 
period not exceeding ten years. 

Active  substances  that  are  considered  as  candidates  for  substitution  in  accordance 
with paragraph 1 shall be identified as such in Annex I. 

CHAPTER III 
RENEWAL AND REVIEW OF AN ACTIVE SUBSTANCE 
INCLUSION 

Article 10 
Conditions for renewal 

The Commission shall renew the inclusion of an active substance in Annex I if the 
active substance still complies with the requirements referred to in Article 4.  

Based on new elements examined or adaptations to technical progress, the renewal of 
the inclusion may be accompanied, as appropriate, by conditions and restrictions.  

Unless  otherwise  specified  in  the  decision  to  renew  the  inclusion  of  an  active 
substance in Annex I, the renewal shall be for an unlimited period of time. 

Article 11 
Submission and validation of applications  

The applicant shall submit the application for  renewal of the inclusion  of an  active 
substance  in  Annex  I  to  the  Agency  at  least  18  months  before  the  expiry  of  the 
inclusion in Annex I for a given product-type  

The application shall be accompanied by the fees payable under Article 70. 

When applying for renewal, the applicant shall submit a list of all data relating to the 
active substance that have been generated since the inclusion of the active substance 
in Annex I and a justification as to whether the conclusions of the initial assessment 
of  the  active  substance  are  still  valid.  The  evaluating  competent  authority  may 
require the applicant to submit the data referred to in this list at any time. 

2. 

The  Agency  shall,  within  one  month  after  the  receipt  of  the  application,  notify  the 
evaluating  competent  authority  that  carried  out  the  initial  evaluation  of  the 

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application  for  inclusion  in  Annex  I  that  the  application  is  available  in  the  Agency 
database. 

3. 

Within two months after the receipt of an application, the Agency shall validate the 
application if it complies with the following requirements: 

4. 

5. 

6. 

1. 

(a) 

information referred to paragraph 1 has been submitted; 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 

If  the  Agency  considers  that  the  application  is  incomplete,  it  shall  inform  the 
applicant  as  to  what  additional  information  is  required  for  the  validation  of  the 
application  and  shall  set  a  reasonable  time  limit  for  the  submission  of  that 
information.  

The Agency shall, within two months after the receipt of the additional information, 
determine  whether  the  additional  information  submitted  is  sufficient  to  validate  the 
application. 

The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and shall inform the applicant thereof. In such cases 
a  part  of  the  fee  paid  to  the  Agency  in  accordance  with  Article  70  shall  be 
reimbursed. 

An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 4.  

If the Agency, on basis of the validation made pursuant to paragraph 3, considers that 
the  application  is  complete,  it  shall  without  delay  inform  the  applicant  and  the 
evaluating competent authority thereof. 

Article 12 
Evaluation of applications for renewal 

On the basis of the available information and a need to review the conclusions of the 
initial  evaluation  of  the  application  for  inclusion  in  Annex  I,  the  evaluating 
competent  authority  that  carried  out  the  initial  evaluation  shall,  within  one  month 
after the validation referred to in Article 11, decide whether a full evaluation of the 
application for renewal is necessary.  

If the evaluating competent authority decides that a full evaluation of the application 
is necessary, the evaluation shall be carried out in accordance with paragraphs 1 to 4 
of  Article  8.  The  decision  on  the  application  shall  be  adopted  in  accordance  with 
paragraphs 5, 6 and 7 of this Article.  

2. 

If the evaluating competent authority decides that a full evaluation of the application 
is  not  necessary,  it  shall,  within  six  months,  prepare  and  submit  to  the  Agency  a 
recommendation on the renewal of the inclusion of the active substance in Annex I.  

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Prior  to  submitting  the  recommendation  to  the  Agency,  the  evaluating  competent 
authority  shall  provide  the  applicant  with  an  opportunity  to  provide  written  or  oral 
comments  on  the  recommendation  within  one  month.  The  evaluating  competent 
authority  shall 
its 
recommendation. 

these  comments  when  finalising 

take  due  account  of 

3. 

4. 

5. 

6. 

7. 

1. 

On the receipt of the recommendation from the evaluating competent authority, the 
Agency shall make it available to the Commission, the competent authorities of other 
Member  States  and  the  applicant  and  allow  a  period  of  three  months  during  which 
they may submit written comments to it. 

The  Commission  may  ask  the  Agency  for  an  opinion  on  scientific  or  technical 
matters raised by a competent authority objecting to the recommendation referred to 
in paragraph 2. The Agency shall issue an opinion within six months from the date 
on which the matter was referred to it. 

At the end of the period referred to in paragraph 3 or on receipt of the opinion of the 
Agency,  the  Commission  shall  adopt  a  decision  concerning  a  renewal  of  the 
inclusion of the active substance in Annex I. That decision, designed to amend non-
essential  elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 72(4). 

Where,  for  reasons  beyond  the  control  of  the  applicant,  the  inclusion  of  the  active 
substance  in  Annex  I  is  likely  to  expire  before  a  decision  has  been  taken  on  its 
renewal,  the  Commission  shall,  in  accordance  with  the  procedure  referred  to  in 
Article  72(2), adopt a  decision  postponing  the expiry date of inclusion for a period 
sufficient to enable it to examine the application.  

Where the Commission decides not to renew the inclusion of an active substance in 
Annex  I,  it  may  grant  a  period  of  grace  for  the  disposal,  storage,  placing  on  the 
market  and  use  of  existing  stocks  of  biocidal  products  containing  that  active 
substance.  

The period of grace shall not exceed six months for the placing on the market and an 
additional maximum of twelve months for the disposal, storage, and use of existing 
stocks of the biocidal products containing that active substance. 

Article 13 
Review of inclusion of an active substance in Annex I 

The Commission may review the inclusion of an active substance in Annex I at any 
time where there are serious indications that the requirements referred to in Article 4 
are  no  longer  complied  with.  Where  those  indications  are  confirmed,  the 
Commission shall adopt a decision amending the inclusion of an active substance in 
Annex I or removing it from that Annex.  

That decision, designed to amend non-essential elements of this Regulation, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 72(4). On imperative grounds of urgency, the Commission may have recourse 
to the urgency procedure referred to in Article 72(5). 

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2. 

3. 

The  Commission  may  consult  the  Agency  on  any  questions  of  a  scientific  or 
technical nature related to the review of inclusion of an active substance in Annex I. 
The  Agency  shall,  within  nine  months  from  the  request,  prepare  an  opinion  and 
submit it to the Commission. 

Where  the  Commission  removes  the  entry  of  an  active  substance  from  Annex  I,  it 
may grant a period of grace for the disposal, storage, placing on the market and use 
of existing stocks of biocidal products containing that active substance.  

The period of grace shall not exceed six months for the placing on the market and an 
additional maximum of twelve months for the disposal, storage, and use of existing 
stocks of the biocidal products containing that active substance. 

Article 14 
Implementing measures 

The Commission may adopt detailed measures for the implementation of Articles 10 to 13 of 
this Regulation specifying the procedures related to the renewal and review of an inclusion of 
an active substance in Annex I.  

Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 72(4). 

CHAPTER IV 
GENERAL PRINCIPLES OF AUTHORISATION OF 
BIOCIDAL PRODUCTS 

Article 15 
Placing on the market and use of biocidal products 

1. 

2. 

3. 

4. 

No biocidal product may be placed on the market or used unless an authorisation has 
been issued for that biocidal product in accordance with this Regulation. 

Application for authorisation shall be made by, or on behalf of, the person who shall 
be  responsible  for  the  placing  on  the  market  of  a  biocidal  product  in  a  particular 
Member State or in the Community. 

Application  for  national  authorisation  in  a  Member  State  shall  be  submitted  to  the 
competent  authority  of  that  Member  State  (hereinafter  referred  to  as  'the  receiving 
competent authority'). 

Application for Community authorisation shall be submitted to the Agency.  

A holder of an authorisation shall have a permanent office within the Community.  

An  authorisation  may  be  granted  for  a  unique  product  formulation  or  for  a  frame 
formulation.  

An authorisation shall be granted for a maximum period of 10 years. 

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5. 

Biocidal  products  shall  be  used  properly.  Proper  use  shall  include  compliance  with 
the  conditions  for  granting  an  authorisation  established  by  Article  16  and  labelling 
requirements laid down in Article 58.  

Proper  use  shall  also  involve  the  rational  application  of  a  combination  of  physical, 
biological,  chemical  or  other  measures  as  appropriate,  whereby  the  use  of  biocidal 
products is limited to the minimum necessary.  

Article 16 
Conditions for granting an authorisation 

1. 

A biocidal product shall be authorised only if the following conditions are met: 

(a) 

(b) 

the active substances included therein are listed in Annex I and any conditions 
included  in  that  Annex  together  with  those  active  substances  are  complied 
with; 

it  is  established  according  to  the  common  principles  for  the  evaluation  of 
dossiers for biocidal products laid down in Annex VI, that the biocidal product, 
when  used  as  authorised  and  having  regard  to  the  factors  referred  to  in 
paragraph 2, complies with the following criteria: 

(i) 

it is sufficiently effective; 

(ii) 

it  has  no  unacceptable  effects  on  the  target  organisms,  in  particular 
unacceptable resistance or cross-resistance or  unnecessary suffering  and 
pain for vertebrates; 

(iii) 

it has no unacceptable effects itself or as a result of its residues, directly 
or indirectly, on human or animal health; 

(iv) 

it has no unacceptable effects itself, or as a result of its residues, on the 
environment having particular regard to the following considerations: 

- 

- 

- 

- 

its fate and distribution in the environment;  

contamination of surface waters (including estuarial and seawater), 
groundwater and drinking water, air and soil; 

its impact on non-target organisms; 

its impact on biodiversity and the ecosystem; 

(c) 

the  nature,  the  quantity  and  the  technical  equivalence  of  active  substances  in 
the  biocidal  product  and,  where  appropriate,  any 
toxicologically  or 
ecotoxicologically  significant  impurities  and  non-active  substances,  and  its 
residues of toxicological or environmental significance, which result from uses 
to be authorised, can be determined according to the relevant requirements in 
Annexes II and III; 

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(d) 

its  physical  and  chemical  properties  have  been  determined  and  deemed 
acceptable  for  purposes  of  the  appropriate  use,  storage  and  transport  of  the 
product. 

2. 

The evaluation of the compliance of the biocidal product with the criteria set out in 
point (b) of paragraph 1 shall take into account the following factors: 

(a) 

all normal conditions under which the biocidal product may be used; 

(b)  how any material or article treated with it or containing it may be used; 

(c) 

the consequences of its use and disposal. 

An authorisation to place a low-risk biocidal product on the market shall be subject 
to compliance with the requirements of points (b), (c) and (d) of paragraph 1. 

A biocidal product shall only be authorised for uses for which relevant information 
has been submitted in accordance with Article 18. 

A biocidal product shall not be authorised for placing on the market to, or use by, the 
general public if it fulfils any of the following criteria for classification: 

(a) 

(b) 

toxic, very toxic or a category 1 or 2 carcinogen, or a category 1 or 2 mutagen 
or toxic for reproduction category 1 or 2 according to Directive 1999/45/EC; 

toxic,  very  toxic  or  a  category  1A  or  1B  carcinogen,  or  a  category  1A  or  1B 
mutagen or toxic for reproduction category 1A or 1B according to Regulation 
(EC) No 1272/2008.  

In  the  case  of  a  frame  formulation,  a  reduction  in  the  percentage  of  the  active 
substance  in  the  reference  biocidal  product  may  be  allowed,  and/or  an  alteration  in 
the 
percentage  composition  of  one  or  more  non-active  substances,  and/or 
replacement of one or more non-active substances by others presenting the same or 
lower risk. 

3. 

4. 

5. 

6. 

Article 17 
Criteria for low-risk biocidal products 

1. 

A  biocidal  product  shall  be  considered  a  low-risk  biocidal  product  if  both  the 
following conditions are fulfilled: 

(a) 

(b) 

for  any  given  environmental  compartment,  the  ratio  of  the  predicted 
environmental  concentration  (PEC)  to  predicted  no-effect  concentration 
(PNEC) may be derived and does not exceed 0.1;  

for  any  effect  to  human  health,  the  margin  of  exposure  (the  ratio  of  no 
observed adverse effect level (NOAEL) and exposure concentration) is higher 
than 1,000. 

However, a biocidal product shall not be considered a low-risk biocidal product if at 
least one of the following conditions is present: 

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(a) 

it  contains  one  or  more  active  substances  which  fulfil  the  criteria  for  being 
persistent,  bio-accumulative  and  toxic  (PBT)  or  very  persistent  and  very  bio-
accumulative  (vPvB)  in  accordance  with  Annex  XIII  of  Regulation  (EC)  No 
1907/2006; 

(b) 

it contains one or more active substances qualified as endocrine disrupters;  

(c) 

it  contains  one  or  more  active  substances  which  have  been  classified  in 
accordance with Regulation (EC) No 1272/2008 as or which meets the criteria 
to be classified as one of the following: 

(i) 

carcinogenic; 

(ii)  mutagenic; 

(iii)  neurotoxic; 

(iv) 

immunotoxic; 

(v) 

toxic to reproduction; 

(vi)  sensitising. 

2. 

3. 

4. 

Notwithstanding  paragraph  1,  a  biocidal  product  shall  be  considered  a  low-risk 
biocidal product if the active substances in the biocidal product are contained in such 
way  that  only  a  negligible  exposure  can  take  place  under  normal  conditions  of  use 
and the product is handled under strictly controlled conditions during all other stages 
of its lifecycle. 

For  a  low-risk  biocidal  product  it  shall  be  demonstrated  that  the  potential  for  the 
development of resistance in target organisms due to the use of the biocidal product 
is low.  

In  addition  to  the  active  substances  referred  to  in  Article  15(2)  of  Regulation  (EC) 
No  1907/2006,  active  substances  manufactured  or  imported  for  use  in  low-risk 
biocidal  products  that  are  authorised  for  placing  on  the  market  in  accordance  with 
Article 15 shall be regarded as being registered and the registration as completed for 
manufacture  or  import  for  use  in  a  low-risk  biocidal  product  and  therefore  as 
fulfilling the requirements of Chapters 1 and 5 of Title II of that Regulation. 

Article 18 
Data requirements for an application for authorisation 

1. 

The  applicant  for  an  authorisation  shall  submit  the  following  documents  together 
with the application: 

(a) 

(b) 

a dossier or letter of access for the biocidal product satisfying the requirements 
set out in Annex III;  

a proposal for a summary of the biocidal product characteristics that includes 
the information referred to in points (a), (b) and (e) to (m) of Article 20(2); 

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2. 

3. 

4. 

5. 

(c) 

(d) 

for  other  than  low-risk  biocidal  products,  a  dossier  or  a  letter  of  access  to  a 
dossier  satisfying  the  requirements  set  out  in  Annex  II  for  each  active 
substance in the biocidal product; 

for  low-risk  biocidal  products,  any  relevant  information  in  support  of  the 
conclusion  that  the  biocidal  product  is  to  be  considered  a  low-risk  biocidal 
product. 

The  application  for  authorisation  shall  be  accompanied  by  the  fees  payable  under 
Article 70. 

The  receiving  competent  authority  may  require  that  applications  for  a  national 
authorisation  be  submitted  in  one  or  more  of  the  official  languages  of  the  Member 
State where that competent authority is situated. 

If the application concerns a biocidal product that is intended by its manufacturer to 
be used also for the purposes referred to in Article 2(7), it shall be accompanied by a 
declaration  of  conformity  regarding  the  compliance  with  the  relevant  essential 
requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC. 

The Commission, in accordance with the procedure referred to in Article 72(2), shall 
draw up technical notes for guidance to facilitate the implementation of point (d) of 
paragraph 1. 

The technical notes shall be published in the ‘C’ series of the Official Journal of the 
European Union. 

Article 19 
Waiving of data requirements 

1. 

Notwithstanding Article 18, the applicant need not provide data required under that 
Article if any of the following grounds applies: 

(a) 

the  information  is  not  necessary  owing  to  the  exposure  associated  with  the 
proposed uses; 

(b) 

it is not scientifically necessary to supply the information;  

(c) 

it is not technically possible to supply the information.  

2. 

3. 

The applicant may propose to adapt the data required under Article 18 in accordance 
with  Annex  IV.  The  justification  for  the  proposed  adaptations  to  the  data 
requirements shall be clearly stated in the application with reference to the specific 
rules in Annex IV. 

The competent authority shall inform the applicant about the possibility of proposing 
the adaptation of data requirements, the grounds on which such an adaptation can be 
requested and, where possible, shall provide assistance in preparing such a proposal. 

The Commission shall adopt the measures designed to set the criteria defining what 
constitutes  adequate  justification to adapt the data required under Article 18 on the 
ground referred to in paragraph 1(a).  

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Those  measures  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 

Article 20 
Content of authorisation  

1. 

2. 

An authorisation shall stipulate the terms and the conditions relating to the placing on 
the market and use of the biocidal product. 

An  authorisation  shall  include  the  summary  of  the  biocidal  product  characteristics 
listing the following information: 

(a) 

trade name of the biocidal product; 

(b)  name and address of the authorisation holder; 

(c) 

date of the authorisation and its date of expiry; 

(d) 

authorisation number; 

(e) 

qualitative and quantitative composition in terms of the active substances and 
non-active  substances,  knowledge  of  which  is  essential  for  proper  use  of  the 
biocidal product; 

(f)  manufacturers of the biocidal product (names and addresses including location 

of manufacturing sites); 

(g)  manufacturers of the active substances (names and addresses including location 

of manufacturing sites); 

(h)  physical state and nature of the biocidal product; 

(i) 

hazard and precautionary statements; 

(j) 

the  product-type  in  accordance  with  Annex  V  and  the  target  harmful 
organisms; 

(k) 

application doses and instructions for use; 

(l) 

categories of users; 

(m)  particulars of likely direct or indirect adverse effects and first aid instructions; 

(n) 

instructions for safe disposal of the product and its packaging; 

(o) 

in the case of a biocidal product that is intended by its manufacturer to be used 
also for the purposes referred to in Article 2(7), any specific use conditions and 
a statement that the biocidal product is in conformity with the relevant essential 
requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC.  

3. 

In addition to paragraph 2, in the case of a frame formulation, the authorisation shall 
indicate, as appropriate, the following information: 

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(a) 

(b) 

the  reference  biocidal  product  within  the  group  of  products  comprising  the 
frame  formulation  that  has  the  highest  allowed  concentration  of  the  active 
substances;  

the  permitted  alteration  of  the  composition  of  this  reference  biocidal  product 
expressed in percentage of the non-active substances contained in the biocidal 
products which are considered to belong to that frame formulation;  

(c) 

the  non-active  substances  that  may  be  substituted  in  the  authorised  biocidal 
products belonging to that frame formulation. 

Article 21 
Comparative assessment of biocidal products  

The receiving competent authority or, in the case of evaluation of an application for a 
Community  authorisation,  the  evaluating  competent  authority  shall  perform  a 
comparative  assessment  as  part  of  the  evaluation  of  an  application  for  an 
authorisation  or  a  renewal  of  an  authorisation  of  a  biocidal  product  containing  an 
active substance that is a candidate for substitution in accordance with Article 9(1).  

The results of the comparative assessment shall be forwarded, without delay, to the 
competent  authorities  of  other  Member  States  and  the  Agency  and,  in  the  case  of 
evaluation of an application for a Community authorisation, also to the Commission. 

The receiving competent authority or, in the case of a decision on an application for a 
Community  authorisation,  the  Commission  shall  prohibit  or  restrict  the  placing  on 
the  market  or  use  of  a  biocidal  product  containing  an  active  substance  that  is  a 
candidate  for  substitution  where  the  comparative  assessment  weighing  up  the  risks 
and benefits in accordance with Annex VI demonstrates that all the following criteria 
are met: 

(a) 

(b) 

(c) 

for the uses specified in the application, another authorised biocidal product or 
a  non-chemical  control  or  prevention  method  already  exists  which  presents 
significantly lower risk for human or animal health or the environment;  

the biocidal product or non-chemical control or prevention method referred to 
in point (a) does not present significant economic or practical disadvantages;  

the  chemical  diversity  of  the  active  substances  is  adequate  to  minimise  the 
occurrence of resistance in the target harmful organism.  

By  way  of  derogation  from  paragraph  1,  a  biocidal  product  containing  an  active 
substance that is a candidate for substitution shall be authorised without comparative 
assessment  in  cases  where  it  is  necessary  to  acquire  experience  first  through  using 
that product in practice. 

Where the comparative assessment involves a question which, by reason of its scale 
or  consequences,  would  be  better  addressed  at  the  Community  level,  in  particular 
where  it  is  relevant  to  two  or  more  competent  authorities,  the  receiving  competent 
authority may refer the question to the Commission for a decision. The Commission 
shall adopt the decision in accordance with Article 72(3). 

1. 

2. 

3. 

4. 

5. 

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The Commission shall adopt implementing rules specifying the procedures related to 
comparative  assessments  involving  questions  of  Community  interest.  Those  rules, 
designed  to  amend  non-essential  elements  of  this  Regulation  by  supplementing  it, 
shall be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 72(4). 

6. 

7. 

Notwithstanding Article 15(4), an authorisation for a biocidal product containing an 
active substance that is a candidate for substitution shall be granted for a period not 
exceeding five years. 

Where  it  is  decided  not  to  authorise  or  to  restrict  the  use  of  a  biocidal  product 
pursuant  to  paragraph  3,  that  cancellation  or  amendment  of  the  authorisation  shall 
take  effect  five  years  after  the  decision  or  at  the  end  of  the  inclusion  period  of  the 
candidate for substitution, whichever is the earlier. 

CHAPTER V 
NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS 

Article 22 
Submission and validation of application 

1. 

Within  one  month  after  the  receipt  of  an  application  for  a  national  authorisation 
referred  to  in  Article  15,  the  receiving  competent  authority  shall  validate  the 
application if it complies with the following requirements:  

(a) 

the information referred to in Article 18 has been submitted; 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 

2. 

If  the  receiving  competent  authority  considers  that  the  application  is  incomplete,  it 
shall  inform  the  applicant  as  to  what  additional  information  is  required  for  the 
validation of the application and shall set a reasonable time limit for the submission 
of that information.  

The  receiving  competent  authority  shall,  within  one  month  from  the  receipt  of  the 
additional  information,  determine  whether  the  additional  information  submitted  is 
sufficient to validate the application. 

The receiving competent authority shall reject the application if the applicant fails to 
submit  the  requested  information  within  the  deadline  and  inform  the  applicant 
thereof.  

3. 

If  the  receiving  competent  authority,  on  basis  of  the  validation  made  pursuant  to 
paragraph 1, considers that the application is complete, it shall without delay inform 
the applicant thereof. 

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45 

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1. 

2. 

3. 

4. 

Article 23 
Evaluation of application  

The  receiving  competent  authority  shall,  within  twelve  months  after  the  validation 
referred to in Article 22, decide on the application in accordance with Article 16. 

If  an  application  relating  to  the  same  biocidal  product  is  being  examined  by  the 
competent  authority  of  another  Member  State  or  if  the  competent  authority  of 
another  Member  State  has  already  authorised  the  same  biocidal  product,  the 
receiving competent authority shall decline to assess the application and inform the 
applicant thereof.  

However,  the  applicant  may  request  that  his  application  be  assessed  in  accordance 
with Article 25 or 28. 

If  it  appears  that  additional  information  is  necessary  in  order  to  carry  out  a  full 
evaluation  of  the  application,  the  receiving  competent  authority  shall  request  the 
applicant  to  submit  such  information.  The  twelve-month  period  referred  to  in 
paragraph 1 shall be suspended from the date of issue of the request until the date the 
information is received. 

The receiving competent authority shall draft a  report  summarising  the conclusions 
of its assessment and the reasons for authorising a biocidal product or for refusing to 
grant  an  authorisation.  The  receiving  competent  authority  shall  send  the  draft 
assessment  report  to  the  applicant  who  shall  be  provided  with  the  opportunity  to 
submit  oral  or  written  comments  within  one  month.  The  receiving  competent 
authority shall take due account of these comments when finalising its assessment. 

The receiving competent authority shall approve the summary of the biocidal product 
characteristics referred to in Article 20(2). It shall forward the applicant a copy of the 
final assessment report. 

5. 

As soon as the receiving competent authority has taken a decision on an application, 
it  shall  enter  the  following  information  in  the  Community  Register  of  Biocidal 
Products: 

(a) 

the summary of biocidal product characteristics; 

(b) 

the  report  summarising  the  conclusions  of  the  assessment  of  the  biocidal 
product  and  the  reasons  for  authorising  the  biocidal  product  or  refusing  to 
authorise it; 

(c) 

the  administrative  decisions  taken  by  the  receiving  competent  authority 
concerning the application. 

Article 24 
Renewal of a national authorisation 

1. 

The authorisation holder or his representative shall submit an application for renewal 
of  a  national  authorisation  to  the  receiving  competent  authority  at  least  18  months 
before the expiry date of the authorisation.  

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46 

   EN 

 
2. 

3. 

4. 

5. 

6. 

7. 

8. 

The application shall be accompanied by the fees payable under Article 70. 

The  receiving  competent  authority  shall  renew  the  national  authorisation,  provided 
that the conditions set out in Article 16 are still satisfied.  

When applying for renewal, the applicant shall submit a list of all data related to the 
biocidal  product  that  have  been  generated  since  the  previous  authorisation  and  a 
justification  as  to  whether  the  conclusions  of  the  initial  assessment  of  the  biocidal 
product are still valid.  

The  receiving  competent  authority  may  require  the  applicant  to  submit  the  data 
referred to in the list at any time.  

Within  one  month  after  the  receipt  of  an  application  for  a  renewal  of  a  national 
authorisation,  the  receiving  competent  authority  shall  validate  the  application  if  it 
complies with the following requirements:  

(a) 

the information referred to in paragraph 3 has been submitted; 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 

If  the  receiving  competent  authority  considers  that  the  application  is  incomplete,  it 
shall  inform  the  applicant  as  to  what  additional  information  is  required  for  the 
validation of the application and shall set a reasonable time limit for the submission 
of that information.  

The  receiving  competent  authority  shall,  within  one  month  from  the  receipt  of  the 
additional  information,  determine  whether  the  additional  information  submitted  is 
sufficient to validate the application. 

The receiving competent authority shall reject the application if the applicant fails to 
submit  the  requested  information  within  the  deadline  and  inform  the  applicant 
thereof.  

If  the  receiving  competent  authority,  on  basis  of  the  validation  made  pursuant  to 
paragraph 4, considers that the application is complete, it shall without delay inform 
the applicant thereof. 

The  decision  on  the  application  for  renewal  of  the  national  authorisation  shall  be 
taken within six months after the validation. 

If,  when  the  application  for  renewal  is  evaluated,  it  appears  that  additional 
information is necessary in order to carry out a full evaluation of the application, the 
receiving competent authority shall ask that the applicant submits such information. 
The six-month period referred to in paragraph 6 shall be suspended from the date of 
the request until the date the information is received. 

Where, for reasons beyond the control of the holder of the national authorisation, no 
decision  is  taken  on  the  renewal  of  the  national  authorisation  before  its  expiry,  the 

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receiving competent authority shall grant the renewal of the national authorisation for 
the period necessary to complete the evaluation. 

9. 

As soon as the competent authority has taken a decision concerning the renewal of a 
national authorisation, it shall enter the information referred to in Article 23(5) in the 
Community Register of Biocidal Products. 

CHAPTER VI 
MUTUAL RECOGNITION PROCEDURES 

Article 25 
Mutual recognition of national authorisations in sequence 

1. 

The holder of a national authorisation for a biocidal product granted by a competent 
authority  in  accordance  with  Article  15  (hereinafter  referred  to  as  'the  reference 
competent authority') may apply for a national authorisation of the biocidal product 
in another Member State under the mutual recognition procedure in sequence. 

2. 

The application for mutual recognition shall be accompanied by: 

(a) 

(b) 

(c) 

a  reference  to  the  national  authorisation  granted  by  the  reference  competent 
authority; 

an  electronic  summary  of  the  dossier  satisfying  the  requirements  set  out  in 
Annex III; 

a reference to the report of the reference competent authority summarising the 
conclusions  of  its  assessment  and  the  reasons  for  authorising  the  biocidal 
product. 

The application shall be accompanied by the fees payable under Article 70. 

3. 

4. 

5. 

6. 

The  receiving  competent  authority  may  require  a  translation  of  the  national 
authorisation  and  application  into  one  or  several  of  the  official  languages  of  the 
Member State where that competent authority is situated. 

The receiving competent authority shall decide on the application within four months 
of the receipt of the application.  

The  receiving  competent  authority  shall  authorise  the  biocidal  product  concerned 
under the same conditions as the reference competent authority. 

As  soon  as  the  competent  authorities  have  taken  a  decision  on  an  application  for 
mutual recognition of a national authorisation under this Article, they shall enter the 
information  referred  to  in  points  (a)  and  (c)  of  Article  23(5)  in  the  Community 
Register of Biocidal Products. 

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1. 

2. 

3. 

4. 

1. 

2. 

Article 26 
Application for mutual recognition by pest control bodies 

Where  no  application  for  a  national  authorisation  has  been  submitted  in  a  Member 
State  for  a  biocidal  product  that  is  already  authorised  in  another  Member  State, 
official  or  scientific  bodies  involved  in  pest  control  activities  or  professional 
organisations  may  apply,  with  the  consent  of  the  authorisation  holder  in  another 
Member  State,  for  a  national  authorisation  for  the  same  biocidal  product,  the  same 
use  and  under  the  same  conditions  for  use  in  that  Member  State  under  the  mutual 
recognition procedure provided for in Article 25.  

The applicant shall demonstrate that the use of such a biocidal product is of general 
interest for that Member State.  

The application shall be accompanied by the fees payable under Article 70. 

By way of derogation from paragraph 1, where the authorisation holder does not give 
his  consent,  the  applicant  may  indicate  that  in  the  application  and  the  competent 
authority of the Member State concerned may accept the application on grounds of 
public interest.  

If the competent authority of the concerned Member State considers that the biocidal 
product fulfils the conditions referred to in Article 16 and the conditions under this 
Article are complied with, the competent authority shall authorise the placing of the 
biocidal product on the market.  

The  official  or  scientific  bodies  involved  in  pest  control  activities  or  professional 
organisations shall have the rights and obligations of the authorisation holder. 

Article 27 
Objections regarding the conditions for a national authorisation 

When the  competent authority, within  four months of the receipt of the application 
for mutual recognition, considers that a biocidal product, which has been authorised 
in  another  Member  State,  does  not  satisfy  the  requirements  of  Article  16,  it  shall 
without delay notify the Commission, the competent authorities of the other Member 
States  and  the  applicant  thereof  and  shall  provide  them  with  an  explanatory 
document  identifying  the  biocidal  product  and  its  specifications  and  setting  out  the 
grounds  on  which  it  proposes  to  refuse  to  recognise  or  to  restrict  the  national 
authorisation. 

The  Commission  shall  adopt  a  decision  on  whether  the  grounds  set  out  by  the 
competent  authority  justify  refusal  to  recognise,  or  restriction  of,  the  national 
authorisation in accordance with the procedure referred to in Article 72(3).  

If the Commission decision confirms the grounds presented for refusing or restricting 
the subsequent authorisation, the competent authority that had previously authorised 
the biocidal product shall without delay review its national authorisation to comply 
with that decision.  

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If the Commission decision confirms the initial national authorisation, the competent 
authority that proposed to refuse to recognise a national authorisation, or to recognise 
the national authorisation subject to certain conditions, shall without delay authorise 
the biocidal product concerned in accordance with the initial authorisation. 

Article 28 
Mutual recognition of national authorisations in parallel 

1. 

If the applicant seeks to receive national authorisations for a biocidal product in more 
than one Member State in parallel, he shall submit to a reference competent authority 
of his choice an application containing: 

(a) 

information referred to in Article 18;  

(b) 

a  list  of  all  other  Member  States  where  a  national  authorisation  is  sought 
(hereinafter referred to as the 'other concerned Member States').  

The application shall be accompanied by the fees payable under Article 70. 

The  reference  competent  authority  shall  be  responsible  for  the  evaluation  of  the 
application. 

The  applicant  shall  submit  to  the  competent  authorities  of  the  other  concerned 
Member States an application for mutual recognition of the authorisation for which it 
has applied to the reference competent authority. This application shall contain: 

(a) 

an electronic summary of the dossier as required in Annex III; 

(b) 

the  names  of  the  reference  competent  authority  and  of  the  other  concerned 
Member States.  

The  reference  competent  authority  shall,  within  one  month  after  the  receipt  of  an 
application referred to in paragraph 1, validate the application if it complies with the 
following requirements: 

(a) 

the information referred to in paragraph 1 has been submitted; 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted.  

If  the  reference  competent  authority  considers  that  the  application  is  incomplete,  it 
shall  inform  the  applicant  as  to  what  additional  information  is  required  for  the 
validation of the application and shall set a reasonable time limit for the submission 
of  that  information.  The  reference  competent  authority  shall  also  inform  the  other 
concerned Member States. 

The  reference  competent  authority  shall,  within  one  month  after  the  receipt  of  the 
additional  information,  determine  whether  the  additional  information  submitted  is 
sufficient to validate the application. 

2. 

3. 

4. 

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5. 

6. 

7. 

8. 

9. 

The reference competent authority shall reject the application if the applicant fails to 
submit the requested information within the deadline and shall inform the applicant 
and the other concerned Member States thereof.  

If the reference competent authority, on the basis of the validation made pursuant to 
paragraph 3, considers that the application is complete, it shall without delay inform 
the applicant and the other concerned Member States. 

The  reference  competent  authority  shall  evaluate  the  information  referred  to  in 
paragraph 1 and prepare a report summarising the conclusions of its assessment and a 
draft of the summary of the biocidal product characteristics within 12 months from 
the  receipt  of  a  valid  application  and  shall  communicate  the  report  and  the  draft 
summary  to  the  competent  authorities  of  other  concerned  Member  States  and  the 
applicant. The reference competent authority shall send the draft assessment report to 
the  applicant  who  shall  be  provided  with  the  opportunity  to  submit  oral  or  written 
comments  within  one  month.  The  reference  competent  authority  shall  take  due 
account of these comments when finalising its assessment. 

Within  four  months  after  receipt  of  the  documents  referred  to  in  paragraph  6,  the 
competent  authorities  of  other  concerned  Member  States  shall  approve  the 
assessment  report  and  the  summary  of  the product  characteristics,  and  shall  inform 
the reference competent authority accordingly.  

The  reference  competent  authority  and  the  competent  authorities  of  the  other 
concerned  Member  States  shall  authorise  the  biocidal  product  on  the  basis  of  the 
approved assessment report and the summary of the biocidal product characteristics 
within one month after the end of the period referred to in paragraph 7. 

If  one  or  more  competent  authorities  of  other  concerned  Member  States  have  not 
approved  the  assessment  report  and  the  summary  of  the  biocidal  product 
characteristics  within  four  months  after  receipt  of  the  documents  referred  to  in 
paragraph  6,  they  shall  notify  the  Commission,  the  applicant,  the  reference 
competent authority and the competent authorities of other concerned Member States 
and  shall  provide  them  with  an  explanatory  document  identifying  the  biocidal 
product and its specifications and setting out the grounds on which they propose to 
refuse to recognise, or to restrict, the national authorisation.  

The  Commission  shall  adopt  a  decision  on  whether  the  grounds  set  out  by  the 
competent  authority  justify  refusal  to  recognise,  or  restriction  of,  the  national 
authorisation in accordance with the procedure referred to in Article 72(3).  

If  the  Commission  decision  dismisses  the  grounds  presented  for  refusing  or 
restricting the national authorisation the competent authority that proposed to refuse 
to  recognise  the  authorisation,  or  to  restrict  the  authorisation,  shall  without  delay 
authorise 
the  national 
the  biocidal  product  concerned 
authorisation issued by the reference competent authority. 

in  accordance  with 

10. 

As  soon  as  the  competent  authorities  have  taken  a  decision  on  an  application  for  a 
national  authorisation  in  more  than  one  Member  State  in  parallel,  they  shall  enter 
information referred to in Article 23(5), where applicable, in the Community Register 
of Biocidal Products.  

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1. 

2. 

1. 

2. 

