Opinion of the European Economic and Social Committee on the 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) (COM(2005) 618 final — 2005/0244 (COD))
Date: 2006-05-17
Institutions: European Economic and Social Committee
Subjects: approximation of laws, dangerous substance, health risk, marketing restriction, toxic substance

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Official Journal of the European Union

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Opinion of the European Economic and Social Committee on the 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)

(COM(2005) 618 final — 2005/0244 (COD))

(2006/C 195/03)

On 17 January 2006 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 25 April 2006. The rapporteur was Mr Sears.

At its 427th plenary session, held on 17 and 18 May 2006 (meeting of 17 May), the European Economic
and Social Committee adopted the following opinion by 126 votes with 2 abstentions.

1. Conclusions and recommendations

that

The proposal follows an announcement by the leading
1.1
manufacturer of perfluorooctane sulfonates (PFOS)
it
would cease to manufacture and market consumer products
based on these entities. This decision was based on the manu-
facturer's determination of possible risks to human health and
the environment. Since then these risks have been quantified
and the decision confirmed as being correct for the end-use in
question. The major risk has been eliminated and action here is
to ensure no recurrence of the problem. Meanwhile the needs
of other users need to be protected until alternative materials
or processes become available and/or until full impact assess-
ments are undertaken.

1.2
The EESC supports the proposal, with particular refer-
ence to the restriction on marketing and use of PFOS-related
substances, the derogations for the specified residual end-uses,
and the need for continuing research.

The EESC notes that the end-uses to which derogations
1.3
must be given differ significantly in the quantities used, in the
likelihood and extent of human or environmental exposure,
and in the time required to identify, develop and gain accep-
tance for, suitable and safer materials or processes. The EESC
therefore believes that the derogations should be subject to
review by the Commission on a case-by case basis on the
advice of the Scientific Committee on Health and Environ-
mental Risks (SCHER). Indications of the factors affecting these
reviews are given in the specific comments. The timing of any
risk or impact assessments should be consistent with the
increasing demand for
risk assessment under
chemicals
REACH. It is essential that the Commission maintains sufficient
in-house resource to enable it to fulfil these obligations in a
timely and informed manner.

tent authorities in the Member States of previously identified
priority substances. This approach is however likely to be, and
indeed is specifically intended to be, a more frequent occur-
rence under REACH. A proportionate, acceptable and effective
outcome for PFOS should provide a model for the future appli-
cation of REACH.

2. Summary of the Commission's proposal

2.1
The Commission bases its proposal on an OECD hazard
assessment completed in November 2002 and on a UK risk
finalised in July 2005. These and other
evaluation report
studies, primarily in the US, were prepared following the
announcement on 16 May 2000 by 3M of a voluntary with-
drawal of PFOS-related substances from their principal applica-
tion in providing grease, oil and water resistance to textiles,
carpets, paper and general coatings.

2.2
The Commission accepts the SCHER Opinion of 18
March 2005 that, despite limitations in the available metho-
dology for testing these entities, the data so far available indi-
cate PFOS to be very persistent, very bio-accumulative and
potentially toxic and that risk reduction measures are justified
to prevent any recurrence of wide-scale use.

2.3
The Commission and SCHER also agree that there are
specific low volume applications where effective substitute
products or processes are not yet available. Given that the
continued use of PFOS-related products in these residual appli-
cations does not appear to pose any additional risks to human
health and the environment, derogations from the overall
restriction on marketing and use should be given. The end uses
to which derogations must be given are set out and discussed
in the proposal.

The EESC notes that the actions described above,

in
1.4
reaction to an unexpected change in external circumstances,
contrast with the normal process of risk management where
measures are defined following risk assessments by the compe-

2.4
Further work is required under the Research Framework
Programme (PERFORCE) on exposures, sources, routes and
physico-chemical parameters of these PFOS-related substances.

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2.5
The proposal is intended to guarantee a high level of
protection for health and the environment. The Internal Market
in such products will be preserved. The costs to the affected
sectors are believed to be minimal. Considerable consultation
has taken place.

