Opinion of the European Economic and Social Committee on the Proposal for a Decision of the European parliament and of the Council amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of certain dangerous substances and preparations 2-(2-methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate COM(2007) 559 final — 2007/0200 (COD)
Date: 2008-03-12
Institutions: European Economic and Social Committee
Subjects: chemical product, dangerous substance, health risk, marketing restriction, paints and varnishes

9.8.2008

EN

Official Journal of the European Union

C 204/13

Opinion of the European Economic and Social Committee on the Proposal for a Decision of the
European parliament and of the Council amending Council Directive 76/769/EEC as regards restric-
tions on the marketing and use of certain dangerous substances and preparations 2-(2-methox-
yethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and
ammonium nitrate

COM(2007) 559 final — 2007/0200 (COD)

(2008/C 204/03)

On 23 October 2007, the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the

Proposal for a Decision of the European parliament and of the Council amending Council Directive 76/769/EEC as
regards restrictions on the marketing and use of certain dangerous substances and preparations 2-(2-methoxyethoxy)
ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate

The Section for Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 27 February 2008. The rapporteur was Mr Sears.

At its 443th plenary session, held on 12 and 13 March 2008 (meeting of 12 March), the European
Economic and Social Committee adopted the following opinion by 125 votes with 2 abstentions.

1. Conclusions and recommendations

their obligation to provide relevant information in a timely
fashion during the risk assessment. Without this discipline, the
outcomes rapidly become meaningless.

1.1
This proposal from the Commission for a Decision of
the European Parliament and Council seeks to amend Council
Directive 76/769/EEC by adding restrictions on the marketing
and use of
these were
five unrelated substances. Four of
contained in the original priority lists set out between 1994 and
2000. The measures proposed address risks to the general
is intro-
public only. The last substance, ammonium nitrate,
duced under this heading to improve the safety of ammonium
nitrate based fertilisers during normal handling by farmers and
distributors, and as a move to combat terrorism, in particular
by limiting access to explosive precursors. In this later case,
sales to retailers and to the general public will also be affected.

1.2
The EESC supports some but not all of the proposals
made. The detailed arguments for each substance and the
preparations in which they are contained are set out in para-
graphs 5 to 9.9.

The EESC recognises that this is, almost, the last such
1.3
amendment of Council Directive 76/769/EEC before it
is
replaced on 1 June 2009 by Regulation (EC) 1907/2006
(REACH). However, as with previous amendments, it regrets that
unrelated substances and preparations have been brought
together in this manner and notes the long delays that have
occurred since these were first noted as ‘priority’ substances
under Council Regulation (EEC) 793/93.
this is due to
resource or skill constraints in the Commission or in other rele-
vant bodies, including the newly formed Chemicals Agency in
Helsinki,
these must be addressed as soon as possible and
certainly before 1 June 2009. Manufacturers must also recognise

If

1.4
Finally the EESC clearly supports the Council's Declara-
tion on Combating Terrorism and the many individual actions
that follow from this. The EESC believes that it has a key role to
play in this process and is currently developing a number of
Opinions on this topic. Agreeing what actions are proportionate
and which legislative routes should be followed to ensure timely
and effective responses from all those affected will be critical to
achieving long term security.

2. Introduction

Regulation (EC) No 1907/2006 of 18 December 2006 of
2.1
the European Parliament and of the Council concerning the
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) will come into effect on 1 June 2009. This
will repeal and replace a number of existing Council and
Commission Regulations and Directives,
including Council
Directive 76/769/EEC of 27 July 1976 on the marketing and
use of certain dangerous substances and preparations. This
Directive, to which this proposal is an amendment, is designed
to preserve the Internal Market and at the same time ensure a
high level of protection of human health and the environment.

2.2
Annex I of Council Directive 76/769/EEC sets out the
specific restrictions on the marketing and use of certain
dangerous substances and preparations that have been agreed

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and put in place over the last 30 years. On 1 June 2009 these
will become the cornerstone of Annex XVII of Regulation (EC)
No 1907/2006 (REACH).

2.3
Previous amendments to Council Directive 76/769/EEC
(i.e., to add further restrictive measures) have been in the form
of Directives requiring implementation by Member States. This
proposal by the Commission is, for a Decision, which will not
require transposition into national laws which would otherwise
have to be repealed on 1 June 2009 when Regulation EC No
1907/2006 (REACH) comes into force.

It

2.4
is understood that a final proposal under Council
Directive 76/769/EEC will be brought forward in the coming
months, also for a Decision, on restrictions on the marketing
and use of dichloromethane. All subsequent proposals for
restrictions on the marketing and use of dangerous substances
or preparations will be under Regulation EC No 1907/2006
(REACH).

The substances (and any preparations containing them)
2.5
for which restrictions on marketing and use have been deemed
necessary have generally resulted from evaluations of certain
‘priority substances’ under Council Regulation (EEC) 793/93.
Four priority lists for assessment were established, the last of
these being dated 30 October 2000, for implementation by the
competent authorities
the 141
in the member
substances
listed, 83 have final Risk Assessment Reports
(RARs). 39 of these have been evaluated by the appropriate
scientific committees of the EU and the results published in the
Official Journal. Restrictive measures have been agreed for 22 of
these substances. Restrictive measures for a further 4 substances
(identified and discussed below in paragraphs 5 to 9.9 as
DEGME, DEGBE, MDI and cyclohexane) are included in this
proposal.

states. Of

2.6
The slow progress made under this Regulation was cited
as one of the main reasons for introducing a new approach for
all
‘existing’ substances under Regulation EC No 1907/2006
(REACH). Council Regulation (EEC) 793/93 will therefore also
be repealed on 1 June 2009.

2.7
A number of substances not included in the original four
priority lists have also been assessed for their impact on human
health and the environment, and/or proposals made to restrict
their marketing and use, as new problems have been addressed
at the request of
the member states. Ammonium nitrate is
included under this heading.

consumers for domestic scale application. Unfortunately it is
also an effective, low cost and widely used component of explo-
sives, for legitimate use in industrial or military blasting and for
illegitimate use by terrorists. It is on these grounds that restric-
tions on its marketing and use are sought under Council Direc-
tive 76/769/EEC.

2.9
Other bases for legislation addressing terrorism or explo-
sive precursors could have been chosen, but, under the existing
EU Treaty, would have required unanimity across the member
states. The process will change under the Treaty of Lisbon, when
fully ratified, but that too will not be for some time.

2.10
It is understood that other drug and explosive precur-
sors are likely to be added to Annex XVII of Regulation EC No
1907/2006 (REACH), therefore this course of action is deemed
appropriate at the present time.

2.11
All of the above refers to ‘existing’ substances, i.e., the
100,195 substances that were deemed to have been on the
European Community market between 1 January 1971 and 18
September 1981. These are listed in the European Inventory of
Existing Commercial Chemical Substances (EINECS) published
in the Official Journal of the EU in 1990. Substances placed on
the market after 18 September 1981 are defined to be ‘new’ and
require a detailed pre-marketing notification in order to protect
human health and the environment.

3. Summary of the Commission's proposal

The Commission's proposal seeks to protect human
3.1
health, in particular of consumers, whilst preserving the Internal
Market for three substances (DEGME, DEGBE and cyclohexane)
taken from the 1st priority list, dated 25 May 1994, and one
substance (MDI) from the 3rd priority list, dated 27 January
1997, as established under Council Regulation (EEC) 793/93.

In

line

with

Commission

3.2
Recommendation
1999/721/EEC of 12 October 1999, and with subsequent
similar Recommendations on the results of the risk evaluation
and risk reduction strategies for a number of substances, a series
of specific and very detailed restrictions are proposed which will
apply only to sales to the general public and will not have any
impact on conditions in the work place or on the environment.
The costs to industry and to society at large are believed to be
minimal and therefore the actions proposed are believed to be
proportionate to the risks identified. Further health data are
requested in the case of preparations containing MDI.

2.8
Ammonium nitrate is a peculiar and particular case in
that its characteristics are well known and it did not therefore
require evaluation for its effects on human health or the envir-
onment. It has been used for many years in very large quantities
world-wide as a nitrogen-based fertiliser and poses no unex-
pected risks in the work place or to professional users or to

3.3
A fifth substance, ammonium nitrate, used widely as a
fertiliser, is added because of its ability to act as an oxidant and,
in particular to explode when mixed with other substances. The
restrictions proposed are intended to ensure that all ammonium
nitrate fertilisers meet a common safety standard and in addition

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to limit the range of ammonium nitrate based products sold to
the general public with the aim of reducing the quantities that
can be easily diverted into illegal uses. Thus the restriction may
be said to benefit the health and safety of the public at large.
Professional users (farmers and legitimate manufacturers of
explosives) will not be affected by this restriction. Although the
costs (and benefits) are proving difficult to quantify, they are
believed to be proportionate to the risks
identified (and
measures proposed).

paints or paint strippers in concentrations equal or higher than
0.1 % by mass (i.e., at anything above levels caused by contami-
nation of or co-production in other permitted constituents).
This is seen as being a reasonable response by the industry
sectors affected. The EESC therefore supports this limitation on
the marketing and use of DEGME.

3.4
The Decision would come into force on the third day
following that of its publication in the Official Journal of the
EU.

6. 2-(2-butoxyethoxy)ethanol (DEGBE)

for

report) and,

3.5
The proposal is accompanied by an explanatory memor-
andum, a Commission staff working document (impact assess-
the four substances assessed under
ment
Council Regulation (EEC) 793/93,
lengthy and detailed Risk
Assessment Reports (RARs) published by the European Chemi-
cals Bureau, together with additional material, both supportive
and critical, from the various scientific committees and other
bodies that have helped prepare or evaluate the relevant data.

4. General comments

As with many of the previous amendments to Council
this proposal deals with unrelated

4.1
Directive 76/769/EEC,
substances which, for clarity, will be discussed separately.

5. 2-(2-methoxyethoxy)ethanol (DEGME)

5.1
DEGME is a high boiling glycol ether miscible with
water, typically used as an intermediate in synthetic chemistry,
as co-solvent in various household decorative products, or as a
fuel.
low temperature anti-icing agent,
According to the RAR prepared for the Dutch Government and
completed in July 1999, total production in Europe at the start
of the 1990s was around 20 000 tonnes, of which just over
half was for export.

instance in jet

for

Consumer exposure resulted from its use in paints and
5.2
‘do it
paint strippers supplied for domestic non-professional
yourself’
(DYI) application. As would be anticipated from its
physical properties, DEGME is readily absorbed through the skin
and, in the absence of any regular and guaranteed use of protec-
tive clothing, there was a risk to consumers via dermal expo-
sure.

5.3
According to the most recent surveys, DEGME has now
been replaced by other solvents in all paints and paint strippers
sold to the general public. Therefore the appropriate action is to
ensure that this situation continues for products manufactured
in, or imported to, the EU. The proposal therefore ensures that,
from 18 months after the entry into force of the Decision,
DEGME shall not be placed on the market as a constituent in

6.1
DEGBE is also a member of the glycol ether family, with
a slightly higher boiling point than DEGME but with similar
physical properties, including miscibility with water. It is widely
used as a solvent in water-borne paints where it helps film
formation and increases durability. This in turn reduces the
frequency of painting and limits overall exposures. The RAR
estimated total production in Europe to be around 46 000
tonnes in 1994; by 2000 this had increased to 58 000 tonnes,
of which 33 000 tonnes were used in paints.

6.2
The RAR identified some risks to consumers of respira-
tory irritation following the inhalation of fine droplets during
the use of water-borne spray paints containing DEGBE. Inhala-
tion of vapour arising from brush or roller applications was not
of toxicological concern.

6.3
Based on evidence submitted after the completion of the
RAR in 1999, and recognising the difficulty of replacing DEGBE
as a vital component in water-borne paints, it was concluded
that the fixing of a maximum level of 3 % by mass for DEGBE
in paints designed for spray application would be appropriate to
protect the health of consumers. Paints with higher concentra-
tions of DEGBE may be placed on the market for supply to the
general public, but only with the marking ‘Do not use in paint
spraying equipment’. Sales to professional users, who are more
likely to use the appropriate protective equipment, will be unaf-
fected. The distribution channels are regarded as being suffi-
ciently different to make this possible.

