Report from the Commission to the Council and the European Parliament - Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18(5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive
Date: 2008-10-08
Institutions: European Commission
Subjects: chemical product, market approval, marketing, plant health product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.10.2008 
COM(2008) 620 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

Evaluation of the implementation of Directive 98/8/EC concerning the placing of 
biocidal products on the market (submitted in accordance with Article 18(5) of the 
Directive) and progress report on the work programme referred to in Article 16(2) of 
the same Directive 

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REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

Evaluation of the implementation of Directive 98/8/EC concerning the placing of 
biocidal products on the market (submitted in accordance with Article 18(5) of the 
Directive) and progress report on the work programme referred to in Article 16(2) of 
the same Directive 

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1. 

INTRODUCTION 

Directive 98/8/EC of the European Parliament and the Council, adopted on 16 February 1998, 
regulates  the  placing  of  biocidal  products  on  the  EU  market.  It  sets  out  a  Community 
harmonised system for the authorisation and placing on the market of biocidal products; for 
the  mutual  recognition  of  these  authorisations  within  the  Community;  and  for  the 
establishment at Community level of a positive list of active substances which may be used in 
biocidal products. It aims to ensure a high level of protection for human and animal health and 
for the environment.  

Among other actions, the Directive established a 10-year work programme for the systematic 
examination of the active substances used in biocidal products that were present on the market 
before  its  entry  into  force  (14  May  2000).  During  this  10-year  period,  Member  States  may 
continue to apply their structures for the placing of biocidal products on the market.  

Before  the  Directive  came  into  force,  many  Member  States  did  not  have  in  place  full 
legislative regimes for these products. In the past eight years, the active substances being used 
have been systematically inventoried, and a programme for the evaluation of these substances 
has been set up. As a consequence of the implementation of the Directive, active substances 
that were of marginal use, along with a number that had unfavourable environmental or health 
profiles have been removed from use.  A process of assessment of  the  active substances has 
been set up, with a rigorous system of peer review. This extensive body of work has now laid 
the groundwork for the evaluation of the remaining active substances over the next years, and 
for  the  product  approval  stage  over  the  next  decade.  The  report  identifies  a  number  of 
provisions of the Directive that require attention in the forthcoming revision of the Directive. 

2. 

CONTEXT OF THE REPORT 

Article 16(2) of the Directive requires the Commission to forward to the European Parliament 
and Council a report on the progress achieved with the review programme no later than two 
years  before  its  scheduled  completion.  Article  18(5)  requires  the  Commission  to  draw  up  a 
report  on  the  implementation  of  the  Directive,  and  in  particular  on  the  functioning  of  the 
simplified procedures, seven years after the entry into force of the Directive. In the interests of 
efficiency, the Commission has decided to present its conclusions on the implementation of 
the Directive and on the progress of its review programme in the form of a joint report. 

For  the  preparation  of  this  report,  a  study  on  the  implementation  of  the  Directive  was 
commissioned. This study was prepared on the basis of an extensive stakeholder consultation. 
In  addition,  a  separate  study  had  previously  been  commissioned  on  the  specific  issue  of 
articles treated with biocides1. 

The conclusions of the present report also draw on facts and figures from the composite report 
required  under  Article  24  of  the  Directive,  based  on  information  supplied  by  the  Member 
States.  

1 

Both studies available at: http://ec.europa.eu/environment/biocides/study.htm  

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The  aim  of  the  present  report  is  to  inform  the  other  Community  Institutions,  the  Member 
States and the public about the implementation of the Directive and the review programme in 
particular, over the period from 14 May 2000 to 1 March 2008. It has to be noted, however, 
that  the  implementation  of  a  significant  part  of  the  Directive's  provisions  has  not  started. 
Notably, there have been no authorisations of biocidal products yet.  

The  report  includes  the  situation  in  the  10  Member  States  who  joined  the  EU  on  1  January 
2004, but does not cover the situation in Bulgaria or Romania. 

3. 

IMPLEMENTATION  OF  THE  DIRECTIVE  -  THE  REVIEW  PROGRAMME  FOR  ACTIVE 
SUBSTANCES 

Following the adoption of the Directive, the Commission and the Member States embarked on 
a  programme  of  work  with  the  aim  of  systematically  examining  the  risks  associated  with 
active substances that may be authorised for use in biocidal products.  