3. General comments

3.1
Fluorinated chemicals were developed in the late 1940s
and have been used in increasing quantities to generate inert
liquids with low surface tension (very spreadable) or solid
surfaces with specific (usually non-stick) properties. A sub-
group of
these, PFOS-related products, were developed by
companies such as 3M to provide grease, oil and water resis-
tance in a range of industrial and consumer applications. By
the year 2000, approximately 4 500 tonnes per year were
being manufactured and marketed worldwide in products such
as 3M Scotchgard™ carpet and fabric conditioner. Following
the withdrawal of PFOS-related substances, these products have
been reformulated around other fluorinated chemicals with
similar surfactant properties but with reduced impacts on
health and the environment.

3.2
As the name (‘PFOS’) suggests, these are products where
all (‘per’) the hydrogen atoms on an eight-member (‘octane’)
carbon chain have been replaced by fluorine (‘fluoro’) atoms
and one SO3 — (‘sulfonate’) group to form a stable negatively
charged entity (‘anion’) which can in turn form a water-soluble,
crystalline salt with metals such as lithium, sodium or potas-
sium, or with other positively charged groups (‘cations’) such as
NH4
+ (‘ammonium’). ‘PFOS’ is not a single ‘substance’ but refers
to components (‘entities’ or ‘moieties’) of ‘substances’ under EU
laws on ‘substances’ and ‘preparations’. PFOS-related substances
are made by a specific chemical process called ‘electro-chemical
fluorination’.

The combination of ‘organic’ (carbon-based, oil soluble)
3.3
and ‘inorganic’
(metal salt, water soluble) properties makes
PFOS-related substances extremely effective as surface active
agents (‘surfactants’) in a range of specialist applications. The
entities resist oxidation (are inert and do not burn) or any
other environmental breakdown (are stable and therefore
persistent). Given their solubility in both oil and water, they are
likely to bio-accumulate. They may or may not be toxic to
different species under different conditions of exposure. Their
unusual physical and chemical properties mean that, as SCHER
noted, laboratory test methods may prove unreliable in deter-
mining their effects in the environment as a whole.

3.5
According to an OECD estimate in 2004, later quoted
by SCHER, total annual usage of PFOS-related substances in the
EU in 2000 was approximately 500 tonnes, of which 98 % was
used to treat fabrics, paper or coatings. Annual emissions were
believed to be around 174 tonnes. By 2004, worldwide usage
had dropped significantly. Annual emissions in the EU were by
then estimated in the worst case at 10 tonnes, assuming 9
tonnes from unrecovered waste water from metal plating.
According to more recent German data, much of this too can
be recovered..

SCHER also noted that it is only in recent years that
3.6
analytical techniques have become sufficiently sophisticated to
detect and reliably determine PFOS concentrations in environ-
mental samples. It is therefore difficult to track changes due to
the above reductions. SCHER could however conclude that
emissions from the ongoing uses for which derogations are
proposed will affect PFOS concentrations only on the local
level and will insignificantly affect the overall concentration in
the environment. More specifically, SCHER concluded that the
overall risks for the environment and the general public were
negligible with regard to their continuing use in the photo-
graphic, semiconductor and aviation industries. Usage in the
plating industry was however a cause for concern and should
be restricted.

it

is difficult

3.7
Occupational hazards for each of the sectors require
separate assessments. However, in the case of the photographic,
semiconductor and aviation industries, given the nature of the
industries involved and the high levels of protection already in
place,
to see how the use of PFOS-related
substances would present any additional hazards in the work-
place. Usage in the chromium plating industry is however
again a cause for concern. In the case of fire-fighting foams,
the health and environmental risks of the proposed substitutes
must be assessed before any decision is taken. Proper disposal
routes for existing stocks and for run-off from major fires must
also be agreed.

3.8
The EESC endorses the above and trusts that the neces-
sary actions will be included in the work plans of the Commis-
sion.

4. Specific comments

4.1
The EESC supports the two restrictions on PFOS-related
substances as defined in the proposal, i.e. (1) they may not be
placed on the market or used as a substance or constituent of
preparations equal or higher than 0.1 % by mass and (2) they
may not be placed on the market in products or parts thereof
in a concentration equal or higher than 0.1 % by mass.

3.4
Fully fluorinated short-chain polymers with similar
properties to PFOS-related substances as surfactants but with
lower or negligible impacts on human health and the environ-
ment can be made by a process known as ‘telomerisation’.
These products (‘telomers’) are not the subject of this proposal.

The EESC also supports the derogation in paragraph (3)
4.2
that paragraphs (1) and (2) above shall not apply in the six
specific cases set out in the proposal and discussed in the para-
graphs following.