Article 29 
Adjustment to local circumstances 

The  competent  authority  that  has  received  an  application  for  mutual  recognition  in 
accordance  with  Articles  25  or  28  may,  within  two  months  from  the  receipt  of  the 
application, propose to the applicant that certain conditions referred to in points (e), 
(f),  (h),  (j)  and  (l)  of  Article  58(2)  in  the  authorisation  be  adjusted  to  local 
circumstances, so that conditions for issue of an authorisation laid down in Article 16 
are  satisfied,  and  shall  inform  the  Commission  thereof,  if  it  establishes  that,  in  its 
territory, one of the following conditions is met: 

(a) 

the target species is not present in harmful quantities; 

(b)  unacceptable  tolerance  or  resistance  of  the  target  organism  to  the  biocidal 

product is demonstrated; 

(c) 

the  relevant  circumstances  of  use,  in  particular  the  climate  or  the  breeding 
period of the target species, differ significantly from those in the Member State 
where  the  initial  evaluation  was  carried  out  or  the  Member  State  where  the 
issued,  and  an  unchanged  national 
initial  national  authorisation  was 
authorisation  may  therefore  present  unacceptable  risks  to  humans  or  to  the 
environment.  

The  competent  authorities  shall  communicate  to  the  Commission  all  proposals 
concerning adjustment of conditions in national authorisations to local circumstances 
and the reasons for proposing adjustment. 

If,  within  2  months,  an  agreement  on  the  proposed  adjustments  is  not  reached 
between  the  applicant  and  the  competent  authority  that  has  received  an  application 
for  mutual  recognition,  that  competent  authority  shall  without  delay  inform  the 
Commission  thereof  and  provide  an  explanatory  document  on  the  proposed 
adjustments identifying the biocidal product and its specifications and setting out the 
grounds on which it proposes to adjust the conditions of the national authorisation.  

The Commission shall adopt a decision on the proposed adjustment of the conditions 
of the national authorisation to local circumstances in accordance with the procedure 
referred to in Article 72(3). The competent authority of the concerned Member State 
shall without delay adopt all appropriate measures to comply with that decision. 

Article 30 
Opinion of the Agency 

The  Commission  may  ask  the  Agency  for  an  opinion  on  scientific  or  technical 
matters raised by a Member State objecting to the mutual recognition of a national 
authorisation  or  seeking  to  adjust  the  authorisation  to  local  circumstances.  The 
Agency  shall  issue  an  opinion  within  6  months  from  the  date  on  which  the  matter 
was referred to it. 

Before issuing its opinion, the Agency shall provide the applicant or the authorisation 
holder with an opportunity to present written or oral explanations within a specified 
time limit not exceeding one month. 

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The  Agency  may  suspend  the  time  limit  referred  to  in  paragraph  1  to  allow  the 
applicant or the authorisation holder to prepare the explanations. 

Article 31 
Derogation regarding certain product-types 

By way of derogation from Articles 25 and 28, competent authorities of Member States may 
refuse mutual recognition of national authorisations granted for product types 15, 17 and 23 of 
Annex V provided that such a refusal can be justified on grounds of the protection of health of 
humans, animals or plants, the protection of national treasures possessing artistic, historic or 
archaeological  value,  or  the  protection  of  industrial  and  commercial  property.  Competent 
authorities  of  Member  States  shall  without  delay  inform  each  other  and  the  Commission  of 
any decision taken in this respect and shall indicate the reasons thereof. 

CHAPTER VII 
COMMUNITY AUTHORISATIONS OF BIOCIDAL 
PRODUCTS 

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Section 1 
Granting of Community authorisations 

Article 32 
Community authorisation 

A Community authorisation issued by the Commission in accordance with this Section shall 
be valid throughout the Community unless otherwise specified. It shall confer the same rights 
and  obligations  in  each  of  the  Member  States  as  an  authorisation  issued  by  the  competent 
authority of that Member State.  

Article 33 
Biocidal products for which Community authorisation may be granted 

1. 

The Community authorisation may be granted to the following categories of biocidal 
products: 

2. 

1. 

(a) 

biocidal products containing one or more new active substances;  

(b) 

low-risk biocidal products.  

Following  the  report  of  the  Commission  on  the  implementation  of  this  Regulation 
referred to in Article 54(4) and in light of the experience gained with the Community 
authorisations,  the  Commission  may  add  other  categories  of  biocidal  products  in 
paragraph 1 of this Article.  

Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 

Article 34 
Submission and validation of application 

The  person  responsible  for  the  placing  of  a  biocidal  product  on  the  market,  or  his 
representative,  shall  submit  an  application  for  a  Community  authorisation  to  the 
Agency  and  inform  the  Agency  of  the  name  of  the  competent  authority  of  the 
Member  State  of  his  choice  which  shall  be  responsible  for  the  evaluation  of  the 
application (hereinafter referred to as 'the evaluating competent authority').  

The  Agency  shall,  within  one  month  after  the  receipt  of  the  application,  notify  the 
evaluating  competent  authority  that  the  application  is  available  in  the  Agency 
database. 

2. 

Within two months after the receipt of an application, the Agency shall validate the 
application if it complies with the following requirements:  

(a) 

the information referred to in Article 18 has been submitted; 

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3. 

4. 

5. 

1. 

2. 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 

If  the  Agency  considers  that  the  application  is  incomplete,  it  shall  inform  the 
applicant  as  to  what  additional  information  is  required  for  the  validation  of  the 
application  and  shall  set  a  reasonable  time  limit  for  the  submission  of  that 
information.  

The Agency shall, within two months from the receipt of the additional information, 
determine  whether  the  additional  information  submitted  is  sufficient  to  validate  the 
application. 

The  Agency  shall  reject  the  application  if  the  applicant  fails  to  complete  his 
application  within  the  deadline  and  inform  the  applicant  and  the  evaluating 
competent  authority  thereof.  In  such  cases  a  part  of  the  fee  paid  to  the  Agency  in 
accordance with Article 70 shall be reimbursed. 

An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 3.  

If the Agency, on the basis of the validation made pursuant to paragraph 2, considers 
that the application is complete, it shall without delay inform the applicant and the 
evaluating competent authority thereof. 

Article 35 
Evaluation of applications 

The evaluating competent authority shall, within twelve months after the validation, 
evaluate  the  dossiers  in  accordance  with  Article  16  including,  where  relevant,  any 
proposal to adapt data requirements submitted in accordance with Article 19(2). 

The evaluating competent authority shall provide the applicant with an opportunity to 
provide  written  or  oral  comments  on  the  conclusions  of  the  evaluation  within  one 
month. The evaluating competent authority shall take due account of these comments 
when finalising its evaluation. 

The evaluating competent authority shall send the conclusions of the assessment and 
the assessment report to the Agency. 

If, when the dossiers are evaluated, it appears that additional information is necessary 
to carry out the evaluation, the evaluating competent authority shall ask the applicant 
to submit such information within a specified time limit, and shall inform the Agency 
thereof.  

The twelve-month period referred to in paragraph 1 shall be suspended from the date 
of issue of the request until the date the information is received. 

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3. 

Within nine months from the receipt of the conclusions of the evaluation, the Agency 
shall  prepare  and  submit  to  the  Commission  an  opinion  on  the  authorisation  of  the 
biocidal product.  

If  the  Agency  recommends  the  authorisation  of  the  biocidal  product,  the  opinion 
shall contain at least the following elements: 

(a) 

a statement on whether the conditions of points (b), (c) and (d) of Article 16(1) 
are  fulfilled,  and  a  draft  summary  of  the  biocidal  product  characteristics,  as 
referred to in Article 20(2); 

(b)  where relevant, details of any terms or conditions which should be imposed on 

the placing on the market or use of the biocidal product; 

(c) 

the final assessment report on the biocidal product. 

On receipt of the opinion of the Agency, the Commission shall adopt a decision on 
the  Community  authorisation  of  the  biocidal  product  in  accordance  with  the 
procedure  referred  to  in  Article  72(3).  As  soon  as  the  Commission  has  taken  a 
decision to grant a Community authorisation, it shall enter the information referred to 
in Article 23(5) in the Community Register of Biocidal Products. 

The Commission may, on the request of a Member State, decide that the Community 
authorisation  shall  not  apply  in  the  territory  of  that  Member  State  for  a  biocidal 
product of the product-types 15, 17 or 23 of Annex V provided that such a request 
can be justified on grounds of the protection of health of humans, animals or plants, 
the  protection  of  national  treasures  possessing  artistic,  historic  or  archaeological 
value, or the protection of industrial and commercial property. 

The  Commission  may,  on  the  request  of  a  Member  State,  decide  that  certain 
conditions of the Community authorisation should be adjusted to the different local 
circumstances in that Member State in accordance with Article 29. 

If the decision referred to in paragraph 4 refuses to grant a Community authorisation 
to  a  biocidal  product  because  it  does  not  fulfil  the  criteria  for  a  low-risk  biocidal 
product  in  accordance  with  Article  17,  the  applicant  may  apply,  if  relevant,  for  a 
Community authorisation in accordance with point (a) of Article 33(1) or a national 
authorisation in accordance with Chapter V. 

The competent authority that has been notified of the application for the evaluation 
as  referred  to  in  Article  34(1)  may,  within  one  month  after  the  receipt  of  the 
notification,  submit  a  duly  substantiated  request  to  the  Commission  to  appoint 
another  evaluating  competent  authority.  The  Commission  shall  take  a  decision  in 
accordance with the procedure referred to in Article 72(2). 

4. 

5. 

6. 

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Section 2 
Renewal of Community authorisations 

Article 36 
Submission and validation of applications 

1. 

2. 

3. 

4. 

The authorisation holder or his representative shall submit an application for renewal 
of  a  Community  authorisation  to  the  Agency  at  least  18  months  before  the  expiry 
date of the authorisation. 

The application shall be accompanied by the fees payable under Article 70. 

The  Agency  shall,  within  one  month  after  the  receipt  of  the  application,  notify  the 
evaluating  competent  authority  that  carried  out  the  initial  evaluation  of  the 
application  for  Community  authorisation  that  the  application  is  available  in  the 
Agency database. 

The  Commission  shall  renew  a  Community  authorisation,  provided  that  the 
conditions set out in Article 16 are still satisfied.  

When applying for renewal, the applicant shall submit a list of all data relating to the 
biocidal  product  that  have  been  generated  since  the  previous  authorisation  and  a 
justification  as  to  whether  the  conclusions  of  the  initial  assessment  of  the  biocidal 
product are still valid.  

The evaluating competent authority that carried out the initial evaluation may require 
the applicant to submit the data referred to in the list at any time.  

5. 

Within two months after the receipt of an application, the Agency shall validate the 
application if it complies with the following requirements: 

(a) 

information referred to paragraph 4 has been submitted; 

(b) 

it is accompanied by the fees payable under Article 70. 

The validation shall not include an assessment of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 

6. 

If  the  Agency  considers  that  the  application  is  incomplete,  it  shall  inform  the 
applicant  as  to  what  additional  information  is  required  for  the  validation  of  the 
application  and  shall  set  a  reasonable  time  limit  for  the  submission  of  that 
information.  

The Agency shall, within two months after the receipt of the additional information, 
determine  whether  the  additional  information  submitted  is  sufficient  to  validate  the 
application. 

The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and shall inform the applicant thereof. In such cases 

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7. 

8. 

1. 

2. 

3. 

4. 

5. 

a  part  of  the  fee  paid  to  the  Agency  in  accordance  with  Article  70  shall  be 
reimbursed. 

An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 6.  

If the Agency, on basis of the validation made pursuant to paragraph 5, considers that 
the  application  is  complete,  it  shall  without  delay  inform  the  applicant  and  the 
evaluating competent authority thereof. 

Article 37 
Evaluation of applications for renewal 

On the basis of the available information and a need to review the conclusions of the 
initial  assessment  of  the  application  for  Community  authorisation,  the  evaluating 
competent  authority  that  carried  out  the  initial  evaluation  of  the  application  for 
Community authorisation shall, within one month after the validation referred to in 
Article  36(5),  decide  whether  a  full  evaluation  of  the  application  for  renewal  is 
necessary 

If the evaluating competent authority decides that a full evaluation of the application 
is necessary, the evaluation shall be carried out in accordance with paragraphs 1 to 3 
of  Article  35.  The  decision  on  the  application  shall  be  adopted  in  accordance  with 
paragraph 5 of this Article. 

If  the  evaluating  competent  authority  that  carried  out  the  initial  evaluation  of  the 
application  for  Community  authorisation  decides  that  a  full  evaluation  of  the 
application  is  not  necessary,  it  shall,  within  twelve  months  after  the  validation, 
prepare  and  submit  to  the  Agency  a  recommendation  on  the  renewal  of  the 
authorisation. 

Prior  to  submitting  the  recommendation  to  the  Agency,  the  evaluating  competent 
authority  shall  provide  the  applicant  with  an  opportunity  to  provide  written  or  oral 
comments  on  the  recommendation  within  one  month.  The  evaluating  competent 
authority  shall 
its 
recommendation. 

these  comments  when  finalising 

take  due  account  of 

On the receipt of the recommendation from the evaluating competent authority, the 
Agency shall make it available to the competent authorities of other Member States 
and the applicant and allow a period of three months during which they may submit 
written comments to it. 

The  Commission  may  ask  the  Agency  for  an  opinion  on  scientific  or  technical 
matters raised by a competent authority objecting to the recommendation referred to 
in paragraph 2. The Agency shall issue an opinion within six months from the date 
on which the matter was referred to it. 

At the end of the period referred to in paragraph 3 or on receipt of the opinion of the 
Agency, the Commission shall adopt a decision to renew, or to refuse to renew, the 
Community  authorisation  in  accordance  with  the  procedure  referred  to  in  Article 
72(3).  As  soon  as  the  Commission  has  taken  a  decision,  it  shall  update  the 

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6. 

1. 

2. 

3. 

information  referred  to  in  Article  23(5)  in  the  Community  Register  of  Biocidal 
Products. 

Where, for reasons beyond the control of the holder of the Community authorisation, 
no  decision  is  taken  on  the  renewal  of  the  authorisation  before  its  expiry,  the 
Commission  shall  grant  the  renewal  of  the  Community  authorisation  for  the  period 
necessary to complete the evaluation in accordance with the procedure referred to in 
Article 72(2). 

CHAPTER VIII 
CANCELLATION, REVIEW AND AMENDMENTS OF 
AUTHORISATIONS 

Article 38 
Obligation for notification of new information 

If  the  holder  of  an  authorisation  becomes  aware  of  information  concerning  the 
authorised biocidal product or the active substance(s) it contains,  which  may  affect 
the  authorisation  he  shall  without  delay  notify  the  competent  authority  that  granted 
the  national  authorisation  and  the  Agency  or,  in  the  case  of  a  Community 
authorisation, the Commission and the Agency. In particular, the following shall be 
notified: 

(a) 

new knowledge or information on the effects of the active substance or biocidal 
product for humans or the environment;  

(b)  data  indicating  the  potential  of  the  active  substance  for  the  development  of 

resistance;  

(c) 

new  knowledge  or  information  indicating  that  the  biocidal  product  is  not 
sufficiently effective. 

The  competent  authority  that  granted  the  national  authorisation  or  in  the  case  of  a 
Community  authorisation,  the  Agency,  shall  examine  whether  the  authorisation 
needs to be amended or cancelled in accordance with Article 39.  

The  competent  authority  that  granted  the  national  authorisation  or  in  the  case  of  a 
Community  authorisation,  the  Agency,  shall  without  delay  notify  competent 
authorities  of  other  Member  States  and,  where  appropriate,  the  Commission  of  any 
such information it received.  

Competent authorities of Member States that have issued national authorisations for 
the  same  biocidal  product  under  the  mutual  recognition  procedure  shall  examine 
whether  the  authorisation  needs  to  be  amended  or  cancelled  in  accordance  with 
Article 39. 

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Article 39 
Cancellation or amendment of an authorisation 

1. 

The  competent  authority  of  a  Member  State  or,  in  the  case  of  a  Community 
authorisation, the Commission, may at any time cancel or amend an authorisation it 
has granted in the following cases: 

(a) 

the requirements referred to in Article 16 are not satisfied;  

(b) 

false or misleading information was supplied concerning the facts on the basis 
of which the authorisation was granted; 

(c) 

a condition included in the authorisation has not been complied with;  

(d) 

the authorisation holder fails to comply with his obligations resulting from this 
Regulation.  

Where  the  competent  authority  or,  in  the  case  of  a  Community  authorisation,  the 
Commission,  intends  to  cancel  or  amend  an  authorisation,  it  shall  inform  the 
authorisation  holder  thereof  and  give  him  the  opportunity  to  submit  written  or  oral 
comments  or  additional  information  within  a  specified  time  limit.  The  evaluating 
competent  authority  shall  take  due  account  of  these  comments  when  finalising  its 
decision. 

Where  the  competent  authority  or,  in  the  case  of  a  Community  authorisation,  the 
Commission, cancels or amends an authorisation in accordance with paragraph 1, it 
shall without delay notify the authorisation holder, the competent authorities of other 
Member States and, where relevant, the Commission.  

Competent  authorities  which  have  issued  authorisations  for  the  same  biocidal 
product under the mutual recognition procedure shall, within four months, cancel or 
amend  the  authorisations  accordingly,  taking  into  account  local  circumstances,  and 
shall notify the Commission thereof.  

In the case of disagreement between competent authorities of certain Member States, 
the points of disagreement shall be referred without delay to the Commission and the 
procedure laid down in Articles 27 and 30 shall apply mutatis mutandis. 

As soon as the competent authority or the Commission in the case of a Community 
authorisation,  has  taken  a  decision  to  cancel  or  amend  an  authorisation,  it  shall 
update  the  information  referred  to  in  Article  23(5)  relating  to  the  biocidal  product 
concerned in the Community Register of Biocidal Products. 

2. 

3. 

4. 

Article 40 
Cancellation of an authorisation at the request of the authorisation holder 

The competent authority that has granted the national authorisation or in case of Community 
authorisation, the Commission, shall cancel the authorisation at the request of its holder, who 
shall state the reasons for such request. If such a request concerns a Community authorisation, 
it shall be submitted to the Agency.  

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As  soon  as  the  competent  authority  or  the  Commission  in  the  case  of  a  Community 
authorisation, has taken a decision to cancel an authorisation, it shall update the information 
referred  to  in  Article  23(5)  information  relating  to  the  biocidal  product  concerned  in  the 
Community Register of Biocidal Products. 

Article 41 
Amendment of an authorisation at the request of the authorisation holder 

1. 

2. 

The  terms  and  conditions  of  an  authorisation  shall  not  be  changed  unless  the 
authorisation  has  been  amended  by  the  competent  authority  which  has  previously 
authorised  the  biocidal  product  concerned,  or  in  the  case  of  a  Community 
authorisation, by the Commission. 

An  application  by  an  authorisation  holder  to  amend  the  terms  and  conditions  of  an 
authorisation shall be submitted to the competent authorities of all the Member States 
which have previously authorised the biocidal product concerned, or in the case of a 
Community authorisation, to the Agency.  

The application shall be accompanied by the fees payable under Article 70. 

Article 42 
Implementing measures 

The  Commission  shall  adopt  implementing  measures  specifying  the  criteria  and  procedures 
related to a cancellation of an authorisation or amendments of the terms and conditions of an 
authorisation under Articles 39 to 41, including a dispute settlement mechanism.  

Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 72(4). 

Article 43 
Period of grace 

Notwithstanding Article 77, where the competent authority or in the case of a biocidal product 
authorised  at  Community  level,  the  Commission,  cancels  or  amends  an  authorisation  or 
decides not to renew it, it shall grant a period of grace for the disposal, storage, placing on the 
market and use of existing stocks except in cases where continued placing on the market or 
use of the product would constitute an unacceptable risk to human health or the environment.  

The  period  of  grace  shall  not  exceed  six  months  for  the  placing  on  the  market  and  an 
additional  maximum  period  of  twelve  months  for  the  disposal,  storage,  and  use  of  existing 
stocks of the biocidal products concerned. 

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Article 44 
Parallel trade 

1. 

2. 

A competent authority of a Member State (hereinafter referred to as 'Member State of 
introduction')  may  grant  a  parallel  trade  permit  for  a  biocidal  product  that  is 
authorised  in  another  Member  State  (hereinafter  referred  to  as  'Member  State  of 
origin') to be placed on the market and used in the Member State of introduction, if it 
determines  that  the  biocidal  product  is  substantially  identical  in  composition  to  a 
biocidal product already authorised in that Member State (hereinafter referred to as 
'the reference product').  

The applicant who intends to place the biocidal product on the market in the Member 
State  of  introduction  shall  submit  the  application  for  a  parallel  trade  permit  to  the 
competent authority of the Member State of introduction. 

The  application  shall  be  accompanied  by  all  the  information  necessary  to 
demonstrate  that  the  biocidal  product  is  substantially  identical  to  the  reference 
product as defined in paragraph 3. 

A  parallel  trade  permit  shall  be  granted  within  two  months  from  submission  of  an 
application.  The  competent  authority  of  the  Member  State  of  introduction  may 
request  from  the  competent  authority  of  the  Member  State  of  origin  additional 
information necessary to determine whether the product is substantially identical to 
the reference product. The competent authority of the Member State of origin shall 
provide the requested information within one month of receiving the request.  

3. 

A  biocidal  product  shall  be  considered  as  substantially  identical  to  the  reference 
product if one of the following conditions is met: 

(a) 

(b) 

(c) 

the  source  of  the  active  substances  it  contains  is  the  same  in  terms  of 
manufacturer and location of the production plant;  

it is either the same or similar with regard to the non-active substances present 
and the type of formulation;  

it is either the same or equivalent in terms of the potential adverse impact on 
the  safety  of  the  product  with  regard  to  human  or  animal  health  or  the 
environment. 

4. 

An application for a parallel trade permit shall include the following information and 
items:  

(a) 

(b) 

name and authorisation number of the biocidal product in the Member State of 
origin; 

the  competent  authority  of  the  Member  State  of  origin  that  authorised  the 
reference product;  

(c) 

name and address of the authorisation holder in the Member State of origin; 

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(d)  original  label  and  instructions  for  use  with  which  the  biocidal  product  is 
distributed in the Member State of origin if it is considered as necessary for the 
examination by the competent authority of the Member State of introduction;  

(e) 

name and address of the applicant;  

(f) 

(g) 

(h) 

(i) 

name to be given to the biocidal product to be distributed in the Member State 
of introduction; 

a draft label for the product intended to be placed on the market in the Member 
State of introduction; 

a sample of the product which is intended to be introduced if it is considered as 
necessary by the competent authority of the Member State of introduction; 

name and authorisation number of the reference product in the Member State 
of introduction. 

The  competent  authority  of  the  Member  State  of  introduction  may  require  a 
translation of the relevant parts of the original instructions for the use referred to in 
point (d).  

The  parallel  trade  permit  shall  prescribe  the  same  conditions  for  placing  on  the 
market and use as the authorisation of the reference product.  

The  parallel  trade  permit  shall  be  valid  for  the  duration  of  authorisation  of  the 
reference product in the Member State of introduction.  

If  the  authorisation  holder  of  the  reference  product  applies  for  cancellation  of 
authorisation  in  accordance  with  Article  40  and  the  requirements  of  Article  16  are 
still  fulfilled,  the  validity  of  the  parallel  trade  permit  shall  expire  on  the  date  on 
which the authorisation of the reference product would have normally expired. 

Without prejudice to specific provisions in this Article, Articles 38 to 41 and Chapter 
XIII shall apply mutatis mutandis to biocidal products placed on the market under a 
parallel trade permit. 

The  competent  authority  of  the  Member  State  of  introduction  may  withdraw  a 
parallel  trade  permit  if  the  authorisation  of  the  introduced  biocidal  product  is 
withdrawn in the Member State of origin because of safety or efficacy reasons. 

Where  a  decision  concerning  the  application  for  a  parallel  trade  permit  is  taken  in 
accordance with the provisions of this Article, the competent authorities of Member 
States  which  have  taken  such  a  decision  shall  enter  the  information  referred  to  in 
Article 23(5) in the Community Register of Biocidal Products. 

5. 

6. 

7. 

8. 

9. 

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CHAPTER IX 
DEROGATIONS 

Article 45 
Derogation from the requirements  

1. 

By way of derogation from Articles 15 and 16, a competent authority may authorise 
for  a  period  not  exceeding  nine  months,  the  placing  on  the  market  of  a  biocidal 
product  not  complying  with  the  provisions  of  this  Regulation  for  a  limited  and 
controlled use if such a measure is necessary because of a danger to public health or 
the environment which cannot be contained by other means.  

The  competent  authority  referred  to  in  the  first  subparagraph  shall  without  delay 
inform  the  other  competent  authorities  and  the  Commission  of  its  action  and  the 
justification  for  it.  The  competent  authority  shall  without  delay  inform  the  other 
competent authorities and the Commission of a revocation of such action. 

The Commission shall without delay decide whether, and under what conditions, the 
action taken by the competent authority may be extended for a period not exceeding 
18 months in accordance with the procedure referred to in Article 72(3).  

2. 

By  way  of  derogation  from  point  (a)  Article  16(1)  and  until  an  active  substance  is 
listed  in  Annex  I,  competent  authorities  and  the  Commission  may  authorise,  for  a 
period  not  exceeding  three  years,  the  placing  on  the  market  of  a  biocidal  product 
containing a new active substance not listed in Annex I.  

Such  an  authorisation  may  be  issued  only  if,  after  dossiers  have  been  evaluated  in 
accordance  with  Article  8,  the  evaluating  competent  authority  has  submitted  a 
recommendation  for  inclusion  of  the  new  active  substance  in  Annex  I  and  the 
competent authority which received the application for the provisional authorisation 
or  in  case  of  Community  authorisation,  the  Agency,  considers  that  the  biocidal 
product may be expected to comply with points (c) and (d) of Articles 16(1). 

The  competent  authorities  or  the  Commission  shall  enter  the  information  on  the 
authorisation  referred  to  in  Article  23(5)  in  the  Community  Register  of  Biocidal 
Products. 

If  the  Commission  decides  not  to  include  an  active  substance  in  Annex  I,  the 
competent  authority  which  granted  an  authorisation  referred  to  in  the  first 
subparagraph or the Commission shall cancel that authorisation. 

Where a decision on the inclusion of an active substance in Annex I has not yet been 
adopted  by  the  Commission  when  the  period  of  three  years  expires,  the  competent 
authority which granted a provisional authorisation, or the Commission, may extend 
the provisional authorisation for a period not exceeding one year, provided there are 
good  reasons  to  believe  that  the  active  substance  will  satisfy  the  requirements  of 
Article  4.  Competent  authorities  which  extended  the  provisional  authorisation  shall 
inform  the  other  competent  authorities  and,  where  appropriate,  the  Commission  of 
such action. 

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3. 

1. 

2. 

3. 

In  addition  to  the  active  substances  referred  to  in  Article  15(2)  of  Regulation  (EC) 
No  1907/2006,  active  substances  manufactured  or  imported  for  use  in  biocidal 
products  which  are  authorised  for  placing  on  the  market  in  accordance  with  this 
Article  shall  be  regarded  as  being  registered  and  the  registration  as  completed  for 
manufacture or import for the use in a biocidal product and therefore as fulfilling the 
requirements of Chapters 1 and 5, Title II of Regulation (EC) No 1907/2006. 

Article 46 
Research and development 

By  way  of  derogation  from  Article  15,  an  experiment  or  a  test  for  the  purposes  of 
research  or  development  involving  the  placing  on  the  market  of  an  unauthorised 
biocidal  product  or  an  active  substance  intended  exclusively  for  use  in  a  biocidal 
product may only take place in the case of scientific research and development or in 
the  case  of  product  and  process-oriented  research  and  development,  and  under  the 
conditions laid down in the second and third subparagraphs. 

In the case of scientific research and development, the person who intends to carry 
out the experiment or the test shall notify the competent authority prior to the start. 
The  person  shall  draw  up  and  maintain  written  records  detailing  the  identity  of  the 
biocidal  product  or  active  substance,  labelling  data,  quantities  supplied  and  the 
names  and  addresses  of  those  persons  receiving  the  biocidal  product  or  active 
substance,  and  shall  compile  a  dossier  containing  all  available  data  on  possible 
effects  on  human  or  animal  health  or  impact  on  the  environment.  The  persons 
concerned  shall,  if  requested,  make  this  information  available  to  the  competent 
authority. 

In  the  case  of  product  and  process-oriented  research  and  development,  the  person 
who intends to carry out the experiment or the test shall, prior to the placing of the 
biocidal  product  or  the  active  substance  on  the  market,  notify  the  information 
required in the second subparagraph to the competent authority of the Member State 
where the placing on the market occurs. 

An  unauthorised  biocidal  product  or  an  active  substance  for  exclusive  use  in  a 
biocidal product shall not be placed on the market for the purpose of any experiment 
or  test  which  may  involve,  or  result  in,  release  of  the  biocidal  product  into  the 
environment  unless  the  competent  authority  has  assessed  the  data  submitted  by  the 
person interested in the placing of such product on the market and issued a national 
authorisation for this purpose which limits the quantities to be used and the areas to 
be treated and which may impose further conditions. The competent authority shall 
without  delay  inform  the  Commission  and  other  competent  authorities  about  the 
issued national authorisation. 

Where any experiment or test takes place in a Member State other than the Member 
State where placing on the market of the biocidal product occurs, the applicant shall 
obtain experiment or test authorisation from the competent authority of the Member 
State in the territory of which the experiments or tests are to be conducted. 

If  the  proposed  experiments  or  tests  referred  to  in  paragraphs  1  and  2  may  have 
harmful effects on human or animal health or any unacceptable adverse effect on the 

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environment,  the competent authority  of the Member State concerned may prohibit 
them  or  allow  them  subject  to  such  conditions  as  it  considers  necessary  to  prevent 
those  consequences.  The  competent  authority  shall  without  delay  inform  the 
Commission and other competent authorities about such measures. 

4. 

The  Commission  shall  adopt  measures  to  specify  the  overall  applicable  maximum 
quantities  of  active  substances  or  biocidal  products  that  may  be  released  during 
experiments and the minimum data to be submitted in accordance with paragraph 2.  

Those  measures  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 

CHAPTER X 
TREATED ARTICLES OR MATERIALS 

Article 47 
Placing on the market of treated articles or materials 

1. 

Treated materials or articles that incorporate one or more biocidal products shall not 
be placed on the market unless the biocidal product(s) used for treating the materials 
or  articles  are  authorised  for  this  use  in  the  Community  or  in  at  least  one  Member 
State. 

2. 

Treated articles or materials shall be labelled with the following information: 

(a) 

the name of all active substances that were used to treat the article or materials 
or that were incorporated in the articles or materials;  

(b)  where relevant, the biocidal property attributed to treated articles or materials; 

(c) 

(d) 

the  authorisation  number  of  all  biocidal  products  that  were  used  for  the 
treatment or were incorporated in the articles or materials; 

any hazard statement or precautionary statement set out in the authorisation for 
the biocidal product. 

The labelling shall be clearly visible, easily legible and appropriately durable. 

Where  this  is  necessary  because  of  the  size  or  the  function  of  the  treated  article  or 
material, the labelling shall be printed on the packaging, on the instructions for use or 
on the warranty of the treated article or material. 

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CHAPTER XI 
DATA PROTECTION AND DATA-SHARING 

1. 

2. 

3. 

4. 

5. 

1. 

Article 48 
Protection of information held by competent authorities or the Agency 

Information  submitted  for  the  purposes  of  this  Regulation  shall  not  be  used  by 
competent authorities or the Agency for the benefit of a subsequent applicant, except 
in one of the following cases: 

(a) 

the subsequent applicant has written agreement in the form of a letter of access 
from the first applicant that he can use that information,  

(b) 

the relevant time limit for data protection has expired.  

When  an  applicant  submits  any  information  to  a  competent  authority  or  to  the 
Agency,  he  shall  also  provide  a  list  of  all  the  information  submitted.  In  the  list  he 
shall specify whether he is the owner of the information or whether he only holds a 
letter of access to that information. In the latter case, the list shall contain the name 
and contact details of the owner. The applicant shall inform the competent authority 
or the Agency about any changes to the ownership of the information. 

On receipt of the list referred to in paragraph 2, the competent authorities shall send 
it to the Agency.  

The  list  referred  to  in  paragraph  2  shall  be  entered  by  the  Agency  in  the  Biocides 
Data Sharing Register.  

The  Commission,  the  Agency,  the  advisory  scientific  committees  set  up  under 
Commission Decision 2004/210/EC setting up Scientific Committees in the field of 
consumer safety, public health and the environment45 and the competent authorities 
shall have access to the information referred to in paragraph 1. 

Article 49 
Information protection periods 

Information  submitted  for  the  purposes  of  Directive  98/8/EC  or  of  this  Regulation 
shall benefit from data protection under the conditions laid down in this Article. The 
protection period for this information shall start when the information is submitted. 

Information protected under Directive 98/8/EC or under this Article or for which the 
protection period expired under Directive 98/8/EC or under this Article shall not be 
protected again.  

45 

OJ L 66, 4.3.2004, p. 45 

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2. 

The  protection  period  for  information  submitted  in  view  of  the  inclusion  of  an 
existing active substance in Annex I shall end 10 years from the date of the inclusion 
of the relevant active substance in Annex I for the particular product-type.  

The  protection  period  for  information  submitted  in  view  of  the  inclusion  of  a  new 
active substance in Annex I shall end 15 years from the date of the inclusion of the 
relevant active substance in Annex I for the particular product-type.  

The protection period for information submitted in view of the renewal or review of 
the inclusion of an active substance in Annex I shall end 5 years from the date of the 
decision concerning the renewal or the review being taken 

3. 

The  protection  period  for  information  submitted  in  view  of  the  authorisation  of  a 
biocidal product containing only existing active substances shall end 10 years from 
the date of the first authorisation of the product. 

The  protection  period  for  information  submitted  in  view  of  the  authorisation  of  a 
biocidal product containing a new active substance shall end 15 years from the date 
of the first authorisation of the product. 

The  protection  period  for  information  submitted  in  view  of  the  renewal  or 
amendment of the authorisation of a biocidal product shall end 5 years from the date 
of the renewal or amendment of the authorisation. 

4. 

By  way  of  derogation  from  the  first  subparagraph  of  paragraph  2,  the  protection 
period  for  information  submitted  to  a  Member  State  under  national  systems  or 
practices  for  the  approval  of  biocidal  products,  before  it  was  submitted  for  the 
purposes  of  Directive  98/8/EC  or  of  this  Regulation,  shall  end  at  the  expiry  of  any 
remaining period provided for under national rules or on 14 May 2014, whichever is 
the earlier, unless this information has been generated after 14 May 2000.  

Article 50 
Letter of access 

1. 

A letter of access shall contain at least the following information: 

(a) 

name and contact details of the data owner and the beneficiary; 

(b)  date on which the letter of access takes effect and its expiry date; 

(c) 

the submitted information to which the letter of access grants citation rights; 

(d) 

the address of the manufacturing facility where the active substance or biocidal 
product is produced;  

(e) 

the conditions under which it may be revoked.  

2. 

Revocation of a letter of access prior to its expiry date shall not affect the validity of 
the authorisation issued on the basis of the letter of access in question. 

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1. 

2. 

1. 

2. 

3. 

Article 51 
Mandatory information sharing 

In order to avoid animal testing, testing on vertebrate animals for the purposes of this 
Regulation  shall  be  undertaken  only  as  a  last  resort.  Testing  on  vertebrate  animals 
shall not be repeated for the purposes of this Regulation.  

Any person intending to perform tests or studies involving vertebrate animals or non-
vertebrate  animals,  hereinafter  "the  prospective  applicant",  shall  ask  the  competent 
authority or the Agency whether such tests or studies have already been submitted in 
connection with a previous application. The competent authority or the Agency shall 
verify  if  there  is  any  data  on  such  tests  or  studies  in  the  Biocides  Data  Sharing 
Register. 

Where  those  tests  or  studies  have  already  been  submitted  in  connection  with  a 
previous  application,  the  competent  authority  or  the  Agency  shall  without  delay 
communicate  the  name  and  contact  details  of  the  owner  of  the  information  to  the 
prospective applicant.  

Where the data acquired under those tests or studies are still protected under Article 
49,  and  involve  tests  on  vertebrate  animals  the  prospective  applicant  shall  request 
from the owner of the information the right to refer to the tests or studies.  

Where the data acquired under those tests or studies are still protected under Article 
49,  and  do  not  involve  tests  on  vertebrate  animals,  the  prospective  applicant  may 
request from the owner of the information the right to refer to the tests or studies.  

Article 52 
Compensation for mandatory information sharing 

Where  a  request  has  been  made  in  accordance  with  Article  51(2),  the  prospective 
applicant  and  the  owner  of  the  information  shall  make  every  effort  to  reach  an 
agreement  on  the  sharing  of  the  results  of  the  tests  or  studies  requested  by  the 
prospective  applicant.  Such  an  agreement  may  be  replaced  by  submission  of  the 
matter to an arbitration body and a commitment to accept the arbitration order. 

