Decision No 1348/2008/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 2-(2-methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate (Text with EEA relevance)
Date: 2008-12-16
Institutions: Council of the European Union, European Parliament
Subjects: chemical product, dangerous substance, health risk, marketing restriction

L 348/108

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DECISIONS ADOPTED JOINTLY BY THE EUROPEAN PARLIAMENT AND THE
COUNCIL

DECISION No 1348/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2008

amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 2-(2-
methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane
and ammonium nitrate

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty
Community, and in particular Article 95 thereof,

establishing the European

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Whereas:

(1)

(2)

(MDI)

(DEGME),

The risks posed to human health by 2-(2-methoxyetho-
2-(2-butoxyethoxy)ethanol
xy)ethanol
(DEGBE), methylenediphenyl diisocyanate
and
cyclohexane have been assessed in accordance with
Council Regulation (EEC) No 793/93 of 23 March
1993 on the evaluation and control of
the risks of
existing substances (3). The risk assessment for all these
chemical substances identified the need to limit the risks
conclusions were
posed to human health. Those
confirmed by the Scientific Committee on Toxicity,
Ecotoxicity and the Environment.

Recommendations

Commission
of
12 October 1999 on the results of the risk evaluation
and on the risk reduction strategies for the substances:
2-(2-butoxyethoxy)ethanol; 2-(2-methoxyethoxy)ethanol;

1999/721/EC

(1) OJ C 204, 9.8.2008, p. 13.
(2) Opinion of

the European Parliament of 9 July 2008 (not yet
published in the Official Journal) and Decision of the Council of
18 November 2008.
(3) OJ L 84, 5.4.1993, p. 1.

chloro;

C10-13,

Benzene,

Alkanes,
C10-13-alkyl
derivs. (4) and 2008/98/EC of 6 December 2007 on
risk reduction measures for the substances: Piperazine;
Cyclohexane; Methylenediphenyl diisocyanate; But-2yne-
1,4-diol; Methyloxirane; Aniline; 2-Ethylhexylacrylate;
3,5-dinitro-2,6-dimethyl-4-tert-
1,4-Dichlorobenzene;
butylacetophenone; Di-(2-ethylhexyl)phthalate;
Phenol;
5-tert-butyl-2.4,6-trinitro-m-xylene (5),
adopted within
the
framework of Regulation (EEC) No 793/93,
proposed a strategy for limiting the risks for DEGME,
and cyclohexane
DEGBE, MDI
recom­
mending
under Council
restriction measures
that
Directive 76/769/EEC of 27 July 1976 on the approx­
imation of
regulations and administrative
provisions of the Member States relating to restrictions
on the marketing
certain dangerous
and use of
substances and preparations (6) must be applied for
preparations containing these substances placed on the
market for supply to the general public.

respectively,

the laws,

(3)

(4)

to protect consumers,

In order
therefore appears
necessary to restrict the placing on the market and the
use of preparations containing DEGME, DEGBE, MDI or
cyclohexane for specific applications.

it

strippers,

cleaning agents,

DEGME is very rarely used as a constituent of consumer
paints, paint
self-shining
emulsions and floor sealants. The aforementioned risk
assessment has shown that there is a risk to the health
of consumers through dermal exposure to paints and
paint-strippers containing DEGME. DEGME used as a
constituent of paints
should
therefore not be placed on the market for supply to
the general public. Even though the use of DEGME as
a constituent of cleaning agents, self-shining emulsions
and floor sealants has not been assessed, it may pose a
similar risk and therefore DEGME used as a constituent
of those preparations should also not be placed on the
market for supply to the general public. A limit value of
0,1 % by mass of DEGME in those preparations should
be adopted for market surveillance purposes.

and paint

strippers

(4) OJ L 292, 13.11.1999, p. 42.
(5) OJ L 33, 7.2.2008, p. 8.
(6) OJ L 262, 27.9.1976, p. 201.