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this is, broadly,

Photolithography:

4.2.1
the process by
which computer chips are patterned. New developments in
semiconductor manufacture require specialised process fluids to
allow the patterning to take place with very high reliability,
density and uniformity. The PFOS-related substances provide
unique electrochemical and surfactant properties and are
regarded as ‘mission critical’ by the semiconductor industry.
The process fluids, which do not remain in the finished
products, are subject to rigorous specification and testing for
each technology at each plant of every manufacturer. Used in
‘clean room’ manufacturing environments where all contamina-
tion must be eliminated, there is no possibility of workplace
exposure. According to a 2002 mass balance for the industry,
total emissions were below 45 kg per year. Product develop-
ment times are up to 10 years. Despite extensive global R&D,
no substitutes have been identified for these remaining uses.
The most probable route for the removal of PFOS-related
substances could be a new method of chip manufacture, yet to
be invented. In the absence of this derogation, manufacture
could not take place in the EU, although it could be continued
without difficulty elsewhere. Given all of the above, and in the
absence of any new evidence for concern, the EESC recom-
mends that no time limit should be set for the removal of this
derogation.

4.2.2
Photographic coatings: PFOS-related substances are
purchased in concentrated solutions then extensively diluted to
provide a range of properties essential
for both workplace
health and safety and overall product performance control in
specialist photo imaging applications. These desired properties
friction and adhesion
include electrostatic charge control,
control, dirt repellence and other surfactant properties for high
performance imaging. Production techniques require as many
as 18 imaging layers to be applied on to a fast moving film
base to provide a uniform layer typically less than 0.11 mm
thick. The fluids used must not be photoactive but must allow
even spreading and good adhesion of subsequent layers. The
antistatic properties are essential to minimise the risk of fire or
explosion and subsequent injury to employees or to operating
equipment. Usage of PFOS-related substances has been reduced
by at least 60 % in recent years by substitution in less critical
applications and by the overall decline in film usage v. digital
for many consumer, health and industrial applications. The
remaining usages contribute less than 8 kg to the environment
per year. It is likely that further moves towards digital will
result in continuing decreases in the quantities required for film
manufacture, although demand for photographic paper,
for
instance, for printing digital images, is expected to continue.
Despite extensive research, no replacements have been identi-
fied for these few remaining uses of PFOS-related substances.
New processes, not yet invented, requiring 10 years or more to
develop,
test and accredit, will be required to
complete the process. In the absence of this derogation, manu-
facture could not take place in the EU although could be
continued without difficulty elsewhere. Given all of the above,
and in the absence of any new evidence for concern, the EESC
recommends that no time limit should be set for the removal
of this derogation.

implement,

4.2.3 Mist suppressants for chromium plating: PFOS-
related substances in dilute solution protect the health and
safety of workers engaged in the decorative and protective
chromium plating of metal or plastic substrates for the automo-
bile and other consumer-driven industries. They also act as
in particular in
surface tension reducers and wetting agents,
plastics etching. The working environment
for chromium
plating is recognised to be harsh and potentially dangerous, in
particular in processes based on Cr(VI), a known carcinogen.
The suppression of mists and increased human exposure is
therefore essential. The situation can be improved through the
use of processes based on Cr(III) but these are not yet fully
available. Only PFOS-based surfactants have so far proved to be
stable in either of these circumstances. Annual usage in Europe
in 2000, according to SCHER, was around 10 tonnes. Estimates
of the total annual release to the environment differ consider-
ably, depending on the processes used and the degree to which
these are controlled with respect to emissions, recycling and
waste incineration. A German industry estimate, based on local
best practice, suggests that total emissions could be as low as
500 kg per year if extrapolated across Europe. If less good
technology and controls are used,
the emissions could be
higher. Given that chromium plating is the largest remaining
ongoing use of PFOS-related substances, and that the tech-
nology is evolving and to some extent alternatives are already
available, it seems appropriate that a time limit should be set
for this proposed derogation and further, that, as suggested by
SCHER, occupational exposure analyses and longer term assess-
ments of the risk to the environment should be conducted
without delay. These should be undertaken in cooperation with
the industry to ensure that manufacturing can continue in the
EU. There is no incentive to drive out one critical stage of auto-
mobile manufacture, with the obvious risk that the remaining
production would eventually follow. Neither should any prema-
ture
lead to
increased risks for worker health. The EESC recommends that
this derogation should apply for a period of five years only
before review by the Commission and SCHER.