The programme has been set up under a Commission Regulation2 which laid down the rules 
for the first phase of the review of active substances. During this phase, the industry had to 
identify the active ingredients they used in their products, and if they wished to continue using 
them  for  biocidal  purposes,  to  notify  them  for  evaluation  by  providing  initially  a  limited 
dossier with information on the substances.  

At the end of this exercise, another Commission Regulation3 was adopted on the second phase 
of  the  review  programme,  drawing  up  an  inventory  of  the  identified  existing  active 
substances; a timetable for the evaluation of the notified substances; a list of the designated 
Rapporteur  Member  States  for  the  first  two  priority  lists;  and  provisions  regarding  the 
procedural aspects of the review programme.  

The  second  Commission  Regulation  was  subsequently  amended4  to  designate  Rapporteur 
Member States for the two remaining priority lists, as well as to address certain other issues 
that arose during the implementation, such as the possibility to grant temporary derogations 
for  active  substances  that  were  not  scheduled  for  evaluation,  but  the  use  of  which  is 
considered essential for one or more Member States. 

In  parallel  to  developing  the  regulatory  framework  for  the  review  of  active  substances,  the 
Commission  has  produced  and  agreed  with  the  Member  States  a  significant  number  of 
publicly  available5  comprehensive  guidance  documents,  to  assist  the  Member  States  and 
industry with their tasks.  

2 

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Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme 
referred  to  in  Article  16(2)  of  Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council  on 
biocidal products (OJ L 228, 8.9.2000, p. 6.) 
Commission Regulation (EC) No 2032/2003 of 4 November 2003 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 the 
Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 
1896/2000. 
By  Commission  Regulations  (EC)  n°  1048/2005  and  1849/2006.  Regulation  2032/2003  was  repealed 
and  replaced  by  Commission  Regulation  (EC)  n°  1451/2007  (mostly  for  simplification  and 
consolidation purposes). 
Available on: http://ec.europa.eu/environment/biocides/index.htm and http://ecb.jrc.it/biocides/  

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3.1. 

Progress made under the review programme to date 

At  the  end  of  the  first  phase  of  the  review  programme,  the  industry  had  identified  964 
substances as active ingredients of biocidal products that were present on the market before 
14  May  2000.  Of  these,  416  active  substances  were  notified  for  evaluation  in  one  or  more 
product-types.  548  (about  60%)  of  the  identified  substances  were  not  supported  and  were 
subsequently phased-out by 1 September 2006. Based on the results of the study referred to in 
chapter  2,  it  is  estimated  that  these  active  substances  were  used  in  only  13%-33%  of  the 
biocidal  products  on  the  market.  Some  of  these  active  substances  were  no  longer  used  in 
biocides, while others were not supported due to their unfavourable toxicity profile. In some 
cases,  they  were  addressing  a  limited  market  that  would  not  permit  to  cover  the  evaluation 
cost. The preparatory work for this report did not identify any cases where the loss of these 
active  substances  left  users  without  a  substitute,  or  led  to  the  proliferation  of  the  target 
harmful  organisms,  but  those  risks  can  not  be  fully  excluded.  On  the  other  hand,  the 
withdrawal  of  certain  substances  of  known  high  toxicity  is  a  clear  beneficial  effect  of  the 
review programme. 

By  1  March  2008,  half  of  the  initially  notified  active  substance/product-type  combinations 
have been withdrawn from the review programme (see Figure 1). 
Figure 1: Active substance/PT combinations initially notified and eventually supported by the industry6  

180

160

140

120

100

80

60

40

20

0

Notified

In review

8 14 16 18 19 21 1 2 3 4 5 6 13 7 9 10 11 12 15 17 20 22 23

This may be explained by the fact that some active substances were notified without a serious 
intent  to  submit  the  full  dossier  for  evaluation;  others  were  notified  for  too  many  product-
types, and for some it became apparent during the course of dossier preparation or evaluation 
that the cost would be higher than initially expected. 

As the finalisation of the evaluation of active substances has only recently begun, Annex I to 
the Directive currently lists only a small number of active substances. Annex IA contains one 
approved active substance.  

6 

The order of the PTs in figure 1 follows the order of evaluation. For substances of the 4th priority list 
(i.e. for product-types 7, 9, 10 to 12, 15, 17, 20, 22 and 23) a drop off of 50% has been assumed on the 
basis of the experience of submission rated for the previous priority lists. 

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3.2. 

