1999/836/EC: Commission Decision of 26 October 1999 on the national provisions concerning mineral wool notified by Germany derogating from Directive 97/69/EC adapting to technical progress for the 23rd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (notified under document number C(1999) 3490) (Text with EEA relevance) (Only the German text is authentic)
Date: 1999-10-26
Institutions: European Commission
Subjects: Germany, dangerous substance, labelling, national law, packaging, wool

L 329/100

EN

Official Journal of the European Communities

22.12.1999

COMMISSION DECISION

of 26 October 1999

on the national provisions concerning mineral wool notified by Germany derogating from
Directive 97/69/EC adapting to technical progress for the 23rd time Council Directive 67/548/EEC
on the approximation of the laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances

(notified under document number C(1999) 3490)

(Only the German text is authentic)

(Text with EEA relevance)

(1999/836/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community, and in particular Article 95(6) thereof,

classification, packaging and labelling of dangerous
substances (3) was adopted on 5 December 1997. The
latest date for Member States to comply with this was
16 December 1998.
the 23rd adaptation
Inter alia,
introduced:

Whereas:

I. THE FACTS

1. Community legislation

and the Council (2),
substances

(1) Annex I to Council Directive 67/548/EEC of 27 June
1967 on the approximation of the laws, regulations and
administrative provisions relating to the classification,
packaging and labelling of dangerous substances (1), as
last amended by Directive 1999/33/EC of the European
list of
a
Parliament
dangerous
harmonised
classification and labelling that apply to such substances.
All manufacturers, importers or distributors are required
to use the harmonised classification and labelling when
placing a dangerous
substance on the Community
market. The list is regularly updated to take account of
the
and technical
knowledge. This is done by revising specific entries in the
list and by adding new entries to the list.

contains
the

in scientific

continuous

displaying

increase

list

The foreword to Annex I describes particular aspects of
the
the
interpretation of notes that may be added to specific
entries. The foreword is also updated when necessary.

substances

dangerous

such

of

as

(cid:151) a general entry on mineral wool
dangerous substances in Annex I,

into the list of

(cid:151) a specific Note Q relating to mineral wool into the

foreword to Annex I.

The draft for the 23rd adaptation was discussed for more
than seven years among the Commission, Member State
experts such as the Commission Working Group on
Classification and Labelling (cid:151) Health Effects, and experts
from the industry involved. The results of these in-depth
discussions were taken into account when drafting the
draft. Member States delivered a favourable opinion when
voting on the draft, with the exception of Germany who
voted against.

(3) The general entry on mineral wool defines mineral wool
as consisting of man-made vitreous (silicate) fibres with
random orientation with an alkaline oxide and an
alkaline earth oxide content greater than 18 % by weight.
All mineral wools are classified as:

(cid:151) carcinogenic, category 3,
irritant; symbol Xi, R 38,

risk phrase R 40; and

Updates of Annex I are adopted by adaptations
to
technical progress in accordance with Article 28 of
Directive 67/548/EEC.

(cid:151) or labelled with the symbol Xn, R 38-40, safety

phrases S (2-)36/37.

(2) Commission Directive 97/69/EC of 5 December 1997
adapting to technical progress for the 23rd time Directive
laws,
67/548/EEC on
regulations and administrative provisions relating to the

approximation

the

the

of

An exception to this general entry would be a specific
wool which was given an individual entry in Annex I.
The general entry exempts any such possible individual
entries by using the descriptor (cid:145)with the exception of
those specified elsewhere in this Annex(cid:146).

(1) OJ 196, 16.8.1967, p. 1.
(2) OJ L 199, 30.7.1999, p. 57.

(3) OJ L 343, 13.12.1997, p. 19.

22.12.1999

EN

Official Journal of the European Communities

L 329/101

Directive 97/69/EC further provides for the addition of a
Note Q to the foreword to Annex I. According to Note
Q,
the classification of a specific mineral wool as
carcinogenic, category 3, need not apply if the result of
an animal test with the wool is (cid:145)negative(cid:146). Note Q offers
the option of four such tests. If a mineral wool were to
meet this requirement it would not have to be labelled as
carcinogenic. However, the classification and labelling as
(cid:145)irritant(cid:146) would remain.

