Proposal for a Directive of the European Parliament and of the Council relating to restrictions on the marketing and use of perfluorooctane sulfonates (amendment of Council Directive 76/769/EEC)
Date: 2005-12-05
Institutions: European Commission
Subjects: approximation of laws, dangerous substance, health risk, marketing restriction, toxic substance

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.12.2005 
COM(2005) 618 final 

2005/0244 (COD) 

. 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

relating to restrictions on the marketing and use of perfluorooctane sulfonates 
(amendment of Council Directive 76/769/EEC) 

. 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

INTRODUCTION AND CONTEXT 

Perfluorooctane sulfonates (PFOS) are anions that are commercially available in the form of 
salts,  derivatives  and  polymers.  The  major  uses  for  PFOS-related  substances  were  in 
providing grease, oil and water resistance to materials such as textiles, carpets, paper and in 
general coating. The substances used in these areas were largely PFOS-polymers for fabrics 
and  PFOS-substances  for  paper  treatment  and  coatings.  Other  smaller  volume  uses  are  in 
chromium plating, photography, photolithography, fire fighting foams and in hydraulic fluids 
for aviation. 

The proposal is primarily based on the following studies: 

–  An  OECD  hazard  assessment  was  endorsed  at  the  34th  Joint  Meeting  of  the  Chemicals 
Committee  and  the  Working  Party  on  Chemicals,  Pesticides  and  Biotechnology  
(5-8 November 2002). According to this assessment PFOS is persistent in the environment, 
bio accumulative and toxic to mammalian species. 

–  A  risk  evaluation  report  and  a  risk  reduction  strategy  which  includes  an  impact 
assessment have been prepared by the United Kingdom in accordance with the principles 
of  Council  Regulation  (EEC) 793/93  of  23 March 1993  on  the  evaluation  and  control  of 
the risks of existing substances1. 

–  The Scientific Committee on Health and Environmental Risks (SCHER) examined the 
scientific  aspects  of  the  above  mentioned  risk  reduction  strategy  and  confirmed  in  its 
opinion adopted on 18 March 2005 that the data indicate that PFOS was very persistent, 
very bio-accumulative and toxic.  

Estimates of emissions from each use area have been made. The risk assessment identified a 
need  for  reducing  the  risks  to  health  and  the  environment  from  PFOS.  The  risk  reduction 
strategy recommended marketing and use restrictions for certain uses. The proposed Directive 
would cover the great part of the exposure risks by preventing the use of PFOS in carpets, 
textiles, upholstery,  leather, apparel,  paper, packaging  and  other  applications.  These  uses 
seem already to be phased out and the proposal would prevent their reintroduction. There 
are  some  further  smaller  and  specific  uses 
in  chromium  plating,  photography, 
photolithography,  fire  fighting  foams  and  in  hydraulic  fluids  for  aviation.  The  volumes 
used  in  these  limited  areas,  and  the  emissions  into  the  environment,  would  need  to  be 
further  assessed,  but  they  are  currently  expected  to  be  very  small.  The  advantages  and 
disadvantages of regulating these uses would have to be subject to impact assessment. 

An  ongoing  research  project  PERFORCE  (http://www.science.uva.nl/perforce/)  which  is 
financed by the Research Framework Programme is generating new data, e.g. on exposures, 
sources and routes and physico-chemical parameters of PFOS. 

1 

OJ L 84, 5.4.1993, p. 1. 

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Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations 
and administrative provisions of the Member States relating to restrictions on the marketing 
and  use  of  certain  dangerous  substances  and  preparations2  should  therefore  be  amended 
accordingly. 

The  objective  of  the  Directive  would  be  to  introduce  harmonised  provisions  with  regard  to 
PFOS, thus preserving the internal market whilst ensuring a high level of protection of human 
health and the environment, as required by Article 95 of the Treaty. 

2. 

JUSTIFICATION FOR PROPOSAL 

What are the objectives of the proposal in relation to the Community’s obligations? 

Due to the fact that certain uses of chemicals cannot be controlled under certain conditions, 
safety  for  health  and  the  environment  can  only  be  ensured  by  prohibiting  such  uses  of  the 
substances and preparations concerned. 