Where such agreement is reached, the owner of the information shall make available 
to the prospective applicant the information and shall give the prospective applicant 
the permission to refer to the data owner's tests or studies.  

Where  no  such  agreement  is  reached  two  months  after  the  request  was  made 
according to Article 51(2), the prospective applicant shall without delay inform the 
Agency  and  the  owner  of  the  information  thereof.  Within  two  months  of  being 
informed  about  the  failure  to  reach  an  agreement,  the  Agency  shall  give  the 
prospective  applicant  the  right  to  refer  to  the  tests  or  studies  involving  tests  on 
vertebrate animals. National courts shall decide on the proportionate share of the cost 
that the prospective applicant shall pay to the data owner.  

4. 

The costs of sharing the tests or studies shall be determined in a fair, transparent and 
non-discriminatory manner. 

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5. 

1. 

An appeal may be brought, in accordance with Article 67, against Agency decisions 
under paragraph 3 of this Article.  

Article 53 
Use of data for subsequent applications for authorisations 

In  the  case  of  a  biocidal  product  which  has  already  been  authorised  in  accordance 
with  Articles  15,  25  or  28,  and  where  all  periods  of  protection  of  information 
according  to  Article  49  have  expired,  the  receiving  competent  authority  or  the 
Agency  may  agree  that  a  subsequent  applicant  for  authorisation  may  refer  to  data 
provided  by  the  first  applicant  in  so  far  as  the  subsequent  applicant  can  provide 
evidence  that  the  biocidal  product  is  similar  to  and  its  active  substances  are 
technically equivalent to the one formerly authorised, including degree of purity and 
nature of impurities. 

An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the first subparagraph of this paragraph.  

2. 

Notwithstanding  paragraph  1,  subsequent  applicants  shall  provide  the  following 
information accordingly to the receiving competent authority or the Agency: 

(a) 

(b) 

(c) 

(d) 

all  necessary  data  for  the  identification  of  the  biocidal  product,  including  its 
composition; 

the  information  needed  to  identify  the  active  substance  and  to  establish 
technical equivalence of the active substance; 

all necessary data for the evaluation of substances of concern contained in the 
biocidal product; 

the  data  needed  to  demonstrate  that  the  biocidal  product  has  comparable 
efficacy to the biocidal product formerly authorised in accordance with Articles 
15, 25 or 28. 

CHAPTER XII 
INFORMATION AND COMMUNICATION 

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Section 1 
Monitoring and reporting 

Article 54 
Compliance with requirements 

1. 

2. 

3. 

4. 

1. 

2. 

Competent  authorities  shall  take  the  necessary  arrangements  for  biocidal  products 
which  have  been  placed  on  the  market  on  their  own  or  incorporated  in  treated 
materials to be monitored to establish whether they comply with the requirements of 
this Regulation. Regulation (EC) No 765/2008 of the European Parliament and of the 
Council  setting  out  the  requirements  for  accreditation  and  market  surveillance 
relating  to  the  marketing  of  products  and  repealing  Regulation  (EEC)  No  339/9346 
shall apply accordingly. 

Competent authorities shall carry out official controls in order to enforce compliance 
with this Regulation.  

Every  three  years,  starting  in  2013,  competent  authorities  shall  submit  to  the 
Commission  a  report  on  the  implementation  of  this  Regulation  in  their  respective 
territories. The report shall include: 

(a) 

information  on  the  results  of  official  controls  carried  out  in  accordance  with 
paragraph 2; 

(b) 

information on any poisonings involving biocidal products. 

The  Commission  shall  draw  up  a  report  on  the  implementation  of  this  Regulation 
and, in particular, on the functioning of the Community authorisation procedure and 
mutual recognition, by 1 January 2023. The Commission shall submit the report to 
the European Parliament and the Council.  

Article 55 
Confidentiality 

Regulation  (EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council 
regarding  public  access 
to  European  Parliament,  Council  and  Commission 
documents47  and  the  rules  of  the  Management  Board  of  the  Agency,  adopted  in 
accordance  with  Article  118(3)  Regulation  (EC)  No  1907/2006,  shall  apply  to 
documents held by the Agency for the purposes of this Regulation.  

Disclosure of the following information shall be deemed to undermine the protection 
of the commercial interests of the concerned person: 

(a) 

details of the full composition of a biocidal product; 

46 
47 

OJ L 218, 13.8.2008, p. 30 
OJ L 145, 31.5.2001, p. 43. 

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3. 

4. 

1. 

(b) 

the precise use, function or application of a substance or mixture;  

(c) 

(d) 

the precise tonnage of the substance or mixture manufactured or placed on the 
market; 

links between a manufacturer of an active substance and the person responsible 
for  the  placing  of  a  biocidal  product  on  the  market  or  between  the  person 
responsible  for  the  placing  of  a  biocidal  product  on  the  market  and 
thedistributors of the product. 

However,  where  urgent  action  is  essential  to  protect  human  health,  safety  or  the 
environment, the Agency or the competent authorities may disclose the information 
referred to in this paragraph. 

Any person submitting information related to an active substance to the Agency or a 
competent  authority  for  the  purposes  of  this  Regulation  can  request  that  the 
information in Article 56(2) shall not be made available including a justification as to 
why  the  disclosure  of  the  information  could  be  harmful  for  his  or  any  other 
concerned party's commercial interests. 

Information accepted as confidential by a competent authority or the Agency shall be 
treated  as  confidential  by  the  other  competent  authorities,  the  Agency  and  the 
Commission. 

Article 56 
Electronic public access 

The  following  information  held  by  the  competent  authorities,  the  Agency  or,  as 
appropriate,  the  Commission  on  active  substances  shall  be  made,  free  of  charge, 
publicly available: 

(a)  without  prejudice  to  point  (e)  of  paragraph  2  of  this  Article,  the  name  in  the 
International Union of Pure and Applied Chemistry (IUPAC) nomenclature for 
active substances fulfilling the criteria for any of the following hazard classes 
or categories set out in Annex I to Regulation (EC) No 1272/ 2008: 

(i) 

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 
2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; 

(ii)  hazard  classes  3.1  to  3.6,  3.7  adverse  effects  on  sexual  function  and 
fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 
3.10; 

(iii)  hazard class 4.1; 

(iv)  hazard class 5.1;  

(b) 

if applicable, the name of the active substance as given in European Inventory 
of Existing Commercial Chemical Substances (EINECS); 

(c) 

the classification and labelling of the active substance; 

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(d)  physicochemical  data  concerning  the  active  substance  and  data  on  pathways 

and environmental fate; 

(e) 

the result of each toxicological and ecotoxicological study; 

(f) 

(g) 

(h) 

acceptable  exposure  level  or  predicted  no-effect  concentration  established  in 
accordance with Annex VI to this Regulation; 

the guidance on safe use provided in accordance with Annex II and Annex III 
to this Regulation; 

analytical  methods  if  requested  in  accordance  with  Annex  II  or  III  to  this 
Regulation  which  make  it  possible  to  detect  a  dangerous  substance  when 
discharged into the environment as well as to determine the direct exposure of 
humans. 

If the information listed in the first subparagraph concerns a new active substance, it 
shall be made publically available only after the date on which the inclusion of the 
new active substance in Annex I to this Regulation becomes effective. 

2. 

The following information on active substances whether on their own, in mixtures or 
in  materials  or  articles,  or  information  on  biocidal  products  shall  be  made  publicly 
available, free of charge, except where a party submitting the information submits a 
justification  in  accordance  with  Article  55(3),  accepted  as  valid  by  the  competent 
authority, the Agency or, as appropriate, the Commission, as to why such publication 
is potentially harmful for the commercial interests of the applicant or any other party 
concerned:  

(a) 

(b) 

(c) 

if essential to classification and labelling, the degree of purity of the substance 
and  the  identity  of  impurities  and/or  additives  which  are  known  to  be 
dangerous; 

the study summaries or robust study summaries of the information referred to 
in paragraph 1(d) and (e) of this Article; 

information,  other  than  that  listed  in  paragraph  1  of  this  Article,  contained  in 
the safety data sheet; 

(d) 

the trade name(s) of the substance; 

(e) 

subject  to  Article  24  of  Regulation  (EC)  No  1272/2008,  the  name  in  the 
IUPAC nomenclature for active substances referred to in paragraph 1(a) of this 
Article that are only used as one or more of the following: 

(i) 

in scientific research and development; 

(ii) 

in product and process orientated research and development. 

3. 

After the authorisation has been granted, confidentiality shall not in any case apply 
to: 

(a) 

the name and address of the applicant; 

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(b) 

the name and address of the biocidal product manufacturer; 

(c) 

the name and address of the active substance manufacturer; 

(d) 

the content of the active substance or substances in the biocidal product and the 
name of the biocidal product; 

(e) 

physical and chemical data concerning the biocidal product; 

(f) 

any ways of rendering the active substance or biocidal product harmless; 

(g) 

a summary of the results of the tests required pursuant to Article 18 to establish 
the product's efficacy and effects on humans, animals and the environment and, 
where applicable, its ability to promote resistance; 

(h) 

recommended  methods  and  precautions  to  reduce  dangers  from  handling, 
storage, transport and use as well as from fire or other hazards; 

(i) 

safety data sheets; 

(j)  methods of analysis referred to in point (c) of Article 16(1); 

(k)  methods of disposal of the product and of its packaging; 

(l) 

procedures to be followed and measures to be taken in the case of spillage or 
leakage; 

(m) 

first aid and medical advice to be given in the case of injury to persons. 

Article 57 
Record-keeping and reporting 

1. 

2. 

Producers,  importers  and  professional  users  of  biocidal  products  shall  keep  records 
of  the  biocidal  products  they  produce,  place on  the  market  or  use  for  at  least  three 
years. They shall make available the relevant information contained in these records 
to the competent authority on request.  

The Commission shall adopt implementing measures to specify the form and content 
of the information in the records, and to ensure the uniform application of paragraph 
1 in accordance with the procedure referred to in Article 72(3). 

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Section 2 
Information about biocidal products 

Article 58 
Classification, packaging and labelling of biocidal products 

1. 

Biocidal  products  shall  be  classified,  packaged  and  labelled  in  accordance  with 
Directive  1999/45/EC  and,  where  applicable,  Regulation  (EC)  1272/2008  and  the 
approved  summary  of  the  biocidal  product  characteristics,  in  particular  the  hazard 
statements  and  the  precautionary  statements,  as  referred  to  in  point  (i)  of  Article 
20(2) of this Regulation. 

In addition, products which may be mistaken for food, drink or feedingstuffs shall be 
packaged  to  minimise  the  likelihood  of  such  a  mistake  being  made.  If  they  are 
available  to  the  general  public,  they  shall  contain  components  to  discourage  their 
consumption. 

2. 

Labels  shall  not  be  misleading  and,  in  any  case,  shall  not  mention  the  indications 
‘low-risk  biocidal  product’,  ‘non-toxic’,  ‘harmless’  or  similar  indications.  In 
addition, the label must show clearly and indelibly the following information:  

(a) 

the identity of every active substance and its concentration in metric units; 

(b) 

the  authorisation  number  allocated  to  the  biocidal  product  by  the  competent 
authority; 

(c) 

the type of mixture; 

(d) 

the uses for which the biocidal product is authorised; 

(e) 

(f) 

(g) 

directions  for  use  and  the  dose  rate,  expressed  in  metric  units,  for  each  use 
provided for under the terms of the authorisation; 

particulars of likely direct or indirect adverse side effects and any directions for 
first aid; 

if  accompanied  by  a  leaflet,  the  sentence  ‘Read  attached  instructions  before 
use’; 

(h)  directions for safe disposal of the biocidal product and its packaging, including, 

where relevant, any prohibition on reuse of packaging; 

(i) 

(j) 

the  formulation  batch  number  or  designation  and  the  expiry  date  relevant  to 
normal conditions of storage; 

the  period  of  time  needed  for  the  biocidal  effect,  the  interval  to  be  observed 
between  applications  of  the  biocidal  product  or  between  application  and  the 
next use of the product treated, or the next access by man or animals to the area 
where  the  biocidal  product  has  been  used,  including  particulars  concerning 

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decontamination means and measures and duration of necessary ventilation of 
treated  areas;  particulars  for  adequate  cleaning  of  equipment;  particulars 
concerning precautionary measures during use, storage and transport;  

(k)  where  applicable,  the  categories  of  users  to  which  the  biocidal  product  is 

restricted;  

(l)  where  applicable,  information  on  any  specific  danger  to  the  environment 
particularly  concerning  protection  of  non-target  organisms  and  avoidance  of 
contamination of water; 

(m) 

for  biocidal  products  containing  micro-organisms,  labelling  requirements  in 
accordance with Directive 2000/54/EC. 

By way of derogation from the first subparagraph, where this is necessary because of 
the size or the function of the biocidal product, the information referred to in points 
(c),  (e),  (f),  (h),  (i),  (j)  and  (l)  may  be  indicated  on  the  packaging  or  on  an 
accompanying leaflet integral to the packaging.  

3. 

Member  States  may  require  that  biocidal  products  placed  on  the  market  of  their 
territories are labelled in their national language or languages. 

Article 59 
Safety Data Sheets 

The safety-data sheets shall be prepared and made available in accordance with Annex II of 
Regulation  (EC)  No  1907/2006,  for  biocidal  products  classified  as  hazardous,  and  in 
accordance with the requirements of Article 31 of that Regulation, for active substances used 
exclusively in biocidal products. 

Article 60 
Community Register of Biocidal Products 

1. 

2. 

3. 

4. 

A Community Register for Biocidal Products shall be established and maintained by 
the Commission. 

The  Community  Register  for  Biocidal  Products  shall  be  used  for  the  exchange  of 
information between competent authorities, the Agency and the Commission. 

Applicants  shall  use  the  Community  Register  for  Biocidal  Products  to  generate  the 
application form for all procedures relating to the authorisation of biocidal products, 
the mutual recognition and the parallel trade permit. 

Competent authorities shall update in the Community Register for Biocidal Products 
the information relating to biocidal products which have been authorised within their 
territory or for which a national authorisation has been refused, amended, renewed or 
cancelled. The Commission shall update the information relating to biocidal products 
which  have  been  authorised  in  the  Community  or  for  which  a  Community 
authorisation has been refused, amended, renewed or cancelled. 

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5. 

1. 

2. 

1. 

2. 

3. 

1. 

The Commission may adopt detailed rules on the types of information to be entered 
in the Community Register for Biocidal Products and the procedures related to it, in 
accordance with the procedure referred to in Article 72(2). 

Article 61 
Biocides Data Sharing Register 

The  Biocides  Data  Sharing  Register  shall  be  established  and  maintained  by  the 
Agency.  

The Biocides Data Sharing Register shall contain information provided by competent 
authorities and the Agency in accordance with paragraphs 3 and 4 of Article 48.  

The  Register  shall  only  be  accessible  to competent  authorities,  the  Agency  and  the 
Commission. Competent authorities and the Agency shall respond to all enquiries by 
prospective  applicants  concerning  information  contained  in  the  Biocides  Data 
Sharing  Register  in  order  to  facilitate  sharing  of  information  and  shall  on  request 
provide  the  contact  details  of  the  owner  of  the  information  in  question  and  a 
statement  whether  and  for  how  long  the  information  is  subject  to  data  protection 
under this Regulation. 

Article 62 
Advertising 

Any advertisement for biocidal products shall be accompanied by the sentences ‘Use 
biocides  safely.  Always  read  the  label  and  product  information  before  use’.  The 
sentences shall be clearly distinguishable in relation to the whole advertisement. 

Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear 
reference to the product-type as set out in Annex V being advertised. 

Advertisements for biocidal products shall not refer to the product in a manner which 
is  misleading  in  respect  of  the  risks  from  the  product  to  human  health  or  the 
environment.  In  any  case,  the  advertising  of  a  biocidal  product  shall  not  mention 
‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indication.  

Article 63 
Poison control 

Member States shall appoint a body or bodies responsible for receiving information 
on biocidal products which have been placed on the market, including information on 
the  chemical  composition  of  such  products,  and  for  making  such  information 
available in cases where suspected poisoning arises from biocidal products.  

Member  States  may  decide  to  appoint  the  body  or  bodies  that  have  already  been 
appointed in accordance with Article 45 of Regulation (EC) No 1272/2008 to carry 
out the tasks under this Article. 

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2. 

The bodies appointed by the Member States shall provide all the requisite guarantees 
for  maintaining  the  confidentiality  of  the  information  received.  Such  information 
may only be used for the following purposes: 

(a) 

to  meet  medical  demand  by  formulating  preventive  and  curative  measures,  in 
particular in case of emergency; 

(b)  where  requested  by  the  Member  State,  to  undertake  statistical  analysis  to 

identify where improved risk management measures may be needed.  

CHAPTER XIII 
THE AGENCY 

Article 64 
Role of the Agency 

The Agency shall carry out the tasks conferred on it by Chapters II, III, IV, VI, VII, VIII, IX, 
X, XI, XII and XIV of this Regulation. 

Article 65 
Biocidal Products Committee 

1. 

A Biocidal Products Committee is hereby established within the Agency. 

The  Biocidal  Products  Committee  shall  be  responsible  for  preparing  the  opinion  of 
the Agency on the following issues:  

(a) 

applications  for  inclusion  and  renewal  of  inclusion  of  active  substances  in 
Annex I; 

(b) 

review of inclusion of active substances in Annex I;  

(c) 

identification of active substances which are candidates for substitution;  

(d) 

applications for Community authorisation of biocidal products and for renewal, 
cancellation and amendments of Community authorisation;  

(e) 

scientific and technical matters in the case of objections to mutual recognition; 

(f) 

any other questions that arise from the operation of this Regulation relating to 
risks to human health or the environment.  

2. 

Articles  85,  87  and  88  of  Regulation  (EC)  No  1907/2006  concerning  the 
establishment, the composition and the qualification and interests of the Committee 
for  Risk  Assessment  shall  apply  mutatis  mutandis  to  the  Biocidal  Products 
Committee. 

The Biocidal Products Committee may establish working groups and delegate certain 
tasks to those working groups. 

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The  members  of  the  Biocidal  Products  Committee  shall  be  supported  by  the 
scientific  and  technical  resources  available  to  the  Member  States.  Member  States 
shall  provide  adequate  scientific  and  technical  resources  to  the  members  of  the 
Biocidal  Products  Committee  that  they  have  nominated.  Competent  authorities  of 
Member States shall facilitate the activities of the Biocidal Products Committee and 
their working groups. 

Article 66 
Operation of the Biocidal Products Committee and the Secretariat of the Agency 

1. 

2. 

Articles 78 to 84, 89 and 90 of Regulation  (EC) No 1907/2006 shall apply mutatis 
mutandis taking into account the role of the Agency with respect to this Regulation.  

The Secretariat of the Agency referred to in point (g) of Article 76(1) of Regulation 
(EC) No 1907/2006 shall undertake the following tasks: 

(a) 

establishing and maintaining the Biocides Data Sharing Register; 

(b)  performing the tasks relating to the validation of the applications referred to in 

Articles 7(3), 11(3) and 34(2) of this Regulation; 

(c) 

providing technical and scientific guidance and tools for the application of this 
Regulation  by  the  Commission  and  the  competent  authorities  of  Member 
States; 

(d)  providing  advice  and  assistance  to  applicants  for  the  inclusion  of  an  active 

substance in Annex I or for a Community authorisation; 

(e) 

preparing explanatory information on this Regulation; 

(f) 

(g) 

establishing and maintaining database(s) with information on active substances 
and biocidal products; 

at the request of the Commission, providing technical and scientific support to 
improve  cooperation  between  the  Community,  the  competent  authorities, 
international organisations and third countries on scientific and technical issues 
relating to biocidal products; 

(h)  notification of decisions taken by the Agency; 

(i) 

provision of formats for submission of information to the Agency. 

3. 

The Secretariat shall make the information identified in Article 56(1) and (2) in the 
database(s)  publicly  available,  free  of  charge,  over  the  Internet,  except  where  a 
request  made  under  Article  55(3)  is  considered  justified.  The  Agency  shall  make 
other information in the databases available on request in accordance with Article 55. 

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Article 67 
Appeal 

1. 

An  appeal  against  decisions  of  the  Agency  taken  pursuant  to  Articles  7(4),  11(4), 
34(3), 36(6), 52(3) and 53(1) shall lie with the Board of Appeal. 

Articles  92(1)  and  (2),  93  and  94  of  Regulation  (EC)  No  1907/2006  shall  apply  to 
appeal procedures lodged under this Regulation. 

A  fee  may  be  payable  by  a  person  bringing  an  appeal  in  accordance  with  Article 
70(2) of this Regulation. 

2. 

An appeal lodged pursuant to paragraph 1 shall have suspensive effect. 

Article 68 
The budget of the Agency 

1. 

For the purposes of this Regulation, the revenues of the Agency shall consist of: 

(a) 

a subsidy from the Community, entered in the general budget of the European 
Communities (Commission Section); 

(b) 

the fees paid by undertakings; 

(c) 

any charges paid to the Agency for services provided under this Regulation; 

(d) 

any voluntary contribution from the Member States. 

2. 

Revenue and expenditure for activities related to this Regulation and those relating to 
activities under Regulation (EC) No 1907/2006 shall be dealt with separately in the 
Agency’s budget with a separate budgetary and accounting reporting. 

Revenue of the Agency referred to in Article 96(1) of Regulation (EC) No 1907/2006 
shall not be used for carrying out tasks under this Regulation. 

Article 69 
Formats and software for submission of information to the Agency 

The Agency shall specify formats and make them available free of charge, and shall specify 
software packages and make them available on its website for submissions to the Agency. The 
competent  authorities  and  applicants  shall  use  these  formats  and  packages  in  their 
submissions to the Agency pursuant to this Regulation.  

The format of the technical dossier referred to in Articles 6(1), 11(1), 18 and 36(4) shall be 
IUCLID. 

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CHAPTER XIV 
FINAL PROVISIONS 

Article 70 
Fees and charges 

1. 

The Commission shall establish rules concerning: 

(a) 

the system of fees payable to the Agency;  

(b) 

the harmonised structure of fees; 

(c) 

(d) 

the circumstances under which a proportion  of the fees is to be transferred to 
the competent authority of the evaluating Member State; 

the  partial  reimbursement  of  the  fee  in  cases  the  applicant  fails  to  submit  the 
information requested within the deadline during validation of the application.  

Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing  it,  shall  be  adopted  according  to  the  regulatory  procedure  with 
scrutiny referred to in Article 72(4).  

2. 

The  harmonised  structure  of  fees  and  conditions  of  payment  shall  be  based  on  the 
following principles: 

(a) 

(b) 

(c) 

(d) 

(e) 

a  reduced  fee  shall  be  set  for  small  and  medium-sized  enterprises  within  the 
meaning of Recommendation 2003/361/EC concerning the definition of micro, 
small and medium-sized enterprises48; 

the  fee  structure  shall  take  into  account  whether  information  has  been 
submitted jointly or separately; 

in  duly  justified  circumstances  and  where  it  is  accepted  by  the  competent 
authority or the Agency, it shall be possible to waive the fee;  

an annual fee shall be paid by persons placing biocidal products on the market; 
and 

the structure and amount of the fees shall take account of the work required by 
this Regulation to be carried out by the Agency and the competent authorities 
and shall be fixed at such level as to ensure that the revenue derived from the 
fees  when  combined  with  other  sources  of  the  Agency's  revenue  pursuant  to 
this Regulation is sufficient to cover the cost of the services delivered.  

3. 

Member  States shall  oblige  those who have placed or  are  seeking to place biocidal 
products on the market and those supporting inclusion of active substances in Annex 

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I to pay fees in accordance with the harmonised structure of fees and conditions of 
payment to be adopted in accordance with paragraph 1.  

4. 

In accordance with the rules referred to in paragraph 1, the Agency shall oblige those 
who have placed or are seeking to place biocidal products on the market and those 
supporting inclusion of active substances in Annex I to pay fees. The structure and 
the  amount  of  fees  payable  to  the  Agency  shall  be  determined  in  accordance  with 
paragraph 1. 

The Agency may collect charges for other services it provides. 

Article 71 
Competent authorities 

1. 

Member  States  shall  designate  a  competent  authority  or  competent  authorities 
responsible for the application of this Regulation.  

Member  States  shall  inform  the  Commission  of  the  names  and  addresses  of  the 
designated  competent  authorities  by  1  January  2013.  Member  States  shall,  without 
undue delay, inform the Commission of any changes to the names and addresses of 
the competent authorities. 

2. 

The Commission shall make publicly available the list of the competent authorities. 

Article 72 
Standing Committee  

1. 

2. 

3. 

4. 

5. 

The Commission shall be assisted by the Standing Committee on Biocidal Products. 

Where  reference  is  made  to  this  paragraph,  Articles  3  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 

Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

Where reference is made to this paragraph, Article 5a (1), (2), (4) and (6), and Article 
7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

Article 73 
Adaptation to scientific and technical progress 

The Commission may adapt the Annexes to scientific and technical progress.  

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Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall  be 
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).  

Article 74 
Updating of Annex I 

By  1  January  2013,  the  Commission  shall,  in  accordance  with  the  procedure  referred  to  in 
Article 72(3), amend Annex I with effect from the date of applicability of this Regulation in 
order to take into account any amendment to Annex I adopted under Directive 98/8/EC since 
the entry into force of this Regulation. 

Article 75 
Penalties 

Member  States  shall  lay  down  the  provisions  on  penalties  applicable  to  infringement  of  the 
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented. The penalties provided for must be effective, proportionate and dissuasive. The 
Member  States  shall  notify  those  provisions  to  the  Commission  no  later  than  1  December 
2015 and shall notify the Commission without delay of any subsequent amendment affecting 
them. 

Article 76 
Safeguard clause 

Where,  based  on  new  evidence,  a  Member  State  has  justifiable  grounds  to  consider  that  a 
biocidal product, although satisfying the requirements of this Regulation, constitutes a serious 
risk  to  human  or  animal  health  or  to  the  environment,  it  may  take  appropriate  provisional 
measures.  The  Member  State  shall  without  delay  inform  the  Commission  and  the  other 
Member States thereof and give reasons for its decision based on the new evidence.  

The  Commission  shall,  in  accordance  with  the  procedure  referred  to  in  Article  72(3),  either 
authorise  the  provisional  measure  for  a  time  period  defined  in  the  decision  or  require  the 
Member State to revoke the provisional measure.  

Article 77 
Transitional measures 

1. 

The  Commission  shall  carry  on  with  the  work  programme  for  the  systematic 
examination of all existing active substances commenced in accordance with Article 
16(2)  of  Directive  98/8/EC  and  achieve  it  by  14  May  2014.  The  Commission  may 
adopt implementing rules to carry out the work programme and to specify the related 
rights  and  obligations  of  the  competent  authorities  and  the  participants  in  the 
programme.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Regulation by supplementing it, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 72(4). 

Depending upon the progress of the work programme, the Commission may extend 
the duration of the work programme for a determined period. That measure, designed 

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2. 

to  amend  non-essential  elements  of  this  Regulation  by  supplementing  it,  shall  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 72(4). 

During the work programme, the Commission shall decide pursuant to the procedure 
laid down in Article 72(4) that an active substance shall be  included in Annex I of 
this Regulation and under which conditions, or, in cases where the requirements of 
Article 4 are not satisfied or where the requisite information and data have not been 
submitted  within  the  prescribed  period,  that  such  active  substance  shall  not  be 
included in Annex I of this Regulation. The decision shall specify the date on which 
the inclusion in Annex I becomes effective. 

By  way  of  derogation  from  Articles  15(1),  16(1)  and  18(1)  of  this  Regulation,  and 
without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue 
to  apply  its  current  system  or  practice  of  placing  biocidal  products  on  the  market 
until two years after the date on which the inclusion in Annex I becomes effective. It 
may, in particular, according to its national rules, authorise the placing on the market 
in its territory of a biocidal product containing existing active substances which are 
evaluated under Regulation (EC) No. 1451/2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European 
Parliament  and  of  the  Council  concerning  the  placing  of  biocidal  products  on  the 
market49 but which are not yet listed in Annex I to this Regulation for that product 
type. 

In derogation from the first subparagraph, in the case of a decision not to include an 
active  substance  in  Annex  I  of  this  Regulation,  a  Member  State  may  continue  to 
apply  its  current  system  or  practice  of  placing  biocidal  products  on  the  market  no 
longer  than  twelve  months  after  the  applicability  date  of  a  decision  taken  in 
accordance with the third subparagraph of paragraph 1. 

3. 

Following  a  decision  to  include  a  particular  active  substance  in  Annex  I  of  this 
Regulation  Member  States  shall  ensure  that  authorisations  for  biocidal  products 
containing that active substance are granted, modified or cancelled as appropriate in 
accordance  with  this  Regulation  within  two  years  from  the  date  on  which  the 
inclusion becomes effective. 

To  that  effect,  applications  for  authorisation  of  biocidal  products  containing  only 
existing  active  substances  shall  be  submitted  to  the  competent  authorities  of  the 
Member States no later than the date which the inclusion of the active substance(s) in 
Annex  I  of  this  Regulation  becomes  effective.  In  the  case  of  biocidal  products 
containing  more  than  one  active  substance,  applications  for  authorisation  shall  be 
submitted no later than the date on which the inclusion of the last active substance 
becomes effective. 

Biocidal products, for which an application for a product authorisation has not been 
submitted in accordance with the second subparagraph, shall no longer be placed on 
the market with effect from six months after the date on which the inclusion becomes 
effective. Disposal, storage and use of existing stocks of biocidal products for which 

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an  application  for  authorisation  has  not  been  submitted  in  accordance  with  the 
second subparagraph are allowed until eighteen months after the date on which the 
inclusion becomes effective. 

4. 

Biocidal  products  for  which  the  competent  authority  of  the  Member  State  has 
rejected an application for authorisation submitted under paragraph 3 or has decided 
not to grant authorisation, shall no longer be placed on the market with effect from 
six months after such a rejection or a decision. 

Article 78 
Transitional measures concerning active substances evaluated under Directive 98/8/EC 

1. 

2. 

The Agency shall be responsible for coordinating the evaluation process of dossiers 
submitted after 1 January 2012 and shall facilitate the preparation of the evaluation 
by  providing  organisational  and  technical  support  to  the  Member  States  and  the 
Commission. 

Dossiers  submitted  for  the  purposes  of  Directive  98/8/EC  for  which  the  evaluation 
has  not  been  completed  by  1  January  2013  shall  continue  to  be  evaluated  by  the 
competent  authorities  in  accordance  with  the  provisions  of  Directive  98/8/EC  and, 
where relevant, Regulation (EC) No 1451/2007.  

Notwithstanding paragraph 1, the Agency shall also be responsible for coordinating 
the  evaluation  process  of  dossiers  submitted  for  the  purposes  of  Directive  98/8/EC 
for  which  the  evaluation  has  not  been  completed  by  1  January  2013  and  shall 
facilitate the preparation of the evaluation by providing organisational and technical 
support to the Member States and the Commission from 1 January 2014. 

Article 79 
Transitional measures concerning low-risk biocidal products registered under Directive 
98/8/EC 

1. 

2. 

Low-risk biocidal products as defined in Article 2(1) (b) of Directive 98/8/EC shall 
be registered in accordance with point (i) of Article 3(2) of Directive 98/8/EC. The 
provisions of Directive 98/8/EC shall apply to these products until the expiry of the 
registration. The registration shall not be renewable. 

Applications for the registration of low-risk biocidal products as defined in point (b) 
of  Article  2(1)  of  Directive  98/8/EC  shall  be  submitted  at  the  latest  twelve  months 
after the date on which the inclusion in Annex IA becomes effective. 

Low-risk  biocidal  products  as  defined  in  point  (b)  of  Article  2(1)  of  Directive 
98/8/EC  for  which  an  application  was  submitted  in  accordance  with  the  first 
subparagraph may continue to be placed on the market until the date of the decision 
granting the registration or refusing to grant the registration. In the case of a refusal 
to  grant  a  registration  to  place  such  low-risk  biocidal  product  on  the  market,  such 
low-risk biocidal product shall no longer be placed on the market within six months 
after such decision. 

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3. 

1. 

2. 

Low-risk  biocidal  products  as  defined  in  point  (b)  of  Article  2(1)  of  Directive 
98/8/EC  for  which  an  application  was  not  submitted  in  accordance  with  the  first 
subparagraph may continue to be placed on the market until six months after the date 
referred to in paragraph 1.  

Disposal, storage and use of existing stocks of low-risk biocidal products which are 
not  authorised  for  the  relevant  use  by  the  competent  authority  are  allowed  until 
twelve months after the date of the decision referred to in the second subparagraph or 
twelve months after the date referred to in the third subparagraph, whichever is the 
later. 

This Regulation shall apply to low-risk biocidal products as defined in point  (b) of 
Article  2(1)  of  Directive  98/8/EC  as  of  the  expiry  of  the  registration  referred  to  in 
paragraph 1. 

Article 80 
Transitional measures concerning in situ generated active substances  

Applications for the authorisation of substances, mixtures and devices considered as 
biocidal products in accordance with the second sentence of point (a) of Article 3(1) 
which were available on the market on ... [OJ: insert the date referred to in the first 
subparagraph of Article 85] shall be submitted at the latest by 1 January 2017. 

Substances, mixtures and devices considered as biocidal products in accordance with 
the second sentence of point (a) of Article 3(1) which were available on the market 
on ... [OJ: insert the date referred to in the first subparagraph of Article 85] and for 
which an application was submitted in accordance with paragraph 1 may continue to 
be  placed  on  the  market  until  the  date  of  the  decision  granting  the  authorisation  or 
refusing to grant the authorisation. In the case of a refusal to grant an authorisation to 
place such biocidal product on the market, such biocidal product shall no longer be 
placed on the market within six months after such decision. 

Substances, mixtures and devices considered as biocidal products in accordance with 
the second sentence of point (a) of Article 3(1) which were available on the market 
on ... [OJ: insert the date referred to in the first subparagraph of Article 85] and for 
which  an  application  was  not  submitted  in  accordance  with  paragraph  1  may 
continue  to  be  placed  on  the  market  until  six  months  after  the  date  referred  to  in 
paragraph 1.  

Disposal,  storage  and  use  of  existing  stocks  of  biocidal  products  which  are  not 
authorised  for  the  relevant  use  by  the  competent  authority  or  the  Commission  are 
allowed  until  twelve  months  after  the  date  of  the  decision  referred  to  in  the  first 
subparagraph or twelve months after the date referred to in the second subparagraph, 
whichever is the later. 

Article 81 
Transitional measures concerning treated articles and materials 

By way of derogation from Article 47, treated articles and materials that incorporate biocidal 
products  which  are  not  authorised  in  the  Community  or  in  at  least  one  Member  State  and 

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which  were  available  on  the  market  on  ...  [OJ:  insert  the  date  referred  to  in  the  first 
subparagraph of Article 85] may, until the date of a decision granting authorisation to these 
biocidal products, continue to be placed on the market if the application for authorisation is 
submitted at the latest by 1 January 2017. In the case of a refusal to grant an authorisation to 
place  a  biocidal  product  on  the  market,  treated  articles  and  materials  that  incorporate  such 
biocidal  product  shall  no  longer  be  placed  on  the  market  within  six  months  after  such 
decision.  

Article 82 
Transitional measures concerning food contact materials 

1. 

Applications  for  the  authorisation  of  biocidal  products  which  are  food  contact 
materials and which were available on the market on [OJ: insert the date referred to 
in  the  first  subparagraph  of  Article  85]  shall  be  submitted  at  the  latest  1  January 
2017. 

Food contact materials which were available on the market on [OJ:  insert the date 
referred  to  in  the  first  subparagraph  of  Article  85]  for  which  an  application  was 
submitted in accordance with paragraph 1 may continue to be placed on the market 
until  the  date  of  the  decision  granting  the  authorisation  or  refusing  to  grant  the 
authorisation.  In  case  of  a  refusal  to  grant  an  authorisation  to  place  such  biocidal 
product on the market, such biocidal product shall no longer be placed on the market 
within six months after such decision. 

Food contact materials which were available on the market on [OJ:  insert the date 
referred to in the first subparagraph of Article 85] for which an application was not 
submitted in accordance with paragraph 1 may continue to be placed on the market 
until six months after the date referred to in paragraph 1.  

2. 