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(5)

(6)

(7)

(8)

DEGBE is used as a constituent of paints and cleaners.
The aforementioned risk assessment
for DEGBE has
shown that there is a risk to the health of consumers
through inhalation exposure during spray painting appli­
cation. A derived safe concentration limit of 3 % for
DEGBE in spray paints should be introduced to prevent
the risk of
inhalation exposure for consumers. Even
though the use of DEGBE as a constituent of spray
cleaners in aerosol dispensers has not been assessed, it
may pose a similar risk and therefore DEGBE used as a
constituent of those cleaners should also not be placed
on the market for supply to the general public in concen­
trations equal to or greater than 3 % by mass. Aerosol
dispensers
should comply with the requirements of
Council Directive 75/324/EEC of 20 May 1975 on the
approximation of the laws of the Member States relating
to aerosol dispensers (1).

For paints other than spray paints, a warning against
using such paints in spraying equipment should be
required where those paints contain DEGBE in a concen­
tration which is equal to or greater than 3 % by mass.

In order to ensure an appropriate phase-out of spray
paints and spray cleaners
in aerosol dispensers not
meeting the concentration limits for DEGBE, different
the
dates
restriction in respect of the first placing on the market
and the final sale for DEGBE in spray paints and spray
cleaners in aerosol dispensers.

should be fixed for

the applicability of

The risk assessment for MDI has shown that there is a
need to limit the risks during consumer applications of
preparations containing MDI due to concerns relating to
inhalation and dermal exposure. To prevent and limit
these risks, the placing on the market for supply to the
general public of preparations containing MDI should be
permitted only under certain conditions such as the
mandatory supply of appropriate protective gloves and
of additional
instructions with the packaging. These
gloves should comply with the requirements of Council
Directive 89/686/EEC of 21 December 1989 on the
the Member States
approximation of
relating to personal protective equipment (2). As the
provision of the protective equipment and the printing
of relevant instructions will require specific efforts by
producers, a longer period of
transition should be
provided.

laws of

the

adhesives

containing cyclohexane for carpet laying and concluded
that restriction measures were necessary to limit the risk
for consumers during such applications. Neoprene-based
contact
should
containing
therefore only be placed on the market for supply to
the general public with a
size.
Harmonised instructions provided with the product
should warn consumers against use under conditions of
poor ventilation or for carpet laying.

reduced package

cyclohexane

(10) Ammonium nitrate, which is widely used throughout the
Community as a fertiliser, can act as an oxidising agent.
In particular,
it has the ability to explode when mixed
with certain other substances. Ammonium nitrate ferti­
lisers should therefore meet certain requirements when
placed on the market to ensure that they are safe against
accidental detonation.

(11)

(12)

the European
Regulation (EC) No 2003/2003 of
the Council of 13 October 2003
Parliament and of
relating
to
harmonised
requirements,
for
ammonium nitrate fertilisers. Fertilisers complying with
those requirements may be labelled ‘EC fertiliser’ and may
circulate freely within the internal market.

fertilisers (3)
including

provides
safety

requirements,

for

to

requirements

For fertilisers intended for sale only within a single
Member State, manufacturers may choose to conform
only
level.
Therefore those fertilisers may not comply with the
safety requirements set at Community level. To ensure
a uniform level of safety within the Community, all
ammonium nitrate fertilisers should therefore conform
to the same safety requirements.

national

existing

at

(13) Annex III to Regulation (EC) No 2003/2003 specifies a
test of resistance to detonation for ammonium nitrate
containing more than 28 % by mass of
fertilisers
nitrogen in relation to ammonium nitrate.
It also
specifies a number of physical characteristics and limits
on the chemical impurity content for such fertilisers in
order to minimise the risk of detonation. Ammonium
nitrate fertilisers that comply with those requirements,
or that contain less than 28 % by mass of nitrogen, are
accepted by all Member States as being safe for use in
agriculture.

(9)

The risk assessment
for cyclohexane focused on the
exposure of consumers during the use of preparations

(14) All ammonium nitrate fertilisers placed on the market
within the Community should therefore conform to the
safety requirements
in Regulation (EC) No
2003/2003.

set out

(1) OJ L 147, 9.6.1975, p. 40.
(2) OJ L 399, 30.12.1989, p. 18.

(3) OJ L 304, 21.11.2003, p. 1.