ANNEX

CAS No

EC No

No 650-016-00-2

Note A
Note Q1
Note R

Mineral wool, unless specified elsewhere in this Annex:

2. National provisions

(4) The national provisions at issue consist of a proposal by
Germany that the Note Q referred to in Article 1(1)(c) of
Directive 97/69/EC, and the classification of mineral
wools set out in the Annex to that Directive, should be
incorporated into its national
laws, amending these as
follows (see item I in that request):

(cid:145)Note Q1:

The classification as category 2, carcinogenic, need not
apply if it can be established that the substance meets
one of the following conditions:

(cid:151) an appropriate test involving intraperitoneal injection
of a dose of 1 (cid:215) 109 WHO fibres,
in the size
distribution of a typical workplace has shown no
evidence of excess carcinogenicity,

(cid:151) the chemical composition of the substances is such
that the algebraic sum of the percentages of weight
of the oxides Na2O + K2O + CaO + MgO + BaO +
B2O3 ﬂ 2Al2O3 is greater than 30.

Note Q2:

The classification as a category 3 carcinogen need not
apply if it can be shown that the substance fulfils one of
the following conditions:

(cid:151) an appropriate intraperitoneal test at a dose of 5 (cid:215)
109 WHO fibres, in the size distribution of a typical
excess
workplace, has
carcinogenicity,

shown no evidence of

(cid:151) the half life after intra-tracheal instillation of 2 mg of
a fine suspension for fibres with a length of 5 (cid:181)m, a
diameter of less than 3 (cid:181)m and a length-to-diameter
ratio of more than 3:1 (WHO fibres)
is not more
than 40 days, or

(cid:151) the chemical composition of the substance is such
that the algebraic sum of the percentages of weight
of the oxides Na2O + K2O + CaO + MgO + BaO +
B2O3 ﬂ 2Al2O3 is greater than 40.

vitreous

[Man-made
random
(silicate)
orientation and an alkaline oxide and an alkaline earth
(Na2O + K2O + CaO + MgO + BaO)
oxide content
greater than 18 % by weight]

fibres with

Classification

Carc. Cat 2; R 49

Labelling

T

R: 49
S: 53/45

CAS No

EC No

No 650-016-00-2

Note A
Note Q2
Note R

Mineral wool, unless otherwise specified in this Annex:

vitreous

[Man-made
random
(silicate)
orientation and an alkaline oxide and an alkaline earth
(Na2O + K2O + CaO + MgO + BaO)
oxide content
greater than 18 % by weight]

fibres with

Classification

Carc. Cat 3; R 40

Labelling

Xn

R: 40
S: (2-)22(cid:146)

3. Comparing the national provisions with

Community legislation

(5) The communication from Germany is

in line with
Directive 97/69/EC in that mineral wool consists of
man-made
random
(silicate)
orientation and an alkaline oxide and alkaline earth oxide
content greater than 18 % by weight.

fibres with

vitreous

L 329/102

EN

Official Journal of the European Communities

22.12.1999

the communication considers

However,
that mineral
wools need to be divided into two categories. The first of
these should be:

the protection of the working environment(cid:146) (see Item II
of the request and the amplifications therein).

(cid:151) classified as carcinogenic, category 2, R 49, and be

(cid:151) labelled with symbol T, R 49, S 53-45.

Inter alia Note Q1 should exempt these mineral wools
from the classification as carcinogenic, category 2 on
condition that either:

(cid:151) the result of an animal test has been (cid:145)negative(cid:146), or

(cid:151) the carcinogenicity index (cid:145)KI(cid:146) which is a number
calculated from the chemical composition of
the
wool, exceeds 30.

the Office of

On 17 December 1998,
the Permanent
Representative of the Federal Republic of Germany to the
European Communities
the
sent
Secretariat-General of the European Commission in an
official letter that was received on 21 December 1998.

request

that

to

(7) The German request was passed on to the other Member
States for comment. No comment was received from the
Member States with regard to the content of
the
notification transmitted to them.

III. ASSESSMENT

lt can be assumed that such wools should then be
classified as carcinogenic, category 3.

1. Rules applying

The second category of mineral wools should be

(cid:151) classified as carcinogenic, category 3, R 40, and be

(cid:151) labelled with symbol Xn, R 40, S (2-)22.

Inter alia Note Q2 should exempt these mineral wools
from the classification as carcinogenic, category 3 on
condition that either:

(cid:151) the result of an animal test has been (cid:145)negative(cid:146) and
the communication offers the option of two such
tests, or

(cid:151) the KI exceeds 40.

Such wools should then not be classified and labelled at
all, not even as irritant, R 38.

II. PROCEDURE

(9)

(6) On 11 December 1998,

the Office of the Permanent
Representative of the Federal Republic of Germany to the
European Communities informed the Secretariat-General
of the European Commission, by fax, of a request based
on former Article 100a(4) of the Treaty establishing the
European Community that
the Commission should
confirm the proposal made by the Federal Government
to incorporate the Note Q referred to in Article 1(1)(c) of
Directive 97/69/EC and the classification of mineral wool
in the Annex to that Directive into its national laws in an
amended form (see above). Germany feels
the
intended national provisions are justified by (cid:145)the major
requirements
referred to in Article 36, namely the
protection of health and of human and animal lives, and

that

former Article 100a of

(8) The Treaty of Amsterdam has substantially amended the
provisions of
the Treaty
establishing the European Community by replacing
paragraphs 3, 4 and 5 of that Article with eight new
paragraphs
the
renumbering of all of the Articles the amended Article
has now become Article 95 of the Treaty establishing the
European Community.

10. Owing

numbered

to

to

3

The Treaty of Amsterdam does not contain any specific
transitional provisions on the rules applying to the earlier
notifications concerning the time of entry into force of
this Treaty, such as the German notification, which is the
subject of this Decision.

In the absence of specific provisions extending their
scope, the former provisions of Article 100a(4) of the EC
Treaty are to be regarded as repealed from the date of
entry into force of the new provisions (1 May 1999).
Instead the new provisions of the Treaty apply to the
examination of
this notification with immediate effect
from that date.

intending to introduce

It emerges from Germany’s notification that this is aimed
at approval by the Commission of provisions which
Germany is
after Directive
97/69/EC has been adopted. However, those provisions
are not compatible with that Directive. The Commission
should therefore examine that notification in the light of
Article 95(5) EC that apply if
this were the case.
Moreover,
the Commission must, where appropriate,
carry out the checks provided for by Article 95(6) EC.
The provisions of Article 95(4) EC cannot be applied in
this instance since they solely relate to a situation where
a Member State wishes to receive approval to maintain
national
the
already
harmonisation measure concerned has been adopted, this
not being the case in this instance.

provisions

adopted

before

22.12.1999

EN

Official Journal of the European Communities

L 329/103

(10)

It must be stressed that, on the date Germany sent its
notification, the Treaty rules applying did not make any
provision that this notification had to be based on new
scientific proof
the
environment or workplace because a specific problem in
that Member State had arisen after the harmonisation
measure had been adopted. This notification must be
examined in the light of that specific situation.

relating to the protection of

2. Conditions attached to acceptability

(11) The notification of Germany is intended to obtain an
authorisation to introduce national provisions that are
incompatible with Commission Directive 97/69/EC. That
Directive constitutes one of the harmonisation measures
referred to in Article 95(5) EC,
the scope of which
deliberately includes harmonisation measures that have
been adopted by the Commission.

As required by Article 95(5) EC, Germany notified the
Commission of the actual wording of the provisions that
they were intending to introduce, accompanying their
request by an explanation of the reasons which, they felt,
justified the introduction of those provisions.

the above,

the Commission feels that

In view of
the
notification prepared by Germany in order to obtain
approval for the introduction of national provisions that
were incompatible with Directive 97/69/EC, on the basis
of the provisions of
former Article l00a(4) of the EC
Treaty, can be acceptable pursuant to Article 95(5) EC.

3. Assessment of merits

(12)

from Article 95 of

the
It emerges
Commission must satisfy itself that all of the conditions
enabling a Member State to avail itself of the scope for
divergence offered by that Article are met.

the Treaty that

therefore assess whether

The Commission must
the
conditions provided for by Article 95(5) EC are met. This
requires (a)
(cid:145)new scientific proof with regard to the
protection of the environment and workplace(cid:146), (b) which
the
causes
introduction of national provisions to be necessary (cid:145)as a
result of a problem that is specific to that Member State(cid:146),
(c) where
the
the problem concerned arose
harmonisation measure had been adopted(cid:146).

the applicant Member State to consider

(cid:145)after

the introduction of

such national provisions

In addition, pursuant to Article 95(6) EC, where it feels
is
that
those
justified the Commission must check whether
national provisions are, or are not a means of arbitrary
discrimination or a hidden restriction of trade between
the Member States and whether they do, or do not,
constitute (cid:145)an impediment
the
internal market(cid:146).

to the functioning of

3.1 New scientific evidence concerning the protection of
the environment or workplace following a specific
problem in the Member State concerned arising
after the harmonisation measure has been adopted

(13) Germany is basing its request on the (cid:145)major requirements
referred to in Article 36, namely the protection of health
and of human and animal life, and the protection of the
workplace(cid:146).