Disposal,  storage  and  use  of  existing  stocks  of  biocidal  products  which  are  not 
authorised  for  the  relevant  use  by  the  competent  authority  or  the  Commission  is 
allowed until twelve months after the date of the decision referred to in the second 
subparagraph of paragraph 1 or twelve months after the date referred to in the third 
subparagraph of paragraph 1, whichever is the later. 

Article 83 
Transitional measures concerning access to the active substance dossier 

As  of  1  January  2014,  the  person  responsible  for  the  placing  on  the  market  of  a  biocidal 
product containing one or more existing active substances shall own a dossier or have a letter 
of access to a dossier, or to each component of the dossier, satisfying the requirements set out 
in Annex II for each of these active substances unless all relevant protection periods referred 
to in Article 49 have expired. 

Biocidal  products  for  which  the  person  responsible  for  the  placing  on  the  market  does  not 
fulfil the requirement of the first subparagraph shall no longer be placed on the market. 

Disposal,  storage  and  use  of  existing  stocks  of  biocidal  products  which  do  not  fulfil  the 
requirement of the first subparagraph is allowed until 1 January 2015. 

EN 

87 

   EN 

 
Article 84 
Repeal 

Without prejudice to Article 78 and 79, Directive 98/8/EC is hereby repealed. 

References to the repealed Directive shall be construed as references to this Regulation. 

Article 85 
Entry into force 

This Regulation shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union. 

It shall apply from 1 January 2013. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President  

EN 

88 

   EN 

 
LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS FOR INCLUSION IN BIOCIDAL PRODUCTS 

ANNEX I 

Expiry date of 
inclusion 

Product 
type 

Specific provisions (*) 

Common Name 

IUPAC Name 
Identification 
Numbers 

Date of 
inclusion 

Minimum 
purity of the 
active 
substance in 
the biocidal 
product as 
placed on the 
market 

Deadline for 
compliance with 
Article 77(3) 
(except for 
products containing 
more than one 
active substance, 
for which the 
deadline to comply 
with Article 77(3) 
shall be the one set 
out in the last of 
the inclusion 
decisions relating 
to its active 
substances) 

sulfuryl fluoride 

sulfuryl difluoride 

994 g/kg 

1 January 2009  31 December 2010 

31 December 2018 

8 

EC No: 220-281-5 

CAS No: 2699-79-8 

Authorisations are subject to the following 
conditions: 

(1) 

(2) 

(3) 

the  product  may  only  be  sold  to  and  used 
by professionals trained to use it; 

appropriate  risk  mitigation  measures  are 
included for operators and bystanders; 

concentrations  of  sulfuryl  fluoride 
remote tropospheric air are monitored. 

in 

Reports  of  the  monitoring  referred  to  in  point  (3) 

EN 

89 

EN 

 
  
 
 
 
 
dichlofluanid 

N-
(Dichlorofluoromethyl
thio)-N′,N′-dimethyl-
N-phenylsulfamide 

EC No: 214-118-7 

CAS No: 1085-98-9  

clothianidin 

(E)-1-(2-Chloro-1,3-
thiazol-5-ylmethyl)-3-
methyl-2-
nitroguanidine 

EC No: 433-460-1 

CAS No: 210880-92-5 

960 g/kg 

1 March 2009 

28 February 2011 

28 February 2019 

8 

are  to  be  transmitted  by  authorisation  holders 
directly to the Commission every fifth year starting 
from 1 January 2009. 

Authorisations are subject to the following 
conditions: 

(1) 

(2) 

(3) 

Products  authorised  for  industrial  and/or 
professional  use  must  be  used  with 
appropriate personal protective equipment. 

In  view  of  the  risks  identified  for  the  soil 
compartment  appropriate  risk  mitigation 
measures  must  be  taken  to  protect  that 
compartment. 

safety-data 

sheets  of 
Labels  and/or 
products  authorised  for 
industrial  use 
indicate that freshly treated timber must be 
stored after treatment on impermeable hard 
standing to prevent direct losses to soil and 
that any losses must be collected for re-use 
or disposal. 

950 g/kg 

1 February 
2010 

31 January 2012 

31 January 2020 

8 

Authorisations  are  subject 
conditions: 

to 

the 

following 

In  view  of  the  risk  identified  for  the  soil,  surface 
water  and  groundwater  compartments,  products 
shall  not  be  authorised  for  the  treatment  of  wood 
that will be used outdoors unless data is submitted 
to  demonstrate  that  the  product  will  meet  the 
requirements  of  Article  16  and  Annex  VI,  if 
necessary  by  the  application  of  appropriate  risk 
mitigation  measures.  In  particular,  labels  and/or 
safety-data  sheets  of  products  authorised  for 
industrial  use  indicate  that  freshly  treated  timber 
shall be stored after treatment on impermeable hard 

EN 

90 

EN 

 
  
976 g/kg 

1 November 
2009 

31 October 2011 

31 October 2014 

14 

Difethialone 

3-[3-(4′-
bromo[1,1′biphenyl]-
4-yl)-1,2,3,4-
tetrahydronaphth-1-
yl]-4-hydroxy-2H-1-
benzothiopyran-2-one 

EC No: n/a 

CAS No: 104653-34-1 

standing to prevent direct losses to soil and that any 
losses shall be collected for reuse or disposal. 

In  view  of  the  fact  that  the  active  substance 
characteristics render it potentially persistent, liable 
to  bioaccumulate  and  toxic,  or  very  persistent  and 
very  liable  to  bioaccumulate,  the  active  substance 
shall  be  considered  a  candidate  for  substitution  in 
accordance with Article 9. 

Authorisations  are  subject 
conditions: 

to 

the 

following 

(1) 

(2) 

(3) 

(4) 

The  nominal  concentration  of  the  active 
substance in the products shall not exceed 
0,0025  %  w/w  and  only  ready-for-use 
baits shall be authorised. 

Products  shall  contain  an  aversive  agent 
and, where appropriate, a dye. 

Products  shall  not  be  used  as  tracking 
powder. 

minimised, 

Primary  as  well  as  secondary  exposure  of 
the 
humans,  non-target  animals  and 
by 
are 
environment 
considering  and  applying  all  appropriate 
and  available  risk  mitigation  measures. 
These 
the 
restriction to professional use only, setting 
an  upper  limit  to  the  package  size  and 
laying  down  obligations  to  use  tamper 
resistant and secured bait boxes. 

include,  amongst  others, 

etofenprox 

3-phenoxybenzyl-2-
(4-ethoxyphenyl)-2-

970 g/kg 

1 February 
2010 

31 January 2012 

31 January 2020 

8 

Authorisations  are  subject 
conditions: 

to 

the 

following 

EN 

91 

EN 

 
  
tebuconazole 

methylpropylether 

EC No: 407-980-2 

CAS No: 80844-07-1 

1-(4-chlorophenyl)-
4,4-dimethyl-3-(1,2,4-
triazol-1-
ylmethyl)pentan-3-ol 

EC No: 403-640-2 

CAS No: 107534-96-3 

950 g/kg 

1 April 2010 

31 March 2012 

31 March 2020 

8 

In view of the risk identified for workers, products 
cannot be used year round unless dermal absorption 
data  is  provided  to  demonstrate  that  there  are  no 
unacceptable  risks  from  chronic  exposure.  In 
addition,  products  intended  for  industrial  use  shall 
be  used  with  appropriate  personal  protective 
equipment. 

Authorisations  are  subject 
conditions: 

to 

the 

following 

shall  be 

to  protect 

In  view  of  the  risks  identified  for  the  soil  and 
aquatic  compartments  appropriate  risk  mitigation 
those 
taken 
measures 
compartments.  In  particular,  labels  and/or  safety 
data sheets of products authorised for industrial use 
indicate  that  freshly  treated  timber  shall  be  stored 
after  treatment  under  shelter  or  on  impermeable 
hard  standing  to  prevent  direct  losses  to  soil  or 
water  and  that  any  losses  shall  be  collected  for 
reuse or disposal. 

In addition, products shall not be authorised for the 
in situ treatment of wood outdoors or for wood that 
will be in continuous contact with water unless data 
is  submitted  to  demonstrate  that  the  product  will 
meet the requirements of Article 16 and Annex VI, 
if  necessary  by  the  application  of  appropriate  risk 
mitigation measures. 

carbon dioxide 

carbon dioxide 

990 ml/l 

1 November 
2009 

31 October 2011 

31 October 2019 

14 

EC No: 204-696-9 

CAS No: 124-38-9 

(cid:206)propiconazole  1-[[2-(2,4-

930 g/kg 

1 April 2010 

31 March 2012 

31 March 2020 

8 

Authorisations  are  subject 

to 

the 

following 

EN 

92 

EN 

 
  
 
dichlorophenyl)-4-
propyl-1,3-dioxolan-
2-yl]methyl]-1H-
1,2,4-triazole 

EC No: 262-104-4 

CAS No: 60207-90-1 

conditions: 

In  view  of  the  assumptions  made  during  the  risk 
assessment,  products  authorised  for 
industrial 
and/or  professional  use  shall  be  used  with 
appropriate personal protective equipment, unless it 
can be demonstrated  in  the application  for  product 
authorisation 
industrial  and/or 
professional  users  can be  reduced  to  an  acceptable 
level by other means. 

risks 

that 

to 

shall  be 

to  protect 

In  view  of  the  risks  identified  for  the  soil  and 
aquatic  compartments  appropriate  risk  mitigation 
measures 
those 
taken 
compartments.  In  particular,  labels  and/or  safety 
data sheets of products authorised for industrial use 
shall  indicate  that  freshly  treated  timber  shall  be 
stored  after 
treatment  under  shelter  or  on 
impermeable hard standing to prevent direct losses 
to  soil  or  water  and  that  any  losses  shall  be 
collected for reuse or disposal. 

Difenacoum 

3-(3-biphenyl-4-yl-
1,2,3,4-tetrahydro-1-
naphthyl)-4-
hydroxycoumarin 

EC No: 259-978-4 

960 g/kg 

1 April 2010 

31 March 2012 

31 March 2015 

14 

In addition, products shall not be authorised for the 
in situ treatment of wood outdoors or for wood that 
will  be  exposed  to  weathering  unless  data  is 
submitted to demonstrate that the product will meet 
the  requirements  of  Article  16  and  Annex  VI,  if 
necessary  by  the  application  of  appropriate  risk 
mitigation measures. 

In  view  of  the fact  that  the  active  substance 
characteristics render it potentially persistent, liable 
to  bioaccumulate  and  toxic,  or  very  persistent  and 
very  liable  to  bioaccumulate, the  active  substance 
shall  be  considered  a  candidate  for  substitution  in 
accordance with Article 9. 

Authorisations  are  subject 

to 

the 

following 

EN 

93 

EN 

 
  
CAS No: 56073-07-5 

conditions: 

(1) 

(2) 

(3) 

(4) 

The  nominal  concentration  of  the  active 
substance in the products shall not exceed 
75 mg/kg and only ready-for-use products 
shall be authorised. 

Products  shall  contain  an  aversive  agent 
and, where appropriate, a dye. 

Products  shall  not  be  used  as  tracking 
powder. 

minimised, 

Primary  as  well  as  secondary  exposure  of 
the 
humans,  non-target  animals  and 
environment 
by 
are 
considering  and  applying  all  appropriate 
and  available  risk  mitigation  measures. 
the 
These 
restriction to professional use only, setting 
an  upper  limit  to  the  package  size  and 
laying  down  obligations  to  use  tamper 
resistant and secured bait boxes. 

include,  amongst  others, 

977 g/kg 

1 July 2010 

30 June 2012 

30 June 2020 

8 

Authorisations  are  subject 
conditions: 

to 

the 

following 

(1) 

in  other  systems 

in  view  of  the  possible  risks  for  the 
environment  and  workers,  products  shall 
not  be  used 
than 
industrial, fully automated and closed ones 
for  product 
application 
unless 
authorisation  demonstrates  that  risks  can 
be 
in 
to  acceptable 
accordance with Article 16 and Annex VI; 

reduced 

levels 

the 

K-HDO 

Cyclohexylhydroxydi
azene 1-oxide, 
potassium salt 

EC No: n/a 

CAS No: 66603-10-9 

(This entry also covers 
the hydrated forms of 
K-HDO) 

EN 

94 

EN 

(2) 

in  view  of  the  assumptions  made  during 
the risk assessment, products shall be used 

 
  
IPBC 

3-iodo-2-propynyl 
butylcarbamate 

EC No: 259-627-5 

CAS No: 55406-53-6 

980 g/kg 

1 July 2010 

30 June 2012 

30 June 2020 

8 

with 
appropriate  personal  protective 
the  application  for 
equipment,  unless 
product  authorisation  demonstrates  that 
risks to users can be reduced to acceptable 
levels by other means; 

(3) 

in  view  of  the  risk  identified  for  infants, 
products  shall  not  be  used 
the 
treatment of wood that may enter in direct 
contact with infants. 

for 

Authorisations  are  subject 
conditions: 

to 

the 

following 

In  view  of  the  assumptions  made  during  the  risk 
assessment,  products  authorised  for 
industrial 
and/or  professional  use,  shall  be  used  with 
appropriate personal protective equipment, unless it 
can be demonstrated  in  the application  for  product 
authorisation 
industrial  and/or 
professional  users  can be  reduced  to  an  acceptable 
level by other means. 

risks 

that 

to 

shall  be 

to  protect 

In  view  of  the  risks  identified  for  the  soil  and 
aquatic  compartments  appropriate  risk  mitigation 
measures 
those 
taken 
compartments.  In  particular,  labels  and/or  safety 
data sheets of products authorised for industrial use 
shall  indicate  that  freshly  treated  timber  shall  be 
stored  after 
treatment  under  shelter  or  on 
impermeable hard standing to prevent direct losses 
to  soil  or  water  and  that  any  losses  shall  be 
collected for reuse or disposal. 

Thiabendazole 

2-thiazol-4-yl-1H-
benzoimidazole 

985 g/kg 

1 July 2010 

30 June 2012 

30 June 2020 

8 

Authorisations  are  subject 
conditions: 

to 

the 

following 

In  view  of  the  assumptions  made  during  the  risk 

EN 

95 

EN 

 
  
EC No: 205-725-8 

CAS No: 148-79-8 

assessment,  products  authorised  for 
industrial 
and/or professional use, with respect to the double-
vacuum and dipping application tasks, shall be used 
with  appropriate  personal  protective  equipment, 
unless it can be demonstrated in the application for 
product authorisation that risks to industrial and/or 
professional  users  can be  reduced  to  an  acceptable 
level by others means. 

shall  be 

to  protect 

In  view  of  the  risks  identified  for  the  soil  and 
aquatic  compartments  appropriate  risk  mitigation 
measures 
those 
taken 
compartments.  In  particular,  labels  and/or  safety 
data sheets of products authorised for industrial use 
shall  indicate  that  freshly  treated  timber  shall  be 
stored  after 
treatment  under  shelter  or  on 
impermeable hard standing to prevent direct losses 
to  soil  or  water  and  that  any  losses  shall  be 
collected for reuse or disposal. 

thiamethoxam 

thiamethoxam 

980 g/kg 

1 July 2010 

30 June 2012 

30 June 2020 

8 

Authorisations  are  subject 
conditions: 

to 

the 

following 

Products  shall  not  be  authorised  for  the  in  situ 
treatment of wood outdoors or for wood that will be 
exposed  to  weathering,  unless  data  is  submitted  to 
demonstrate 
the 
requirements  of  Article  16  and  Annex  VI,  if 
necessary  by  the  application  of  appropriate  risk 
mitigation measures. 

the  product  will  meet 

that 

EC No: 428-650-4 

CAS No: 153719-23-4 

In  view  of  the  assumptions  made  during  the  risk 
assessment,  products  authorised  for 
industrial 
and/or  professional  use  shall  be  used  with 
appropriate personal protective equipment, unless it 
can be demonstrated  in  the application  for  product 
authorisation 
industrial  and/or 
professional  users  can be  reduced  to  an  acceptable 

risks 

that 

to 

EN 

96 

EN 

 
  
level by other means. 

shall  be 

to  protect 

In  view  of  the  risks  identified  for  the  soil  and 
aquatic  compartments  appropriate  risk  mitigation 
measures 
those 
taken 
compartments.  In  particular,  labels  and/or  safety 
data sheets of products authorised for industrial use 
shall  indicate  that  freshly  treated  timber  shall  be 
stored  after 
treatment  under  shelter  or  on 
impermeable hard standing to prevent direct losses 
to  soil  or  water  and  that  any  losses  shall  be 
collected for reuse or disposal. 

(*)  For  the  implementation  of  the  common  principles  of  Annex  VI,  the  content  and  conclusions  of  assessment  reports  are  available  on  the  Commission  website: 
http://ec.europa.eu/comm/environment/biocides/index.htm 

Products  shall  not  be  authorised  for  the  in  situ 
treatment of wood outdoors or for wood that will be 
exposed  to  weathering,  unless  data  have  been 
submitted to demonstrate that the product will meet 
the  requirements  of  Article  16  and  Annex  VI,  if 
necessary  by  the  application  of  appropriate  risk 
mitigation measures. 

EN 

97 

EN 

 
  
1. 

2. 

3. 

4. 

5. 

6. 

7. 

ANNEX II 

Data requirements for active substances 

Dossiers  on  active  substances  shall  contain  the  information  needed  to  establish, 
where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level 
(AOEL),  Predicted  Environmental  Concentration  (PEC)  and  Predicted  No-Effect 
Concentration (PNEC).  

Information  which  is  however  not  necessary  owing  to  the  nature  of  the  biocidal 
product or of its proposed uses need not be supplied.  

A detailed and full description of the studies conducted and of the methods used or a 
bibliographical reference to those methods shall be included.  

The formats made available by the Commission must be used for submission of the 
dossiers. In addition, the special software package (IUCLID) made available by the 
Commission must be used for those parts of the dossiers to which IUCLID applies. 
Formats  and  further  guidance  on  data  requirements  and  dossier  preparation  are 
available on the Agency homepage. 

Tests submitted for the purpose of authorisation shall be conducted according to the 
methods described in Council Regulation (EC) No 440/200850. However, if a method 
is inappropriate or not described, other methods shall be used which are, whenever 
possible, internationally recognised and must be justified in the application.  

Tests  performed  should  comply  with  the  relevant  requirements  of  protection  of 
laboratory animals, set out in Council Directive 86/609/EEC on the approximation of 
laws, regulations  and administrative provisions of the Member States regarding the 
protection  of  animals  used  for  experimental  and  other  scientific  purposes51,  and,  in 
the case of ecotoxicological and toxicological tests, good laboratory practice, set out 
in  Directive  2004/10/EC  of  the  European  Parliament  and  of  the  Council  on  the 
harmonisation  of  laws,  regulations  and  administrative  provisions  relating  to  the 
application of the principles of good laboratory practice and the verification of their 
application  for  tests  on  chemical  substances52  or  other  international  standards 
recognised as being equivalent by the Commission or the Agency. 

Where testing is done, a detailed description (specification) of the material used and 
its impurities must be provided. 

Where test data exist that have been generated before ... [OJ: insert the date referred 
to in the first subparagraph of Article 85] by methods other than those laid down in 
Regulation  (EC)  No  440/2008,  the  adequacy  of  such  data  for  the  purposes  of  this 
Regulation and the need to conduct new tests according to the Regulation (EC) No 
440/2008  must  be  decided  by  the  competent  authority  of  the  Member  State 
concerned,  on  a  case-by-case  basis,  taking  into  account,  among  other  factors,  the 
need to minimise testing on vertebrate animals. 

50 
51 
52 

OJ L 142, 31.5.2008, p. 1. 
OJ L 358, 18.12.1986, p. 1.  
OJ L 50, 20.2.2004, p. 44. 

EN 

98 

   EN 

 
                                                 
8. 

9. 

All available relevant knowledge and information in literature should be provided.  

Any other relevant physicochemical, toxicological and ecotoxicological information 
that is available shall also be provided. 

EN 

99 

   EN 

 
TITLE 1 – CHEMICAL SUBSTANCES 

TIER I 

Information required to support the inclusion of a substance in Annex I is listed in the table 
below. The standard data package consists of tier I data. Tier II data may need to be submitted 
depending  on  the  characteristics  and  intended  use  of  the  active  substance  or  on  the 
conclusions  of  the  assessment  of  the  tier  I  data,  in  particular  if  a  danger  for  health  or  the 
environment has been identified. 

The  table  also  provides  specific  rules  according  to  which  the  required  information  may  be 
omitted, replaced by other information or adapted in another way. If the conditions are met to 
allow adaptations, the applicant shall clearly state this fact and the reasons for each adaptation 
under the appropriate headings in the dossier. 

Conditions for not requiring a specific test that are set out in the appropriate test methods in 
the Regulation (EC) No 440/2008 that are not repeated in column 2, also apply. 

Before new tests are carried out to determine the properties listed in this Annex, all available 
in  vitro  data,  in  vivo  data,  historical  human  data,  data  from  valid  (Q)SARs  and  data  from 
structurally  related  substances  (read-across  approach)  shall  be  assessed  first.  In  vivo  testing 
with  corrosive  substances  at  concentration/dose  levels  causing  corrosivity  shall  be  avoided. 
Prior to testing, further guidance on testing strategies should be consulted in addition to this 
Annex. 

Information required: 

Unless 
otherwise 
indicated,  all  data 
shall  be  provided  at 
Tier I. 

Specific rules for adaptation from standard 
information required: 

1. Applicant 

1.1. Name and address 

1.2.  Active  substance  manufacturer 
(name, address, location of plant) 

2. Identity of the active substance 

2.1.  Common  name  proposed  or 
accepted by ISO and synonyms 

Chemical 

2.2. 
nomenclature) 

name 

(IUPAC 

2.3.  Manufacturer's  development  code 
number(s) 

EN 

100 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.4. CAS and EC numbers (if available) 

2.5.  Molecular  and  structural  formula 
(including  full  details  of  any  isomeric 
composition), molecular mass 

2.6.  Method  of  manufacture  (syntheses 
pathway 
terms)  of  active 
substance 

in  brief 

2.7. Specification of purity of the active 
substance in g/kg or g/l, as appropriate 

2.8.  Identity  of  impurities  and  additives 
(e.g.  stabilisers), 
the 
structural  formula  and 
the  possible 
range  expressed  as  g/kg  or  g/l,  as 
appropriate 

together  with 

2.9.  The  origin  of  the  natural  active 
substance  or  the  precursor(s)  of  the 
active  substance,  e.g.  an  extract  of  a 
flower 

2.10.  Exposure  data  in  conformity  with 
Annex VIIA to Directive 92/32/EEC 

3. Physical and chemical properties 
of the active substance 

3.1.  State  of  the  substance  at  20°C 
and 101,3 kPa 

3.2. Melting/freezing point 

3.3. Boiling point 

3.4. Relative density 

3.2. The study does not need to be conducted 
below a lower limit of -20°C. 

3.3.  The  study  does  not  need 
conducted: 

to  be 

– for gases; or 

–  for  solids  which  either  melt  above  300°C 
or  decompose  before  boiling.  In  such  cases 
the boiling point under reduced pressure may 
be estimated or measured; or 

–  for  substances  which  decompose  before 
boiling  (e.g.  auto-oxidation,  rearrangement, 
degradation, decomposition, etc.). 

3.4. The study does not need to be conducted 
if: 

– the substance is only stable in solution in a 
particular solvent and the solution density is 
similar  to  that  of  the  solvent.  In  such  cases, 
an indication of whether the solution density 
is higher or lower than the solvent density is 
sufficient; or 

EN 

101 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
3.5. Vapour pressure 

3.6. Surface tension 

3.7. Water solubility  

Partition 

3.8. 
octanol/water 

coefficient 

n-

3.9. Flash-point 

–  the  substance  is  a  gas.  In  this  case,  an 
estimation  based  on  calculation  shall  be 
made  from  its  molecular  weight  and  the 
Ideal Gas Laws. 

3.5. The study does not need to be conducted 
if the melting point is above 300°C. 

If  the  melting  point  is  between  200°C  and 
300°C,  a  limit  value  based  on  measurement 
or  a  recognised  calculation  method 
is 
sufficient. 

3.6.  The  study  need  only  be  conducted  if:

–  based  on  structure,  surface  activity  is 
expected or can be predicted; or  

– surface activity is a desired property of the 
material. 

If  the  water  solubility  is  below  1  mg/l  at 
20°C the test does not need to be conducted.  

3.7. The study does not need to be conducted 
if: 

–  the  substance  is  hydrolytically  unstable  at 
pH 4, 7 and 9 (half-life less than 12 hours); 
or 
– the substance is readily oxidisable in water.

If the substance appears "insoluble" in water, 
a  limit  test  up  to  the  detection  limit  of  the 
analytical method shall be performed. 

3.8. The study does not need to be conducted 
if  the  substance  is  inorganic.  If  the  test 
cannot  be  performed  (e.g.  the  substance 
decomposes,  has  a  high  surface  activity, 
reacts  violently  during  the  performance  of 
the  test  or  does  not  dissolve  in  water  or  in 
octanol,  or  it  is  not  possible  to  obtain  a 
sufficiently  pure  substance),  a  calculated 
value  for  log  P  as  well  as  details  of  the 
calculation method shall be provided. 

3.9. The study does not need to be conducted 
if: 

– the substance is inorganic; or 

the  substance  only  contains  volatile 
– 
organic  components  with  flash-points  above 
100°C for aqueous solutions; or 

–  the  estimated  flash-point  is  above  200°C; 
or 

EN 

102 

   EN 

 
 
 
 
 
 
 
 
 
 
3.10. Flammability 

3.11. Explosive properties 

– the flash-point can be accurately predicted 
by  interpolation  from  existing  characterised 
materials. 

3.10.  The  study  does  not  need 
conducted: 

to  be 

– if the substance is a solid which possesses 
explosive  or  pyrophoric  properties.  These 
properties  should  always  be  considered 
before considering flammability; or 

–  for  gases,  if  the  concentration  of  the 
flammable  gas  in  a  mixture with  inert gases 
is  so  low  that,  when  mixed  with  air,  the 
concentration  is  all  time  below  the  lower 
limit; or 

–  for  substances  which  spontaneously  ignite 
when in contact with air. 

3.11.  The  study  does  not  need 
conducted if: 

to  be 

–  there  are  no  chemical  groups  associated 
with  explosive  properties  present  in  the 
molecule; or 

–  the  substance  contains  chemical  groups 
associated  with  explosive  properties  which 
include  oxygen  and  the  calculated  oxygen 
balance is less than –200; or 

–  the  organic  substance  or  a  homogenous 
mixture  of  organic  substances  contains 
chemical  groups  associated  with  explosive 
properties, but the exothermic decomposition 
energy  is  less  than  500  J/g  and  the  onset  of 
exothermic  decomposition  is  below  500  ºC; 
or 

for  mixtures  of 

- 
inorganic  oxidising 
substances  (UN  Division  5.1)  with  organic 
materials,  the  concentration of  the  inorganic 
oxidising substance is: 

– less than 15 %, by mass, if assigned to UN 
Packaging  Group  I  (high  hazard)  or  II 
(medium hazard) 

– less than 30 %, by mass, if assigned to UN 
Packaging Group III (low hazard). 

Note:  Neither  a  test  for  propagation  of 
detonation  nor  a  test  for  sensitivity  to 
detonative 
the 
is 
exothermic decomposition energy of organic 
materials is less than 800 J/g. 

required 

shock 

if 

EN 

103 

   EN 

 
 
 
 
3.12. Self-ignition temperature 

3.13. Oxidising properties 

3.14. Granulometry 

3.12.  The  study  does  not  need 
conducted: 

to  be 

–  if  the  substance  is  explosive  or  ignites 
spontaneously with air at room  temperature; 
or 

–  for  liquids  non  flammable  in  air,  e.g.  no 
flash point up to 200°C; or 

– for gases having no flammable range; or 

–  for  solids,  if  the  substance  has  a  melting 
point  <  160°C,  or  if  preliminary  results 
exclude  self-heating  of  the  substance  up  to 
400°C. 

3.13.  The  study  does  not  need 
conducted if: 

to  be 

– the substance is explosive; or 

– the substance is highly flammable; or 

– the substance is an organic peroxide; or 

–  the  substance  is  incapable  of  reacting 
exothermically  with  combustible  materials, 
for  example  on  the  basis  of  the  chemical 
structure 
substances  not 
containing  oxygen  or  halogen  atoms  and 
these elements are not chemically bonded to 
nitrogen  or  oxygen,  or  inorganic  substances 
not containing oxygen or halogen atoms). 

(e.g.  organic 

The  full  test  does  not  need  to  be  conducted 
for  solids  if  the  preliminary  test  clearly 
indicates that the test substance has oxidising 
properties. 

Note  that  as  there  is  no  test  method  to 
determine 
the  oxidising  properties  of 
gaseous  mixtures,  the  evaluation  of  these 
properties must be realised by an estimation 
method  based  on  the  comparison  of  the 
oxidising potential of gases in a mixture with 
that  of  the  oxidising  potential  of  oxygen  in 
air. 

3.14.  The  study  does  not  need 
to  be 
conducted  if  the  substance  is  marketed  or 
used in a non solid or granular form. 

3.15.  Stability  in  organic  solvents  and 
identity of relevant degradation products 

Tier II 

3.15.  Stability 
in  organic  solvents  and 
identity  of  relevant  degradation  products

Only required if stability of the substance is 
considered to be critical. 

EN 

104 

   EN 

 
 
 
 
 
 
 
3.16. Dissociation constant 

3.17. Viscosity 

Tier II 

Tier II 

Tier II 

Tier II 

Tier II 

3.16. Dissociation constant 

3.17. Viscosity 

3.18.  Solubility  in  organic  solvents, 
temperature  on 
including  effect  of 
solubility53 

3.19.  Stability  in  organic  solvents 
used in biocidal products and identity 
of relevant breakdown products54  

4.  Methods  of  detection  and 
identification 

for 

4.1.  Analytical  methods 
the 
determination  of  pure  active  substance 
and,  where  appropriate,  for  relevant 
isomers  and 
degradation  products, 
impurities  of  the  active  substance  and 
additives (e.g. stabilisers) 

4.2.  Analytical  methods 
including 
limits  of 
the 
recovery 
determination  for  the  active  substance, 
and for residues thereof 

rates  and 

including 
4.3  Analytical  methods 
limits  of 
recovery  rates  and 
the 
determination 
active 
for 
substance,  and  for  residues  thereof, 
in/on  food  or  feedingstuffs  and  other 
products where relevant 

the 

5.  Effectiveness  against 
organisms and intended uses 

target 

Function, 

5.1. 
rodenticide, insecticide, bactericide 

e.g. 

fungicide, 

5.2.  Organism(s)  to  be  controlled  and 
products,  organisms  or  objects  to  be 
protected 

5.3.  Effects  on  target  organisms,  and 
likely  concentration  at  which  the  active 
substance will be used 

5.4.  Mode  of  action  (including  time 
delay) 

5.5. Field of use envisaged 

5.6.  User: 
general public (non-professional) 

industrial,  professional, 

53 
54 

These data must be submitted for the purified active substance of stated specification. 
These data must be submitted for the active substance of stated specification. 

EN 

105 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
5.7.  Information  on  the  occurrence  or 
possible  occurrence  of  the  development 
of 
appropriate 
resistance 
management strategies 

and 

5.8.  Likely  tonnage  to  be  placed  on  the 
market per year 

6.  Toxicological  profile  for  man 
and animals including metabolism 

6.1.  Skin  irritation  or  skin  corrosion 

6.1.1. In vivo skin irritation  

6.2. Eye irritation 

6.1.  The  assessment  of  this  endpoint  shall 
comprise  the  following  consecutive  steps:

(1) an assessment of the available human and 
animal 
data,
(2)  an  assessment  of  the  acid  or  alkaline 
reserve, 
(3) 
(4) in vitro study for skin irritation. 

in  vitro  study  for  skin  corrosion,

Steps 3 and 4 do not need to be conducted if:

– the available information indicates that the 
criteria are met for classification as corrosive 
to the skin or irritating to eyes; or 

–  the  substance  is  flammable  in  air  at  room 
temperature; or 

– the substance is classified as very toxic in 
contact with skin; or 

– an acute toxicity study by the dermal route 
does  not  indicate  skin  irritation  up  to  the 
limit dose level (2 000 mg/kg body weight). 

6.1.1.  The  study  does  not  need  to  be 
conducted if: 

–  the  substance  is  classified  as  corrosive  to 
the skin or as a skin irritant; or 

– the substance is a strong acid (pH < 2,0) or 
base (pH > 11,5); or 

–  the  substance  is  flammable  in  air  at  room 
temperature; or 

– the substance is classified as very toxic in 
contact with skin; or 

– an acute toxicity study by the dermal route 
does  not  indicate  skin  irritation  up  to  the 
limit dose level (2 000 mg/kg body weight). 

6.2.  The  assessment  of  this  endpoint  shall 
comprise  the  following  consecutive  steps:

EN 

106 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2.1. In vivo eye irritation  

6.3. Skin sensitisation 

(1) an assessment of the available human and 
animal data, 

(2)  an  assessment  of  the  acid  or  alkaline 
reserve, 

(3) in vitro study for eye irritation. 

Step 3 does not need to be conducted if: 

– the available information indicates that the 
criteria are met for classification as corrosive 
to the skin or irritating to eyes; or 

–  the  substance  is  flammable  in  air  at  room 
temperature. 

6.2.1.  The  study  does  not  need  to  be 
conducted if: 

–  the  substance  is  classified  as  irritating  to 
eyes with risk of serious damage to eyes; or
–  the  substance  is  classified  as  corrosive  to 
the  skin  and  provided  that  the  applicant 
classified the substance as eye irritant; or 

– the substance is a strong acid (pH < 2,0) or 
base (pH > 11,5); or 

–  the  substance  is  flammable  in  air  at  room 
temperature. 

6.3.  The  assessment  of  this  endpoint  shall 
comprise  the  following  consecutive  steps:

(1)  an  assessment  of  the  available  human, 
animal and alternative data, 

(2) In vivo testing. 

Step 2 does not need to be conducted if: 

– the available information indicates that the 
substance  should  be  classified  for  skin 
sensitisation or corrosivity; or 

– the substance is a strong acid (pH < 2,0) or 
base (pH > 11,5); or 

–  the  substance  is  flammable  in  air  at  room 
temperature. 

testing.  Only 

The  Murine  Local  Lymph  Node  Assay 
(LLNA)  is  the  first-choice  method  for  in 
vivo 
exceptional 
circumstances  should  another  test  be  used. 
Justification  for  the use of  another  test  shall 
be provided. 

in 

EN 

107 

   EN 

 
 
 
 
6.4. Mutagenicity 

6.4. Appropriate in vivo mutagenicity studies 
shall  be  considered  in  case  of  a  positive 
result  in  any  of  the  genotoxicity  studies  in 
Tier I. 

6.4.1.  In  vitro  gene  mutation  study  in 
bacteria 

6.4.1.  Further  mutagenicity  studies  shall  be 
considered in case of a positive result. 

6.4.2.  In  vitro  cytogenicity  study  in 
vitro 
cells 
mammalian 
micronucleus study 

or 

in 

6.4.3.  In  vitro  gene  mutation  study  in 
mammalian  cells,  if  a negative result  in 
Tier I, sections 6.4.1. and section 6.4.2. 

6.4.4. In vivo genotoxicity study 

Tier II 

6.4.2. The study does not usually need to be 
conducted if: 

– adequate data from an in vivo cytogenicity 
test are available or 

– the substance is known to be carcinogenic 
category  1A  or  1B  or  mutagenic  category 
1A, 1B or 2. 

6.4.3. The study does not usually need to be 
conducted if adequate data from a reliable in 
vivo  mammalian  gene  mutation  test  are 
available. 

6.4.4 If there is a positive result in any of the 
in  vitro  genotoxicity  studies  in  Tier  I  and 
there are no results available from an in vivo 
study already, an appropriate in vivo somatic 
cell genotoxicity study shall be proposed by 
the applicant. 

If  there  is  a  positive  result  from  an  in  vivo 
somatic cell study available, the potential for 
germ cell mutagenicity should be considered 
on  the  basis  of  all  available  data,  including 
toxicokinetic 
clear 
conclusions  about  germ  cell  mutagenicity 
can  be  made,  additional  investigations  shall 
be considered. 

evidence. 

no 

If 

6.5. Acute toxicity 

6.5.1. By oral route 

6.5.  The  study/ies  do(es)  not  generally  need 
to be conducted if: 

–  the  substance  is  classified  as  corrosive  to 
the skin. 