removal of PFOS-related mist

suppressants

safety, under

Hydraulic fluids for aviation: these are the fluids
4.2.4
used to drive the control surfaces and other components of
commercial, military and general aviation aeroplanes. They are
used, and must continue to function on a daily basis to the
highest possible operating standards to maintain aircraft and
the most extreme conditions of
passenger
temperature and pressure. The business is global, and products,
components and systems are subject to extensive testing and
certification by aircraft manufacturers and by relevant national
and international bodies. A typical approval cycle for a new
formulation can take up to 20 years. PFOS-related substances
are used in small quantities (around 0.1 % by mass) to provide
erosion resistance for mechanical parts, valves,
tubes and
orifices. Despite extensive testing, no substitutes or, to date,
any indications of possible substitutes, have been found. They
are used in closed systems under tightly controlled conditions.
Total releases to soil and water were estimated by SCHER to be
below 15 kg per year. Given all of the above, and in the

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absence of any new evidence for concern, the EESC recom-
mends that no time limit should be set for the removal of this
derogation.

4.2.5
Fire-fighting foams: fluorinated surfactants have been
used in high-specification fire-fighting foams for many years.
PFOS-related substances have been largely replaced in new
foams manufactured to replace stocks used to extinguish actual
fires or to provide stocks for new developments, airports,
petroleum refineries and chemical plants, marine vessels and
tank farms. However, the health and environmental impact of
these alternative products has not yet been fully assessed. All
foams have to be sold with 15-20 year guarantees, as ideally
they are never used. Significant stocks of PFOS-containing
foams therefore still exist and disposal of these stocks is now
the key issue. The surfactants must allow water-based foams to
spread quickly on the surface of the burning hydrocarbons,
rather than sinking below them, in order to cut off the supply
of oxygen and prevent burn-back. Both surfactants and foams
must be stable under intense conditions of use and both must
resist oxidation. Performance standards for foams for different
fire scenarios are set by national and international bodies.
Stocks of 3 % or 6 % concentrates are stored in central depots,
for distribution and dilution on site when a fire occurs. Large
volumes may be required and the problems of waste disposal
of the run-off after the fire may be considerable. The run-off is
inevitably contaminated by the products that were on fire, by
the by-products of uncontrolled low temperature carbon incin-
eration (polyaromatic hydrocarbons (PAHs) and dioxins) and by
the components of the foams. The recent fire in a storage
depot in Buncefield, UK, for instance, has left a residue of 20
million litres of contaminated waste. High temperature incin-
eration is the only assured approach, but this is inefficient and
costly where the bulk of the material is water. Annual emis-
sions to the environment are therefore hard to determine,
being dependent on the number, scale and circumstances of
each fire, and critically on the extent to which the run-off can

Brussels, 17 May 2006.

be contained by bund walls. SCHER quoted an annual release
in the EU of under 600 kg and noted that this could overstate
actual releases. The EESC agrees with SCHER that the existing
stocks of PFOS-based foam concentrates should not be inciner-
ated until the alternatives have been fully evaluated. The EESC
therefore recommends that
the necessary impact and risk
assessments should be undertaken as quickly as possible and
that remaining PFOS-based foams should be used only where
essential on performance grounds and where the run-off can be
contained by bund walls. The Commission should work with
the industry and with national competent authorities to ensure
that there are adequate disposal routes for the large volumes of
the EESC
waste generated. Given the many uncertainties,
believes that there is no point in setting a time limit for the
removal of this derogation, but every point in resolving the
outstanding questions as fast as possible.

4.2.6 Other controlled closed systems: this is, or should
be, a standard derogation for the majority of substances subject
to EU marketing and use restrictions. Provided that raw mate-
rials can be safely delivered to the system, and products and
waste products safely removed, then very low emission systems
allow continuing manufacture of essential intermediates with
minimal risk to human health or the environment. Workplace
reviews of
the operating conditions should be undertaken
under routine health and safety inspection. In the absence of
any new evidence of concern, the EESC recommends that no
time limit should be set for the removal of this derogation.

4.3
The Commission will continue to have a key role in
ensuring a satisfactory outcome in each of the above sectors. A
in and
continuing programme of research will be required,
outside the affected sectors to develop alternative products and
processes. The Directives affecting these sectors should be
modified when necessary to reflect changes in current or
proposed global practice.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND