Commission Directive 2006/8/EC of  23 January 2006  amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations   (Text with EEA relevance)
Date: 2006-01-23
Institutions: European Commission
Subjects: approximation of laws, carcinogenic substance, classification, labelling, packaging, toxic substance

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COMMISSION DIRECTIVE 2006/8/EC

of 23 January 2006

amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to
concerning the
Directive 1999/45/EC of
the Member States
approximation of the laws, regulations and administrative provisions of

the European Parliament

the Council

and of

relating to the classification, packaging and labelling of dangerous preparations

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 1999/45/EC of
the European
Parliament and of the Council of 31 May 1999 concerning
the approximation of the laws, regulations and administrative
provisions of the Member States relating to the classification,
packaging and labelling of dangerous preparations (1), and in
particular the first paragraph of Article 20 thereof,

Whereas:

(1)

(2)

Preparations composed of more than one substance
being classified in Annex I
to Council Directive
67/548/EEC of 27 June 1967 on the approximation of
laws, regulations and administrative provisions relating to
the classification, packaging and labelling of dangerous
substances (2) as carcinogenic, mutagenic and/or toxic for
reproduction must currently be labelled with risk phrases
(R-phrases) to indicate both category 1 or 2 and category
3 classification. However, providing both R-phrases sends
a conflicting message. Preparations should therefore only
be classified and labelled with the higher category.

limits

(SCLs)

specific

For substances very toxic to the aquatic environment
(classified as N) and assigned the R-phrases R50 or
are
R50/53,
concentration
currently applied to substances listed in Annex I
to
Directive 67/548/EEC in order to avoid an underesti-
mation of the hazard. This measure creates distortions
listed in
between preparations containing substances
Annex I to Directive 67/548/EEC, to which SCLs are
applied, and those preparations containing substances
not yet included in Annex I, but classified and labelled
provisionally in accordance with Article 6 of Directive
67/548/EEC and to which no SCLs are applicable. It is
therefore necessary to ensure that SCLs are applied in the
same way to all preparations containing substances very
toxic to the aquatic environment.

(3)

On 6 August 2001, the Commission adopted Directive
2001/59/EC (3) adapting to technical progress Directive
67/548/EEC. Directive 2001/59/EC revised the criteria in

(1) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Council

Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35).

(2) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission

Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

(3) OJ L 225, 21.8.2001, p. 1.

Annex VI to Directive 67/548/EEC for the classification
and labelling of ozone depleting substances. The revised
Annex III now only provides for the assignment of the
symbol N in addition to R-phrase R59.

requirements

The terminology used to describe the packaging and the
labelling
in Annex V to Directive
1999/45/EC has raised concerns due to the lack of
consistency.
is therefore appropriate to modify the
wording in Annex V to Directive 1999/45/EC to make
it more accurate.

It

Annexes II, III and V to Directive 1999/45/EC should
therefore be amended accordingly.

The measures provided for
in this Directive are in
accordance with the opinion of the Committee for the
adaptation to technical progress of the Directives on the
technical barriers to trade in dangerous
removal of
substances and preparations established under Article
20 of Directive 1999/45/EC,

(4)

(5)

(6)

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II, III and V to Directive 1999/45/EC are amended in
accordance with the Annex to this Directive.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 March 2007 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

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This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 23 January 2006.

For the Commission

Günter VERHEUGEN
Vice-President

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Official Journal of the European Union

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Directive 1999/45/EC is amended as follows:

1. Annex II is amended as follows:

(a)

table VI is replaced by the following table:

ANNEX

‘Table VI

Classification of the substance

Classification of the preparation

Categories 1 and 2

Category 3

Carcinogenic substances of
category 1 or 2 with R45 or
R49

Concentration ≥ 0,1 %
carcinogenic
R45, R49 obligatory as appropriate

Carcinogenic substances of
category 3 with R40

Mutagenic substances of
category 1 or 2 with R46

Mutagenic substances of
category 3 with R68

Concentration ≥ 0,1 %
mutagenic
R46 obligatory

Substances “toxic for repro-
duction” of category 1 or 2
with R60 (fertility)

Concentration ≥ 0,5 %
toxic for reproduction (fertility)
R60 obligatory

Substances “toxic for repro-
duction” of category 3 with
R62 (fertility)

Substances “toxic for repro-
duction” of category 1 or 2
with R61 (development)

Concentration ≥ 0,5 %
toxic for reproduction (development)
R61 obligatory

Substances “toxic for repro-
duction” of category 3 with
R63 (development)

Concentration ≥ 1 %
carcinogenic
R40 obligatory (unless already
assigned R45 (*))

Concentration ≥ 1 %
mutagenic
R68 obligatory (unless already
assigned R46)

Concentration ≥ 5 %
toxic for reproduction (fertility)
R62 obligatory (unless already
assigned R60)

Concentration ≥ 5 %
toxic for reproduction (development)
R63 obligatory (unless already
assigned R61)

(*) In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish

between the exposure routes, whereas R49 is only assigned for the inhalation route.’

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(b) table VI A is replaced by the following table:

‘Table VI A

Classification of the substance

Classification of the preparation

Categories 1 and 2

Category 3

Carcinogenic substances of
category 1 or 2 with R45 or
R49

Concentration ≥ 0,1 %
carcinogenic
R45, R49 obligatory as appropriate

Carcinogenic substances of
category 3 with R40

Mutagenic substances of
category 1 or 2 with R46

Mutagenic substances of
category 3 with R68

Substances “toxic for repro-
duction” of category 1 or 2
with R60 (fertility)

Substances “toxic for repro-
duction” of category 3 with
R62 (fertility)

Concentration ≥ 0,1 %
mutagenic
R46 obligatory

Concentration ≥ 0,2 %
toxic for reproduction (fertility)
R60 obligatory

Concentration ≥ 1 %
carcinogenic
R40 obligatory (unless already
assigned R45 (*))

Concentration ≥ 1 %
mutagenic
R68 obligatory (unless already
assigned R46)

Concentration ≥ 1 %
toxic for reproduction (fertility)
R62 obligatory (unless already
assigned R60)

Substances “toxic for repro-
duction” of category 1 or 2
with R61 (development)

Concentration ≥ 0,2 %
toxic for reproduction (development)
R61 obligatory

Substances “toxic for repro-
duction” of category 3 with
R63 (development)

Concentration ≥ 1 %
toxic for reproduction (development)
R63 obligatory (unless already
assigned R61)

(*) In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish

between the exposure routes, whereas R49 is only assigned for the inhalation route.’

2. Annex III is amended as follows:

(a)

in Part A, point 2 of section (b)(1) (I), is deleted;

(b) in Part B, table 1 is replaced by the following tables:

‘Table 1a

Acute aquatic toxicity and long-term adverse effects

Classification of the substance

Classification of the preparation

N, R50-53

N, R51-53

R52-53

N, R50-53

N, R51-53

R52-53

see Table 1b

see Table 1b

Cn

≥ 25 %

see Table 1b

2,5 % ≤ Cn < 25 %

Cn

≥ 25 %

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Preparations containing a substance classified with N, R50-53, the concentration limits and the resulting classi-
fication given in table 1b are applicable.

Acute aquatic toxicity and long-term adverse effects of substances very toxic to the aquatic environment

Table 1b

LC50 or EC50 value (“L(E)C50
”)
of substance classified as N,
R50-53 (mg/l)

0,1 < L(E)C50

≤ 1

0,01 < L(E)C50

≤ 0,1

Classification of the preparation

N, R50-53

Cn

≥ 25 %

Cn

≥ 2,5 %

N, R51-53

R52-53

2,5 % ≤ Cn < 25 %

0,25 % ≤ Cn < 2,5 %

0,25 % ≤ Cn < 2,5 %

0,025 % ≤ Cn < 0,25 %

0,001 < L(E)C50

≤ 0,01

Cn

≥ 0,25 %

0,025 % ≤ Cn < 0,25 %

0,0025 % ≤ Cn < 0,025 %

0,0001 < L(E)C50

≤ 0,001

Cn

≥ 0,025 %

0,0025 % ≤ Cn < 0,025 %

0,00025 % ≤ Cn <
0,0025 %

0,00001 < L(E)C50
0,0001

≤

Cn

≥ 0,0025 %

0,00025 % ≤ Cn <
0,0025 %

0,000025 % ≤ Cn <
0,00025 %

For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentration
limits are calculated accordingly (in factor 10 intervals).’

(c)

in part B, table 2 is replaced by the following table:

‘Table 2

Acute aquatic toxicity

LC50 or EC50 value (“L(E)C50

”) of substance classified either as

N, R50 or as N, R50-53 (mg/l)

0,1 < L(E)C50

≤ 1

0,01 < L(E)C50

≤ 0,1

0,001 < L(E)C50

≤ 0,01

0,0001 < L(E)C50

≤ 0,001

0,00001 < L(E)C50

≤ 0,0001

Classification of the preparation N, R50

Cn

≥ 25 %

Cn

≥ 2,5 %

Cn

≥ 0,25 %

Cn

≥ 0,025 %

Cn

≥ 0,0025 %

For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentration
limits are calculated accordingly (in factor 10 intervals).’

(d) in part B, table 5 of point II, is replaced by the following table:

‘Table 5

Dangerous for the ozone layer

Classification of the substance

Classification of the preparation N, R59

N with R59

Cn

≥ 0,1 %’

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3. Annex V is replaced by the following:

‘ANNEX V

SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS

A. For preparations classified as dangerous within the meaning of Articles 5, 6 and 7

1.

Preparations sold to the general public

1.1. The label on the packaging containing such preparations, in addition to the specific safety advice, must bear
the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria laid down in Annex VI to
Directive 67/548/EEC.

1.2. When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is physically
impossible to give such information on the package itself, packages containing such preparations must be
accompanied by precise and easily understandable instructions for use including, where appropriate,
instructions for the destruction of the empty package.

2.

Preparations intended for use by spraying

The label on the packaging containing such preparations must compulsorily bear the safety advice S23
accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in
Annex VI to Directive 67/548/EEC.

3.

Preparations containing a substance assigned phrase R33: Danger of cumulative effects

When a preparation contains at least one substance assigned the phrase R33, the label on the packaging of the
preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the
concentration of this substance present in the preparation is equal to or higher than 1 %, unless different
values are set in Annex I to Directive 67/548/EEC.

4.

Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies

When a preparation contains at least one substance assigned phrase R64, the label on the packaging of the
preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the
concentration of this substance present in the preparation is equal to or higher than 1 %, unless different
values are set in Annex I to Directive 67/548/EEC.

B. For preparations irrespective of their classification within the meaning of Articles 5, 6 and 7

1.

Preparations containing lead

1.1. P a i n t a n d v a r n i s h e s

The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed
as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard
6503/1984, must show the following particulars:

“Contains lead. Should not be used on surfaces liable to be chewed or sucked by children”.

In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows:

“Warning! Contains lead”.

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2.

Preparations containing cyanoacrylates

2.1. A d h e s i v e s

The label on the immediate packaging of adhesives based on cyanoacrylate must bear the following
inscriptions:

“Cyanoacrylate

Danger

Bonds skin and eyes in seconds

Keep out of the reach of children”.

Appropriate advice on safety must accompany the package.

3.

Preparations containing isocyanates

The label on the packaging of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc.,
or as mixtures thereof) must bear the following inscriptions:

“Contains isocyanates.

See information supplied by the manufacturer”.

4.

Preparations containing epoxy constituents with an average molecular weight ≤ 700

The label on the packaging of preparations containing epoxy constituents with an average molecular weight
≤ 700 must bear the following inscriptions:

“Contains epoxy constituents.

See information supplied by the manufacturer”.

5.

Preparations sold to the general public which contain active chlorine

The label on the packaging of preparations containing more than 1 % of active chlorine must bear the
following particular inscriptions:

“Warning! Do not use together with other products. May release dangerous gases (chlorine)”.

6.

Preparations containing cadmium (alloys) and intended to be used for brazing or soldering

The label on the packaging of the above mentioned preparations must bear the following inscription printed
in clearly legible and indelible characters:

“Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions”.

7.

Preparations available as aerosols

Without prejudice to the provisions of this Directive, preparations available as aerosols are also subject to the
labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/EEC as last
amended by Directive 94/1/EC.

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8.

Preparations containing substances not yet tested completely

Where a preparation contains at least one substance which,
in accordance with Article 13.3 of Directive
67/548/EEC, bears the inscription “Caution — substance not yet tested completely”, the label on the packaging
of the preparation must bear the inscription “Warning — this preparation contains a substance not yet tested
completely” if this substance is present in a concentration ≥ 1 %.

9.

Preparations not classified as sensitising but containing at least one sensitising substance

The label on the packaging of preparations containing at least one substance classified as sensitising and being
present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that
specified under a specific note for the substance in Annex I to Directive 67/548/EEC must bear the inscription:

“Contains (name of sensitising substance). May produce an allergic reaction”.

10. Liquid preparations containing halogenated hydrocarbons

For liquid preparations which show no flashpoint or a flashpoint higher than 55 °C and contain a halogenated
hydrocarbon and more than 5 % flammable or highly flammable substances, the label on the packaging must
bear the following inscription as appropriate:

“Can become highly flammable in use” or “Can become flammable in use”.

11. Preparations containing a substance assigned phrase R67: vapours may cause drowsiness and dizziness

When a preparation contains one or more substances assigned the phrase R67, the label on the packaging of
the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when
the total concentration of these substances present in the preparation is equal to or higher than 15 %, unless:

— the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26,

— or the preparation is in a package not exceeding 125 ml.

12. Cements and cement preparations

The label on the packaging of cements and cement preparations containing more than 0,0002 % soluble
chromium (VI) of the total dry weight of the cement must bear the inscription:

“Contains chromium (VI). May produce an allergic reaction”

unless the preparation is already classified and labelled as a sensitiser with phrase R43.

C. For preparations not classified within the meaning of Articles 5, 6 and 7 but containing at least one

dangerous substance

1.

Preparations not intended for the general public

The label on the packaging of preparations referred to in Article 14.2.1(b) must bear the following inscription:

“Safety data sheet available for professional user on request”.’