Ongoing work under the review programme 

The original timetable of the review programme was based on the assumption that two years 
would suffice from submission of the dossier by the participant to adoption of a decision on 
the inclusion of an active substance. In practice this proved impossible to achieve, given the 
timelines  set  out  in  the  Directive,  and  those  imposed  by  procedural  requirements  for 
implementing  measures.  No  active  substance  has  been  evaluated  to-date  in  less  than  three 
years and the average period of evaluation seems to be closer to approximately  four to  five 
years so far.  

Furthermore, it should be noted that the review Regulation gives the possibility to take over 
the  role  of  participant  to  support  an  active  substance  for  which  all  initial  notifiers  have 
withdrawn. In such cases, a new deadline is set for the person taking over, in order to compile 
and  submit  a  complete  dossier.  This  process  gives  a  second  chance  to  have  an  active 
ingredient  evaluated  and  available  on  the  market,  but  can  stretch  the  time  needed  for  the 
review to five years or more. 

Several  factors  can  be  noted  as  reasons  for  the  slower  than  scheduled  pace  of  the  review 
programme: technical complexity of the work; insufficient human resources; in certain cases, 
lack  of  experience  with  dossier  preparation  and  dossier  evaluation;  the  need  to  develop 
appropriate  testing  methodologies  and  exposure  scenarios  for  a  wide  range  of  uses;  overly 
optimistic  timeframe  for  the  review,  considering  the  significant  number  of  active 
substance/product type combinations that were subsequently notified.  

It is estimated – taking into consideration the progress rate with the review programme so far 
- that the last decisions on the remaining active substances will be taken only in 2014. Annex 
1 sets out the anticipated timing for the remaining work. 

Lastly,  it  has  to  be  noted  that  Article  16(3)  of  the  Directive  does  not  specify  a  particular 
period of time for the preparation of biocidal product dossiers following the inclusion of an 
active substance into Annex I or IA, the submission of product authorisation applications to 
the Member States, and for granting, modifying, or cancelling product authorisations on the 
basis  of  the  evaluation  of  the  submitted  dossiers.  This  stage  is  however  essential  for 
harmonisation and the achievement of the biocides internal market and also prolongs the time 
requirements in the transitional period.  

4. 

IMPLEMENTATION OF THE DIRECTIVE - SIMPLIFIED PROCEDURES  

In addition to Annex I covering 'standard' active substances, the positive list of the Directive 
comprises two further Annexes, Annex IA and IB. Annex IA is for active substances that have 
a  low  toxicity  and  ecotoxicity  profile,  and  therefore  may  be  used  in  'low-risk'  biocidal 
products. Annex IB lists 'basic substances', or 'commodities', that is, substances which are not 
primarily marketed for biocidal purposes, but that nevertheless have a certain biocidal action. 

4.1. 

Low risk products 

The  possibility  of  lower  data  requirements  with  regard  to  the  biocidal  product  dossier,  and 
shorter deadlines for registration and mutual recognition presents a substantial benefit to the 
companies marketing biocidal products.  

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However, for the producers of active substances, there is no real benefit in the inclusion of an 
active substance in Annex IA instead of Annex I. This is due to the fact that, initially the same 
amount of data has to be submitted for all active substances. In particular, the same  studies 
have  to  be  generated  and  submitted  for  the  evaluation  of  active  substances  that  are  of 
recognised concern, as for those that are generally considered to be of low risk. It is only after 
the evaluation that it is decided whether an active substance can be included in Annex IA or in 
Annex I. 

4.2. 

Basic substances 

So far, there has been no request by the industry or the Member States to include an active 
substance into Annex IB. There appear to be two main reasons: whilst the amount of data – 
and therefore, expense - necessary to compile a basic active substance dossier is the same as 
for  a  'regular'  substance,  ownership  of  these  data  is  not  protected  by  the  Directive. 
Furthermore,  the  only  advantage  of  this  simplified  procedure,  which  is  that  no  marketing 
authorisation  or  registration  is  needed  for  products  containing  basic  substances,  is 
counteracted by the prohibition to market them directly for biocidal use.  

4.3. 

Frame formulations 

A frame formulation contains specifications for a group of biocidal products, which present 
minor  variations  with  regard  to  a  reference  product.  As  the  first  authorisations  of  biocidal 
products are not expected to be issued before 2009, no frame formulations have been created 
yet in practice. It appears, however, that several Member States already apply the principle of 
this  simplified  procedure  in  their  existing  national  systems,  by  reducing  the  administrative 
requirements when an application for authorisation concerns the same product in a range of 
different  colours.  The  study  referred  to  in  section  2  concluded  that  the  concept  behind  this 
simplified procedure has the potential to deliver genuine benefits, but that greater clarification 
on what is covered and how it will operate is needed. 

5. 

IMPLEMENTATION OF THE DIRECTIVE – OTHER ISSUES 

5.1. 

The scope of the Directive 

During  implementation,  a  number  of  issues  have  arisen  in  relation  to  exact  scope  of 
application  of  the  Directive.  One  such  issue  that  needs  to  be  addressed  concerns  treated 
articles.  Articles  that  are  treated  with  biocidal  products  in  order  to  protect  them  from 
deterioration,  which  have  no  external  biocidal  effect,  nor  are  they  marketed  as  a  biocidal 
product,  are  currently  outside  the  scope  of  the  Directive.  When  the  treatment  takes  place 
within the EU there is no particular problem, because the supply of the biocide to the operator 
that treats the articles counts as placing on the market and can be regulated. However, the case 
is different when the articles are treated in third countries and are then imported into the EU 
(e.g.  treated  wood  or  textiles).  They  may  have  been  treated  with  substances  found 
unacceptable for human health or for the environment and banned or severely restricted in the 
EU.  This  situation  presents  risks  for  human  health  and  the  environment,  and  could  be 
discriminatory to European industry. 

Other scope questions concerned the exact delineation of products that could also be covered 
by  other  Community  Directives  (i.e.  Veterinary  Medicinal  Products,  Cosmetic  Products)  or 
whether  certain  substances  generated  in-situ  are  covered  or  not,  and  there  was  general 

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agreement  that  active  substances  that  are  also  food  or  feed  (e.g.  pepper  used  as  a  repellent, 
sugar or juices used as attractants in traps) should be exempted from the Directive.  

5.2. 

Data protection and data sharing 

While  Article  13  of  the  Directive,  and  several  other  of  its  provisions,  clearly  encourage 
applicants  to  co-operate  in  compiling  the  necessary  information  for  the  evaluation  of  active 
substances  or  biocidal  products,  it  does  not  provide  explicitly  for  mandatory  sharing  of 
information that is required for the purposes of the Directive. Instead, the owner of the data 
may  decide  –  but  is  not  obliged  –  to  give  a  subsequent  applicant  the  right  to  refer  to 
information they have submitted to a competent authority by providing them with a 'letter of 
access'.  Whenever  an  agreement  cannot  be  reached  between  the  owner  of  the  data  package 
and the other applicant, the latter may be either obliged to duplicate the studies (particularly 
undesirable  where  animal  studies  are  concerned),  or  to  abandon  the  market  until  such  time 
that all relevant data protection periods have expired.  

At the current stage of the review programme, it is estimated that on a total of 472 dossiers 
submitted  in  support  of  the  inclusion  of  an  active  substance/product-type  combination, 
approximately 25% of these dossiers were submitted either by a consortium or task force of 
enterprises or at least two enterprises that joined efforts. In 10% of the cases more than one 
dossier was submitted for the same active substance/product-type combination, which means 
that the interested parties did not manage to come to an agreement to share data and submit a 
collective dossier. 

Another  issue  that  was  raised  repeatedly  by  the  industry  is  on  companies  that  continue  to 
market  products  containing  active  substances  which  are  being  evaluated  under  the  review 
programme, without having themselves notified or in contributed to the cost of the evaluation 
(the so-called 'free-riders').  

5.3. 

Fees applied by the Member States 

Article  25  of  the  Directive  provides  that  the  Member  States  are  responsible  for  establishing 
fees to be paid by the persons placing, or seeking to place biocidal products on the market, in 
order to recover the administrative cost related to the procedures of the Directive. As a result, 
the systems and fees established are widely disparate throughout the EU. As an example, the 
fee for evaluating an active substance dossier with regard to one product-type (i.e. type of use) 
may range from € 50,000 to € 350,000; the paymen
t mode may also differ significantly from 
one Member state to another. This creates an inequitable situation for the biocides industry, in 
particular for the participants in the review programme, who have no choice of the Member 
State that will examine their active substance dossier.  

5.4. 

Data requirements 

The  substantial  requirements  of  the  Directive  in  terms  of  toxicity  and  ecotoxicity  studies 
guarantee  a  high  level  of  protection  for  human  and  animal  health  and  for  the  environment. 
However, since the Directive does not distinguish between active substances when it comes to 
data  requirements,  these  have  been  perceived  as  excessive  for  certain  substances  that  are 
generally considered to be of low risk. Although the possibility to waive data requirements is 
provided  for  under  the  Directive,  the  application  of  this  principle  seems  to  be  applied 
unevenly  by  the  Member  States.  This  has  led  to  different  approaches  and  hence  a  risk  of 
inequality of treatment.  

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5.5. 

Product authorisation and mutual recognition 

Product  authorisation  in  the  Member  States,  following  inclusion  of  an  active  substance  in 
Annex I or IA, and mutual recognition have not yet begun in any significant way. However, a 
Mutual Recognition Facilitation Group has been set up with Member States and stakeholders, 
in order to smooth the working of the product authorisation stage, and anticipate issues with 
the mutual recognition of authorisations and registrations in particular. 

6. 

IMPACT OF THE DIRECTIVE ON THE MARKET AND IN PARTICULAR ON SMES 

While  it  is  premature  to  assess  the  full  impact  of  the  Directive  on  the  biocidal  products 
market, some trends have been observed which allow some initial conclusions to be drawn.  

Based  on  the  results  of  the  identification  and  notification  exercise,  presented  as  Annexes  to 
Commission Regulation (EC) n° 2032/2003, it appears that 60% of the active substances used 
in biocidal products before 2000 were not supported for evaluation and had to be taken off the 
market by 1 September 2006. The percentage of active substances that will disappear from the 
market  by  the  end  of  the  review  programme  will  probably  be  even  higher,  given  that  for 
almost  50%  of  the  initially  notified  active  substance/product  type  combinations  no  dossier 
was submitted. However, a part of these substances that were not supported by the industry 
(from  the  start,  or  later),  were  apparently  no  longer  in  use  or  had  few  chances  of  being 
included in the Directive's positive list, in view of their unfavourable toxicity profile. 

Still, for a number of substances the criterion for not supporting their inclusion was evidently 
financial: the expected profits would never cover the cost of a dossier. In this context, bigger 
companies fared better than SMEs.  

So far eight dossiers in support of the inclusion of new active substances have been submitted 
to  the  Member  States  for  evaluation.  Of  these,  five  were  accepted  as  complete.  It  has  been 
argued that the high cost and resource implications of substance evaluation under the Biocides 
Directive  may  discourage  investments  in  biocidal  products  with  new  active  substances  and 
potentially  better  human  health  or  environmental  profiles,  especially  in  'niche  markets'.  The 
Directive currently provides for an additional five years of data protection and the possibility 
of  a  provisional  product  authorisation  as  the  only  incentives  for  the  development  of  new 
active substances.  

7. 

IMPACT OF THE DIRECTIVE ON THE ENVIRONMENT AND PUBLIC HEALTH 

The  Directive  has  laid  down  for  the  first  time  a  framework  allowing  for  a  comprehensive 
assessment  of  all  active  substances  and  biocidal  products.  The  available  knowledge  and 
control of biocidal products has been significantly improved across the EU, and particularly in 
those  Member  States  that  did  not  have  any  existing  systems,  or  where  only  a  part  of  all 
biocides  was  covered.  As  a  direct  result  of  identifying  and  starting  to  evaluate  the  biocides 
that  were  on  the  EU  market,  a  number  of  obsolete  products  have  been  removed,  thereby 
improving the level of knowledge about the chemicals that are being used. In addition to this, 
some  active  substances  with  highly  hazardous  profiles  (strychnine,  arsenic  compounds, 
tributyltin compounds, or certain ozone depleting substances, for example), have been taken 
off the EU biocides market, which represents a clear environmental and health benefit.  

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8. 

CONCLUSIONS AND PROPOSALS FOR THE REVISION OF THE DIRECTIVE 

The  Directive  has  set  the  foundations  for  improving  the  level  of  environmental  and  public 
health  protection  offered  to  EU  citizens  in  relation  to  biocidal  products.  During  a  five  year 
effort before the effective start of the active substance review in 2004, the Commission, in co-
operation  with  the  Member  States  and  industry  have  inventoried  the  European  biocides 
market  and  put  into  place  a  structured  procedure  for  the  assessment  and  evaluation  of  the 
existing active substances. Although it has not been possible to meet the time lines originally 
envisaged for the review of the existing active substances, progress has been similar to if not 
faster  than  other  comparable  regulatory  systems,  such  as  for  plant  protection  products 
(Directive 91/414/EEC) or existing chemical substances (Regulation (EC) n° 793/93). 

8.1. 

The future of the review programme up to and beyond 2010 

As set out in section 2.2, it has become clear that the review programme will not be finalised 
by the date originally set, that is, 14 May 2010, which also happens to be the date by which 
the  national  rules  for  the  placing  on  the  market  of  biocidal  products  will  cease  to  apply. 
Allowing  the  transitional  period  to  elapse  without  completing  the  review  programme  for 
active  substances  would  mean  that  the  harmonised  rules  of  the  Directive  about  product 
authorisation could not apply for all the biocidal products already on the market. If neither set 
of rules – harmonised or national – could apply, there would be a legal void with regard to the 
placing on the market of biocidal products. This could have negative effects on public health 
(important  biocidal  products  withdrawn  from  the  market),  and  would  have  severe  adverse 
economic effects on all companies operating in the biocides sector. 

Therefore, this Communication is accompanied by a proposal for the revision of the Directive 
that  would  extend  the  review  programme,  the  transitional  period,  and  certain  provisions  on 
data protection that accompany this period for an additional three years.  

This will allow time for the substantive revision of the Directive to come into force and to set 
out  an  approach  to  the  remaining  elements  of  the  review  programme  that  will  ensure  the 
timely and effective conclusion of this work. 

8.2. 

The substantive revision of the Directive 

A  proposal  for  the  substantive  revision  of  the  Directive  will  follow  later  in  2008.  It  will 
address the issues raised in sections 4 to 6 of this report.  

The Commission is currently considering a range of measures to address the issues identified, 
such as: 

– 

– 

– 

– 

– 

the simplification and adaptation of the scope of the Directive;  

a  tiered  approach  to  data  requirements  that  will  take  proportionality  into 
consideration; 

a simplification of the data protection rules, including some mandatory data-sharing;  

greater harmonisation or co-ordination of fee structures;  

improvement of the simplified procedures,  

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– 

– 

measures  to  facilitate  complying  with  the  Directive  for  SMEs,  and  measures  to 
encourage innovation; 

measures  to  improve  the  internal  market  in  biocidal  products,  including  the 
reinforcement of mutual recognition. 

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Product-type 

Notified 

Still in 

Dossier to be 
submitted by 

First decision 
expected by 

Last decision 
expected by 

Annex I 

Annex 1 

   2006  2007  2008  2009  2010  2011  2012  2013  2014 

Wood preservatives 

Rodenticides 

Molluscicides 

Insecticides 

Repellents & attractants 

Antifouling products 

Disinfectants 

Preservatives 
metalworking-fluids) 

(in-can  & 

80 

17 

13 

104 

41 

46 

87 

163 

108 

105 

52 

143 

104 

40 

14 

0 

61 

19 

10 

35 

82 

50 

55 

21 

47 

30 

28/03/2004 

12/01/2007 

29/08/2009 

1 

2 

2 

30 

10 

7 

2 

30/04/2006 

13/02/2009 

1/10/2011 

31/07/2007 

16/05/2010 

31/12/2012 

5 

3 

2 

30 

20 

6 

5 

5 

3 

5 

5 

5 

5 

5 

5 

5 

6 

5 

25 

5 

25 

25 

27 

25 

20 

25 

25 

15 

1 

25 

17 

25 

40 

14 

0 

61 

19 

10 

35 

82 

50 

55 

21 

47 

30 

EN 

12 

EN 

 
  
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
(for 
Preservatives 
fibres,  masonry, 
cooling  & 
systems) 

films, 
liquid 
processing 

Avicides 

Piscicides 

Food/feed preservatives 

Embalming fluids 

Control 
vertebrates 

of 

other 

89 

138 

94 

127 

118 

2 

3 

25 

24 

4 

45 

69 

47 

64 

59 

1 

2 

13 

12 

2 

31/10/2008 

17/08/2011 

3/04/2014 

4 

4 

4 

4 

4 

25 

16 

25 

25 

15 

25 

18 

25 

25 

10 

25 

25 

5 

1 

1 

4 

4 

2 

9 

8 

45 

69 

47 

64 

59 

1 

1 

13 

12 

2 

Total 

1687 

777 

1 

4 

50 

50 

63 

196 

230 

153 

30 

777 

EN 

13 

EN