The national provisions that Germany intends to apply to
the classification and labelling of mineral wool are in
conformity with Directive 97/69/EC with regard to the
such a wool must have.
chemical composition that
Furthermore,
those provisions are in conformity with
Notes A and R, which are attached to the classification of
mineral wool both in the German provisions and in
Directive 97/69/EC.

However, the German draft provisions provide for two
classes of mineral wool which, with reference
to
carcinogenicity, are classified as category 2 (stronger
carcinogen) and category 3 (weaker carcinogen), whereas
Directive 97/69/EC only classifies mineral wool
in
category 3. It is therefore not possible to evaluate the
criteria for exemption from category 2 in the notification
from Germany as compared with the exemption criteria
in Directive 97/69/EC.

For mineral wool classified as (cid:145)category 3, carcinogenic(cid:146)
the German notification places the exemption criteria in
a Note Q2, whereas Directive 97/69/EC places such
criteria in Note Q.

The first exemption criterion in Note Q2 gives more
details concerning an intra-peritoneal test than Note Q in
an
Directive
test(cid:146). The criteria in both
(cid:145)appropriate intra-peritoneal
notes could be considered as equivalent, at
in
certain cases.

97/69/EC, which

requires

simply

least

the intra-tracheal

The second criterion in Note Q2 describes a test with
intra-tracheal instillation in detail. Again, the description
of
in Note Q in
Directive 97/69/EC is less detailed. A notable difference
is, however, that Note Q2 also includes relatively short
mineral wool
fibres, whereas Note Q in Directive
97/69/EC concentrates on longer fibres.

instillation test

L 329/104

EN

Official Journal of the European Communities

22.12.1999

(CI)

The third criterion in Note Q2 refers to the chemical
composition of a wool required for exemption from the
classification as carcinogenic. This is an application of
index which, according to the opinion (4)
the KI
adopted by the Scientific Committee for Toxicology,
Ecotoxicology and the Environment (CSTEE) by written
(cid:145)not been
procedure on 10 September 1999, has
extensively
chemical
the
to
composition of a fibre is informative with regard to its
carcinogenicity(cid:146). There is no equivalent to the KI
(CI)
index in Note Q in Directive 97/69/EC.

confirm that

tested

considered to contain any evidence
that has not
previously been considered by the Commission and other
Member
the
in the meetings
development and adoption of Directive 97/69/EC(cid:146).

leading

States

to

Thus, with regard to the scientific arguments presented
by Germany,
the situation is the same as before the
adoption of Directive 97/69/EC. These arguments had
not convinced the experts from the other Member States
during the preparatory scientific discussions.

Finally, Note Q in Directive 97/69/EC also lists a
short-term biopersistence test by inhalation and a long
term inhalation test as criteria for exempting mineral
wool from classification as carcinogenic. Neither of these
two tests is referred to in Note Q2 in the notification
from the German authorities.

It can therefore be concluded that the scientific/technical
arguments put
forward in the German notification
cannot be considered a better basis for the classification
of mineral wool
in Directive
97/69/EC.

than the provisions

that

follows
the criteria for
This being the case it
from the classification as a
exempting mineral wool
carcinogen proposed in the German notification differ to
a considerable extent
from the criteria laid down in
Directive 97/69/EC. One of the proposed criteria, namely
the use of the chemical composition has, in the opinion
of the CSTEE, not been extensively tested and therefore
does not appear to be acceptable.

(14)

In order to address the scientific/technical reasons put
forward in the notification from Germany for applying
national provisions which diverge from the requirements
of Directive 97/69/EC, the Commission called on experts
in the field of classification and labelling to draw up a
technical report. In short the arguments from Germany
can be summarised as:

(cid:151) the classification of mineral wool as laid down in
Directive 97/69/EC conflicts with the provisions of
Directive 67/548/EEC and is not
toxicologically
sound,

(cid:151) the exemption criteria in Note Q in Directive

97/69/EC contradict scientific knowledge,

(cid:151) the planned national provisions

tie in with the
principles laid down at Community level for avoiding
unnecessary animal experiments.