In  addition  to  the  oral  route  (6.5.1),  for 
substances other  than gases, the  information 
mentioned  under  6.5.2  to  6.5.3  shall  be 
provided  for  at  least  one  other  route.  The 
choice  for  the  second  route  will  depend  on 
the  nature  of  the  substance  and  the  likely 
route of human exposure. If there is only one 
route  of  exposure,  information  for  only  that 
route need be provided. 

6.5.1.  The  study  need  not  be  conducted  if  a 
study  on  acute  toxicity  by  the  inhalation 
route (6.5.2) is available. 

EN 

108 

   EN 

 
 
 
 
 
 
 
6.5.2. By inhalation 

6.5.3. By dermal route 

6.6. Repeated dose toxicity 

6.6.1.  Short-term  repeated  dose  toxicity 
study  (28 days),  one  species,  male  and 
female,  most  appropriate 
route  of 
administration,  having  regard  to  the 
likely route of human exposure. 

6.5.2.  Testing  by  the  inhalation  route  is 
if  exposure  of  humans  via 
appropriate 
inhalation  is  likely  taking  into  account  the 
vapour  pressure  of  the  substance  and/or  the 
possibility  of  exposure  to  aerosols,  particles 
or droplets of an inhalable size. 

6.5.3.  Testing  by 
appropriate if: 

the  dermal  route 

is 

(1)  inhalation  of  the  substance  is  unlikely; 
and 

(2)  skin  contact  in  production  and/or  use  is 
likely; and 

(3)  the  physicochemical  and  toxicological 
properties  suggest  potential  for  a  significant 
rate of absorption through the skin. 

6.6.1.  The 
short-term 
(28 days) does not need to be conducted if: 

toxicity 

study 

– a reliable sub-chronic (90 days) or chronic 
toxicity  study  is  available,  provided  that  an 
appropriate  species,  dosage,  solvent  and 
route of administration were used; or 

–  where  a  substance  undergoes  immediate 
disintegration and there are sufficient data on 
the cleavage products; or 

–  relevant  human  exposure  can  be  excluded 
in accordance with Annex IV section 3 

The appropriate route shall be chosen on the 
following basis: 

Testing by the dermal route is appropriate if: 

(1)  inhalation  of  the  substance  is  unlikely; 
and 

(2)  skin  contact  in  production  and/or  use  is 
likely; and 

(3)  the  physicochemical  and  toxicological 
properties  suggest  potential  for  a  significant 
rate of absorption through the skin. 

Testing by the inhalation route is appropriate 
if exposure of humans via inhalation is likely 
taking  into  account  the  vapour  pressure  of 
the  possibility  of 
the  substance  and/or 
exposure to aerosols, particles or droplets of 

EN 

109 

   EN 

 
 
 
 
 
  
 
an inhalable size. 

The  sub-chronic  toxicity  study  (90 days) 
(Tier  II,  section  6.6.2)  shall  be  proposed  by 
the  applicant  if:  the  frequency  and  duration 
of  human  exposure  indicates  that  a  longer 
term study is appropriate;  

and one of the following conditions is met: 

–  other  available  data  indicate  that  the 
substance  may  have  a  dangerous  property 
that  cannot  be  detected  in  a  short-term 
toxicity study; or 

appropriately  designed 

– 
toxicokinetic 
studies reveal accumulation of the substance 
or its metabolites in certain tissues or organs 
which would possibly remain undetected in a 
short term toxicity study but which are liable 
to  result  in  adverse  effects  after  prolonged 
exposure. 

Further  studies  shall  be  proposed  by  the 
applicant or may be required in case of: 

–  failure  to  identify  a  NOAEL  in  the  28  or 
the  90  days  study,  unless  the  reason  for  the 
failure  to  identify  a  NOAEL  is  absence  of 
adverse toxic effects; or 

toxicity  of  particular  concern 

– 
serious/severe effects); or 

(e.g. 

is 

evidence 

inadequate 

–  indications  of  an  effect  for  which  the 
available 
for 
toxicological  and/or  risk  characterisation.  In 
such cases it may also be more appropriate to 
perform  specific  toxicological  studies  that 
are designed to investigate these effects (e.g. 
immunotoxicity, neurotoxicity); or 

–  the  route  of  exposure  used  in  the  initial 
repeated  dose  study  was  inappropriate  in 
relation  to  the  expected  route  of  human 
exposure  and  route-to-route  extrapolation 
cannot be made; or 

in  consumer  products 

– particular concern regarding exposure (e.g. 
use 
to 
exposure  levels  which  are  close  to  the  dose 
levels  at  which  toxicity  to  humans  may  be 
expected); or 

leading 

–  effects  shown  in  substances  with  a  clear 
relationship  in  molecular  structure  with  the 
substance being studied, were not detected in 
the 28 or the 90 days study. 

EN 

110 

   EN 

 
6.6.2.  Sub-chronic  toxicity  study  (90-
day),  one  species,  rodent,  male  and 
female,  most  appropriate 
route  of 
administration,  having  regard  to  the 
likely route of human exposure. 

Tier II 

6.6.2.  The 
sub-chronic 
(90 days) does not need to be conducted if: 

toxicity 

study 

showing 

is  available 

reliable  short-term 

toxicity  study 
–  a 
(28 days) 
severe 
toxicity  effects  according  to  the  criteria  for 
classifying  the  substance  as  R48,  for  which 
the  observed  NOAEL-28 days,  with 
the 
application  of  an  appropriate  uncertainty 
factor,  allows  the  extrapolation  towards  the 
NOAEL-90 days  for 
the  same  route  of 
exposure; or 

–  a  reliable  chronic 
toxicity  study 
is 
that  an  appropriate 
available,  provided 
species  and  route  of  administration  were 
used; or 

a 

substance  undergoes 

immediate 
– 
disintegration and there are sufficient data on 
the  cleavage  products  (both  for  systemic 
effects and effects at the site of uptake); or 

–  the  substance  is  unreactive,  insoluble  and 
not  inhalable  and  there  is  no  evidence  of 
absorption  and  no  evidence  of  toxicity  in  a 
28-day  "limit  test",  particularly  if  such  a 
pattern 
limited  human 
exposure. 

is  coupled  with 

The appropriate route shall be chosen on the 
following basis: 

Testing by the dermal route is appropriate if: 

(1)  skin  contact  in  production  and/or  use  is 
likely; and 

(2) the physicochemical properties suggest a 
significant  rate  of  absorption  through  the 
skin; and 

(3) one of the following conditions is met: 

–  toxicity  is  observed  in  the  acute  dermal 
toxicity  test  at  lower  doses  than  in  the  oral 
toxicity test; or 

–  systemic  effects  or  other  evidence  of 
absorption  is  observed  in  skin  and/or  eye 
irritation studies; or 

–  in  vitro  tests  indicate  significant  dermal 
absorption; or 

–  significant  dermal  toxicity  or  dermal 
penetration  is  recognised  for  structurally 
related substances. 

EN 

111 

   EN 

 
Testing by the inhalation route is appropriate 
if: 

– exposure of humans via inhalation is likely 
taking  into  account  the  vapour  pressure  of 
the  possibility  of 
the  substance  and/or 
exposure to aerosols, particles or droplets of 
an inhalable size. 

Further  studies  shall  be  proposed  by  the 
applicant or may be required in case of: 

– failure to identify a NOAEL in the 90 days 
study  unless  the  reason  for  the  failure  to 
identify  a  NOAEL  is  absence  of  adverse 
toxic effects; or 

toxicity  of  particular  concern 

– 
serious/severe effects); or 

(e.g. 

is 

evidence 

inadequate 

–  indications  of  an  effect  for  which  the 
available 
for 
toxicological  and/or  risk  characterisation.  In 
such cases it may also be more appropriate to 
perform  specific  toxicological  studies  that 
are designed to investigate these effects (e.g. 
immunotoxicity, neurotoxicity); or 

6.6.3. Long-term repeated toxicity study 
(≥ 12 months) 

Tier II 

6.6.4. Further studies 

Tier II 

in  consumer  products 

– particular concern regarding exposure (e.g. 
use 
to 
exposure  levels  which  are  close  to  the  dose 
levels  at  which  toxicity  to  humans  may  be 
expected).  

leading 

6.6.3.  A  long-term  repeated  toxicity  study 
(≥ 12 months)  may  be  proposed  by  the 
applicant  or  required  if  the  frequency  and 
duration  of  human  exposure  indicates  that  a 
longer  term  study  is  appropriate  and  one  of 
is  met:
the 

conditions 

following 

–  serious  or  severe 
toxicity  effects  of 
particular  concern  were  observed  in  the  28-
day  or  90-day  study  for  which  the  available 
toxicological 
inadequate  for 
evidence 
evaluation or risk characterisation; or 

is 

–  effects  shown  in  substances  with  a  clear 
relationship  in  molecular  structure  with  the 
substance being studied were not detected in 
the 28-day or 90-day study; or 

–  the  substance  may  have  a  dangerous 
property that cannot be detected in a 90-day 
study. 

6.6.4.  Further  studies  shall  be  proposed  by 
the  applicant  or  may  be  required  in  case  of:

EN 

112 

   EN 

 
 
 
is 

effects); 

evidence 

toxicity  of  particular  concern 

(e.g. 
– 
or
serious/severe 
–  indications  of  an  effect  for  which  the 
for 
available 
toxicological 
risk 
evaluation 
characterisation. In such cases it may also be 
more  appropriate 
specific 
toxicological  studies  that  are  designed  to 
investigate 
(e.g. 
effects 
immunotoxicity, neurotoxicity); or 

inadequate 
and/or 

to  perform 

these 

in  consumer  products 

– particular concern regarding exposure (e.g. 
use 
to 
exposure  levels  which  are  close  to  the  dose 
levels at which toxicity is observed). 

leading 

If  a  substance  is  known  to  have  an  adverse 
effect  on  fertility,  meeting  the  criteria  for 
classification  as  Repr  Cat  1A  or  1B:  May 
damage  fertility  (H360F),  and  the  available 
data  are  adequate  to  support  a  robust  risk 
assessment, 
testing  for 
then  no  further 
fertility  will  be  necessary.  However,  testing 
for development toxicity must be considered. 

6.7. Reproductive toxicity  

Tier II 

6.7.  The  studies  need  not  be  conducted  if:

–  the  substance  is  known  to  be  a  genotoxic 
carcinogen and appropriate risk management 
measures 
or
–  the  substance  is  known  to  be  a  germ  cell 
mutagen  and  appropriate  risk  management 
measures are implemented; or 

implemented; 

are 

no 

that 

data 

–  the  substance  is  of  low  toxicological 
activity (no evidence of toxicity seen in any 
of the tests available), it can be proven from 
toxicokinetic 
systemic 
absorption  occurs  via  relevant  routes  of 
exposure  (e.g.  plasma/blood  concentrations 
limit  using  a  sensitive 
below  detection 
method and absence of the substance and of 
metabolites of the substance in urine, bile or 
exhaled air) and there is no or no significant 
human exposure. 

If  a  substance  is  known  to  have  an  adverse 
effect  on  fertility,  meeting  the  criteria  for 
classification  as  Repr  Cat  1A  or  1B:  May 
damage  fertility  (H360F),  and  the  available 
data  are  adequate  to  support  a  robust  risk 
assessment, 
testing  for 
then  no  further 
fertility  will  be  necessary.  However,  testing 
for development toxicity must be considered. 

substance 

is  known 

If  a 
to  cause 
developmental  toxicity,  meeting  the  criteria 
for classification as Repr Cat 1A or 1B: May 
damage  the  unborn  child  (H360D),  and  the 
available  data  are  adequate  to  support  a 

EN 

113 

   EN 

 
 
no 

for 
Screening 
6.7.1. 
reproductive/developmental 
toxicity, 
one species (OECD 421 or 422), if there 
available 
is 
information  on 
related 
substances,  from  (Q)SAR  estimates  or 
from in vitro methods that the substance 
may be a developmental toxicant. 

from 
structurally 

evidence 

robust  risk  assessment, 
then  no  further 
testing  for  developmental  toxicity  will  be 
necessary.  However,  testing  for  effects  on 
fertility must be considered. 

6.7.1.  This  study  does  not  need  to  be 
conducted if: 

–  the  substance  is  known  to  be  a  genotoxic 
carcinogen and appropriate risk management 
measures are implemented; or 

–  the  substance  is  known  to  be  a  germ  cell 
mutagen  and  appropriate  risk  management 
measures are implemented; or 

–  relevant  human  exposure  can  be  excluded 
in accordance with Annex IV section 3; or 

II,  6.7.2)  or  a 

–  a  pre-natal  developmental  toxicity  study 
(Tier 
two-generation 
reproductive  toxicity  study  (Tier  II,  section 
6.7.3) is available.  

If  a  substance  is  known  to  have  an  adverse 
effect  on  fertility,  meeting  the  criteria  for 
classification  as  Repr  Cat  1A  or  1B:  May 
damage  fertility  (H360F),  and  the  available 
data  are  adequate  to  support  a  robust  risk 
assessment, 
testing  for 
then  no  further 
fertility  will  be  necessary.  However,  testing 
for development toxicity must be considered. 

substance 

is  known 

If  a 
to  cause 
developmental  toxicity,  meeting  the  criteria 
for classification as Repr Cat 1A or 1B: May 
damage  the  unborn  child  (H360D),  and  the 
available  data  are  adequate  to  support  a 
robust  risk  assessment, 
then  no  further 
testing  for  developmental  toxicity  will  be 
necessary.  However,  testing  for  effects  on 
fertility must be considered. 

In  cases  where  there  are  serious  concerns 
about  the  potential  for  adverse  effects  on 
fertility  or  development,  either  a  pre-natal 
developmental toxicity study (Tier II, section 
6.7.2)  or  a  two  generation  reproductive 
toxicity study (Tier II, section 6.7.3) may be 
proposed  by  the  applicant  instead  of  the 
screening study. 

6.7.2. The study shall be initially performed 
on  one  species.  A  decision  on  the  need  to 
perform  a  study  at  this  tonnage  level  or  the 
next on a second species should be based on 
the  outcome  of  the  first  test  and  all  other 
relevant available data. 

6.7.2.  Pre-natal  developmental  toxicity 
study,  one  species,  most  appropriate 
route of administration, having regard to 
the  likely  route  of  human  exposure 
(B.31  of 
the  Regulation  (EC)  No 
440/2008 or OECD 414). 

Tier II 

EN 

114 

   EN 

 
 
6.7.3. The study shall be initially performed 
on  one  species.  A  decision  on  the  need  to 
perform  a  study  at  this  tonnage  level  or  the 
next on a second species should be based on 
the  outcome  of  the  first  test  and  all  other 
relevant available date. 

6.9.  A  carcinogenicity  study  may  be 
proposed by the applicant or may be required 
if: 

–  the  substance  has  a  widespread  dispersive 
use or there is evidence of frequent or long-
term human exposure; and 

–  the  substance  is  classified  as  mutagen 
category 2  or  there  is  evidence  from  the 
repeated dose study(ies) that the substance is 
able 
induce  hyperplasia  and/or  pre-
neoplastic lesions. 

to 

If  the  substance  is  classified  as  mutagen 
category  1A  or  1B,  the  default  presumption 
would  be  that  a  genotoxic  mechanism  for 
carcinogenicity  is  likely.  In  these  cases,  a 
carcinogenicity  test  will  normally  not  be 
required.  

Tier II 

6.7.3.  Two-generation 
reproductive 
toxicity  study,  one species,  male  and 
female,  most  appropriate 
route  of 
administration,  having  regard  to  the 
likely  route  of  human  exposure,  unless 
already  provided  as  part  of  Tier  I 
requirements 

6.8. Toxicokinetics 

6.8.1. Dermal absorption study 

6.9. Carcinogenicity study 

Tier II 

6.9.1.  Medical  surveillance  data  on 
manufacturing  plant  personnel 
if 
available 

6.9.2. Direct observation, e.g. clinical 
cases, poisoning incidents if available 

6.9.3.  Health  records,  both  from 
industry  and  any  other  available 
sources 

6.9.4. Epidemiological studies on the 
general population, if available 

6.9.5.  Diagnosis 
poisoning 
including  specific  signs  of  poisoning 
and clinical tests, if available 

of 

6.9.6. 
observations, if available 

Sensitisation/allergenicity 

6.9.7. Specific treatment in case of an 
accident  or  poisoning: 
first  aid 
measures,  antidotes  and  medical 
treatment, if known 

6.9.8. Prognosis following poisoning 

EN 

115 

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6.10.  Summary 
of  mammalian 
toxicology and conclusions, including 
no  observed  adverse  effect 
level 
(NOAEL),  no  observed  effect  level 
(NOEL),  overall  evaluation  with 
regard  to  all  toxicological  data  and 
any other information concerning the 
active  substances.  Where  possible 
any  suggested  worker  protection 
in 
measures  should  be 
summary form 

included 

6.11 Additional studies 

Tier II 

6.11.1 Neurotoxicity study 

Tier II 

Additional  data  which  may  be  required 
depending  on 
and 
intended use of the active substance. 

characteristics 

the 

is 

the 

that 

active 

substance 

indications 

If 
an 
organophosphorus  compound  or  if  there  are 
the  active 
any  other 
substance  may  have  neurotoxic  properties 
then  neurotoxicity  studies  will  be  required. 
The  test  species  is  the  adult  hen  unless 
another  test  species  is  justified  to  be  more 
delayed 
If 
appropriate. 
neurotoxicity 
tests  will  be  required.  If 
anticholine esterase activity is detected a test 
for response to reactivating agents should be 
considered 

appropriate, 

6.11.2. Toxic effects on livestock and 
pets 

the 
6.11.3.  Studies 
exposure  of  the  active  substance  to 
humans 

related 

to 

Tier II 

Tier II 

6.11.4. Food and feedingstuffs 

Tier II 

If  the  active  substance  is  to  be  used  in 
mixtures  for  use  where  food  for  human 
consumption  is  prepared,  consumed  or 
stored, or where feedingstuff for livestock 
is  prepared,  consumed  or  stored  the  tests 
referred to in Section 9.1 shall be required 

Tier II 

Tier II 

in 

6.11.5. If any other tests related to the 
exposure  of  the  active  substance  to 
its  proposed  biocidal 
humans, 
products,  are  considered  necessary, 
then  the  test(s)  referred  to  in Section 
9.1,  Title  I  of  Annex  III  shall  be 
required 

then 

tests 

6.11.6. If the active substance is to be 
used  in  products  for  action  against 
plants 
toxic 
effects  of  metabolites  from  treated 
plants,  if  any,  where  different  from 
those  identified  in  animals  shall  be 
required 

to  assess 

6.11.7.  Mechanistic  study  -  any 
studies  necessary  to  clarify  effects 

Tier II 

EN 

116 

   EN 

 
 
 
 
 
 
 
 
 
reported in toxicity studies 

Ecotoxicological 

7. 
profile 
including  environmental  fate  and 
behaviour 

7.1. Aquatic toxicity 

7.1.1.  Short-term  toxicity  testing  on 
species 
invertebrates 
Daphnia)  

(preferred 

The  applicant  may  consider  long-term 
toxicity testing instead of short-term. 

7.1.2.  Growth  inhibition  study  aquatic 
plants (algae preferred) 

7.1.3. Short-term toxicity testing on fish: 
The  applicant  may  consider  long-term 
toxicity testing instead of short-term.  

 7.1.  Long-term  toxicity  testing  shall  be 
proposed  by  the  applicant  if  the  assessment 
performed under Tier I indicates the need to 
investigate  further  the  effects  on  aquatic 
organisms.  The  choice  of  the  appropriate 
test(s)  depends  on 
the 
assessment performed under Tier I. 

results  of 

the 

7.1.1.  The  study  does  not  need  to  be 
conducted if: 

–  there  are  mitigating factors  indicating  that 
aquatic  toxicity  is  unlikely  to  occur,  for 
instance  if  the  substance  is  highly  insoluble 
in water or the substance is unlikely to cross 
biological membranes; or 

–  a  long-term  aquatic  toxicity  study  on 
invertebrates is available; or 

–  adequate  information  for  environmental 
classification and labelling is available. 

The  long-term  aquatic  toxicity  study  on 
Daphnia  (Tier  II,  section  7.1.5)  shall  be 
considered  if  the  substance  is  poorly  water 
soluble. 

7.1.2.  The  study  does  not  need  to  be 
conducted  if  there  are  mitigating  factors 
indicating that aquatic toxicity is unlikely to 
occur  for  instance  if  the  substance  is  highly 
insoluble 
is 
unlikely to cross biological membranes. 

the  substance 

in  water  or 

7.1.3.  The  study  does  not  need  to  be 
conducted if: 

–  there  are  mitigating factors  indicating  that 
aquatic  toxicity  is  unlikely  to  occur,  for 
instance  if  the  substance  is  highly  insoluble 
in water or the substance is unlikely to cross 
biological membranes; or 

– a long-term aquatic toxicity study on fish is 
available. 

7.1.4.  Activated 
inhibition testing 

sludge 

respiration 

7.1.4.  The  study  does  not  need  to  be 
conducted if: 

– there is no emission to a sewage treatment 
plant; or 

–  there  are  mitigating factors  indicating  that 

EN 

117 

   EN 

 
 
  
 
 
 
 
 
 
microbial  toxicity  is  unlikely  to  occur,  for 
instance  the substance  is highly  insoluble  in 
water; or 

–  the  substance  is  found  to  be  readily 
test 
biodegradable 
concentrations 
range  of 
concentrations  that  can  be  expected  in  the 
influent of a sewage treatment plant. 

the 
in 

and 
are 

applied 

the 

7.1.5.  Long-term  toxicity  testing  on 
invertebrates 
species 
Daphnia),  (unless  already  provided  as 
part of Tier I requirements) 

(preferred 

Tier II 

7.1.6. Long-term toxicity testing on fish, 
(unless already provided as part of Tier I 
requirements) 

Tier II 

The  information  shall  be  provided  for 
one  of  the  sections  7.1.6.1,  7.1.6.2  or 
7.1.6.3. 

7.1.6.1.  Fish  early-life  stage  (FELS) 
toxicity test 

Tier II 

7.1.6.2.  Fish  short-term  toxicity  test  on 
embryo and sac-fry stages 

Tier II 

7.1.6.3. Fish, juvenile growth test 

Tier II 

7.2. Degradation 

7.2.1. Biotic 

7.2.1.1. Ready biodegradability 

7.2.1.2.  Simulation  testing  on  ultimate 
degradation in surface water 

Tier II 

The study may be replaced by a nitrification 
inhibition test if available data show that the 
substance  is  likely  to  be  an  inhibitor  of 
microbial  growth  or  function,  in  particular 
nitrifying bacteria. 

7.2.  Further  biotic  degradation  testing  shall 
be  considered  if  the  assessment  performed 
under Tier I indicates the need to investigate 
further  the degradation of  the  substance  and 
its  degradation  products.  The  choice  of  the 
appropriate  test(s)  depends  on  the  results  of 
the  assessment  performed  under  Tier  I  and 
may include simulation testing in appropriate 
media (e.g. water, sediment or soil). 

7.2.1.1.  The  study  does  not  need  to  be 
conducted if the substance is inorganic. 

7.2.1.2. The study need not be conducted if:

– the substances is highly insoluble in water; 
or 

– the substance is readily biodegradable. 

EN 

118 

   EN 

 
  
 
  
  
  
  
 
 
  
 
 
7.2.1.3.  Soil  simulation 
testing  (for 
substances  with  a  high  potential  for 
adsorption to soil) 

7.2.1.4. Sediment simulation testing (for 
substances  with  a  high  potential  for 
adsorption to sediment) 

7.2.2. Abiotic 

7.2.2.1. Hydrolysis as a function of pH. 

Tier II 

7.2.1.3.  The  study  need  not  be  conducted:

–  if  the  substance  is  readily  biodegradable; 
or 

–  if  direct  and  indirect  exposure  of  soil  is 
unlikely. 

Tier II 

7.2.1.4.  The  study  need  not  be  conducted:

–  if  the  substance  is  readily  biodegradable; 
or 

– if direct and indirect exposure of sediment 
is unlikely. 

7.2.2.1.  The  study  does  not  need  to  be 
conducted if: 

–  the  substance  is  readily  biodegradable;  or
– the substance is highly insoluble in water. 

Identification  of  degradation 

7.2.3. 
products 

Tier II 

7.2.3.  Unless 
biodegradable 

the  substance 

is 

readily 

7.3.  Fate  and  behaviour 
environment 

in 

the 

7.3.1. Adsorption/desorption screening 

7.3.1.  The  study  does  not  need  to  be 
conducted if: 

–  based  on  the  physicochemical  properties 
the substance can be expected to have a low 
potential  for  adsorption  (e.g.  the  substance 
has 
partition 
low 
a 
coefficient); or 

octanol  water 

–  the  substance  and  its  relevant  degradation 
products decompose rapidly.  

7.3.2.  Bioaccumulation 
species, preferably fish  

in 

aquatic 

Tier II 

7.3.2. The study need not be conducted if: 

–  the  substance  has  a  low  potential  for 
bioaccumulation 
log 
(for 
Kow < 3)  and/or  a  low  potential  to  cross 
biological membranes; or 

instance 

a 

on 
7.3.3.  Additional 
adsorption/desorption  depending  on  the 
results of the study required under Tier I 

information 

– direct and indirect exposure of the aquatic 
compartment is unlikely. 

Tier II 

7.3.3.  The  study  need  not  be  conducted  if:

–  the  substance  has  a  low  potential  for 
bioaccumulation 
log 
(for 
Kow < 3)  and/or  a  low  potential  to  cross 
biological membranes; or 

instance 

a 

EN 

119 

   EN 

 
 
 
 
  
 
 
  
 
 
–  based  on  the  physicochemical  properties 
the substance can be expected to have a low 
potential  for  adsorption  (e.g.  the  substance 
has 
partition 
low 
a 
coefficient); or 

octanol  water 

– the substance and its degradation products 
decompose rapidly. 

Tier II 

Tier II 

Tier II 

Tier II 

Tier II 

7.4. Additional studies 

7.4.1.  Acute  toxicity  test  on  one  other, 
non-aquatic, non-target organism 

7.4.2.  Any  other  biodegradability  tests 
that  are  relevant  from  the  results  in 
section 7.2.1.1 

7.4.3.  Phototransformation 
(estimation 
identification of breakdown products 

method), 

air 
including 

in 

7.4.4.  If  the  results  from  section  7.4.2 
indicate the need to do so, or the active 
substance  has  an  overall  low  or  absent 
abiotic  degradation, 
tests 
described  in  sections  10.1.1  and  10.2.1 
and,  where  appropriate,  section  10.3 
shall be required 

then 

the 

8. Measures necessary to protect man, 
animals and the environment 

Tier II 

Tier II 

8.1.  Identification  of  any  substances 
falling within the scope of List I or List 
II of the Annex to Directive 80/68/EEC 
on the protection of groundwater against 
pollution  caused  by  certain  dangerous 
substances55. 

Notes: 

(1) These data must be submitted for the 
purified  active  substance  of  stated 
specification. 

(2) These data must be submitted for the 
active substance of stated specification. 

9.  Additional  human  health-related 
studies 

Tier II 

9.1. Food and feedingstuffs studies 

Tier II 

55 

OJ L 20, 26.1.1980, p. 43. 

Additional  data  which  may  be  required 
depending  on 
and 
intended use of the active substance. 

characteristics 

the 

Additional  data  which  may  be  required 
depending  on 
and 
intended use of the active substance. 

characteristics 

the 

EN 

120 

   EN 

 
 
 
 
 
 
 
 
                                                 
9.1.1.  Identification  of  degradation  and 
reaction  products  and  of  metabolites  of 
the  active  substance 
treated  or 
contaminated foods or feedingstuffs 

in 

Tier II 

substance, 

9.1.2.  Behaviour  of  the  residue  of  the 
degradation 
active 
its 
its 
products  and,  where 
relevant, 
treated 
on 
metabolites 
or 
the 
feedingstuffs 
food  or 
contaminated 
including the kinetics of disappearance 

9.1.3.  Overall  material  balance  for  the 
active substance. Sufficient residue data 
from  supervised  trials  to  demonstrate 
that  residues  likely  to  arise  from  the 
proposed  use  would  not  be  of  concern 
for human or animal health 

Tier II 

Tier II 

9.1.4.  Estimation  of  potential  or  actual 
exposure  of  the  active  substance  to 
humans through diet and other means 

Tier II 

9.1.5. If residues of the active substance 
remain on feedingstuffs for a significant 
period  of 
feeding  and 
metabolism studies in livestock shall be 
required to permit evaluation of residues 
in food of animal origin 

time 

then 

Tier II 

9.1.6.  Effects  of  industrial  processing 
the 
and/or  domestic  preparation  on 
nature and magnitude of residues of the 
active substance 

Tier II 

9.1.7.  Proposed  acceptable  residues  and 
the justification of their acceptability 

Tier II 

9.1.8.  Any  other  available  information 
that is relevant 

Tier II 

9.1.9.  Summary  and  evaluation  of  data 
submitted under 1.1 to 1.8 

Tier II 

9.2. Other test(s) related to the exposure 
to humans 

Tier II 

Suitable test(s) and a reasoned case will 
be required 

10.  Additional  studies  on  fate  and 
behaviour in the environment 

Tier II 

10. Fate and behaviour in soil 

Tier II 

10.  If  the  results  of  the  ecotoxicological 
studies  and  the  intended use(s)  of  the  active 
the 
indicate  a  danger 
substance 
environment  then  the  tests  described  in  this 
Section shall be conducted. 

for 

EN 

121 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
10.1.1.  Rate  and  route  of  degradation 
including identification of the processes 
involved  and 
identification  of  any 
metabolites and degradation products in 
at 
types  under 
appropriate conditions 

three 

least 

soil 

Tier II 

three  soil 

10.1.2.  Absorption  and  desorption  in  at 
least 
types  and,  where 
relevant,  absorption  and  desorption  of 
metabolites and degradation products 

Tier II 

10.1.3.  Mobility  in  at  least  three  soil 
types  and  where  relevant  mobility  of 
metabolites and degradation products 

Tier II 

10.1.4.  Extent  and  nature  of  bound 
residues 

Tier II 

10.2. Fate and behaviour in water 

Tier II 

10.2.1. Rate and route of degradation in 
aquatic systems (as far as is not covered 
by  section  7.2)  including  identification 
of metabolites and degradation products 

Tier II 

10.2.2.  Absorption  and  desorption  in 
water  (soil  sediment  systems)  and, 
and 
where 
desorption 
and 
degradation products 

absorption 
of  metabolites 

relevant, 

Tier II 

10.3. Fate and behaviour in air 

Tier II 

If  the  active  substance  is  to  be  used  in 
mixtures  for  fumigants,  if  it  is  to  be 
applied  by  a  spray  method,  if  it  is 
volatile,  or  if  any  other  information 
indicates  that  this  is  relevant,  then  the 
rate and route of degradation in air shall 
be determined as far as is not covered by 
section 7.4.3 

11. Additional ecotoxicological studies  Tier II 

11.1. Effects on birds 

11.1.1.  Acute  oral  toxicity  -  this  need 
not  be  done  if  an  avian  species  was 
selected for study in section 7.4.1 

Tier II 

Tier II 

11.1.2.  Short-term  toxicity  -  eight-day 
dietary  study  in  at  least  one  species 
(other than chickens) 

Tier II 

11.  If  the  results  of  the  ecotoxicological 
studies  and  the  intended use(s)  of  the  active 
substance 
the 
indicate  a  danger 
environment  then  the  tests  described  in  this 
Section shall be conducted. 

for 

EN 

122 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
11.1.3. Effects on reproduction 

Tier II 

11.2. Effects on aquatic organisms 

Tier II 

11.2.1.  Prolonged 
appropriate species of fish 

toxicity 

to 

an 

Tier II 

11.2.2.  Effects  on  reproduction  and 
growth rate on an appropriate species of 
fish 

Tier II 

11.2.3. 
appropriate species of fish 

Bioaccumulation 

in 

an 

Tier II 

11.2.4.  Daphnia  magna  reproduction 
and growth rate 

Tier II 

11.3.  Effects  on  other  non-target 
organisms 

Tier II 

beneficial 

11.3.1. Acute toxicity to honeybees and 
other 
e.g. 
predators.  A  different  test  organism 
shall be chosen from that used in section 
7.4.1 

arthropods, 

Tier II 

11.3.2.  Toxicity  to  earthworms  and  to 
other soil non-target macro-organisms 

Tier II 

11.3.3. Effects on soil non-target micro-
organisms 

Tier II 

11.3.4.  Effects  on  any  other  specific, 
non-target  organisms  (flora  and  fauna) 
believed to be at risk 

Tier II 

12. Classification and labelling 

13.  Summary  and  evaluation  of 
Sections 1 to 12 

EN 

123 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TITLE 2 - MICRO-ORGANISMS 

Dossiers  shall  be  prepared  on  strain  level  of  the  micro-organism  unless  information  is 
submitted that shows that the species is known to be sufficiently homogeneous regarding all 
characteristics, or the applicant provides other arguments. 

Where the micro-organism has been genetically modified within the meaning of Article 2(2) 
of  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  on  the  deliberate 
release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC56, a copy of the evaluation of the data concerning the assessment of the 
risks  to  the  environment  as  established  in  Article  4(2)  of  that  Directive,  shall  also  be 
submitted. 

If  the  biocidal  product  action  is  known  to  be  partly  or  entirely  due  to  the  effect  of  a 
toxin/metabolite, or if significant residues of toxins/metabolites are to be expected not related 
to  the  effect  of  the  active  micro-organism,  a  dossier  for  the  toxin/metabolite  shall  be 
submitted in accordance with the requirements of Title 1. 

The following data will be required to support submissions. 

1. 

Identity of the micro-organism 

1.1. 

Applicant 

1.2. 

Manufacturer 

1.3. 

Name and species description, strain characterisation 

1.3.1.  Common name of the micro-organism (including alternative and superseded names) 

1.3.2.  Taxonomic name and strain indicating whether it is a stock variant, a mutant strain or 
a  genetically  modified  organism  (GMO);  for  viruses,  taxonomic  designation  of  the 
agent, serotype, strain or mutant 

1.3.3.  Collection and culture reference number where the culture is deposited 

1.3.4.  Methods,  procedures  and  criteria  used  to  establish  the  presence  and  identity  of  the 

micro-organism (e.g. morphology, biochemistry, serology, etc.) 

1.4. 

Specification of the material used for manufacturing of formulated products 

1.4.1.  Content of the micro-organism 

1.4.2. 

Identity and content of impurities, additives, contaminating micro-organisms 

1.4.3.  Analytical profile of batches 

2. 

Biological properties of the micro-organism 

56 

OJ L 106, 17.4.2001, p. 1 

EN 

124 

   EN 

 
                                                 
2.1. 

History  of  the  micro-organism  and  its  uses.  Natural  occurrence  and  geographical 
distribution 

2.1.1.  Historical background 

2.1.2.  Origin and natural occurrence 

2.2. 

Information on target organism(s) 

2.2.1.  Description of the target organism(s) 

2.2.2.  Mode of action 

2.3. 

Host specificity range and effects on species other than the target organism 

2.4. 

Development stages/life cycle of the micro-organism 

2.5. 

Infectiveness, dispersal and colonisation ability 

2.6. 

Relationships to known plant or animal or human pathogens 

2.7. 

Genetic stability and factors affecting it 

2.8. 

Information on the production of metabolites (especially toxins) 

2.9. 

Antibiotics and other anti-microbial agents 

2.10.  Robustness to environmental factors 

2.11. 

Effects on materials, substances and products 

3. 

Additional information on the micro-organism 

3.1. 

Function 

3.2. 

Field of use envisaged 

3.3. 

Product type(s) and category of users for which the micro-organism should be listed 
in Annex I  

3.4. 

Method of production and quality control 

3.5. 

Information  on  the  occurrence  or  possible  occurrence  of  the  development  of 
resistance of the target organism(s) 

3.6. 

Methods to prevent loss of virulence of seed stock of the micro-organism 

3.7. 

Recommended  methods  and  precautions  concerning  handling,  storage,  transport  or 
fire 

3.8. 

Procedures for destruction or decontamination 

3.9. 

Measures in case of an accident 

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3.10. 

Procedures for waste management 

3.11.  Monitoring  plan  to  be  used  for  the  active  micro-organism  including  handling, 

storage, transport and use 

3.12.  Classification of the micro-organism in the relevant risk group specified in Article 2 

of Directive 2000/54/EC 

4. 

Analytical methods 

4.1. 

Methods for the analysis of the micro-organism as manufactured 

4.2. 

Methods to determine and quantify residues (viable or non-viable) 

5. 

Effects on human health 

TIER I 

5.1. 

