Proposal for a Directive of the European Parliament and of the Council amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods (Text with EEA relevance)
Date: 2008-10-07
Institutions: European Commission
Subjects: animal health, chemical product, environmental protection, labelling, marketing, public health

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 7.10.2008 
COM(2008) 618 final 

2008/0188 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 98/8/EC concerning the placing of biocidal products on the market 
as regards the extension of certain time periods  

(Text with EEA relevance) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Grounds for and objectives of the proposal 

This proposal for a European Parliament and Council Directive to amend Directive 98/8/EC of 
16 February 1998 concerning the placing of biocidal products on the market (hereinafter, 'the 
Directive')  is  submitted  following  a  report  forwarded  by  the  Commission  to  the  European 
Parliament  and  the  Council  on  the  progress  with  the  10-year  work  programme  for  the 
evaluation  of  active  substances  used  in  biocidal  products,  referred  to  in  Article  16(2)  of  the 
Directive and on the implementation of the Directive in accordance with its Article 18(5). 

General context 

As set out in the above-mentioned report, the current progress rate of the review programme 
will not permit its completion by 14 May 2010 as planned. This is mainly due to the fact that, 
before any review could start, it was necessary to establish an inventory of active substances 
used in biocidal products placed on the European market of biocidal products, and list the ones 
that the industry or specific Member States were interested to have examined in view of their 
possible  inclusion  into  Annex  I  or  IA  of  the  Directive  (the  Community  positive  list).  This 
elaborate exercise has taken three full years to complete. It was only at the end of 2003 that 
the timetable, priorities and list of Rapporteur Member States for the review programme could 
be  set,  while  the  first  dossiers  with  studies  for  evaluation  were  not  submitted  before  2004. 
Overall, 964 active substances were identified, of which 468 were notified for evaluation. 

The  experience  so  far  with  the  review  programme  indicates  that  the  evaluation  of  a  regular 
active substance dossier never takes less than three years, even under optimum conditions, and 
the average time required is in the order of four years. 

Article  16(1)  of  the  Directive  provides  for  a  transitional  period  of  ten  years  (14.5.2000-
14.5.2010), during which the biocides market will continue to be regulated by national rules. 
Gradually, as more and more active substances are evaluated and included in the Community 
positive  list,  the  national  rules  for  biocidal  product  authorisations  are  replaced  by  the 
harmonised  conditions  established  by  the  Directive.  However,  as  the  end  of  the  transitional 
period  coincides  with  the  end  of  the  review  programme,  this  means  in  practice  that,  on  the 
very  next  day,  only  products  that  contain  active  substances  included  in  the  Community 
positive list and are authorised in accordance with the Directive can be legally placed on the 
market. For the reasons explained above, it is almost certain that the review of a great part of 
the  active  substances  will  not  be  finalised  by  14.5.2010.  As  a  consequence,  all  products 
containing active substances not yet evaluated would have to be withdrawn from the market.  

Even if all the active substances were evaluated and a decision was adopted for their inclusion, 
or  not,  in  the  Directive's  positive  list  by  14  May  2010,  these  decisions  would  need  to  be 
transposed  by  the  Member  States  and  authorisations  or  registrations  for  biocidal  products 
containing the substances concerned would have to be issued in accordance with Article 16(3) 
of  the  Directive.  This  implies  the  preparation  and  submission  by  the  industry  of  complete 
dossiers on specific biocidal products,  their evaluation by the competent  authorities,  and the 
issuance of new authorisations or registrations at Member State level and subsequent mutual 
recognition in other Member States. Only then would be the market regulated by harmonised 

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rules. However, the Directive, as it is now, does not allow for such a period, but requires that 
the market be fully harmonised by 14 May 2010. 

Article  12  of  the  Directive,  on  data  protection,  will  need  to  be  adjusted  as  well  to  the  new 
deadline  of  the  review  programme,  because  otherwise  there  is  a  risk  that  the  information 
submitted for the purposes of the Directive from 14 May 2010 until the proposed new deadline 
for the completion of the review programme - that is, on 14 May 2013, will not be protected. 

Considering the findings of the above-mentioned report, the proposed extension of three years 
might not be enough to finalise the review programme. However, providing for a significantly 
longer extension might work against intensifying the efforts to complete the evaluation work 
in  a  timely  manner.  For  this  reason,  it  is  proposed  to  provide  for  an  implementing  measure 
procedure  to  allow  for  flexibility  in  the  review  programme  and  corresponding  transitional 
period for any remaining dossiers. 

