Proposal for a COUNCIL DIRECTIVE amending Directive 98/8/EC of the European Parliament and of the Council to include creosote as an active substance in Annex I thereto
Date: 2011-02-10
Institutions: European Commission
Subjects: chemical product, health risk, market approval, marketing, marketing standard, plant health legislation, plant health product

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EUROPEAN COMMISSION 

Brussels, 10.2.2011 
COM(2011) 50 final 

2011/0025 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE  

amending Directive 98/8/EC of the European Parliament and of the Council to include 
creosote as an active substance in Annex I thereto 

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EXPLANATORY MEMORANDUM 

According  to  Directive  98/8/EC  of  the  European  Parliament  and  the  Council  of 
16 February 19981 concerning the placing of biocidal products on the market, a programme of 
work shall be carried out concerning the review of all active substances contained in biocidal 
products  already  on  the  market  on  14 May 2000  (existing  active  substances).  Creosote  was 
identified  as  an  existing  active  substance  and  evaluated  in  the  context  of  that  work 
programme. 

In accordance with the second subparagraph of Article 16(2) of Directive 98/8/EC, it may be 
decided  through  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 28/4)  of  the 
Directive that an existing active substance shall be included in Annex I to the Directive. In the 
view of the Commission, the conclusions of the evaluation of creosote are that the conditions 
for the inclusion of the substance in Annex I are met under certain conditions. Accordingly, 
the  Commission  submitted  a  draft  Directive  for  vote  in  the  Committee  established  under 
Article  28(1)  of  Directive 98/8/EC.  The  Committee  did  not  deliver  a  favourable  opinion  on 
the draft Directive in its meeting on 17 December 2010. 

Thus  in  accordance  with  the  procedure  set  out  in  Article  5(a)  of  Decision  1999/468/EC  a 
Proposal  for  a  Council  Directive  is  submitted  to  Council  and  forwarded  to  the  European 
Parliament. 

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OJ L 123, 24.4.1998, p. 1 

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2011/0025 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE  

amending Directive 98/8/EC of the European Parliament and of the Council to include 
creosote as an active substance in Annex I thereto 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union,  

Having  regard  to  Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council  of 
16 February 1998  concerning  the  placing  of  biocidal  products  on  the  market2,  and  in 
particular the second subparagraph of Article 16(2) thereof, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Commission Regulation (EC) No 1451/2007 of 4 December 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  market3  establishes  a  list  of  active  substances  to  be  assessed,  with  a 
view  to  their  possible  inclusion  in  Annex  I,  IA  or  IB  to  Directive  98/8/EC.  That  list 
includes creosote. 

Pursuant to Regulation (EC) No 1451/2007, creosote has been evaluated in accordance 
with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, 
as defined in Annex V to that Directive. 

Sweden  was  designated  as  Rapporteur  Member  State  and  submitted  the  competent 
authority  report, 
the  Commission  on 
31 October 2007  in  accordance  with  Article  14(4)  and  (6)  of  Regulation  (EC) 
No 1451/2007. It follows from the report that the evaluation only covers Grade B and 
Grade C creosote as specified in European Standard EN 13991:2003. 

together  with  a  recommendation, 

to 

A  stakeholder  consultation  was  launched  on  30  April  2008.  The  outcome  of  the 
consultation was made public and discussed in the 30th meeting of representatives of 
Members  States  Competent  Authorities  for  the  implementation  of  Directive  98/8/EC 
concerning the placing of biocidal products on the market.  

(5) 

The  competent  authority  report  was  reviewed  by  the  Member  States  and  the 
Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the 

2 
3 

OJ L 123, 24.4.1998, p. 1. 
OJ L 325, 11.12.2007, p. 3. 

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(6) 

(7) 

(8) 

(9) 

findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 17 December 2010 in an assessment report. 

It appears from the assessment report that wood preservatives containing creosote may 
be  expected  to  satisfy  the  requirements  laid  down  in  Article  5  of  Directive  98/8/EC, 
when  applied  on  wood  in  some  of  the  scenarios  evaluated.  Furthermore,  there  were 
strong  indications  in  the  abovementioned  stakeholder  consultation  that  there  are 
considerable  socio-economic  benefits  of  using  creosote  in  certain  applications.  Life 
cycle  analyses  submitted  and  published  in  the  context  of  the  consultation  have 
suggested that, in certain cases, no appropriate alternatives to creosote exist, which are 
less  damaging  to  the  environment.  It  is  therefore  appropriate  to  include  creosote  in 
Annex I. 

However,  for  certain  wood  use  scenarios  presented  in  the  assessment  report, 
unacceptable risks for the environment were identified in the risk assessment. 

Furthermore, creosote is considered to be a non-threshold carcinogen and is classified 
as carcinogen category 1B in accordance with 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 
(EC) 
Directives  67/548/EEC  and  1999/45/EC,  and  amending  Regulation 
No 1907/20064.  