6.4
These measures will become effective 18-24 months
after the Decision comes into force to allow time for any refor-
mulation and re-labelling required. This is seen as being a
reasonable response by the industry sectors affected. The EESC
therefore supports this limitation on the marketing and use of
DEGBE as being the appropriate way to protect the health of
consumers and to preserve the Internal Market.

7. Methylenediphenyl Diisocyanate (MDI)

7.1 MDI is the name given to a mix of similar products
(isomers) which if pure would exist as waxy solids but are more
generally available as a highly reactive viscous brown liquid.
According to the RAR, worldwide production in 1996 exceeded
2 500 000 tonnes, of which at least 500 000 tonnes were

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produced in the EU. In the presence of suitable low weight
polyols or glycols (or even water) and a blowing agent, MDI
reacts extremely rapidly to produce polyurethane foams. These
can be either rigid or flexible with a wide range of uses in the
building and other trades as structural components, sealers,
fillers, moulds and adhesives.

against all possible gaseous exposures would cost around ten
times the cost of the can, with no guarantee that it would be
used when required.

7.2
Consumer exposure comes primarily from the use of
one-component foams (OCF), sold in spray cans to DIY enthu-
siasts to fill irregular holes in plaster or brick work or to seal
around newly installed doors or windows. Total sales to this
sector are around 10 000 tonnes per annum of MDI. This is
sufficient for the production of around 36 million cans per year
for consumers and a further 134 million cans per year for
professionals. Alternative products — for instance glass fibre to
seal around windows — are less convenient to use and would
bring a different set of concerns.

7.3
Quantifying the risks to consumers for dermal and
respiratory exposure and sensitisation, based on evidence from
work place exposures, has not proved easy. Pure samples of the
isomers are hard to obtain. The very rapid reaction of MDI with
water to make an inert insoluble solid makes standard hazard
testing difficult. The practical application route for a consumer
of spraying via a directional tube from a small hand-held can
limits the total amount available. A standard can is emptied in
2-4 minutes. Rapid curing in the presence of water vapour in
the air removes the MDI. The solid end product is inert and
non-hazardous. Usage is likely to be once-off (to fill or seal a
particular hole, door or window) and infrequent
(for most
users) and certainly does not replicate daily exposures under
shop floor conditions. As ever in DIY applications, personal
protective equipment may or may not be routinely used.

Given the above,

7.4
it is not surprising that, although a
theoretical risk exists, it has proved difficult or even impossible
to identify any cases of actual dermal or respiratory sensitisation
in the public at large (or indeed in the work place where appro-
priate protective measures can be put in place). This in turn
means that identifying a proportionate, cost-effective, and prac-
tical response is more difficult.

7.6
The Commission therefore proposes that all cans sold to
the general public should contain polyethylene gloves (for
instance, folded into the cap) and that the can should be suitably
labelled with respect to the dangers of allergic (non-standard)
reactions to MDI from those already sensitised, or of asthma
like reactions (from asthma sufferers) or of dermal reactions
(from those already suffering from skin problems).

The EESC supports the first of these measures, i.e., the
7.7
provision of polyethylene gloves which should be worn in any
case for most DIY applications. Any requirement for these to
conform to a more stringent standard which would prevent the
gloves from being distributed should be resisted if this impor-
tant and proportionate measure is to remain enforceable.

7.8
The EESC questions however the detail of the proposed
additional labelling, even if due time is given to allow this to be
introduced at proportionate cost. It is unclear, for instance, how
a member of the general public would know that they had been
‘sensitised to diisocyanates other than MDI’ — or why that is
particularly important. As sufferers from chronic (long term)
asthma or dermatitis will be aware, almost any household or
DYI product can bring about an acute (short term) adverse reac-
tion. In these circumstances, the importance of good ventilation
and the use of protective clothing (gloves) are all important —
together with advice to cease any use of the product immedi-
ately if the symptoms occur. This is good advice for all users,
whatever their past history, and must be included on the label.
Given that the cans, and therefore their labels, are small, all such
advice must be clear, to the point and legible under normal
conditions of use. If further handling or safety instructions are
required, these should be included in any accompanying leaflet.

7.5
In this respect the impact assessment reasonably points
out that whilst light weight, cheap and perfectly adequate poly-
ethylene gloves can, and should, be provided with each can sold
to the general public for once-off occasional use, heavy duty
neoprene or nitrile gloves, as required for industrial applications,
can not.
light-weight cotton dust masks
could be supplied with each can, they would be ineffective in
the case of actual risk — whereas a full gas mask to protect

In contrast, whilst

7.9
The EESC also questions the proposal in indent (6) that
‘natural or legal persons placing on the market for the first time
preparations containing MDI … shall within 3 years collect data
on possible cases of persons suffering from respiratory allergy
… and make these data available to the Commission .. in accord
with a study protocol that shall involve specialised centres …to
demonstrate that there is no need for further restrictions’. Given
that MDI has been in routine use since the 1970s, and that, as
noted above, current sales exceed 36 million cans per year from
existing manufacturers who are excluded from this requirement,
it is difficult to see this as being anything other than a poorly
justified bar to market entry.

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7.10
The Commission's impact assessment report explains
that this follows from a concern expressed in the RAR that
‘some risks for respiratory allergy for workers … could poten-
tially be relevant for consumers’. Later in the same paragraph it
states that ‘information currently available from poison centres
seems to indicate that there are no or few cases of respiratory
allergy of consumers caused by MDI containing products’.
Whatever the alleged limitations of this reporting route, it is
unclear that the proposal by the Commission would be any
more definitive. This proposal therefore seems disproportionate
to a risk that is acknowledged to be hypothetical and which
lacks any supporting evidence following actual widespread use.

7.11
The EESC therefore recommends that this part of the
restriction on marketing and use is withdrawn. If there are still
valid doubts over the safety of these products, which cannot in
the short term be replaced, these should be explored with the
manufacturers and proper processes for the collection of data
and for their evaluation followed.

8. Cyclohexane

large scale. A limitation on package size for the products sold to
the general public would therefore seem appropriate and gener-
ally acceptable.

The Commission therefore proposes that cyclohexane
8.4
shall not be placed on the market as a component of neoprene-
based adhesives for sale to the general public in packages of
more than 650 grams. Any packages sold should be marked
‘Do not use for carpet laying’ and should show a warning ‘Do
not use under conditions of poor ventilation’.

Practical tests for worst case scenarios, for instance fixing
8.5
large cork panels to an interior wall, suggest that this would
adequately limit consumer exposures which, as in the other
cases discussed above, would be expected to be infrequent and
short-lived. There appears to be no evidence of actual incidents
being reported from the use of neoprene-based adhesives
despite their wide-spread and long term use. The measures can
however be introduced without undue disruption to either
manufacturers or consumers. The EESC therefore supports this
limitation on the marketing and use of cyclohexane as being
proportionate to the risks discussed.

Cyclohexane is colourless liquid made in very large quan-
8.1
tities by the hydrogenation of benzene.
It is almost entirely
(>95 %) used in the synthesis of adipic acid and, from that,
nylon. World wide production capacity currently exceeds
5 000 000 tonnes, of which around 1 500 000 tonnes is
located in the EU. These processes are in closed systems and
exposure levels are low. Cyclohexane also occurs naturally in
combustion products,
in crude oil
and plants, and in gasoline vapours.

including tobacco smoke,

8.2
Cyclohexane is also used as a solvent for, amongst other
things, the neoprene-based contact adhesives used in the leather
(shoes), automobile and construction industries. This in turn
includes large scale carpet laying by professionals and similar
smaller scale repairs or other DIY applications by the general
public. Total usage in adhesives in the EU is less than 10 000
tonnes per year.

8.3
As with all hydrocarbons, good ventilation and the use
of appropriate protective clothing or breathing equipment is
essential. This can be reasonably guaranteed for professional
use, but not
the public. However, as with
preparations including MDI, the physical characteristics of the
products marketed significantly limit the risks. The fast-setting
contact adhesives are ideal for small applications but are extre-
mely difficult for a non-professional to use satisfactorily on a

for members of

9. Ammonium Nitrate

9.1
Ammonium nitrate is a white solid, sold in pellets, that
has been produced from ammonia from natural gas for more
than 100 years. World-wide production exceeds 20 000 000
tonnes. It is important as a nitrogen fertiliser and as a raw mate-
rial for explosives. This latter capability and its ready availability
and low cost have attracted the interest of
terrorists. Other
components are required, for instance diesel oil, but these too
are easy to acquire. Ammonium nitrate was for many years the
explosive of choice for the IRA and was also used in high
profile bombings in Oklahoma, the World Trade Centre and
Bali. It has recently been used in attacks by extremist groups
operating in London and other European capitals. Recipes for
the production of such devices are readily available on the
internet. As little as 2 kg can prove devastating. Quantities in
excess of 500 kg can seemingly be obtained without difficulty
by determined members of the general public, if necessary by
the repeat buying of smaller quantities from garden shops or
retail stores. Controlling this is clearly difficult.

For professional users (farmers) control is exercised via
9.2
maintaining large minimum sizes of shipment (so that a single
package cannot easily be transported or removed illegally) and
by requiring careful product stewardship at all stages of the

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supply chain. Ammonium nitrate as generally supplied is
unstable and may decompose and become unusable. It must
therefore be stored carefully and applied to the ground as soon
as possible. This limits the amounts available for diversion to
other uses.

(SCEEP). A number of private and public sector specialists are
involved in this, with inputs from CEFIC and FECC, representing
chemical manufacturers and distributors, and EFMA representing
fertiliser manufacturers.

Ammonium nitrate may be supplied in a number of
9.3
strengths ( % nitrogen content) and with or without other essen-
tial elements (typically phosphorus and potassium derivatives).
In its pure state it is approximately 35 % nitrogen. Some dilu-
tion is necessary to avoid damage to vegetation. The different
qualities may be manufactured by blending in active compo-
nents or inert fillers, such as chalk, or by chemical reactions to
produce the desired ratio of key ingredients. Products sold to
farmers may have 28 % or more of nitrogen. These ‘high
nitrogen’ fertilisers are subject to controls under Regulation (EC)
No 2003/2003 to ensure that they deliver the required quantity
of nitrogen and can be safely used without the risk of explosion.
Fertilisers conforming to these standards can be labelled as ‘EC
fertilisers’ and can be traded across national borders. Fertilisers
that do not meet these standards cannot cross borders and are
known as ‘national fertilisers’. Consumer products typically have
20-25 % nitrogen. The lower the percentage of nitrogen, the
higher the transport costs per unit of fertiliser and the greater
volume that must be applied to a given area. Although ammo-
nium nitrate fertilisers are regarded as essential for commercial
farming, this is not the case for the much smaller volumes sold
via retail outlets to the general public, and other products may
be substituted.

the higher

From the point of view of anyone seeking to make illegal
9.4
explosives,
the nitrogen content of ammonium
nitrate the better. Mechanically blended mixes can be re-concen-
trated via simple solution and crystallisation. Chemically bound
mixes are harder or impossible to concentrate. Concentrations
as low as 16 % have been made to explode by government
experts in Denmark. Given time and resource anything is
possible, although competing formulations using equally avail-
able raw materials eventually become more attractive. These are
set out
in the Terrorist's Handbook and other web-based
resources available to the general public.

agreed

Following the Madrid bombings in March 2004,

the
9.5
European Council
a Declaration on Combating
Terrorism. This set up an Explosives Security Experts Task Force
(ESETF) charged with developing an Action Plan to combat the
use of explosive devices by terrorists. This was completed in
June 2007. One of the 47 specific actions required the setting
up of a Standing Committee of Experts on Explosive Precursors

The intent of the current proposal is to bring all ammo-
9.6
nium nitrate fertilisers sold to farmers (or distributors) up to the
standards set out in Regulation (EC) No 2003/2003 and to limit
the nitrogen content of products sold to the general public. If
adopted, ammonium nitrate could not be placed on the market
for supply to the general public from 18 months of the Deci-
sion coming into force ‘as a substance or in preparations that
contain 20 % or more by mass of nitrogen in relation to ammo-
nium nitrate’.

9.7
The EESC fully supports the first part of this proposal
that all ‘high nitrogen’ fertilisers supplied to farmers, whether or
not traded across national borders, should comply with Regu-
lation (EC) No 2003/2003.

9.8 With regard to the second limitation, with respect to
sales to the general public, the EESC notes that the volumes
concerned may be larger than previously thought, at more than
50 000 tonnes and that EFMA, acting for fertiliser manufac-
turers, has accepted the 20 % limit for blended fertilisers (which
could be re-concentrated without too much difficulty) but has
proposed a limit of 24,5 % for chemically bound products
(where this is much harder). Given that discussions are ongoing
within SCEEP, this and any related possibilities need to be fully
explored before the Decision is finalised. Whatever else is
known about countering terrorism, it is clear that full agreement
and commitment between the various stakeholders, in this case
including manufacturers, distributors,
retail outlets and the
general public, will be essential if real progress is to be made on
limiting access to explosive precursors.

9.9
The EESC accepts with some reluctance that Council
Directive 76/769/EEC is the only basis for legislation available
to the Commission in the short term, and that therefore the
measures have to be proposed and discussed in this manner. It
is to be hoped that a better system can be put in place, once the
Lisbon Treaty has been fully ratified.

10. Specific comments

The EESC regrets, as it has done in its Opinions on
10.1
previous amendments to Council Directive 76/769/EEC, that
these continue to bring together unrelated products on which
quite separate decisions must be taken. This is not good practice

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and serves no useful purpose. It is certainly not an example of
good governance. It can only be hoped that an improved proce-
dure will be in place from 1 June 2009 under Regulation (EC)
No 1907/2006 (REACH).

10.2
The EESC also notes the long time taken to bring these
to fruition. The first priority list was published in May 1994.
Even if this proposal is fast-tracked as desired, there will be little
impact on the market until the end of 2010 (and indeed even
it is difficult to see that any improvements in human
then,
health will be recorded).
It is also difficult to portray these
delays as being entirely due to the manufacturers who were
required to supply the data upon which the RARs are based, as
these have been available for some time. If this is due to lack of
resource within the Commission or its scientific committees or
other bodies or agencies responsible for the safety of the general

public, this must clearly be addressed before a much greater
work load, largely unprioritised, becomes evident from 1 June
2009 onwards.

10.3
The EESC clearly supports the Council's 2004 Declara-
tion on Combating Terrorism and the various actions that have
followed from this, and believes that civil society has a key role
to play in this. It therefore hopes to be considered a valid and
useful
interlocutor and stakeholder in this process and notes
that a number of related Opinions are currently being prepared
on this topic. Agreeing what actions are proportionate and
which legislative routes should be followed to ensure timely and
effective responses from all those affected will be critical to
achieving long term peace and security within and around the
EU.

Brussels, 12 March 2008.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

Opinion of the European Economic and Social Committee on the Proposal for a Council Regulation
setting up the Fuel Cells and Hydrogen Joint Undertaking

COM(2007) 571 final — 2007/0211 (CNS)

(2008/C 204/04)

On 30 November 2007 the Council decided to consult the European Economic and Social Committee,
under Article 95 of the Treaty establishing the European Community, on the

Proposal for a Council Regulation setting up the Fuel Cells and Hydrogen Joint Undertaking

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 27 February 2008. The rapporteur was Mr Dantin.

At its 443rd plenary session, held on 12 and 13 March 2008 (meeting of 12 March), the European
Economic and Social Committee adopted the following opinion by 117 votes, with 7 abstentions.

1. Conclusions and recommendations

concerning,
development.

in particular,

the environment and sustainable

1.1
The Committee welcomes the decision on setting up the
Fuel Cells and Hydrogen Joint Undertaking. It considers that this
approach to relaunching investment in R&D has the potential to
give European businesses a stable frame of reference, making it
possible to overcome the current fragmentation of Community
financing and coordinate research, which is often too widely
dispersed, thereby helping to make it more effective.

In welcoming the decision under discussion, the EESC
1.3
wishes firstly to underline the importance for the EU of the
strategy being proposed for investment and coordination of
research.
In so doing, the Committee feels that the strategy
strongly supports the creation of a European research area.

1.2
It welcomes the choice of this sector, which ties in with
the Lisbon strategy, with the Barcelona objectives on funds
devoted to R&D, and also with other Community policies

However,

1.4
the multiplicity of sources of
funding, the number of stakeholders and the substantial Com-
munity resources involved, the use and ownership of the end

in view of