The  aim  of  the  proposal  is  to  preserve  the  Internal  Market.  When  Member  States  adopt 
national  provisions  restricting  the  marketing  and  use  of  dangerous  substances  and 
preparations  there  will  be  obstacles  to  trade  because  of  differences  in  legislation  between 
Member States. The Draft Proposal aims to improve the conditions for the functioning of the 
Internal Market to the benefit of the protection of health and the environment. 

What are the courses of action available to the Community? 

The  only  course  of  action  available  is  to  make  a  proposal  for  an  amendment  to 
Directive 76/769/EEC providing for harmonised rules on the use of PFOS. 

Are  uniform  rules  necessary?  Is  it  not  sufficient  to  establish  targets  to  be  implemented  by 
Member States? 

The  proposed  Directive  would  establish  uniform  rules  for  the  circulation  of  PFOS.  It  also 
guarantees a high level of protection of health and the environment. The proposed amendment 
to Directive 76/769/EEC is the only way to meet these goals. Targets would be insufficient. 

3. 

RATIONALE OF THE PROPOSAL 

The  proposed  Directive  would  extend  Annex I  to  Directive 76/769  by  adding  the  substance 
PFOS. Marketing and use of this substance would thus be restricted. 

4. 

COSTS AND BENEFITS 

4.1. 

Costs 

The proposed Directive should pose only minor problems to the industry or trade, as the uses 
of  PFOS  are  declining  in  the  concerned  cases,  and  companies  have  already  developed 
alternatives. 

2 

OJ L 262, 27.9.1976, p. 201. 

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4.2. 

Benefits 

The benefits of the proposal are to establish an Internal Market as well as to protect human 
health and the environment. The proposed restriction will ensure that for certain uses which 
pose a risk to human health or the environment PFOS are no longer on the market. 

5. 

PROPORTIONALITY 

The  proposed  Directive  would  yield  benefits  in  terms  of  protecting  human  health  and  the 
environment. This will be achieved at little cost. 

6. 

CONSULTATIONS  PERFORMED 
AMENDMENT 

IN  PREPARING  THE  DRAFT 

Advice  on  the  preparation  of  the  proposal  was  sought  through  meetings  involving  experts 
from  Member  States  and  the  European  Chemical  Industry  Council  (CEFIC),  the  outcome  of 
which  is  reflected  in  the  proposal.  The  European  Consumers’  Organisation  BEUC  has  also 
been invited to give comments. 

7. 

CONFORMITY WITH THE TREATY 

This proposal is intended to preserve the Internal Market and at the same time ensure a high 
level  of  protection  of  human  health  and  the  environment.  It  is  therefore  in  conformity  with 
Article 95(3) of the Treaty. 

8. 

EUROPEAN  PARLIAMENT  AND  EUROPEAN  ECONOMIC  AND  SOCIAL 
COMMITTEE 

In  compliance  with  Article 95  of  the  Treaty,  the  Codecision  Procedure  with  the  European 
Parliament is applicable. The European Economic and Social Committee has to be consulted. 

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2005/0244 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

relating to restrictions on the marketing and use of perfluorooctane sulfonates 
(amendment of Council Directive 76/769/EEC) 

(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 Commission 3, 

Having regard to the opinion of the European Economic and Social Committee 4, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty 5, 

Whereas: 

(1) 

(2) 

(3) 

An  OECD  hazard  assessment  has  been  done  on  the  basis  of  information  that  was 
available  by  July  2002.  This  assessment  concluded  that  the  potential  hazards  of 
perfluorooctane sulfonates (PFOS) indicate cause for concern. 

The risks posed to health and environment by PFOS have been assessed in accordance 
with  the  principles  of  Council  Regulation  (EEC) 793/93  of  23 March 1993  on  the 
evaluation  and  control  of  the  risks  of  existing  substances6.  The  risk  assessment 
identified a need to reduce the risks to health and environment. 

The  Scientific  Committee  on  Health  and  Environmental  Risks  (SCHER)  has  been 
consulted. The SCHER has seen a need for further scientific risk assessment of PFOS 
but  it  also  agreed  that  risk  reduction  measures  might  be  necessary  to  avoid  the  re-
occurrence of former uses. According to SCHER, on-going critical uses in the aviation 
industry, the semiconductor industry, and the photographic industry do not appear to 
pose  a  relevant  risk  to  the  environment  or  human  health,  if  releases  into  the 
environment  and  workplace  exposure  are  minimised.  With  regard  to  fire-fighting 
foams, the SCHER agrees that health and environmental risks of substitutes must be 

3 
4 
5 
6 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ  L  84,  5.4.1993,  p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  1882/2003  of  the  European 
Parliament and of the Council (OJ L 57, 25.2.2003). 

EN 

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(4) 

(5) 

(6) 

(7) 

(8) 

assessed  before  a  final  decision  can  be  taken.  With  regard  to  chromium  plating 
measures to reduce the emissions should be assessed. 

In order to protect health and the environment, it therefore appears necessary that the 
placing  on  the  market  and  the  use  of  PFOS  should  be  restricted.  The  proposed 
Directive  would  cover  the  major  part  of  the  exposure  risks.  Other  minor  uses  of 
PFOS do not seem to pose a risk and they are therefore currently exempted.  They 
will be further examined and they will be the subject of a specific impact assessment. 

The  products  containing  PFOS  should  also  be  restricted  in  order  to  protect  the 
environment. The present directive should only restrict new products and should not 
apply to products already in use or on the second hand market. 

Council  Directive  76/769/EEC  of  27  July  1976  on  the  approximation  of  the  laws, 
regulations and administrative provisions of the Member States relating to restrictions 
on the marketing and use of certain dangerous substances and preparations7 should be 
amended accordingly. 

The  objective  of  this  Directive  is  to  introduce  harmonised  provisions  with  regard  to 
PFOS, thus preserving the internal market whilst ensuring a high level of protection of 
human health and the environment, as required by Article 95 of the Treaty. 

for 

requirements 

This  Directive  is  without  prejudice  to  the  Community  legislation  laying  down 
the  protection  of  workers,  such  as  Council 
minimum 
Directive 89/391/EEC  of  12 June 1989  on  the  introduction  of  measures  to  encourage 
improvements in the safety and health of workers at work 8, and individual directives 
based thereon, in particular 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)  (codified  version)9  and 
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)10, 

7 

8 

9 
10 

OJ  L  262,  27.9.1976,  p.  201.  Directive  as  last  amended  by  Commission  Directive  2004/21/EC 
(OJ L 57, 25.2.2004, p. 4). 
OJ L 183,  29.6.1989,  p. 1.  Directive  as  amended  by  Regulation  (EC)  No  1882/2003  of  the  European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 158, 30.4.2004, p. 50. 
OJ L 131, 5.5.1998, p. 11. 

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HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Annex I to Directive 76/769/EEC is amended as set out in the Annex to this Directive. 

Article 2 

1. 

Member States shall adopt and publish, by xx xx 200x [one year after the date of its 
entry  into  force]  at  the  latest,  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive.  They  shall  forthwith  communicate  to  the 
Commission  the  text  of  those  provisions  and  a  correlation  table  between  those 
provisions and this Directive. 

They shall apply those provisions from xx xx 200x [eighteen months after the entry 
into force of this Directive]. 

When Member States adopt those provisions, the provisions 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 day 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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The following point [XX] is added to Annex I of Directive 76/769/EEC:  

ANNEX 

“[XX]. 
Perfluorooctane sulfonates 
C8F17SO2X 
(X = OH, Metal salt, halide, 
amide, and other derivatives 
including polymers) 

(1) May not be placed on the market or used as a substance or 
constituent of preparations in a concentration equal or higher 
than 0.1 % by mass. 

"(2) May not be placed on the market in products or parts 
thereof in a concentration equal or higher than 0.1% by mass" 

(3) By way of derogation, paragraphs 1 and 2 shall not apply 
to 

- photoresists or anti reflective coatings for 
photolithography processes, 

- industrial photographic coatings applied to films, papers, 
or printing plates,  

- mist suppressants for chromium plating,  

- hydraulic fluids for aviation,  

- fire fighting foams, 

- controlled closed systems where the concentration of 
PFOS released into the environment is less than 1µg per kg, 
and where that release corresponds to less than 0.1% by 
mass of the PFOS used in the system. 

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