Creosote,  which  is  a  mixture  of  hundreds  of  compounds,  contains  mainly  polycyclic 
aromatic  hydrocarbons  ('PAHs').  Some  of  these  have  been  considered  by  the 
Committee  for  Risk  Assessment  of  the  European  Chemicals  Agency  as  persistent, 
toxic  ('PBT';  anthracene5)  or  very  persistent  and  very 
bioaccumulative  and 
bioaccumulative ('vPvB'; fluoranthene, phenanthrene and pyrene6) in accordance with 
the criteria set out in Annex XIII of 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)  PAHs are listed as substances subject to release reduction provisions in Annex III to 
the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on 
to  Regulation (EC) 
Persistent  Organic  Pollutants  ('POPs')  and 
No 850/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on 
persistent organic pollutants and amending Directive 79/117/EEC8.  

in  Annex III 

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OJ L 353, 31.12.2008, p. 1. 
Member State Committee support document for identification of anthracene as a substance of very high 
concern, adopted on 8 October 2008. 
Member  State  Committee  support  document  for  identification  of  anthracene  oil,  anthracene  low  as  a 
substance  of  very  high  concern  because  of  its  CMR,  PBT  and  vPvB  properties,  adopted  on 
4 December 2009. 
OJ L 396, 30.12.2006, p. 1. 
OJ L 158, 30.4.2004, p. 7. 

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(11)  A guidance document adopted by Decision 2009/4 of the Executive Body to the 1979 
Convention  on  Long-Range  Transboundary  Air  Pollution  lists  best  available 
techniques  to  control  emissions  of  POPs  from  major  stationary  sources.  Part E  of 
Section V  of  that  guidance  document  specifically  addresses  emissions  of  PAHs 
associated  with  the  preservation  of  wood  using  coal  tar  derived  products  containing 
PAHs, such as creosote. The techniques relate to impregnation, storage, handling and 
use of the wood, and include using alternatives that minimize reliance on PAH-based 
products. It also recommends best available techniques to be applied if treated wood is 
burned. 

(12)  According to the second subparagraph of Article 6(2) of Regulation (EC) No 850/2004 
read in conjunction with Annex III to that Regulation, Member States are required to 
adopt  action  plans  including  measures  to  promote  the  development  and,  where  they 
deem  appropriate,  require  the  use  of  substitute  or  modified  materials,  products  and 
processes  to  prevent  the  formation  and  release  of  PAHs.  Pursuant  to  Article 3(3)  of 
Regulation (EC)  No 850/2004,  Member  States  and  the  Commission  shall,  within  the 
assessment and authorisation schemes for existing chemicals and pesticides under the 
relevant Union legislation, take appropriate measures to control existing chemicals and 
pesticides which exhibit characteristics of POPs. 

(13)  Directive 2000/60/EC  of 

the  Council  of 
23 October 2000 establishing a framework for Community action in the field of water 
policy9  identifies  PAHs  as  priority  hazardous  substances,  from  which  pollution  of 
surface waters through discharge, emission or loss must cease or be phased out.  

the  European  Parliament  and  of 

(14) 

It  is  therefore  appropriate  to  limit  the  inclusion  to  five  years  only  and  to  make  it 
subject to a comparative risk assessment in accordance with the second subparagraph 
of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.  

(15)  Furthermore,  biocidal  products  containing  creosote  should  be  authorised  only  for 
applications  where,  all  local  and  other  circumstances  taken  into  account,  no 
appropriate  alternatives  are  available.  When  an  application  is  made  for  product 
authorisation or mutual recognition, the Member State receiving the application should 
therefore  ask  the  applicant  for  an  analysis  regarding  the  technical  and  economic 
feasibility of substitution. Based on this analysis and any other information available 
to  it,  an  authorising  Member  State  should  justify  their  conclusion  that  there  are  no 
appropriate alternatives and report the justification to the Commission at a stage when 
product  authorisations  can  be  expected  to  have  been  granted.  In  this  context,  to 
increase  transparency,  it  is  appropriate  to  require  Member  States  to  include  in  the 
report  their  information  on  how  the  development  of  alternatives  is  promoted  in 
accordance  with  Article 6(2)  of  Regulation (EC)  No 850/2004,  either  directly  or  by 
reference to a published action plan. To further increase transparency, it is appropriate 
to ensure that this information is made public. 

(16)  Not all potential uses of wood treated with creosote have been evaluated at the Union 
level.  It  is  therefore  appropriate  that  Member  States  assess  those  uses  or  exposure 
scenarios  and  those  risks  to  compartments  and  populations  that  have  not  been 
representatively  addressed  in  the  Union  level  risk  assessment  and,  when  granting 

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OJ L 327, 22.12.2000, p. 1. 

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product  authorisations,  ensure  that  appropriate  measures  are  taken  or  specific 
conditions imposed in order to reduce the identified risks to acceptable levels. 

(17)  Entry  number  31  in  Annex  XVII  to  Regulation  (EC)  No 1907/2006  regulates  the 
conditions for the use of creosote in wood treatment and for the placing on the market 
of wood treated with creosote. It is appropriate to require that product authorisations 
for  biocidal  products  containing  creosote  are  subject  to  compliance  with  those 
restrictions.  Through  Commission  Decisions  1999/832/EC  of  26  October  1999 
concerning  the  national  provisions  notified  by  the  Kingdom  of  the  Netherlands 
concerning  the  limitations  of  the  marketing  and  use  of  creosote10,  2002/59/EC  of  23 
January  2002  concerning  draft  national  provisions  notified  by  the  Kingdom  of  the 
Netherlands under Article 95(5) of the EC Treaty on limitations on the marketing and 
use  of  creosote-treated  wood11,  and  2002/884/EC  of  31  October  2002  concerning 
national provisions on restrictions on the marketing and use of creosote-treated wood 
notified  by  the  Netherlands  under  Article  95(4)  and  (5)  of  the  EC  Treaty12,  the 
Commission  has  authorised  the  Netherlands  to  maintain  existing  and  more  stringent 
national  provisions  notified  under  the  EC  Treaty.  By  virtue  of  Article 67(3)  of 
Regulation (EC)  No 1907/2006,  and  as  stated  in  the  Communication  from  the 
Commission  pursuant  to  Article  67(3)  of  Regulation  (EC)  No 1907/200613,  these 
restrictions may be maintained until 1 June 2013. They include a prohibition of the use 
of  creosote-treated  wood  for  applications  involving  contact  with  surface  water  or 
groundwater.  

(18) 

In the light of the findings of the assessment report, it is appropriate to require that risk 
mitigation measures are applied at product authorisation level to products containing 
creosote  and  used  as  wood  preservatives.  Due  to  the  carcinogenic  properties  of 
creosote,  it  is  appropriate  to  require  that  product  authorisations  for  biocidal  products 
containing  the  substance  are  subject  to  the  requirement  that  all  possible  measures  in 
accordance  with  Regulation  (EC)  No  1907/2006  and  Directive  2004/37/EC  of  the 
European Parliament and of the Council of 29 April 2004 on the protection of workers 
from  the  risks  related  to  exposure  to  carcinogens  or  mutagens  at  work  (Sixth 
individual  Directive  within  the  meaning  of  Article  16(1)  of  Council  Directive 
89/391/EEC)14  be  applied  to  protect  workers,  including  down-stream  users,  from 
exposure  during  treatment  and  handling  of  treated  wood.  In  the  view  of  the  risks 
identified for the soil and aquatic compartments, appropriate measures should be taken 
to  protect  those  compartments.  Instructions  should  therefore  be  provided  to  indicate 
that  freshly  treated  timber  must  be  stored  after  treatment  under  shelter  or  on 
impermeable hard standing, or both, and that any losses must be collected for reuse or 
disposal.  

(19) 

It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal treatment of biocidal products on the market 
containing the active substance creosote and also to facilitate the proper operation of 
the biocidal products market in general. 

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14 

OJ L 329, 22.12.1999, p. 25. 
OJ L 23, 25.1.2002, p. 37. 
OJ L 308, 9.11.2002, p. 30. 
OJ C 130, 9.6.2009 EN, p. 3. 
OJ L 158, 30.4.2004, p. 50. 

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(20)  A reasonable period should be allowed to elapse before an active substance is included 
in  Annex  I  in  order  to  permit  Member  States  and  the  interested  parties  to  prepare 
themselves  to  meet  the  new  requirements  entailed  and  to  ensure  that  applicants  who 
have  prepared  dossiers  can  benefit  fully  from  the  10-year  period  of  data  protection, 
which,  in  accordance  with  Article  12(1)(c)(ii)  of  Directive  98/8/EC,  starts  from  the 
date of inclusion. 

(21)  After  inclusion,  Member  States  should  be  allowed  a  reasonable  period  to  implement 

Article 16(3) of Directive 98/8/EC. 

(22)  Directive 98/8/EC should therefore be amended accordingly. 

(23)  The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an 
opinion on the measures provided for in this Directive and the Commission therefore 
submitted  to  the  Council  a  proposal  relating to  the  measures  and  forwarded  it  to  the 
European Parliament, 

HAS ADOPTED THIS DIRECTIVE: 

Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive. 

Article 1 

Article 2 

Transposition 

1. 

Member  States  shall  adopt  and  publish,  by  30 April 2012  at  the  latest,  the  laws, 
regulations and administrative provisions necessary to comply with this Directive.  

They shall apply those provisions from 1 May 2013. 

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 twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

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Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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In Annex I to Directive 98/8/EC, the following entry is added: 

No 

Common 
Name 

IUPAC Name 

Identification 
Numbers 

Date 
inclusion 

of 

the 

Minimum  purity 
of 
active 
substance  in  the 
biocidal  product 
as  placed  on  the 
market 

ANNEX 

one 

for  compliance 
Deadline 
with  Article  16(3)  (except 
containing 
products 
for 
active 
more 
than 
substance,  for  which 
the 
to  comply  with 
deadline 
Article  16(3)  shall  be  the 
one set out in the last of the 
inclusion  decisions  relating 
to its active substances) 

Expiry  date  of 
inclusion 

Product 
type 

Specific provisions (*) 

"(**) 
[OPOCE: 
please 
insert 
substance 
number] 

Creosote 

Creosote 

EC No: 232-287-5 

CAS No: 8001-58-9 

Grade  B  or  Grade 
as 
C 
creosote 
specified 
in 
European 
Standard 
13991:2003 

EN 

1 May 2013 

30 April 2015 

30 April 2018 

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Biocidal  products  containing  creosote  may  only  be 
authorised  for  uses  where  the  authorising  Member 
State, based on an analysis regarding the technical and 
economic  feasibility  of  substitution  which  it  shall 
request  from  the  applicant,  as  well  as  on  any  other 
information  available 
that  no 
to 
appropriate  alternatives  are  available.  Those  Member 
States authorising such products in their territory shall 
no  later  than  31  July  2016  submit  a  report  to  the 
Commission  justifying  their  conclusion  that  there  are 
no  appropriate  alternatives  and  indicating  how  the 
is  promoted.  The 
development  of  alternatives 
Commission  will  make 
reports  publicly 
available. 

it,  concludes 

these 

The active substance is to be subject to a comparative 
risk  assessment 
the  second 
subparagraph of Article 10(5)(i) before its inclusion in 
this Annex is renewed. 

in  accordance  with 

When  assessing  the  application  for  authorisation  of  a 
product  in  accordance  with  Article  5  and  Annex  VI, 
Member  States  shall  assess,  where  relevant  for  the 
particular  product,  those  uses  or  exposure  scenarios 
and  those  risks  to  environmental  compartments  and 
that  have  not  been  representatively 
populations 

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addressed at the Union level risk assessment. 

Member  States  shall  ensure  that  authorisations  are 
subject to the following conditions:  

(1) 

(2) 

(3) 

the 
Creosote  may  only  be  used  under 
conditions  mentioned  in  point  2  of  the 
second  column  of  entry  No  31  in  Annex 
XVII  to  Regulation  (EC)  No  1907/2006of 
the  European  Parliament  and  of  the  Council 
the 
of  18  December  2006  concerning 
Registration,  Evaluation,  Authorisation  and 
Restriction 
(REACH), 
of  Chemicals 
establishing  a  European  Chemicals  Agency, 
amending  Directive 
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/EC15. 

1999/45/EC 

Creosote  shall  not  be  used  for  the  treatment 
of  wood  intended  for  those  uses  referred  to 
in point 3 of the second column of entry No 
31  in  Annex  XVII  to  Regulation  (EC) 
No 1907/2006. 

Appropriate  risk  mitigation  measures  shall 
be taken to protect workers, including down-
stream users, from exposure during treatment 
and handling of treated wood in compliance 
with  Regulation  (EC)  No 1907/2006  and 
Directive  2004/37/EC  of 
the  European 
Parliament  and  of  the  Council  of  29 April 
2004  on  the  protection  of  workers  from  the 
risks  related  to  exposure  to  carcinogens  or 
mutagens at work (Sixth individual Directive 

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OJ L 396, 30.12.2006, p. 1 

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(4) 

within  the  meaning  of  Article  16(1)  of 
Council Directive 89/391/EEC)16. 

Appropriate  risk  mitigation  measures  shall 
be  taken  to  protect  the  soil  and  aquatic 
labels  and, 
compartments.  In  particular, 
where  provided,  safety  data  sheets  of 
products authorised shall indicate that freshly 
treated timber must be stored after treatment 
under  shelter  or  on 
impermeable  hard 
standing,  or  both,  to  prevent  direct  losses  to 
soil  or  water  and  that  any  losses  must  be 
collected for re-use or disposal. 

the  content  and  conclusions  of  assessment 

reports  are  available  on 

the  Commission  website: 

(*)  For 
http://ec.europa.eu/comm/environment/biocides/index.htm 

implementation  of 

the 

the  common  principles  of  Annex  VI, 

16 

OJ L 158, 30.4.2004, p. 50. 

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