Existing provisions in the area of the proposal 

Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council  of  16  February  1998 
concerning the placing of biocidal products on the market. Certain dates and one procedure in 
Directive 98/8/EC are to be amended by the present proposal. 

Consistency with the other policies and objectives of the Union 

Not applicable. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

There  has  been  extensive  informal  consultations  with  the  Member  States  about  the  foreseen 
progress with the review programme, in particular during the Competent Authorities' meetings 
in Brussels (4 per year), where industry representatives are also present as observers. Ways to 
speed  up  the  evaluation  of  active  substances  and  to  organise  a  co-ordinated  authorisation  of 
biocidal  products  were  also  explored  and  discussed  during  a  special  seminar  titled  "Post 
Annex I Inclusion" that took place on 13 March 2007, in the margin of the 24th Competent 
Authorities meeting in Brussels.  

Summary of responses and how they have been taken into account 

The  Member  States  also  believe  that  completion  of  the  review  programme  of  all  notified 
active substances is highly  unlikely to happen by 14 May 2010. They underlined as reasons 
the lack of quality or completeness of the submitted information, which considerably delays 
the procedure; the insufficient resources to deal with the current and the foreseen amount of 
work, in particular considering the additional needs for scientific personnel created recently by 
REACH;  and  the  difficulty  with  regard  to  the  implementation  of  very  demanding  technical 
provisions  of  the  Directive.  All  these  opinions  expressed  by  the  Member  States  have  been 
fully  taken  into  account,  together  with  the  aim  to  accomplish,  as  fast  as  possible,  the 
harmonisation of the biocides market. 

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Collection and use of expertise 

There was no need for external expertise. 

Impact assessment 

From the experience acquired so far with the review programme and by the most conservative 
estimations,  it  is  expected  that  at  least  three  more  years  will  be  necessary  to  complete  the 
review  programme  and  achieve  effective  harmonisation  of  the  market.  If  no  extension  is 
given, the marketing of a substantial part of all biocidal products currently on the market will 
be illegal, as national rules will no longer apply after 14 May 2010, and as of that  date,  the 
Directive  allows  only  the  placing  on  the  market  of  biocidal  products  that  contain  active 
substances included in the Community positive list and that have been authorised or registered 
in accordance with its provisions.  

It  is  for  this  reason  that  the  Commission  decided  to  propose  as  a  matter  of  urgency  an 
amendment  of  the  Directive  with  regard  to  the  length  of  the  review  programme  and  of  the 
transitional period, separately from the co-decision procedure on the revision of the Directive 
(foreseen  to  be  launched  at  the  end  of  2008),  which  will  follow  later,  once  all  options  to 
remedy  identified problems and weaknesses have been thoroughly investigated in an impact 
assessment.  

Without these amendments, there will be significant adverse economic effects on the industry 
(who would no longer be allowed to market a large part of their products) and adverse effects 
on  human  health  and  on  the  environment,  due  to  the  lack  of  available  products  to  combat 
many harmful organisms.  

Given  the  relatively  brief  extension  proposed  for  the  review  programme  and  the  transitional 
period,  and  as  a  precautionary  measure,  the  Commission  also  proposes  to  provide  for  the 
possibility  to  extend  the  review  programme  and  corresponding  transitional  period  for  any 
remaining dossiers after 14.5.2013 by Comitology decisions. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

The  proposed  amendments  to  Directive  98/8/EC  concern  Articles  12(1)(c)(i),  12(2)(c)(i), 
16(1) and 16(2). Basically, the 10-year work programme referred to in Article 16(2) becomes 
the  13-year  programme,  and  the  phrase  "the  date  referred  to  in  Article  34(1)"  -  i.e.  14  May 
2000, the actual date of entry into force of the Directive - or the phrase "10 years from the date 
referred to in Article 34(1)" in the above-mentioned provisions is replaced by an actual date, 
in a way that, the expiry of the transitional period and the end of the review programme will 
be  postponed  by  three  years.  As  a  necessary  measure  to  cover the  data  ownership  rights  for 
information under evaluation during the period from the current end of the review programme 
(14.5.2010) until the proposed end (14.5.2013), the data protection rights referred to in Article 
12(1)(c)(i) and 12(2)(c)(i) will also have to be extended by three years. Finally, a Comitology 
procedure is proposed to extend – if necessary - the review programme and transitional period 
for any remaining problematic active substance dossiers after 2013. 

Legal basis 

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Article 95 TEC 

Subsidiarity principle 

The  proposal  falls  under  the  exclusive  competence  of  the  Community.  The  subsidiarity 
principle therefore does not apply. 

Proportionality principle 

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

If  the  current  provisions  of  the  Directive  relating  to  the  review  programme  and  transitional 
period  are  not  amended  in  time,  there  would  be  significant  adverse  economic  effects  on  the 
industry (who would no longer continue to market a large part of their products) and adverse 
effects  on  human  health  and  on  the  environment,  as  there  would  no  longer  be  products 
available  to  combat  many  harmful  organisms.  The  proposed  amendments  are  the  simplest 
solution to allow for a continuation of the status-quo until the review programme is concluded 
in an orderly fashion.  

The  proposed  measures  are  not  expected  to  create  an  additional  financial  or  administrative 
burden  on  the  Community,  the  national,  regional  or  local  authorities,  nor  for  the  economic 
operators or the citizens of the EU. 

Choice of instruments 

Proposed instruments: directive. 

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

As the instrument to be amended is a Directive of the European Parliament and of the Council, 
the  most  appropriate  legislative  act  to  amend  it  would  be  another  European  Parliament  and 
Council  Directive,  especially  considering  the  very  limited  scope  of  the  amendments.  The 
choice of legal instrument may however be re-examined in the foreseen substantive revision of 
the  Directive  (planned  for  November  2008),  which  will  amend  the  current  provisions  to  a 
much wider extent. 

4. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget, other than the necessary resources 
for  monitoring  the  implementation  of  the  Directive  and  its  review  programme  that  are,  or 
should have been, provided for. 

5. 

ADDITIONAL INFORMATION 

Correlation table 

The  Member  States  are  required  to  communicate  to  the  Commission  the  text  of  national 
provisions  transposing  the  Directive  as  well  as  a  correlation  table  between  those  provisions 
and this Directive. 

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European Economic Area 

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

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2008/0188 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 98/8/EC concerning the placing of biocidal products on the market 
as regards the extension of certain time periods  

(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) 

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5 

Article 16(1) of Directive 98/8/EC of the European Parliament and of the Council of 
16 February 1998 concerning the placing of biocidal products on the market5 provides 
for a transitional period of ten years, starting from 14 May 2000, the date of entry into 
force of that Directive during which Member States may apply their national rules or 
practices for placing biocidal products on the market, and in particular, authorise the 
marketing  of  biocidal  products  containing  active  substances  that  are  not  included  in 
the positive list of that Directive, that is, its Annexes I, IA or IB. 

Article  16(2)  of  Directive  98/8/EC  establishes  a  10-year  work  programme,  starting 
also from 14 May 2000, during which all the active substances contained in biocidal 
products  that  were  present  on  the  market  before  that  date  will  be  systematically 
examined and, if found acceptable from the point of view of human and animal health 
and the environment, they will be included in the Community positive list. 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 123, 24.4.1998, p. 1, Directive as last amended by Directive 2008/31/EC (OJ L 81, 20.3.2008, p. 
57). 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

Paragraphs  1(c)(i)  and  2(c)(i)  of  Article  12  of  Directive  98/8/EC  provide  for  the 
protection  of  all  information  submitted  for  its  purposes  for  a  period  of  10  years, 
starting also from 14 May 2000, unless a shorter period of protection has been granted 
in a particular Member State, in which case the latter will apply in its territory. That 
protection  concerns  only  information  submitted  in  support  of  the  inclusion  in  the 
positive  list  of  Directive  98/8/EC  of  active  substances  used  in  biocidal  products  that 
were  present  on  the  market  before  the  date of  entry  into  force  of  Directive  98/8/EC, 
i.e. the so-called 'existing' active substances.  

Once an existing active substance has been evaluated and included in the positive list 
of Directive 98/8/EC, its market is considered as harmonised, and the transitional rules 
for the placing on the market of products containing the active substance are replaced 
by the provisions of that Directive.  

In accordance with Article 16(2) of Directive 98/8/EC, the Commission has submitted 
a report6 on the progress achieved with the 10-year work programme, two years before 
its completion. It is expected, based on the findings of that report, that the review of a 
significant  number  of  active  substances  will  not  be  finalised  by  14  May  2010. 
Furthermore, even for the active substances for which a decision on their inclusion in 
the positive list of Directive 98/8/EC has been adopted by 14 May 2010, a sufficient 
time period is necessary for Member States to transpose the relevant acts and to grant, 
cancel  or  modify  the  relevant  products  authorisations,  in  order  to  comply  with  the 
harmonised provisions of Directive 98/8/EC. There is a serious risk that, at the end of 
the transitional period on 14 May 2010, national rules will no longer apply, while the 
relevant harmonised rules will not have been adopted yet. An extension of the 10-year 
work  programme  is  therefore  considered  necessary,  to  permit  the  finalisation  of  the 
review of all active substances notified for evaluation. 

It  is  also  necessary  that  the  end  of  the  review  programme  coincides  with  that  of  the 
transitional period, in a way that national systems or practices will regulate the placing 
of biocidal products on the market until they are ready to be replaced by harmonised 
provisions. 

Also for reasons of consistency and in order to avoid the loss of data protection while 
certain active substances are still under evaluation, the protection of all data submitted 
for the purposes of Directive 98/8/EC should be extended in order to coincide with the 
end of the review programme, 

The extension of the review programme  proposed  may  not  be  enough  to  finalise  the 
evaluation for a number of active substances. On the other hand, a significantly longer 
extension  might  work  against  intensifying  the  efforts  to  complete  the  review 
programme  in  a  timely  manner.  Whereas  a  more  flexible  procedure  to  extend  the 
review programme and the corresponding transitional period for any remaining active 
substances after 14.5.2013 should be provided for, 

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OJ C , , p. . 

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HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 98/8/EC is hereby amended as follows:  

1. 

Article 12 is amended as follows: 

(a) paragraph 1(c)(i) is replaced by the following: 

“(i)  until  14  May  2013  for  any  information  submitted  for  the  purposes  of  this 
Directive, except where such information is already protected under existing national 
rules relating to biocidal products. In such cases, the information shall continue to be 
protected  in  that  Member  State  until  the  expiry  of  any  remaining  period  of  data 
protection provided for under national rules, but not beyond 14 May 2013;” 

(b)  paragraph 2(c)(i) is replaced by the following: 

“(i)  until  14  May  2013  for  any  information  submitted  for  the  purposes  of  this 
Directive, except in the case where data are already protected according to existing 
national rules relating to biocidal products, in which case such data shall be protected 
in  that  Member  State  until  the  expiry  of  any  remaining  period  of  data  protection 
provided for under those national rules, but not beyond 14 May 2013;” 

2. 

Article 16 is amended as follows: 

(a) 

in paragraph 1 the first sentence is replaced by the following: 

"By  way  of  further  derogating  from  Articles  3(1),  5(1),  8(2)  and  8(4),  and  without 
prejudice to paragraphs 2 and 3, a Member State may, until 14 May 2013, continue 
to apply its current system or practice of placing biocidal products on the market.” 

(b)  paragraph 2 is amended as follows : 

(i) 

in the first subparagraph the first sentence is replaced by the following: 

“Following  the  adoption  of  this  Directive,  the  Commission  shall  commence  a 
thirteen-year  programme  of  work  for  the  systematic  examination  of  all  active 
substances  already  on  the  market  on  the  date  referred  to  in  Article  34(1)  as  active 
substances  of  a  biocidal  product  for  purposes  other  than  those  defined  in  Article 
2(2)(c) and (d).” 

(ii) 

at the end of the first subparagraph the following sentence is added: 

"Depending  upon  the  conclusions  of  the  report,  it  may  be  decided,  in  accordance 
with  the  procedure  laid  down  in  Article  28(3),  whether  the  transitional  period 
referred to in the first paragraph and the 13-year period of the work programme is to 
be extended for a period to be determined." 

in  the  second  subparagraph,  the  words  "During  that  10-year  period"  are 

(iii) 
replaced by the words "During that thirteen-year period". 

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Article 2 
Transposition 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  14  May  2010  at  the  latest. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This  Directive  shall  enter  into  force  on  the  20th  day  following  that  of  its  publication  in  the 
Official Journal of the European Union. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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