Basic information 

5.1.1.  Medical data 

5.1.2.  Medical surveillance on manufacturing plant personnel 

5.1.3.  Sensitisation/allergenicity observations 

5.1.4.  Direct observation, e.g. clinical cases 

5.2. 

Basic studies 

5.2.1.  Sensitisation 

5.2.2.  Acute toxicity, pathogenicity, and infectiveness 

5.2.2.1.  Acute oral toxicity, pathogenicity and infectiveness 

5.2.2.2.  Acute inhalation toxicity, pathogenicity and infectiveness 

5.2.2.3.  Intraperitoneal/subcutaneous single dose 

5.2.3. 

In vitro genotoxicity testing 

5.2.4.  Cell culture study 

5.2.5. 

Information on short-term toxicity and pathogenicity 

5.2.5.1.  Health effects after repeated inhalatory exposure 

5.2.6.  Proposed treatment: first aid measures, medical treatment 

5.2.7.  Any pathogenicity and infectiveness to humans and other mammals under conditions 

of immunosuppression 

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END OF TIER I 

TIER II 

5.3. 

Specific toxicity, pathogenicity and infectiveness studies 

5.4. 

Genotoxicity — In vivo studies in somatic cells 

5.5. 

Genotoxicity — In vivo studies in germ cells 

END OF TIER II 

5.6. 

Summary  of  mammalian  toxicity,  pathogenicity  and  infectiveness  and  overall 
evaluation 

6. 

Residues in or on treated materials, food and feedingstuffs 

6.1. 

Persistence and likelihood of multiplication in or on treated materials, feedingstuffs 
or foodstuffs 

6.2. 

Further information required 

6.2.1.  Non-viable residues 

6.2.2.  Viable residues 

6.3. 

Summary  and  evaluation  of  residues  in  or  on  treated  materials,  food  and 
feedingstuffs 

7. 

Fate and behaviour in the environment 

7.1. 

Persistence and multiplication 

7.1.1.  Soil 

7.1.2.  Water 

7.1.3.  Air 

7.2. 

Mobility 

7.3. 

Summary and evaluation of fate and behaviour in the environment 

8. 

Effects on non-target organisms 

8.1. 

Effects on birds 

8.2. 

Effects on aquatic organisms 

8.2.1.  Effects on fish 

8.2.2.  Effects on freshwater invertebrates 

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8.2.3.  Effects on algae growth 

8.2.4.  Effects on plants other than algae 

8.3. 

Effects on bees 

8.4. 

Effects on arthropods other than bees 

8.5. 

Effects on earthworms 

8.6. 

Effects on soil micro-organisms 

8.7. 

Further studies 

8.7.1.  Terrestrial plants 

8.7.2.  Mammals 

8.7.3.  Other relevant species and processes 

8.8. 

Summary and evaluation of effects on non-target organisms 

9. 

Summary  and  evaluation  of  sections  1  to  8  including  conclusions  of  the  risk 
assessment and recommendations 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

ANNEX III 

Data requirements for biocidal products 

Dossiers  on  product  shall  contain  the  information  needed  to  establish,  where 
relevant,  Acceptable  Daily  Intake  (ADI),  Acceptable  Operator  Exposure  Level 
(AOEL),  Predicted  Environmental  Concentration  (PEC)  and  Predicted  No-Effect 
Concentration (PNEC). 

Information  which  is  however  not  necessary  owing  to  the  nature  of  the  biocidal 
product or of its proposed uses need not be supplied.  

A detailed and full description of the studies conducted and of the methods used or a 
bibliographical reference to those methods shall be included.  

The formats made available by the Commission must be used for submission of the 
dossiers. In addition, the special software package (IUCLID) made available by the 
Commission must be used for those parts of the dossiers to which IUCLID applies. 
Formats  and  further  guidance  on  data  requirements  and  dossier  preparation  are 
available on the Agency homepage. 

Tests submitted for the purpose of authorisation shall be conducted according to the 
methods  described  in  Regulation  (EC)  No  440/2008.  However,  if  a  method  is 
inappropriate  or  not  described,  other  methods  shall  be  used  which  are,  whenever 
possible, internationally recognised and must be justified in the application.  

Tests  performed  should  comply  with  the  relevant  requirements  of  protection  of 
laboratory animals, set out in Council Directive 86/609/EEC on the approximation of 
laws, regulations  and administrative provisions of the Member States regarding the 
protection  of  animals  used  for  experimental  and  other  scientific  purposes57,  and,  in 
the case of ecotoxicological and toxicological tests, good laboratory practice, set out 
in  Directive  2004/10/EC  of  the  European  Parliament  and  of  the  Council  on  the 
harmonisation  of  laws,  regulations  and  administrative  provisions  relating  to  the 
application of the principles of good laboratory practice and the verification of their 
application  for  tests  on  chemical  substances58  or  other  international  standards 
recognised as being equivalent by the Commission or the Agency. 

Where testing is done, a detailed description (specification) of the material used and 
its  impurities  must  be  provided.  Where  necessary,  data  as  established  in  Annex  II 
shall  be  required  for  all  the  toxicologically/eco-toxicologically  relevant  chemical 
components of the biocidal product, in particular if the components are substances of 
concern as defined in Article 3. 

Where test data exist that have been generated before ... [OJ: insert the date referred 
to in the first subparagraph of Article 85] by methods other than those laid down in 
Regulation  (EC)  No  440/2008,  the  adequacy  of  such  data  for  the  purposes  of  this 
Regulation and the need to conduct new tests according to the Regulation (EC) No 

57 
58 

OJ L 358, 18.12.1986, p. 1. 
OJ L 50, 20.2.2004, p. 44. 

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440/2008  must  be  decided  by  the  competent  authority  of  the  Member  State,  on  a 
case-by-case  basis,  taking  into  account,  among  other  factors,  the  need  to  minimise 
testing on vertebrate animals. 

9. 

All available relevant knowledge and information in literature should be provided. 

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TITLE 1 – Chemical products 

Dossier requirements  

The following data will be required to support submissions. 

1. 

Applicant  

1.1. 

Name and address, etc. 

1.2. 

Formulator  of  the  biocidal  product  and  the  active  substance(s)  (names,  addresses, 
including location of plant(s)) 

2. 

Identity  

2.1. 

2.2. 

2.3. 

Trade name or proposed trade name, and manufacturer's development code number 
of the preparation, if appropriate 

Detailed quantitative and qualitative information on the composition of the biocidal 
product, e.g. active substance(s), impurities, adjutants, inert components 

Physical  state  and  nature  of  the  biocidal  product,  e.g.  emulsifiable  concentrate, 
wettable powder, solution 

3. 

Physical, chemical and technical properties  

3.1. 

Appearance (physical state, colour) 

3.2. 

Explosive properties 

3.3. 

Oxidising properties 

3.4. 

Flash-point and other indications of flammability or spontaneous ignition 

3.5. 

Acidity/alkalinity and if necessary pH value (1 % in water) 

3.6. 

Relative density 

3.7. 

3.8. 

3.9. 

Storage stability - stability and shelf-life. Effects of light, temperature and humidity 
on  technical  characteristics  of  the  biocidal  product;  reactivity  towards  container 
material 

Technical characteristics of the biocidal product, e.g. wettability, persistent foaming, 
flowability, pourability and dustability 

Physical  and  chemical  compatibility  with  other  products  including  other  biocidal 
products with which its use is to be authorised 

4. 

Methods of identification and analysis 

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4.1. 

4.2. 

Analytical method for determining the concentration of the active substance(s) in the 
biocidal product 

In  so  far  as  not  covered  by  Annex  II,  Section  4.2,  analytical  methods  including 
toxicologically  and 
limits  of  determination 
recovery 
ecotoxicologically  relevant  components  of  the  biocidal  product  and/or  residues 
thereof, where relevant in or on the following: 

rates  and 

the 

for 

4.2.1.  Soil 

4.2.2.  Air 

4.2.3.  Water (including drinking water) 

4.2.4.  Animal and human body fluids and tissues 

4.2.5.  Treated food or feedingstuffs 

5. 

Intended uses and efficacy  

5.1. 

Product type and field of use envisaged 

5.2. 

Method of application including description of system used 

5.3. 

5.4. 

Application  rate  and  if  appropriate,  the  final  concentration  of  the  biocidal  product 
and active substance in the system in which the preparation is to be used, e.g. cooling 
water, surface water, water used for heating purposes 

Number  and  timing  of  applications,  and  where  relevant,  any  particular  information 
relating to geographical variations, climatic variations, or necessary waiting periods 
to protect man and animals 

5.5. 

Function, e.g. fungicide, rodenticide, insecticide, bactericide 

5.6. 

Pest organism(s) to be controlled and products, organisms or objects to be protected 

5.7. 

Effects on target organisms 

5.8. 

Mode of action (including time delay) in so far as not covered by Annex II, Section 
5.4 

5.9. 

User: industrial, professional, general public (non-professional) 

5.10. 

The proposed label claims for the product  

5.11. 

Efficacy  data  to  support  these  claims,  including  any  available  standard  protocols 
used, laboratory tests, or field trials, where appropriate 

5.12.  Any other known limitations on efficacy including resistance 

6. 

Toxicological studies 

6.1. 

Acute toxicity 

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For  studies  of  Sections  6.1.1  to  6.1.3,  biocidal  products  other  than  gases  shall  be 
administered  via  at  least  two  routes,  one  of  which  should  be  the  oral  route.  The 
choice  of  the  second  route  will  depend  on  the  nature  of  the  product  and  the  likely 
route  of  human  exposure.  Gases  and  volatile  liquids  should  be  administered  by  the 
inhalation route 

6.1.1.  Oral 

6.1.2.  Dermal 

6.1.3. 

Inhalation 

6.1.4.  For  biocidal  products  that  are  intended  to be  authorised  for  use  with  other  biocidal 
products,  the  mixture  of  products,  where  possible,  shall  be  tested  for  acute  dermal 
toxicity and skin and eye irritation, as appropriate 

6.2. 

Skin and eye irritation59 

6.3. 

Skin sensitisation 

6.4. 

Information on dermal absorption 

6.5. 

Available 
substances (i.e. substances of concern) 

toxicological  data  relating 

to 

toxicologically  relevant  non-active 

6.6. 

Information related to the exposure of the biocidal product to man and the operator 

Where  necessary,  the  test(s)  described  in  Annex  II,  shall  be  required  for  the 
toxicologically relevant non-active substances of the preparation 

7. 

Ecotoxicological studies 

7.1. 

Foreseeable routes of entry into the environment on the basis of the use envisaged 

7.2. 

7.3. 

Information on the ecotoxicology of the active substance in the product, where this 
cannot be extrapolated from the information on the active substance itself 

Available  ecotoxicological  information  relating  to  ecotoxicological  relevant  non-
active substances (i.e. substances of concern), such as information from safety data 
sheets 

8. 

Measures to be adopted to protect man, animals and the environment 

8.1. 

8.2. 

59 

Recommended methods and precautions concerning handling, use, storage, transport 
or fire 

Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical 
treatment if available; emergency measures to protect the environment; in so far as 
not covered by Annex II, Title1, point 8.3 

Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential 
corrosive properties. 

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8.3. 

Procedures, if any, for cleaning application equipment 

8.4. 

Identity of relevant combustion products in cases of fire 

8.5. 

Procedures  for  waste  management  of  the  biocidal  product  and  its  packaging  for 
industry,  professional  users  and  the  general  public  (non-professional  users),  e.g. 
possibility  of  reuse  or  recycling,  neutralisation,  conditions  for  controlled discharge, 
and incineration 

8.6. 

Possibility  of  destruction  or  decontamination  following  release  in  or  on  the 
following: 

8.6.1.  Air 

8.6.2.  Water, including drinking water 

8.6.3.  Soil 

8.7. 

8.8. 

Observations on undesirable or unintended side-effects, e.g. on beneficial and other 
non-target organisms 

Specify any repellents or poison control measures included in the preparation that are 
present to prevent action against non-target organisms 

9. 

Where relevant, the following additional data shall also be provided 

9.1. 

Further human health-related studies 

9.1.1.  Food and feedingstuffs studies 

9.1.1.1.  If residues of the biocidal product remain on feedingstuffs for a significant period of 
time,  then  feeding  and  metabolism  studies  in  livestock  shall  be  required  to  permit 
evaluation of residues in food of animal origin 

9.1.1.2.  Effects  of  industrial  processing  and/or  domestic  preparation  on  the  nature  and 

magnitude of residues of the biocidal product 

9.1.2.  Other test(s) related to the exposure to humans 

Suitable test(s) and a reasoned case will be required for the biocidal product 

9.2. 

Further studies on fate and behaviour in the environment  

9.2.1.  Where relevant all the information required in Annex II, Section 12 

9.2.2.  Testing for distribution and dissipation in the following: 

9.2.2.1.  Soil 

9.2.2.2.  Water 

9.2.2.3.  Air 

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Test  requirements  1  and  2  above  are  applicable  only  to  ecotoxicologically  relevant 
components of the biocidal product 

9.3. 

Further Ecotoxicological studies  

9.3.1.  Effects on birds 

9.3.1.1.  Acute oral toxicity, if not already done in accordance with Annex II, Section 7 

9.3.2.  Effects on aquatic organisms 

9.3.2.1.  In case of application on, in, or near to surface waters 

9.3.2.1.1. Particular studies with fish and other aquatic organisms 

9.3.2.1.2. Residue data in fish concerning the active substance and including toxicologically 

relevant metabolites 

9.3.2.1.3. The studies referred to in Annex II, Section 13.2.1, 2.2, 2.3 and 2.4 may be required 

for relevant components of the biocidal product 

9.3.2.1.4.  If  the  biocidal  product  is  to  be  sprayed  near  to  surface  waters  then  an  overspray 

study may be required to assess risks to aquatic organisms under field conditions 

9.3.3.  Effects on other non-target organisms 

9.3.3.1.  Toxicity to terrestrial vertebrates other than birds 

9.3.3.2.  Acute toxicity to honeybees 

9.3.3.3.  Effects on beneficial arthropods other than bees 

9.3.3.4.  Effects on earthworms and other soil non-target macro-organisms, believed to be at 

risk 

9.3.3.5.  Effects on soil non-target micro-organisms 

9.3.3.6.  Effects on any other specific, non-target organisms (flora and fauna) believed to be at 

risk 

9.3.3.7.  If the biocidal product is in the form of bait or granules 

9.3.3.7.1. Supervised trials to assess risks to non-target organisms under field conditions 

9.3.3.7.2.  Studies  on  acceptance  by  ingestion  of  the  biocidal  product  by  any  non-target 
organisms thought to be at risk 

10. 

Classification, packaging and labelling 

– 

– 

Proposals for safety-data sheets, where appropriate 

Hazard symbol(s) 

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– 

– 

– 

– 

Indications of danger 

Hazard statements 

Precautionary statements 

Packaging  (type,  materials,  size,  etc.),  compatibility  of  the  preparation  with 
proposed packaging materials to be included 

11. 

Summary and evaluation of Sections 2 to 10 

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TITLE 2 – MICRO-ORGANISMS 

Dossier requirements 

The following data will be required to support submissions. 

1. 

Applicant  

1.1. 

Name and address, etc. 

1.2. 

Formulator  of  the  biocidal  product  and  the  micro-organism(s)  (names,  addresses, 
including location of plant(s)) 

2. 

Identity of the biocidal products 

2.1. 

2.2. 

Trade name or proposed trade name, and manufacturer's development code number 
of the biocidal product 

Detailed quantitative and qualitative information on the composition of the biocidal 
product 

2.3. 

Physical state and nature of the biocidal product 

2.4. 

Function 

3. 

Physical, chemical and technical properties of the biocidal product 

3.1. 

Appearance (colour and odour) 

3.2. 

Storage stability and shelf-life 

3.2.1.  Effects of light, temperature and humidity on technical characteristics of the biocidal 

product 

3.2.2.  Other factors affecting stability 

3.3. 

Explosivity and oxidising properties 

3.4. 

Flash point and other indications of flammability or spontaneous ignition 

3.5. 

Acidity, alkalinity and pH value 

3.6. 

Viscosity and surface tension 

3.7. 

Technical characteristics of the biocidal product 

3.7.1.  Wettability 

3.7.2.  Persistent foaming 

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3.7.3.  Suspensibility and suspension stability 

3.7.4.  Dry sieve test and wet sieve test 

3.7.5.  Particle  size  distribution  (dustable  and  wettable  powders,  granules),  content  of 

dust/fines (granules), attrition and friability (granules) 

3.7.6.  Emulsifiability, re-emulsifiability, emulsion stability 

3.7.7.  Flowability, pourability (rinsability) and dustability 

3.8. 

Physical,  chemical  and  biological  compatibility  with  other  products  including 
biocidal products with which its use is to be authorised or registered 

3.8.1.  Physical compatibility 

3.8.2.  Chemical compatibility 

3.8.3.  Biological compatibility 

3.9. 

Summary  and  evaluation  of  physical,  chemical  and  technical  properties  of  the 
biocidal product 

4. 

Analytical methods 

4.1. 

Methods for the analysis of the biocidal product 

4.2. 

Methods to determine and quantify residues 

5. 

Intended use and efficacy 

5.1. 

Field of use envisaged 

5.2. 

Mode of action 

5.3. 

Details of intended use 

5.4. 

Application rate 

5.5. 

Content of micro-organism in material used (e.g. in the application device or bait) 

5.6. 

Method of application 

5.7. 

Number and timing of applications and duration of protection 

5.8. 

Necessary waiting periods or other precautions to avoid adverse effects to human and 
animal health and the environment 

5.9. 

Proposed instructions for use 

5.10.  Category of users 

5.11. 

Information on the possible occurrence of the development of resistance 

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5.12. 

Effects on the materials or products treated with the biocidal product 

6. 

Effects on human health 

6.1. 

Basic acute toxicity studies 

6.1.1.  Acute oral toxicity 

6.1.2.  Acute inhalation toxicity 

6.1.3.  Acute percutaneous toxicity 

6.2. 

Additional acute toxicity studies 

6.2.1.  Skin irritation 

6.2.2.  Eye irritation 

6.2.3.  Skin sensitisation 

6.3. 

Data on exposure 

6.4. 

Available toxicological data relating to non-active substances 

6.5. 

Supplementary studies for combinations of biocidal products 

6.6. 

Summary and evaluation of effects on human health 

7. 

8. 

9. 

Residues in or on treated materials, food and feedingstuffs 

Fate and behaviour in the environment 

Effects on non-target organisms 

9.1. 

Effects on birds 

9.2. 

Effects on aquatic organisms 

9.3. 

Effects on bees 

9.4. 

Effects on arthropods other than bees 

9.5. 

Effects on earthworms 

9.6. 

Effects on soil micro-organisms 

9.7. 

Additional  studies  on  additional  species  or  higher  tier  studies  such  as  studies  on 
selected non-target organisms 

9.7.1.  Terrestrial plants 

9.7.2.  Mammals 

9.7.3.  Other relevant species and processes 

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9.8. 

Summary and evaluation of effects on non-target organisms 

10. 

Classification, packaging and labelling 

As  established  in  point  b  of  Article  18(1),  proposals  including  justification  for  the 
hazard  and  precautionary  statements  in  accordance  with  the  provisions  set  in 
Regulation  (EC)  No  1272/2008  and  Directive  1999/45/EC  must  be  submitted.  The 
classification  comprises  of  the  description  of  the  category/categories  of  danger  and 
qualifying hazard statements for all dangerous properties.  

10.1. 

Packaging  and  compatibility  of  the  biocidal  product  with  proposed  packaging 
materials 

10.2. 

Procedures for cleaning application equipment 

10.3.  Re-entry  periods,  necessary  waiting  periods  or  other  precautions  to  protect  man, 

livestock and the environment 

10.4.  Recommended  methods  and  precautions  concerning:  handling, storage, transport or 

fire 

10.5.  Measures in the case of an accident 

10.6. 

Procedures  for  destruction  or  decontamination  of  the  biocidal  product  and  its 
packaging 

10.6.1.  Controlled incineration 

10.6.2.  Others 

10.7.  Monitoring  plan  to  be  used  for  the  active  micro-organism  and  other  micro-
organism(s) contained in the biocidal product including handling, storage, transport 
and use 

10.8. 

Indication  on  the  need  for  biocidal  product  to  carry  the  biohazard  sign  specified  in 
Annex II to Directive 2000/54/EC 

11. 

Summary  and  evaluation  of  Sections  1  to  10  including  conclusions  of  the  risk 
assessment and recommendations 

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ANNEX IV 

GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS 

The  applicant  may  propose  to  adapt  the  data  requirements  set  out  in  Annexes  II  and  III 
according to the general rules set out in this Annex. The reasons for such adaptations to the 
data requirements must be clearly stated under the appropriate heading of the dossier referring 
to the specific rule(s) of this Annex. 

1. 

TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY 

1.1. 

Use of existing data 

1.1.1.  Data on physical-chemical properties from experiments not carried out according to 

GLP or the relevant test methods. 

Data shall be considered to be equivalent to data generated by the corresponding test 
methods if the following conditions are met: 

(1) 

adequacy for the purpose of classification and labelling and risk assessment; 

(2) 

sufficient documentation is provided to assess the adequacy of the study; and 

(3) 

the  data  are  valid  for  the  endpoint  being  investigated  and  the  study  is 
performed using an acceptable level of quality assurance.  

1.1.2.  Data  on  human  health  and  environmental  properties  from  experiments  not  carried 

out according to GLP or the relevant test methods. 

Data shall be considered to be equivalent to data generated by the corresponding test 
methods if the following conditions are met: 

(1) 

adequacy for the purpose of classification and labelling and risk assessment; 

(2) 

(3) 

adequate  and  reliable  coverage  of  the  key  parameters  foreseen  to  be 
investigated in the corresponding test methods; 

exposure duration comparable to or longer than the corresponding test methods 
if exposure duration is a relevant parameter; and 

(4) 

adequate and reliable documentation of the study is provided. 

1.1.3.  Historical human data 

Historical  human  data,  such  as  epidemiological  studies  on  exposed  populations, 
accidental or occupational exposure data, biomonitoring studies, clinical studies and 
human  volunteer  studies  performed  in  accordance  with  internationally  accepted 
ethical standards shall be considered. The strength of the data for a specific human 
health  effect  depends,  among  other  things,  on  the  type  of  analysis  and  on  the 
parameters  covered  and  on  the  magnitude  and  specificity  of  the  response  and 

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consequently  the  predictability  of  the  effect.  Criteria  for  assessing  the  adequacy  of 
the data include: 

(1) 

the proper selection and characterisation of the exposed and control groups; 

(2) 

adequate characterisation of exposure; 

(3) 

sufficient length of follow-up for disease occurrence; 

(4)  valid method for observing an effect; 

(5)  proper consideration of bias and confounding factors; and 

(6) 

a reasonable statistical reliability to justify the conclusion. 

In all cases adequate and reliable documentation shall be provided. 

1.2.  Weight of evidence  

There  may  be  sufficient  weight  of  evidence  from  several  independent  sources  of 
information  leading  to  the  assumption/conclusion  that  a  substance  has  or  has  not  a 
particular dangerous property, while the information from each single source alone is 
regarded  insufficient  to  support  this  notion.  There  may  be  sufficient  weight  of 
evidence  from  the  use  of  newly  developed  test  methods,  not  yet  included  in  the 
relevant  test  methods  or  from  an  international  test  method  recognised  by  the 
Commission  as  being  equivalent,  leading  to  the  conclusion  that  a  substance  has  or 
has not a particular dangerous property.  

Where  sufficient  weight  of  evidence  for  the  presence  or  absence  of  a  particular 
dangerous property is available: 

– 

– 

further testing on vertebrate animals for that property shall be omitted, 

further testing not involving vertebrate animals may be omitted. 

In all cases adequate and reliable documentation shall be provided. 

1.3. 

Qualitative or Quantitative structure-activity relationship ((Q)SAR) 

Results obtained from valid qualitative or quantitative structure-activity relationship 
models  ((Q)SARs)  may  indicate  the  presence  or  absence  of  a  certain  dangerous 
property.  Results  of  (Q)SARs  may  be  used  instead  of  testing  when  the  following 
conditions are met: 

– 

– 

– 

– 

results  are  derived  from  a  (Q)SAR  model  whose  scientific  validity  has  been 
established, 

the substance falls within the applicability domain of the (Q)SAR model, 

results  are  adequate  for  the  purpose  of  classification  and  labelling  and  risk 
assessment, and 

adequate and reliable documentation of the applied method is provided. 

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1.4. 

In vitro methods 

Results  obtained  from  suitable  in  vitro  methods  may  indicate  the  presence  of  a 
certain  dangerous  property  or  may  be  important  in  relation  to  a  mechanistic 
understanding, which may be important for the assessment. In this context, ‘suitable’ 
means  sufficiently  well  developed  according 
test 
development criteria. 

internationally  agreed 

to 

Such confirmation may be waived, if the following conditions are met: 

(1) 

results are derived from an in vitro method whose scientific validity has been 
established by a validation study, according to internationally agreed validation 
principles; 

(2) 

results  are  adequate  for  the  purpose  of  classification  and  labelling  and  risk 
assessment; and 

(3) 

adequate and reliable documentation of the applied method is provided. 

1.5. 

Grouping of substances and read-across approach 

Substances whose physicochemical, toxicological and ecotoxicological properties are 
likely to be similar or follow a regular pattern as a result of structural similarity may 
be  considered  as  a  group,  or  ‘category’  of  substances.  Application  of  the  group 
concept  requires  that  physicochemical  properties,  human  health  effects  and 
environmental effects or environmental fate may be predicted from data for reference 
substance(s) within the group by interpolation to other substances in the group (read-
across  approach).  This  avoids  the  need  to  test  every  substance  for  every  endpoint. 
The similarities may be based on: 

(1) 

a common functional group; 

(2) 

the common precursors and/or the likelihood of common breakdown products 
via  physical  and  biological  processes,  which  result  in  structurally  similar 
chemicals; or 

(3) 

a  constant  pattern  in  the  changing  of  the  potency  of  the  properties  across  the 
category. 

If  the  group  concept  is  applied,  substances  shall  be  classified  and  labelled  on  this 
basis. 

In all cases results should: 

– 

– 

– 

be adequate for the purpose of classification and labelling and risk assessment, 

have  adequate  and  reliable  coverage  of  the  key  parameters  addressed  in  the 
corresponding test method, 

cover an exposure duration comparable to or longer than the corresponding test 
method if exposure duration is a relevant parameter, and 

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– 

adequate and reliable documentation of the applied method shall be provided. 

2. 

TESTING IS TECHNICALLY NOT POSSIBLE 

Testing  for  a  specific  endpoint  may  be  omitted,  if  it  is  technically  not  possible  to 
conduct  the  study  as  a  consequence  of  the  properties  of  the  substance:  e.g.  very 
volatile,  highly  reactive  or  unstable  substances  cannot  be  used,  mixing  of  the 
substance with water may cause danger of fire or explosion or the radio-labelling of 
the substance required in certain studies may not be possible. The guidance given in 
the relevant test methods, more specifically on the technical limitations of a specific 
method, shall always be respected.  

3. 

PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING 

3.1. 

3.2. 

Testing  in  accordance  with  sections  6  and  7  of  Annexes  II  and  III  may  be  omitted 
based on exposure considerations.  

In  all  cases,  adequate  justification  and  documentation  shall  be  provided.  The 
justification  shall  be  based  on  an  exposure  assessment  in  accordance  with  the 
Technical Notes for Guidance. 

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ANNEX V 

BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN 
ARTICLE 2(1) 

These product-types exclude products where they are covered by the Directives mentioned in 
Article 2(2) for the purposes of those Directives. 

MAIN GROUP 1: Disinfectants and general biocidal products  

These product types exclude cleaning products that are not intended to have a biocidal effect, 
including washing liquids, powders and similar products. 

Product-type 1: Human hygiene biocidal products 

Products in this group are biocidal products used for human hygiene purposes. 

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

Products used  for  the disinfection  of  air, surfaces, materials,  equipment  and  furniture which 
are  not  used  for  direct  food  or  feedingstuffs  contact  in  private,  public  and  industrial  areas, 
including hospitals, as well as products used as algaecides. 

Usage  areas  include,  inter  alia,  swimming  pools,  aquariums,  bathing  and  other  waters;  air-
conditioning systems; walls and floors in health and other institutions; chemical toilets, waste 
water, hospital waste, soil or other substrates (in playgrounds). 

Product-type 3: Veterinary hygiene biocidal products 

Products  in  this  group  are  biocidal  products  used  for  veterinary  hygiene  purposes  including 
products used in areas in which animals are housed, kept or transported. 

Product-type 4: Food and feed area disinfectants 

Products used for the disinfection of equipment, containers, consumption utensils, surfaces or 
pipework  associated  with  the  production,  transport,  storage  or  consumption  of  food, 
feedingstuffs or drink (including drinking water) for humans and animals. 

Product-type 5: Drinking water disinfectants 

Products used for the disinfection of drinking water (for both humans and animals). 

MAIN GROUP 2: Preservatives  

Product-type 6: In-can preservatives 

Products  used  for  the  preservation  of  manufactured  products,  other  than  foodstuffs  or 
feedingstuffs, in containers by the control of microbial deterioration to ensure their shelf life. 

Product-type 7: Film preservatives 

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Products  used  for  the  preservation  of  films  or  coatings  by  the  control  of  microbial 
deterioration in order to protect the initial properties of the surface of materials or objects such 
as paints, plastics, sealants, wall adhesives, binders, papers, art works. 

Product-type 8: Wood preservatives 

Products used for the preservation of wood, from and including the saw-mill stage, or wood 
products by the control of wood-destroying or wood-disfiguring organisms. 

This product type includes both preventive and curative products. 

Product-type 9: Fibre, leather, rubber and polymerised materials preservatives 

Products used for the preservation of fibrous or polymerised materials, such as leather, rubber 
or paper or textile products and rubber by the control of microbiological deterioration. 

Product-type 10: Masonry preservatives 

Products  used  for  preservation  and  remedial  treatment  of  masonry  or  other  construction 
materials other than wood by the control of microbiological and algal attack. 

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

Products  used  for  the  preservation  of  water  or  other  liquids  used  in  cooling  and  processing 
systems by the control of harmful organisms such as microbes, algae and mussels. 

Products used for the preservation of drinking water are not included in this product type. 

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. 

Product-type 13: Metalworking-fluid preservatives 

Products  used  for  the  preservation  of  metalworking  fluids  by  the  control  of  microbial 
deterioration. 

MAIN GROUP 3: Pest control  

Product-type 14: Rodenticides 

Products used for the control of mice, rats or other rodents. 

Product-type 15: Avicides 

Products used for the control of birds. 

Product-type 16: Molluscicides 

Products used for the control of molluscs. 

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Product-type 17: Piscicides 

Products used for the control of fish; these products exclude products for the treatment of fish 
diseases. 

Product-type 18: Insecticides, acaricides and products to control other arthropods 

Products used for the control of arthropods (e.g. insects, arachnids and crustaceans). 

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. 

MAIN GROUP 4: Other biocidal products  

Product-type 20: - 

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. 

Product-type 22: Embalming and taxidermist fluids 

Products  used  for  the  disinfection  and  preservation  of  human  or  animal  corpses,  or  parts 
thereof. 

Product-type 23: Control of other vertebrates 

Products used for the control of vermin. 

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ANNEX VI 

COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL 
PRODUCTS 

DEFINITIONS 

(a) 

Hazard identification 

This  is  the  identification  of  the  adverse  effects  which  a  biocidal  product  has  an 
inherent capacity to cause. 

(b) 

Dose (concentration) - response (effect) assessment 

This is the estimate of the relationship between the dose, or level of exposure, of an 
active substance or substance of concern in a biocidal product and the incidence and 
severity of an effect. 

(c) 

Exposure assessment 

This  is  the  determination  of  the  emissions,  pathways  and  rates  of  movement  of  an 
active  substance  or  a  substance  of  concern  in  a  biocidal  product  and  its 
transformation or degradation in order to estimate the concentration/doses to which 
human populations, animals or environmental compartments are or may be exposed. 

(d) 

Risk characterisation 

This  is  the  estimation  of  the  incidence  and  severity  of  the  adverse  effects  likely  to 
occur in a human population, animals or environmental compartments due to actual 
or predicted exposure to any active substance or substance of concern in a biocidal 
product. This may include 'risk estimation` i.e. the quantification of that likelihood. 

(e) 

Environment 

Water,  including  sediment,  air,  land,  wild  species  of  fauna  and  flora,  and  any 
interrelationship between them, as well as any relationship with living organisms. 

INTRODUCTION  

1. 

2. 

This Annex lays down principles to ensure that evaluations made and decisions taken 
by  a  competent  authority  or  the  Agency,  or  the  Commission,  where  relevant, 
concerning  the  authorisation  of  a  biocidal  product  providing  it  is  a  chemical 
preparation results in a harmonised high level of protection for humans, animals and 
the environment in accordance with point (b) of Article 16(1). 

In  order  to  ensure  a  high  and  harmonised  level  of  protection  of  human  and  animal 
health  and  of  the  environment, any risks arising  from the  use of  a biocidal product 
shall  be  identified.  To  achieve  this,  a  risk  assessment  shall  be  carried  out  to 
determine the acceptability or otherwise of any risks identified during the proposed 

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3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

normal use of the biocidal product. This is done by carrying out an assessment of the 
risks associated with the relevant individual components of the biocidal product. 

A  risk  assessment  on  the  active  substance  or  substances  present  in  the  biocidal 
product is always required. This will already have been carried out for the purpose of 
the inclusion of the active substance into Annex I. This risk assessment shall entail 
hazard  identification,  and,  as  appropriate,  dose  (concentration)  -  response  (effect) 
assessment, exposure assessment and risk characterisation. Where a quantitative risk 
assessment cannot be made a qualitative assessment shall be produced. 

Additional  risk  assessments  shall  be  carried  out,  in  the  same  manner  as  described 
above,  on  any  other  substance  of  concern  present  in  the  biocidal  product  where 
relevant for the use of the biocidal product. 

In order to carry out a risk assessment data are required. These data are detailed in 
Annexes II, III and IV and, recognising that there are a wide variety of product types, 
are  flexible  according  to  the  product  type  and  associated  risks.  The  data  required 
shall  be  the  minimum  necessary  to  carry  out  an  appropriate  risk  assessment. 
Competent  authorities  or  the  Agency  should  take  due  consideration  of  the 
requirements  of  Article  6  and  Article  19  of  this  Regulation  in  order  to  avoid 
duplication  of  data  submissions.  The  minimum  set  of  data  required  for  an  active 
substance in any biocidal product type, however, shall be that detailed in Annex VI 
to Regulation (EC) No 1907/2006; these data will already have been submitted and 
assessed as part of the risk assessment required for entry of the active substance into 
Annex  I  to  this  Regulation.  Data  may  also  be  required  on  a  substance  of  concern 
present in a biocidal product. 

The  results  of  the  risk  assessments  carried  out  on  an  active  substance  and  on  a 
substance of concern present in the biocidal product shall be integrated to produce an 
overall assessment for the biocidal product itself. 

When  making  evaluations  and  taking  decisions  concerning  the  authorisation  of  a 
biocidal product the competent authorities or the Agency shall: 

(a) 

take into consideration other relevant technical or scientific information which 
is  reasonably  available  to  them  with  regard  to  the  properties  of  the  biocidal 
product, its components, metabolites, or residues; 

(b) 

evaluate,  where  relevant,  justifications  submitted  by  the  applicant  for  not 
supplying certain data. 

It  is  known  that  many  biocidal  products  present  only  minor  differences  in 
composition  and  this  should  be  taken  into  account  when  evaluating  dossiers.  The 
concept of 'frame-formulations` is relevant here. 

It is known that certain biocidal products are considered as posing only a low risk, 
these  biocidal  products,  while  complying  with  the  requirements  of  this  Annex,  are 
subject to a simplified procedure as detailed in Article 16(3) of this Regulation. 

The application of these common principles shall lead to the competent authorities or 
the Commission deciding whether or not a biocidal product can be authorised, such 
authorisation may include restrictions on use or other conditions. In certain cases the 

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competent  authorities  may  conclude  that  more  data  are  required  before  an 
authorisation decision can be made. 

11. 

During the process of evaluation and decision-making, applicants and the competent 
authorities shall cooperate in order to resolve any questions on the data requirements 
quickly or to identify at an early stage any additional studies required, or to amend 
any proposed conditions for the use of the biocidal product or to modify its nature or 
its composition in order to ensure full compliance with the requirements of Article 16 
and of this Annex. The administrative burden, especially for small and medium-sized 
enterprises (SMEs), shall be kept to the minimum necessary without prejudicing the 
level of protection afforded to humans, animals and the environment. 