(15)

to whether

The technical report was forwarded to the CSTEE for
assessment as
it correctly addressed the
reasons put forward in the notification from Germany. In
its opinion of 10 September 1999 the CSTEE considered
in a general comment
(cid:145)A scientific evaluation of
either document (the German communication and the
technical
lack of
references to the scientific literature. The text of both
report)
documents
mixes allusions
and to their
potential normative consequences, without drawing a
clear distinction between the two(cid:146).

is made difficult by the

(particularly that of

the technical

to scientific

findings

report)

that

Furthermore,
in evaluating the scientific basis for the
classification of mineral wool the CSTEE opinion refers,
among other
to scientific findings that were
dismissed in both the notification from Germany and
also the technical report.

things,

Thus, the scientific arguments in the German notification
are considered incomplete and cannot serve as a sound
basis for the classification of mineral wool. Similarly the
It can
technical
therefore be concluded that the scientific developments
in the field of man-made mineral
fibres need further
evaluation.

is of unsatisfactory quality.

report

In addition, in the light of the requirements laid down in
Article 95(5) the Commission asked the CSTEE whether
the
its
communication:

by Germany

forward

reasons

put

in

The technical report refuted each individual argument
presented. This included reference to the year long,
in
depth scientific/technical discussions that had taken place
(cid:145)The
during the preparation of Directive 97/69/EC:
is not
Communication from the Federal Government

(a) represented or contained new scientific evidence
which had arisen after 5 December 1997 (the date of
adoption of Directive 97/69/EC);

(4) http://europa.eu.int/comm/dg24/health/sc/sct/out48_en.html

workplace;

(b) related to the protection of the environment or the

22.12.1999

EN

Official Journal of the European Communities

L 329/105

(c) constituted a justification based on a problem which
was specific to the Federal Republic of Germany.

constitute an impairment of
internal market(cid:146).

the functioning of

the

The CSTEE included its response in its abovementioned
opinion of 10 September 1999.

(a) with regard to the first requirement of Article 95(5)
mentioned above, the opinion of the CSTEE was that
the reasons put forward in the notification from the
German authorities did not specifically allude to any
scientific evidence which had arisen after 5 December
1997.

(17) Since the request made by Germany is not justified in the
light of the basic conditions set out in Article 95(5) (see
the Commission is not obliged to check
point 3.1),
whether the national provisions referred to are, or are
not, a means of arbitrary discrimination or a hidden
barrier to trade between Member States and if they either
do or do not constitute an impairment of the functioning
of the internal market.

the
The Commission
requirement concerning new scientific evidence in
Article 95(5) is not fulfilled.

considers

therefore

that

(b) With regard to the second requirement of Article
95(5) mentioned above, the opinion of the CSTEE
stated that
evidence provided by
Germany did indeed relate to the protection of the
workplace.

scientific

the

Consequently,
95(5) can be considered as fulfilled.

the second requirement of Article

(c) With regard to the third requirement of Article 95(5)
mentioned above, the opinion of the CSTEE was that
the problem of protecting the workplace which
Germany intend to tackle with its notification is not
specific to Germany.

The Commission therefore considers that the third
requirement of Article 95(5) is likewise not fulfilled.

In view of the opinion of the CSTEE, the Commission
feels that the basic conditions set out in Article 95(5) are
not met in this particular instance.

3.2. Arbitrary means of discrimination/hidden

restriction of trade between the Member
States/impairment of the functioning of the
internal market

(16) Under Article 95(6), the Commission will either approve
or reject any given national provisions (cid:145)after having
checked whether
these are or are not a means of
arbitrary discrimination or a hidden barrier to trade
between Member States and if they either do or do not

IV. CONCLUSION

(18)

In view of the above factors, the Commission feels that
the request made by Germany:

(cid:151) is acceptable,

(cid:151) but is not justified.

The Commission therefore concludes by rejecting that
request in accordance with Article 95(6) of the Treaty,

HAS ADOPTED THIS DECISION:

Article 1

The national provisions concerning mineral wool, of which the
Commission was notified by Germany by fax on 11 December
and by a letter dated 17 December 1998, and which diverge
from Directive 97/69/EC are hereby rejected.

Article 2

This Decision is addressed to the Federal Republic of Germany.

Done at Brussels, 26 October 1999.

For the Commission

Margot WALLSTR(cid:214)M

Member of the Commission