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types

to fertiliser

(15) Ammonium nitrate fertilisers have been misused for the
illicit manufacture of explosives. Fertiliser types that can
be used for this purpose have a nitrogen content as low
as 16 %. Access
and types of
preparations that contain more than 16 % by mass of
nitrogen in relation to ammonium nitrate
should
therefore be limited to farmers and professional users.
‘farmer’ and ‘agri­
For this purpose,
the concepts of
cultural activity’ need to be defined so that
farming
and other similar professional activities such as the main­
tenance of parks, gardens or sport pitches can still benefit
fertilisers with a higher content of
from the use of
nitrogen. Member States may, however,
socioe­
conomic reasons, apply a limit of up to 20 % by mass
of nitrogen in relation to ammonium nitrate for their
territories.

for

(16)

(REACH)

The provisions of this Decision are adopted with a view
to being incorporated into Annex XVII to Regulation
(EC) No 1907/2006 of the European Parliament and of
the Council of 18 December 2006 concerning the Regis­
tration, Evaluation, Authorisation and Restriction of
European
Chemicals
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
Commission
76/769/EEC
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (1) as set out in Article 137(3) of that Regu­
lation.

establishing

and

and

a

and of

health of workers at work (2) and individual Directives
in particular Directive 2004/37/EC of
based thereon,
the European Parliament
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) (3) 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
the
meaning of Article 16(1) of Directive 89/391/EEC) (4),

individual Directive within

(fourteenth

HAVE ADOPTED THIS DECISION:

Article 1

Annex I
accordance with the Annex to this Decision.

to Directive 76/769/EEC is hereby amended in

Article 2

This Decision shall enter into force on the third day following
its publication in the Official Journal of the European Union.

Article 3

This Decision is addressed to the Member States.

(17) Directive 76/769/EEC should be amended accordingly.

Done at Strasbourg, 16 December 2008.

(18)

This Decision is without prejudice to the Community
legislation laying down minimum requirements for the
such as Council Directive
protection of workers,
89/391/EEC of 12 June 1989 on the introduction of
measures to encourage improvements in the safety and

For the European Parliament
The President

H.-G. PÖTTERING

For the Council
The President

B. LE MAIRE

(1) OJ L 396, 30.12.2006, p. 1. Corrected by OJ L 136, 29.5.2007,

p. 23.

p. 3.

(4) OJ L 131, 5.5.1998, p. 11.

(2) OJ L 183, 29.6.1989, p. 1.
(3) OJ L 158, 30.4.2004, p. 50. Corrected by OJ L 229, 29.6.2004,

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In Annex I to Directive 76/769/EEC, the following points are added:

ANNEX

‘53. 2-(2-methoxyethoxy)
ethanol (DEGME)
CAS No: 111-77-3
Einecs No: 203-906-6

54. 2-(2-butoxyethoxy)
ethanol (DEGBE)
CAS No: 112-34-5
Einecs No: 203-961-6

55. Methylenediphenyl
diisocyanate (MDI)
CAS No: 26447-40-5
Einecs No: 247-714-0

Shall not be placed on the market after 27 June 2010, for supply to the general public,
as a constituent of paints, paint strippers, cleaning agents, self-shining emulsions or floor
sealants in concentrations equal to or greater than 0,1 % by mass.

(1) Shall not be placed on the market for the first time after 27 June 2010, for supply
to the general public, as a constituent of spray paints or spray cleaners in aerosol
dispensers in concentrations equal to or greater than 3 % by mass.

(2) Spray paints and spray cleaners in aerosol dispensers containing DEGBE and not
conforming to paragraph 1 shall not be placed on the market for supply to the
general public after 27 December 2010.

(3) Without prejudice to other Community legislation concerning the classification,
packaging and labelling of dangerous substances and preparations, paints, other
than spray paints, containing DEGBE in concentrations equal to or greater than
3 % by mass that are placed on the market for supply to the general public shall be
visibly, legibly and indelibly marked by 27 December 2010 as follows:

“Do not use in paint spraying equipment”.

(1) Shall not be placed on the market after 27 December 2010, as a constituent of
preparations in concentrations equal to or greater than 0,1 % by mass for supply to
the general public, unless the packaging:

(a) contains protective gloves which comply with the requirements of Council
Directive 89/686/EEC of 21 December 1989 on the approximation of the
laws of the Member States relating to personal protective equipment (*).

(b) is marked visibly,

legibly and indelibly as follows, and without prejudice to
other Community legislation concerning the classification, packaging and
labelling of dangerous substances and preparations:

“— Persons already sensitised to diisocyanates may develop allergic reactions

when using this product.

— Persons suffering from asthma, eczema or skin problems should avoid

contact, including dermal contact, with this product.

— This product should not be used under conditions of poor ventilation
type A1

unless a protective mask with an appropriate gas filter (i.e.
according to standard EN 14387) is used.”

(2) By way of derogation, paragraph 1(a) shall not apply to hot melt adhesives.

56. Cyclohexane

CAS No: 110-82-7
Einecs No: 203-806-2

(1) Shall not be placed on the market for the first time after 27 June 2010, for supply
to the general public, as a constituent of neoprene-based contact adhesives in
concentrations equal to or greater than 0,1 % by mass in package sizes greater
than 350 g.

(2) Neoprene-based contact adhesives containing cyclohexane and not conforming to
paragraph 1 shall not be placed on the market for supply to the general public after
27 December 2010.

(3) Without prejudice to other Community legislation concerning the classification,
packaging and labelling of dangerous substances and preparations, neoprene-
based contact adhesives containing cyclohexane in concentrations equal
to or
greater than 0,1 % by mass that are placed on the market for supply to the
general public after 27 December 2010 shall be visibly,
legibly and indelibly
marked as follows:

“— This product is not to be used under conditions of poor ventilation.

— This product is not to be used for carpet laying.”

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57. Ammonium nitrate (AN)
CAS No 6484-52-2
Einecs No 229-347-8

(1) Shall not be placed on the market for the first time after 27 June 2010 as a
substance, or in preparations that contain more than 28 % by mass of nitrogen
in relation to ammonium nitrate, for use as a solid fertiliser, straight or compound,
unless
for ammonium
nitrate fertilisers of high nitrogen content set out in Annex III to Regulation (EC)
No 2003/2003 of the European Parliament and of the Council of 13 October 2003
relating to fertilisers (**).

the fertiliser complies with the technical provisions

(2) Shall not be placed on the market after 27 June 2010 as a substance, or in
preparations that contain 16 % or more by mass of nitrogen in relation to
ammonium nitrate except for supply to:

(a) downstream users and distributors, including natural or legal persons licensed or
authorised in accordance with Council Directive 93/15/EEC of 5 April 1993 on
the harmonisation of the provisions relating to the placing on the market and
supervision of explosives for civil use (***);

(b) farmers for use in agricultural activities, either full time or part time and not

necessarily related to the size of the land area.

For the purposes of this subparagraph:

(i) “farmer” shall mean a natural or legal person, or a group of natural or legal
persons, whatever legal status is granted to the group and its members by
national
law, whose holding is situated within Community territory, as
referred to in Article 299 of the Treaty, and who exercises an agricultural
activity,

(ii) “agricultural activity” shall mean the production, rearing or growing of
agricultural products including harvesting, milking, breeding animals and
keeping animals for farming purposes, or maintaining the land in good
agricultural and environmental condition as established under Article 5 of
Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing
common rules for direct support schemes under the common agricultural
policy and establishing certain support schemes for farmers (****);

(c) natural or legal persons engaged in professional activities such as horticulture,
plant growing in greenhouses, maintenance of parks, gardens or sport pitches,
forestry or other similar activities.

(3) However, for the restrictions in paragraph 2, Member States may until 1 July 2014,
for socioeconomic reasons, apply a limit of up to 20 % by mass of nitrogen in
relation to ammonium nitrate for substances and preparations placed on the market
within their territories. They shall inform the Commission and other Member States
thereof.

(*) OJ L 399, 30.12.1989, p. 18.
(**) OJ L 304, 21.11.2003, p. 1.
(***) OJ L 121, 15.5.1993, p. 20.
(****) OJ L 270, 21.10.2003, p. 1.’