12. 

The  judgments  made  by  the  competent  authorities  during  the  evaluation  and 
decision-making  process  must  be  based  on  scientific  principles,  preferably 
recognised at international level, and be made with the benefit of expert advice. 

EVALUATION 

General principles 

13. 

14. 

15. 

16. 

The  data  submitted  in  support  of  an  application  for  authorisation  of  a  biocidal 
product  shall  be  examined  for  overall  scientific  value  by  the  receiving  competent 
authorities. After acceptance of these data the competent authorities shall utilise them 
by carrying out a risk assessment based on the proposed use of the biocidal product. 

A risk assessment on the active substance present in the biocidal product shall always 
be  carried  out.  If  there  are,  in  addition,  any  substances  of  concern  present  in  the 
biocidal product then a risk assessment shall be carried out for each of these. The risk 
assessment shall cover the proposed normal use of the biocidal product together with 
a  realistic  worst-case  scenario  including  any  relevant  production  and  disposal  issue 
either of the biocidal product itself or any material treated with it. 

For  each  active  substance  and  each  substance  of  concern  present  in  the  biocidal 
product, the risk assessment shall entail a hazard identification and the establishment 
of  appropriate  no-observed-adverse-effect  levels  (NOAEL),  where  possible.  It  shall 
also  include,  as  appropriate,  a  dose  (concentration)  -  response  (effect)  assessment, 
together with an exposure assessment and a risk characterisation. 

The  results  arrived  at  from  a  comparison  of  the  exposure  to  the  no-effect  level 
concentrations for each of the active substances and any substances of concern shall 
be integrated to produce an overall risk assessment for the biocidal product. Where 
quantitative results are not available the results of the qualitative assessments shall be 
integrated in a similar manner. 

17. 

The risk assessment shall determine: 

(a) 

the risk to humans and animals, 

(b) 

the risk to the environment, 

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(c) 

the  measures  necessary 
the  general 
environment during both the proposed normal use of the biocidal product and 
in a realistic worst-case situation. 

to  protect  humans,  animals  and 

18. 

In  certain  cases  it  may  be  concluded  that  further  data  are  required  before  a  risk 
assessment  can  be  finalised.  Any  such  additional  data  requested  shall  be  the 
minimum necessary to complete such a risk assessment. 

Effects on humans  

19. 

20. 

The risk assessment shall take account of the following potential effects arising from 
the use of the biocidal product and the populations liable to exposure. 

The  effects  previously  mentioned  result from  the  properties  of  the  active  substance 
and any substance of concern present. They are: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

acute and chronic toxicity, 

irritation, 

corrosivity, 

sensitisation, 

repeated dose toxicity, 

mutagenicity, 

carcinogenicity, 

reproduction toxicity, 

neurotoxicity, 

any other special properties of the active substance or substance of concern, 

other effects due to physico-chemical properties. 

21. 

The populations previously mentioned are: 

– 

– 

– 

professional users, 

non-professional users, 

humans exposed indirectly via the environment. 

22. 

The hazard identification shall address the properties and potential adverse effects of 
the active substance and any substances of concern present in the biocidal product. If 
this results in the biocidal product being classified according to the requirements of 
Article  58  then  dose  (concentration)  -  response  (effect)  assessment,  exposure 
assessment and risk characterisation shall be required. 

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23. 

24. 

25. 

26. 

27. 

28. 

29. 

30. 

In  those  cases  where  the  test  appropriate  to  hazard  identification  in  relation  to  a 
particular potential effect of an active substance or a substance of concern present in 
a biocidal product has been conducted but the results have not lead to classification 
of the biocidal product then risk characterisation in relation to that effect shall not be 
necessary  unless  there  are  other  reasonable  grounds  for  concern,  e.g.  adverse 
environmental effects or unacceptable residues. 

The  competent  authorities  shall  apply  points  25  to  28  when  carrying  out  a  dose 
(concentration) - response (effect) assessment on an active substance or a substance 
of concern present in a biocidal product. 

For  repeated  dose  toxicity  and  reproductive  toxicity  the  dose  response  relationship 
shall  be  assessed  for  each  active  substance  or  substance  of  concern  and,  where 
possible,  the  no-observed-adverse-effect  level  (NOAEL)  identified.  If  it  is  not 
possible  to  identify  a  NOAEL,  the  lowest-observed-adverse-effect  level  (LOAEL) 
shall be identified. 

For  acute  toxicity,  corrosivity  and  irritation,  it  is  not  usually  possible  to  derive  a 
NOAEL  or  LOAEL  on  the  basis  of  tests  conducted  in  accordance  with  the 
requirements of this Regulation. For acute toxicity, the LD50 (median lethal dose) or 
LC50  (median  lethal  concentration)  value  or,  where  the  fixed  dose  procedure  has 
been used, the discriminating dose shall be derived. For the other effects it shall be 
sufficient to determine whether the active substance or substance of concern has an 
inherent capacity to cause such effects during use of the product. 

For mutagenicity and carcinogenicity it shall be sufficient to determine whether the 
active  substance  or  substance  of  concern  has  an  inherent  capacity  to  cause  such 
effects during use of the biocidal product. However, if it can be demonstrated that an 
active  substance  or  a  substance  of  concern  identified  as  a  carcinogen  is  non-
genotoxic, it will be appropriate to identify a N(L)OAEL as described in point 25. 

With respect to skin sensitisation and respiratory sensitisation, in so far as there is no 
consensus on the possibility of identifying a dose/concentration below which adverse 
effects  are  unlikely  to  occur  in  a  subject  already  sensitised  to  a  given  substance,  it 
shall be sufficient to evaluate whether the active substance or substance of concern 
has an inherent capacity to cause such effects during use of the biocidal product. 

Where toxicity data derived from observations of human exposure, e.g. information 
gained  from  manufacture,  from  poison  centres  or  epidemiology  surveys,  are 
available special consideration shall be given to those data when carrying out the risk 
assessment. 

An  exposure  assessment  shall  be  carried  out  for  each  of  the  human  populations 
(professional  users,  non-professional  users  and  humans  exposed  indirectly  via  the 
environment) for which exposure to a biocidal product occurs or can reasonably be 
foreseen.  The  objective  of  the  assessment  shall  be  to  make  a  quantitative  or 
qualitative estimate of the dose/concentration of each active substance or substance 
of  concern  to  which  a  population  is,  or  may  be  exposed  during  use  of  the  biocidal 
product. 

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31. 

The exposure assessment shall be based on the information in the technical dossier 
provided in conformity with Article 6 and Article 19 and on any other available and 
relevant information. Particular account shall be taken, as appropriate, of: 

– 

– 

– 

– 

– 

– 

– 

– 

adequately measured exposure data, 

the form in which the product is marketed, 

the type of biocidal product, 

the application method and application rate, 

the physico-chemical properties of the product, 

the likely routes of exposure and potential for absorption, 

the frequency and duration of exposure, 

the  type  and  size  of  specific  exposed  populations  where  such  information  is 
available. 

32. 

Where  adequately  measured,  representative  exposure  data  are  available,  special 
consideration  shall  be  given  to  them  when  conducting  the  exposure  assessment. 
Where calculation methods are used for the estimation of exposure levels, adequate 
models shall be applied. 

These models shall: 

– 

– 

– 

make  a  best  possible  estimation  of  all  relevant  processes  taking  into  account 
realistic parameters and assumptions, 

be  subjected  to  an  analysis  taking  into  account  possible  elements  of 
uncertainty, 

be  reliably  validated  with  measurements  carried  out  under  circumstances 
relevant for the use of the model, 

– 

be relevant to the conditions in the area of use. 

Relevant monitoring data from substances with analogous use and exposure patterns 
or analogous properties shall also be considered. 

33. 

Where,  for  any  of  the  effects  set  out  in  point  20  a  NOAEL  or  LOAEL  had  been 
identified, the risk characterisation shall entail comparison of the NOAEL or LOAEL 
with  the  evaluation  of  the  dose/concentration  to  which  the  population  will  be 
exposed.  Where  a  NOAEL  or  LOAEL  cannot  be  established  a  qualitative 
comparison shall be made. 

Effects on animals  

34. 

Using the same relevant principles as described in the section dealing with effects on 
humans, the competent authorities shall consider the risks posed to animals from the 
biocidal product. 

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Effects on the environment  

35. 

36. 

37. 

38. 

39. 

The  risk  assessment  shall  take  account  of  any  adverse  effects  arising  in  any  of  the 
three environmental compartments - air, soil and water (including sediment) - and of 
the biota following the use of the biocidal product. 

The hazard identification shall address the properties and potential adverse effects of 
the active substance and any substances of concern present in the biocidal product. If 
this results in the biocidal product being classified according to the requirements of 
this  Regulation  then  dose  (concentration)  -  response  (effect)  assessment,  exposure 
assessment and risk characterisation shall be required. 

In  those  cases  where  the  test  appropriate  to  hazard  identification  in  relation  to  a 
particular potential effect of an active substance or a substance of concern present in 
a biocidal product has been conducted but the results have not led to classification of 
the  biocidal  product  then  risk  characterisation  in  relation  to  that  effect  shall  not  be 
necessary unless there are other reasonable grounds for concern. Such grounds may 
derive  from  the  properties  and  effects  of  any  active  substance  or  substance  of 
concern in the biocidal product, in particular: 

– 

– 

– 

– 

– 

– 

any indications of bioaccumulation potential, 

the persistence characteristics, 

the shape of the toxicity/time curve in ecotoxicity testing, 

indications  of  other  adverse  effects  on  the  basis  of  toxicity  studies  (e.g. 
classification as a mutagen), 

data on structurally analogous substances, 

endocrine effects. 

A dose (concentration) - response (effect) assessment shall be carried out in order to 
predict  the  concentration  below  which  adverse  effects  in  the  environmental 
compartment of concern are not expected to occur. This shall be carried out for the 
active  substance  and  for  any  substance  of  concern  present  in  the  biocidal  product. 
This  concentration  is  known  as  the  predicted  no-effect  concentration  (PNEC). 
However, in some cases, it may not be possible to establish a PNEC and a qualitative 
estimation of the dose (concentration) - response (effect) then has to be made. 

The PNEC shall be determined from the data on effects on organisms and ecotoxicity 
studies  submitted  in  accordance  with  requirements  of  Article  6  and  Article  18.  It 
shall be calculated by applying an assessment factor to the values resulting from tests 
on organisms, e.g. LD50 (median lethal dose), LC50 (median lethal concentration), 
EC50 (median effective concentration), IC50 (concentration causing 50 % inhibition 
level 
of  a  given  parameter,  e.g.  growth),  NOEL(C) 
(concentration)), or LOEL(C) (lowest-observed-effect level (concentration)). 

(no-observed-effect 

40. 

An  assessment  factor  is  an  expression  of  the  degree  of  uncertainty  in  extrapolation 
from test data on a limited number of species to the real environment. Therefore, in 

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general,  the  more  extensive  the  data  and  the  longer  the  duration  of  the  tests,  the 
smaller is the degree of uncertainty and the size of the assessment factor. 

The  specifications  for  the  assessment  factors  shall  be  elaborated  in  the  notes  for 
technical guidance which, to this end, shall be based particularly on the indications 
given in point 3.3.1 of Annex I to Regulation (EC) No. 1907/2006. 

For each environmental compartment an exposure assessment shall be carried out in 
order  to  predict  the  concentration  likely  to  be  found  of  each  active  substance  or 
substance of concern present in the biocidal product. This concentration is known as 
the predicted environmental concentration (PEC). However in some cases it may not 
be possible to establish a PEC and a qualitative estimate of exposure then has to be 
made. 

A  PEC,  or  where  necessary  a  qualitative  estimate  of  exposure,  need  only  be 
determined  for  the  environmental  compartments  to  which  emissions,  discharges, 
disposal  or  distributions  including  any  relevant  contribution  from  material  treated 
with biocidal products are known or are reasonably foreseeable. 

41. 

42. 

43. 

The PEC, or qualitative estimation of exposure, shall be determined taking account 
of, in particular, and if appropriate: 

– 

– 

– 

– 

– 

– 

– 

adequately measured exposure data, 

the form in which the product is marketed, 

the type of biocidal product, 

the application method and application rate, 

the physico-chemical properties, 

breakdown/transformation products, 

likely  pathways 
adsorption/desorption and degradation, 

to  environmental  compartments  and  potential 

for 

– 

the frequency and duration of exposure. 

44. 

Where  adequately  measured,  representative  exposure  data  are  available,  special 
consideration  shall  be  given  to  them  when  conducting  the  exposure  assessment. 
Where calculation methods are used for the estimation of exposure levels, adequate 
models shall be applied. The characteristics of these models shall be as listed in point 
32.  Where  appropriate,  on  a  case-by-case  basis,  relevant  monitoring  data  from 
substances with analogous use and exposure patterns or analogous properties should 
also be considered. 

45. 

For  any  given  environmental  compartment,  the  risk  characterisation  shall,  as  far  as 
possible,  entail  comparison  of  the  PEC  with  the  PNEC  so  that  a  PEC/PNEC  ratio 
may be derived. 

EN 

155 

   EN 

 
46. 

If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall 
entail a qualitative evaluation of the likelihood that an effect is occurring under the 
current  conditions  of  exposure  or  will  occur  under  the  expected  conditions  of 
exposure. 

Unacceptable effects 

47. 

48. 

49. 

Data  shall  be  submitted  to  and  evaluated  by  the  competent  authorities  to  assess 
whether  the  biocidal  product  does  not  cause  unnecessary  suffering  in  its  effect  on 
target  vertebrates.  This  shall  include  an  evaluation  of  the  mechanism  by  which  the 
effect is obtained and the observed effects on the behaviour and health of the target 
vertebrates;  where  the  intended  effect  is  to  kill  the  target  vertebrate  the  time 
necessary to obtain the death of the target vertebrate and the conditions under which 
death occurs shall be evaluated. 

The  competent  authorities  shall,  where  relevant,  evaluate  the  possibility  of  the 
development of resistance to an active substance in the biocidal product by the target 
organism. 

If there are indications that any other unacceptable effects may occur the competent 
authorities  shall  evaluate  the  possibility  of  such  effects  occurring.  An  example  of 
such an  unacceptable effect  would  be an adverse  reaction to  fastenings and fittings 
used in wood following the application of a wood preservative. 

Efficacy 

50. 

51. 

Data  shall  be  submitted  and  evaluated  to  ascertain  if  the  efficacy  claims  of  the 
biocidal product can be substantiated. Data submitted by the applicant or held by the 
competent authorities or the Agency must be able to demonstrate the efficacy of the 
biocidal product against the target organism when used normally in accordance with 
the conditions of authorisation. 

Testing  should  be  carried  out  according  to  Community  guidelines  if  these  are 
available and applicable. Where appropriate, other methods can be used as shown in 
the list below. If relevant acceptable field data exist, these can be used. 

ISO, CEN or other international standard method 

national standard method 

industry standard method (accepted by competent authorities or the Agency) 

individual producer standard method (accepted by competent authorities or the 
Agency) 

data  from  the  actual  development  of  the  biocidal  product  (accepted  by 
competent authorities or the Agency). 

– 

– 

– 

– 

– 

Summary 

52. 

In each of the areas where risk assessments have been carried out, i.e. effects on man, 
animals, and the environment, the competent authorities shall combine the results for 

EN 

156 

   EN 

 
the active substance together with the results for any substance of concern to produce 
an overall assessment for the biocidal product itself. This should take account of any 
likely synergistic effects of the active substance(s) and substances of concern in the 
biocidal product. 

53. 

For biocidal products containing more than one active substance any adverse effects 
shall also be combined to produce an overall effect for the biocidal product itself. 

DECISION MAKING  

General principles 

54. 

Subject  to  point  90,  the  competent  authorities  or  the  Commission  shall  come  to  a 
decision  regarding  the  authorisation  for  use  of  a  biocidal  product  as  a  result  of  the 
integration  of  the  risks  arising  from  each  active  substance  together  with  the  risks 
from each substance of concern present in the biocidal product. The risk assessments 
shall  cover  normal  use  of  the  biocidal  product  together  with  a  realistic  worst-case 
scenario including any relevant disposal issue either of the biocidal product itself or 
any material treated with it. 

55. 

In  making  a  decision  concerning  authorisation,  the  competent  authorities  or  the 
Commission  shall  arrive  at  one  of  the  following  conclusions  for  each  product  type 
and for each area of use of the biocidal product for which application has been made: 

(1) 

the biocidal product cannot be authorised; 

(2) 

biocidal 
the 
conditions/restrictions; 

product 

can 

be 

authorised 

subject 

to 

specific 

(3)  more data is required before a decision on authorisation can be made. 

If  the  conclusion  arrived  at  by  the  competent  authorities  or  the  Commission  is  that 
additional  information  or  data  are  required  before  an  authorisation  decision  can  be 
made,  then  the  need  for  any  such  information  or  data  shall  be  justified.  This 
additional information or data shall be the minimum necessary to carry out a further 
appropriate risk assessment. 

The competent authorities or the Commission shall only grant authorisation to those 
biocidal products which, when used according to their conditions of authorisation, do 
not  present  an  unacceptable  risk  to  humans,  animals  or  the  environment,  are 
efficacious and which contain active substances permitted at Community level to be 
used in such biocidal products. 

The  competent  authorities  or  the  Commission  shall  impose,  where  appropriate, 
conditions  or  restrictions  when  giving  authorisations.  The  nature  and  severity  of 
these shall be selected on the basis of, and be appropriate to, the nature and extent of 
the  expected  advantages  and  the  risks  likely  to  arise  from  the  use  of  the  biocidal 
product. 

56. 

57. 

58. 

59. 

In  the  decision-making  process  the  competent  authorities  or  the  Commission  shall 
take into consideration the following: 

EN 

157 

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– 

– 

– 

– 

– 

– 

– 

the  results  of  the  risk  assessment,  in  particular  the  relationship  between 
exposure and effect, 

the nature and severity of the effect, 

the risk management which can be applied, 

the field of use of the biocidal product, 

the efficacy of the biocidal product, 

the physical properties of the biocidal product, 

the benefits of using the biocidal product. 

60. 

61. 

The  competent  authorities  or  the  Commission  shall,  when  taking  a  decision 
concerning the authorisation of a biocidal product, take into account the uncertainty 
arising  from  the  variability  in  the  data  used  in  the  evaluation  and  decision-making 
process. 

The competent authorities or the Commission shall  prescribe that biocidal products 
shall be used properly. Proper use shall include application at an efficacious dose and 
minimisation of use of biocidal products where possible. 

Effects on humans 

62. 

63. 

64. 

65. 

66. 

The competent authorities or the Commission shall not authorise a biocidal product if 
the  risk  assessment  confirms  that,  in  foreseeable  application  including  a  realistic 
worst possible scenario, the product presents an unacceptable risk to humans. 

The  competent  authorities  or  the  Commission  shall  consider  possible  effects  on  all 
human  populations,  namely  professional  users,  non-professional  users  and  humans 
exposed  directly  or  indirectly  through  the  environment  when  making  a  decision  on 
the authorisation of a biocidal product. 

The competent authorities or the Commission shall examine the relationship between 
the exposure and the effect, and use this in the decision-making process. A number 
of  factors  need  to  be  considered  when  examining  this  relationship  and  one  of  the 
most  important  is  the  nature  of  the  adverse  effect  of  the  substance.  These  effects 
include  acute  toxicity,  irritancy,  corrosivity,  sensitisation,  repeated  dose  toxicity, 
mutagenicity,  carcinogenicity,  neurotoxicity,  reproduction  toxicity  together  with 
physico-chemical properties, and any other adverse properties of the active substance 
or substance of concern. 

The  competent  authorities  or  the  Commission  shall,  where  possible,  compare  the 
results obtained with those obtained from previous risk assessments for an identical 
or similar adverse effect and decide on an appropriate margin of safety (MOS) when 
making an authorisation decision. 

An appropriate MOS is typically 100 but an MOS higher or lower than this may be 
appropriate depending on, among other things, the nature of the critical toxicological 
effect. 

EN 

158 

   EN 

 
67. 

68. 

69. 

The  competent  authorities  or  the  Commission  shall,  if  appropriate,  impose,  as  a 
condition  of  authorisation,  the  wearing  of  personal  protective  equipment  such  as 
respirators,  breathing-masks,  overalls,  gloves  and  goggles  in  order  to  reduce 
exposure  for  professional  operators.  Such  equipment  must  be  readily  available  to 
them. 

If for non-professional users the wearing of personal protective equipment would be 
the  only  possible  method  for  reducing  exposure,  the  product  shall  not  normally  be 
authorised. 

If  the  relationship  between  the  exposure  and  the  effect  cannot  be  reduced  to  an 
acceptable level then no authorisation can be given by the competent authorities or 
the Commission for the biocidal product. 

Effects on animals 

70. 

71. 

The competent authorities or the Commission shall not authorise a biocidal product if 
the  risk  assessment  confirms  that,  in  normal  use,  the  biocidal  product  presents  an 
unacceptable risk to non-target animals. 

Using  the  same  relevant  criteria  as  described  in  the  section  dealing  with  effects  on 
humans, the competent authorities or the Commission shall consider the risks posed 
to animals from the biocidal product when making an authorisation decision. 

Effects on the environment 

72. 

The competent authorities or the Commission shall not authorise a biocidal product if 
the risk assessment confirms that the active substance, or any substance of concern, 
or  any  degradation,  or  reaction  product  presents  an  unacceptable  risk  in  any  of  the 
environmental  compartments,  water  (including  sediment),  soil  and  air.  This  shall 
include the assessment of risks to non-target organisms in these compartments. 

In  considering  whether  there  is  an  unacceptable  risk  competent  authorities  or  the 
Commission shall, when coming to a final decision in accordance with point 90, take 
into account the criteria in points 75 to 85. 

73. 

The basic tool used in the decision making is the PEC/PNEC ratio or, if this is not 
available, a qualitative estimation. Due consideration shall be given to the accuracy 
of this ratio due to variability in the data used both in measurements of concentration 
and of estimation. 

In  the  determination  of  the  PEC  the  most  appropriate  model  should  be  used  taking 
into account the environmental fate and behaviour of the biocidal product. 

74. 

For any given environmental compartment if the PEC/PNEC ratio is equal to or less 
than 1 the risk characterisation shall be that no further information and/or testing are 
necessary. 

If the PEC/PNEC ratio is greater than 1 the competent authorities or the Commission 
shall  judge,  on  the  basis  of  the  size  of  that  ratio  and  on  other  relevant  factors,  if 
further  information  and/or  testing  are  required  to  clarify  the  concern  or  if  risk 

EN 

159 

   EN 

 
reduction measures are necessary or if the product cannot be given an authorisation 
at all. Relevant factors to be considered are those previously mentioned in point 37. 

Water 

75. 

The competent authorities or the Commission shall not authorise a biocidal product, 
if  under  the  proposed  conditions  of  use,  the  foreseeable  concentration  of  the  active 
substance  or  of  any  other  substance  of  concern  or  of  relevant  metabolites  or 
breakdown  or  reaction  products  in  water  (or  its  sediments)  has  an  unacceptable 
impact on non-target species in the aquatic, marine or estuarine environment unless it 
is  scientifically  demonstrated  that  under  relevant  field  conditions  there  is  no 
unacceptable effect. 

76. 

The competent authorities or the Commission shall not authorise a biocidal product 
if, under the proposed conditions of use, the foreseeable concentration of the active 
substance  or  of  any  other  substance  of  concern  or  of  relevant  metabolites  or 
breakdown  or  reaction  products  in  groundwater  exceeds  the  lower  of  the  following 
concentrations: 

– 

– 

the  maximum  permissible  concentration  laid  down  by  Directive  80/778/EEC 
relating to the quality of water intended for human consumption60, or 

the maximum concentration as laid down following the procedure for including 
the active substance in Annex I to this Regulation, on the basis of appropriate 
data, in particular toxicological data 

unless it is scientifically demonstrated that under relevant field conditions the lower 
concentration is not exceeded. 

77. 

The competent authorities or the Commission shall not authorise a biocidal product if 
the foreseeable concentration of the active substance or a substance of concern or of 
relevant metabolites, breakdown or reaction products to be expected in surface water 
or  its  sediments  after  use  of  the  biocidal  product  under  the  proposed  conditions  of 
use: 

– 

exceeds,  where  the  surface  water  in  or  from  the  area  of  envisaged  use  is 
intended for the abstraction of drinking water, the values fixed by 

– 

Council  Directive  75/440/EEC  concerning  the  quality  required  of 
surface water intended for the abstraction of drinking water in the 
Member States61, 

– 

Directive 80/778/EEC or 

– 

has an impact deemed unacceptable on non-target species 

unless  it  is  scientifically  demonstrated  that  under  relevant  field  conditions  this 
concentration is not exceeded. 

60 
61 

OJ L 229, 30.8.1980, p. 11. 
OJ L 194, 25.7.1975, p. 26. 

EN 

160 

   EN 

 
                                                 
78. 

Soil 

79. 

Air 

80. 

The  proposed  instructions  for  use  of  the  biocidal  product,  including  procedures  for 
cleaning  application  equipment,  must  be  such  that  the  likelihood  of  accidental 
contamination of water or its sediments is minimised. 

Where  unacceptable  contamination  of  soil  is  likely  to  occur,  the  competent 
authorities  or  the  Commission  shall  not  authorise  a  biocidal  product  if  the  active 
substance or substance of concern contained in it, after use of the biocidal product: 

– 

– 

during tests in the field, persists in soil for more than one year, or 

during  laboratory  tests,  forms  non-extractable  residues  in  amounts  exceeding 
70 % of the initial dose after 100 days with a mineralisation rate of less than 5 
% in 100 days, 

– 

has unacceptable consequences or effects on non-target organisms, 

unless  it  is  scientifically  demonstrated  that  under  field  conditions  there  is  no 
unacceptable accumulation in soil. 

The competent authorities or the Commission shall not authorise a biocidal product 
where  there  is  a  foreseeable  possibility  of  unacceptable  effects  on  the  air 
compartment  unless  it  is  scientifically  demonstrated  that  under  relevant  field 
conditions there is no unacceptable effect. 

Effects on non-target organisms 

81. 

The competent authorities or the Commission shall not authorise a biocidal product 
where  there  is  a  reasonably  foreseeable  possibility  of  non-target  organisms  being 
exposed to the biocidal product if for any active substance or substance of concern: 

– 

– 

the PEC/PNEC is above 1 unless it is clearly established in the risk assessment 
that  under  field  conditions  no  unacceptable  effects  occur  after  use  of  the 
biocidal product according to the proposed conditions of use, or 

the bioconcentration factor (BCF) related to fat tissues in non-target vertebrates 
is above 1 unless it is clearly established in the risk assessment that under field 
conditions no unacceptable effects occur, either directly or indirectly, after use 
of the product according to the proposed conditions of use. 

82. 

The competent authorities or the Commission shall not authorise a biocidal product 
where  there  is  a  reasonably  foreseeable  possibility  of  aquatic  organisms  including 
marine  and  estuarine  organisms  being  exposed  to  the  biocidal  product  if  for  any 
active substance or substance of concern in it: 

– 

the PEC/PNEC is above 1 unless it is clearly established in the risk assessment 
that under field conditions the viability of aquatic organisms including marine 
and estuarine organisms is not threatened by the biocidal product according to 
the proposed conditions of use, or 

EN 

161 

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– 

the  bioconcentration  factor  (BCF)  is  greater  than  1  000  for  substances  which 
are  readily  biodegradable  or  greater  than  100  for  those  which  are  not  readily 
biodegradable unless it is clearly established in the risk assessment that under 
field conditions no unacceptable impact, either directly or indirectly, occurs on 
the  viability  of  exposed  organisms  including  marine  and  estuarine  organisms 
after use of the biocidal product according to the proposed conditions of use. 

83. 

The competent authorities or the Commission shall not authorise a biocidal product 
where  there  is  a  reasonably  foreseeable  possibility  of  micro-organisms  in  sewage 
treatment  plants  being  exposed  to  the  biocidal  product  if  for  any  active  substance, 
substance  of  concern,  relevant  metabolite,  breakdown  or  reaction  product  the 
PEC/PNEC ratio is above 1 unless it is clearly established in the risk assessment that 
under field conditions no unacceptable impact, either directly or indirectly, occurs on 
the viability of such micro-organisms. 

Unacceptable effects 

84. 

If  the  development  of  resistance  to  the  active  substance  in  the  biocidal  product  is 
likely the competent authorities or the Commission shall take steps to minimise the 
consequences of this resistance. This may involve modification of the conditions of 
authorisation or even refusal of any authorisation. 

85. 

An  authorisation  for  a  biocidal  product  intended  to  control  vertebrates  shall  not  be 
given unless: 

– 

– 

– 

death is synchronous with the extinction of consciousness, or, 

death occurs immediately, or, 

vital functions are reduced gradually without signs of obvious suffering. 

For  repellent  products,  the  intended  effect  shall  be  obtained  without  unnecessary 
suffering and pain for the target vertebrate. 

Efficacy 

86. 

87. 

Competent  authorities  or  the  Commission  shall  not  authorise  a  biocidal  product 
which  does  not  possess  acceptable  efficacy  when  used  in  accordance  with  the 
conditions specified on the proposed label or with other conditions of authorisation. 

The  level,  consistency  and  duration  of  protection,  control  or  other  intended  effects 
must, as a minimum, be similar to those resulting from suitable reference products, 
where such products exist, or to other means of control. Where no reference products 
exist,  the  biocidal  product  must  give  a  defined  level  of  protection  or  control  in  the 
areas  of  proposed  use.  Conclusions  as  to  the  performance  of  the  biocidal  product 
must be valid for all areas of proposed use and for all areas in the Member State or, 
where appropriate, in the Community, except where the biocidal product is intended 
for use in specific circumstances. Competent authorities shall evaluate dose response 
data  generated  in  trials  (which  must  include  an  untreated  control)  involving  dose 
rates lower than the recommended rate, in order to assess if the recommended dose is 
the minimum necessary to achieve the desired effect. 

EN 

162 

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Summary 

88. 

In  each  of  the  areas  where  risk  assessments  have  been  carried  out,  i.e.  effects  on 
humans, animals, and the environment, the competent authorities or the Commission 
shall combine the conclusions arrived at for the active substance and the substances 
of  concern  to  produce  an  overall  conclusion  for  the  biocidal  product  itself.  A 
summary  should  also  be  made  of  the  efficacy  assessment  and  of  the  unacceptable 
effects. 

The result shall be: 

– 

– 

– 

– 

– 

a summary of the effects of the biocidal product on humans, 

a summary of the effects of the biocidal product on animals, 

a summary of the effects of the biocidal product on the environment, 

a summary of the efficacy assessment, 

a summary of the unacceptable effects. 

OVERALL INTEGRATION OF CONCLUSIONS  

89. 

90. 

91. 

The  competent  authorities  or  the  Commission  shall  combine  the  individual 
conclusions  arrived  at  with  regard  to  effects  of  the  biocidal  product  on  the  three 
sectors  namely,  humans,  animals  and  the  environment  to  arrive  at  an  overall 
conclusion for the global effect of the biocidal product. 

The  competent  authorities  or  the  Commission  shall  then  take  due  consideration  of 
any  relevant  unacceptable  effects,  the  efficacy  of  the  biocidal  product  and  the 
benefits of using the biocidal product before taking an authorisation decision on the 
biocidal product. 

The competent authorities or the Commission shall ultimately decide whether or not 
the biocidal product can be authorised and whether this authorisation shall be subject 
to any restrictions or conditions in conformity with this Annex and this Regulation. 

EN 

163 

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APPENDIX 1 

CORRELATION TABLE 

This Regulation 

Directive 98/8/EC 

Article 1 

Article 2 
2.1 
2.2 
2.3 
2.4 
2.5 
2.6 

Article 3 
3.1 
3.2 

Article 4 
4.1 
4.2 
4.3 
4.4 

Article 5 

Article 6 
6.1 
6.2 
6.3 

Article 7 
7.1 
7.2 
7.3 
7.4 
7.5 
7.6 

Article 8 
8.1 
8.2 
8.3 
8.4 
8.5 

Article 1.1 

Article 1.2 
Article 1.2 
Article 1.3 
Article 1.4 

Article 2.1 
Article 2.2 

Article 10.1 
Article 10.3 
Article 10.2 
Article 10.2 

Article 11.1.a 
Article 11.1.a.i and ii 

Article 11.1.a 

Article 11.2 1st subparagraph 
Article 11.2 2nd subparagraph 
Article 10.1 1st subparagraph 

Article 11.4 

EN 

164 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.6 

Article 9 
9.1 
9.2 
9.3 
9.4 
9.5 

Article 10 
10.1 
10.2 

Article 11 
11.1 
11.2 
11.3 
11.4 
11.5 
11.6 

Article 12 
12.1 
12.2 
12.3 
12.4 
12.5 
12.6 
12.7 

Article 13 
13.1 
13.2 
13.3 

Article 14 

Article 15 
15.1 
15.2 
15.3 
15.4 
15.5 

Article 16 
16.1 
16.2 
16.3 

Article 11.3 

Article 10.4 

Article 10.4 

Article 3.1 
Article 8.1 
Article 3.4 
Article 3.6 
Article 3.7 

Article 5.1 
Article 5.1.b 

EN 

165 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 5.2 
Article 2.1.j 

Article 2.1.b 

Article 8.2 

Article 8.12 

Article 33 

Article 5.3 

Article 10.5.i 

Article 10.5.iii 

Article 3.3.i 

16.4 
16.5 
16.6 

Article 17 
17.1 
17.2 
17.3 
17.4 

Article 18 
18.1 
18.2 
18.3 
18.4 
18.5 

Article 19 
19.1 
19.2 

Article 20 
20.1 
20.2 
20.3 

Article 21 
21.1 
21.2 
21.3 
21.4 
21.5 
21.6 

Article 22 
22.1 
22.2 
22.3 

Article 23 
23.1 
23.2 
23.3 
23.4 
23.5 
23.6 

Article 24 
24.1 

EN 

166 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
24.2 
24.3 
24.4 
24.5 
24.6 
24.7 
24.8 
24.9 

Article 25 
25.1 
25.2 
25.3 
25.4 
25.5 
25.6 

Article 26 
26.1 
26.2 
26.3 
26.4 

Article 27 
27.1 
27.2 

Article 28 
28.1 
28.2 
28.3 
28.4 
28.5 
28.6 
28.7 
28.8 
28.9 
28.10 

Article 29 
29.1 
29.2 

Article 30 
30.1 
30.2 

Article 31 

Article 32 

Article 3.6 

Article 3.6 

Article 4.1 
Article 4.1 

Article 4.1 

Article 4.4 
Article 4.5 

Article 4.2 

Article 4.6 

EN 

167 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 33 
33.1 
33.2 

Article 34 
34.1 
34.2 
34.3 
34.4 
34.5 

Article 35 
35.1 
35.2 
35.3 
35.4 
35.5 
35.6 

Article 36 
36.1 
36.2 
36.3 
36.4 
36.5 
36.6 
36.7 
36.8 

Article 37 
37.1 
37.2 
37.3 
37.4 
37.5 
37.6 

Article 38 
38.1 
38.2 
38.3 

Article 39 
39.1 
39.2 
39.3 
39.4  

Article 40 

Article 14.1 

Article 14.2 

Article 7.1 
Article 7.3 

Article 7.2 

EN 

168 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 7.5 

Article 15.1 
Article 15.2 

Article 17.1 
Article 17.2 
Article 17.3 
Article 17.5 

Article 12.1 

Article 12.3 

Article 12.1.c.ii and 1.b and 1.d.ii 
Article 12.2.c.i and ii 

Article 41 

Article 42 

Article 43  

Article 44 
44.1 
44.2 
44.3 
44.4 
44.5 
44.6 
44.7 
44.8 
44.9 

Article 45 
45.1 
45.2 
45.3 
Article 46 
46.1 
46.2 
46.3 
46.4 
Article 47 
47.1 
47.2 
Article 48 
48.1 
48.2 
48.3 
48.4 
48.5 

Article 49 
49.1 
49.2 

49.3 
49.4 
Article 50 
50.1 
50.2 
Article 51 
51.1 
51.2 
Article 52 

EN 

169 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
52.1 
52.2 
52.3 
52.4 
52.5 
Article 53 
53.1 
53.2 
Article 54 
54.1 
54.2 
54.3 
54.4 
Article 55 
55.1 
55.2 
55.3 
55.4 
Article 56 
56.1 
56.2 
56.3 
Article 57 
57.1 
57.2 
Article 58 
58.1 
58.2 
58.3 
Article 59 
Article 60 
60.1 
60.2 
60.3 
60.4 
60.5 
Article 61 
61.1 
61.2 
Article 62 
62.1 
62.2 
62.3 
Article 63 
63.1 
63.2 
63.3 
Article 64 
Article 65 
65.1 

Article 13.2 

Article 13.1 

Article 24 

Article 24 

Article 19.1 
Article 19.2 

Article 20.1 and 2 
Article 20.3 
Article 20.6 
Article 21 2nd subparagraph 

Article 22.1 1st and 2nd subparagraphs 
Article 22.1 3rd subparagraph 
Article 22.2 

Article 23 1st subparagraph 
Article 23 2nd subparagraph 

EN 

170 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
65.2 
Article 66 
66.1 
66.2 
66.3 
Article 67 
67.1 
67.2 
Article 68 
68.1 
68.2 
Article 69 
Article 70 
70.1 
70.2 
70.3 
70.4 
Article 71 
71.1 
71.2 
Article 72 
72.1 
72.2 
72.3 
72.4 
72.5 
Article 73 
Article 74  
Article 75  
Article 76  
Article 77 
77.1 
77.2 
77.3 
77.4 
Article 78 
78.1 
78.2 
Article 79 
Article 80 
80.1 
80.2 
Article 81 
Article 82 
82.1 
82.2 
Article 83 
Article 84 
Article 85 

Article 25 

Article 26.1 and 2 

Article 28.1 

Article 28.3 
Article 28.4 

Articles 29 and 30 

Article 32 

Article 16.2 
Article 16.1 
Article 16.3 

EN 

171 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex I 
Annex II 
Annex III 
Annex IV 
Annex V 
Annex VI 

Annex I 
Annex II A, III A and IV A 
Annex II B, III B and IV B 

Annex V 
Annex VI 

EN 

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APPENDIX 2 

LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  regulation  of  the  European  Parliament  and  of  the  Council  concerning  the 
placing on the market and use of biocidal products. 

2. 

ABM / ABB FRAMEWORK 

Policy area: 07 Environment 

Activity  Code  07  03:  Implementation  of  Community  environmental  policy  and 
legislation 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B..A lines)) including headings: 

NEW  BUDGET  LINE  TO  BE  CREATED  UNDER  TITLE  07  ENVIRONMENT  – 
Chemicals Agency – activities in the field of the Legislation on Biocidal Products — Subsidy 
under Titles 1 &2 

NEW  BUDGET  LINE  TO  BE  CREATED  UNDER  TITLE  07  ENVIRONMENT  – 
Chemicals Agency – activities in the field of the Legislation on Biocidal Products — Subsidy 
under Title 3 

The new budget lines to be created will cover ECHA’s staff and administrative expenditure 
(titles 1 and 2) and ECHA's operating expenditure (title 3) for the activities to be carried out 
in  the  field  of  biocidal  products  in  accordance  with  this  Regulation,  as  part  of  the  annual 
subsidy to the European Chemicals Agency (ECHA) from the Community budget (in addition 
to the appropriations under budget items 02 03 03 01 and 02 03 03 02 to finance the activities 
of the REACH Regulation62). 

3.2. 

Duration of the action and of the financial impact: 

The  duration  of  the  action  is  not  limited  in  time  as  the  proposal  establishes  the  rules 
applicable to the placing on the market of biocidal products. The financial impact is, however, 
expected to be limited to supporting the European  Chemicals  Agency  (ECHA)  in  taking  up 
the  additional  tasks  related  to  the  assessment  of  active  substances  used  in  biocidal  products 
and  of  certain  biocidal  products.  ECHA  will  indeed  receive  from  industry  specific  fees  for 
certain of these activities as well as an annual fee for products authorised by the Community. 

62 

Regulation (EC) N° 1907/2006 

EN 

173 

   EN 

 
 
                                                 
It is expected that ECHA will be involved in these tasks from the year 2012. As 2013 is the 
last  year  of  the  current  financial  programming,  estimates  of  the  commitment  and  payment 
appropriations have been limited to that of 2012 and 2013 in this financial statement.  

A detailed analysis of the ECHA budget for these additional tasks is provided in annexes to 
the financial statement for the years 2012 and 2013 as well as for the next 8 following years 
(i.e.  until  2021),  in  order  to  match  the  timetable  attached  to  the  REACH  revised  legislative 
Financial Statement (SEC(2006)924). 

3.3. 

Budgetary characteristics: 

Budget 
line 

NEW 

NEW 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Non-
comp 

Non-
comp 

Diff 

YES 

YES 

Diff 

YES 

YES 

NO 

NO 

No 2 

No 2 

EN 

174 

   EN 

 
4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

2012 

2013 

201463 

2015 

2016 

2017 
and later 

Total 

   Operational expenditure 

   Commitment Appropriations 

(CA) 

   Payment 
(PA) 

Appropriations 

8.1. 

a 

b 

1,023  2,280 

1,023  2,280 

   Administrative expenditure within reference amount 

3,303 

3,303 

   Technical  &  administrative 

assistance (NDA) 

8.2.4. 

c 

- 

- 

- 

- 

- 

- 

- 

   TOTAL REFERENCE AMOUNT 

   Commitment 

Appropriations 

a+c 

1,023  2,280 

  Payment Appropriations 

b+c 

1,023  2,280 

   Administrative expenditure not included in reference amount 

   Human 

associated 
(NDA) 

resources 

and 
expenditure 

   Administrative  costs,  other 
than  human  resources  and 
not 
associated 
included 
reference 
in 
amount (NDA) 

costs, 

8.2.5. 

d 

- 

- 

- 

8.2.6. 

e 

0,204  0,204 

- 

- 

- 

- 

- 

- 

- 

   Total indicative financial cost of intervention 

  TOTAL  CA  including  cost 

of Human Resources 

  TOTAL  PA  including  cost 

of Human Resources 

a+c+d
+e 

b+c+d
+e 

1,227  2,484 

1,227  2,484 

3,303 

3,303 

- 

0,408 

3,711 

3,711 

63 

Estimates  of  the  commitment  and  payment  appropriations  are  limited  to  the  current  financial 
programming running until 2013.  

EN 

175 

   EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
4.1.2.  Compatibility with Financial Programming 

(cid:133) 

Proposal is compatible with existing financial programming. 

X 

(cid:133) 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective (1,227M€ in 2012 and 2,484M€ in 2013). 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement64 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

X 

Proposal has no financial implications on revenue 

There  is  no  impact  on  the  revenue  side  of  the  Community  budget.  ECHA's  budget 
foresees  its  own  revenues  consisting  of  the  fees  paid  by  industry,  which  ECHA  is 
authorised to collect by virtue of the tasks entrusted to it under this Regulation and a 
balancing subsidy from the Community budget. 

For tasks related to biocidal products, the proposal foresees that ECHA would charge 
fees for the inclusion and renewal of inclusion of active substances in Annex I, for 
the evaluation of application for the authorisation, modification of authorisation and 
renewal of authorisation of certain biocidal products at the Community level, as well 
as an annual fee to be paid by holders of Community authorisations. 

Although the activities relating to inclusion of active substances and authorisation of 
biocidal  products  are  expected  to  be  self-financed  after  a  few  years,  a  balancing 
subsidy from the Community budget could still be necessary, if the fee structure does 
not  cover  the  expenses.  The  present  financial  fiche  has  been  established  with  the 
hypothesis that some tasks would not be covered by the fees: 

– 

– 

– 

– 

– 

– 

Preparation of opinions on questions referred to ECHA by virtue of Article 30 
of  the  proposal,  in  case  of  disagreement  between  Member  States  during  a 
mutual recognition procedure 

Tasks related to data sharing and confidentiality 

Development of general and specific guidance documents 

Completion of Review Programme for existing substances 

Reductions for SMEs (as proposed in point (a) of Article 70(2)) 

Other tasks of Community interest not covered by fees 

Also,  Article  68  of  the  proposal  requires  a  clear  separation  of  ECHA's  budget 
between activities to be carried out in accordance with the provisions of the REACH 
Regulation  and  the  new  and  additional  tasks  derived  from  this  proposal.  As  a 
consequence,  expenditures  and  revenues  under  these  additional  tasks  have  to  be 
clearly identified by the accounting system of the agency. 

64 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

176 

   EN 

 
                                                 
4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

2012 

2013 

2014 

2015 

2016 

2017 

and 
later 

Total  number  of  human 
resources 

- 

- 

- 

- 

- 

- 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Needs to be met in the short or long term 

Before  any  substance  can  be  authorised  for  use  in  a  biocidal  product,  it  must  be  assessed 
whether  its  use  poses  any  unacceptable  risk  for  the  environment  or  public  health.  This 
assessment  is  done  by  Member  State  competent  authorities  followed  by  a  peer  review 
organised at the Community level, before a decision is taken by the Commission. 

In addition, to improve the authorisation process of biocidal products  as well as to promote 
innovation and the development of new products with better health or environmental profile, 
it  is  proposed  that  certain  products  –  those  containing  new  active  substances  or  those 
presenting a low risk – will be authorised directly at the Community level at the choice of the 
applicant.  Other  categories  of  biocidal  products  will  continue  being  authorised  at  Member 
State level. 

Also,  for  biocidal  products  to  be  authorised  by  the  Member  States,  through  the  mutual 
recognition  procedure,  divergence  of  opinions  between  Member  States  will  need  to  be 
addressed  through  an  ad  hoc  conflict  resolution  procedure.  Most  of  these  divergences  of 
opinions are expected to be of a scientific or a technical nature. 

Last,  genuine  scientific  and  technical  support for  the  implementation  of  the  Regulation  will 
need to be provided. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Until today the Commission Joint Research Centre provides a significant input to the review 
programme of existing active substances65. However, with the downsizing of its activities in 

65 

The current Directive 98/8/EC provides for the systematic evaluation of active substances, which were 
already on the market on 14 May 2000, when that Directive came into force. This evaluation is carried 
out by  Member  States, which  have  all  been  allocated  a number  of  substances  for  which  they  have  to 
produce  assessment  reports.  These  assessment  reports  are  then  peer  reviewed  by  the  other  Member 
States  and  discussed  at  different  meetings  organised  by  the  Commission  JRC  for  the  scientific  and 
technical  issues  and  then  by  DG  Environment  for  the  final  discussions  before  the  final  steps  of  the 
decision-making  process  are  taken  (Comitology  procedure).  The  scientific  and  technical  discussions 
and  the  preparatory  work  they  entail  to  read  the  reports  and  analyse  the  different  issues  require 

EN 

177 

   EN 

 
 
 
 
 
 
 
                                                 
the field of chemical substances due to the transfer of many of these activities to ECHA, the 
Commission  JRC  already  announced  that  it  would  also  stop  its  activities  in  the  field  of 
biocidal products at the end of 2013 and would then concentrate on other priorities. 

As the Commission services will then no longer have the expertise and resources to address 
issues  of  scientific  or  technical  nature  linked  to  the  evaluation  of  active  substances  and  the 
authorisation  of  biocidal  products,  it  was  considered  most  appropriate  to  seek  advice  and 
support from an external body.  

Relying on an external body to carry out the risk assessment is also in line with the approach 
adopted  in  other  sectors  such  as  medicinal  products,  plant  protection  products,  food,  where 
there is a clear separation between risk assessment (carried out by scientific bodies) and risk 
management (carried out by the Commission). 

Having  excluded  the  possibility  of  establishing  a  specific  body  to  be  in  charge  of  the  risk 
assessment of active substances and biocidal products, three existing bodies were considered 
as possible candidates to provide this scientific and technical support in the field of biocides: 

– 

– 

The  European  Agency  for  the  Evaluation  of  Medicinal  Products  (EMEA),  because 
the  proposal  to  authorise  certain  biocidal  products  at  the  Community  level  is 
modelled upon the lines and principles of what already exist since 1995 for medicinal 
products for veterinary and human use; 

The  European  Food  Safety  Authority  (EFSA),  because  Directive  98/8/EC  is  often 
referred to as the sister Directive of Directive 91/414/EEC regulating the placing on 
the  market  of  plant  protection  products  and  where  EFSA  is  the  official  scientific 
body in charge of preparing opinions for the Commission; and 

– 

The European Chemicals Agency (ECHA). 

Limited synergies can however be expected from the first two options. On the other hand, the 
choice  of  ECHA  is  expected  to  create  significant  synergies,  on  the  basis  of  the  following 
considerations: 

– 

– 

– 

First  and  foremost,  the  evaluation  of  active  substances  used  in  biocidal  products 
follows  many  of  the  methodologies  and  principles  that  also  apply  to  chemical 
substances.  Data  requirements  are  similar  and  the  risk  assessment  of  these 
substances, notably when they have certain hazardous properties, is even of the direct 
competence of ECHA. 

In addition, the proposal includes rules concerning data sharing for biocidal products, 
which have now been aligned on those of REACH and make mandatory the sharing 
of  data  involving  testing  on  vertebrate  animals.  Only  REACH  and  ECHA  have 
already set up the mechanisms and the databases to make such sharing possible. 

Last  but  not  least,  producers,  downstream  users  of  biocidal  products  and  even  the 
Commission already have a number of obligations under REACH. Notably, the data 
held  by  the  Commission  JRC  relating  to  active  substances  under  evaluation  in  the 

significant  resources,  which  are  currently  provided  by  the  Commission  JRC  and  financed  under  the 
LIFE + programme under budget line 07 03 07. 

EN 

178 

   EN 

 
                                                                                                                                                         
review  programme  shall  be  made  available  to  ECHA,  in  accordance  with  the 
provision of Article 16 of the REACH Regulation. 

– 

Another  important  element  of  choice  is  that  many  of  the  ECHA  scientific  staff  is 
already  familiar  with  biocidal  products,  through  previous  work  at  the  Commission 
JRC, in Member States Competent Authorities as well as in industry. 

For these reasons, it is felt that the ECHA, amongst the other options at hand - a new agency, 
the Commission JRC, the EMEA or EFSA - considered at an early stage of the process is the 
most effective one in terms of possible synergies. 

In  addition,  with  the  phasing  out  of  the  Commission  JRC  support  concerning  the  review 
programme of existing active substances announced for the end of 2013, ECHA is expected to 
take over that role from 2014 onwards.  

The  legislative  proposal  therefore  relies  on  the  assumption  that  a  number  of  tasks  of  a 
scientific and technical nature related to the assessment of active substances used in biocidal 
products and of certain biocidal products will be given to ECHA. 

To this end, financial resources are needed to ensure that ECHA has the appropriate level of 
staff  and  is  able  to  convene  as  many  meetings  as  necessary  to  deliver  its  opinions  to  the 
Commission. 

EN 

179 

   EN 

 
5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

The objectives of the proposal are to ensure a high level of protection of public health and the 
environment as well as the harmonisation of the internal market for biocidal products, while 
enhancing competitiveness and innovation. 

To achieve these objectives it is necessary that the hazards and risks from active substances 
and biocidal products are fully known before they are placed on the market. 

To ensure the efficient implementation of the proposal it is appropriate to rely on the existing 
European Chemicals Agency, which will receive and deliver opinions on data submitted by 
industry, for example, for the evaluation of active substances or certain biocidal products, and 
will  be  the  focal  point  for  providing  scientific  advice  and  assistance  to  the  Commission,  to 
Member State competent authorities, to enterprises, especially SMEs, and for making relevant 
information available to the public. 

The  harmonisation  of  the  internal  market  for  biocidal  products  and  the  enhancement  of 
competitiveness  and  innovation  will  be  strengthen  by  having  a  coherent  approach  to  the 
treatment  of  applications  submitted  by  industry,  by  simplifying  procedures  for  the 
authorisation  of  products,  and  by  encouraging  the  development  of  ‘new’  substances  and 
products  having  a  better  public  health  or  environmental  profile,  so  as  to  enable  Europe  to 
compete  better  with  its  international  competitors,  and  bring  about  the  greater  availability  of 
substances or products with lower risks. 

The objectives and indicators identified to date are as follows: 

Objectives 

Assessment  of  new  active  substances  in  view  of  their 
inclusion in Annex I of the Regulation 

Indicators for the policy 

Number of opinions delivered. 

Time  from  reception  of  a  valid  application 
transmission of opinion to the Commission. 

to 

Renewal of Annex I inclusion 

Number of opinions delivered. 

Time  from  reception  of  a  valid  application 
transmission of opinion to the Commission. 

to 

Authorisations of low-risk products 

Number of opinions delivered. 

Authorisations  of  products  containing  new  active 
substances 

Opinion  in  case  of  disagreement  during  mutual 
recognition procedures 

Time  from  reception  of  a  valid  application 
transmission of opinion to the Commission. 

to 

Number of opinions delivered. 

Time  from  reception  of  a  valid  application 
transmission of opinion to the Commission. 

to 

Number of opinions delivered. 

Time  from  reception  of  a  Commission  request  to 
transmission of opinion to the Commission. 

Tasks related to data sharing and confidentiality 

Number of searches in the database. 

Number of request for information for non-confidential 
data. 

Development  of  general  and  specific  guidance 
documents 

Number of guidance documents developed. 

EN 

180 

   EN 

 
Maintenance  of  Community  register  on  biocidal 
products 

Completion  of  the  review  programme  of  existing 
substances 

Number of searches in the database 

Number of opinions delivered. 

Time  from  reception  of  a  draft  Competent  authority 
report to finalisation of Competent authority report. 

5.4.  Method of Implementation (indicative) 

X 

Centralised Management 

X 

X 

directly by the Commission 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

X 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

(cid:133) 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

The  overall  responsibility  for  the  implementation  and  enforcement  of  the  proposed 
legislation  will  rest  with  the  Commission  services.  However,  the  scientific  and 
technical support will be provided by the European Chemicals Agency. ECHA will 
in  particular  have  to  provide  opinions  on  the  level  of  risk  presented  by  active 
substances  used  in  biocidal  products  as  well  as  on  the  authorisations  of  certain 
biocidal  products.  ECHA  will  only  provide  opinions  on  the  basis  of  which  the 
Commission will take decisions (comitology procedure). 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

In  order  to  evaluate  the  progress  of  implementation  and  effects  of  the  new  policy,  the 
indicators as set out in 5.3 will be gathered and monitored at regular intervals. For the most 
part, this will be done as part of the normal activity of ECHA on an annual basis. 

In addition to this, Member States shall submit to the Commission every three years a report on 
enforcement  and  control  measures  and  results  of  these  measures.  The  Commission  shall  also 

EN 

181 

   EN 

 
 
 
draw up a report on the implementation of the Regulation and in particular on the functioning 
of the Community authorisation procedure and mutual recognition. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

The  Impact  Assessment  carried  out  by  the  Commission  addresses  five  policy  issues  that 
require action: the extension of the scope of the Regulation to include articles and materials 
treated with biocidal products; the improvement of procedures for product authorisation with 
the  possibility  to  authorise  certain  products  at  the  Community  level;  the  introduction  of 
mandatory data-sharing at product authorisation and active substance approval stage along the 
principles of the REACH Regulation; a clarification on data requirements with a combination 
of data waiving with the use of existing information and a new approach for low-risk biocidal 
products; a partial harmonisation of fee structure to encourage the development of more new 
active substances and the retention of more existing active substances. 

6.2.2.  Measures taken following an intermediate/ex-post evaluation (lessons  learned from 

similar experiences in the past) 

The  proposal  is  also  based  on  the  conclusions  of  a  study  carried  out  in  2007  to  analyse  the 
deficiencies  of 
(available  at 
http://ec.europa.eu/environment/biocides/study.htm)  were  incorporated  in  the  Commission 
implementation  of  Directive  98/8/EC  (available  at 
report  on 
http://ec.europa.eu/environment/biocides/impl_report.htm). 

the  current  Directive.  The 

impacts  of 

this  study 

results  of 

the 

the 

6.2.3.  Terms and frequency of future evaluation 

As indicated in Section 6.1 a general report will be prepared by ECHA and submitted to the 
Commission. This information will be used by the Commission in order to prepare the report 
on the implementation of the Regulation. 

7. 

ANTI-FRAUD MEASURES  

The European Chemicals Agency has specific budgetary control mechanisms and procedures. 
These are however based on Regulation (EC, Euratom) No 2343/2002.  

The  Management  Board  of  ECHA,  which  comprises  representatives  of  the  Member  States, 
the  Commission  and  the  European  Parliament  (Article  79(1)  of  the  REACH  Regulation), 
produces an estimate of the revenue and expenditure of ECHA (Article 96(5)) and adopts the 
final  budget  (Article  96(9)).  Each  year,  the  provisional  and  final  accounts  are  sent  to  the 
European  Court  of  Auditors  (paragraphs  4  and  7  of  Article  97).  The  European  Parliament 
gives  a  discharge  to  the  Director  of  ECHA  regarding  the  implementation  of  the  budget 
(Article 97(10)).  

In  order  to  combat  fraud,  corruption  and  other  unlawful  activities,  the  provisions  of 
Regulation (EC) No 1073/1999  concerning  investigations  conducted  by  the  European  Anti-
Fraud Office (OLAF) apply without restrictions to ECHA, in accordance with Article 98(1) of 
Regulation (EC) No 1907/2006. 

In accordance with Article 98(2), ECHA is also bound by the Interinstitutional Agreement of 
May 25, 1999 concerning internal investigations by the European Anti-Fraud Office (OLAF).

EN 

182 

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8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

Type of output 

Av. 
cost 

Year 2012 

Year 2013 

Year 2014 

Year 2015 

Year 2016 

Year 2017 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

Please  refer  to  Annex 1  for  a  detailed  breakdown  of  ECHA’s  costs  and  to  Annex  2  for  the  main  underlying 
assumptions. 

1,023 

2,280 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE 
No.11ECHA 
scientific 
technical support 

and 

TOTAL COST 

EN 

183 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year 
2012 

Year 
2013 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Officials or 
temporary 
staff66 (XX 
01 01) 

A*/AD 

B*, 
C*/AST 

Staff  financed67  by  art. 
XX 01 02 

Other staff68 financed by 
art. XX 01 04/05 

TOTAL 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

No additional staff will be necessary. Additional resources will however be required 
to  cover  participation  in  meetings  held  in  ECHA  and  for  the  organisation  of  an 
increased number of meetings of the Standing Committee on Biocidal Products (see 
8.2.6). 

8.2.2.  Description of tasks deriving from the action 

Not applicable. 

8.2.3. 

Sources of human resources (statutory) 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

66 
67 
68 

Cost of which is NOT covered by the reference amount 
Cost of which is NOT covered by the reference amount 
Cost of which is included within the reference amount 

EN 

184 

   EN 

 
 
 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

Technical 

1 
and 
assistance (including related staff costs) 

administrative 

Executive agencies 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

Total  Technical  and  administrative 
assistance 

EUR million (to 3 decimal places) 

Year 
2012 

Year 
2013 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017  

and 
later 

TOTAL 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

EUR million (to 3 decimal places) 

Type of human resources 

Year 
2012 

Year 
2013 

Year 
2014 

Year 
2015 

Year 
2016 

Officials  and  temporary  staff 
(XX 01 01) 

- 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

Year 
2017  

and later 

- 

- 

- 

EN 

185 

   EN 

 
 
 
 
 
8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
2012 

Year 
2013 

Year 
2014 

Year 
2015 

Year 
2016 

07 01 02 11 01 – Missions 

0,024 

0,024 

07 01 02 11 02 – Meetings & Conferences 

- 

0 

07 01 02 11 03 – Committees  

0,180 

0,180 

07 01 02 11 04 – Studies & consultations 

07 01 02 11 05 - Information systems 

- 

- 

0 

0 

2 

Total 

Other  Management 

0,204 

0,204 

Expenditure (XX 01 02 11) 

3  Other 

expenditure 

- 

0 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

- 

- 

- 

- 

- 

- 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

0,204 

0,204 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

Year 
2017 

and 
later 

- 

- 

- 

- 

- 

- 

- 

TOTAL 

0,048 

0 

0,360 

0,408 

0 

0,408 

Calculation - Other administrative expenditure not included in reference amount 

20 2-day missions to Agency per year at 1200 EUR per mission 

Standing Committee on Biocidal Products: 6 one-day meetings per year at 30.000 EUR/meeting 

The needs for human and administrative resources shall be covered within the allocation that 
can be granted to the managing DG in the framework of the annual allocation procedure in the 
light of budgetary constraints. 

EN 

186 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 1 

Draft Budget for the European Chemicals Agency (in Euros) 

Tasks related to biocidal products 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

Expenditure 

Title1 

Salaries & allocations 

Other personnel costs 

578,600 

1,959,800 

3,680,700 

4,240,600 

4,157,700 

4,157,700 

4,032,400 

4,320,800 

4,358,000 

4,285,900 

19,300 

157,200 

315,700 

362,900 

362,900 

362,900 

362,900 

377,300 

384,600 

384,600 

Total Title 1 

597,900 

2,117,000 

3,996,400 

4,603,500 

4,520,600 

4,520,600 

4,395,300 

4,698,100 

4,742,600 

4,670,500 

Title 2 

Rental of building and associated costs 

Information & communication technology 

Movable property and associated costs 
Current administrative expenditure 
Postal charges and telecommunication 
Expenditure  on  meetings  other  than  those 
covered under Title 3 

69,200 

23,800 

4,900 
4,900 
2,900 

234,500 

80,700 

16,700 
16,500 
9,700 

440,500 

151,500 

31,300 
30,900 
18,200 

507,500 

174,500 

36,100 
35,600 
21,000 

497,500 

171,100 

35,400 
34,900 
20,600 

497,500 

171,100 

35,400 
34,900 
20,600 

482,600 

166,000 

34,300 
33,900 
19,900 

517,100 

177,800 

36,800 
36,300 
21,400 

521,500 

179,400 

37,100 
36,600 
21,500 

512,900 

176,400 

36,500 
36,000 
21,200 

400 

1,400 

2,600 

3,000 

2,900 

2,900 

2,800 

3,100 

3,100 

3,000 

Total Title 2 

106,100 

359,500 

675,000 

777,700 

762,400 

762,400 

739,500 

792,500 

799,200 

786,000 

Title 3 
Development  of  databases  and  software 
tools  related  to  the  operation  of  biocidal 
products related activities 

300,000 

300,000 

Evaluation activities 

Information and publications 

Helpdesk services 

Studies and Consultants 

Mission expenses 

Technical training of staff and stakeholders 
Meetings  of  the  Committee  on  biocidal 
products and subgroups 

Fees paid back to Evaluating Member State 

Fees paid back to rapporteurs 

2,100 

1,400 

8,000 

1,600 

3,500 

2,400 

0 

0 

0 

7,900 

5,300 

29,600 

5,900 

12,800 

83,700 

15,200 

10,300 

57,100 

11,400 

24,700 

96,000 

17,500 

11,800 

65,500 

13,100 

28,300 

93,500 

17,000 

11,500 

63,800 

12,800 

27,600 

93,500 

17,000 

11,500 

63,800 

12,800 

27,600 

91,000 

16,600 

11,200 

62,000 

12,400 

26,900 

95,100 

17,300 

11,700 

64,800 

13,000 

28,100 

93,500 

17,000 

11,500 

63,700 

12,700 

27,600 

91,900 

16,700 

11,300 

62,700 

12,500 

27,100 

8,900 

17,100 

19,600 

19,100 

19,100 

18,600 

19,400 

19,100 

18,800 

707,200 

707,200 

707,200 

707,200 

707,200 

707,200 

707,200 

707,200 

707,200 

2,520,000 

2,758,600 

2,877,300 

3,115,900 

3,373,700 

3,631,500 

4,215,800 

4,646,400 

4,885,000 

326,000 

328,400 

324,800 

327,200 

330,400 

333,600 

350,400 

360,800 

363,200 

Total Title 3 

319,000 

3,923,600 

4,013,700 

4,161,100 

4,395,600 

4,656,600 

4,911,000 

5,522,800 

5,959,500 

6,196,400 

Total 

Revenues 

1,023,000 

6,400,100 

8,685,100 

9,542,300 

9,678,600 

9,939,600  10,045,800  11,013,400  11,501,300  11,652,900 

Community subvention 

Fee income of agency 

Over income to next year 

1,023,000 

2,280,100 

3,941,100 

4,294,300 

3,806,600 

3,411,600 

2,861,800 

2,629,400 

2,173,300 

1,700,900 

0 

0 

4,120,000 

4,744,000 

5,248,000 

5,872,000 

6,528,000 

7,184,000 

8,384,000 

9,328,000 

9,952,000 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Total 

1,023,000 

6,400,100 

8,685,100 

9,542,300 

9,678,600 

9,939,600  10,045,800  11,013,400  11,501,300  11,652,900 

EN 

187 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
  
ANNEX 2 

Applied methodology and main underlying assumptions for the financial model of the 
European Chemicals Agency for activities relating to biocides 

Computation of staff costs 

Due to the fact that the Commission JRC in Ispra currently has a major role in operating the 
review programme of substances used in biocidal products established by Directive 98/8/EC, 
significant  experience  exists  with  regard  to  how  long  certain  tasks  take  and  what  kind  of 
resources are needed in order to carry them out (differentiation between different categories 
of staff). 

Based  on  this  experience  and  on  the  model  developed  for  the  operation  of  REACH,  a  staff 
model has been developed for the operation of the activities related to biocides. The output of 
this staff model is how many staff (by grade) are required in a given year to fulfil the tasks of 
ECHA (operational tasks of the biocides legislation).  

To these staff numbers additional resource requirements have been added for the management 
and training of these resources, taking into account economies of scale that can be achieved in 
particular in support tasks and staff from existing arrangements set up for the implementation 
of  the  REACH  Regulation  (e.g.  for  international  relations,  for  external  communication, 
helpdesk services, the Legal Department, Audit and Internal Control, Human Resources (HR), 
Finance,  Information  Technology  (IT)  Building  Management).  Based  on  the  current  ECHA 
staff  ratio,  these  additional  resources  amount  to  20%  of  those  required  for  the  operational 
tasks related to the biocidal legislation. 

For  the  scientific  staff,  the  ratio  in  %  of  AD  and  AST  grades  is  in  compliance  with  the 
REACH  staff  model.  As  is  the  case  for  staff  carrying  out  REACH  related  tasks,  a  higher 
number of AD than AST staff is justified because of the complexity of the scientific tasks. 

For  2012,  it  is  proposed  that  ECHA  should  be  able  to  recruit  staff  to  prepare  the  grounds 
before the date when ECHA tasks relating to biocidal products come into operation.  

From 2013, ECHA would then be responsible for the different tasks set out in the proposal. 

From  2014,  the  responsibility  of  coordinating  the  review  programme  of  existing  substances 
would  be  transferred  from  the  Commission  JRC  to  ECHA  (cf.  Article  71  of  the  proposal). 
ECHA  would  therefore  need  extra  resources  to  carry  out  this  additional  task.  Based  on  the 
current assumptions, ECHA would require 10 additional scientific officers to carry that task 
(3 of whom could already be recruited in the last quarter of 2013 to prepare the activities and 
ensure a smooth hand-over). However, as the review programme is expected to be completed 
within 4 to 5 years afterwards, this additional task could be carried out in part via contractual 
staff to limit the impact on the establishment plan. 

Annex 3 sets out the proposed establishment plan related to this proposal. The budget set out 
in Annex 1 takes into account permanent / temporary staff (i.e. that appear in establishment 
plan) and contract agents (count for staff costs but do not appear in establishment plan). 

EN 

188 

   EN 

 
 
 
 
All the resources computed have been multiplied by the average annual cost by grade and that 
has led to the total staff costs. In addition, the weighting factor for Helsinki (119.8% – cost of 
living adjustment applicable to all staff) has been applied. 

The other personnel costs in  Title 1 have been assumed to represent 10% of salary costs of 
permanent / temporary staff. 

Applied average costs for permanent/temporary staff by grade per annum (source ECHA) 

Grade 

AD 13 
AD 12 
AD 5-11 
AST 7-11 
AST 1-6 

Salary 
187,472 
175,575 
114,264 
103,973 
112,189 

Applied average costs for contract agents by function group per annum (source ECHA) 

Grade 

Salary 

FG IV 
FG III 
FG II 
FG I 

72,139 
52,674 
39,836 
34,747 

For the purpose of the computation of the staff required it has been assumed that per year the 
following resources would be needed: 

– 

– 

– 

– 

a desk officer per 10 applications for product authorisation; 

a desk officer per 10 applications for substance evaluation 

a desk officer per 30 applications to amend an existing product authorisation 

a  desk  officer  per  20  opinions  requested  in  case  of  disagreement  during  Mutual 
Recognition 

Computation of building, equipment and miscellaneous operating expenditure: 

All  building,  equipment,  furniture,  IT  and  other  administrative  expenditure  have  been 
computed based on the number of required staff multiplied by average cost figures per person 
based on the current Agency budget. 

Operating expenditure: 

Major cost items in this area are general operating expenditures and all expenditure related to 
the Committee for Biocidal Products. 

The  major  cost  driver  for  the  general  operating  expenditure  is  the  expenditure  for  the 
Committee  for  Biocidal  Products  and  the  fees  paid  back  to  the  Competent  Authorities  in 
charge of the scientific evaluation. 

EN 

189 

   EN 

 
 
 
 
 
 
For  the  Committee  for  Biocidal  Products  and  its  experts  groups,  the  costs  include  the 
to  currently  applicable 
reimbursement  of 
Commission rates. 

travel,  hotel,  daily  allowances  according 

It has also been assumed for the purpose of the computation of ECHA expenses, that 60% and 
5%  of  the  fee  paid  to  ECHA  would  be  paid  back  to  the  Competent  Authorities  and  the 
Rapporteur in charge of the scientific evaluation respectively. 

This represents only an hypothesis and is therefore provisional and without prejudice to 
ECHA’s decision in this matter. 

Computation of expected fee income: 

It  is  assumed  that  ECHA  will  have  a  very  simple  fee  structure  for  tasks  related  to  biocidal 
products.  

For the purpose of the computation of the expected fee income it has been assumed that: 

– 

– 

– 

– 

Fees for inclusion of an active substance in Annex I amount to EUR 400,000 

Fees  for  renewal  of  Annex  I  inclusion  amount  to  EUR  40,000  when  a  thorough 
evaluation is required but can be reduced to 10,000 when this is not the case. 

Fees for product authorisation amount to EUR 100,000 for products containing new 
active substances, to EUR 80,000 for low-risk products. 

Annual fees amount to EUR 20,000 

The  amounts  of  fees  above  were  calculated  on  the  basis  of  the  average  value  of  the  fees 
charged by the Member States. 

As noted in the impact assessment, there are however differences in the structure and level of 
fees from one Member State to another:  

Fees  charged  for  the  evaluation  of  active  substances  vary  from  €10,000  to  €356,000  per 
substance (Figure 1) 

Fees  for  the  authorisation  of  biocidal  products  range  from  €626  to  €85,500  per  biocidal 
product (Figure 2). 

EN 

190 

   EN 

 
Figure 1: Member States Fees and Fee Ranges for Active Substance Evaluation 
(Fee in Thousand EURO – Vertical lines indicate Member State Fee Ranges) 

Figure 2: Member States Fees and Fee Ranges for Product Authorisation 
(Fee in Thousand EURO – Vertical lines indicate Member State Fee Ranges) 

These  fees  will  however  have  to  be  established  by  a  separate  Fee  Regulation  (Commission 
Regulation).  In  that  context  it  will  be  necessary  to  establish  the  fee  structure  that  allows 
certain reduction for SMEs as foreseen in the proposal.  

The rates of fees and the structure outlined above represent only one hypothesis and are 
therefore provisional and without prejudice to the Commission’s decision in this matter. 

The  corresponding  revenues  were  calculated  based  on  a  certain  number  of  procedures  per 
year. 

– 

– 

EN 

Evaluation of new active substances: 5/year 

Authorisation of products based on new active substances: 4/year 

191 

   EN 

 
 
 
– 

– 

Authorisation of low risk biocidal products: 20/year 

Amendments of Community authorisations: 0,5/year/product authorised. 

EN 

192 

   EN 

 
ANNEX 3 

ESTABLISHMENT PLAN 

Additional staff to carry out activities related to biocidal products 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

AD 13 

AD 12 

AD 5-11 

AST 7-11 

AST 1-6 

0 

1 

1 

0 

0 

1 

2 

8 

3 

4 

1 

3 

1 

3 

1 

3 

1 

3 

1 

3 

1 

3 

1 

3 

1 

3 

15 

15 

15 

15 

15 

15 

15 

15 

4 

7 

4 

7 

4 

7 

4 

7 

4 

7 

5 

8 

5 

8 

5 

8 

Overall 

2 

18 

30 

30 

30 

30 

30 

32 

32 

32 

EN 

193 

   EN